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

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

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1642608 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-08-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary oedema, Toxicity to various agents
SMQs:, Cardiac failure (narrow), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: ADHD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101083074

Write-up: Acute drug intoxication (suspected); pulmonary congestive oedema; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21124411. A 37-year-old male received BNT162b2 (COVID-19 Vaccine - Manufacturer Unknown) via an unspecified route of administration on 08Aug2021, at 37-year-old, as single dose (Batch/Lot number was unknown) for COVID-19 immunization. Body temperature before vaccination was not provided. The family history was not provided. The patient had medical history of attention deficit hyperactivity disorder(ADHD) and ongoing. Since the vaccination was not workplace vaccination, the vaccination was highly likely to be a Pfizer product. It was unknown what was described in the vaccination coupons. Concomitant drugs included multiple psychotropic drugs and sleeping pills for ADHD and others. On 08Aug2021 (the day of vaccination), the patient received a dose of COVID-19 Vaccine. On 11Aug2021 (3 days after the vaccination), the patient experienced acute drug intoxication (suspected) and pulmonary congestive oedema. On 11Aug2021 (3 days after the vaccination), the outcome of the acute drug intoxication (suspected) was fatal. The outcome of pulmonary congestive oedema was unknown. The course of the events was as follow: On 11Aug2021, at 12:41 (3 days, 12 hours, and 41 minutes after vaccination), the place of work reported to the police that the patient did not come to work, and the police officers went to the site for safety confirmation. The patient was found dead in his bedroom. On 12Aug2021, at 15:30 (4 days, 15 hours, and 30 minutes after vaccination), an autopsy based on the death investigation and identification act was performed at reporting physician''s institution. According to pulmonary congestive oedema and the presence of white granulated substance in the digestive tract, the patient had acute drug intoxication suspected, and the investigation was being performed. According to the environmental research by the police, when the patient went to work on 10Aug2021 (2 days after vaccination), no particular unusual appearance was observed in his physical condition. The reporting physician classified the event (acute drug intoxication) as serious (death) and assessed that the events were unrelated to COVID-19 Vaccine. There was no other possible cause of the event such as any other diseases. Reporter Comment: According to the environmental research by the police, something like a suicide note was not confirmed. However, on 09Aug2021 (one day after vaccination), there was an event which could significantly change the patient''s personal relationship. It was considered that there was a possibility that the patient would attempt suicide due to the event. The lot number for COVID-19 Vaccine, was not provided and will be requested during follow up.; Reporter''s Comments: According to the environmental research by the police, something like a suicide note was not confirmed. However, on 09Aug2021 (one day after vaccination), there was an event which could significantly change the patient''s personal relationship. It was considered that there was a possibility that the patient would attempt suicide due to the event.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (drug intoxication and pulmonary edema) 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: Acute drug intoxication (suspected); Autopsy-determined Cause(s) of Death: presence of white granulated substance in the digestive tract; pulmonary congestive oedema


VAERS ID: 1642611 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-05-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction
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: 2021-05-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101084959

Write-up: Cerebral infarction; This is a spontaneous case from a contactable physician received via Pfizer. An 85-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 30May2021 (Batch/Lot number was not reported) as dose 1, 0.3 ml, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was an 85-year-old female. The family history was not provided. The medical history was unknown. On 30May2021 (the day of vaccination), the patient received the first dose dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an intramuscular route of administration at a dose of 0.3 mL, single for COVID-19 immunization. On 31May2021 (one day after the vaccination), the patient experienced cerebral infarction. On 31May2021 (one day after the vaccination), the outcome of the event was fatal. Cause of death was cerebral infarction. The course of the event was as follows: On 30May2021 (the day of vaccination), the care house resident received the first dose of BNT162b2 vaccination for prevention of infection. On 31May2021 (one day after vaccination), the patient experienced cerebral infarction, and she was admitted to the neurosurgery hospital. However, the patient died. As of this date, the causality between the event and BNT162b2 was unknown. The reporting physician classified the event as serious(fatal) and assessed it as probably related to BNT162b2. It was unknown if autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event cerebral infarction . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1642612 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain herniation, Carotid artery occlusion, Cerebral infarction, Fibrin degradation products, Malaise, Platelet count
SMQs:, Haemorrhage laboratory terms (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension (healthy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: FDP; Result Unstructured Data: Test Result:increased; Comments: At the time of the first blood sampling; Test Name: Platelet; Result Unstructured Data: Test Result:decreased; Comments: At the time of the first blood sampling
CDC Split Type: JPPFIZER INC202101085961

Write-up: Brain herniation; Extensive cerebral infarction due to internal carotid artery occlusion; Extensive cerebral infarction due to internal carotid artery occlusion; unwell; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A 71-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 21Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation at the age of 71-year-old. Medical history included ongoing hypertension. The patient''s concomitant medications were not reported. The patient was a non-pregnant 71-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications 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 ongoing hypertension, and the patient was healthy. On 21Jun2021 at an unspecified time (as reported) (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: unknown, Expiration date: unknown) intramuscular administration for COVID-19 immunization. On 24Jun2021 at 12:00 (3 days after the vaccination), the patient experienced extensive cerebral infarction due to internal carotid artery occlusion. On 26Jun2021 at an unspecified date (5 days after the vaccination), the patient experienced brain herniation. The events resulted in hospitalization, emergency room/department or urgent care, and death. The outcome of the events was fatal with treatment including fluid replacement and edaravone injection. No autopsy was performed. The outcome of unwell was unknown. The course of the event was as follows: The patient was somehow unwell after the vaccination. Three days after the second vaccination, the patient collapsed and was taken to Hospital A by ambulance. The patient had an extensive cerebral infarction due to internal carotid artery occlusion. The day after next, the patient experienced brain herniation. On 01Jul2021, the patient died. At the time of the first blood sampling, "platelets decreased" and "fibrin degradation products (FDP) increased" were noted. The reporting physician assessed the events as serious (hospitalization, death). Since the vaccination, the patient has not been tested for COVID-19. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the close temporal association the possibility of causal association between the events cerebral infraction , carotid artery occlusion brain herniation and the suspect drug BNT162B2 cannot be excluded.The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: Extensive cerebral infarction due to internal carotid artery occlusion; Brain herniation; Extensive cerebral infarction due to internal carotid artery occlusion


VAERS ID: 1642697 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Death, Headache, Pain, Parkinson's disease, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Parkinson''s disease
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210850673

Write-up: BODY PAIN; VOMITING UNTIL HEART GOT SO WEAK; HEADACHE; FEVER; PARKINSON''S ON RIGHT HAND AND FOOT BECAME SEVERE UNTIL WHOLE BODY WAS SHAKING; DIED; HEART WAS NOT ABLE TO DO WELL; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: Parkinson''s on right hand and foot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 27-JUL-2021 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 fever, headache, body pain, vomiting until heart got so weak, Parkinson''s on right hand and foot became severe until whole body was shaking. On 03-AUG-2021 (on the seventh day), the patient''s heart was not able to do well. Reporter informed consulted doctor and was given medicine to rule out the side effects. On 04-AUG-2021, 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 04-AUG-2021, and the outcome of fever, body pain, headache, vomiting until heart got so weak, Parkinson''s on right hand and foot became severe until whole body was shaking and heart was not able to do well was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20210850552.; Sender''s Comments: V0: 20210850673-COVID-19 VACCINE AD26.COV2.S-DIED. 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. 20210850673-COVID-19 VACCINE AD26.COV2.S-Parkinson''s on right hand and foot became severe until whole body was shaking. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1642698 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-09
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Febrile convulsion, Headache, Nausea, Pyrexia, Thrombocytopenia, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (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), 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: PHJNJFOC20210851953

Write-up: THROMBOCYTOPENIA; FEVER; HEADACHE; LOSS OF APPETITE; NAUSEA; FEBRILE SEIZURE; VOMITING; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA: PH-PHFDA-300100023] concerned a 59 year old female. 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 was not reported) dose was not reported, 1 total, administered on 28-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 09-AUG-2021 at 12:18, the patient experienced fever, headache, loss of appetite, nausea, thrombocytopenia, febrile seizure and vomiting. On an unspecified date, the patient died from fever, headache, loss of appetite, nausea, thrombocytopenia, febrile seizure, and vomiting. 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: 20210851953-COVID-19 VACCINE AD26.COV2.S- Fever, headache, loss of appetite, nausea, thrombocytopenia, febrile seizure, 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).; Reported Cause(s) of Death: FEVER; HEADACHE; LOSS OF APPETITE; NAUSEA; THROMBOCYTOPENIA; FEBRILE SEIZURE; VOMITING


VAERS ID: 1642699 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205621A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852089

Write-up: COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; SHORTNESS OF BREATH; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300100965] concerned a 36 year old male with an 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: 205621A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced shortness of breath. On an unspecified date, the patient experienced covid-19 and suspected clinical vaccination failure. On an unspecified date, the patient died from shortness of breath, and covid-19. It was unknown, if an autopsy was performed. The outcome of suspected clinical vaccination failure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, Other Medically Important Condition, and Life Threatening). This report was associated with a Regulatory Authority.; Sender''s Comments: V0- 20210852089-covid-19 vaccine ad26.cov2.s-Shortness of breath, Covid-19. 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). 20210852089-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: SHORTNESS OF BREATH; COVID-19


VAERS ID: 1642700 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-13
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

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: 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: PHJNJFOC20210852101

Write-up: CHEST PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA,PH-PHFDA-300100280] concerned a 46 year old male of unknown race and ethnicity. 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: 212C21A, expiry: Unknown) dose was not reported, 1 total, administered on 11-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021 10:45, the patient experienced chest pain. On an unspecified date, the patient died from chest pain. 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: V0:20210852101-Covid-19 vaccine ad26.cov2.s-Chest pain. 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: CHEST PAIN


VAERS ID: 1642702 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: 20210804; Test Name: Body temperature; Result Unstructured Data: Fever =38?C
CDC Split Type: PHJNJFOC20210852388

Write-up: FEVER =38?C DIFFICULTY OF BREATHING; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300100763] concerned a 74 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. It was unspecified whether autopsy was performed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, frequency one total dose was administered on 28-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 04-AUG-2021, one week after vaccination the patient experienced fever =38?c with headache. On 13-Aug-2021, the patient develops cough with difficulty of breathing. On 04-AUG-2021, Laboratory data included: Body temperature (NR: not provided) Fever =38?C. On an unspecified date, the patient died from fever =38?c. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210852388-Covid-19 vaccine ad26.cov2.s-Fever =38?c difficulty of breathing . 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 =38?C


VAERS ID: 1642703 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PHJNJFOC20210852436

Write-up: SHORTNESS OF BREATH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300100252] 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, intramuscular, batch number: 205C21A, and expiry: Unknown) dose was not reported, frequency one total, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced shortness of breath. On an unspecified date, the patient died from shortness of breath. 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: V0-20210852436-COVID-19 VACCINE AD26.COV2.S-Shortness Of Breath( Fatal). This event is considered un-assessable. 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: SHORTNESS OF BREATH


VAERS ID: 1642704 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-13
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Malaise, 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: 2021-08-01
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852452

Write-up: DIFFICULTY OF BREATHING; FEVER; BODY MALAISE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300100441] concerned a 35 year old female. 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: 213C21A and expiry: UNKNOWN) dose was not reported, frequency one total, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021 11:00, the patient experienced difficulty of breathing, fever and body malaise. On an unspecified date in AUG-2021, the patient died from difficulty of breathing, fever, and body malaise. It was unknown if 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: 20210852452- Covid-19 vaccine ad26.cov2.s- Difficulty of breathing, fever, body malaise. 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: DIFFICULTY OF BREATHING; FEVER; BODY MALAISE


VAERS ID: 1642706 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / 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: PHJNJFOC20210852566

Write-up: DEATH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300101218] concerned a 77 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, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total, administered on 15-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event death was reported as fatal. This report was serious (Death).; Sender''s Comments: V0. 20210852566-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: 1642708 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PHJNJFOC20210852645

Write-up: ABDOMINAL PAIN, BODY MALAISE, FATIGUE, FEVER, LOSS OF APPETITE, MUSCLE PAIN, DIFFICULTY OF BREATHING AND CHILLS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300100510] concerned an 84 year old female of an 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: 213C21A and expiry: unknown) dose was not reported, 1 total was administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced abdominal pain, body malaise, fatigue, fever, loss of appetite, muscle pain, difficulty of breathing and chills. On an unspecified date, the patient died from difficulty of breathing. Autopsy details were not reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to difficulty of breathing. This report was serious (Death).; Sender''s Comments: V0: 20210852645 -covid-19 vaccine ad26.cov2.s- abdominal pain, body malaise, fatigue, fever, loss of appetite, muscle pain, difficulty of breathing and chills (Dyspnoea). 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: DIFFICULTY OF BREATHING


VAERS ID: 1642709 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-10
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / 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: PHJNJFOC20210852683

Write-up: COVID 19 VACCINE; This spontaneous report received from a physician via a Regulatory Authority [PHIFDA, PH-PHFDA-300099984] concerned a 64 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213C21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-AUG-2021 at 04:30, the patient experienced fever. The patient also experienced cough, coryza, and dyspnea. On an unspecified date, the patient died from covid 19 vaccine (fever). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210852683-JANSSEN COVID-19 VACCINE Ad26.COV2.S- covid 19 vaccine (fatal outcome) -This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COVID 19 VACCINE


VAERS ID: 1642710 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-05
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PHJNJFOC20210852708

Write-up: RESPIRATORY DISTRESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300101326] concerned a male of an unspecified age, race and ethnic origin. The patient''s weight, height and medical history were not reported at the time of vaccination. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205C21A, expiry: unknown) dose was not reported, 1 total administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021 at 09:00, the patient experienced respiratory distress. On an unspecified date, the patient died from respiratory distress. Autopsy details were not reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of respiratory distress. This report was serious (Death).; Sender''s Comments: V0: 20210852708-Covid-19 vaccine ad26.cov2.s -Respiratory distress. 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: RESPIRATORY DISTRESS


VAERS ID: 1642713 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205621A / UNK - / -

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: 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: PHJNJFOC20210852725

Write-up: SUDDEN CHEST PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300100527] concerned a 69 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, intramuscular, batch number: 205621A, and expiry: unknown) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021 at 15:00, the patient experienced sudden chest pain. On an unspecified date, the patient died from sudden chest pain. It was unknown if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0-20210852725-Covid-19 vaccine ad26.cov2.S-Sudden chest pain. 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: SUDDEN CHEST PAIN


VAERS ID: 1642715 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Fatigue
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Blood glucose; Result Unstructured Data: elevated blood sugar level of 580; Test Date: 202108; Test Name: Blood pressure; Result Unstructured Data: 170/140 mmHg, Elevated
CDC Split Type: PHJNJFOC20210852733

Write-up: FATIGUE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300101182] concerned a 72 year old female with an 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: 212C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, at 9:00, the patient experienced fatigue and had loss of appetite, body malaise and chills 4 days after vaccination. The patient was hospitalized (date and duration unspecified) and upon admission patient had an elevated blood pressure of 170/140 and an elevated blood sugar level of 580. On an unspecified date, the patient died from fatigue. 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 Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210852733-Covid-19 vaccine ad26.cov2.s -Fatigue. 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: FATIGUE


VAERS ID: 1642717 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 2BC21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 6
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: PHJNJFOC20210852768

Write-up: DIFFICULTY OF BREATHING; CHEST PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA (PH-PHFDA-300100473)] concerned a 64 year old male of unknown race and ethnicity. The patient''s height and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 2BC21A expiry: Unknown) dose was not reported, 1 total, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced difficulty of breathing and chest pain few hours before the patient was died. On AUG-2021, the patient died from difficulty of breathing, and chest pain. 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: V0-20210852768-covid-19 vaccine ad26.cov2.s-Difficulty breathing, Chest pain. 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: DIFFICULTY OF BREATHING; CHEST PAIN


VAERS ID: 1642718 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852778

Write-up: DIZZINESS; VOMITING; HEADACHE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300100327] concerned a 34 year old male of unknown race and ethnicity. The patient''s weight, height, and medical history 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: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 9.39 the patient experienced dizziness, vomiting, headache. On an unspecified date, the patient died from dizziness, vomiting, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210852778-COVID-19 VACCINE AD26.COV2.S -Dizziness, Vomiting, Headache. 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; VOMITING; HEADACHE


VAERS ID: 1642720 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852799

Write-up: RESPIRATORY DISTRESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300101324] concerned a 77 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: 205C21A, expiry: unknown) dose was not reported, 1 total, administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021 at 18:20, the patient experienced respiratory distress, and was hospitalized (date unspecified). Number of hospitalization days were not reported. On an unspecified date, the patient died from respiratory distress. 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, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210852799 - Covid-19 vaccine ad26.cov2.s- Respiratory distress. 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: RESPIRATORY DISTRESS


VAERS ID: 1642722 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Chills, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852819

Write-up: DYSPNEA; CHILLS; FEVER; ABDOMINAL PAIN; BODY WEAKNESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA: PH-PHFDA-300100190] concerned a 75 year old female of an unspecified race and ethnicity. 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: 213C21A, expiry: unknown) dose was not reported, with frequency time 1 total administered on 29-JUL-2021, for prophylactic vaccination. No concomitant medication were reported. On 30-JUL-2021, at 17:00, the patient experienced abdominal pain and body weakness. On 03-AUG-2021, at 20:00, she experienced chills and fever. On 04-AUG-2021, at 15:00, she experienced dyspnea (reported as difficulty of breathing). On an unspecified date, she was hospitalized and died from abdominal pain, body weakness, fever, chills, and dyspnea. It was not reported if autopsy was performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210852819-COVID-19 VACCINE AD26.COV2.S-abdominal pain, body weakness, fever, chills, and dyspnea. 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: ABDOMINAL PAIN; BODY WEAKNESS; FEVER; CHILLS; DYSPNOEA


VAERS ID: 1642723 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-08
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cough, Respiratory symptom
SMQs:, Anaphylactic reaction (broad), Guillain-Barre 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: PHJNJFOC20210852873

Write-up: RESPIRATORY SYMPTOM; BODY WEAKNESS; COUGH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDAPH-PHFDA-300100694] concerned a 73-year-old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 213C21A expiry: UNKNOWN) dose was not reported, 1 total administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021 10:00, the patient experienced cough. On 14-AUG-2021 10:00, the patient experienced respiratory symptom, body weakness. On an unspecified date, the patient died from cough, respiratory symptom, and body weakness. 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: 20210852873 -covid-19 vaccine ad26.cov2.s- Experienced cough, experienced respiratory symptom, body 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: COUGH; RESPIRATORY SYMPTOM; BODY WEAKNESS


VAERS ID: 1642726 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210853050

Write-up: DEATH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-300100705] concerned an 85 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A and expiry: unknown) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced death due to unknown cause. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event was fatal. This report was serious (Death).; Sender''s Comments: V0: 20210853050- COVID-19 VACCINE AD26.COV2.S- Death. 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: UNKNOWN CAUSE OF DEATH


VAERS ID: 1642727 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-09
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / 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? 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210853062

Write-up: DIFFICULTY BREATHING; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300101457] concerned a 61 year old male, race and ethnic origin was not unspecified. 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: 213C21A, expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021, the patient experienced fever. On 16-AUG-2021, the patient experienced difficulty breathing. On an unspecified date, the patient died from fever, and difficulty breathing. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Life Threatening).; Sender''s Comments: V0: 20210853062-COVID-19 VACCINE AD26.COV2.S- fever, difficulty breathing (with fatal outcome). These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: FEVER; DIFFICULTY BREATHING


VAERS ID: 1642728 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-28
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210853104

Write-up: COUGH; FEVER; DYSPNEA; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300101482] concerned a 68 year old male patient of unspecified race and ethnicity. 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: 213C21A, and expiry: unknown) dose was not reported, 1 total, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, at 20:00, the patient experienced cough, fever and dyspnea. On an unspecified date, the patient died from cough, fever, and dyspnea. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cough, fever, and dyspnea was fatal. This report was serious (Death).; Sender''s Comments: V0: 20210853104-covid-19 vaccine ad26.cov2.s -Cough, Fever, Dyspnea . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COUGH; FEVER; DYSPNEA


VAERS ID: 1642730 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-27
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 2050214 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PHJNJFOC20210853222

Write-up: COUGH; SHORTNESS OF BREATH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300100962] concerned a 57 year old male with 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, batch number: 2050214, expiry: UNKNOWN) dose was not reported, 1 total, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the patient experienced cough, shortness of breath. On an unspecified date, the patient died from cough, and shortness of breath. 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 cough and shortness of breath on an unspecified date. This report was serious (Death).; Sender''s Comments: V0: 20210853222- covid-19 vaccine ad26.cov2.s-cough, 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: COUGH; SHORTNESS OF BREATH


VAERS ID: 1642731 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-06
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Muscular weakness, Myalgia, Pelvic pain, Productive cough
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Sexual dysfunction (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: PHJNJFOC20210853230

Write-up: BODY WEAKNESS; COUGH; DIFFICULTY OF BREATHING; PELVIC PAIN; LOWER EXTREMITY PAIN; This spontaneous report received from a physician via a Regulatory Authority [PHIFDA, PH-PHFDA-300101144] concerned a 73 year old female with an 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: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-AUG-2021, the patient experienced pelvic pain and lower extremity pain. On 08-AUG-2021, the patient experienced cough and difficulty of breathing. On 13-AUG-2021, the patient experienced body weakness. On an unspecified date, the patient died from pelvic pain, lower extremity pain, cough, difficulty of breathing, and body weakness. 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: V0:20210853230-COVID-19 VACCINE AD26.COV2.S-Pelvic pain,Lower extremity pain,Cough,Difficulty of breathing,Body 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: PELVIC PAIN; LOWER EXTREMITY PAIN; COUGH; DIFFICULTY OF BREATHING; BODY WEAKNESS


VAERS ID: 1642732 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-05
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210853274

Write-up: COUGH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300101317] concerned a 73 year old female 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, intramuscular, batch number: 213C21A, and expiry: Unknown) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced cough. It was reported that a week after being vaccinated, the patient developed body pains accompanied by loss of appetite. On 12-AUG-2021, the patient sought consult and admitted to the institution. It was unspecified if an autopsy was performed On an unspecified date, the patient died from cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210853274- Covid-19 vaccine ad26.cov2.s-Cough. 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: COUGH


VAERS ID: 1642736 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-19
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101079334

Write-up: difficulty of breathing; fever; This is a spontaneous report from a contactable other health professional. This is a report received from the Food and Drug Administration. Regulatory authority report number PH-PHFDA-300098739. A 43-year-old male patient received BNT162b2 (COMIRNATY), intramuscularly on 02Jul2021 (Lot Number: fd5996) at the age of 43 years old, as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced fever on 19Jul2021 19:00, difficulty of breathing on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event fever was fatal, of the event difficulty of breathing was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever


VAERS ID: 1642737 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Nasopharyngitis, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101079335

Write-up: COVID INFECTION; Cough; Cold; Fever; Pneumonia; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300098952. A 68-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 07Jul2021 (Lot Number: FD5996, at age of 68 years old) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced COVID infection, cough, cold, fever and pneumonia on 13Jul2021. The outcome of events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID INFECTION; Cough; Cold; Fever; Pneumonia


VAERS ID: 1642739 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-07-31
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardiac arrest, Cardiac hypertrophy, Cardiomegaly, Cholelithiasis, Myocardial infarction, Obesity, Pulmonary oedema, Renal cyst, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Respiratory failure (broad)

Life Threatening? Yes
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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20212

Write-up: Oedema pulmonary; Myocardial hypertrophy - cor bovinum; Cholecystolithiasis; Obesity; Renal cyst; Cardiac dilatation; Acute transmural myocardial infarction (approximately 30 days after the second dose of vaccine); Sudden cardiac arrest (approximately 30 days after the second dose of vaccine); Thrombotic myocardial infarction of the anterior interventricular branch of the coronary artery (approximately 30 days after the second dose of vaccine); Ventricular fibrillation (approximately 30 days after the second dose of vaccine); This regulatory authority case was reported by a physician and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Acute transmural myocardial infarction (approximately 30 days after the second dose of vaccine)), CARDIAC ARREST (Sudden cardiac arrest (approximately 30 days after the second dose of vaccine)), MYOCARDIAL INFARCTION (Thrombotic myocardial infarction of the anterior interventricular branch of the coronary artery (approximately 30 days after the second dose of vaccine)), VENTRICULAR FIBRILLATION (Ventricular fibrillation (approximately 30 days after the second dose of vaccine)), PULMONARY OEDEMA (Oedema pulmonary), CARDIAC HYPERTROPHY (Myocardial hypertrophy - cor bovinum), CHOLELITHIASIS (Cholecystolithiasis), OBESITY (Obesity), RENAL CYST (Renal cyst) and CARDIOMEGALY (Cardiac dilatation) in a 43-year-old male patient who received mRNA-1273 (Spikevax) for Prophylaxis. No Medical History information was reported. On 14-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 14-Jun-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 31-Jul-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (Acute transmural myocardial infarction (approximately 30 days after the second dose of vaccine)) (seriousness criteria death, medically significant and life threatening), CARDIAC ARREST (Sudden cardiac arrest (approximately 30 days after the second dose of vaccine)) (seriousness criteria death, medically significant and life threatening), MYOCARDIAL INFARCTION (Thrombotic myocardial infarction of the anterior interventricular branch of the coronary artery (approximately 30 days after the second dose of vaccine)) (seriousness criteria death, medically significant and life threatening) and VENTRICULAR FIBRILLATION (Ventricular fibrillation (approximately 30 days after the second dose of vaccine)) (seriousness criteria death, medically significant and life threatening). On an unknown date, the patient experienced PULMONARY OEDEMA (Oedema pulmonary) (seriousness criteria death, medically significant and life threatening), CARDIAC HYPERTROPHY (Myocardial hypertrophy - cor bovinum) (seriousness criteria death and life threatening), CHOLELITHIASIS (Cholecystolithiasis) (seriousness criteria death and life threatening), OBESITY (Obesity) (seriousness criteria death and life threatening), RENAL CYST (Renal cyst) (seriousness criteria death and life threatening) and CARDIOMEGALY (Cardiac dilatation) (seriousness criteria death and life threatening). The patient died on 31-Jul-2021. The reported cause of death was acute transmural myocardial infarction of other sites. An autopsy was performed. The autopsy-determined cause of death was Oedema pulmonary, Cholecystolithiasis, myocardial hypertrophy - cor bovinum, Renal cyst, Cardiac dilatation and Obesity. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered ACUTE MYOCARDIAL INFARCTION (Acute transmural myocardial infarction (approximately 30 days after the second dose of vaccine)), CARDIAC ARREST (Sudden cardiac arrest (approximately 30 days after the second dose of vaccine)), MYOCARDIAL INFARCTION (Thrombotic myocardial infarction of the anterior interventricular branch of the coronary artery (approximately 30 days after the second dose of vaccine)), VENTRICULAR FIBRILLATION (Ventricular fibrillation (approximately 30 days after the second dose of vaccine)), PULMONARY OEDEMA (Oedema pulmonary), CARDIAC HYPERTROPHY (Myocardial hypertrophy - cor bovinum), CHOLELITHIASIS (Cholecystolithiasis), OBESITY (Obesity), RENAL CYST (Renal cyst) and CARDIOMEGALY (Cardiac dilatation) to be unlikely related. Concomitant products were not provided. Treatment medication were not reported. Company Comment: The reported events appear temporally dissociated. Medical history was not reported, however mentioned in the Autopsy results (Myocardial hypertrophy, Cardiac dilatation, Obesity), and may play a contributory role in the development of the reported events. Based on reporter''s causality and temporal dissociation the events were assessed as unlikely related to mRNA-1273.; Sender''s Comments: The reported events appear temporally dissociated. Medical history was not reported, however mentioned in the Autopsy results (Myocardial hypertrophy, Cardiac dilatation, Obesity), and may play a contributory role in the development of the reported events. Based on reporter''s causality and temporal dissociation the events were assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Acute transmural myocardial infarction of other sites; Autopsy-determined Cause(s) of Death: Oedema pulmonary; Cholecystolithiasis; Myocardial hypertrophy - cor bovinum; Renal cyst; Cardiac dilatation; Obesity


VAERS ID: 1642747 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR; VENTILAN [SALBUTAMOL SULFATE]; SERTRALINE; LEXOTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to nuts; Asthma; Depression; Portal vein thrombosis (hypocoagulated in 2019)
Allergies:
Diagnostic Lab Data: Test Name: Blood gas test; Result Unstructured Data: Test Result:<6.8; Comments: pH < 6.8; Test Name: Sat O2; Test Result: 31 %; Test Name: Sat O2; Test Result: 70 %; Comments: very little reactive and is obnubilated; Test Name: TPC; Result Unstructured Data: Test Result:$g3
CDC Split Type: PTPFIZER INC202101073360

Write-up: anaphylaxis with cardio respiratory arrest; anaphylaxis with cardio respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number PT-INFARMED-G202108-1169. A 41-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 06Aug2021 (Batch/Lot Number: FE8235) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation . Medical history included food allergy from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing , asthma from an unknown date and unknown if ongoing , portal vein thrombosis from an unknown date and unknown if ongoing hypocoagulated in 2019. Concomitant medication(s) included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; salbutamol sulfate (VENTILAN [SALBUTAMOL SULFATE]) taken for an unspecified indication, start and stop date were not reported; sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported; bromazepam (LEXOTAN) taken for an unspecified indication, start and stop date were not reported. The patient experienced anaphylaxis with pcr (anaphylactic reaction) (death) on 08Aug2021 , cardio-respiratory arrest (death) on 08Aug2021. The patient underwent lab tests and procedures which included oxygen saturation: 31 % on , oxygen saturation: 70 % on very little reactive and is obnubilated , blood gases: <6.8 on pH < 6.8 , platelet count: $g3 on . The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of anaphylaxis with pcr (anaphylactic reaction), cardio-respiratory arrest. The patient died on 09Aug2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: anaphylaxis with cardio respiratory arrest; anaphylaxis with cardio respiratory arrest; Hypoxic-ischaemic encephalopathy


VAERS ID: 1642855 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Loss of consciousness; could not breath; This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) and DYSPNOEA (could not breath) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criteria death, hospitalization and medically significant) and DYSPNOEA (could not breath) (seriousness criteria death and hospitalization). The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were reported. Company Comment: Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1642863 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Private       Purchased by: ?
Symptoms: Adverse event, 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: Arrhythmia; Diabetes; Kidney disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; Others; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) and ADVERSE EVENT (Others) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Kidney disorder, Diabetes and Arrhythmia. On 16-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and ADVERSE EVENT (Others) (seriousness criterion death). The patient died on 17-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Batch number of the suspect product is unknown. The concomitant medications on use were not provided. No treatment information was provided. The patient did not showed symptoms after receiving the vaccine. Death occurred on 17 July 2021. Company comment: This is the case of a sudden death in this 68-year-old female patient. Reportedly, the patient died the day after vaccine administration, however, the cause of death and the autopsy results were not provided at this moment. The causality is strongly confounded with the underlying comorbidities of Kidney disorder, Diabetes and Arrhythmia. However, based on the current available information and temporal association between the use of the product and the occurrence of the event, a causal relationship cannot be excluded. Furthermore, very limited information regarding the "others" event reported (Adverse event NOS) and a causal relationship cannot be excluded, as well.; Sender''s Comments: This is the case of a sudden death in this 68-year-old female patient. Reportedly, the patient died the day after vaccine administration, however, the cause of death and the autopsy results were not provided at this moment. The causality is strongly confounded with the underlying comorbidities of Kidney disorder, Diabetes and Arrhythmia. However, based on the current available information and temporal association between the use of the product and the occurrence of the event, a causal relationship cannot be excluded. Furthermore, very limited information regarding the "others" event reported (Adverse event NOS) and a causal relationship cannot be excluded, as well.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1642881 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-16
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse event, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high (high blood pressure); Cholangiocarcinoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: adverse event NOS; Death; This regulatory authority case was reported by an other and describes the occurrence of DEATH (Death) and ADVERSE EVENT (adverse event NOS) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high (high blood pressure) and Cholangiocarcinoma. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse event NOS) (seriousness criterion death). The patient died on 16-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The reporter stated that the patient behaved normally from 3July2021 to 15July2021. The batch number of the suspect product is unknown. No concomitant medications were provided by the reporter. No treatment information was provided was provided by the reporter. This is the case of death in this 81-year-old female patient. Reportedly, the patient died 14 days after vaccine administration, however, the cause of death and the autopsy results were not provided at this moment. The causality is strongly confounded with the underlying comorbidities of high blood pressure and cholangiocarcinoma, as well as with the patient''s elderly age. However, based on the current available information and temporal association between the use of the product and the occurrence of the event, a causal relationship cannot be excluded. Furthermore, very limited information regarding the "others" event reported (Adverse event NOS) and a causal relationship cannot be excluded, as well.; Sender''s Comments: This is the case of death in this 81-year-old female patient. Reportedly, the patient died 14 days after vaccine administration, however, the cause of death and the autopsy results were not provided at this moment. The causality is strongly confounded with the underlying comorbidities of high blood pressure and cholangiocarcinoma, as well as with the patient''s elderly age. However, based on the current available information and temporal association between the use of the product and the occurrence of the event, a causal relationship cannot be excluded. Furthermore, very limited information regarding the "others" event reported (Adverse event NOS) and a causal relationship cannot be excluded, as well.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1642883 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Fatigue
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: Bedridden (for more than a year and was cared for at home by family and long term care resources.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Fatigue; DEATH; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (DEATH) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bedridden (for more than a year and was cared for at home by family and long term care resources.). On 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). The patient died on 18-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, FATIGUE (Fatigue) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medication were not reported. The patient received the Moderna vaccine at home from the home care service on July 12 and did not show any specific abnormalities. The patient felt more fatigued but could eat without assistance and did not display any specific symptoms of discomfort. At 7:00 a.m. on 18 Jul 2021, the family went to assist the patient with brushing their teeth as normal and found that the patient was not breathing when washing their face. The family called an ambulance. The patient was not taken to the hospital because they were Out of hospital cardiac arrest .; Sender''s Comments: This case concerns a 82 year-old female patient with reported fatal outcome (Preferred term: Death) 5 days after receiving the first dose of the mRNA-1273 vaccine. Cause of death was not further specified. Very limited information has been provided at this time. Patient?s age and history of being bedridden could be confounding factors for the case.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1653431 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute respiratory distress syndrome, Alanine aminotransferase, Aspartate aminotransferase, Atrial pressure, Base excess, Blood fibrinogen, Blood glucose, Blood lactic acid, Blood pressure measurement, Cardiovascular examination, Catheter placement, Chest X-ray, Computerised tomogram thorax, Disseminated intravascular coagulation, Dyspnoea, Electrocardiogram, Embolism venous, Fibrin D dimer, Fraction of inspired oxygen, Haemoglobin, Heart rate, Lymphocyte percentage, Neutrophil count, Neutrophil percentage, Oxygen saturation, PCO2, PO2, Physical examination, Platelet count, Polymerase chain reaction, Positive end-expiratory pressure, Pulmonary arterial wedge pressure, Respiratory failure, Respiratory rate, SARS-CoV-2 RNA, Thrombin time, Thrombocytopenia, Ultrasound Doppler, Vaccination failure, White blood cell count, pH body fluid
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; METOPROLOL; PANTOPRAZOLE
Current Illness: Gastrooesophageal reflux disease; Hyperlipidemia; Hypertension; Non-insulin-dependent diabetes mellitus; Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; Ex-smoker (10 year history of 15 packs per day); Comments: no drug use, no known drug allergies, family history significant for hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: PCR; Result Unstructured Data: positive for COVID-19; Test Name: Electrocardiogram; Result Unstructured Data: regular rhythm with sinus tachycardia with no signs of ectopy.; Test Name: Pulse oximetry; Result Unstructured Data: 67 %{saturation}, RA; Test Name: Heart rate; Result Unstructured Data: 136 {beats}/min; Test Name: Respiratory rate; Result Unstructured Data: 40 {breaths}/min; Test Name: Blood pressure; Result Unstructured Data: 174/104 mmHg; Test Name: Cardiovascular examination; Result Unstructured Data: significant for rhythm sinus tachycardia; Test Name: Physical examination; Result Unstructured Data: Bilateral crackle sounds were heard; Test Name: SARS-CoV-2 RNA; Result Unstructured Data: results not reported.; Test Name: CT pulmonary angiogram; Result Unstructured Data: Thrombus crossing the bifurcation that extended into the right upper; Test Name: Chest X-ray; Result Unstructured Data: revealed bilateral airspace consolidations; Test Name: Doppler ultrasound; Result Unstructured Data: showed occlusive and non-occlusive thrombus bilaterally; Test Name: Hemoglobin; Result Unstructured Data: 11.1 g/dL; Test Name: Hemoglobin; Result Unstructured Data: 10.9 g/dL; Test Name: Platelet count; Result Unstructured Data: 100000 /mm3; Test Name: Platelet count; Result Unstructured Data: 72000 /mm3; Test Name: White blood cell count; Result Unstructured Data: 17100 /mm3; Test Name: White blood cell count; Result Unstructured Data: 18500 /mm3; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 37 sec; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 45 sec, <35; Test Name: Thrombin time; Result Unstructured Data: 16.4 sec, 12; Test Name: Thrombin time; Result Unstructured Data: 17.0 sec, 12; Test Name: Fibrin D dimer; Result Unstructured Data: 3.6 ug/mL{eqv}; Test Name: Fibrin D dimer; Result Unstructured Data: 4.0 ug/mL{eqv}; Test Name: Fibrinogen; Result Unstructured Data: 132 mg/dL; Test Name: Catheter placement; Result Unstructured Data: elevated filling pressure on the right side of the heart; Test Name: Aspartate aminotransferase; Result Unstructured Data: 43 U/L; Test Name: Aspartate aminotransferase; Result Unstructured Data: 60 U/L; Test Name: Alanine aminotransferase; Result Unstructured Data: 82 U/L, <35; Test Name: Alanine aminotransferase; Result Unstructured Data: 92 U/L; Test Name: Glucose; Result Unstructured Data: 164 mg/dL; Test Name: Lactic acid; Result Unstructured Data: 9.0 mmol/L; Test Name: Lactic acid; Result Unstructured Data: 10.3 mmol/L; Test Name: Neutrophil percentage; Result Unstructured Data: 80.6 %; Test Name: Absolute neutrophil count; Result Unstructured Data: 14100 /mm3; Test Name: Lymphocyte percentage; Result Unstructured Data: 10.3 %; Test Name: Lymphocyte percentage; Result Unstructured Data: 9.8 %; Test Name: pH; Result Unstructured Data: 7.45; Test Name: pH; Result Unstructured Data: 7.25; Test Name: PCO2; Result Unstructured Data: 40.2 per mmHg; Test Name: PCO2; Result Unstructured Data: 67.6 per mmHg; Test Name: PO2; Result Unstructured Data: 58.3 per mmHg; Test Name: PO2; Result Unstructured Data: 50.8 per mmHg; Test Name: Base excess; Result Unstructured Data: 4 mmol/L, -2; Test Name: Base excess; Result Unstructured Data: 1 mmol/L; Test Name: O2 saturation; Result Unstructured Data: 90.0 %; Test Name: O2 saturation; Result Unstructured Data: 76.1%; Test Name: FIO2; Result Unstructured Data: 100 %; Test Name: PEEP; Result Unstructured Data: 5 cm[H2O]; Test Name: Pulmonary capillary wedge pressure; Result Unstructured Data: 14 mmHg; Test Name: Atrial pressure; Result Unstructured Data: 21 mmHg; Test Name: O2 saturation; Result Unstructured Data: 57 %{saturation}, RA; Test Name: Fibrinogen; Result Unstructured Data: 95 mg/dL
CDC Split Type: VCJNJFOC20210811642

Write-up: VENOUS THROMBOEMBOLISM; THROMBOCYTOPENIA; WORSENED RESPIRATORY DETERIORATION; ARDS; DISSEMINATED INTRAVASCULAR COAGULATION; SEVERE DYSPNEA; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report was received from literature. This report concerned a 52 year old male of unspecified race and ethnicity. The authors presented a case of venous thromboembolism (VTE) by severe growths of pulmonary embolism and deep vein thrombosis (DVT) with disseminated intravascular coagulation (DIC) in a COVID-19-positive patient following vaccine administration. The patient''s weight was 151.5 kilograms, and height was 180.3 centimeters. The patient''s concurrent conditions included: hypertension, hyperlipidemia, obesity, gastroesophageal reflux disease, non-insulin dependent diabetes mellitus, former smoker, and no alcohol use, and other pre-existing medical conditions included: no drug use, no known drug allergies, family history significant for hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 03-MAR-2021 (also reported as 31-MAR-2021) for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included atorvastatin, metoprolol, and pantoprazole. On 10-APR-2021, 38 days after receiving vaccination, the patient experienced confirmed clinical vaccination failure. A positive PCR test confirmed the patient''s diagnosis for COVID-19 on April 10, 2021, approximately eight days after he was exposed by a co-worker on 02-April-2021. On 11-APR-2021, the patient presented to the intensive care unit (ICU) with a 10-day onset of dyspnea and a dry cough. On an unspecified date, the patient also experienced venous thromboembolism, thrombocytopenia, and disseminated intravascular coagulation. Emergency Medical Services (EMS) reported the patient''s O2 saturation at 57% room air and immediately placed him on BiPap for supplemental oxygen therapy upon arrival. The patient reported his shortness of breath had worsened in the last 24 hours. Aggravating factors included exertion and an attempt to speak. His review of systems was remarkable for exacerbating chest pain and a dry cough with a worsened shortness of breath. An electrocardiogram (ECG) obtained en route reported regular rhythm with sinus tachycardia with no signs of ectopy. The PR, QRS, and T-waves were normal with no changes to his ST-wave. On arrival, he displayed severe respiratory deterioration with dyspnea and hyperventilation with measured pulse oximetry of room air at 67%. Physical examination was notable for a heart rate of 136 beats per minute, a respiration rate of 40 breaths per minute, and hypertension (174 mmHg/104 mmHg). The cardiovascular examination was significant for rhythm sinus tachycardia with S1 and S2 heart tones present. For his pulmonary examination, he required mechanical ventilation at a rate of 15 liters per minute, 100% BiPap, and 5 cmH2O for positive end-expiratory pressure (PEEP). Bilateral crackle sounds were heard, along with an observed asymmetrical chest mount and intercostal retractions. The use of his accessory muscles was noted. Given the report of a positive COVID-19 diagnosis with severe dyspnea and hyperventilation, there was high suspicion for SARS-associated pneumonia as the cause for his ARDS (acute respiratory distress syndrome). He received an RNA nose swab and was started on a combination of Remdesivir, Rocephin, Zithromax, and Decadron (6 mg IV q 12 hours). Vaportherm was provided for additional oxygenation along with normal saline 150 cc/hour for sepsis. He was emergently taken to radiology for suspected pulmonary masses. Chest X-rays revealed bilateral airspace consolidations with no acute osseous abnormalities to confirm lateral airspace disease These consolidations would likely be a result of an infection/inflammation due to sepsis or viral pneumonia. A computed tomography (CT) angiogram revealed a thrombus crossing the bifurcation that extended into the right upper, middle, and lower lobe segmental branches with a greater thrombus burden on the left pulmonary arteries and the right ventricle. Minimal atheromatous plaques were found with no dissection or thoracic aortic aneurysm. Bilateral ground-glass consolidations with interstitial thickening were discovered in the lungs with an increased right to left heart ratio suggesting an underlying right heart strain to a certain degree. Upper and lower extremity Doppler ultrasounds showed occlusive and non-occlusive thrombus bilaterally on the patient''s lower extremity veins. Laboratory analysis was conducted upon the patient''s arrival. It showed increased concentrations of glucose (164 mg/dL), alanine (82 U/liter), and aspartate aminotransferase (43 U/liter) with a low platelet count of 100,000 ?L. Low levels of fibrinogen at 132 mg/dl were measured. Elevated prothrombin time (PT) and partial-thromboplastin (PTT) were measured at 16.4 and 37 seconds, respectively. Elevated acidity levels were observed for the patient with increased lactic acid levels from 9.0 mmol/L to 10.3 mmol/L and a decreased pH from 7.455 to 7.255. The patient''s arterial blood gas values revealed a low partial pressure of oxygen (pO2) of 58.3 mmHg and increased partial pressure of carbon dioxide (pCO2) of 40.2 mmHg. These blood gas values put the patient at a higher risk for respiratory failure with a decreased PaO2/FiO2 ratio of 58.3 mmHg/100%. This ratio meets the threshold feature for increased severity of ARDS. Severe hypoxia with a Pao2/FiO2 ratio less than 250 is associated with Community-acquired pneumonia (CAP). He had an abnormally elevated D-dimer level at 3.6 ug/mL. The patient continued hyperventilating with a decline in oxygen saturation from 90% to 76.1%. He was deemed critical but in stable condition within the capability of the ICU. The attending physician explained to the patient and his family the status of his continued respiratory failure by the findings of the DVT and PE. The patient was transferred upon recommendations made by his attending physician and the intensivist to a nearby healthcare facility for higher-level (tertiary) care for further management. He underwent radiological intervention two days later to remove the clots from his lungs. The patient continued to experience worsened dyspnea with no significant improvement, which resulted in his expiration approximately one month following his initial admission. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of worsening respiratory deterioration, and the outcome of the other events was not reported. The report was associated with a product quality complaint: 90000188811 This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210811595.; Sender''s Comments: V0: This report received from literature concerned a 52 year old male, unknown ethnicity, who had severe dyspnea, pulmonary embolism and deep vein thromboses due to COVID-19 infection that was detected by PCR test done 38 days after receiving the Janssen Covid-19 vaccine. The patient''s weight was 151.5 kilograms and height was 180.3 centimeters (BMI 46.6, obese). The patient''s concurrent conditions included: hypertension, hyperlipidemia, obesity, gastroesophageal reflux disease, and non-insulin dependent diabetes mellitus. Concomitant medications included atorvastatin, metoprolol, and pantoprazole. The patient had a 10 year smoking history of 15 packs per day but had stopped for the past 2 years. He had no known allergies and denied alcohol or drug abuse. Thirty days post vaccine, he was exposed to a co-worker who was infected with COVID-19 and was confirmed positive for COVID-19 by PCR eight days after. Thirty-nine days post vaccine, he was admitted to the ICU for worsening cough and dyspnea. His oxygen saturation was 57%, for which he was intubated and required mechanical ventilation. COVID-19 associated pneumonia was considered. Remdesivir, Ceftriaxone, Azithromycin, and Dexamethasone were given as treatment. Laboratory results included: chest xray had consolidation suggestive of pneumonia; computed tomography (CT) angiogram showed thromboses in the lungs, with the greater thrombus in the left pulmonary arteries; doppler ultrasound showed thrombus on the veins of both lower extremities; glucose 164 mg/dL; platelet count 100,000 ?L; fibrinogen 132 mg/dl, and D-dimer level 3.6 ug/mL. Condition was not improving, which resulted to his demise. The presence of comorbidities (hypertension, diabetes and obesity) and the history smoking may have contributed to the severity of the covid-19 infection. Thrombocytopenia and thromboses were secondary to the COVID-19 infection; hence, the causal association of the events to vaccination is assessed to be inconsistent.; Reported Cause(s) of Death: WORSENED RESPIRATORY DETERIORATION


VAERS ID: 1653432 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4222 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Aspartate aminotransferase, Blood chloride, Blood creatine, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood glucose, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, Cardiac arrest, Catheterisation cardiac, Circulatory collapse, Coagulation factor, Full blood count, Haematocrit, Haemoglobin, Heart rate, Interchange of vaccine products, Investigation, Lymphocyte count, Mean cell volume, Myocardial infarction, PO2, Platelet count, Prothrombin level, Respiratory rate, SARS-CoV-2 test, Troponin I, Urine analysis, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: APTTs; Result Unstructured Data: Test Result:22.9; Comments: s; Test Date: 20210803; Test Name: GPT; Result Unstructured Data: Test Result:46; Comments: U/L (increased); Test Date: 20210803; Test Name: GOT; Result Unstructured Data: Test Result:33; Comments: U/L (normal); Test Date: 20210803; Test Name: Cl; Result Unstructured Data: Test Result:103.3 mmol/L; Comments: normal; Test Date: 20210803; Test Name: Creatine; Result Unstructured Data: Test Result:127 umol/l; Comments: increased; Test Date: 20210803; Test Name: CK; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210803; Test Name: CK; Result Unstructured Data: Test Result:128.7; Comments: U/l (normal); Test Date: 20210803; Test Name: CKMB; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210803; Test Name: CK-MB; Result Unstructured Data: Test Result:43.0; Comments: U/l (increased); Test Date: 20210803; Test Name: Glucosse; Result Unstructured Data: Test Result:9.8 mmol/L; Comments: increased; Test Date: 20210803; Test Name: K; Result Unstructured Data: Test Result:3.2 mmol/L; Comments: decreased; Test Date: 20210801; Test Name: Blood Pressure; Result Unstructured Data: Test Result:110/76 mmHg; Comments: before vaccination; Test Date: 20210801; Test Name: Blood Pressure; Result Unstructured Data: Test Result:120/80 mmHg; Comments: post vaccination; Test Date: 20210803; Test Name: Blood Pressure; Result Unstructured Data: Test Result:110/70 mmHg; Test Date: 20210803; Test Name: Na; Result Unstructured Data: Test Result:145.7 mmol/L; Comments: increased; Test Date: 20210803; Test Name: ure; Result Unstructured Data: Test Result:7.6 mmol/L; Comments: increased; Test Date: 20210801; Test Name: Temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210803; Test Name: Temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Test Date: 20210803; Test Name: RHC; Result Unstructured Data: Test Result:4.8; Comments: T/L (normal); Test Date: 20210803; Test Name: Coagulation; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210803; Test Name: CBC; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210803; Test Name: HCT; Test Result: 45.6 %; Comments: normal; Test Date: 20210803; Test Name: HGB; Result Unstructured Data: Test Result:152; Comments: g/L (normal); Test Date: 20210801; Test Name: Pulse; Result Unstructured Data: Test Result:87; Comments: /minutes before vaccination; Test Date: 20210801; Test Name: Pulse; Result Unstructured Data: Test Result:76; Comments: post vaccination; Test Date: 20210803; Test Name: Pulse; Result Unstructured Data: Test Result:85; Comments: /minutes; Test Date: 20210803; Test Name: APTT disease/control; Result Unstructured Data: Test Result:0.76; Comments: decreased; Test Date: 20210803; Test Name: SHM; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210803; Test Name: LYMPH; Result Unstructured Data: Test Result:5.23; Comments: G/L (increased); Test Date: 20210803; Test Name: LYMPH percent; Test Result: 53.3 %; Comments: increased; Test Date: 20210803; Test Name: MCV; Result Unstructured Data: Test Result:95.0; Comments: fL (increased); Test Date: 20210803; Test Name: PLT; Result Unstructured Data: Test Result:167; Comments: G/L (normal); Test Date: 20210801; Test Name: SpO2; Test Result: 99 %; Comments: before vaccination; Test Date: 20210801; Test Name: SpO2; Test Result: 96 %; Comments: post vaccination; Test Date: 20210803; Test Name: SpO2; Test Result: 97 %; Test Date: 20210803; Test Name: Prothrombin; Result Unstructured Data: Test Result:11.1; Comments: s; Test Date: 20210803; Test Name: Prothrombin INR; Result Unstructured Data: Test Result:1.00; Comments: normal; Test Date: 20210803; Test Name: Prothrombin percent; Test Result: 100 %; Comments: normal; Test Date: 20210801; Test Name: Breathing; Result Unstructured Data: Test Result:19; Comments: times/minute before vaccination; Test Date: 20210803; Test Name: Breathing; Result Unstructured Data: Test Result:17; Comments: times/minute; Test Date: 20210803; Test Name: Antigen rapid test for Sars-CoV-2; Test Result: Negative ; Test Date: 20210803; Test Name: COVID fast test; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210803; Test Name: Qualitative Troponin I; Result Unstructured Data: Test Result:33.69; Comments: pg/ml (increased); Test Date: 20210803; Test Name: Tro I; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210803; Test Name: Urine test; Result Unstructured Data: Test Result:qualitative Marijuana negative; Comments: Qualitative Amphetamin negative, Morphin positive, Test Methmphetamin negative; Test Date: 20210803; Test Name: WBC; Result Unstructured Data: Test Result:9.82; Comments: G/L (normal)
CDC Split Type: VNPFIZER INC202101003615

Write-up: Cardiac arrest; out-of-hospital fatal circulatory arrest suspected of myocardial infarction; out-of-hospital fatal circulatory arrest suspected of myocardial infarction; received the second COVID vaccination with COMIRNATY; This is a spontaneous report from a contactable healthcare professional via Company Representative. A 52-year-old male patient received the second dose of BNT162B2 (COMIRNATY) at 52-year-old, intramuscularly in arm left on 01Aug2021 09:45 (Batch/Lot Number: FF4222; Expiration Date: 31Oct2021) at single dose for COVID-19 immunisation, and the first dose of covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), via an unspecified route of administration on 05Jun2021 (with no abnormal signs after vaccination) at single dose for COVID-19 immunisation. Medical history included chest pain from Jun2021. It was reported that the patient did not have any allergy history and no history of COVID. The patient''s concomitant medications were not reported. On 01Aug2021 (09:10), the patient arrived the vaccination institute at the hospital. After completing medical declaration, the patient completed vaccination administrative procedure by the nurse. The patient was measured vital sign including Temperature 36.3 C, Blood Pressure 110/76 mmHg, Pulse: 87/minutes, Breathing: 19 times/minute and SpO2 99 percent. At 09:30, the patient was screened by physician. The physician concluded the patient satisfied all vaccination conditions. The physician consulted COVID-19 vaccine of Pfizer-BioNTech (Comirnaty) for the second dose and explained the effect, benefit, dose, route of administration and common reactions post vaccination for the patient. Instructing how to follow up 30 minutes post vaccination at vaccination institute and follow up and manage post vaccination at home at list within 28 days post vaccination and abnormal signs which required to come to medical center. The patient signed consent form to receive COVID-19 vaccination program. The physician recorded indication on the screening form prior vaccination. On 01Aug2021 (09:45), the patient had received the second COVID vaccination with COMIRNATY. He was also well complied with the post-vaccination monitoring. After vaccinating, the patient was instructed to wait at waiting room to follow up 30 minutes post vaccination and to follow up at home at least 28 days especially in the 7 first days. After vaccinating, the patient was monitored 30 minutes at the waiting room. There were no adverse events captured in 30 minutes post vaccination. After that the patient was measured vital signs including Blood Pressure 120/80 mmHg, Pulse 76 times/minutes, SpO2 96 percent and signed to confirm he was monitored post vaccination. Before returning home, the patient was instructed how to follow up at home at least 28 days post vaccination, especially in the first 7 days and provided instruction documents of COVID vaccination. According to his family member, the patient started having chest pain between sternum from 00:00 of 03Aug2021, 3 episodes of pain, severe pain with shortness of breath, sweating, increasing chest pain. The ER team at the hospital was call to his house to help immediately. At the patient house, the vial signs were recorded including Pulse 85 times/minute, Blood Pressure 110/70 mmHg, Breathing 17 times/minute, SpO2 97% and Temperature: 36.7 C. The patient is awake, the skin and mucous membranes are pale pink, sweating, chest pain (right), no vomiting. Clear fast heart rate, Clear T1 T2, Clear RRPN lungs, No rale and soft belly without distention. The patient was diagnosed as Chest pain (right) post vaccinating Pfizer vaccine. The patient was treated with morphine at 10 mg/ml, half vial via IM and oxygen supply (4 times/minute). The patient was transferred to the hospital which took time about 2 hours and 15 minutes, the patient started cyanosis, agonal breathing, the emergency team carried out balloon compressions and cardiac compressions, after arriving at the hospital continued with the emergency team. The patient was diagnosed as cardiac arrest reason unknown/follow up heart attack post vaccination of Pfizer vaccine. The patient was hospitalized at the hospital at 02:21 of 03Aug2021 with condition in unconsciousness status, G 3 points, no pulse, agonal breathing, inguinal pulse, carotid pulse unresponsive, no cardiac rhythm noted. The patient was diagnosed as cardiac arrest. The treatment medication including Adrenalin 1 mg, 1 vial via IM and Sodium Chloride (Reported as Natriclorid) 0.9 percent x 1000 ml maintaining IV. The patient was performed circulatory arrest, chest compressions 30:2, squeezed the oxygen ball, established 2 intravenous lines, set Monitor to follow up, invited resuscitation consultation. The relevant test which was conducted including CBC, SHM, COVID fast test, Coagulation, Tro I, CK and CKMB. At 02:23 of 03Aug2021, the patient was unconsciousness, G 3 points, purple veins floating all over the body, inguinal pulse, carotid pulse unresponsive and continued emergency circulatory arrest. The treatment medication including Adrenalin 1 mg, 1 vial via IV and Adrenalin 1 mg, 5 vials with Sodium Chloride (Reported as Natriclorid) 0.9 percent x 500 ml infusion xc g/p. At 02:25 of 03Aug2021, the patient was in unconsciousness, G 3 points, pale skin and mucous membranes, purple veins all over the body, breathing through mask, continuous cardiac compression according to CAB circulatory arrest emergency protocol, unable to capture carotid and inguinal pulses. The patient was diagnosed as circulatory arrest and follow up due to myocardial infarction. The patient was performed endotracheal intubation, continued resuscitation of circulatory arrest according to CAB protocol. More urine toxicology tests was suggested to be performed. At 02:30 of 03Aug2021, the patient was in a deep unconsciousness, G 3 points, PXAS (-), dilated pupils 4 mm on both sides, inguinal and carotid pulses were not able to capture. The patient was continued resuscitation for circulatory arrest and received Adrenalin 1 mg, 18 vials, IV each 3 minutes. At 02:40 of 03Aug2021, the patient was in deep unconsciousness, G 3 points, PXAS (-), inguinal and carotid pulse were not able to capture. The patient was continued resuscitation for circulatory arrest. At 03:00 of 03Aug2021, the patient was in a deep unconsciousness, G 3 points, PXAS (-), dilated pupils 4 mm on both sides, inguinal and carotid pulses were not able to capture. The patient was continued resuscitation for circulatory arrest. At 03:11 of 03Aug2021, the patient was in a deep unconsciousness, G 3 points, PXAS (-), dilated pupils 4 mm on both sides, inguinal and carotid pulses were not able to capture, no heart sound, straight line ECG. After resuscitation, cardiac arrest for 50 minutes was ineffective. It was diagnosed as out-of-hospital fatal circulatory arrest suspected of myocardial infarction. The relevant test result including: CBC at 02:43 of 03Aug2021 including RHC 4.8 T/L (normal), HGB 152 g/L (normal), HCT 45.6 percent (normal), MCV 95.0 fL (increased), PLT 167 G/L (normal), WBC 9.82 G/L (normal), LYMPH percent 53.3 percent (increased), LYMPH 5.23 G/L (increased) and other parameters are normal. Coagulation at 02:43 of 03Aug2021 including Prothrombin s 11.1 s, Prothrombin percent 100 percent (normal), Prothrombin INR 1.00 (normal), APTTs 22.9 s, APTT disease/control 0.76 (decreased). Urine test including qualitative Marijuana negative, Qualitative Amphetamin negative, Morphin positive, Test Methmphetamin negative. Biochemistry test at 02:43 of 03Aug2021 including ure 7.6 mmol/l (increased), Creatine 127 umol/L (increased), Glucosse 9.8 mmol/l (increased), GOT 33 U/L (normal), GPT 46 U/L (increased), CK 128.7 U/l (normal), CK-MB 43.0 U/l (increased), Na 145.7 mmol/L (increased), K 3.2 mmol(decreased) and Cl 103.3 mmol/L (normal). Immuno test at 02:31 of 03Aug2021 including Qualitative Troponin I 33.69 pg/ml (increased). Antigen rapid test for Sars-CoV-2 at 02:43 of 03Aug2021 was negative. The patient died on 03Aug2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information is expected.; Sender''s Comments: A causal association between BNT162B2 and the reported serious unlisted events namely cardiac arrest, circulatory collapse, myocardial infaction and interchange of vaccine product, cannot be excluded based on a compatible temporal relation. 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: out-of-hospital fatal circulatory arrest suspected of myocardial infarction; out-of-hospital fatal circulatory arrest suspected of myocardial infarction; Cardiac arrest


VAERS ID: 1653439 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-29
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 20G1 2-02 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Asthenia, Body temperature, Death, Dyspnoea, Gait inability, Hyperhidrosis, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.8 C; Test Name: Oxygen saturation; Result Unstructured Data: 90 %; Comments: 90 percentage on oxygen face mask; Test Name: Oxygen saturation; Result Unstructured Data: 71 %; Comments: 71 percentage on room air
CDC Split Type: ZAJNJFOC20210810762

Write-up: SWEATING; MEMORY LOSS; DYSPNEA; DIFFICULTY IN BREATHING WITH OXYGEN SATURATIONS OF 71 PERCENT ON ROOM AIR AND 90 PERCENT ON OXYGEN FACE MASK; UNABLE TO WALK INDEPENDENTLY; BODY WEAKNESS; DEATH; This spontaneous report received from a health care professional concerned a 58 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, route of admin not reported, batch number: 4382388,20G12-02 and expiry: 23-FEB-2022) dose was not reported, 1 total administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021 (three days before medical intervention), the patient experienced difficulty in breathing, general body weakness, dyspnea and unable to walk independently. On 01-JUN-2021 at 12.20 hours, she experienced sweating and memory loss. She had medical intervention and admitted to the hospital. Her oxygen saturations (NR: not provided) was 71 percent on room air and 90 percent on oxygen face mask. Her body temperature (NR: not provided) was 36.8 C (degrees Celsius). On 06-JUN-2021, she died due to dyspnea, body weakness, sweating, memory loss, unable to walk independently, and difficulty in breathing with oxygen saturations of 71 percent on room air and 90 percent on oxygen face mask. It was reported that, her autopsy was not performed. The action taken with Covid-19 vaccine ad26.cov2. s was not applicable. The patient died of death, dyspnea, difficulty in breathing with oxygen saturations of 71 percent on room air and 90 percent on oxygen face mask, unable to walk independently, body weakness, sweating and memory loss on 06-JUN-2021. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening).; Sender''s Comments: V0: 20210810762 -covid-19 vaccine ad26.cov2.s- Death, Dyspnea, Difficulty in breathing with oxygen saturations was 71 percent on room air and 90 percent on oxygen face mask, unable to walk independently, body weakness, sweating, memory loss. 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). Dyspnea, Difficulty in breathing with oxygen saturations was 71 percent on room air and 90 percent on oxygen face mask, unable to walk independently, body weakness, sweating, memory loss.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1653440 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-28
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? Yes
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: Medical History/Concurrent Conditions: Chronic cough; Lung fibrosis; Comments: The patient did not have any similar adverse event prior 30 days of vaccination.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAJNJFOC20210810778

Write-up: DEATH; This spontaneous report received from a consumer concerned a 56 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s past medical history included severe lung fibrosis, and chronic cough. The patient did not have any similar adverse event prior 30 days of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 4382388, 20G12-02 and expiry: 23-FEB-2023) dose was not reported, 1 total administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the patient died from unknown cause of death. It was unknown whether an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Life Threatening).; Sender''s Comments: V0.20210810778-covid-19 vaccine ad26.cov2.s -died from unknown cause of 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: 1653444 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 209A21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   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: Medical History/Concurrent Conditions: Antiretroviral therapy (VI (Viral Load) lower than detachable)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAJNJFOC20210813187

Write-up: DEATH/DIED 2 DAYS POST VACCINATION/LATER PASSED ON; DYSPNOEA; MILD PAIN; MILD HEADACHE; This spontaneous report received from a health care professional via health authority concerned a 37 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included: ART (antiretroviral therapy), VL (viral load) lower than detectable. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 209A21A and expiry: 11-AUG-2021) dose was not reported, frequency time was 1 total, administered on 27-JUL-2021 around 14:00 for prophylactic vaccination. Further information on needle (size 22G, batch number 20201110DAN, expiry date 10-NOV-2025) and syringe (size 1ml, batch number 210330DAN, expiry date MAR-2026) were also reported. No concomitant medications were reported. On 29-JUL-2021, 09:10 the patient had complaints of dyspnoea, mild pain and mild headache and treated at the local clinic (unspecified treatment) and later passed on/death/died 2 days post vaccination. On 29-JUL-2021, the patient died from unknown cause of death, dyspnoea, mild pain, and mild headache. An autopsy was not performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death/died 2 days post vaccination/later passed on, dyspnoea, mild pain, and mild headache on 29-JUL-2021. This report was serious (Death).; Sender''s Comments: V0-20210813187-Covid-19 vaccine ad26.cov2.S-Death/died 2 days post vaccination/later passed on, Dyspnoes, Mild pain, Mild headache . 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; DYSPNOEA; MILD PAIN; MILD HEADACHE


VAERS ID: 1653450 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-23
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic cough; Lung fibrosis
Preexisting Conditions: Comments: The patient was not pregnant at the time of event reporting. The patient had no drug allergies.
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: COVID-19 antigen test; Result Unstructured Data: Positive
CDC Split Type: ZAJNJFOC20210836187

Write-up: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative concerned a 56 year old female. Initial information was processed along with the additional information received from the central quality vigilance on 19-AUG-2021. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: severe lung fibrosis, and chronic cough. The patient was not pregnant at the time of event reporting and the patient had no drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JUL-2021, rapid antigen test (RAT) was performed to the patient and she was tested positive for covid-19 (coded as suspected covid-19 infection and suspected clinical vaccination failure. The patient died at home with Covid -19 related infection and complications despite being vaccinated. She was not admitted to the hospital. She only had one dose of the vaccine. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspected covid-19 infection on an unspecified date, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with the product quality complaint number (PQC): 90000190023. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed.; Sender''s Comments: V0:20210836187-Covid-19 vaccine ad26.cov2.s-Suspected Covid-19 Infection. 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). V0: 20210836187-Covid-19 vaccine ad26.cov2.s-Suspected Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.; Reported Cause(s) of Death: COVID-19 RELATED INFECTION AND COMPLICATIONS


VAERS ID: 1653451 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Obesity
Preexisting Conditions: Comments: The patient had no risk factors and no co-administered vaccines. She had no known allergies or any history of drug abuse or illicit drug usage.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAJNJFOC20210841171

Write-up: CARDIAC COMPLICATIONS; HYPERTENSION; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative concerned a 58 year old female of an unspecified race and ethnic origin. The patient''s weight was 148 kilograms, and height was 167 centimeters. The patient''s concurrent conditions included obese and hypertension and other pre-existing medical conditions included the patient had no risk factors and no co-administered vaccines. She had no known allergies or any history of drug abuse or illicit drug usage. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, frequency time 1 total administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient had cardiac complications, hypertension, and suspected covid-19 infection (suspected clinical vaccination failure) and was hospitalized on 01-JUN-2021 for an unspecified days. On 06-JUN-2021, the patient died. An autopsy was not performed. The health care professional (HCP) said that the circumstances leading to death were mostly hypertension, cardiac complications, and suspected covid-19 infection or a combination of all three. The health care professional (HCP) also stated that there was no information written on the patients medical record which said that the vaccination contributed to the patient''s death. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected clinical vaccination failure was not reported. The patient died of hypertension, cardiac complications, and suspected covid-19 infection on 06-JUN-2021. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: 20210841171-Covid-19 vaccine ad26.cov2.s - cardiac complications, hypertension, and suspected covid-19 infection. 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). 20210841171-Covid-19 vaccine ad26.cov2.s -Suspected Vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: HYPERTENSION; CARDIAC COMPLICATIONS; COVID-19 INFECTION


VAERS ID: 1653636 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1436 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Glycosylated haemoglobin, Headache, Pyrexia, Urinary tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   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: Diabetic; Hypertensive
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: HBA1c; Result Unstructured Data: Test Result:8.4
CDC Split Type: ZAPFIZER INC202101026953

Write-up: Urinary tract infection; Chest pain; Mild Headache; Mild fever; This is a spontaneous report from a contactable physician. A 72-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 24Jun2021 12:47 (Batch/Lot Number: FC1436; Expiration Date: 19Jul2021) at the age of 72-year-old, as unknown dose, single for covid-19 immunisation. Medical history included hypertensive, diabetic. The patient''s concomitant medications were not reported. On 25Jun2021, patient experienced chest pain, mild headache, mild fever, patient diagnosed with urinary tract infection on an unspecified date and died at home on 07Jul2021. The patient underwent lab tests and procedures which included HBA1c: 8.4 in Apr2021. The outcome of urinary tract infection was fatal, other event outcome was unknown. The patient died on 07Jul2021. No autopsy performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: A causal association between BNT162B2 and the reported event urinary tract infection cannot be completely excluded based on information provided. However, patient''s underlying diabetic condition and advanced age might have contributed to the event. 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: Urinary tract infection


VAERS ID: 1653637 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-14
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Cardiogenic shock, Cough, Drug ineffective, Dyspnoea, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood cholesterol abnormal; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: covid-19 test; Test Result: Positive
CDC Split Type: ZAPFIZER INC202101027061

Write-up: Covid - 19; Covid - 19; cough; sore throat; Shortness of breath; Cardiogenic shock; covid pneumonia; Fever; Body aches; This is a spontaneous report from a contactable other HCP. A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypertension, cholesterol (abnormal). The patient''s concomitant medications were not reported. The patient experienced cough on 14Jun2021, sore throat on 14Jun2021, shortness of breath on 14Jun2021, covid-19 on 22Jun2021, covid pneumonia on an unspecified date, fever on 20Jun2021, body aches on 20Jun2021. The patient was hospitalized for cough, sore throat, shortness of breath, covid-19 from 22Jun2021 to an unknown date. The patient underwent lab tests and procedures which included covid-19 test: positive on 23Jun2021. Therapeutic measures were taken as a result of cough, sore throat, shortness of breath, covid-19. The patient died on 07Jul2021. It was not reported if an autopsy was performed. It also reported cause of death was cardiogenic shock. Outcome of events fever and body aches was unknown, while of the other events was fatal. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on temporal association and profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the reported serious events cannot be completely 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: Cardiogenic shock; cough; sore throat; shortness of breath; covid-19; covid-19; covid pneumonia


VAERS ID: 1653639 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Fatigue, Heart rate, Malaise, Oxygen saturation, Physical examination, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   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: PARACETAMOL; IBUPROFEN; CALCIUM CARBONATE; VITAMIN D1; ALLERGENS NOS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain (09:10); Chronic pain; Obesity; Osteoarthritis; Pain
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: Test Result:121/78; Test Date: 20210730; Test Name: Pulse rate; Result Unstructured Data: Test Result:120; Test Date: 20210730; Test Name: Oxygen Saturation; Test Result: 96 %; Test Date: 20210730; Test Name: Chest exam; Result Unstructured Data: Test Result:slight wheeze; Test Date: 20210803; Test Name: COVID test; Test Result: Positive
CDC Split Type: ZAPFIZER INC202101027236

Write-up: Died; Tachycardia; Not feeling well; exhausted; This is a spontaneous report from a contactable other hcp. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 1 via an unspecified route of administration on 30Jul2021 12:45 (Batch/Lot Number: FE9174; Expiration Date: 31Oct2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic pain, osteoarthritis, severely obese, pain, and complaining of back pain on 30Jul2021 09:10. Concomitant medications included paracetamol for pain; ibuprofen taken for pain; calcium carbonate; vitamin d1; and allergens nos. The patient died on 31Jul2021. Patient also experienced tachycardia, not feeling well, and exhausted and all on 30Jul2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure: 121/78 on 30Jul2021, Pulse rate: 120 on 30Jul2021, oxygen saturation: 96 % on 30Jul2021, chest exam: slight wheeze on 30Jul2021, COVID test: positive on 03Aug2021. The patient died on 31Jul2021. An autopsy was not performed.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event death and the suspect drug cannot be confirmed. The case will be reassessed once new information is available.; Reported Cause(s) of Death: Died


VAERS ID: 1653641 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
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 INC202101027898

Write-up: she passed away as a result of covid; she passed away as a result of covid; This is a spontaneous report from a contactable consumer (Patient''s daughter). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID19 mRNA VACCINE), via an unspecified route of administration on 13Jul2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported, she passed away on 07Aug2021 as a result of covid. It was not reported if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: covid


VAERS ID: 1653642 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-13
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Hypoaesthesia, Pain, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202101031096

Write-up: Death; Numbness of left upper arm; Mild fever; Mild body aches/general body pains; This is a spontaneous report from a contactable healthcare professional. A 73-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FE2090, expiry date: 30Jun2021), via an unspecified route of administration on 30Jun2021 11:14 (at the age of 73 years old) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death on 15Jul2021 22:00, numbness of left upper arm, mild fever and mild body aches/general body pains on 13Jul2021 07:15. The outcome of the event death was fatal while the outcome of all other events was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Death


VAERS ID: 1653646 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-08-05
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5029 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HIV infection; Hypertension; Pulmonary TB (completed treatment on 03Aug2021)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202101033164

Write-up: Death; This is a spontaneous report from a contactable physician. A 50-years-old male patient received bnt162b2 (COMIRNATY) dose 1 administration on 19Jul2021 15:17 (Batch/Lot Number: FC5029; Expiration Date: 31Oct2021) at the age of 50-years-old for covid-19 immunization. Diluent batch# 90PD090, expiry date Mar2022. The vaccine was reconstituted on 19Jul2021. Medical history included HIV infection, hypertension, pulmonary tuberculosis (completed treatment on 03Aug2021). The patient''s concomitant medications were not reported. The patient was reported to have died (death) on 05Aug2021. The patient did not report any symptoms. The autopsy was conducted on 10Aug2021, awaiting post mortem. No further details were available at the time of this report.; Sender''s Comments: The event Death is assessed as possibly related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from patient''s medical history and/or concomitant medications. case can be reassess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1653650 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Condition aggravated, Dyspnoea, Skin lesion
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 15
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: Asthmatic; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202101034815

Write-up: Enhanced disease folllowing immunisation; Generalized body weakness; Chills; Shortness of breath; body sores; This is a spontaneous report from a contactable nurse. A 92-year-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Jul2021 (Batch/Lot Number: FE2090; Expiration Date: 21Oct2021) at the age of 92-year-old, as dose 2, single for COVID-19 immunization. Medical history included asthmatic and hypertension. The patient''s concomitant medications were not reported. It was reported the patients disease was enhanced folllowing immunisation, generalized body weakness, chills and shortness of breath on 15Jul2021. The patient was hospitalized due to these events on 25Jul2021. He developed the above symptoms two days after vaccination 13Jul2021, on admission he lies not communicating, had body sores. It was also reported diluent (Batch/Lot Number: K1955A, Expiration Date: 31May2023), date of reconstitution 17Jul2021. The outcome of events enhanced folllowing immunisation, generalized body weakness, chills, shortness of breath was resulting in death. The outcome of event body sores was unknown. The patient died on 30Jul2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Enhanced disease folllowing immunisation; Generalized body weakness; Chills; Shortness of breath


VAERS ID: 1653652 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Bilirubin conjugated, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood chloride, Blood creatinine, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, C-reactive protein, Carbohydrate antigen 125, Carbohydrate antigen 19-9, Carcinoembryonic antigen, Dyspnoea, Gamma-glutamyltransferase, Glomerular filtration rate, Haematocrit, Haemoglobin, Heart rate, Laboratory test, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Oxygen saturation, Platelet count, Protein total, Red blood cell count, Red blood cell sedimentation rate, Red cell distribution width, Respiratory rate, Syncope, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SLOW K; AMLOC [AMLODIPINE BESILATE]; CLEXANE; LASIX [FUROSEMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute confusion state; Goiter (CA); Goiter; Hypertension; Syncope
Allergies:
Diagnostic Lab Data: Test Date: 20201115; Test Name: ALT; Result Unstructured Data: Test Result:25 U/L; Test Date: 20201115; Test Name: AST; Result Unstructured Data: Test Result:21 U/L; Test Date: 20201115; Test Name: DBil; Result Unstructured Data: Test Result:4 umol/l; Comments: High; Test Date: 20201115; Test Name: Albumin; Result Unstructured Data: Test Result:43 g/l; Test Date: 20201115; Test Name: ALP; Result Unstructured Data: Test Result:146 U/L; Comments: High; Test Date: 20201115; Test Name: Total Bilirubin; Result Unstructured Data: Test Result:8 umol/l; Test Date: 20201115; Test Name: Chloride; Result Unstructured Data: Test Result:108 mmol/L; Comments: High; Test Date: 20201115; Test Name: Creatinine; Result Unstructured Data: Test Result:73 umol/l; Test Date: 20201115; Test Name: Potassium; Result Unstructured Data: Test Result:3.5 mmol/L; Test Name: BP; Result Unstructured Data: Test Result:182/107 mmHg; Test Date: 20201115; Test Name: sodium; Result Unstructured Data: Test Result:145 mmol/L; Test Date: 20201115; Test Name: Urea; Result Unstructured Data: Test Result:4.6 mmol/L; Test Name: Temp; Result Unstructured Data: Test Result:37 degrees celcius; Test Date: 20201117; Test Name: CA 125; Result Unstructured Data: Test Result:13 KU/L; Test Date: 20201117; Test Name: CA 19-9; Result Unstructured Data: Test Result:31 KU/L; Test Date: 20201117; Test Name: CEA; Result Unstructured Data: Test Result:3.3 ug/L; Test Date: 20201115; Test Name: C-Reactive Protein; Result Unstructured Data: Test Result:4 mg/l; Test Date: 20201115; Test Name: GGT; Result Unstructured Data: Test Result:32 U/L; Test Date: 20201115; Test Name: eGFR (CKD-EPI formula); Result Unstructured Data: Test Result:72 ml/min/1.73m2; Test Date: 20201115; Test Name: eGFR (MDRD formula); Result Unstructured Data: Test Result:$g60 ml/min/1.73m2; Test Date: 20201115; Test Name: Haematocrit; Result Unstructured Data: Test Result:0.448 L/L; Test Date: 20201115; Test Name: Haemoglobin; Result Unstructured Data: Test Result:14.5 g/dl; Test Name: Pulse; Result Unstructured Data: Test Result:145 b/m; Test Date: 20201117; Test Name: AFP; Result Unstructured Data: Test Result:1.3 ug/L; Test Date: 20201115; Test Name: MCH; Test Result: 28.3 pg; Test Date: 20201115; Test Name: MCHC; Result Unstructured Data: Test Result:32.4 g/dl; Comments: Low; Test Date: 20201115; Test Name: MCV; Result Unstructured Data: Test Result:87.5 fL; Test Date: 20201115; Test Name: MPV; Result Unstructured Data: Test Result:13.6 fL; Comments: High; Test Name: SP02; Test Result: 72 %; Test Date: 20201115; Test Name: Platelet count; Result Unstructured Data: Test Result:191 x10 9/l; Test Date: 20201115; Test Name: Total protein; Result Unstructured Data: Test Result:76 g/l; Test Date: 20201115; Test Name: Red cell count; Result Unstructured Data: Test Result:5.12 x10 12/l; Test Date: 20201118; Test Name: ESR; Result Unstructured Data: Test Result:19 mm /hr; Comments: High; Test Date: 20201115; Test Name: Red cell distribution width; Test Result: 14.0 %; Test Name: Resp rate; Result Unstructured Data: Test Result:8 b/m; Test Date: 20201115; Test Name: White Cell Count; Result Unstructured Data: Test Result:12.84 x10 9/l; Comments: High
CDC Split Type: ZAPFIZER INC202101034987

Write-up: collapsed at home; Gasping; This is a spontaneous report from a contactable other HCP. A non-pregnant 70-year-old female patient received BNT162B2 via an unspecified route of administration on 20Jul2021 13:30 (at 70-year-old) (Batch/Lot Number: FE9174, Expiration Date: 31Oct2021; Diluent Batch/Lot Number: L19557; Expiration Date: May2023. Time of reconstitution 13H30) as dose2 single for COVID-19 immunisation. Medical history included CA goitre, hypertension (HPT) from 16Nov2020, MN goitre from 16Nov2020, collapsed from 16Nov2020, and acute confusion from 16Nov2020. Concomitant medications included potassium chloride (SLOW K); amlodipine besilate (AMLOC); enoxaparin sodium (CLEXANE); furosemide (LASIX). The patient previously received BNT162B2 via an unspecified route of administration on 08Jun2021 10:04 (at 70-year-old) (Batch/Lot Number: FE9174, Expiration Date: 31Oct2021; Diluent Batch/Lot Number: L19557; Expiration Date: May2023. Time of reconstitution 10H04) as dose 1 single for COVID-19 immunisation. It is reported that the patient was gasping on an unspecified date with outcome of unknown, and collapsed at home on an unspecified date with fatal outcome. The patient underwent lab tests and procedures which included alanine aminotransferase: 25 u/l on 15Nov2020, aspartate aminotransferase: 21 u/l on 15Nov2020, bilirubin conjugated: 4 umol/l on 15Nov2020 (High), blood albumin: 43 g/l on 15Nov2020, blood alkaline phosphatase: 146 u/l on 15Nov2020 High, blood bilirubin: 8 umol/l on 15Nov2020, blood chloride: 108 mmol/l on 15Nov2020 (High), blood creatinine: 73 umol/l on 15Nov2020, blood potassium: 3.5 mmol/l on 15Nov2020, blood pressure measurement: 182/107 mmHg, blood sodium: 145 mmol/l on 15Nov2020, blood urea: 4.6 mmol/l on 15Nov2020, body temperature: 37 degrees celcius, carbohydrate antigen 125: 13 ku/l on 17Nov2020, carbohydrate antigen 19-9: 31 ku/l on 17Nov2020. The patient died before entering casualty department on 20Jul2021. No autopsy was performed.; Sender''s Comments: Based on the current available limited information and the plausible drug-event association, a possible contributory role of the suspect product BNT162B2 to the development of syncope cannot be fully excluded/assessed. 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: collapsed at home


VAERS ID: 1653663 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 pneumonia; High cholesterol
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: SARS-CoV-2 PCR; Test Result: Negative
CDC Split Type: ZAPFIZER INC202101051876

Write-up: Vomiting; Diarrhoea; Death; This is a spontaneous report from a contactable physician. A 74-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: FE2090, expiration date: 31Oct2021), via an unspecified route of administration on 12Jul2021 08:45 (at the age of 74-years-old) at dose 2, single for COVID-19 immunisation. Medical history included COVID-19 pneumonia and high cholesterol. The patient''s concomitant medications were not reported. On 14Jul2021, the patient experienced vomiting and diarrhoea. The patient was hospitalized on Jul2021 due to vomiting and diarrhoea. On 20Jul2021, the patient experienced death due to unknown cause. The patient underwent SARS-CoV-2 PCR test on 18Jul2021 with negative result. It was reported that autopsy was not performed. No further details were provided at the time of report. Outcome of the events vomiting and diarrhoea was unknown, and for unknown cause of death was fatal.; Reported Cause(s) of Death: death


VAERS ID: 1653664 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH CUPKMMCF4TJ4 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Death, Heart rate increased, Local reaction, Toxic shock syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Toxic-septic shock conditions (narrow), Other ischaemic heart disease (narrow), Dehydration (broad), Sepsis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202101052234

Write-up: Unknown cause of Death; Heart pain; Toxic shock syndrome; Increase in heart beat; Severe local reaction; This is a spontaneous report from a contactable consumer received via the Regulatory Authority. The regulatory authority number is ZA-SAHPRA-202107240820408700-UXQF9. A 63-year-old male patient received the first dose of BNT162B2 (COMIRNATY, solution for injection) via an unspecified route of administration on 03Jun2021 (at the age of 63 years old) (Lot Number: CUPKMMCF4TJ4) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 08Jun2021, the patient experienced increase in heartbeat, heart pain (angina pectoris), severe local reaction and toxic shock syndrome. The outcome of the events was unknown. The patient was reported to have died (death) on 08Jun2021. 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: Unknown cause of Death


VAERS ID: 1653665 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH V4RHJJ3T4TWJ / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Confusional state, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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 INC202101052235

Write-up: Confusion; Shortness of breath; Weakness worsened; This is a spontaneous report from a non-contactable consumer received via the Regulatory Authority. The regulatory authority number was ZA-SAHPRA-202107262053591070-QFZFO. An 81-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 14Jul2021 (Lot Number: V4RHJJ3T4TWJ, unknown expiration; at the age of 81 years old) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient''s weakness worsened on 14Jul2021. The patient experienced shortness of breath on 15Jul2021 and confusion on 16Jul2021. Outcome of events weakness worsened, and confusion were not recovered. The patient died on an unspecified date due to shortness of breath. It was unknown if an autopsy was performed. The event shortness of breath was assessed as serious (disability and death). No follow-up attempts are possible; information about batch number was already obtained.; Reported Cause(s) of Death: shortness of breath


VAERS ID: 1653666 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH VPA2NFGAKCP9 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Death, Local reaction, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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 INC202101052236

Write-up: Severe local reaction; Severe abdominal pain; Severe vomiting; Nausea; Death; This is a spontaneous report from a contactable healthcare professional (HCP). Received via the Regulatory Authority (RA). The regulatory authority number was ZA-SAHPRA-202107291058179510-WPMAN. An 81-year-old male patient received bnt162b2 (COMIRNATY, solution for injection) on 23Jul2021 (Batch/Lot Number: VPA2NFGAKCP9) (at the age of 81-years-old) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced severe local reaction, severe abdominal pain, severe vomiting, nausea on 23Jul2021 with outcome of unknown. The patient died of an unknown cause (death) on an unspecified date in 2021. It was unknown if an autopsy was performed. No further information was provided at the time of this report.; Reported Cause(s) of Death: Death


VAERS ID: 1653667 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH VUPCRCJWVH9 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abscess, Anaphylactic reaction, Death, Encephalopathy, Febrile convulsion, Pyrexia, Sepsis, Thrombocytopenia, Toxic shock syndrome
SMQs:, Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202101052237

Write-up: Death; Anaphylaxis; Toxic shock syndrome; Sepsis; Thrombocytopenia; Encephalopathy; Fever greater than 38?C; Febrile seizure; Abscess; This is a spontaneous report from a non-contactable consumer, received via the Regulatory Authority. Regulatory authority number: ZA-SAHPRA-202107300922387950-KSD9E. A 72-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 15Jul2021 (Batch/Lot Number: VUPCRCJWVH9; Expiration Date: 30Jul2021) as dose 1, single (at the age of 72-years-old) for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fever greater than 38 degrees Celsius, anaphylaxis, toxic shock syndrome, febrile seizure, encephalopathy, abscess, sepsis, thrombocytopenia on 16Jul2021. The patient died on an unspecified date. The outcome of the event death was fatal while the outcome of the rest of the events was unknown. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1653668 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-02
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pneumonia, Pyrexia, Sepsis, Thrombosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: body temperature; Result Unstructured Data: Test Result:Fever greater than 38?C
CDC Split Type: ZAPFIZER INC202101052238

Write-up: Pneumonia; Fever greater than 38?C; Sepsis; Clot blood; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority (RA). The regulatory authority number is ZA-SAHPRA-202107311951133960-JWRGL. A 94-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Jun2021 (Batch/Lot number was not reported) dose 1, single (at the age of 94-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 02Jul2021, the patient experienced fever greater than 38?C, sepsis, clot blood and pneumonia. The patient died from pneumonia on an unspecified date. It was not reported if an autopsy was performed. Fever greater than 38?C, sepsis, clot blood were considered serious as medically significant by the regulatory authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1653669 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-16
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Asthenia, Cough, Death, Dyspnoea, Headache
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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), 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: ZAPFIZER INC202101052239

Write-up: Patient died; Cough; Headache; Shortness of breath; Weakness generalized; Altered state of consciousness; This is a spontaneous report from a non-contactable physician received via the Regulatory Authority. The regulatory authority number was ZA-SAHPRA-300055714. A 50-year-old female patient received the first dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on 07Jul2021 (Batch/Lot number was not reported) (at the age of 50 years old) as single dose for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced headache, shortness of breath, weakness generalized, and altered state of consciousness on 16Jul2021. On 17Jul2021, the patient had cough. It was reported that the patient died on an unspecified date. Outcome of the events was unknown. The patient died due to unknown cause. 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: Unknown cause of death


VAERS ID: 1653703 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1436 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Dyspnoea, Headache, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202101065655

Write-up: Fainting; Shortness of breath; Loss of energy; Mild headache; Died; This is a spontaneous report from a contactable physician. A 67-year-old male patient received bnt162b2 (BNT162B2, Lot Number: FC1436; Expiration Date: 31Oct2021) dose 1 via unspecified route of administration on 12Jul2021 11:44 (at the age of 67-year-old) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced mild headache (headache), loss of energy (asthenia), shortness of breath (dyspnoea) on 12Jul2021; and fainted (syncope) on 15Jul2021. The patient was hospitalized on 25Jul2021 due to mild headache, loss of energy, shortness of breath, and fainted. The patient died on 30Jul2021. Cause of death was unknown. It was unknown if an autopsy was performed. The outcome of the events mild headache, loss of energy, shortness of breath, and fainted was not recovered.; Sender''s Comments: Based on the current available information and the close drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of headache, asthenia, dyspnea, syncope cannot be fully excluded. As there is limited information in the case provided, the causal association between the events death (unknown cause) cannot be fully assessed/excluded. 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: death


VAERS ID: 1653705 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, COVID-19 pneumonia, Coma scale, Heart rate, Hypotension, Oxygen saturation, Physical examination, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 7
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: Diabetic; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: BP; Result Unstructured Data: Test Result:100/54; Test Date: 20210728; Test Name: temperature; Result Unstructured Data: Test Result:36.4; Test Date: 20210728; Test Name: GCS; Result Unstructured Data: Test Result:15/15; Test Date: 20210728; Test Name: Pulse; Result Unstructured Data: Test Result:66; Test Date: 20210728; Test Name: oxygen saturation; Test Result: 85 %; Comments: on 40% and 95%0n 100% oxygen; Test Date: 20210728; Test Name: examination; Result Unstructured Data: Test Result:bilateral Crackles; Test Date: 20210722; Test Name: tested for Covid 19; Test Result: Positive
CDC Split Type: ZAPFIZER INC202101069893

Write-up: BP: 100/54; Covid-19 pneumonia/cough, shortness of breath, sore throat/ tested for Covid 19 positive/ ill, Respiratory distress/ Sats: 85%/ bilateral Crackles; This is a spontaneous report from a contactable other health professional. A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 administration at age of 40 years on 18Jul2021 15:03 (Batch/Lot Number: FE2090; Expiration Date: 31Oct2021) for covid-19 immunization. Medical history included diabetic and obese. The patient''s concomitant medications were unspecified drugs for diabetic treatment. The Patient brought in casualty by an ambulance, accompanied by his brother on the 28Jul2021. The brother gave a history of patient cough, shortness of breath, sore throat that started a week before (21Jul2021). The patient tested for Covid 19 on 22Jul2021 and was found to be positive. According to the brother, the patient was vaccinated with Pfizer on the 18Jul2021. No reaction reported nor noted on that day. The patient was on Diabetic treatment and was obese. On arrival; he looked acutely ill, Respiratory distress. Temperature: 36.4, Pulse: 66, BP: 100/54, Sats: 85% on 40% and 95%0n 100% oxygen. As per doctors examination: bilateral Crackles, GCS 15/15 The patient was admitted in the Covid 19 Isolation ward and was diagnosed with Covid 19 pneumonia. The doctor ordered face mask oxygen 100%, IV fluids, IV antibiotics and steroids. The patient demised on the 28Jul2021. Serious criteria reported as life-threatening, hospitalization and death. The outcome of the events was fatal. An autopsy was not performed. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the event COVID-19 pneumonia, Hypotension cannot be excluded but also consider patient''s medical history of DM and Obesity as confounding factor. 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/cough, shortness of breath, sore throat/ tested for Covid 19 positive/ ill, Respiratory distress/ Sats: 85%/ bilateral Crackles; BP: 100/54


VAERS ID: 1653706 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202101072979

Write-up: Developed deep veined thrombosis; Pulmonary embolism; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration on 02Jul2021 at single dose, for covid-19 immunisation. Medical history included covid-19 and she had co-morbidities. The patient''s concomitant medications were not reported. The patient developed deep veined thrombosis, pulmonary embolism both in Jul2021. The patient was hospitalized due to pulmonary embolism and deep vein thrombosis. The patient (reporter''s mother) passed away on the 13Jul2021 after having the Pfizer vaccine on the 02Jul2021. She had co- morbidities but had recovered from Covid yet started to respond badly within a few days of having the vaccine. She developed deep veined thrombosis and then a pulmonary embolism and was sent home from the hospital due to a lack of beds. The official notice of death stipulates the underlying cause of death as the Pfizer vaccine. The patient died on 13Jul2021. It was not reported if an autopsy was performed. The outcome of the events pulmonary embolism and deep vein thrombosis was fatal. The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Pulmonary embolism; Developed deep veined thrombosis


VAERS ID: 1653707 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Local reaction
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100997600

Write-up: Severe local reaction; Death; This is a spontaneous report from a contactable health professional received via the Regulatory Authority (RA). The regulatory authority number was ZA-SAHPRA-202107240119296310-80779. An elderly female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 21Jul2021 (Batch/Lot Number: FE2090; Expiration Date: 10Oct2021) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 21Jul2021 10:00, the patient had severe local reaction. The patient also then died on 21Jul2021 (cause of death not reported). Outcome of severe local reaction was unknown. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1654203 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-20
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101087749

Write-up: Death/NOS death; This is a spontaneous report from a contactable physician downloaded from the Agency EudraVigilance-WEB Regulatory Authority number AT-BASGAGES-2021-041467. A 15-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 01Jul2021 (Batch/Lot Number: FD6840) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were none. Patient was found dead in bed on the morning of 20Jul2021. There were no known previous illnesses. The forensic autopsy could not find a cause of death until today. Also reported on 20Jul2021 the patient experienced death/NOS death. An autopsy was performed, and results were not provided. Sender Comment: BASGAGES-comment: Follow-up information has been requested. Comirnaty/ Death NOS/ Health Care Professional/ WHO Assessment/ Possible. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1654255 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death neonatal, Maternal exposure during pregnancy, Premature baby
SMQs:, Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101103083

Write-up: I had preterm delivery and my baby loss; I had preterm delivery and my baby loss; Had my first dosage of phizer covid vaccine while I was 23 weeks pregnant; This is a spontaneous report from the Pfizer sponsored program, received from a contactable consumer (patient''s mother). This consumer reported information for both mother and fetus/baby. This is a fetus/baby report. A neonate patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number was not reported), transplacental on 20Jun2021 as DOSE 1, Single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer reported that she had first dosage of phizer covid vaccine while she was 23 weeks pregnant on 20Jun2021. 7 days after vaccine she saw discharge and bleeding. She went to hospital and on 02Jul2021 and had preterm delivery and baby loss. The patient died on 02Jul2021. It was not reported if an autopsy was performed. The consumer stated that she was healthy woman without problem in this pregnancy. She think Pfizer is related to my loss. Information on batch number has been requested; Sender''s Comments: Linked Report(s) : CA-PFIZER INC-202101103041 mother and baby cases; Reported Cause(s) of Death: I had preterm delivery and my baby loss; Had my first dosage of phizer covid vaccine while I was 23 weeks pregnant; I had preterm delivery and my baby loss


VAERS ID: 1654271 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR; Test Result: Positive
CDC Split Type: CRPFIZER INC202101074908

Write-up: COVID-19; drug ineffective; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for covid-19 immunisation on unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced covid-19 and drug ineffective (death, hospitalization) on an unspecified date. Hospitalized in intensive care for COVID-19, with confirmation by PCR. Patient passed away. 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: COVID-19; drug ineffective


VAERS ID: 1654285 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-08-16
   Days after vaccination:154
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction
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: 2021-08-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101086388

Write-up: Middle cerebral artery infarct; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority. Authority number DE-PEI-202100169616. An 82-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 15Mar2021 at the age of 82-years-old (Batch/Lot Number: Unknown) as 0.3 mL single dose for COVID-19 immunization. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 on 20Feb2021 at the age of 82-years-old (Batch/Lot Number: Unknown) as 0.3 mL for COVID-19 immunization. The patient''s concomitant medications were not reported. 5 months after vaccination, on 16Aug2021 the patient experienced Middle cerebral artery infarct (death, hospitalization). The patient died on 17Aug2021. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Middle cerebral artery infarct


VAERS ID: 1654287 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-17
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101086715

Write-up: Exitus letalis; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory authority, DE-PEI-202100169704. A 66-year-old female patient received BNT162B2 (COMIRNATY), at the age of 66-year-old, via an unspecified route of administration on 03Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced exitus letalis on 17Aug2021. The outcome of the event was fatal. The patient died on 17Aug2021. It was unknown if an autopsy was performed. Relatedness of drug to reaction/event assessed as D. Unclassifiable by PEI. Senders comments: Dose number unknown. Exitus letalis on 17Aug2021 (at the night 16Aug2021/17Aug2021). No obvious cause of death, close time connection. No previous vaccination complications known. Investigation by the public prosecutors office. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Exitus letalis


VAERS ID: 1654367 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-08-09
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Aspartate aminotransferase, Base excess, Basophil count, Blood bicarbonate, Blood chloride, Blood creatinine, Blood glucose, Blood lactate dehydrogenase, Blood osmolarity, Blood potassium, Blood sodium, Blood urea, C-reactive protein, COVID-19 pneumonia, Carbon dioxide, Chest X-ray, Eosinophil count, Fibrin D dimer, Gamma-glutamyltransferase, Haematocrit, Haemoglobin, International normalised ratio, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Monocyte count, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet count, Prothrombin level, Prothrombin time, 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? 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: Test Name: APTT; Test Result: 27.2 s; Test Name: APTT (Cephalin T.); Result Unstructured Data: Test Result:0.93; Comments: no unit reported; Test Name: ALT (GPT); Result Unstructured Data: Test Result:21.00; Comments: unit reported: U/L; Test Name: AST (GOT); Result Unstructured Data: Test Result:28.0; Comments: unit reported: U/L; Test Name: excess of bases in blood; Result Unstructured Data: Test Result:- 1,200 mmol/L; Comments: (-2.0 - 3.0); Test Name: Excess of bases in extracellular liquid; Result Unstructured Data: Test Result:2,000 mmol/L; Comments: (-2.0 - 3.0); Test Name: Basophils; Result Unstructured Data: Test Result:0.0 10E3 / microL; Test Name: Arterial bicarbonate; Result Unstructured Data: Test Result:22.100 mmol/L; Test Name: Standard bicarbonate; Result Unstructured Data: Test Result:23.400 mmol/L; Test Name: Chloride; Result Unstructured Data: Test Result:105.00 mmol/L; Test Name: creatinine; Test Result: 0.77 mg/dl; Test Name: Glucose; Test Result: 232 mg/dl; Test Name: LDH; Result Unstructured Data: Test Result:211.00; Comments: unit reported: U/L; Test Name: calculated osmolality; Result Unstructured Data: Test Result:299 mosm/kg; Test Name: potassium; Result Unstructured Data: Test Result:4.70 mmol/L; Test Name: Sodium; Result Unstructured Data: Test Result:139.00 mmol/L; Test Name: urea; Test Result: 46.00 mg/dl; Test Name: arterial TCO2; Result Unstructured Data: Test Result:51.700; Comments: unit: vol%; Test Name: chest X-ray; Result Unstructured Data: Test Result:preserved CTI, right basal infiltrate; Test Name: C-reactive protein; Result Unstructured Data: Test Result:69.00 mg/l; Test Name: Eosinophils; Result Unstructured Data: Test Result:0.0 10E3 / microL; Test Name: D-Dimer; Result Unstructured Data: Test Result:1691.0 ng/ml; Test Name: gamma-glutamyltransferase; Result Unstructured Data: Test Result:18.00; Comments: unit reported: U/L; Test Name: hematocrit; Test Result: 40.6 %; Test Name: Hemoglobin; Result Unstructured Data: Test Result:13.4 g/dl; Test Name: I.N.R.; Result Unstructured Data: Test Result:0.97 R.N.; Test Name: Lymphocytes; Result Unstructured Data: Test Result:1.8 10E3 / microL; Test Name: MCH; Test Result: 32.3 pg; Test Name: MCHC; Result Unstructured Data: Test Result:33.1 g/dl; Test Name: MCV; Result Unstructured Data: Test Result:97.7; Comments: unit reported: fL; Test Name: monocytes; Result Unstructured Data: Test Result:0.2 10E3 / microL; Test Name: neutrophils; Result Unstructured Data: Test Result:4.7 10E3 / microL; Test Name: arterial O2 saturation; Test Result: 94.400 %; Test Name: arterial PCO2; Result Unstructured Data: Test Result:32.000 mmHg; Test Name: Arterial pH; Result Unstructured Data: Test Result:7.447; Comments: no unit reported; Test Name: Platelet; Result Unstructured Data: Test Result:119 10E3 / microL; Test Name: PO2; Result Unstructured Data: Test Result:68.800 mmHg; Test Name: Prothrombin activity; Test Result: 109.0 %; Test Name: Prothrombin time; Test Result: 11.3 s; Test Date: 20210809; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210809; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive Ct 12; Test Name: Leukocytes; Result Unstructured Data: Test Result:6.99 x10E3 / microL
CDC Split Type: ESPFIZER INC202101088995

Write-up: COVID-19 pneumonia; vaccination failure; This is a spontaneous report from a contactable Physician downloaded from the Agency EudraVigilance-WEB ES-AEMPS-977111 A non-pregnant 98-years-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 29Mar2021 (Lot Number: ER9470; Expiration Date: 31Jul2021), first dose of bnt162b2 (COMIRNATY) intramuscular on 05Mar2021 (Lot Number: ET1831; Expiration Date: 30Jun2021) both as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced covid-19 pneumonia, vaccination failure (death, hospitalization, life threatening) on 09Aug2021. It was reported that the patient came to the emergency room due to the presence of cough, being in close contact with daughter with CRP COVID + (06Aug2021), who accompanied her. she did not report nausea or vomiting. No diarrhea. No dysthermic sensation, no dyspnea. Not anosmia or ageusia. Slightly shaken during the interview, anamnesis completed with the help of family member. The patient underwent lab tests and procedures which included Chest X-ray: preserved CTI, right basal infiltrate. Antigenic test: positive PCR Covid-19 POSITIVE Ct 12 on 09Aug2021. BIOCHEMISTRY Glucose 232.00 mg / dl (60.0 - 100.0), Urea 46.00 mg / dl (21.0 - 50.0), Creatinine 0.77 mg / dl (0.5 - 0.9), Sodium 139.00 mmol / L (135.0 - 145.0), Potassium 4.70 mmol / L (3.5 - 5.0), Chloride 105.00 mmol / L (101.0 - 111.0), LDH 211.00 U / L (120.0 - 246.0), ALT (GPT) 21.00 U / L (6.0 - 40.0), AST (GOT) 28.00 U / L (6.0 - 40.0), gamma-glutamyltransferase 18.00 U / L (6.0 - 36.0), calculated osmolality 299 mOsm / kg, C-reactive protein 69.00 mg / L (0.1 - 10.0) HEMOGRAM Leukocytes 6.99 x10E3 / microL (4.0 - 11.5), Neutrophils 4.7 10E3 / microL (1.5 - 7.5), Lymphocytes 1.8 10E3 / microL (1.2 - 4.0), Monocytes 0.2 10E3 / microL (0.2 -1.0), Eosinophils 0.0 10E3 / microL (0.0 - 0.4), Basophils 0.0 10E3 / microL (0.0 -0.2), Hemoglobin 13.4 g / dL (12.0 - 16.0), Hematocrit 40.6% (36.0 - 46.0), MCV 97.7 fL (82.0 - 97.0), MCH 32.3 pg (26.0 - 31.0), MCHC. 33.1 g / dL (32.0 - 36.0), Platelet 119 10E3 / microL (150.0 - 400.0) COAGULATION Prothrombin time 11.3 sec (9.5 - 14.0), Prothrombin activity 109.0% (70.0 - 120.0), I.N.R. 0.97 R.N. (0.8 - 1.2), APTT (Cephalin T.) 27.2 sec (23.0- 36.0), APTT RATIO (T. Cephalin) 0.93 (0.8 - 1.25), D-Dimer (immunoturbidimetry) 1691.0 ng / ml (0.0 - 500.0) ARTERIAL GASOMETRY Arterial pH 7.447 (7.35 - 7.45), arterial PCO2 32,000 mmHg (35.0 - 45.0), PO2arterial 68,800 mmHg (90.0 - 100.0), Arterial bicarbonate 22,100 mmol / L (22.0 -28.0), arterial TCO2 51,700 vol% , arterial O2 saturation 94,400% (95.0 - 98.0), BEb (excess of bases in blood) -1,200 mmol / L (-2.0 - 3.0), BEecf (Excess of bases in extracellular liquid) -2,000 mmol / L (-2.0 - 3.0), SBC (Standard bicarbonate) 23,400 mmol / L (19.0 - 24.0). Therapeutic measures were taken including Dexamethasone 6 mg / 24 h 7 days; Enoxaparin 40mg / 24 h; Omeprazole 20 mg / 24h; Paracetamol 1g every 8 if required. The patient died on an unspecified date. It was not reported if an autopsy was performed. On 24Aug2021, investigation result received. 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 ''ET1831/ ER9470''. 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. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: covid-19 pneumonia; vaccination failure


VAERS ID: 1654382 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-07-20
   Days after vaccination:103
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SELOKEN [METOPROLOL TARTRATE]; SEROPLEX; ATORVASTATIN; KARDEGIC; LANSOPRAZOLE; TAMSULOSIN; EUPRESSYL [URAPIDIL]; AZITHROMYCINE; DACRYOSERUM [BORIC ACID;SODIUM BORATE]; FOLIC ACID; XANAX; ALLOPURINOL; PARACETAMOL; MACROGOL; ARANESP
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carotid artery stenosis; Cataract bilateral NOS; Cochlea implant (left); Constipation; Deafness; Diphtheria; Hypercholesterolaemia; Hypertension arterial; Kidney failure; Major depressive disorder; Meningitis; Penicillin allergy (amoxicillin); Pneumonia aspiration; Prostate adenoma; Spinal cord compression
Allergies:
Diagnostic Lab Data: Test Name: chest scanner; Result Unstructured Data: Test Result:probable COVID infection with pulmonary superinfec; Comments: probable COVID infection with pulmonary superinfection.; Test Name: chest scanner; Result Unstructured Data: Test Result:extension of COVID lesions in the lungs.; Comments: The second scan performed found an extension of COVID lesions in the lungs.no deep vein thrombosis which could suggest pulmonary embolism.; Test Date: 20210720; Test Name: covid-19 test; Test Result: Positive ; Comments: Delta variant COVID
CDC Split Type: FRPFIZER INC202101086836

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; COVID infection with pulmonary superinfection; This is a spontaneous report from a contactable physician downloaded from the Agency EudraVigilance-WEB, regulatory authority number FR-AFSSAPS-DJ20213116. A 91-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscularly on 08Apr2021 (Batch/Lot Number: EW2246) as single dose, and dose 1 intramuscularly on 10Mar2021 (Batch/Lot Number: EP2166) as single dose for covid-19 immunization. Medical history included Diphtheria, Repeated meningitis, Spinal cord compression, Deafness, Prostate adenoma, arterial hypertension, Hypercholesterolemia, Renal failure, Left cochlear implant, Carotid artery stenosis, Depressive syndrome, Pneumonia aspiration in 2021, Bilateral cataract, constipation, Penicillin allergy. Concomitant medications included metoprolol tartrate (SELOKEN) 100 mg: at 1 tablet in the evening taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (SEROPLEX) 5 mg at 2 tablets in the evening taken for an unspecified indication, start and stop date were not reported; atorvastatin 10 mg in the evening taken for an unspecified indication, start and stop date were not reported; acetylsalicylate lysine (KARDEGIC) 160 at 1 sachet at noon taken for an unspecified indication, start and stop date were not reported; lansoprazole 15 mg at 1 tablet in the evening taken for an unspecified indication, start and stop date were not reported; tamsulosin 0.4 mg prolonged release at 1 tablet in the evening taken for an unspecified indication, start and stop date were not reported; urapidil (EUPRESSYL) 30 mg morning and evening taken for an unspecified indication, start and stop date were not reported; azithromycine ophthalmic at 1 drop morning, noon and evening in both eyes taken for an unspecified indication, start and stop date were not reported; boric acid, sodium borate (DACRYOSERUM) ophthalmic at 1 single-dose container morning, noon and evening in both eyes taken for an unspecified indication, start and stop date were not reported; folic acid 5 mg at 1 tablet in the morning taken for an unspecified indication, start and stop date were not reported; alprazolam (XANAX) 0.25 mg at bedtime taken for an unspecified indication, start and stop date were not reported; allopurinol 100 mg: 1 at noon taken for an unspecified indication, start and stop date were not reported; paracetamol 500 mg capsule at 2 capsules morning, noon and evening taken for an unspecified indication, start and stop date were not reported; macrogol 10 g oral powder sachet: 1 to 2 per day according to constipation, to be stopped in case of diarrhea, taken for constipation, start and stop date were not reported; darbepoetin alfa (ARANESP) 20 ug subcutaneously once a week taken for an unspecified indication, start and stop date were not reported. The patient previously received amoxicillin and experienced allergy. The patient experienced vaccination failure and covid-19 confirmed by positive covid-19 test on 20Jul2021, COVID infection with pulmonary superinfection on an unspecified date in 2021. The patient was hospitalized from 23Jul2021 to an unknown date. Clinical course: patient lives at home with many helpers. Lifted with the verticalizer. Four children, one son lives with him. Another son and a daughter take care of him on a daily basis. The patient has tested positive for COVID (family context). Diagnosis on 20Jul2021. The patient was hospitalized on 23Jul2021 in a context of deterioration in general condition following contamination by the Delta variant COVID. He has stopped eating since 20Jul, becomes drowsy. The chest scan found a probable COVID infection with pulmonary superinfection. Despite this treatment with preventive anticoagulation and corticosteroid therapy, the patient gradually deteriorated. The second scan performed found an extension of COVID lesions in the lungs. No deep vein thrombosis which could suggest pulmonary embolism. The patient died on 02Aug2021 as a result of this COVID infection. An autopsy was not performed. Overall, fatal vaccine failure in a 91-year-old patient despite complete vaccination with bnt162b2. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination failure; COVID infection with pulmonary superinfection; COVID-19 confirmed by positive COVID-19 test


VAERS ID: 1654383 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Computerised tomogram, Extra dose administered, Hypotension, Off label use, SARS-CoV-2 test, Tremor, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Medication errors (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   Days after onset: 89
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: COUMADIN; LANSOPRAZOLE; AMIODARONE; FUROSEMIDE; CANDESARTAN; ATORVASTATIN; BISOPROLOL; INSULIN; ALLOPURINOL; JOSIR; CALCIFEROL [COLECALCIFEROL]; VITAMIN B12 [VITAMIN B12 NOS]; DOLIPRANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Diabetic nephropathy; Dyslipidaemia; Heart failure; Hypertension arterial; Implantable defibrillator user; Insufficiency renal (patient refusal of dialysis); Ischemic stroke; Obesity; Sleep apnea syndrome; Type 2 diabetes mellitus (on an insulin pump since 2016)
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: Chest CT scan; Result Unstructured Data: Test Result:acute lung edema (hilifuge ground glass). no clear; Comments: Chest CT scan without injection: acute lung edema (hilifuge ground glass). no clear COVID sign but entity semiological can overlap. Moderate bilateral pleurisy.; Test Date: 20210807; Test Name: Covid-19 PCR test; Result Unstructured Data: Test Result:presence of the L452R mutation (delta variant) on; Comments: presence of the L452R mutation (delta variant) on PCR; Test Date: 20210806; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Nasal swab positive for Covid19
CDC Split Type: FRPFIZER INC202101086842

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; Prolonged episode of tremors with hypotension; Prolonged episode of tremors with hypotension; 3rd injection not recorded on SI COVID vaccine but performed on 14May2021; 3rd injection not recorded on SI COVID vaccine but performed on 14May2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-DJ20213141. A 83-year-old male patient received bnt162b2 (COMIRNATY), dose 3 intramuscular on 14May2021 (Batch/Lot Number: FA5831) as dose 3, single, dose 2 intramuscular on 13Apr2021 (Batch/Lot Number: Unknown) as dose 2, single, dose 1 intramuscular on 16Mar2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. Medical history included Right posterior parietal lacunar ischemic stroke from Jun2018, diabetic nephropathy, Severe heart failure, Insufficiency renal (patient refusal of dialysis), Paired sleep apnea syndrome, obesity, dyslipidaemia, atrial fibrillation from Nov2018, type 2 diabetes mellitus from 1986 (on an insulin pump since 2016), Hypertension arterial, Triple-chamber implantable defibrillator carrier for primary prevention. Concomitant medications included warfarin sodium (COUMADIN); lansoprazole; amiodarone; furosemide, start and stop date were not reported; candesartan; atorvastatin; bisoprolol; insulin from 2016 for type 2 diabetes mellitus; allopurinol; tamsulosin hydrochloride (JOSIR); colecalciferol (CALCIFEROL [COLECALCIFEROL]); vitamin b12 [vitamin b12 nos]; paracetamol (DOLIPRANE). Patient who received 2 covid vaccinations with comirnaty: 1st injection on 16Mar21, 2nd injection on 13Apr21. 3rd injection not recorded on SI COVID vaccine but performed on 14May2021 (certificate obtained) (lot FA5831). Patient hospitalized via the emergency room for sudden respiratory distress on the evening of 06Aug2021 without any particular contributing factor (no chest pain, no hyperthermia). Nasal swab positive for Covid19. Chest CT scan without injection: acute lung edema (hilifuge ground glass). no clear COVID sign but entity semiological can overlap. Moderate bilateral pleurisy. It is concluded in acute respiratory distress of mixed origin: Respiratory and cardiogenic + - nephrogenic in a patient with terminal ischemic and rhythmic heart disease. Decision not to transfer the patient to intensive care in view of the age, severe comorbidities and the seriousness of the current picture. 10Aug2021: Prolonged episode of tremors with hypotension, mottling and apyrexia. Could correspond to a septic dump. Regression with 1g of perfalgan. Hemocs impossible because of the bad venous capital. Death on 11Aug2021. Screening: presence of the L452R mutation (delta variant) on PCR of 07Aug2021. in total, vaccine failure after doses of comirnaty, evolution: Fatal. Patient was died on 11Aug2021. outcome of 3rd injection not recorded on SI COVID vaccine but performed on 14May2021 and Prolonged episode of tremors with hypotension was unknown. It was unknown if autopsy was done. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test


VAERS ID: 1654386 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood lactic acid, Body temperature, Brain death, Brain oedema, Cardio-respiratory arrest, Computerised tomogram, Cough, Dyspnoea, Echocardiogram, Electrocardiogram, Hepatic cytolysis, Hyperkalaemia, Investigation, Laboratory test, Microbiology test, Multiple organ dysfunction syndrome, Neurological examination, Oedema peripheral, Pharyngitis, Pulmonary embolism, SARS-CoV-2 test, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Agranulocytosis (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Herniated disc
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: Lactate; Result Unstructured Data: Test Result:15; Comments: unite: mmol / L on admission; Test Name: temperature; Result Unstructured Data: Test Result:Apyretic, excluding antibiotics; Test Date: 20210809; Test Name: injected CTAP CT; Result Unstructured Data: Test Result:: Evidence of diffuse cerebral edema as well as bi; Comments: : Evidence of diffuse cerebral edema as well as bilateral proximal pulmonary embolism; Test Date: 20210809; Test Name: cardiac ultrasound; Result Unstructured Data: Test Result:retained left segmental kinetics, dilated RV with; Comments: retained left segmental kinetics, dilated RV with a paradoxical septum, conserved LV systolic function. Lactate is 15 mmol / L on admission with a pH <7, indicating organ suffering.; Test Name: Doppler echo of the lower limbs at the level of the 4 main veins; Result Unstructured Data: Test Result:not finding any visible thrombosis.; Test Date: 20210809; Test Name: ECG; Result Unstructured Data: Test Result:ECG in asystole, recovered for the first time at 5; Comments: ECG in asystole, recovered for the first time at 5:25 pm after 3 mg of adrenaline and orotracheal intubation. Bolus of 5000 IU of Heparin and 250mg of Aspirin in front of an appearance of BBG on the ECG. Hemodynamic instability requiring the initiation of noradrenaline. New ACR at 5:32 p.m. in asystole requiring up to 7 mg of adrenaline. Implementation of fibrinolysis by Metalyse 10,000 IU at 5:50 p.m. before the suspicion of pulmonary embolism.; Test Date: 20210809; Test Name: ECG; Result Unstructured Data: Test Result:ECG returned to sinus rhythm with complete right b; Comments: At Emergency: ECG returned to sinus rhythm with complete right bundle branch block and tachycardia at 120bpm.; Test Name: Renal and metabolic; Result Unstructured Data: Test Result:Acute anuric renal failure associated with hepatic; Comments: Acute anuric renal failure associated with hepatic shock cytolysis; Test Name: Respiratory; Result Unstructured Data: Test Result:Invasive mechanical ventilation with satisfactory; Comments: Invasive mechanical ventilation with satisfactory hematosis; Test Name: Hemodynamics; Result Unstructured Data: Test Result:Unstable patient requiring 2ug / kg / min noradren; Comments: Unstable patient requiring 2ug / kg / min noradrenaline for MAP objective$g 65 mmHg. Vascular filling by crystalloids. Oligoanuric patient. Gradual decrease in lactatemia with a pH always <7.3.; Test Date: 20210809; Test Name: laboratory results; Result Unstructured Data: Test Result:acute renal failure with hyperkalaemia, hepatic cy; Comments: acute renal failure with hyperkalaemia, hepatic cytolysis and elevated troponin.; Test Name: bacteriological samples; Test Result: Negative ; Test Name: Neurological examination; Result Unstructured Data: Test Result:Patient presenting with fixed areactive bilateral; Comments: Patient presenting with fixed areactive bilateral mydriasis. Persistence of a flat BIS on D1 post ACR. No doppler window to confirm HTIC. Control of ACSOS with initiation of therapeutic hypothermia according to protocol.; Test Date: 20210809; Test Name: pH; Result Unstructured Data: Test Result:<7; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101086774

Write-up: Acute massive pulmonary embolism; cerebral edema; hyperkalaemia; acute renal failure; hepatic cytolysis; cardio-respiratory arrest; dyspnea; calf edema; cough; pharyngitis; multiple organ failure; clinical encephalic death; This is a spontaneous report received from a contactable consumer and Other Health Professional downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-MA20213159. A 55-year-old male patient received the first dose of bnt162b2 (COMIRNATY) on 05Aug2021 (lot number: FE7051) (at the age of 55-years-old) Intramuscularly administered in left arm at single dose for COVID-19 immunisation. Medical history included herniated disc. Concomitant medications were reported as none. On 06Aug2021, the patient presented symptoms such as cough and pharyngitis. On 08Aug2021, patient experienced dyspnea with calf edema. On 09Aug2021, patient experienced sudden worsening of dyspnea with cardio-respiratory arrest: no flow of about 5 minutes, cardiac massage performed. On 09Aug2021, patient experienced Acute massive pulmonary embolism and cerebral edema. On arrival of the SAMU, ECG in asystole, recovered for the first time at 5:25 pm after 3 mg of adrenaline and orotracheal intubation. Bolus of 5000 IU of Heparin and 250mg of Aspirin in front of an appearance of BBG on the ECG. Hemodynamic instability requiring the initiation of noradrenaline. New ACR at 5:32 p.m. in asystole requiring up to 7 mg of adrenaline. Implementation of fibrinolysis by Metalyse 10,000 IU at 5:50 p.m. before the suspicion of pulmonary embolism. Critical patient, very unstable on the hemodynamic plan thereafter with multiple collapsed blood pressure. Stabilization from 6:20 p.m. and transfer to a center with coronary angiography. Given the strong clinical suspicion of pulmonary embolism and the unavailability of the coronary angiography table; the patient is transferred to intensive care for the rest of the treatment. On arrival in intensive care: Patient unstable on noradrenaline at more than 10 mg / h with a cardiac ultrasound which found retained left segmental kinetics, dilated RV with a paradoxical septum, conserved LV systolic function. Lactate is 15 mmol / L on admission with a pH <7, indicating organ suffering. The ECG returned to sinus rhythm with complete right bundle branch block and tachycardia at 120bpm. Hematosis preserved under invasive mechanical ventilation. Mixed acidosis with hypercapnia quickly corrected by increased mechanical ventilation. Neurologically speaking, the patient is sedated with pupils with areactive mydriases and an almost zero BIS upon entering intensive care. Initiation of hypertonic saline osmotherapy. An injected CTAP CT is performed to confirm the strong clinical suspicion: Evidence of diffuse cerebral edema as well as bilateral proximal pulmonary embolism. Collective decision to complete the thrombolysis with 40 mg of Actilyse over 01h. The laboratory results show acute renal failure with hyperkalaemia, hepatic cytolysis and elevated troponin. Evolution in the service from 09Aug2021 to 11Aug2021. Lab data included: Hemodynamics: Unstable patient requiring 2ug / kg / min noradrenaline for MAP objective$g 65 mmHg. Vascular filling by crystalloids. Oligoanuric patient. Gradual decrease in lactatemia with a pH always <7.3. Respiratory: Invasive mechanical ventilation with satisfactory hematosis. Infectious: Apyretic, excluding antibiotics, negative bacteriological samples. Renal and metabolic: Acute anuric renal failure associated with hepatic shock cytolysis. Neurological: Patient presenting with fixed areactive bilateral mydriasis. Persistence of a flat BIS on D1 post ACR. No doppler window to confirm HTIC. Control of ACSOS with initiation of therapeutic hypothermia according to protocol. SARS-CoV-2 test: negative. Completion on 11Aug2021 after 48 hours of stopping curares and 24 hours of stopping sedation of a hypercapnia test which confirms clinical brain death. An etiological assessment is started: Realization of a Doppler echo of the lower limbs at the level of the 4 main veins not finding any visible thrombosis. Request for a hemostasis assessment looking for thrombophilia knowing that the patient has received thrombolysis and heparin, which limits the interpretation of these biological tests. The outcome of the events Acute massive pulmonary embolism; cerebral edema; hyperkalaemia; acute renal failure; hepatic cytolysis; cardio-respiratory arrest; multiple organ failure; clinical encephalic death was fatal. The outcome of other events was unknown. Death of the patient on 11Aug2021 due to multiple organ failure with clinical encephalic death; Acute massive pulmonary embolism; cerebral edema; hyperkalaemia; acute renal failure; hepatic cytolysis; cardio-respiratory arrest. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute massive pulmonary embolism; cerebral edema; hyperkalaemia; acute renal failure; hepatic cytolysis; cardio-respiratory arrest; multiple organ failure; clinical brain death


VAERS ID: 1654399 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Blood triglycerides, COVID-19, Cardio-respiratory arrest, Culture stool, Extra dose administered, Glomerular filtration rate, Glycosylated haemoglobin, High density lipoprotein, Low density lipoprotein, Off label use, Physical examination, Respiratory disorder, SARS-CoV-2 test, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Respiratory failure (broad), Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   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: LANTUS; NOVORAPID; AMLOR; LASILIX; KARDEGIC; ZYMAD; HYDROCORTISONE; TAHOR; HYDROXYZINE; LYRICA; PROPRANOLOL
Current Illness: Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney transplant; Nephropathy; Neuropathy; Retinopathy (insulin-treated since 1996 with retinopathy)
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: BP; Result Unstructured Data: Test Result:150/60 mmHg; Test Date: 202104; Test Name: TG; Result Unstructured Data: Test Result:2.02 g/l; Test Date: 202103; Test Name: stool cultures; Result Unstructured Data: Test Result:ATCD of norovirus diarrhea; Test Date: 202103; Test Name: estimated GFR; Result Unstructured Data: Test Result:22 ml/min; Test Date: 202104; Test Name: consultation in diabeto; Test Result: 9.4 %; Test Date: 202104; Test Name: HDL; Result Unstructured Data: Test Result:0.28 g/l; Comments: low; Test Date: 202104; Test Name: LDL; Result Unstructured Data: Test Result:0.51 g/l; Test Date: 202104; Test Name: Physical examination; Result Unstructured Data: Test Result:no sign of particular cardiovascular disease, with; Comments: no sign of particular cardiovascular disease, with edema of MI without signs of heart failure; Test Date: 20210607; Test Name: PCR test; Result Unstructured Data: Test Result:positive
CDC Split Type: FRPFIZER INC202101086797

Write-up: COVID-19 aggravated; vaccine failure; cardio respiratory arrest; respiratory discomfort; asthenic; off label use; Extra dose administered; This is a spontaneous report from a contactable physician downloaded from the Agency EudraVigilance-WEB, regulatory authority number FR-AFSSAPS-RS20212687. A 81-year-old female patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration, administered in arm right on 25May2021 (Batch/Lot number was not reported) as dose 3, single; dose 2 via an unspecified route of administration, administered in arm right on 13Apr2021 (Batch/Lot Number: EW2246) as dose 2, single; dose 1 intramuscular, administered in arm right on 16Mar2021 (Batch/Lot Number: ET3620) as dose 1, single for covid-19 immunisation. Medical history included neuropathy, kidney transplant, Multicomplicated type 2 diabetes from 1983 and ongoing, retinopathy (insulin-treated since 1996 with retinopathy), transplanted nephropathy from Feb2018 to an unknown date. Multicomplicated type 2 diabetes evolving since 1983, insulin-treated since 1996 with retinopathy, neuropathy and transplanted nephropathy in Feb2018, under immunosuppressive treatment tacrolimus (PROGRAF) + mycophenolate mofetil (CELLCEPT) + prednisone (CORTANCYL). No history of COVID illness. Concomitant medications included insulin glargine (LANTUS); insulin aspart (NOVORAPID); amlodipine besilate (AMLOR); furosemide (LASILIX); acetylsalicylate lysine (KARDEGIC); colecalciferol (ZYMAD); hydrocortisone; atorvastatin calcium (TAHOR); hydroxyzine; pregabalin (LYRICA); propranolol; all taken for an unspecified indication, start and stop date were not reported. The nephrology consultation in Mar2021 mentions a patient with no particular complaints, apart from a diarrheal episode for which stool cultures were carried out (ATCD of norovirus diarrhea). Regular BDC, no breath, free pulmonary auscultation. Stable graft function with an estimated GFR of 22 ml / min. No inflammatory syndrome; Normal NFS, iono, BH. The diabeto consultation in Apr2021 mentioned that diabetes was still insufficiently balanced with an HbA1c of 9.4%. BP at 150/60 mmHg with no sign of particular cardiovascular disease, with edema of MI without signs of heart failure. Lipid balance: Target LDL at 0.51 g / l, low HDL at 0.28 g / l and TG at 2.02 g / l. The patient, a widow, lives relatively independently at home but is very helped by her family (her grandson lives with her) and IDEs at home. Around 01Jun2021, ie on D7 of D3, the patient was asthenic and her condition motivated the performance of a PCR test by IDEs on D14 (07Jun2021) of D3. The patient presented with respiratory discomfort on 07Jun2021 (D14) at the end of the day and her condition deteriorated during the night with a call from the 15th by the family in the early morning of 08Jun2021 to D15. Unfortunately, the patient died at her home before the arrival of the SAMU (patient in cardio respiratory arrest on arrival of the emergency services). The test result returned positive for SARS-CoV-2 on the morning of 08Jun2021 (no screening / sequencing). In total, death on D15 of the 3rd dose of bnt162b2 in an 81-year-old kidney transplant patient in whom a COVID infection had been developing for a week with sudden worsening in 12 hours. The patient died on 08Jun2021. An autopsy was not performed.; Reported Cause(s) of Death: COVID-19 aggravated; vaccine failure; cardio respiratory arrest


VAERS ID: 1654730 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-09
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Myocardial infarction, SARS-CoV-2 test, Somnolence
SMQs:, Myocardial infarction (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   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: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101092920

Write-up: sleeping all day; heard attack; Weakness/ lost his energy; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108201320385770-179N7, Safety Report Unique Identifier GB-MHRA-ADR 25828670. An 81-year-old male patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), the first dose via an unspecified route of administration on 05Mar2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced weakness on 09Mar2021. Case narrative: After 4 days receiving the Pfizer the patient lost his energy. He was sleeping all day for 2 days. After 2 days he was better starting walking again. After one week he started again sleeping all day and on 20Mar2021 he had a heard attack and died. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The event weakness was reported as serious due to death. The patient died on 20Mar2021. It was unknown if an autopsy was performed. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date (No - Negative COVID-19 test). The outcome of the event weakness/ lost his energy was fatal, while other events were unknown. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Weakness/ lost his energy


VAERS ID: 1654771 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / 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: 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: HKPFIZER INC202101093308

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority, (Regulatory authority report number: Not provided), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003177), license party for bnt162b2 (COMIRNATY). In the preceding week till 11:59 pm on 15-Aug-2021, DH received three death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. The cases involved three males aged from 54 to 62. This case was split for 1 of 3 death cases. An adult male patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), unknown on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died with unknown cause of death (reported as sudden death) on an unspecified date. There was no clinical evidence that the incident arose from vaccination. The cases were pending assessment by the Ethics Committee. The event unknown cause of death met the seriousness criterion of death. It was unknown if the autopsy was done. The outcome of event was fatal. The causality was assessed by the reporter and per company as possible. Follow-up closed; no further information is possible. Causality Assessments: Drug: COMIRNATY Unknown cause of death Per Primary reporter: Possible Per Company (BioNTech SE): Possible; Sender''s Comments: Based on the information in the case report, a possible causal relationship between the event sudden death and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : HK-PFIZER INC-202101093411 Same reporter/drug/event, different patients; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1654772 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101093307

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable health professional via Regulatory Authority (regulatory authority report number: not applicable), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003178), license party for bnt162b2(COMIRNATY). The health professional reported 8 reports and this is 1 of 8 reports This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. In the preceding week till 11:59 pm on 15-Aug-2021, DH received three death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. The cases involved three males aged from 54 to 62. This case was split for 1 of 3 death cases. A male patient with unknown age started to receive BNT162B2 (COVID-19 vaccine, Formulation: Solution for injection, Batch/Lot Number was not reported) via unknown route on unspecified date, as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications and past product were not reported. There was no clinical evidence that the incident arose from vaccination. The cases were pending assessment by the Expert Committee. The event unknown cause of death met the seriousness criterion of death. The patient died on an unknown date. It was unknown if the autopsy was done. Initial report was received on 19-Aug-2021. This is one of 8 reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003173 (master case), 2021FOS003174, 2021FOS003175, 2021FOS003176, 2021FOS003177, 2021FOS003178, 2021FOS003179, and 2021FOS003180. A marketing authorization holder of one of COVID-19 vaccine Tozinameran. This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Follow-up closed, no further information is possible; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1654773 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101093306

Write-up: UNKNOWN CAUSE OF DEATH; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (regulatory authority report number: not applicable), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003179), license party for BNT162B2 (COMIRNATY). The healthcare professional reported 8 reports and this was 1 of 8 reports. In the preceding week till 23:59 on 15Aug2021, DH received three death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. The cases involved three males aged from 54 to 62. This case was split for 1 of 3 death cases. A male patient with an unknown age received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: not reported), via an unknown route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. On an unknown date, patient died. It was unknown if the autopsy was done. There was no clinical evidence that the incident arose from vaccination. The cases were pending assessment by the Expert Committee. The event unknown cause of death met the seriousness criterion of death. Initial report was received on 19Aug2021. This was one of 8 reports received from the same reporter and this case had been linked with others. Link AER numbers were as follows: 2021FOS003173 (master case), 2021FOS003174, 2021FOS003175, 2021FOS003176, 2021FOS003177, 2021FOS003178, 2021FOS003179, and 2021FOS003180. A marketing authorization holder of one of COVID-19 vaccine Tozinameran. This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Follow-up closed, no further information is possible.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1654776 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Disease recurrence, Hypercholesterolaemia, Hypertension, Ischaemic cardiomyopathy
SMQs:, Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow), Lipodystrophy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CRESTOR; MOVICOL PLAIN; AQUEOUS [EMULSIFYING WAX;PARAFFIN, LIQUID;WHITE SOFT PARAFFIN]; LERCANIDIPINE; ETOFLAM [ETOFENAMATE]; PARACETAMOL; SOLPADOL [CODEINE PHOSPHATE;PARACETAMOL]; CARDURA XL; RAMIPRIL; CALCICHEW-D3 FORTE; ZIMOVANE; IMODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerotic cardiovascular disease; Chronic kidney disease; Cognitive impairment (Had recently displayed signs of mild cognitive impairment); Emphysema; Kyphoscoliosis; Left cataract extraction; Lower urinary tract infection; Osteoporosis; Trochanteric femoral fracture (Conservative management)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101090377

Write-up: HYPERCHOLESTEROLAEMIA; HYPERTENSION; ISCHEMIC CARDIOMYOPATHY; CALCIFIC CORONARY ARTERY DISEASE WITH AORTIC AND MITRAL VALVULAR DISEASE; CALCIFIC CORONARY ARTERY DISEASE WITH AORTIC AND MITRAL VALVULAR DISEASE; This is a spontaneous report from contactable physicians downloaded from the Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-066625, Safety Report Unique Identifier IE-HPRA-2021-066625. An elderly female patient of unspecified age received BNT162B2 (COMIRNATY, Lot number was not reported and Expiration date was unknown), via an unspecified route of administration on 10Feb2021 as single dose for COVID-19 immunisation. Medical history included arteriosclerotic cardiovascular disease from unspecified date, trochanteric femoral fracture from 2019 to an unknown date (Conservative management), lower urinary tract infection from unspecified date, cognitive impairment from unspecified date (Had recently displayed signs of mild cognitive impairment), kyphoscoliosis from unspecified date, emphysema from unspecified date, left cataract operation from 15Aug2020, chronic kidney disease from unspecified date, osteoporosis from unspecified date. Concomitant medications included rosuvastatin calcium (CRESTOR); macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL PLAIN) taken from 08Jul2020; emulsifying wax, paraffin, liquid, white soft paraffin (AQUEOUS) from 13Jan2021; lercanidipine (Manufacturer unknown); etofenamate (ETOFLAM); paracetamol (Manufacturer unknown); codeine phosphate, paracetamol (SOLPADOL); doxazosin mesilate (CARDURA XL); ramipril (Manufacturer unknown); calcium carbonate, colecalciferol (CALCICHEW-D3 FORTE); zopiclone (ZIMOVANE) and loperamide hydrochloride (IMODIUM). The patient experienced calcific coronary artery disease with aortic and mitral valvular disease, hypercholesterolaemia, hypertension, ischemic cardiomyopathy, all on an unspecified date in 2021. Case narrative: On 10Feb2021, the patient was vaccinated with COVID-19 vaccine (batch no: unknown). The patient went to bed at 7 pm. On 11Feb2021, in the morning, the patient was found dead by a relative. It was reported that the patient had been well up to this time. The case was referred for a post-mortem due to death and it''s proximity to COVID-19 vaccination in an otherwise well woman. It was reported that the patient''s cause of death was ischemic cardiomyopathy with calcific coronary artery disease and aortic and mitral valvular disease. Hypertension and Hypercholesterolaemia. During the autopsy the main findings were; minor superficial injuries, mild emphysema, kyphoscoliosis, osteoporosis, calcific coronary artery disease with mitral valvular disease and aortic valvular disease and chronic kidney disease. It was noted that there was very minor abrasions to the face and bruising to the knees, in keeping with collapse-type injuries. Trauma did not play a role in the death in this case. In the Respiratory System, there was pulmonary congestion and oedema. There was mild emphysematous changes noted. Pulmonary emboli were not identified. In the Gastrointestinal System, there was significant abnormality. In the Genito-urinary System, there was moderate chronic kidney disease. In the Central Nervous System, there was no evidence of recent cerebral pathology or brain trauma. There was microvascular disease. The patient received her COVID-19 vaccine (comirnaty) on the day of her death (as reported), blood was sent for tryptase, this could not be carried out in this case due to postmortem clotting. However, there was no history of any reaction to the injection at the time of autopsy and therefore an allergic reaction was very unlikely. There was no evidence of thrombosis. The events were reported as serious due to death. The patient died on 11Feb2021. An autopsy was performed that revealed hypercholesteremia, hypertension and ischaemic cardiomyopathy with calcific coronary artery disease with mitral valvular disease and aortic valvular disease. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : IE-HPRA-2021-066618; Reported Cause(s) of Death: CALCIFIC CORONARY ARTERY DISEASE WITH AORTIC AND MITRAL VALVULAR DISEASE; Autopsy-determined Cause(s) of Death: HYPERCHOLESTEREMIA; HYPERTENSION; ISCHAEMIC CARDIOMYOPATHY WITH CALCIFIC CORONARY ARTERY DISEASE WITH MITRAL VALVULAR DISEASE AND AORTIC VALVULAR DISEASE


VAERS ID: 1654806 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood smear test, Cardiac failure, Gait inability, Granulocyte count, Hallucination, Laboratory test, Leukocytosis, Polymerase chain reaction, White blood cell count
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDE
Current Illness: Gallbladder stones; Hernia (Right inguino-scrotal hernia); Tachycardia paroxysmal ventricular (Sporadic TPSV (paroxysmal supraventricular tachycardia))
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract (Ocular cataract operated on the left); Ischaemic stroke (Previous ischemic stroke)
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: peripheral smear; Result Unstructured Data: Test Result:no blasts; Comments: peripheral smear; Test Date: 20210614; Test Name: Granulocyte count; Result Unstructured Data: Test Result:44000; Comments: / mmc; Test Date: 20210614; Test Name: Chemistry NOS; Result Unstructured Data: Test Result:unknown; Test Date: 20210614; Test Name: PCR; Result Unstructured Data: Test Result:166; Test Date: 20210614; Test Name: leucocyte count; Result Unstructured Data: Test Result:48540; Comments: / mmc
CDC Split Type: ITPFIZER INC202101086496

Write-up: .Behavioral changes with hallucinations, walking impossible. Development of persistent inflammation and leukocytosis, heart failure with progressive worsening up to death.; Behavioral changes with hallucinations, walking impossible. Development of persistent inflammation and leukocytosis, heart failure with progressive worsening up to death.; Behavioral changes with hallucinations, walking impossible. Development of persistent inflammation and leukocytosis, heart failure with progressive worsening up to death.; Behavioral changes with hallucinations, walking impossible. Development of persistent inflammation and leukocytosis, heart failure with progressive worsening up to death.; This is a spontaneous report from a contactable physician, downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-772074. A 91-year-old male patient received BNT162B2 (COMIRNATY) intramuscularly on 11Jun2021 (Batch/Lot Number: FC1526) as dose 1 at 0.3 ml single for COVID-19 immunisation. Medical history included ongoing Sporadic tachycardia paroxysmal ventricular (TPSV) (paroxysmal supraventricular tachycardia), ocular cataract operated on the left, previous ischemic stroke, ongoing right inguino-scrotal hernia, and ongoing gallbladder stones. Concomitant medication included furosemide. The patient experienced behavioral changes with hallucinations, walking impossible. development of persistent inflammation and leukocytosis, heart failure (decompensation cardiac) on 14Jun2021 with progressive worsening up to death on 02Jul2021. Lab data on 14Jun2021 included leucocyte count 48540 / mmc, granulocyte count 44000 / mmc, PCR 166 Peripheral smear: no blasts. The outcome of events other than decompensation cardiac was unknown. It''s unknown if autopsy performed. No follow up attempts needed, no further information is expected.; Reporter''s Comments: Requested clinical report on the case.; Reported Cause(s) of Death: heart failure


VAERS ID: 1654808 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101089107

Write-up: Cerebral haemorrhage 24 hours after administration of the second dose of the pfizer vaccine; This is a spontaneous report from a contactable consumer downloaded from the Agency EudraVigilance-WEB, regulatory authority number IT-MINISAL02-772888. A 82-year-old female patient received BNT162B2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 18Mar2021 (Lot Number: ET3620) as dose 2, 0.3 mL, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cerebral haemorrhage 24 hours after administration of the second dose of the pfizer vaccine on 19Mar2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter comment: The doctor was warned but refused to report the event No follow-up attempts possible. No further information expected.; Reporter''s Comments: The doctor was warned but refused to report the event; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1654836 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

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: LIXIANA; AMLODIPINE [AMLODIPINE BESILATE]; BERAPROST SODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic thromboembolic pulmonary hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101091374

Write-up: oedema lower limb; shortness of breath; the family found the patient dead at home; This is a spontaneous report from a contactable physician received via Regulatory Authority. A 78-year-old male patient received second dose of received bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 02Aug2021 18:15 (Batch/Lot Number: FF0843; Expiration Date: 31Oct2021) at the age of 78-year-old, as dose 2, single for covid-19 immunisation. Medical history included chronic thromboembolic pulmonary hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included edoxaban tosilate (LIXIANA); amlodipine besilate (AMLODIPINE); beraprost sodium within 2 weeks of vaccination. On 12Jul2021 at 17:45, the patient received the first dose of BNT162b2 (COMIRNATY, Lot# EY0572, Expiration date 31Oct2021) intramuscularly in the left arm. On 02Aug2021 at 18:15, the patient received?the second single dose of BNT162b2. On 17Aug2021 (fifteen days after the vaccination), the patient experienced oedema lower limb and shortness of breath. On 21Aug2021 (nineteen days after the vaccination), the family found the patient dead at home. The date of death was reported as Aug2021. It was unknown if autopsy performed, and unknown if treatment received for the event. The reporting physician assessed the event as serious (death). The causal relationship to the vaccine was not provided. The outcome of oedema lower limb and shortness of breath was unknown. The patient has not been tested for COVID-19 since the vaccination.; 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: the family found the patient dead at home


VAERS ID: 1654837 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-23
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-23
   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: VALSARTAN; NIFEDIPINE; CARBOCISTEINE; MIYA BM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis chronic; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101091529

Write-up: patient died at home; This is a spontaneous report from a contactable physician received via Regulatory Authority. A 80-years-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 05Aug2021 12:00 (Batch/Lot Number: FD1945; Expiration Date: 31Oct2021) age at vaccination of 80-years-old, as single dose, for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, bronchitis chronic from an unknown date and unknown if ongoing. It was unknown if the patient had allergies. On 08Jul2021 at 12:00, the patient received the first dose of BNT162b2 (COMIRNATY, Lot# FC8736, Expiration date 30Sep2021) intramuscularly in the left arm. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valsartan (VALSARTAN) taken for an unspecified indication, start and stop date were not reported; nifedipine (NIFEDIPINE) taken for an unspecified indication, start and stop date were not reported; carbocisteine (CARBOCISTEINE) taken for an unspecified indication, start and stop date were not reported; clostridium butyricum (MIYA BM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Aug2021 at 11:00 (eighteen days after the vaccination), the patient died at home; cause of death, if autopsy performed were unknown. The patient did not receive any treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician assessed the event as serious (death).; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: patient died at home


VAERS ID: 1654838 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202101091594

Write-up: Myocarditis; This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), on an unspecified date in 2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. Clinical course included: On unknown date in 2021 (the day of vaccination), the patient received a dose of BNT162b2 as a single dose for COVID-19 immunization.On unknown date in 2021 (unknown days/hours/minutes after the vaccination), the patient experienced myocarditis. On unknown date in 2021 (unknown days after the vaccination), the outcome of the event was fatal. 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.; Sender''s Comments: A causal association between BNT162B2 and the reported fatal myocarditis cannot be completely excluded based on temporal relationship. However, it is important to note that medical history and concomitant medications were not provided to determine pre-existing risk factors or conditions that may have led to the event. 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: Myocarditis


VAERS ID: 1654841 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-15
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   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: CHLORPROMAZINE HYDROCHLORIDE; HALOPERIDOL; BIPERIDEN HYDROCHLORIDE; BROMOCRIPTINE MESILATE; FLUNITRAZEPAM; BROTIZOLAM; NITRAZEPAM; SODIUM PICOSULFATE; LEVOCETIRIZINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Schizophrenia
Allergies:
Diagnostic Lab Data: Test Date: 20210810; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101093415

Write-up: Pneumonia; This is a spontaneous report from a contactable physician received from the Agency (DA). Regulatory authority report number is v21124484. The patient was a 49-year and 5-month-old female. Body temperature before vaccination was 36.7 degrees centigrade. The family history was not provided. The patient had medical history of schizophrenia. The concomitant medications included chlorpromazine hydrochloride (CHLORPROMAZINE HYDROCHLORIDE) 370 mg/day, haloperidol (HALOPERIDOL) 100 mg/day, biperiden hydrochloride (BIPERIDEN) 4 mg/day, bromocriptine mesylate (BROMOCRIPTINE) 15 mg/day, flunitrazepam (FLUNITRAZEPAM) 2 mg/day, brotizolam (BROTIZOLAM) 0.25 mg/day, nitrazepam (NITRAZEPAM) 8 mg/day, sodium picosulfate hydrate (SODIUM PICOSULFATE) 7.5 mg/day, and levocetirizine hydrochloride (LEVOCETIRIZINE HYDROCHLORIDE) 5 mg/day. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 10Aug2021 at 16:55 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0572, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 15Aug2021 at 10:20 (4 days/17 hours/25 minutes after the vaccination), the patient experienced pneumonia. On 15Aug2021 (5 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 15Aug2021, at 10:00 (4 days, 17 hours, and 5 minutes after vaccination), the patient spoke in a whisper, and she had complexion ill. At 10:20 (4 days, 17 hours, and 25 minutes after vaccination), when the physician visited the patient''s room, the patient was confirmed to have respiratory arrest. Oxygen 10 L/minute Ambu bag was used, and cardiopulmonary resuscitation (CPR) and AED analysis were performed. Shock was not required, and adrenaline was administered. Since the patient had difficulty in opening the mouth, an intubation could not be performed. At 10:55 (4 days and 18 hours after vaccination), the patient was confirmed to die. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was pneumonia. The reporting physician commented as follows: The causality was unassessable, and it was considered that the event was unrelated to the vaccination. However, since this was death case, this case was reported.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1654842 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aneurysm ruptured
SMQs:, Haemorrhage terms (excl laboratory terms) (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: JPPFIZER INC202101094667

Write-up: Aneurysm ruptured; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A female patient in her 80s received bnt162b2 (COMIRNATY; Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 (in her 80s) as single dose for covid-19 immunisation. The family history and medical history were not provided. Concomitant medications were not reported. On unknown date in 2021 (unknown days/hours/minutes after the vaccination), the patient experienced aneurysm ruptured. On unknown date in 2021 (unknown days after the vaccination), the patient died, the outcome of the event was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: The patient was the mother of another patient who visited the outpatient department of the reporting physician. The patient who had a side reaction suspected was not a patient of the reporting physician, and it was unknown where the patient received the vaccination (as reported). Since the event occurred one week or longer after BNT162b2 vaccination, the causality between the event and BNT162b2 vaccination was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events aneurysm ruptured 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: Aneurysm ruptured


VAERS ID: 1654843 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9909 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101095763

Write-up: Death (details unknown); This is a spontaneous report from a physician via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was a 74-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no relevant past drug history. There were no known allergies. Other medical history was unknown. Concomitant medications were unknown. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19 since the vaccination. On 10Aug2021 at 10:00 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY), Solution for injection, Lot number FC9909, Expiration date 30Sep2021, intramuscularly in the left arm for COVID-19 immunisation at age of 74-year-old. On 24Aug2021 (14 days after the vaccination), the patient experienced death (details unknown).The reporter stated that the adverse event resulted in death on 24Aug2021. The death cause was unknown. It was unknown whether autopsy was performed. It was unknown whether treatment was given for the adverse event. The reporting physician assessed the event as serious (death). The causality of the event was not reported.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events death and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 1654845 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-08-19
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   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: Test Date: 20210819; Test Name: Waveform; Result Unstructured Data: Test Result:asystole
CDC Split Type: JPPFIZER INC202101098407

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21124541. A 90-year and 4-month-old female patient received second dose of bnt162b2 (COMIRNATY; Lot number was not reported), via an unspecified route of administration on 28Jun2021 as single dose for covid-19 immunisation . Body temperature before vaccination was not reported. Information on medical history and concomitant medications was unknown. It was not reported if the patient had family history. The patient previously received the first dose of BNT162b2 (COMIRNATY) on an unspecified date as a single dose for COVID-19 immunization. On 19Aug2021 (1 month 22 days after the vaccination), the patient experienced cardio-respiratory arrest and died. It was not reported if an autopsy was performed. The course of the events was as follows: Cardiopulmonary arrest (CPA) developed outside the hospital. Although cardiopulmonary resuscitation (CPR) was performed, there was waveform showing asystole and it was considered difficult to perform resuscitation and then the CPR was cancelled. The patient''s death was confirmed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported if there were other possible causes of the event such as any other diseases.The lot number for BNT162b2 was not provided and will be requested during follow up; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1654846 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-08-20
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-08-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101098432

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician of emergency room received from the Regulatory Authority (RA). Regulatory authority report number is v21124542. A 91-years-old female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Jun2021 (Lot Number: FA2453; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EX3617, Expiration date 31Aug2021). The patient medical history was not reported. The patient''s concomitant medications were not reported. On 20Aug2021 at around 22:40 (2 months 4 days after the vaccination), the patient experienced cardiac arrest. On 20Aug2021 (2 months 4 days after the vaccination), the patient died. The patient was unresponsive, and emergency medical services were requested. The patient was in a state of cardiac arrest. She did not respond to the resuscitation, and then died. The patient underwent lab tests and procedures which included body temperature: 36.3 centigrade on 10Jun2021 before vaccination. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. As for other possible causes of the event such as any other diseases, details were unknown.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1654847 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-23
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Arteriogram, Cardiac failure acute, Cardiogenic shock, Coronary artery thrombosis, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: Coronary angiography; Result Unstructured Data: Test Result:occlusion; Comments: occlusion from left main trunk to left anterior descending coronary artery
CDC Split Type: JPPFIZER INC202101098444

Write-up: Acute myocardial infarction; Coronary artery thrombosis; cardiac failure acute; pulmonary oedema; cardiogenic shock; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21124540. A 72-years-old male patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on Jul2021 (Batch/Lot number was not reported) as single dose (at he age of 72) for covid-19 immunisation. First dose of COMIRNATY was received on an unknown date. Body temperature before vaccination was unknown. Family history was not reported. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced acute myocardial infarction on 23Aug2021 19:50, coronary artery thrombosis on 23Aug2021 19:50 , cardiac failure acute on 23Aug2021 19:50, pulmonary oedema on 23Aug2021 19:50, cardiogenic shock on 23Aug2021 19:50. On 23Aug2021 at 19:50, the patient experienced acute myocardial infarction and coronary artery thrombosis. On 24Aug2021, the outcome of the events was fatal. The course of the events was as follows: On 23Aug2021 at 19:50, the patient had subjective symptom of chest pain and requested ambulance. At 20:30, during the emergency transport, the patient experienced cardiac arrest. At 20:35, the patient arrived at hospital and cardiac arrest was continuing. Percutaneous cardiopulmonary support (PCPS) was introduced and coronary angiography was performed, which revealed occlusion from left main trunk to left anterior descending coronary artery. Percutaneous coronary intervention (PCI) was performed; however, the patient could not be withdrawn from shock. The patient died on 24Aug2021. It was not reported if an autopsy was performed. The reporting physician classified the events as serious (death) and assessed that the causality between the events and BNT162b2 as unassessable. Other possible cause of the events such as any other diseases was not provided. The reporting physician commented as follows: The patient died of acute myocardial infarction, cardiac failure acute, pulmonary oedema, and cardiogenic shock; however, effect of coronavirus vaccine could not be denied. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Coronary artery thrombosis; acute myocardial infarction; cardiac failure acute; pulmonary oedema; cardiogenic shock


VAERS ID: 1654882 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6127 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Embolic stroke, General physical health deterioration, Pneumonia
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 133
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: Anorexia; Atrial fibrillation; COPD; Dehydration; Infarction; Malnutrition; Reduced general condition; TIA
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101086734

Write-up: EMBOLIC STROKE; REDUCED GENERAL CONDITION; PNEUMONIA; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number is NO-NOMAADVRE-FHI-2021-Uxand2. A 79-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 29Apr2021 (lot number: EW6127) as single dose for COVID-19 immunisation. Medical history included reduced general condition, atrial fibrillation, chronic obstructive pulmonary disease (COPD), anorexia, malnutrition, dehydration, transient ischaemic attack (TIA) from 2007 and infarctions from 2008. Concomitant medications were not reported. The patient got reduced general condition and pneumonia the same month (in Apr2021) as vaccination with bnt162b2, first dose. She was in reduced general condition from before, but it escaleted after vaccination. She was hospitalized several times the following months after vaccination, had an embolic stroke in Aug2021 and died 12Aug2021. All events were reported as serious with seriousness criteria of death. The outcome of all events was fatal. It was not reported if an autopsy was performed. Relatives wanted to report as an AE due to the time correlation. It was uncertain whether it was a causal relationship to the vaccine. Reporter and hospital doctor did not think there was a relationship between the events and vaccination. Relatedness of drug to reaction(s)/event(s) ALL by Source of assessment-Regulatory Authority-Possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonia; Embolic stroke; Reduced general condition


VAERS ID: 1654889 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-09
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Decreased appetite, Dysarthria, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), 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: PHJNJFOC20210852673

Write-up: APPETITE LOST; WEAKNESS; HEADACHE; SLURRED SPEECH; FEVER; CHILLS; This spontaneous report received from a physician via a Regulatory Authority [PHIFDA, PH-PHFDA-300101328] concerned a 72 year old male 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, batch number: 1-213C21A, expiry: unknown) dose was not reported, frequency time 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021 22:00, the patient experienced fever, chills, weakness, headache, slurred speech. On 17-AUG-2021 22:00, the patient experienced appetite lost. On an unspecified date, the patient died due to fever, chills, appetite lost, weakness, headache, and slurred speech. It was unknown that 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: 20210852673-COVID-19 VACCINE AD26.COV2.S- Fever, chills, appetite lost, weakness, headache, and slurred speech. 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; CHILLS; APPETITE LOST; WEAKNES; HEADACHE; SLURRED SPEECH


VAERS ID: 1654890 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Haematoma, Malaise
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: Blood pressure; Result Unstructured Data: Elevated
CDC Split Type: PHJNJFOC20210852762

Write-up: HEMATOMA; GENERAL MALAISE; ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300100484] concerned a 74 year old female of unknown race and ethnicity. 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: 213C21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) Elevated. On 08-AUG-2021, the patient experienced hematoma on both upper and lower extremities and body malaise. On an unspecified date, the patient died from elevated blood pressure, hematoma, and general malaise. 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: 20210852762-COVID-19 VACCINE AD26.COV2.S-blood pressure, hematoma, and general malaise. 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: ELEVATED BLOOD PRESSURE; HEMATOMA; GENERAL MALAISE


VAERS ID: 1654891 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-08
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205024 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852828

Write-up: COVID-19; COUGH; SHORTNESS OF BREATH; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300100971] concerned a 57 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 and batch number: 205024 expiry: Unknown) dose was not reported, 1 total, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, the patient experienced cough, shortness of breath. On an unspecified date, the patient experienced covid-19, and was hospitalized. On an unspecified date, the patient died from cough, shortness of breath, and covid-19. 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, Life Threatening and Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210852828-Covid-19 vaccine ad26.cov2.S- Covid-19, Cough, 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: COUGH; SHORTNESS OF BREATH; COVID-19


VAERS ID: 1654892 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21AL2021060 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852838

Write-up: LEG PAIN WITH CELLULITIS; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 48 year old male of unspecified race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 213C21AL2021060 expiry: unknown) dose was not reported, 1 total administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021 at 14:40, the patient experienced leg pain with cellulitis, and was hospitalized (date unspecified). On an unspecified date, the patient died from leg pain with cellulitis. It was unknown if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0- 20210852838-Covid-19 vaccine ad26.cov2.S-Leg pain with cellulitis. 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: LEG PAIN WITH CELLULITIS


VAERS ID: 1654894 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Cough, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), 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: PHJNJFOC20210852924

Write-up: LOSS OF TASTE; FEVER; COUGH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA: PH-PHFDA-300101403] concerned an 83 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 209021A expiry: unknown) dose was not reported, 1 total, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced cough and fever. On 15-AUG-2021, the patient experienced loss of taste. On an unspecified date, the patient died from cough, loss of taste, and fever. 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: 20210852924 -covid-19 vaccine ad26.cov2.s- cough, loss of taste, and fever. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COUGH; LOSS OF TASTE; FEVER


VAERS ID: 1654895 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852972

Write-up: MUSCLE PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300101184] concerned a 62 year old female of unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A, expiry: unknown) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021 08:00, the patient experienced muscle pain, and was hospitalized (date unspecified). It was reported that 8 days after vaccination, the patient had loss of appetite and body malaise. On an unspecified date, the patient died from muscle pain. 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, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210852972-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Muscle pain. 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: MUSCLE PAIN


VAERS ID: 1654898 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: 20210811; Test Name: Body temperature; Result Unstructured Data: =38?C
CDC Split Type: PHJNJFOC20210853148

Write-up: FEVER =38?C; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300101308] concerned a 74 year old female 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, intramuscular, batch number: unknown; expiry: unknown) dose was not reported, start therapy date was 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 11-AUG-2021, the patient experienced fever greater than or equal to 38-degree C. Laboratory data included: Body temperature (NR: not provided) greater than or equal to 38-degree C. It was reported that, one week after vaccination the patient developed fever followed by cough. On 13-Aug-2021, the patient developed difficulty of breathing and was brought to the institution, but she expired along the way. It was unspecified if an autopsy was performed. On an unspecified date, the patient died from fever greater than or equal to 38-degree C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0-20210853148-Covid-19 vaccine ad26.cov2.S- Fever greater than or equal to 38 degree C. 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: FEVER =38?C


VAERS ID: 1654903 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4342 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death neonatal, Maternal exposure timing unspecified
SMQs:, Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202101086729

Write-up: perinatal death of a newborn; Maternal Drug Exposure; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is PL-URPL-3-819-2021. A fetus patient of an unspecified gender received the first dose of BNT162B2 (COMIRNATY) via transplacental (parent route of administration: intramuscular) on 08Jun2021 17:30 (Lot Number: FD4342; Expiration Date: 30Sep2021) as single dose for COVID-19 immunisation. The patient''s mother is a 25-year-old female, age at the vaccination is also 25-year-old. The mother medical history included pregnancy normal. The mother delivered the pregnancy via cesarean delivery. The fetal outcome is neonatal death. The patient medical history and concomitant medications were not reported. The patient had maternal drug exposure on 08Jun2021 17:30, perinatal death of a newborn on 14Jun2021 09:49. Seriousness of the events was reported as death, hospitalization (from Jun2021), medically significant. The outcome of the events was fatal. The patient died on 14Jun2021. It was unknown if an autopsy was performed. Clinical course: The notification (notification type: parent-child) PL-URPL-3-819-2021 was sent to Agency via the system on 25Jun2021 from the district sanitary and epidemiological station. Report related to PL-URPL-3-812-2021 (the report concerns the mother of the deceased patient). Amniotic fluid drained within 5 days after administration of 1st dose of the vaccine on 13Jun2021, surgical delivery, perinatal death of the newborn, a blood clot was found in the umbilical vein afterbirth. After medical consultation, it was established: the course of pregnancy without complications without comorbidities. The reporting person classified them as severe. Due to the assessment of the reporting person, the nature of the side effects and the death of the newborn, the agency classified the report as "serious". Health result: death (on 14Jun2021). The data contained in the electronic report are all available to agency - in the case of obtaining additional information, another version will be sent. Sender''s comment: Report related to PL-URPL-3-812-2021 (the report concerns the mother of the deceased patient). COMIRNATY is an mRNA vaccine against COVID-19 (with modified nucleosides). All reported adverse reactions are not included in COMIRNATY''S Summary of Product Characteristics. Until 07Jul2021 in the database, 13 cases of fetal death were reported after the administration of the COMIRNATY vaccine to the mother. Agency sent an e-mail to the relevant sanitary and epidemiological station with a request for additional information (including: regarding the mother''s medical history (possible chronic diseases, medications used, etc.) and on which week of pregnancy the patient took the vaccine. with a station employee, it was found that the station asked the hospital in writing for the patient''s medical documentation, which, if obtained, will be forwarded to agency, and a follow-up will be sent to EV. The temporal relationship speaks for a cause-and-effect relationship. The reporting person classified them as severe. Due to the assessment of the reporting person, the nature of the side effects and the death of the newborn, the ARMP classified the report as "serious". Relatedness of drug to all reactions/events Source of assessment: NCA Method of assessment: agency Result of Assessment: unclassifiable No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : PL-PFIZER INC-202101086726 mother case; Reported Cause(s) of Death: perinatal death of a newborn; Maternal Drug Exposure


VAERS ID: 1654917 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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 Name: Covid-19 test; Result Unstructured Data: Test Result:Delta infection have been registered
CDC Split Type: ROPFIZER INC202101085751

Write-up: one person vaccinated with complete scheme had been infected with COVID 19 , Delta type and died; one person vaccinated with complete scheme had been infected with COVID 19 , Delta type and died; Report from Medical Life, 2021, 32 (1644); page 3 entitled Anti-COVID vaccination, IN ALMOST ALL COMMUNES. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, reported as "vaccination activities against COVID-19"), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In recent weeks, there is a slow but sustained increase in the number of cases. Thus, the analysis performed by the Institute of Public Health for the last two weeks of July showed that 81.5% of the newly confirmed cases and 92.6% of the deaths are registered in unvaccinated persons. According to the report published by the National Institute of Public Health, as of August 8th (08Aug2021), a total of 313 cases of Delta infection have been registered. Of these new cases, over 80% occurred in unvaccinated individuals. A total of 19 deaths were recorded, of which only one person vaccinated with complete scheme. The patient underwent lab tests and procedures which included covid-19 virus test showed that delta infection have been registered on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. The information about lot number and expiration date cannot be obtained. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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/Delta type and died; COVID-19/Delta type and died


VAERS ID: 1654942 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZER INC202101087038

Write-up: Covid-19; Covid-19; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Biontech manufacturer control number 81317, license party for BNT162B2. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient vaccinated with 2 doses of Covid 19 M-RNA gene therapy vaccine which was biontech, but had covid 19 and died, patient''s spouse was also had covid-19 and was intubated, was currently alive. Reporter required information about vaccine protection, if patient had covid-19 because two doses were not enough and should the 3rd dose be given. The outcome of the events was fatal. The patient died due to Covid-19 on unknown date. It was not reported if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Covid-19; Covid-19


VAERS ID: 1655346 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood test, COVID-19 pneumonia, Cough, Death, Diarrhoea, Dyspnoea, Fatigue, Headache, Oxygen saturation decreased, Pain, SARS-CoV-2 antibody test, SARS-CoV-2 test, Thrombosis, X-ray
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; High cholesterol; Seasonal allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: blood tests; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Test Date: 20210803; Test Name: Sars-cov-2 antibody test; Result Unstructured Data: Test Result:positive; Test Date: 20210612; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:positive; Test Date: 20210803; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:positive; Test Date: 20210803; Test Name: x-rays; Result Unstructured Data: Test Result:UNKNOWN RESULTS
CDC Split Type: ZAPFIZER INC202101090680

Write-up: potential blood clot; Coughing; Diarrhoea; Body aches; passed away; Oxygen levels started to fall; Severe shortness of breath; Bilateral atypical infiltrates consistent with moderate Covid-19 pneumonia; High blood pressure; Tired; Severe headache; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included patient tested positive for Covid-19 on 12Jun2021, high cholesterol and seasonal allergies. The patient''s concomitant medications cholesterol medications. The patient was reported to have experienced high blood pressure on 22Jul2021 after vaccination, later on the same day the patient complained of tiredness, severe headache. The patient was reported to have made notes about the adverse events he experienced which included coughing, breathing difficulty, and received therapeutic interventions, diarrhoea and body aches. On 27Jul2021, the patient consulted a general practitioner (GP), he was prescribed with antibiotics. On 30Jul2021, the patient saw a second doctor who suspected Covid-19 as symptoms were typical to Covid-19 symptoms. The patient was prescribed with medications, name of treatment not specified. The doctor also recommended test for Covid-19. On 31Jul2021, the symptoms are reported to have got worse, oxygen levels started to fall (oxygen saturation decreased) and had slight shortness of breath, with raised blood pressure and running stomach. Oxygen machine was acquired at home setting, was put on nasal oxygen. There were improvements in his oxygen levels, which fluctuated. On 01Aug2021, the medical doctor advised that the patient goes for Covid-19 test, on 03Aug2021 the patient went to hospital (not admitted) for medical tests/blood tests and -x-rays including Covid-19 test, and tested positive for Covid-19 (Sars-cov-2 antibody test positive). The doctors are said to have been concerned about potential blood clots and commented that there were bilateral atypical infiltrates consistent with moderate covid-19 pneumonia (covid-19 pneumonia), he had high infection count (covid-19). He was given medication for diarrhea, and also adjusted medications for blood thinning & infection. The symptoms continued. On 05Aug2021, the patient was admitted to hospital; tests were done, there were concerns of thickness of blood/potential blood clot (blood viscosity increased). On 06Aug2021, he developed severe shortness of breath. He was transferred to another hospital on 08Aug2021 mourning, he passed away on the evening of 08Aug2021. Tests included Sars-cov-2 test: positive both on 12Jun2021 and 03Aug2021. It was not reported if an autopsy was performed. The outcome of passed away was fatal, Bilateral atypical infiltrates consistent with moderate covid-19 pneumonia, high blood pressure, coughing and oxygen levels started to fall was unknown, of other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: passed away


VAERS ID: 1656737 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-11
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Haemoglobin, Myelosuppression, Platelet count, Procalcitonin, Septic shock, Thrombocytopenia, White blood cell count
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Toxic-septic shock conditions (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: CRP; Result Unstructured Data: Test Result:increased; Test Date: 20210816; Test Name: hemoglobin; Result Unstructured Data: Test Result:5.2; Test Date: 20210816; Test Name: thrombocytes; Result Unstructured Data: Test Result:0; Test Date: 20210816; Test Name: procalcitonin; Result Unstructured Data: Test Result:increased; Test Date: 20210816; Test Name: leukocytes; Result Unstructured Data: Test Result:0.2
CDC Split Type: DEPFIZER INC202101094946

Write-up: thrombocytes 0; septic shock with bone marrow suppression; septic shock with bone marrow suppression; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority unique case identification number DE-PEI-CADR2021164812, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100168864. A 77-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: unknown, strength: 0.3 ml) (mRNA tozinameran) on 06Aug2021 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus type 2 and arterial Hypertension. It was unknown whether the patient had known of allergies. The patient''s concomitant medications were not reported. On 11Aug2021, the patient experienced thrombocytopenia and septic shock. On 11Aug2021, the patient had cough and fever was at her general practitioner. On 16Aug2021, she was admitted to the intensive care unit with hemoglobin 5.2, thrombocytes 0 and leukocytes 0.2 with increased C-reactive protein and procalcitonin which suggested septic shock with bone marrow suppression. The patient was intubated and reanimated shortly after admission and unfortunately died in a hospital. The patient died on 16Aug2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included hemoglobin: 5.2, thrombocytes: 0, leukocytes: 0.2, C-reactive protein: increased, procalcitonin: increased, all were on 16Aug2021. This report was serious - death. The outcome of events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: septic shock with bone marrow suppression; thrombocytes 0


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