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

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



Case Details

This is page 128 out of 172

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VAERS ID: 1416262 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Circulatory collapse, Histology, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Hypersensitivity (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: Medical History/Concurrent Conditions: Psychosis
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: Administrative autopsy; Result Unstructured Data: Test Result:acute circulatory failure was diagnosed; Test Name: Histologic examination; Result Unstructured Data: Test Result:unknown results
CDC Split Type: JPPFIZER INC2021672512

Write-up: Acute circulatory failure; pyrexia; This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. A female patient in her 60s received the second dose of the bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as at a single dose for covid-19 immunisation. Medical history included mental illness. The patient''s concomitant medications included several drugs including medications to treat mental illness. The patient previously received the first dose of BNT162b2 on an unknown date for covid-19 immunization. The patient received the vaccine as a part of the group vaccination in the town. It was reported that no specific onset of side effects was heard after the first vaccination. On an unspecified date, the patient experienced acute circulatory failure and pyrexia. The clinical course was as follows: on an unknown date at unknown time (the day of vaccination), the patient received the second dose of BNT162b2. On an unknown date in the morning (the next day of the second vaccination with BNT162b2), the patient experienced pyrexia and received an antipyretic orally. On the same day in the late afternoon, the patient died. On 08Jun2021, administrative autopsy was performed, and acute circulatory failure was diagnosed. It was said that the causal relationship would remain unknown unless the results histologic examination were revealed. The patient underwent lab tests and procedures which included administrative autopsy: acute circulatory failure was diagnosed on 08Jun2021 and histologic examination: unknown results on an unknown date. Therapeutic measures were taken as a result of pyrexia. The clinical outcome of the event, pyrexia, was unknown. The clinical outcome of the event, acute circulatory failure, was fatal. The patient died on an unspecified date due to acute circulatory failure. An autopsy was performed that revealed acute circulatory failure. The reporting physician classified the event as serious (death). The causality was not reported. The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up .; Sender''s Comments: The female patient in her 60s had medical history included mental illness and was on multiple concomitant medications. The next day of the second vaccination with BNT162b2, the patient experienced pyrexia and received an antipyretic orally. It was unknown how many pills/tablets she received. The next day she died from acute circulatory failure. Based on information available, the reported fatal event acute circulatory failure was unlikely directly from vaccination with BNT162b2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.; Reported Cause(s) of Death: Acute circulatory failure; Autopsy-determined Cause(s) of Death: Acute circulatory failure


VAERS ID: 1416265 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death, Cardio-respiratory arrest, Myocardial ischaemia
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), Other ischaemic heart disease (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer of sigmoid colon (excl rectosigmoid); Lumbar spine compression fracture
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021694844

Write-up: Ischamic cardiac death; Ischamic cardiac death; cardio-respiratory arrest; This is a spontaneous report from a contactable physician via COVID-19. The patient was a 90-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified 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 cancer of sigmoid colon from 1999 and lumbar spine compression fracture from Jan2021. On 08Jun2021 at 16:30 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, solution for injection, Lot number FA5829, Expiration date 31Aug2021), intramuscular in the left arm for COVID-19 immunisation. After that, there was no skin symptoms or no problem in vital signs. On 11Jun2021 (3 days after the vaccination), the patient''s family member and a caregiver found the patient in cardio-respiratory arrest in the bathroom. Since drowning was suspected, an external examination was given by a medical examiner. As a result, the cause of death was diagnosed as ischemic cardiac death (estimated). On 12Jun2021 at 08:30, ischemic cardiac death was confirmed. Autopsy was not performed. The reporting physician assessed the event as serious (death). Causality was not provided by the reporting physician. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the events of ischemic cardiac death and cardio-respiratory arrest. The reported events may likely represent intercurrent medical conditions in this elderly patient. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Ischemic cardiac death; cardio-respiratory arrest; Ischemic cardiac death


VAERS ID: 1416266 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: REBAMIPIDE; CALONAL; PREDNISOLONE; MAGNESIUM OXIDE; PHYSIOSOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cryptogenic organising pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021695400

Write-up: Cardio-respiratory arrest; Geromarasmus; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution, and received from the Regulatory authority report. The patient was an 89-year-old female (no pregnancy). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received rebamipide, palacetamol (CALONAL), prednisolone, magnesium oxide and gluconate sodium, magnesium chloride, potassium chloride, sodium acetate, sodium chloride (PHYSIOSOL) 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 cryptogenic organising pneumonia. On 20May2021 at 15:30, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscular in the right arm for COVID-19 immunization. On 10Jun2021 at 15:30 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) intramuscular in the right arm for COVID-19 immunization. On 12Jun2021 at 02:30 (35 hours after the second dose), the patient experienced cardio-respiratory arrest. The event resulted in death. The patient died on 12Jun2021 due to geromarasmus. Treatment was not given for the event. An autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19.; Reported Cause(s) of Death: Cardio-respiratory arrest; Geromarasmus


VAERS ID: 1416267 (history)  
Form: Version 2.0  
Age: 99.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute, Cardio-respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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: 2021-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NICARDIPINE HYDROCHLORIDE; CAPTOPRIL; FUROSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021695593

Write-up: Cardiac failure acute; CPA; This is a spontaneous report from a contactable physician received from the Regulatory authority; report number is v21113870. The patient was a 99-year and 6-month-old female. Body temperature before vaccination was 36.2 degrees centigrade. Family history was not reported. Medical history included hypertension. Concomitant medications included nicardipine hydrochloride (NICARDIPINE HYDROCHLORIDE), captopril (CAPTORIL), and furosemide (FUROSEMIDE). On 08Jun2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) intramuscularly as a single dose for COVID-19 immunisation. On 10Jun2021 presumably at 00:00 (2 days after the vaccination), the patient experienced cardiac failure acute and found in cardiopulmonary arrest (CPA) state. On an unknown date, the outcome of the events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: On 08Jun2021 around 14:00 (the day of vaccination), the patient completed receiving the first intramuscular vaccination with BNT162b2. Thereafter, she spent her time without any changes. On 09Jun2021 at night (1 day after the vaccination), the patient spent her time and fell asleep as usual. On 10Jun2021 in the morning (2 days after the vaccination), the patient was found in a state of CPA. No abnormal appearance was found such as bleeding spots or other findings in skin/mucous membrane or other sites. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. It was not reported whether there was other possible cause of the events such as any other diseases. The reporting physician commented as follows: The patient was very old and had been energetic until last night. We considered that this was within the level of the so-called sudden death in the elderly and report this case for your reference considering the vaccination recently given.; Reported Cause(s) of Death: Cardiac failure acute; CPA


VAERS ID: 1416268 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; CANDESARTAN; AMLODIPINE; ROSUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021695600

Write-up: Acute myocardial infarction suspected; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a 77-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received clopidogrel (CLOPIDOGREL), candesartan (CANDESARTAN), amlodipine (AMLODIPINE), and rosuvastatin (ROSUVASTATIN) 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 cerebral infarction, hypertension, and dyslipidaemia. On 07Jun2021 at 10:30 (the day of vaccination), the patient received the first single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA5715, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. On 09Jun2021 at 17:00 (2 days after the vaccination), the patient experienced acute myocardial infarction suspected. The event resulted in emergency room visit, death. The outcome of the event was death. The course of the event was as follows: On 09Jun, at around 19:00, confirmation of death was made (Sudden death). Since the vaccination, the patient has not been tested for COVID-19. An autopsy was not performed.; Sender''s Comments: Based on the information currently available, the reported event acute myocardial infarction suspected more likely represented intercurrent illness, but not related to bnt162b2. The patient''s underlying risk factors/predisposing condition hypertension, dyslipidaemia and the advanced age of the patient have been assessed to have played a contributory role toward 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: suspected acute myocardial infarction


VAERS ID: 1416269 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-08
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   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: Medical History/Concurrent Conditions: Coronavirus test positive; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: CT; Result Unstructured Data: Test Result:unknown results; Test Date: 202101; Test Name: Coronavirus test; Result Unstructured Data: Test Result:positive
CDC Split Type: JPPFIZER INC2021696363

Write-up: Cardiac arrest; This is a spontaneous case from a contactable pharmacist received via a Pfizer sales representative. The patient was a 71-year-old male. The patient had medical history of hypertension and coronavirus test positive from Jan2021. On 28Apr2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunisation. On 19May2021 (the day of vaccination) the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a unknown, single for COVID-19 immunization. On 08Jun2021 (20 days after the vaccination), the patient experienced cardiac arrest. On 08Jun2021 (20 days after the vaccination), the outcome of the event was fatal. The cause of death was cardiac arrest. The course of the event was as follows: On unknown date in Jan2021, the patient was positive for COVID-19, and he was admitted to the reporting hospital. Thereafter, the patient recovered without problems. The vaccination was performed based on the patient''s wish. On 28Apr2021, the patient received the first dose of BNT162b2 vaccination. On 19May2021 the patient received the second dose of BNT162b2 vaccination. Thereafter, the patient was doing a job without problems. On 08Jun2021 (20 days after vaccination), on the day of death, at around 08:00 (20 days and 8 hours after vaccination), the patient greeted his colleagues without particular problems, however, the colleague noticed anything odd with the patient while he was sitting at the desk. Then, the colleague checked his pulse, but the pulse was not palpable, and cardiopulmonary resuscitation was repeatedly performed. However, unfortunately, the patient did not restore breathing. Although the patient was orally taking an antihypertensive drug, the type of the drug was unknown because the provider was unable to see the medical record. CT was performed after the death, however, the results were unknown, either. It was unknown if autopsy was performed. Information about lot/batch number has been requested. The reporting pharmacist classified the event as serious (death) and assessed that the event was possibly related to BNT162b2.; Sender''s Comments: Despite insufficient diagnostic information surrounding the patient''s demise (''CT was performed after the death, however, the results were unknown. It was unknown if autopsy was performed''), due to a plausible drug-event temporal association, the company cannot completely exclude a contributory role of Comirnaty in the occurrence of the reported cardiac arrest. Medical history of hypertension in 71-year-old patient, cannot be also excluded as confounder. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1416271 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021700237

Write-up: dead; This is a spontaneous report from a contactable physician. This is a non-pregnant 74-year-old female patient. The patient had no allergies to medications, food, or other products. The patient had no other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The concomitant medications was reported as none. The patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number: EY2173, Expiration date: 31Aug2021) intramuscularly in the left arm on 22May2021 at 12:45 PM (at the age of 74-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5715, Expiration date 31Aug2021) via intramuscular, in the left arm, on 12Jun2021 at 12:45 (the day of vaccination, at the age of 74-year-old) for COVID-19 immunization. On the morning of 14Jun2021 (2 days after the vaccination), the patient was found dead. The patient died on 14Jun2021 due to unknown cause of death. It was unknown if an autopsy was performed or the patient received treatments for the event. The patient had no disease and was receiving no oral medication. Since the vaccination, the patient has not been tested for COVID-19.; Reported Cause(s) of Death: dead


VAERS ID: 1416272 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Osteoarthritis of lumbar spine; Prostatic hypertrophy; Rhabdomyolysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021702653

Write-up: Death; This is a spontaneous case from a contactable other healthcare professional (employee of a geriatric health service facility) received via a Pfizer employee. An 86-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 24May2021 (Lot Number: EX3617; Expiration Date: 31Aug2021) at age of 86 years old as a single dose for covid-19 immunisation. Medical history included osteoarthritis of lumbar spine, prostatic hypertrophy, and rhabdomyolysis. Concomitant medication was not provided. On 24May2021 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 26May2021 (2 days after the vaccination), the patient died. The cause of death was unknown. It was not reported if an autopsy was performed. The reporting other healthcare professional classified the event as serious (death) and assessed that the event was probably related to BNT162b2. The reporting other healthcare professional commented as follows: Since the event occurred on Day 3 after the vaccination, the causality between the event and BNT162b2 could not be ruled out. However, the cause of death was unknown.; Sender''s Comments: Based on information provided, as a cautionary measure and for reporting purposes, the Company considers that a causal association between the event Death (Unknown cause of death) and the administration of the Covid - 19 vaccine BNT162B2 (COMIRNATY) cannot be completely excluded. The cause of death was unknown. It was not reported if an autopsy was performed. 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: 1416273 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALFACALCIDOL; AMBROXOL HYDROCHLORIDE; DUTASTERIDE; SILODOSIN; ELIQUIS; MAGNESIUM OXIDE; AMLODIPINE [AMLODIPINE BESILATE]; CANDESARTAN [CANDESARTAN CILEXETIL]; POLYSTYRENE SULFONATE CALCIUM; SAIBOKUTO; D-SORBITOL; EFFEXOR SR; ROZEREM; TRAZOD
Current Illness: Hypertension; Renal impairment
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021702666

Write-up: death; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. The patient was an 86-year-old male. Body temperature before vaccination was not provided. The patient family history was not provided. The patient had ongoing medical histories of hypertension and renal impairment. The ongoing concomitant medications included ALFACALCIDOL capsule at 0.5 ug, daily; ambroxol hydrochloride sustained-release OD-tablet (Orodispersible tablet) at 45 mg, daily; DUTASTERIDE capsule 0.5 mg, at 0.5 mg daily; SILODOSIN tablet 4mg, at 8 mg, daily; ELIQUIS tablet, 5 mg, daily; magnesium oxide 330mg, at 660 mg, daily; amlodipine besilate (AMLODIPINE), tablet at 5 mg, daily; candesartan cilexetil (CANDESARTAN) 4mg, at 8 mg, daily; polystyrene sulfonate calcium, granules 89.29%, at 5.6 g, daily; bupleurum falcatum root, glycyrrhiza spp. root, magnolia spp. bark, panax ginseng root, perilla frutescens var. crispa herb, pinellia ternata tuber, poria cocos sclerotium, scutellaria baicalensis root, zingiber officinale rhizome, ziziphus jujuba var. inermis fruit (SAIBOKUTO) extra granules TSUMURA (for medical use), 5 g, daily; D-SORBITOL, oral solution, 75% at 60 mL, daily; Venlafaxine Hydrochloride (EFFEXOR SR), capsule, 75 mg, daily; ramelteon (ROZEREM), tablet 6 mg at 6 mg, daily; trazodone hydrochloride, tablet 25mg at 12.5 mg, daily; quetiapine fumarate (QUETIAPINE) tablet 12.5mg, 6.25 mg, daily. On 11Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration at age of 86 years as single dose for COVID-19 immunization. On unknown date in 2021 (unknown days/hours/minutes after the vaccination), the patient experienced death. On unknown date in 2021 (unknown days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 11Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination at the reporting clinic. Although the patient was scheduled to receive the second dose of BNT162b2 vaccination on 22Jun2021 (11 days after vaccination), it was contacted that the second dose of the vaccination was desired to be canceled. The reason was revealed as death. The date of death was unknown because it could not be heard from the patient''s family. The cause of death was also unknown. The patient had medical examination history in the reporting clinic 13 years ago. The underlying diseases included hypertension and renal impairment (these information was confirmed according to the medical record and the medical questionnaire for vaccination). The reporter''s comment was as follows; the causality with BNT162b2 was low, and the cause was unknown at this time. The underlying illness has been treated at another hospital, therefore no further information cannot be obtained. Information on the lot/batch number has been requested.; Sender''s Comments: The causal relationship between BNT162b2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The patient is an elderly with a background of hypertension and renal impairment; the contributory role of these factors cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1416274 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain stem 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: 2021-05-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Cerebration impaired; Dementia; Urinary tract infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021702695

Write-up: Brain stem infarction; This is a spontaneous report from a contactable other health professional received via a Pfizer sales representative. An 81-years-old male patient received unknown dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 20May2021 (Lot Number: EX3617; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. The patient was an 81-year-old male. Medical history included urinary tract infection, higher brain dysfunction, dementia, and cerebral infarction. Concomitant medications were not reported. On 20May2021 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number was not reported, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 26May2021 (6 days after the vaccination), the patient experienced brain stem infarction. The outcome of the event was fatal. The course of the event was as follows: On 20May2021, the patient was vaccinated. On 26May2021, the patient died. Brain stem infarction was reported in death certificate. Since the patient died 1 week after the vaccination, causality was considered low. The reporting other health professional classified the event as serious (death) and assessed that that the event was possibly related to BNT162B2. The outcome of the event was fatal. It was unknown if an autopsy was performed.; Sender''s Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the event brain stem infarction onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. 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: Brain stem infarction


VAERS ID: 1416275 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Cerebral infarction; Diabetes mellitus; Hypertension; Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021702856

Write-up: vomiting; This is a spontaneous report from a contactable other healthcare professional. The patient was a 85-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unknown drug 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 hypertension, diabetes mellitus, cerebral infarction, cardiac failure chronic, and renal failure chronic. On 09Jun2021 at 10:15 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) intramuscular/ via an unspecified route of administration in the arm left for COVID-19 immunization. On 10Jun2021 at 15:42 (one day, 5 hours, and 27 minutes after the vaccination), the patient experienced death. The event result in Emergency room/department or urgent care. The outcome of the event was fatal, and it was reported as unknown whether any treatment was provided. Since the vaccination, the patient has not been tested for COVID-19. Follow-up (15Jun2021): This is a spontaneous report from a contactable physician received from the regulatory authority . Regulatory authority report number is v21114025. The patient was 85 year and 6-month-old male. The body temperature before vaccination was 36.6 degrees Celsius. The patient had no remarkable family history. The patient experienced vomiting on 10Jun2021, at 12:00. The course of the event was as follows: On 10Jun2021, around midday at 12:00 (one day, one hour, and 45 minutes after the vaccination), the patient experienced vomiting at his home. The family called an ambulance, and the patient was transferred to the hospital. However, at 15:42 (one day, 5 hours, and 27 minutes after vaccination), the patient was confirmed to be dead. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were cardiac failure chronic and renal failure chronic. The reporting physician commented as follows: Since the patient had multiple underlying diseases, the causality between the event and BNT162b2 was unknown. However, it was likely that there were some kinds of cardiac overload.; Reported Cause(s) of Death: cardiac failure chronic; renal failure chronic; vomiting


VAERS ID: 1416277 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PIRESPA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure; Interstitial pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021703095

Write-up: Death; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was a 73-year-old male. Medical history included chronic respiratory failure due to interstitial pneumonia. Concomitant medication included pirfenidone (PIRESPA) tablet taken for an unspecified indication, start and stop dates were not reported. On 24May2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and expiration date were not provided) via an unspecified route of administration as 1st dose, single for COVID-19 immunization. On 25May2021 in the morning (1 day after the vaccination), the patient experienced death. 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 received the first dose of the vaccine and on the following in the morning, the patient was confirmed to be dead. The reporting physician classified the event as serious (death) and assessed that that the event was unrelated to BNT162b2.; Sender''s Comments: Based on the information available the reported event is considered not related to suspect drug.; Reported Cause(s) of Death: Death


VAERS ID: 1416279 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhagic cerebral infarction
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   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: BETANIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021703307

Write-up: Haemorrhagic cerebral infarction; This is a spontaneous report from a contactable physician. The patient was a non-pregnant 88-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received mirabegron (BETANIS) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Other medical history included bladder cancer. On 20May2021 at unknown time (the day of vaccination), the patient received ?a single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) intramuscularly for COVID-19 immunization. On 23May2021 at 09:00 (3 days after the vaccination), the patient experienced haemorrhagic cerebral infarction. The event resulted in death. The date of death was 23May2021, and the death cause was haemorrhagic cerebral infarction. No autopsy was performed. The outcome of the event was fatal with treatment including infusion therapy. The course of the event was as follows: On 23May2021 around 09:00 (3 days after the vaccination), the neighbor found the patient lying down and called an ambulance. The patient was transported to the emergency center of the reporting hospital. Haemorrhagic cerebral infarction was diagnosed, and on the same day at 14:47, the patient was confirmed dead without recovery of the consciousness. The reporting physician assessed the event as serious (death). The causality of the event was not reported. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on currently known drug safety profile, the reported event haemorrhagic cerebral infarction more likely represented intercurrent illness, but not related to BNT162b2. The patient''s advanced age has been assessed to provide an alternative explanation.Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.; Reported Cause(s) of Death: Haemorrhagic cerebral infarction


VAERS ID: 1416282 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Intestinal ischaemia, Intestinal obstruction, Obturator hernia, Polymerase chain reaction
SMQs:, Gastrointestinal obstruction (narrow), Ischaemic colitis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis obliterans
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: PCR; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab
CDC Split Type: JPPFIZER INC2021724517

Write-up: Obturator hernia; Impaction of intestine/ Intestinal obstruction; intestinal ischaemia; This is a spontaneous report from a non-contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 86-year-old female. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies or past drug history. Other medical history included arteriosclerosis obliterans. On 03Jun2021 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and expiration date were unknown) at 86-year-old intramuscular for COVID-19 immunization at municipal mass vaccination site. On 03Jun2021 (on the same day of the vaccination), the patient experienced obturator hernia, impaction of intestine, and intestinal obstruction. The events resulted in hospitalization (duration of the hospitalization was reported as 1day). The outcome of the events was fatal with treatment including fluid administration. Since the vaccination, the patient has been tested for COVID-19. The patient underwent nasal swab polymerase chain reaction on 04Jun2021 and the result was negative. The reporting physician classified the events as serious (death and hospitalization). The patient was dead on 04Jun2021, an autopsy was not performed and the reported cause of death was intestinal ischaemia. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, the reported events more likely represented intercurrent illnesses, but not related to BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.; Reported Cause(s) of Death: obturator hernia; Impaction of intestine/ Intestinal obstruction; Intestinal ischaemia


VAERS ID: 1416290 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Feeding disorder, Malaise, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN K [VITAMIN K NOS]; ACETYLSALICYLIC ACID; DERMOVATE; OMEPRAZOL; ARTELAC [HYPROMELLOSE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract; Fall; Hypertension; Hyponatraemia (tea-and-toast hyponatremia (2020),); Myocardial infarction; Retinal detachment (status after retinal detachment right eye (1993),)
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: body temperature; Result Unstructured Data: Test Result:38.2; Test Date: 20210329; Test Name: covid test; Test Result: Negative
CDC Split Type: NLPFIZER INC2021699092

Write-up: temperature of 38.2; Not feeling well/malaise; did not eat or drink; weakening; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEBNL-LRB-00490214 Safety Report Unique Identifier NL-LRB-00573095 received via regulatory authority. A 91-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration (at the age of 91-year-old) on 20Mar2021 (Lot Number: EP9605) as dose number unknown, single for covid-19 immunisation. Medical history included cataract (2021), status after retinal detachment OD(right eye) (1993), hypertension (2008), tea-and-toast hyponatremia (2020), suspected small myocardial infarction at home for which no further examination by cardiologist (2020), fall twice, in Jan and Febr2021. Concomitant medications included vitamin k; acetylsalicylic acid; clobetasol propionate (DERMOVATE); omeprazole (OMEPRAZOL); hypromellose (ARTELAC), cooling ointment. The patient experienced not feeling well/malaise, did not eat or drink, weakening on 26Mar2021, temperature of 38.2 on 29Mar2021; all reported as death, medically significant, life threatening. Due to malaise patient did not eat or drink which has led to weakening. On 28Mar2021, 8 days after vaccination, palliative care was started and on 30Mar2021 palliative sedation was started. No diagnostic procedures were done. Patient died on 02Apr2021. Patient received a COVID test on 29Mar2021. The result was negative. On 29Mar2021 she had a temperature of 38.2. Patient had a vulnerable health, but lived on her own with domestic help and help when she was ill. Patient was able to walk up the stairs and had a walker. In the six weeks prior to vaccination there was no decline in her health and no contact with her GP(general practitioner). Patient did fall twice, in Jan and Febr2021, but no injury was found and no cause of the fall was found. The outcome of the events was fatal. The patient died on 02Apr2021. 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: temperature of 38.2; weakening; malaise; did not eat or drink


VAERS ID: 1416304 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7823 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; PANTOZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021699081

Write-up: PASSING AWAY! 29 hrss after the injection, which is actually gene therapy and should not be called a vaccine! 28 and a half hrs after the injection my husband became quite acutely unwell; This is a spontaneous report from a contactable consumer (patient wife) downloaded from the regulatory authority-WEB NL-LRB-00571574. A 65-years-old male patient received bnt162b2 (COMIRNATY strength 0.3 ml), dose 1 via an unspecified route of administration on 13May2021 (Lot Number: EX7823) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. No previous COVID-19 infection. Concomitant medication(s) included apixaban (ELIQUIS) taken for an unspecified indication from Oct2019 to an unspecified stop date; pantoprazole sodium sesquihydrate (PANTOZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) taken for an unspecified indication, start and stop date were not reported. On 14May2021, patient experienced passing away, 29 hours after the injection, which is actually gene therapy and should not be called a vaccine, 28 and a half hours after the injection patient became quite acutely unwell and called a friend, found unconscious on the floor 15 minutes later (sudden death). Resuscitation was ineffective. The outcome of sudden death is fatal. It was not reported if an autopsy was performed. Reporters Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no PASSING AWAY !!! 29 hours after the injection, which is actually gene therapy and should not be called a vaccine! 28 and a half hours after the injection my husband became quite acutely unwell and called a friend, 15 minutes later he was found unconscious on the floor. Resusciatation was unsuccessful. Previous COVID-19 infection: No diagnostic procedures: No No follow-up attempts possible. No further information expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no PASSING AWAY !!! 29 hours after the injection, which is actually gene therapy and should not be called a vaccine! 28 and a half hours after the injection my husband became quite acutely unwell and called a friend, 15 minutes later he was found unconscious on the floor. Resusciatation was unsuccessful. Previous COVID-19 infection: No diagnostic procedures: No; Reported Cause(s) of Death: 15 minutes after being found unconscious, resuscitation ineffective


VAERS ID: 1416305 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GLICLAZIDE; METFORMIN; COVERSYL ARG; RIVAROXABAN; FUROSEMIDE; FERROUS FUMARATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021699086

Write-up: tired; fever on the day of vaccination; he was found dead on 02Jun2021, possibly deceased 30May2021 or 31May2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB NL-LRB-00572085. A 71-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 29May2021 (at the age of 71 years old) (Batch/Lot Number: FA8016) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. No previous COVID-19 infection. Concomitant medications included gliclazide; metformin; perindopril arginine (COVERSYL ARG); rivaroxaban; furosemide; ferrous fumarate. The patient previously received the first dose of bnt162b2 on 24Apr2021 at 0.3ml single for COVID-19 immunization. The patient experienced unknown (death) in May2021 (30May2021 or 31May2021), fever on the day of vaccination (death) on 29May2021, tired (death) on 30May2021. Patient had fever (Saturday evening) on the day of vaccination. The next day his son called on Sunday around afternoon, son called (20 seconds), patient was tired and laying in bed. When his son could not reach him anymore, he went to his house on 02Jun2021, where he found him dead, possibly deceased on 30May2021 or 31May2021. Autopsy was done, no autopsy result available and at first glance there were no obvious cause of death found. Death, or causal relationship is not clear, according to sons evening post-vaccination fever. Outcome of the events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: fever on the day of vaccination; tired; unknown


VAERS ID: 1416307 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-25
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALECENSA; APROVEL; ACLASTA; CALCIGRAN FORTE; LANSOPRAZOL KRKA; ELIQUIS
Current Illness: Thrombocytopenia (mild thrombocytopenia of 144 at time of admission, not controlled further.)
Preexisting Conditions: Medical History/Concurrent Conditions: Non-small cell lung cancer stage IV (ALK-Positive Non-small cell lung cancer)
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:144
CDC Split Type: NOPFIZER INC2021698934

Write-up: Bilateral cerebral infarctions of the cerebrum, cerebellum and thalamus; strokes; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-U2men1. A 74-year-old Female patient received second dose of BNT162B2 (COMIRNATY) Intramuscular on 12May2021 at single dose for COVID-19 immunisation. The medical history included ongoing thrombocytopenia, non-small cell lung cancer stage IV. Concomitant medications included alectinib hydrochloride (ALECENSA) from Sep2019 for non-small cell lung cancer stage IV, irbesartan (APROVEL) for Hypertension, zoledronic acid (ACLASTA), calcium carbonate, colecalciferol (CALCIGRAN FORTE), lansoprazole (LANSOPRAZOL KRKA) and apixaban (ELIQUIS). The patient received first dose of BNT162B2 (COMIRNATY) on unknown date. On 25May2021, the patient developed Bilateral cerebral infarctions of the cerebrum, cerebellum and thalamus. The patient was admitted due to bilateral cerebral infarction 13 days after the second dose of coronary vaccine (Pfizer). Watershed/border zone infarctions. Cardiac embolism as source was not found. No other clear cause was found such as hypercapnia, hypoglycaemia, hypercalcaemia. Only mild thrombocytopenia of 144 at time of admission, not further controlled. Underlying widespread lung cancer (st IV). The strokes were not initially considered to be a side effect of the vaccine, but report it as side effect due to uncertainty about the causal relationship. The patients outcome was Fatal, at the time of the report. The case was considered to be Serious. The Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: BRAIN INFARCTION; strokes


VAERS ID: 1416322 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-05-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood fibrinogen, Cerebral haemorrhage, Fibrin D dimer, International normalised ratio, Platelet count, Platelet factor 4
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: WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Coagulation disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210506; Test Name: Fibrinogen; Result Unstructured Data: Test Result:3.75 g/dl; Test Date: 20210506; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:639 ng/dL; Test Date: 20210506; Test Name: International normalised ratio; Result Unstructured Data: Test Result:2.46; Comments: 2.46 to 6/5; Test Date: 20210506; Test Name: Platelet count; Result Unstructured Data: Test Result:200000 /mm3; Test Date: 20210506; Test Name: Platelet factor 4; Test Result: Positive ; Comments: Positive anti-FP4 antibodies (ELISA)
CDC Split Type: PTPFIZER INC2021699027

Write-up: Massive intraparenchymal hemorrhage; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [PT-INFARMED-J202105-2472]. A 75-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 03May2021 (Batch/Lot number was not reported) as 0.3ml single dose for COVID-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, hypocoagulation. Concomitant medication included warfarin taken for an unspecified indication, start and stop date were not reported. The patient experienced massive intraparenchymal hemorrhage (death, medically significant) on 06May2021. The clinical course was reported as follows: Spontaneous notification refers to a case sent by a doctor for a 75-year-old female who presented massive intraparenchymal hemorrhage, associated with the use of Comirnaty (unknown batch), indicated for immunization against COVID-19, with a scheme of 2 doses vaccination with an interval of at least 21 days between each dose. The adverse drug reaction (ADR) appeared 3 days after administration of the suspected vaccine (which dose is unknown) and had a fatal outcome. A history of ADR to other drugs is unknown. Patient with hypocoagulation due to atrial fibrillation. Analytical results on the day of ADR (06May2021): INR 2.46; D-Dimers 639 ng/ml; Fibrinogen 3.75 g/dL; 200000/mm3 platelets; Anti-FP4 antibodies (by ELISA method) Positive. There is reference to the concomitant use of Warfarin. There was no medication error. The hospital institution of the notifier''s origin refers to this adverse condition as: "Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT)". Evolution of ADR: Death. In subsequent telephone contact, the notifier states that, as no thrombocytopenia occurred, the case does not configure the entity Vaccine-induced Immune Thrombotic Thrombocytopenia. Evolution of ADR: Death. INR 2.46 to 6/5, D-Dimers 639 ng/ml, Fibrinogen 3.75 g/dl, Positive anti-FP4 antibodies (ELISA), Platelets: 200,000/mm3 The patient underwent lab tests and procedures which included blood fibrinogen: 3.75 g/dl on 06May2021, fibrin d dimer: 639 ng/dl on 06May2021, international normalised ratio: 2.46 on 06May2021 (2.46 to 6/5), platelet count: 200000 /mm3 on 06May2021, platelet factor 4: positive on 06May2021 (Positive anti-FP4 antibodies (ELISA)). The patient died in 2021. It was not reported if an autopsy was performed. The outcome of event was fatal. Relatedness of drug to reaction(s)/event(s): Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: definitive Reporter Comment: Concomitant Medication-Warfarin Did Medication Error Occur?-No Other Information-Hypocoagulated by AF, INR 2.46 to 6/5. Other analyses: D-Dimers 639 ng/ml, Fibrinogen 3.75 g/dl, Positive anti-FP4 antibodies (ELISA), Platelets: 200,000/mm3 No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reporter''s Comments: Concomitant Medication-Warfarin Did Medication Error Occur?-No Other Information-Hypocoagulated by AF, INR 2.46 to 6/5. Other analyses: D-Dimers 639 ng/ml, Fibrinogen 3.75 g/dl, Positive anti-FP4 antibodies (ELISA), Platelets: 200000/mm3; Reported Cause(s) of Death: Hemorrhage intracerebral


VAERS ID: 1416323 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-05-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain injury, Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   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: PTPFIZER INC2021699047

Write-up: brain injury; Spontaneous cerebral hemorrhage; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 75-year-old patient of an unspecified gender received bnt162b2 +*(COMIRNATY), dose 1 intramuscular on 03May2021 (Lot Number: EY2172) as 0.3 mL, single dose for immunization against COVID-19. The patient''s medical history and concomitant medications were not reported. The patient experienced spontaneous cerebral hemorrhage (death) on 05May2021. The patient died on 07May2021. It was unknown if an autopsy was performed. The adverse drug reaction (ADR) appeared 2 days after administration of the first dose of the suspected vaccine and had a fatal outcome. No indication for treatment due to the severity and irreversibility of the brain injury. A history of ADR to other drugs was unknown. Evolution of ADR: Death. The outcome of the event spontaneous cerebral hemorrhage was fatal, of the other event was unknown. Relatedness of drug to reaction(s)/event(s): Source of assessment: Reporter, Method of assessment: Unknown, Result of Assessment: Possible. Reporter''s comments: Reaction description - Spontaneous cerebral hemorrhage. Causality - Possible. No follow-up attempts needed. No further information expected. ; Reporter''s Comments: Reaction description - Spontaneous cerebral hemorrhage. Causality - Possible.; Reported Cause(s) of Death: spontaneous cerebral hemorrhage


VAERS ID: 1416564 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0927 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Fall, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021704171

Write-up: Death; Shortness of breath; Collapsed; Severe arm pain; This is a spontaneous report from a non-contactable consumer. A 67-year-old female patient received BNT162b2 (COMIRNATY) first single dose administration on 09Jun2021 (Batch/Lot Number: FD0927) for covid-19 immunization at age of 67-year-old. No specific history of diaphoresis, pallor or swelling at the time of the collapse. The patient was a non smoker; no Covid-19 symptoms. The patient''s concomitant medications were not reported. The patient was reported to had complained of severe painful arm on 10Jun2021. The patient was reported to have experienced shortness of breath, collapsed (non-serious) on 10Jun2021. The patient died on 10Jun2021 at 13:25. The patient was certified dead on arrival to hospital. It was not reported if an autopsy was performed. According to the reporter, it is unknown if the patient had a similar event, or previous reactions/adverse event after immunization; history of allergies/or family history of allergies unknown; no known medical conditions, or acute illness 30 days prior to vaccination; no history of hospitalization in the last 30 days, and the patient is reported not to have tested positive for Covid-19 prior to vaccination. Emergency center notes, 10Jun2021: dead on arrival; pupils fixed and dilated; no reflex; no central pulse or respiration; no evidence of injury, calves soft, no bruises. Outcome of the events was unknown.; Reported Cause(s) of Death: died


VAERS ID: 1417055 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-04
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032H20A / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Carvedilol, Lovastatin, Furosemide, Protoxin.
Current Illness: Unknown.
Preexisting Conditions: Incontinence, HTN, GERD, Dyslipidemia, PAD/ PVD, OA.
Allergies: Unknown.
Diagnostic Lab Data: Unknown.
CDC Split Type:

Write-up: Died doe to unknown causes.


VAERS ID: 1417453 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia aspiration, Vomiting
SMQs:, Acute pancreatitis (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: AUPFIZER INC2021710397

Write-up: Pneumonia aspiration; vomiting; This is a spontaneous report from a contactable other health professional. Regulatory authority report number is 565411. A 93-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pneumonia aspiration, vomiting 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; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: vomiting; Pneumonia aspiration


VAERS ID: 1417454 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-17
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Contusion, Dyspnoea, Lethargy, Pain in extremity, Unresponsive to stimuli
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (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: AUPFIZER INC2021710398

Write-up: Cardiac failure; Unresponsive to stimuli; Contusion; Dyspnoea; Lethargy; Pain in extremity; This is a spontaneous report from a contactable other health professional. Regulatory authority report number is 565693. An 84-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced Cardiac failure; Contusion; Dyspnoea; Lethargy; Pain in extremity; Unresponsive to stimuli on 17May2021. The events were serious as death. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac failure; Unresponsive to stimuli; Contusion; Dyspnoea; Lethargy; Pain in extremity


VAERS ID: 1417455 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-21
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Rash, Rectal haemorrhage
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Hypersensitivity (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: AUPFIZER INC2021710399

Write-up: Rectal hemorrhage; Dyspnea; Rash; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 565833. A 94-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced rectal hemorrhage, dyspnea, rash, all on 21May2021. All the events were with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Dyspnea; Rash; Rectal hemorrhage


VAERS ID: 1417456 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cyanosis, Hallucination, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021710400

Write-up: Hallucination; Unresponsive to stimuli; Asthenia; Cyanosis; This is a spontaneous report from a contactable other health professional. Regulatory authority report number is 567655. An 80-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 09Jun2021 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced hallucination, unresponsive to stimuli, asthenia, cyanosis on 12Jun2021. The patient died on an unspecified date in Jun2021. 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: Hallucination; Unresponsive to stimuli; Asthenia; Cyanosis


VAERS ID: 1417457 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-08
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Atrial fibrillation, Diarrhoea, Hypertension, Sepsis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021710401

Write-up: Acute kidney injury; Atrial fibrillation; Sepsis; Syncope; Diarrhoea; Hypertension; This is a spontaneous report from a contactable health professional via the Regulatory Authority. Regulatory authority report number is 567054. A 76-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced acute kidney injury, atrial fibrillation, sepsis, syncope, diarrhea and hypertension on 08May2021. 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; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Acute kidney injury; Atrial fibrillation; Diarrhea; Hypertension; Sepsis; Syncope


VAERS ID: 1417458 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021710402

Write-up: Adverse event following immunisation; This is a spontaneous report from a contactable other health professional. Regulatory authority report number is 567288. A 68-years-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Type not specified), 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 was not reported. The patient''s concomitant medications were not reported. The patient experienced adverse event following immunisation on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the 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: Adverse event following immunisation


VAERS ID: 1417507 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Dyspnoea, Erythema, Loss of personal independence in daily activities, Rash, Stridor, Tachycardia, Tachypnoea, Unresponsive to stimuli, Use of accessory respiratory muscles, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), 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), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021665373

Write-up: Anaphylactic reaction; Dyspnoea; Erythema; Loss of personal independence in daily activities; Rash; Stridor; Tachycardia; Tachypnoea; Unresponsive to stimuli; Use of accessory respiratory muscles; Wheezing; This is a spontaneous report from a contactable Healthcare Professional. This is a report received from the Regulatory Authority via an on-line database search. Regulatory authority report number 000939409. This information was initially reported to Regulatory Authority between 16Feb2021 and 19Feb2021 from a hospital. An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on an unspecified date (Batch/Lot number was not reported) as dose number unknown, 0.3ml single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction, dyspnoea, erythema, loss of personal independence in daily activities, rash, stridor, tachycardia, tachypnoea, unresponsive to stimuli, use of accessory respiratory muscles, wheezing on an unspecified date, seriousness criteria reported as death. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Anaphylactic reaction; Dyspnoea; Erythema; Loss of personal independence in daily activities; Rash; Stridor; Tachycardia; Tachypnoea; Unresponsive to stimuli; Use of accessory respiratory muscles; Wheezing


VAERS ID: 1418194 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210638382

Write-up: DEATH; This spontaneous report received from a other health professional via social media concerned a patient of unspecified age, sex, 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210638416, 20210638373, 20210638397 and 20210638405.; Sender''s Comments: V0: 20210638382 -Covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1418197 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hepatic haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699255

Write-up: Hepatic haemorrhage; This is a spontaneous report from a physician WEB number DE-PEI-202100093889. A 69-year-old male patient received BNT162B2 (COMIRNATY, Lot Number: ET3045) via unspecified route 0.3 ml single for COVID-19 immunisation on 13Apr2021 at 69-year-old. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced hepatic haemorrhage on 17Apr2021 with outcome of fatal. The patient died on 16May2021. It was unknown if an autopsy was performed. Event assessment: Comirnaty/ event/PEI /Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hepatic haemorrhage


VAERS ID: 1418204 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Death, Haemoglobin, Oxygen saturation, Respiratory rate, Throat irritation
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anaemia postoperative
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Arterial hypertension; C-reactive protein increased; Cognitive disorder; Delirium; Dysfunction thyroid; Femoral neck fracture; Fluid overload; Hypertensive heart disease; Lung disease (basal rattling noises above the Lungs and subtle lower leg edema on both sides.); Neurocognitive deficit; Prostatic hypertrophy; Prosthesis implantation; Spinal anaesthesia (a femoral neck fracture); Surgery (a femoral neck fracture); Tachycardia; Tongue dry
Allergies:
Diagnostic Lab Data: Test Date: 20210315; Test Name: C-reactive protein; Result Unstructured Data: Test Result:increased/ elevation; Test Date: 20210315; Test Name: HB; Result Unstructured Data: Test Result:9.8 g/dl; Test Name: Saturation; Test Result: 98 %; Test Name: Respiratory rate; Result Unstructured Data: Test Result:16; Comments: /min
CDC Split Type: DEPFIZER INC2021704793

Write-up: approx. 20 hours after the 2nd vaccination, the patient was found lifeless in bed on 20MAr2021. Apart from some scratching of the throat on 19Mar2021 at about 17:00, no complaints were made.; approx. 20 hours after the 2nd vaccination, the patient was found lifeless in bed on 20Mar2021. Apart from some scratching of the throat on 19Mar2021 at about 17:00, no complaints were made.; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021035975, Safety Report Unique Identifier DE-PEI-202100023396. A 92-years-old male patient received bnt162b2 (COMIRNATY), via intramuscular, on 19Mar2021 (Lot Number: ER7812), at the age of 92-years-old, as dose 2, 0.3 ml single for COVID-19 immunisation. Medical history included Hypertensive heart disease, Arterial hypertension, Neurocognitive deficit from 2014 , fluid overload, Apoplexy from 2014, a cementless dual head prosthesis from 27Jan2021, thyroid dysfunction, prostatic hypertrophy, slightly tachycardic heart rate, Lung disease (basal rattling noises above the Lungs and subtle lower leg edema on both sides), dry tongue, C-reactive protein increased from 15Mar2021, cognitive deficit, differential diagnosis of delirium, femoral neck fracture, all unknown if ongoing, surgery under spinal anaesthesia for a femoral neck fracture on 15Mar2021 and ongoing Anaemia postoperative. The patient previously received first dose of Comirnaty for Covid-19 immunisation. The patient''s weight was 75 kg, and height was 168 cm. No concomitant medication was reported. On 19Mar2021 at 17:00 the patient experienced throat irritation. The event was reported as non-serious. Approx. 20 hours after the 2nd vaccination, the patient was found lifeless in bed on 20Mar2021 at 6:55 am. Apart from some scratching of the throat on 19Mar2021 at about 17:00, no complaints were made. The patient''s outcome was not recovered for throat irritation, fatal for cause of death unknown. The subject underwent lab tests and procedures which included C-reactive protein increased/ elevation on 15Mar2021, HB 9.8 g/dl on 15Mar2021, Respiratory rate 16/minute on an unknown date, SpO2 saturation 98% on an unknown date. This report was serious: death. The patient died on 20Mar2021. It was not reported if an autopsy was performed. Senders comments: Do you or the person concerned have any known allergies? If yes, which ones? No. Information on risk factors or previous illnesses. Condition after surgery under spinal anaesthesia on 15Mar2021, postoperative anaemia (HB 9.8 g/dl) and CRP elevation, slight hyperhydration, arterial hypertension and hypertensive heart disease, condition after apoplexy in 2014, cognitive deficit, differential diagnosis of delirium. The patient was otherwise circulatory stable, otherwise the transferring hospital would not have organised transport to the vaccination centre. It is questionable whether the reaction - scratching of the throat - was related to the death / The pat. was in hospital from 14Mar2021 to 19Mar2021 due to a femoral neck fracture and was operated on 15Mar2021. On 19Mar2021 he was transferred to another hospital for further treatment in geriatrics, but before that the patient was administered the second BionTech vaccination dose in the vaccination centre privacy. This is an elderly 92-year-old patient with the following diagnoses: Discharge diagnoses: Periprosthetic fracture on the left with application of 2 femoral shaft cerclages on 15Mar2021. Condition after implantation of a cementless dual head prosthesis on the left on 27Jan2011. Secondary diagnoses: condition after humeral head fracture on the left, condition after apoplexy in 2014, arterial hypertension with hypertensive heart disease, thyroid dysfunction, prostatic hypertrophy. Clinically, the patient showed a slightly tachycardic heart rate, basal rales over the lungs and subtle lower leg oedema on both sides on admission (11:00 h, administrative admission 10:18 h). Respiratory rate 16/minute, SpO2 saturation 98%. The tongue was dry. Patient was awake, superficially oriented, short-term memory impaired. Word-finding difficulties. No signs of allergic skin reaction or dyspnoea. Patient was cardiopulmonarily stable. On 19Mar2021, the patient expressed to his relatives by telephone that he had a little scratchy throat. The evening and night''s rest were unremarkable. The night nurse did not notice any abnormalities. The patient was found dead in bed at 6:55 am on 20Mar2021 - about 21 hours after vaccination. With the cause of death unclear, the criminal investigation department was notified. The report is made because of the temporal connection with the second vaccination. Relatedness of drug to reaction(s)/event(s) for all events D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1418245 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Coma, Cough, Flatulence, Fluid retention, Multiple organ dysfunction syndrome
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high
Preexisting Conditions: Medical History/Concurrent Conditions: Fatty liver (without medication); Gout
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021712372

Write-up: multiple organ failure; coma; the whole body, i.e. abdomen was full of water; cough; abdominal discomfort; gas in the abdomen; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Biontech [manufacturer control number: 64764], license party for Comirnaty. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 01May2021 as 1st dose single for covid-19 immunisation. Medical history included fatty liver without medication, medication against gout and ongoing high blood pressure. The patient''s concomitant medications were not reported. The consumer reports the death of her father (the patient) after the 1st dose of Comirnaty. The doctors thought that there was a temporal connection with the vaccination. It is not officially proven that the death is due to the vaccination. 3 days after the vaccination( (04May2021) the patient had a cough, he was given antibiotics. After that he had abdominal discomfort, gas in the abdomen, he was prescribed Durkolax and Lefax. on 17May2021 the man was admitted to the hospital the whole body, i.e. abdomen was full of water, failure of several organs and coma followed. on 21May2021 the patient died of multiple organ failure. The patient died on 21May2021. It was not reported if an autopsy was performed. The outcome of the events the whole body, i.e. abdomen was full of water, cough, abdominal discomfort, gas in the abdomen was unknown. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: multiple organ failure


VAERS ID: 1418255 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-14
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Base excess, Blood gases, Blood lactic acid, Blood test, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure; Chronic obstructive airways disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Base excess; Result Unstructured Data: Test Result:minus 7 Unit not specfied; Test Date: 202105; Test Name: Arterial blood gases; Result Unstructured Data: Test Result:No results provided; Test Date: 202105; Test Name: Lactate; Result Unstructured Data: Test Result:Marginal elevated; Test Date: 202105; Test Name: Blood test; Result Unstructured Data: Test Result:No results provided
CDC Split Type: DKPFIZER INC2021704814

Write-up: dead by pulmonary failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB DK-DKMA-WBS-0068291. A 80-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 15May2021 (Batch/Lot Number: EW6126; Expiration Date: Jul2021) as 2nd dose, single, dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot Number: EW4811; Expiration Date: 31Jul2021) as 1st dose, single for covid-19 immunization. Medical history included ongoing cardiac failure, ongoing chronic obstructive pulmonary disease. The patient''s concomitant medications were not reported. The patient experienced dead by pulmonary failure on 14May2021. The event was serious per hospitalization, life threatening. The patient was hospitalized for dead by pulmonary failure from 20May2021 to an unknown date. This is a spontaneous case, received on 26May2021 from a physician, which describes the occurrence of Pulmonary failure (dead by pulmonary failure) in an 80 years old male patient vaccinated with Comirnaty (tozinameran). There is no information regarding concomitant medication. There is no information regarding past medication. There is no information regarding medical history. Concurrent conditions included Chronic obstructive airways disease and cardiac failure. It is stated that, he may have had affected respiration already on 14May2021, but it is rather uncertain as there has been diffuse nervousness at home due to comorbidity with heart failure and COPD. On 22Apr2021 the patient received first dose of Comirnaty (Batch number: EW4811) for Covid-19 immunization. On 14May2021 (22 days after the first dose and the day before the second dose) it is reported that the patient developed Pulmonary failure. The patient was vaccinated with 2nd dose of Comirnaty (Batch number: EW6126) 15May2021 and the condition worsened. The ADR were by the reporter reported as resulting in hospitalization on 20May2021 and was fatal (23May2021). The patient was treated with antibiotics (not further specified) with good response and respiratory compensation. Reported cause of death: pulmonary failure. The patient underwent lab tests and procedures which included base excess: minus 7 unit not specified in May2021, blood gases: no results provided in May2021, Lactate: marginal elevated in May2021, Arterial blood gases: no results provided in May2021. Therapeutic measures were taken as a result of dead by pulmonary failure. The outcome of event was death. The patient died on 23May2021. An autopsy was not performed. Causality: The physician states that the physicians at the hospital evaluated that the patient condition was due to infection and mixing acidosis. However, the reporting physician believes that the patient rather was normocapnic with pure metabolic acidosis. The patient was during the hospitalisation very fluctuating and this combined with the puzzling course of the condition makes the cause of the condition unclear. The reporting physician believes that some of the test results may have been misintrepreted (not further specified). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pulmonary failure


VAERS ID: 1418318 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-05-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   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: SPIRIVA RESPIMAT; PARACETAMOL STADA; ACIDO ACETILSALICILICO MYLAN; PROLIA; BARNIX; DELTIUS; ZYLORIC; FOSTER NEXTHALER; VENTOLIN ACCUHALER; OMEPRAZOLE MYLAN [OMEPRAZOLE]; HYDREA
Current Illness: COPD; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Accident cerebrovascular; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Accident cerebrovascular) in a 68-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Hypertension arterial and COPD. Concomitant products included PARACETAMOL (PARACETAMOL STADA) for Ache, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA RESPIMAT), BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE (FOSTER NEXTHALER) and SALBUTAMOL SULFATE (VENTOLIN ACCUHALER) for COPD, BARNIDIPINE HYDROCHLORIDE (BARNIX) for Hypertension arterial, DENOSUMAB (PROLIA) for Osteoporosis, OMEPRAZOLE (OMEPRAZOLE MYLAN [OMEPRAZOLE]) for Prophylaxis, ACETYLSALICYLIC ACID (ACIDO ACETILSALICILICO MYLAN) and HYDROXYCARBAMIDE (HYDREA) for Thrombocythemia, ALLOPURINOL (ZYLORIC) for Uric acid, COLECALCIFEROL (DELTIUS) for Vitamin D deficiency. On 07-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Subcutaneous) 1 dosage form. On 08-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Accident cerebrovascular) (seriousness criteria death and medically significant). The patient died on 08-May-2021. The reported cause of death was Accident cerebrovascular. It is unknown if an autopsy was performed. No Treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Accident cerebrovascular


VAERS ID: 1418325 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-07
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic hepatitis (Chronic liver disease.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210635055

Write-up: CARDIO-RESPIRATORY ARREST; SUDDEN DEATH; This spontaneous report received from a physician via a Regulatory Authority [ES-AEMPS-899114] concerned a 59 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included chronic hepatitis (chronic liver disease). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C14-04 expiry: unknown) dose was not reported, 1 total administered to arm on 07-JUN-2021 for covid-19 vaccination. No concomitant medications were reported. On 07-JUN-2021, the patient experienced cardio-respiratory arrest and sudden death (dizziness). The cause of death was cardio-respiratory arrest. 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 cardio-respiratory arrest on 07-JUN-2021. This report was serious (Death).; Sender''s Comments: V0: 20210635055-Covid-19 vaccine ad26.cov2.s-Cardio-respiratory arrest and Sudden 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: CARDIO-RESPIRATORY ARREST


VAERS ID: 1418429 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tabaquism
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021668030

Write-up: Death; Pulmonary pain; Feelings of weakness; Fatigue; Malaise; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-94503. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 31May2021 (Batch/Lot Number: FA5715) as a single dose, for covid-19 immunisation with the first dose given on an unspecified date. Medical history included smoking. The patient''s concomitant medications were not reported. The reporter stated that My husband complained of "sore lungs". My husband died the day after his second dose of Cominarty was administered. The second dose was administered on 31May2021. On the day of his vaccination, he returned after the compulsory rest period after the vaccination with severe fatigue, feeling very weak. On 1Jun2021 at around 3 p.m., he suffered from lung aches for 30 minutes and was declared dead when the emergency services arrived, after 30 minutes of resuscitation maneuvers. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1418473 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001945 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ischaemic stroke, Lymphocyte count increased
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer of lung
Preexisting Conditions: Medical History/Concurrent Conditions: Basal cell carcinoma; Hypertension arterial; Hypertensive heart disease NOS
Allergies:
Diagnostic Lab Data: Test Name: Lymphocyte count increased; Result Unstructured Data: Increased for more than 2 years
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: accident vasculaire c?r?bral isch?mique; This regulatory authority case was reported by a physician and describes the occurrence of ISCHAEMIC STROKE (accident vasculaire c?r?bral isch?mique) in an 82-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001945) for COVID-19 vaccination. The patient''s past medical history included Hypertension arterial, Basal cell carcinoma and Hypertensive heart disease NOS. Concurrent medical conditions included Cancer of lung since 2021. On 10-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 11-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ISCHAEMIC STROKE (accident vasculaire c?r?bral isch?mique) (seriousness criteria death, hospitalization and medically significant). The patient died on 15-May-2021. The reported cause of death was Ischemic stroke. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Lymphocyte count increased: increased (High) Increased for more than 2 years. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not reported. Company Comment This case concerns an 82-year-old female with a serious unexpected event of ischaemic stroke with fatal outcome. Event latency 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Translation received on 17-jun-2021, updated with the lab data information.; Sender''s Comments: This case concerns an 82-year-old female with a serious unexpected event of ischaemic stroke with fatal outcome. Event latency 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1418557 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-27
Onset:2021-03-04
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0641 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Anaemia, Anti-glomerular basement membrane antibody, Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody, Aspartate aminotransferase increased, Bacterial test, Bicytopenia, Bilirubin conjugated, Blood 25-hydroxycholecalciferol, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood bilirubin unconjugated, Blood calcium, Blood chloride, Blood count, Blood creatinine, Blood folate, Blood gases, Blood glucose, Blood iron, Blood lactate dehydrogenase, Blood magnesium, Blood osmolarity, Blood parathyroid hormone, Blood phosphorus, Blood potassium, Blood pressure measurement, Blood sodium, Blood test, Blood urea, Blood urine present, Body temperature, Bradyphrenia, C-reactive protein, Calcium ionised, Computerised tomogram, Coombs direct test, Dizziness, Drug ineffective, Fatigue, Fibrin D dimer, Fraction of inspired oxygen, Gamma-glutamyltransferase, General physical health deterioration, Genital herpes, Haemoglobin, Haptoglobin, Heart rate, Iron binding capacity total, Legionella test, Leukocyturia, Lipase, Mean cell haemoglobin concentration, Mean cell volume, Musculoskeletal stiffness, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, PO2, Pain, Pneumonia, Positron emission tomogram, Protein total, Proteinuria, Prothrombin time, Renal function test, Respiratory rate, SARS-CoV-2 test, Scan brain, Serum ferritin, Slow speech, Staphylococcal bacteraemia, Suspected COVID-19, Thrombocytopenia, Transferrin, Troponin, Urinary tract infection bacterial, Urinary tract infection fungal, Urine cytology, Vitamin B12
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Vasculitis (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (broad), Myelodysplastic syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 65
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 56 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: partial thromboplastin time; Result Unstructured Data: Test Result:1.16; Test Date: 20210310; Test Name: ALAT; Result Unstructured Data: Test Result:16 IU/l; Test Date: 20210319; Test Name: ALAT; Result Unstructured Data: Test Result:35 IU/l; Test Date: 20210320; Test Name: anti-glomerular basement membrane antibodies; Test Result: Negative ; Test Date: 20210320; Test Name: ANCA; Test Result: Positive ; Test Date: 20210320; Test Name: Proteinase 3 Antibody; Result Unstructured Data: Test Result:over 200; Test Date: 20210310; Test Name: Aspartate transaminase; Result Unstructured Data: Test Result:23 IU/l; Test Date: 20210315; Test Name: Aspartate transaminase; Result Unstructured Data: Test Result:31 IU/l; Test Date: 20210310; Test Name: blood cultures; Test Result: Negative ; Test Date: 20210319; Test Name: direct bilirubin; Result Unstructured Data: Test Result:9 umol/l; Test Date: 20210311; Test Name: 25 OH D; Result Unstructured Data: Test Result:7.5 ng/ml; Test Date: 20210310; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:107 IU/l; Test Date: 20210319; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:112 IU/l; Test Name: HCO3; Result Unstructured Data: Test Result:30 mmol/L; Test Date: 20210310; Test Name: HCO3; Result Unstructured Data: Test Result:27.5 mmol/L; Test Date: 20210310; Test Name: total bilirubin; Result Unstructured Data: Test Result:9 umol/l; Test Date: 20210319; Test Name: total bilirubin; Result Unstructured Data: Test Result:21 umol/l; Test Date: 20210319; Test Name: indirect bilirubin; Result Unstructured Data: Test Result:12; Test Date: 20210310; Test Name: serum calcium; Result Unstructured Data: Test Result:2.11 mmol/L; Test Date: 20210315; Test Name: serum calcium; Result Unstructured Data: Test Result:2.22 mmol/L; Test Date: 20210319; Test Name: serum calcium; Result Unstructured Data: Test Result:2.07 mmol/L; Test Date: 20210321; Test Name: serum calcium; Result Unstructured Data: Test Result:2.13 mmol/L; Test Date: 20210323; Test Name: serum calcium; Result Unstructured Data: Test Result:2.19 mmol/L; Test Name: chloride; Result Unstructured Data: Test Result:112 mmol/L; Comments: Hyperchloremia; Test Date: 20210323; Test Name: chloride; Result Unstructured Data: Test Result:111 mmol/L; Test Name: blood count; Result Unstructured Data: Test Result:leucocytes 12G/l; Comments: leucocytes 12G/l with neutrophils 89% platelets 228 G/l; Test Date: 20210310; Test Name: blood count; Result Unstructured Data: Test Result:white blood cells 10 000; Comments: Neutrophils 8 600, lymphocytes 600, monocytes 800, Eosinophils 0, platelets 372.000, reticulocytes at 37.53 G/l; Test Date: 20210312; Test Name: blood count; Result Unstructured Data: Test Result:white blood cells 12 500; Comments: white blood cells 12.500, platelets 397 000, neutrophils 10 700, lymphocytes 900; Test Date: 20210315; Test Name: blood count; Result Unstructured Data: Test Result:white blood cells 17 700; Comments: white blood cells 17 700, platelets 503 000, neutrophils 16 000, lymphocytes 600; Test Date: 20210319; Test Name: blood count; Result Unstructured Data: Test Result:white blood cells 21 500; Comments: white blood cells 21 500, platelets 389 g/l, neutrophils 20 500, lymphocytes 200, monocytes 700; Test Date: 20210321; Test Name: blood count; Result Unstructured Data: Test Result:leucocytes 73.92/mm3; Comments: leucocytes 73.92/mm3; Test Name: creatinine; Result Unstructured Data: Test Result:262 umol/l; Comments: after treatment: between 170 and 260 umol/l; Test Date: 20210310; Test Name: creatinine; Result Unstructured Data: Test Result:118 umol/l; Test Date: 20210315; Test Name: creatinine; Result Unstructured Data: Test Result:185 umol/l; Test Date: 20210317; Test Name: creatinine; Result Unstructured Data: Test Result:197 umol/l; Test Date: 20210319; Test Name: creatinine; Result Unstructured Data: Test Result:217 umol/l; Test Date: 20210321; Test Name: creatinine; Result Unstructured Data: Test Result:239 umol/l; Test Date: 20210323; Test Name: creatinine; Result Unstructured Data: Test Result:255 umol/l; Test Date: 20210311; Test Name: folate; Result Unstructured Data: Test Result:6.4 ng/ml; Test Date: 20210310; Test Name: blood gas; Result Unstructured Data: Test Result:7.48 pH units; Test Date: 20210321; Test Name: blood gas; Result Unstructured Data: Test Result:7.4 pH units; Comments: 23 l/mn; Test Date: 20210310; Test Name: blood glucose; Result Unstructured Data: Test Result:7.5 mmol/L; Test Date: 20210319; Test Name: blood glucose; Result Unstructured Data: Test Result:8 mmol/L; Test Date: 20210321; Test Name: blood glucose; Result Unstructured Data: Test Result:7.9 mmol/L; Test Date: 20210311; Test Name: serum iron; Result Unstructured Data: Test Result:0.4 umol/l; Comments: percentage saturation 1%; Test Date: 20210315; Test Name: LDH; Result Unstructured Data: Test Result:690 IU/l; Test Date: 20210311; Test Name: magnesium; Result Unstructured Data: Test Result:0.8 mmol/L; Test Name: osmolarity; Result Unstructured Data: Test Result:359; Comments: mOsmol/L; Test Date: 20210315; Test Name: osmolarity; Result Unstructured Data: Test Result:328; Comments: mOsmol/L; Test Date: 20210317; Test Name: osmolarity; Result Unstructured Data: Test Result:315; Comments: mOsmol/L; Test Date: 20210319; Test Name: osmolarity; Result Unstructured Data: Test Result:322; Comments: mOsmol/L; Test Date: 20210321; Test Name: osmolarity; Result Unstructured Data: Test Result:342; Comments: mOsmol/L; Test Date: 20210323; Test Name: osmolarity; Result Unstructured Data: Test Result:353; Comments: mOsmol/L; Test Date: 20210311; Test Name: Parathormone; Result Unstructured Data: Test Result:153 pg/mL; Comments: elevated; Test Date: 20210311; Test Name: Phosphorus; Result Unstructured Data: Test Result:0.82 mmol/L; Test Name: potassium; Result Unstructured Data: Test Result:4.6 mmol/L; Test Date: 20210310; Test Name: potassium; Result Unstructured Data: Test Result:3.7 mmol/L; Test Date: 20210315; Test Name: potassium; Result Unstructured Data: Test Result:3.8 mmol/L; Test Date: 20210317; Test Name: potassium; Result Unstructured Data: Test Result:3.5 mmol/L; Test Date: 20210319; Test Name: potassium; Result Unstructured Data: Test Result:3.9 mmol/L; Test Name: arterial tension; Result Unstructured Data: Test Result:120/60; Comments: mmHg; Test Date: 202103; Test Name: arterial tension; Result Unstructured Data: Test Result:14/6; Test Name: plasma sodium; Result Unstructured Data: Test Result:151 mmol/L; Comments: hypernatremia; 135 to 144 mmol/l; Test Date: 20210310; Test Name: plasma sodium; Result Unstructured Data: Test Result:137 mmol/L; Test Date: 20210315; Test Name: plasma sodium; Result Unstructured Data: Test Result:143 mmol/L; Test Date: 20210317; Test Name: plasma sodium; Result Unstructured Data: Test Result:141 mmol/L; Test Date: 20210319; Test Name: plasma sodium; Result Unstructured Data: Test Result:140 mmol/L; Test Date: 20210321; Test Name: plasma sodium; Result Unstructured Data: Test Result:146 mmol/L; Test Date: 20210323; Test Name: plasma sodium; Result Unstructured Data: Test Result:150 mmol/L; Comments: hypernatremia; Test Date: 20210315; Test Name: Complement component; Result Unstructured Data: Test Result:C3 1.53 g/l; Comments: C3 at 1.53 g / l, C4 at 0.37 g / l; Test Date: 20210315; Test Name: Complement component 3; Result Unstructured Data: Test Result:1.53 g/l; Test Name: urea; Result Unstructured Data: Test Result:41 mmol/L; Test Date: 20210310; Test Name: urea; Result Unstructured Data: Test Result:10.1 mmol/L; Test Date: 20210315; Test Name: urea; Result Unstructured Data: Test Result:26.6 mmol/L; Test Date: 20210317; Test Name: urea; Result Unstructured Data: Test Result:19.2 mmol/L; Test Date: 20210319; Test Name: urea; Result Unstructured Data: Test Result:25 mmol/L; Test Date: 20210321; Test Name: urea; Result Unstructured Data: Test Result:35,6 mmol/L; Test Date: 20210323; Test Name: urea; Result Unstructured Data: Test Result:37,9 mmol/L; Test Date: 20210311; Test Name: hematuria; Result Unstructured Data: Test Result:857.12 /mm3; Test Date: 20210313; Test Name: hematuria; Result Unstructured Data: Test Result:1057.89 /mm3; Test Date: 20210321; Test Name: hematuria; Result Unstructured Data: Test Result:1 600 /mm3; Comments: superior; Test Date: 202103; Test Name: body temperature; Result Unstructured Data: Test Result:38,4; Comments: ?C; Test Date: 20210310; Test Name: ionized calcium; Result Unstructured Data: Test Result:1.13; Test Date: 20210311; Test Name: thoraco-abdomino-pelvic scan; Result Unstructured Data: Test Result:bilateral multi-lobular pneumonia; Comments: absence of occlusive syndrome, advanced bilateral multi-lobular pneumonia of severe form greater than 75%; Test Date: 20210322; Test Name: thoraco-abdomino-pelvic scan; Result Unstructured Data: Test Result:Marked improvement in the alveolar-interstitial op; Comments: Marked improvement in the alveolar-interstitial opacities of the two pulmonary fields, predominantly at the level of the upper lobes of the middle lobe with clearly less extensive lesions in the basal pyramids, especially on the left. Appearance of bilateral pleural effusion, more marked on the right.; Test Date: 20210323; Test Name: Coombs direct test; Result Unstructured Data: Test Result:positive; Comments: IgG POS +++ C3D negative; Test Name: C-reactive protein; Result Unstructured Data: Test Result:38 mg/l; Test Date: 20210310; Test Name: C-reactive protein; Result Unstructured Data: Test Result:330 mg/l; Test Date: 20210315; Test Name: C-reactive protein; Result Unstructured Data: Test Result:249 mg/l; Test Date: 20210317; Test Name: C-reactive protein; Result Unstructured Data: Test Result:201 mg/l; Test Date: 20210319; Test Name: C-reactive protein; Result Unstructured Data: Test Result:76 mg/l; Test Date: 202104; Test Name: C-reactive protein; Result Unstructured Data: Test Result:fell from 152 to 78 mg/l; Comments: in 5 days; Test Date: 20210311; Test Name: D-dimer; Result Unstructured Data: Test Result:3.770 ng/ml; Test Date: 20210319; Test Name: FiO2; Test Result: 57 %; Test Date: 20210310; Test Name: gGT; Result Unstructured Data: Test Result:79 IU/l; Test Date: 20210319; Test Name: gGT; Result Unstructured Data: Test Result:192 IU/l; Test Name: hemoglobin; Result Unstructured Data: Test Result:10 g/dl; Test Date: 20210310; Test Name: hemoglobin; Result Unstructured Data: Test Result:7.3 g/dl; Test Date: 20210312; Test Name: hemoglobin; Result Unstructured Data: Test Result:6.5 g/dl; Test Date: 20210313; Test Name: hemoglobin; Result Unstructured Data: Test Result:10.1 g/dl; Test Date: 202103; Test Name: hemoglobin; Result Unstructured Data: Test Result:7.3 g/dl; Comments: anemia; Test Date: 20210315; Test Name: hemoglobin; Result Unstructured Data: Test Result:10.3 g/dl; Test Date: 20210319; Test Name: hemoglobin; Result Unstructured Data: Test Result:11.4 g/dl; Test Date: 20210315; Test Name: haptoglobin; Result Unstructured Data: Test Result:0.05 g/l; Test Name: Heart rate; Result Unstructured Data: Test Result:74; Comments: bpm; Test Date: 202103; Test Name: Heart rate; Result Unstructured Data: Test Result:114; Comments: bpm; Test Date: 20210311; Test Name: total binding capacity; Result Unstructured Data: Test Result:27.25 umol/l; Test Date: 20210320; Test Name: soluble urinary antigens Legionnella; Test Result: Negative ; Test Date: 20210311; Test Name: leukocyturia; Result Unstructured Data: Test Result:14.52 /mm3; Test Date: 20210313; Test Name: leukocyturia; Result Unstructured Data: Test Result:60.81 /mm3; Test Date: 20210310; Test Name: lipase; Result Unstructured Data: Test Result:29 IU/l; Test Date: 20210310; Test Name: MCHC; Result Unstructured Data: Test Result:32 g/dl; Test Date: 20210312; Test Name: MCHC; Result Unstructured Data: Test Result:32.9 g/dl; Test Date: 20210310; Test Name: MCV; Result Unstructured Data: Test Result:84.6; Comments: fl; Test Date: 20210312; Test Name: MCV; Result Unstructured Data: Test Result:84.1; Comments: fl; Test Name: pro-bnp; Result Unstructured Data: Test Result:1911 pg/mL; Test Date: 20210310; Test Name: pro-bnp; Result Unstructured Data: Test Result:3 080 pg/mL; Test Date: 20210319; Test Name: pro-bnp; Result Unstructured Data: Test Result:10 502 pg/mL; Test Name: saturation; Test Result: 100 %; Comments: under 5l O2; Test Date: 20210310; Test Name: saturation; Test Result: 86.6 %; Test Date: 20210312; Test Name: saturation; Test Result: 81 %; Test Date: 202103; Test Name: saturation; Test Result: 98 %; Test Date: 20210321; Test Name: saturation; Test Result: 89.3 %; Test Date: 20210310; Test Name: pCO2; Result Unstructured Data: Test Result:37.4 mmHg; Test Date: 20210321; Test Name: pCO2; Result Unstructured Data: Test Result:47.4 mmHg; Test Date: 20210310; Test Name: pO2; Result Unstructured Data: Test Result:48 mmHg; Test Date: 20210321; Test Name: pO2; Result Unstructured Data: Test Result:56.2 mmHg; Test Name: positron emission tomography scan; Result Unstructured Data: Test Result:diffuse digestive fixation; Comments: diffuse digestive fixation 1/3 supra esophageal; Test Date: 20210315; Test Name: protein; Result Unstructured Data: Test Result:69 g/l; Test Date: 20210320; Test Name: 24 hour proteinuria; Result Unstructured Data: Test Result:0.57 g/l; Test Date: 20210310; Test Name: prothrombin time; Test Result: 92 %; Test Date: 20210319; Test Name: prothrombin time; Test Result: 88 %; Test Date: 20210315; Test Name: glomerular filtration rate; Result Unstructured Data: Test Result:21 ml/min; Comments: ml/mn/1,73; Test Date: 202103; Test Name: respiratory rate; Result Unstructured Data: Test Result:28; Test Date: 20201226; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210310; Test Name: SARS-CoV-2 test; Test Result: Negative ; Comments: double negative; Test Name: brain scan; Result Unstructured Data: Test Result:normal; Test Date: 20210311; Test Name: ferritin; Result Unstructured Data: Test Result:312 ng/ml; Test Date: 20210311; Test Name: transferritin; Result Unstructured Data: Test Result:1.09 g/l; Test Date: 20210310; Test Name: troponine; Result Unstructured Data: Test Result:21 ng/L; Test Name: Cytobacteriological urine test; Result Unstructured Data: Test Result:Multidrug-resistant Pseudomonas; Comments: Multidrug-resistant Pseudomonas with Staphylococcal bacteremia; Test Date: 20210311; Test Name: Cytobacteriological urine test; Test Result: Negative ; Test Date: 20210313; Test Name: Cytobacteriological urine test; Test Result: Negative ; Test Date: 20210311; Test Name: Vitamin B12; Result Unstructured Data: Test Result:349 pg/mL
CDC Split Type: FRPFIZER INC2021697533

Write-up: anemia; worsening of fatigue; stiffness; dizzy; advanced bilateral multi-lobular pneumonia/respiratory discomfort and fever; evoking in the first place a COVID infection(but 2 PCR negative)/suspected COVID lung disease; evoking in the first place a COVID infection(but 2 PCR negative)/suspected COVID lung disease; vasculitis kidney/pulmonary vasculitis/ ANCA vasculitis with pulmonary and renal (and probable digestive) involvement; multidrug-resistant with Staphylococcal bacteremia which; genital herpes treated; bi cytopenia; thrombocytopenia; urinary tract infection with Candida albicans; urinary infection due to Pseudomonas; painful; bradylalia; bradypsychia; deterioration of the general condition; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB FR-AFSSAPS-2021068755. An 89-year-old female patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on 27Feb2021 (Lot Number: ER0641) as single dose, dose 1 via unknown route of administration on 22Jan2021 (lot number unknown) as single dose for covid-19 immunisation. The patient medical history was not reported, no chronic treatment. No personal or family history reported. Lives alone at home, independent, in good general condition and well surrounded by her children. The patient''s concomitant medications were not reported. The patient experienced vasculitis kidney/pulmonary vasculitis/ ANCA vasculitis with pulmonary and renal (and probable digestive) involvement since 04Mar2021. On 22Jan2021, patient had 1st dose of Comirnaty followed by the onset of fatigue attributed to the death of her sister-in-law 19Feb, 2nd dose of Comirnaty lot ER0641 on 27Feb2021 and then, (in 2021) the patient had worsening of fatigue, appearance of stiffness, then respiratory discomfort and fever. Consulted his attending physician prescribes a laboratory assessment which showed anemia at 7.3 g / dl (10Mar2021) and hospitalized her on 10Mar2021. Information included in the declaration was high fever and very great fatigue very tired and dizzy. CLINICAL EXAMINATION AT THE ENTRY Patient conscious, oriented, temperature 38.4C, blood pressure 14/6, heart rate 114 beats / min, respiratory rate 28, saturation 98%, no signs of heart failure, crackles at the base on the right. ADDITIONAL TESTS Laboratory tests results (10Mar2021): Blood gas: pH at 7.48, pCO2 at 37.4 mmHg, pO2 at 48 mmHg, oxygen saturation at 86.6%, ionized calcium at 1.13, blood glucose at 7.5 mmol / l, HCO3 at 27.5mmol / l, Blood cultures are negative, PCR for SARS COVID 2 is negative twice, Blood count test: white blood cells 10000, Neutrophils 8 600, lymphocytes at 600, monocytes at 800, eosinophils at 0, hemoglobin at 7.3 g / dl, MCV at 84.6 fl, mean corpuscular hemoglobin concentration (MCHC) at 32 g / dl , platelets 372 000, reticulocytes 37.53 G / l, prothrombin time 92%, activated partial thromboplastin time 1.16, new tests of blood cultures: negative, CRP at 330 mg / l, sodium 137 mmol / l, serum potassium at 3.7 mmol / l, calcium at 2.11 mmol/l, Urea at 10.1 mmol / l, creatinine at 118 umol / l, blood glucose at 7.5 mmol / l, Total bilirubin at 9 umol / l, ASAT at 23 IU / l, ALT (ALAT) at 16 IU / l, gGT at 79 IU / l, alkaline phosphatase at 107 IU / l, lipase at 29 IU / l, Troponin 21 ng / l, Pro-BNP 3080 pg / ml. 11Mar2021: D-dimers at 3,770 ng / ml, Ferritin at 312 ng / ml, transferrin at 1.09 g / l, serum iron at 0.4 umol / l, percent saturation at 1%, Phosphorus at 0.82 mmol / l, Magnesium at 0.8 mmol / l, Total binding capacity 27.25 umol / l, Parathormone elevated to 153 pg / ml, Vitamin B12 349 pg / ml, 25 OH D 7.5 ng / ml, Folates 6.4 ng / ml, cytobacteriological urine test: leukocyturia 14.52 / mm3, hematuria 857.12 / mm3, the culture came back negative. The thoraco-abdomino-pelvic scanner made on 11Mar2021 concluded in the absence of occlusive syndrome, advanced bilateral multi-lobular pneumonia of severe form greater than 75%, which leads to evoking in the first place a COVID infection (but 2 PCR negative). OUTCOME Due to a suspected COVID lung disease on the scan appearance, she was transferred to the COVID unit. 12Mar: worsening of anemia with hemoglobin at 6.5 g / dl, MCV at 84.1 fl, mean corpuscular hemoglobin concentration (MCHC) at 32.9 g / dl, white blood cells at 12 500, platelets at 397 000, neutrophils at 10 700, lymphocytes at 900. Blood cells transfusion, initiation of treatment with corticosteroid therapy, double antibiotic therapy and preventive anticoagulation with CALCIPARINE. Saturation 81%, requiring increased oxygen therapy with a high concentration mask. Results from 13Mar: hemoglobin at 10.1 g / dl, cytobacteriological urine test negative with hematuria at 1057.89 / mm3, leukocyturia at 60.81 / mm3. March 14, under high concentration mask at 12 l / min: table of respiratory distress with desaturation despite oxygen therapy under high concentration mask, put on OPTIFLOW on 16Mar. So the presence of the association of lung damage, kidney damage and anemia, with a negative COVID test and the notion of anti-COVID vaccination that has been done. Table suggesting pneumo-renal syndrome or alveolar hemorrhage. The images of the scanner were reviewed by internist, pulmonologist and radiologist, they do not suggest a COVID, they retained the appearance suggestive of intra-alveolar hemorrhage. In this context, increase in corticosteroid therapy and bolus of SOLUMEDROL to 240 mg with hydration and continuation of antibiotic therapy with AUGMENTIN and ROVAMYCINE. 15Mar results: CRP 249 mg / l, plasma sodium concentration 143 mmol / l, serum potassium 3.8 mmol / l, calcemia 2.22 mmol / l, osmolarity 328 mosmol / l, protein 69 g / l, urea 26, 6 mmol / l, creatinine at 185 umol / l, glomerular filtration rate 21 ml / min / 1.73, ASAT 31 IU, alanine aminotransferase 38 IU. Hemoglobin 10.3 g / dl, white blood cells 17 700, platelets 503 000, polymorphonuclear neutrophils 16 000, lymphocytes 600. 17Mar: CRP 201 mg / l, plasma sodium concentration 141 mmol / l, serum potassium 3.5 mmol / l, osmolarity 315 mosmol / l, urea 19.2 mmol / l, creatinine 197 umol / l . 19Mar: white blood cells 21 500, hemoglobin 11.4 g / dl, mean cell volume (MCV) at 86.6 fl, platelets 389 G / l, neutrophils 20 500, lymphocytes 200, monocytes 700, CRP 76 mg / l, plasma sodium concentration 140 mmol / l, serum potassium 3.9 mmol / l, serum calcium 2.07 mmol / l, osmolarity calculated at 322 mosmol / l, urea 25 mmol / l, creatinine 217 umol / l, blood glucose 8 mmol / l, total bilirubin 21 umol / l, direct bilirubin at 9 umol / l, Indirect bilirubin 12 umol / l, alanine aminotransferase at 35 IU / l, gGT at 192 IU / l, alkaline phosphatase at 112 IU / l, C3 dosage at 1.53 g / l, C4 at 0.37 g / l, haptoglobin collapsed at 0.05 g / L, LDH at 690 IU / L, pro-BNP at 10 502 pg / ml, prothrombin time at 88%, activated partial thromboplastin time 0.98. Request for an opinion in internal medicine: complete the assessment for vasculitis, redo the pro-BNP, Improvement of the general and respiratory condition under corticosteroid therapy, which allowed the reduction of oxygen under OPTIFLOW for a weaning goal. The vasculitis assessment on 20Mar: anti-nuclear factors in progress, anti-phospholipid antibodies in progress, ANCA positive with anti-PR3 antibodies greater than 200, suggesting Wegener''s disease, 24 hour proteinuria at 0.57 g / l, with presence of blood, test for soluble urinary antigens Legionnella negative, anti-glomerular basement membrane antibodies negative. On 21Mar: natremia at 146 mmol / l, calcium at 2.13 mmol / l, high osmolarity at 342 mosmol / l, urea at 35.6 mmol / l, creatinine at 239 umol / l, glycemia at 7, 9 mmol / l, Blood count: leukocytes at 73.92 / mm3, hematuria greater than 1600 / mm3. Search for cyroglobulins in progress.Blood gases measured at 23 L/ min with 57% FiO2 , pH 7.4, pCO 47.4 mmHg, pO2 56.2 mmHg, oxygen saturation 89.3%. On 23Mar: hypernatremia 150 mmol / l, serum calcium 2.19 mmol / l, urea 37.9 mmol / l, creatinine 255 umol / l, chlorine 111 mmol / l, serum calcium 2.19 , osmolarity 353 mosmol / l, direct Coombs test returned positive for IgG POS, direct Coombs test C3D negative. Control thoracic CT scan on 22Mar2021: marked improvement in the alveolar-interstitial opacities of the two pulmonary fields, predominantly in the upper lobes of the middle lobe with clearly less extensive lesions in the basal pyramids, in particular on the left. Appearance of bilateral pleural effusion, more marked on the right. Topic discussed again with internists: Table of Wegener''s disease and hemolytic anemia. continue rehydration with LASILIX and corticosteroid therapy. Benefit of immunosuppressive therapy (ENDOXAN)? or plasma exchange with the corticosteroid bolus. Transfer for the management of pneumo-renal syndrome secondary to GPA-type ANCA-positive vasculitis in a post-COVID vaccination context. Weight: 56 kg, Height: 152cm BMI: 24.24. Undernourished patient, conscious, cooperating with a Glasgow 15/15 and afebrile. Constants: Arterial pressure 120/60 mmHg, Heart rate 74 bpm, Saturation 100% under 5L of O2. Laboratory tests: Hypernatremia at 151 mmol / l, Plasma osmolarity at 359 mOsm / l, hyperchloremia at 112 mmol / l. Kalaemia at 4.6 mmol / l, bicarbonatemia at 30 mmol / l. Serum creatinine at 262 umol / l, urea at 41 mmol / l. NT-proBNP 1911, leukocytes 12 G / l with 89% Neutrophils , hemoglobin 10 g / dl, Platelets 228 G / l, CRP at 38 mg / l. Therefore, overall predominantly intracellular dehydration with hypernatremia without neurological disorder in a malnourished patient in whom the diagnosis of ANCA vasculitis with pneumo-renal involvement was made. Rehydration. Corticosteroid therapy and antibiotic therapy. Assessment of the indication for immunosuppression. DEVELOPEMENT IN THE DEPARTMENT: Gradual normalization of serum sodium levels maintained between 135 and 144 mmol / l and euvolemia, under regimen of rehydration by hypotonic solute glucose 2.5% From the point of view of vasculitis: Good progress on corticosteroid on the respiratory plan with eupnea in ambient air and improvement of radiological lesions. Stationary evolution on the renal level. With a creatinine that oscillates between 170 and 260 umol / l As part of the extension assessment, diffuse digestive fixation and 1/3 sup esophageal with the positron emission tomography scan. The brain scan was normal. On the advice of the staff, the kidney biopsy was not done on 29Mar2021. Cyclophosphamide 500 mg bolus was administered Immediate viral (genital herpes treated, 2021) and fungal (urinary tract infection with Candida albicans, 2021) and bi cytopenia with anemia and thrombocytopenia (2021) without externalized bleeding which corrected with stabilization after transfusion appeared as a result. By collegial decision, a second bolus at the 3 rd week at a reduced dose of 360 mg of Cyclophosphamide was administered on 19Apr2021 with, on day15 of the bolus, a urinary infection due to Pseudomonas multidrug-resistant with Staphylococcal bacteremia which has progressed well under CEFTRIAXONE AMIKACIN VANCOMYCIN. CRP fell from 152 to 78 mg / l in 5 days. Reappearance of bicytopenia on day2. The patient became bradylalia and bradypsychia in a context of slip syndrome with refusal of mobilization despite the physiotherapist''s visit, to eat, to take oral medications. A geriatric advisory recommended adding Escitalopram (difficult to get her to take because of the dosage form). Faced with the profound deterioration of the general condition, the palliative care team at the bedside of the patient, who had become painful and uncomfortable, recommended the use of opioids. After consultation with the family, hospitalization with home support was decided. Release 05May2021 Death on 09May2021 In total, ANCA vasculitis with pulmonary and renal (and probable digestive) involvement in a woman in good general condition and without associated pathology, the first signs of which began around day6 (04Mar2021) after dose 2 of Comirnaty. Death following haematological and infectious complications related to corticosteroid and cyclophosphamide boluses. The outcome of event ANCA vasculitis and Staphylococcal bacteremia was fatal, of other events was unknown. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number already obtained.; Reported Cause(s) of Death: vasculitis kidney/pulmonary vasculitis/ ANCA vasculitis with pulmonary and renal (and probable digestive) involvement; Staphylococcal bacteremia


VAERS ID: 1418559 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-05-06
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock
SMQs:, Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Dementia; Embolism pulmonary; Hypertension arterial; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021697584

Write-up: Cardiogenic shock; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-2021069082. A 73-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: EW2239), second dose intramuscular on 23Apr2021 as 2nd dose, single for covid-19 immunization. Medical history included asthma, hypertension arterial, pulmonary embolism, dementia, type 2 diabetes mellitus all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced cardiogenic shock on 06May2021. Cardiogenic shock on day 14 of second dose pending hospitalization CR (serum creatinine), it will be the subject of a new version. The outcome of event was fatal. The patient died on 06May2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Arrest cardiac


VAERS ID: 1418568 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-04-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001657 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Disease coronary artery
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Sudden death; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) in a 74-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001657) for COVID-19 vaccination. The patient''s past medical history included Atrial fibrillation, Disease coronary artery and Cardiac failure. On 18-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 19-Apr-2021. The reported cause of death was mort subite. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter. This is a case of sudden death of a 74-year-old male patient, and 2 days after receiving first dose of vaccine (Lot number 3001657). The possible confounding factors are the patient''s medical history of Atrial fibrillation, Coronary artery disease and Cardiac failure. Very limited information regarding concomitant medications, and the clinical details pertaining to death and cause of death was provided at this time. No further information is expected. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021068671.; Sender''s Comments: This is a case of sudden death of a 74-year-old male patient, and 2 days after receiving first dose of vaccine (Lot number 3001657). The possible confounding factors are the patient''s medical history of Atrial fibrillation, Coronary artery disease and Cardiac failure. Very limited information regarding concomitant medications, and the clinical details pertaining to death and cause of death was provided at this time. No further information is expected.; Reported Cause(s) of Death: Mort subite


VAERS ID: 1418579 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Chronic alcoholism; Pneumopathy; Tabaquism
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Embolism pulmonary; Ischemic stroke; This regulatory authority case was reported by a pharmacist and describes the occurrence of PULMONARY EMBOLISM (Embolism pulmonary) and ISCHAEMIC STROKE (Ischemic stroke) in a 54-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Chronic alcoholism, Tabaquism, Pneumopathy in 2020 and AFib. On 22-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 25-May-2021, the patient experienced PULMONARY EMBOLISM (Embolism pulmonary) (seriousness criteria death and medically significant) and ISCHAEMIC STROKE (Ischemic stroke) (seriousness criteria death and medically significant). The patient died on 26-May-2021. The reported cause of death was avc. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medications were not provided. The treatment information was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Company Comment: This is a case of death in a 54 -years-old male subject with no reported medical hx, who died on the 04 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Sender''s Comments: This is a case of death in a 54 -years-old male subject with no reported medical hx, who died on the 04 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Reported Cause(s) of Death: AVC


VAERS ID: 1418591 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-01
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angiogram, Pulmonary thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 41
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CACIT VITAMINE D3 1000 mg/880 MONOPROST 50 microgrammes/ml, ; LACTULOSE; HYDROCHLOROTHIAZIDE; KARDEGIC 75 mg, ; CARDENSIEL 1,25 mg, ; IRBESARTAN; STAGID 700 mg,
Current Illness: Hypertension arterial; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: CT angiography; Test Result: Inconclusive ; Result Unstructured Data
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Double thrombose pulmonaire; This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Double thrombose pulmonaire) in a 91-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042722) for COVID-19 vaccination. Concurrent medical conditions included Type 2 diabetes mellitus and Hypertension arterial. Concomitant products included CACIT VITAMINE D3 1000 mg/880 UI, LATANOPROST (MONOPROST 50 microgrammes/ml), LACTULOSE, HYDROCHLOROTHIAZIDE, KARDEGIC 75 mg, , CARDENSIEL 1,25 mg, comprim? pellicul?, IRBESARTAN and STAGID 700 mg, comprim? s?cable for an unknown indication. On 17-Mar-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PULMONARY THROMBOSIS (Double thrombose pulmonaire) (seriousness criteria death and medically significant). The patient died on 12-May-2021. The reported cause of death was Pulmonary thrombosis. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Angiogram: embolie pulmonaire (Inconclusive) embolie pulmonaire proximale bilat?rale avec signes de gravit?. Treatment information was not provided. On an unknown date, the patient had a COVID-19 PCR test that was negative. Very limited information regarding the event has been provided at this time. Further information is not expected. Sender''s Case Number: FR-AFSSAPS-2021065147. Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up was received on 15 Jun 2021. Updated the date of death, added medical history, concomitant medications, batch number, the start and end date of event.; Sender''s Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Pulmonary thrombosis


VAERS ID: 1418720 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   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: DICLOFENAC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis NOS; Rheumatoid arthritis; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021671542

Write-up: Heart attack; Enlarged heart; This is a spontaneous report from a contactable consumer (patient''s child) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106021602018240-YPY6Q (Safety Report Unique Identifier: GB-MHRA-ADR 25406530). A 55-year-old male patient received BNT162B2 (COMIRNATY; Lot Number was not reported), intramuscular, on 06Jan2021, as dose 1, single, for COVID-19 immunization. The patient''s medical history included rheumatoid arthritis (taking regular medicines for rheumatoid arthritis or other types of arthritis except osteoarthritis). The patient''s concomitant medication included diclofenac (DICLOFENAC) for arthritis. The patient had not had symptoms associated with COVID-19 and was not enrolled in clinical trial. 2 days after the patient received the COVID-19 vaccine (08Jan2021), he had a sudden massive heart attack caused by an enlarged heart. The patient had always had a healthy heart and the patient''s child believed that Pfizer did cause the death of the patient. The patient''s child had taken many months to heal and noted that this will be escalated to the member of government and intended on getting justice for the patient being taken so young. The patient has not tested positive for COVID-19 since having the vaccine. The patient underwent COVID-19 virus test that was negative on 08Jan2021. The outcome of the events was fatal. The patient died on 08Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot or batch number cannot be obtained.; Reported Cause(s) of Death: Heart attack; Enlarged heart


VAERS ID: 1418868 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-30
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: post mortum; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: GBPFIZER INC2021663872

Write-up: Pulmonary embolism; This is a spontaneous report received from a contactable consumer or other non health professional from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106061840379690-0CETX, Safety Report Unique Identifier GB-MHRA-ADR 25427656. A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s medical history and concomitant medications were not reported. The patient experienced pulmonary embolism on 30Mar2021. The patient died 10 days after second vaccine from blood clot in the lung on 30Mar2021. Lab data information was reported as post mortum. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1419198 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   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: DEPON; DIAMICRON; LOBIVON; ORIZAL
Current Illness: Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRMODERNATX, INC.MOD20212

Write-up: Death; Arrest respiratory; Hypertensive heart disease; Arrest cardiac; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death), RESPIRATORY ARREST (Arrest respiratory), HYPERTENSIVE HEART DISEASE (Hypertensive heart disease) and CARDIAC ARREST (Arrest cardiac) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included PARACETAMOL (DEPON), GLICLAZIDE (DIAMICRON), NEBIVOLOL HYDROCHLORIDE (LOBIVON) and AMLODIPINE BESILATE, OLMESARTAN MEDOXOMIL (ORIZAL) for an unknown indication. On 06-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), RESPIRATORY ARREST (Arrest respiratory) (seriousness criteria death and medically significant), HYPERTENSIVE HEART DISEASE (Hypertensive heart disease) (seriousness criteria death and medically significant) and CARDIAC ARREST (Arrest cardiac) (seriousness criteria death and medically significant). The patient died on 08-May-2021. The reported cause of death was Arrest cardiac, Arrest respiratory and Hypertensive heart disease. An autopsy was not performed. No treatment information was provided. Action taken with Moderna Covid vaccine was not applicable. Very limited information regarding this events has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Concomitant medication has been added; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information is not expected; Reported Cause(s) of Death: Arrest cardiac; Arrest respiratory; Hypertensive heart disease


VAERS ID: 1419245 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Alcohol poisoning, Blood glucose, Blood glucose increased, Bradycardia, Brain oedema, Brain stem haemorrhage, Cardiac arrest, Computerised tomogram head, Death, Extradural haematoma, Head injury, Subdural haematoma
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   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: COVERCARD PLUS; NEBIVOLOL; INSUMAN COMB 25; ACETYLSALICYLIC ACID; MERCKFORMIN; PROSOLIN [TAMSULOSIN HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Insulin dependent diabetic
Allergies:
Diagnostic Lab Data: Test Name: blood glucose values; Result Unstructured Data: Test Result:high values; Test Date: 20210508; Test Name: Brain CT; Result Unstructured Data: Test Result:epidural hematoma; Comments: epidural hematoma parietally left side, and subdural hematoma around both hemisphere; Test Date: 20210509; Test Name: Brain CT; Result Unstructured Data: Test Result:central, extensive bleeding; Comments: central, extensive bleeding on the left side; Test Date: 20210511; Test Name: Brain CT; Result Unstructured Data: Test Result:extensive posttraumatic bleeding; Comments: extensive posttraumatic bleeding in the left hemisphere, progressive cerebral edema, and brainstem hemorrhage
CDC Split Type: HUPFIZER INC2021698654

Write-up: death; rapid bradycardization, asystole occurred; rapid bradycardization, asystole occurred; traumatic head injury; alcohol intoxication; epidural hematoma parietally left side; subdural hematoma; high blood glucose values; progressive cerebral edema; brainstem hemorrhage; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-385421. A 75-year-old male patient received bnt162b2 (COMIRNATY, concentrate for dispersion for injection, 30 micrograms of COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran MAH: BioNTech, Manufacturing GmbH/ Pfizer), dose 2 intramuscular, administered in left arm on 06May2021 (Batch/Lot Number: EX6537) as 0.3ML single for covid-19 immunisation. Medical history included Hypertension and not ongoing, Insulin dependent diabetic and not ongoing. Concomitant medications included amlodipine besilate, indapamide, perindopril arginine (COVERCARD PLUS); nebivolol; insulin human, insulin human injection, isophane (INSUMAN COMB 25, insulin human); acetylsalicylic acid; metformin hydrochloride (MERCKFORMIN); tamsulosin hydrochloride (PROSOLIN); all taken for an unspecified indication, start and stop date were not reported.The patient previously received first dose of bnt162b2 (COMIRNATY, batch/lot number: ET 7205) on 01Apr2021 for COVID-19 immunization. This case was reported by a physician on 26May2021, concerning death after the administration of Comirnaty. On 08May2021, the patient was admitted to the hospital for observation due to traumatic head injury under alcohol intoxication. First cranial CT showed epidural hematoma parietally left side, and subdural hematoma around both hemisphere. The patient neurological condition showed rapid progressive deterioration, therefore acute surgery was performed - craniotomy, epidural and subdural hematoma evacuation, drain insertion. Urapidil perfusor was initiated due to high blood pressure values. Postoperative cranial CT showed central, extensive bleeding on the left side on 09May2021. Dehydration, haemostyptic administration, ulcerative- and thromboprophylaxis, and neuroprotective mechanical ventilation were used. Due to high blood glucose values, continuous insulin administration was given. Repeated cranial CT on 11May2021 showed extensive posttraumatic bleeding in the left hemisphere, progressive cerebral edema, and brainstem hemorrhage. His condition gradually declined, he remained contactless despite stopping sedation, and reflexes could not be elicited. On 15May2021, after rapid bradycardization, asystole occurred and the patient died. Autopsy was requested. The patient died on 15May2021. It was not reported if an autopsy was performed. Sender Comment: The patient got a head injury under the influence of alcohol after 2 days, and died due to extensive cerebral bleeding and edema 9 days after vaccination with Comirnaty. The causal relationship between the event and Comirnaty is considered unlikely. The case is serious due to hospitalization and fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: extensive cerebral bleeding; extensive cerebral edema; rapid bradycardization, asystole occurred; rapid bradycardization, asystole occurred


VAERS ID: 1419267 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Coma, Deep vein thrombosis, Ischaemia, Platelet count, Platelet count abnormal, Venous thrombosis
SMQs:, Haematopoietic thrombocytopenia (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 14
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: Platelet count; Result Unstructured Data: altered values
CDC Split Type: ITJNJFOC20210631847

Write-up: ISCHEMIA; DEEP VEIN THROMBOSIS; PERIPHERAL VENOUS THROMBOSIS; ALTERED PLATELET VALUES; COMA; CEREBRAL VENOUS SINUS THROMBOSIS; This spontaneous report received from a company representative via social media concerned a 54 year old male. Initial information was processed with additional information received on 16-JUN-2021 via a company representative from a news report. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable perform follow-up to request the batch number. No concomitant medications were reported. On 09-JUN-2021, 14 days after receiving the vaccine; the patient first started experiencing symptoms (unspecified) and was diagnosed with deep vein thrombosis (also reported as peripheral venous thrombosis) altered platelet values at a hospital. He was treated with heparin without any hospitalization and was sent home. However the patient''s symptoms worsened despite treatment prescribed and he went to a different emergency room/hospital. He was hospitalized on the night between 11-JUN-2021 and 12-JUN-2021 in serious condition. He was admitted to the resuscitation/intensive care area with deep vein thrombosis and ischemia. The hospital suspected adverse ischemic event occurring in the period following the vaccination. On an unspecified date the patient also experienced cerebral venous sinus thrombosis (CVST) and cerebral thrombosis (subsumed to CVST). It was reported the patient went into a coma for the thrombosis and died on 15-JUN-2021. His death was due to cerebral thrombosis, peripheral venous thrombosis and altered platelet values. It was unknown if an autopsy was performed. It was stated no correlation had been confirmed by the physicians following the patient receiving the vaccine and complications; they have also not ruled out possible previous illnesses. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome was fatal for the following events: CVST, peripheral venous thrombosis and altered platelet values. The events coma, deep vein thrombosis and ischemia were not recovered. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition); Sender''s Comments: V0: This spontaneous report received from a patient via social media concerned a 54-year-old man (ethnicity unknown) who experienced Cerebral venous sinus thrombosis (CVST), Deep vein thrombosis (DVT)/peripheral venous thrombosis (PVT), ischemia, and altered platelet values 14 days after vaccine and died on day 20. No past medical history or concomitant medications were reported. On day 14 after receiving vaccine, the patient was diagnosed with deep vein thrombosis (DVT). He was treated with heparin at the hospital on day 14 but not admitted. The patient''s condition worsened between days 16 and 17. On day 17, the patient was hospitalized for DVT and ischemia. The hospital suspected adverse ischemic event occurring in the period following the vaccination. On an unspecified date the patient experienced altered platelet values without a specific reported numerical value. The patient went into a coma and died on day 20 due to thrombosis and altered platelet values. It was unknown if an autopsy was performed. No further details on clinical course, laboratory values, or treatment were reported. It was stated no correlation had been confirmed by the physicians following the patient receiving the vaccine and complications; they have also not ruled out possible previous illnesses. The use of heparin may have increased the risk for the events to occur, and the platelet value is not reported. However, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate.; Reported Cause(s) of Death: PERIPHERAL VENOUS THROMBOSIS; ALTERED PLATELET VALUES; CEREBRAL VENOUS SINUS THROMBOSIS


VAERS ID: 1419338 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002186-05 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease; Hematoma subdural
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of UNRESPONSIVE TO STIMULI in a 94-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002186-05) for COVID-19 vaccination. The patient''s past medical history included Hematoma subdural since an unknown date. Concurrent medical conditions included Alzheimer''s disease. On 15-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 20-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced UNRESPONSIVE TO STIMULI (seriousness criterion death). The patient died on 20-May-2021. The reported cause of death was Unresponsive to stimuli. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant products were reported. No treatment information was provided. Very limited information regarding the death event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received does not contain any new information; Sender''s Comments: Very limited information regarding the death event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unresponsive to stimuli


VAERS ID: 1419341 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-06-01
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7065 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: BISOPROLOL FUMARATE; TRITTICO; TAVOR [LORAZEPAM]; CYMBALTA; COLCHICINE; DELTACORTENE; PANTORC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; Depression; Fibromyalgia; Rheumatic disorder (friction)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021688299

Write-up: in the morning around 9.30 she had chest pain, vomiting episode, left arm pain. In the evening, cardio-circulatory arrest was noted.; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-739997. A 75-years-old female patient received first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EY7065; Expiration Date: 31Aug2021) via an intramuscular route, administered in Arm Right on 13May2021 as 1st dose, single for covid-19 immunisation. Medical history included fibromyalgia, rheumatologic disease (friction), arthrosis, depression. Concomitant medications included bisoprolol fumarate taken as 2.5 mg once a day oral; trazodone hydrochloride (TRITTICO) taken as 150 mg once a day oral; lorazepam (TAVOR [LORAZEPAM]) taken as once a day oral; duloxetine hydrochloride (CYMBALTA) taken as 60 mg once a day; colchicine taken as oral; prednisone (DELTACORTENE) taken as 0.5 mg once a day oral; pantoprazole sodium sesquihydrate (PANTORC) taken as 20 mg once a day oral. Reportedly, actions taken (called emergency number) - COVID 19 COMIRNATY VACCINE (PFIZER): Administration site (right shoulder) Booster dose number (1) On 01Jun2021, the patient experienced in the morning around 9.30 she had chest pain, vomiting episode, left arm pain. in the evening, cardio-circulatory arrest was noted. The event was serious (Death). The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the event was fatal. Health Authority comment: Fibromyalgia, and rheumatological diseases such as friction and arthrosis. Depressions.; Reporter''s Comments: Fibromyalgia, and rheumatological diseases such as friction and arthrosis. Depressions.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1419355 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Sinus bradycardia
SMQs:, Disorders of sinus node function (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; RANEXA; LUVION [CANRENONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Aortic stenosis; Decompensation cardiac; Heteroplasia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021704961

Write-up: Marked asthenia and sinus bradycardia with impossibility to assess spO2; Marked asthenia and sinus bradycardia with impossibility to assess spO2; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-741082. An 89-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 05Jun2021 at age of 89-year-old (Lot Number: FD1921) as dose 2, single for covid-19 immunisation. Medical history included aortic aortic stenosis, decompensation cardiac, heteroplasia all unknown if ongoing and angina pectoris. Patient received 1st dose of bnt162b2 (COMIRNATY) on 23Apr2021 via intramascular for COVID-19 vaccination and no adverse reaction. Concomitant medications included furosemide (FUROSEMIDE) taken for decompensation cardiac; ranolazine (RANEXA) taken for angina pectoris; canrenone (LUVION) taken for decompensation cardiac. The patient experienced marked asthenia and sinus bradycardia with impossibility to assess spo2 on 05Jun2021. The patient died of Marked asthenia and sinus bradycardia with impossibility to assess spO2 on 05Jun2021. It was not reported if an autopsy was performed. Clinical course: Patient suffering from serious pathologies (heart failure, pulmonary heteroplasia, severe aortic stenosis) in precarious health conditions. 1st dose of vaccine 15May2021 (as reported, pending clarification): no adverse reactions 2nd dose of vaccine 05Jun2021: marked asthenia and bradycardia on the same day. At 8.30 pm he was transported by ambulance to the hospital and died during transport. No analyzes or other tests were performed. On 08Jun2021 contacted the reporting physician for clinical report. On 10Jun2021 received clinical report, from the reporter.; Reported Cause(s) of Death: Marked asthenia and sinus bradycardia with impossibility to assess spO2; Marked asthenia and sinus bradycardia with impossibility to assess spO2


VAERS ID: 1419432 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac disorder, Computerised tomogram, Glycosylated haemoglobin
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioplasty; Diabetes mellitus; Dyslipidaemia; Heart disorder; Hypertension; Myocardial infarction old; Restenosis; Stent placement; Triple vessel disease
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Blood pressure; Result Unstructured Data: Test Result:124/70 mmHg; Comments: before or after vaccination; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210605; Test Name: CT tests and others; Result Unstructured Data: Test Result:revealed no traumatic findings; Comments: and a diagnosis of heart disorder was made; Test Date: 20210601; Test Name: HbA1c; Test Result: 6.7 %; Comments: before or after vaccination
CDC Split Type: JPPFIZER INC2021674726

Write-up: Heart disorder; This is a spontaneous report from a contactable physician. This is a report received from the . Regulatory authority report number is v21112526. A 74-year-old male patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EY4834; Expiration Date: 31Aug2021), via an unspecified route of administration on 01Jun2021 at 16:30 at a single dose for covid-19 immunisation. Medical history included heart disease, hypertension, diabetes mellitus, dyslipidaemia, myocardial infarction old, triple vessel disease, a stent was placed in the right coronary artery (RCA) in Jan2018, a stent was placed in the left circumflex artery (LCX) and in the left anterior descending artery (LAD) in Feb2018, restenosis in the stent in the RCA in Sep2018, percutaneous old balloon angioplasty in Sep2018, a stent was placed in the segment in Sep2018, PC2 in the RCA in Oct2019, and PC2 and restenosis repeated in the LCX in Sep2020. Concomitant medication included acetylsalicylic acid (BAYASPIRIN). On 05Jun2021 at 09:17, the patient experienced heart disorder, which required emergency room visist and was serious for death. The course of the event was as follows: on 01Jun2021 around 16:30 (the day of vaccination), the patient received the first dose of BNT162b2. On 05Jun2021 at 09:17 (4 days after the vaccination), the patient experienced heart disorder. The event was further described as: on 01Jun2021 (the day of vaccination), the HbA1c was 6.7%, and the blood pressure 124/70 mmHg. On 01Jun2021 (the day of vaccination), the patient received the first vaccination for the new coronavirus. The patient experienced no abnormality during the observation for 15 minutes or longer and went home. On 05Jun2021 in the morning (4 days after the vaccination), during a walk, the patient was found lying in supine position and was transported to the hospital; he was confirmed dead at 09:17. Computerised tomography (CT) tests and others revealed no traumatic findings, and a diagnosis of heart disorder was made. The patient underwent lab tests and procedures which included blood pressure: 124/70mmHg on 01Jun2021 before or after vaccination, body temperature: 36.3 degrees Centigrade on 01Jun2021 before vaccination, computerised tomogram: revealed no traumatic findings, and a diagnosis of heart disorder was made on 05Jun2021, glycosylated haemoglobin: 6.7% before or after vaccination on 01Jun2021. On 05Jun2021 (4 days after the vaccination), the outcome of the event was fatal. It was unknown whether autopsy was performed. The patient died on 05Jun2021 due to heart disorder. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported whether there was other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Heart disorder


VAERS ID: 1419434 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-12
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute, Dehydration, Gastroenteritis, Respiratory arrest
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Noninfectious diarrhoea (broad), Respiratory failure (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021696771

Write-up: Cardiac failure acute; respiratory arrest; Dehydration due to acute gastroenteritis; Dehydration due to acute gastroenteritis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21113928 and v21114017. The patient was an 83-year and 11-month-old female. Body temperature before vaccination was 36.7 degrees centigrade on 07Jun2021 (the day of vaccination). Family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 07Jun2021 at 14:20 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 07Jun2021 (the day of vaccination), the patient received the first dose of COMIRNATY. Subsequently, the patient had no particular change. On 12Jun2021 at around 10:10 (5 days after the vaccination), the patient experienced dehydration due to acute gastroenteritis. On 12Jun2021 (5 days after the vaccination) just after 10:00, the patient called the hospital and told that the patient had diarrhoea and vomiting but was fine, for which the patient was placed under observation. Just after 16:00, the patient called the hospital and told that the patient had persistent diarrhoea and a feeling of loss of consciousness. Just after 17:00, the patient was visited and was diagnosed as dehydration due to acute gastroenteritis, for which maintenance fluid replacement was initiated. At 20:00, the patient recovered to the point of being able to talk with energy. At 21:00, the patient had respiratory arrest. The patient was immediately visited and at 21:40, death was confirmed. Cause of death was diagnosed as cardiac failure acute. On 12Jun2021 (5 days after the vaccination), the outcome of the events was fatal.it was unknown if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was unassessable. The reporting physician''s comment: Although the causality between the vaccine and the death was unassessable, the case was reported just in case because the patient died following the onset of new disease.; Reported Cause(s) of Death: Dehydration due to acute gastroenteritis; Dehydration due to acute gastroenteritis; Cardiac failure acute


VAERS ID: 1419435 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-13
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021697371

Write-up: Sudden death; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114006. The patient was a 71-year and 9-month-old female. Body temperature before vaccination was 36.4 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). It was not provided if the patient had family history. On 01Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA4597, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 13Jun2021 at 11:14 (12 days after the vaccination), the patient died (reported as "Sudden death"). The cause of death was "sudden death". An autopsy was planned to be performed on 14Jun2021. The course of the events was as follows: When patient''s family member visited her house, they found the patient dead. On 14Jun2021, an autopsy was planned to be performed with approval from the family. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1419437 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Cancer pain (in late Feb2021); Carcinoma excision; Debility; Hepatocellular carcinoma; Hepatocellular carcinoma recurrent; Home care
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021703315

Write-up: Death; This is a spontaneous report from a contactable physician received from the REGULATORY AUTHORITY. Regulatory authority report number is v21114071. The patient was an 84-year and 4-month-old male. Body temperature before vaccination was 36.5 degrees centigrade. Family history was unremarkable. Medical history included hepatocellular carcinoma/end-stage hepatocellular carcinoma (Aug2015), resection of the hepatic segment (Nov2015), post-operative relapse (Dec2018), visiting care (Jan2020), cancer pain was aggravated (late Feb2021), bedridden (late Feb2021), and debility was gradually progressing (late Feb2021). Concomitant medications were not reported. In Aug2015, hepatocellular carcinoma was diagnosed at Hospital. In Nov2015, resection of the hepatic segment was performed at a Hospital. In Dec2018, no active treatment was given because of post-operative relapse, and the course was planned to be observed with palliative care. In Jan2020, visiting care by the reporting clinic was introduced. In late Feb2021, cancer pain was aggravated, the patient was bedridden, and debility was gradually progressing. On 07Jun2021 at 09:40 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5829, Expiration date 31Aug2021) via an unspecified route of administration at age of 84-year-old as a single dose for COVID-19 immunisation. On 10Jun2021at 10:36 (3 days after the vaccination), the patient experienced death. As of the reporting date, the outcome of the event was fatal. It was unknown whether autopsy was performed. The course of the event was as follows: On 07Jun2021 (the day of vaccination), the patient was vaccinated. After the vaccination, the patient spent his days without experiencing symptoms suggestive of apparent side effects such as pyrexia. Since before the vaccination, the patient was being debilitated possibly because of cancer, and there were no specific suspicious findings showing a possibility that the vaccination accelerated the death. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was end-stage hepatocellular carcinoma. The reporting physician commented as follows: Considered that the relationship between the vaccine and the death was unlikely.; Reported Cause(s) of Death: death


VAERS ID: 1419438 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Body temperature, Cardiac failure, Cardiogenic shock, Nucleic acid test
SMQs:, Cardiac failure (narrow), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: IRBESARTAN; AMLODIPINE; CLOPIDOGREL; GLACTIV; ROSUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension; Lipid metabolism disorder; Old cerebral infarction; Pneumoconiosis; Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: before vaccination; Test Date: 20210613; Test Name: LAMP; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: JPPFIZER INC2021703508

Write-up: Cardiac failure; Cardiogenic shock triggered by atrial fibrillation paroxysmal; Cardiogenic shock triggered by atrial fibrillation paroxysmal; This is a spontaneous report from a contactable physician received via the Agency and from the Regulatory Authority. Regulatory authority report number is v21114470. An 80-year and 2-month-old male patient received BNT162B2 (COMIRNATY), 1st dose via an unspecified route of administration on 10Jun2021 16:30 (Lot Number: FA5829; Expiration Date: 31Aug2021) at age of 80 years old as a single dose for covid-19 immunisation. Body temperature before vaccination was 35.8 degrees centigrade. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included irbesartan, amlodipine, clopidogrel, sitagliptin phosphate monohydrate (GLACTIV), and rosuvastatin. 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 pneumoconiosis, hypertension, diabetes mellitus, lipid metabolism disorder, renal failure, and asymptomatic old cerebral infarction. On 10Jun2021 (on the same day of the vaccination), the patient experienced cardiac failure, cardiogenic shock triggered by atrial fibrillation paroxysmal, both on 15Jun2021, all with fatal outcome. Lab test included LAMP conducted by nasal swab on 13Jun2021 and the result was negative. The patient was admitted to the hospital from 10Jun2021 to 16Jun2021. The treatment for events including BiPAP placement and administration of dobutamine, SAMSCA, furosemide, and spironolactone. Since the vaccination, the patient has been tested for COVID-19. The patient died on 16Jun2021. It was not reported if an autopsy was performed. Clinical course: On 10Jun2021 after the vaccination, the patient was coming home late, so family member went to meet the patient. It was found out that the patient had shortness of breath and could not move at the roadside. The patient was brought back home. On 12Jun2021, respiratory distress intensified in decubitus position. On 13Jun2021, the patient had difficulty moving body, for which ambulance was requested and the patient visited an emergency unit of the reporting hospital. The patient was diagnosed with cardiac failure and was hospitalized in intensive care unit. Diffuse decreased left ventricular systolic performance accompanying ischaemia was noted; however, age and underlying diseases were assessed comprehensively and conservative therapy was conducted. On 15Jun2021, the patient developed cardiogenic shock triggered by atrial fibrillation paroxysmal. Arrhythmia improved with administration of medication and electrical cardioversion; however, general condition did not improve. On 16Jun2021 at 02:17, the patient died. The reporting physician classified the event as serious (death and hospitalization) and assessed that the event was related to BNT162b2. Other possible causes of the event such as any other diseases were pneumoconiosis, hypertension, diabetes mellitus, lipid metabolism disorder, and asymptomatic old cerebral infarction. The reporting physician commented as follows: On the way home after the vaccination, the symptom occurred; thus, causality between the event and the vaccine could not be denied completely. However, the timing of the onset could have just overlapped because the patient had underlying diseases.; Reported Cause(s) of Death: Cardiac failure; Atrial fibrillation paroxysmal; Cardiogenic shock


VAERS ID: 1419440 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure decreased, Blood pressure measurement, Body temperature, Gastrointestinal haemorrhage, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   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: BESACOLIN; EC DOPARL; CARBOCISTEINE; PROSTAL [CHLORMADINONE ACETATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Bronchitis chronic; Dementia Alzheimer''s type; Parkinson''s disease; Prostatic hyperplasia; Type 2 diabetes mellitus; Venous thrombosis
Allergies:
Diagnostic Lab Data: Test Date: 20210611; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Comments: 08:50; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination; Test Date: 20210611; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased; Comments: 08:50
CDC Split Type: JPPFIZER INC2021704084

Write-up: oxygen saturation decreased; blood pressure decreased; consciousness disturbed; Massive haemorrhage of digestive tract; This is a spontaneous report from a contactable other health professional. Regulatory authority report number is v21114088. The patient was an 86-year and 2-month-old male. Body temperature before vaccination was 36.9 degrees centigrade (10Jun2021). Family history was unknown. Medical history included atrial fibrillation, dementia Alzheimer''s type, Parkinson''s disease, type 2 diabetes mellitus, venous thrombosis, bronchitis chronic, and prostatic hyperplasia. On 20May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EX3617, Expiration date 31Aug2021) as single dose for COVID-19 immunisation. Concomitant medication included bethanechol chloride (BESACOLIN) powder strength: 5% 0.9 g, benserazide hydrochloride, levodopa (EC DOPARL) combination tablet 6 tablets, carbocisteine (CARBOCISTEINE) tablet strength: 250 mg, 4 tablets, and chlormadinone acetate (PROSTAL) tablet strength: 25mg, 2 tablets, all taken for unspecified indications, start and stop dates were not reported. On 10Jun2021 at around 14:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) via an unspecified route of administration at age of 86 years as a single dose for COVID-19 immunization. On 11Jun2021 at 08:30 (around 18 hours after the vaccination), the patient experienced massive haemorrhage of digestive tract. On 11Jun2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: Atrial fibrillation, dementia Alzheimer''s type, Parkinson''s disease, type 2 diabetes mellitus, venous thrombosis, bronchitis chronic, and prostatic hyperplasia. The patient was interviewed before the second vaccination and no particular problem was found. On the following day of the vaccination, on 11Jun2021 at 08:50, oxygen saturation decreased, blood pressure decreased, and consciousness disturbed were noted. At 09:08, the patient was taken to the reporting hospital by ambulance. Manifestations on arrival included pallor generalized and postmortem rigidity. Cardiopulmonary resuscitation was performed; however, at 09:20, death was confirmed. Autopsy and other examinations could not be conducted. Direct cause of death was assessed as haemorrhage of digestive tract. Prescription: BESACOLIN powder 5% 0.9 g, EC DOPARL combination tablet 6 tablets, CARBOCISTEINE tablet 250 mg 4 tablets, and PROSTAL tablet 25 25mg 2 tablets. The reporting other health professional 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 present but details were not provided. The reporting other health professional commented as follows: Although there was a possibility of adverse reaction due to the vaccine, details were unknown since pathological anatomy and autopsy imaging could not be conducted. The outcome of haemorrhage of digestive tract was fatal, other events was unknown.; Reported Cause(s) of Death: Haemorrhage of digestive tract


VAERS ID: 1419441 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Aortic dissection, Blood pressure measurement, Body temperature, Imaging procedure, Pericardial effusion, Pleural effusion
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210611; Test Name: Blood pressure; Result Unstructured Data: Test Result:unmeasurable; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Name: Ai; Result Unstructured Data: Test Result:aortic dissection, bilateral pleural effusion; Comments: revealed aortic dissection, bilateral pleural effusion, and pericardial effusion
CDC Split Type: JPPFIZER INC2021704178

Write-up: Acute aortic dissection; Bilateral pleural effusion; Pericardial effusion; Consciousness disturbed; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114070. The patient was a 93-year and 5-month-old female. Body temperature before vaccination was 36.7 degrees centigrade. Family history was not reported. Medical history included hypertension and cardiac failure. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported). On 10Jun2021 at 14:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 11Jun2021 at 15:00 (1 day 1 hour after the vaccination), the patient experienced consciousness disturbed. On 11Jun2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 10Jun2021, the patient received COMIRNATY. On 11Jun2021 before 15:00, the patient said that the patient was ''''tired'''' and developed depressed level of consciousness. Blood pressure became unmeasurable and the patient was transferred to the reporting hospital. On arrival, the patient was cardio-respiratory arrest. Family member was consulted and resuscitation was determined not to be performed. Autopsy imaging (Ai) revealed that aortic dissection, bilateral pleural effusion, and pericardial effusion, which were considered as causes of death. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not provided. The reporting physician commented as follows: The patient had an underlying medical history of hypertension and cardiac failure; thus, the cardiovascular system was at high risk. The causal relationship between acute aortic dissection and the vaccination was unknown.; Reported Cause(s) of Death: cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: Acute aortic dissection; Bilateral pleural effusion; Pericardial effusion


VAERS ID: 1419443 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-05-17
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral infarction, Coma scale, Computerised tomogram head, Depressed level of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 19
Permanent Disability? 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: Test Date: 20210426; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210517; Test Name: JCS; Result Unstructured Data: Test Result:III-300; Test Date: 20210517; Test Name: Head CT; Result Unstructured Data: Test Result:extensive cerebral infarction; Comments: in the right cerebral hemisphere
CDC Split Type: JPPFIZER INC2021705589

Write-up: Cerebral infarction; Depressed level of consciousness; This is a spontaneous report from a contactable physician. Regulatory authority report number is v21114221. The patient was an 83-year-old female. Body temperature before vaccination was 36.7 degrees centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 26Apr2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ER9480, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 17May2021 at 08:50 (21 days after the vaccination), the patient experienced cerebral infarction. Depressed level of consciousness was noted. JCS was III-300. Head CT revealed extensive cerebral infarction in the right cerebral hemisphere. Oxygen 5 L/min and infusion of GLYCEOL 200 mL twice daily were initiated. On 05Jun2021 at 0:45 (40 days after the vaccination), the patient died. It was not provided if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was deep vein thrombosis. The reporting physician commented as follows: Causality between the vaccine and cerebral infarction was unknown. Therapeutic measures were taken as a result of the events and included Oxygen and GLYCEOL. The outcome of the event cerebral infarction was fatal; outcome of other event was unknown. The cause of death was cerebral infarction.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1419444 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   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: 20210614; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: Before vaccination; Test Date: 20210615; Test Name: vital signs; Result Unstructured Data: Test Result:no abnormalities were noted; Comments: around 05:30
CDC Split Type: JPPFIZER INC2021705635

Write-up: cardio-respiratory arrest/acute cardiac death; This is a spontaneous report from a contactable physician. Regulatory authority report number is v21114222, and from a contactable pharmacist received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was a 93-year-old female. Body temperature before vaccination was 36.0 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Family history was not provided. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. On an unspecified date, the patient previously received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was unknown) intramuscular as the first single dose for COVID-19 immunization. On 14Jun2021 at 15:10 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot# FA5765, Expiration date 30Sep2021), intramuscular as the second single dose for COVID-19 immunization. On 15Jun2021 at around 05:30 in the morning, when her vital signs were checked, no abnormalities were noted. On 15Jun2021 at around 07:00 (1 day after the vaccination), the patient experienced cardio-respiratory arrest. On 15Jun2021 at around 07:40, the patient was found in cardio-respiratory arrest, and she was transferred to the reporter''s hospital by an ambulance. On arrival, she was in cardio-respiratory arrest condition, resuscitation was performed. However, heartbeat was not returned, and at 09:14, the patient''s death was confirmed. Nothing significant to be noted from AI (autopsy imaging) result. When she was found, marked disturbed consciousness was noted, and at the time of transfer to the emergency department in the reporting hospital, the patient was in pulseless electrical activity (PEA) condition. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was acute cardiac death. The reporting physician commented as follows: The causal relationship with bnt162b2 was uncertain. Postmortem inspection was performed, and the cause of death was acute cardiac death. Pharmacist reported that the cause of death could not identified, and an autopsy was not performed.; Reported Cause(s) of Death: acute cardiac death


VAERS ID: 1419447 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardiac tamponade, Myocardial rupture
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 0
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: Angina pectoris; Coronary stent placement
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: blood test; Result Unstructured Data: Test Result:Troponin T positive
CDC Split Type: JPPFIZER INC2021707210

Write-up: Cardiac tamponade due to Cardiac rupture; Cardiac tamponade due to Cardiac rupture; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES) . Regulatory authority report number is v21114404. The patient was an 84-year-old and 10-month-old female. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine or not. It was unknown whether the patient receive any other medications within 2 weeks of vaccination or not. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient had allergies to medications, food, or other products or not. Other medical history included Angina pectoris and post coronary stent placement. The patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EY2173; Expiration date: 31Aug2021) via an unspecified route of administration on 24May2021 for COVID-19 immunization. On 14Jun2021 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021), at the age of 84 years old, via an unspecified route of administration for COVID-19 immunization. On 15Jun2021, from around 03:30 (1 day after the vaccination), the patient experienced Cardiac tamponade due to Cardiac rupture which was resulted in death. Therapeutic measures including Cardiopulmonary resuscitation were taken as a result of cardiac tamponade due to cardiac rupture. On 15Jun2021, the patient died. An autopsy was not performed. It was unknown whether the patient has been tested for COVID-19 or not since vaccination. Clinical course was as follow: On 14Jun2021, the patient received the second dose of BNT162b2. On 15Jun2021, from around 03:30, the patient felt chest discomfort and visited reporter''s hospital. Troponin T positive was confirmed by blood test. The patient was subsequently hospitalized for suspected Acute coronary syndrome. Emergency catheterisation cardiac was scheduled to be perform. The patient rested in a bed with lying position. From around 12:16, consciousness level depressed. The patient went into cardiac arrest. Cardiac tamponade due to cardiac rupture was diagnosed. Although the cardiopulmonary resuscitation was performed, the patient was not recovered. At 13:10, the patient''s death was confirmed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Cardiac rupture; Cardiac tamponade


VAERS ID: 1419448 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure congestive; Chronic respiratory failure; Febrile neutropenia (received the treatment with antibiotics); Hypoxia; Lung cancer; Oxygen therapy; Pneumoconiosis; Pneumonia (received the treatment with antibiotics); Sputum increased
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021710576

Write-up: respiratory condition aggravated; This is a spontaneous report from a contactable. Regulatory authority report number is v21114224. The patient was an 80-year-old male. Body temperature before vaccination was 36.2 degrees centigrade. Medical history included lung cancer, pneumoconiosis, chronic respiratory failure, cardiac failure congestive, febrile neutropenia, pneumonia, hypoxia on exertion, increased sputum production. He was receiving home oxygen therapy for the treatment of chronic respiratory failure. Concomitant medications and family history were not provided. The patient was being hospitalized for the treatment of lung cancer, pneumoconiosis, chronic respiratory failure and cardiac failure congestive. On 12May2021, the patient received chemotherapy. On 24May2021, the patient had febrile neutropenia and pneumonia, for which the patient received the treatment with antibiotics. On 10Jun2021, since the pneumonia stabilized and he had no fever (36.2 degrees centigrade), he received the vaccination the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY5420, Expiration date 31Aug2021) at the age of 80-year-old, via an unspecified route of administration as a single dose for COVID-19 immunization in the afternoon. On 11Jun2021, no change was noted in his respiratory condition. On 12Jun2021 at 21:28 (2 days after the vaccination), the patient experienced respiratory condition aggravated. On the same day, the patient died. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal). The assessment of causality between the event and BNT162b2 was not provided. The reporter considered that there were possible causes of the event such as any other diseases. The reporting physician commented as follows: Increased sputum production had been noted from before the vaccination. He had hypoxia on exertion due to chronic respiratory failure, cardiac failure.; Reported Cause(s) of Death: respiratory condition aggravated


VAERS ID: 1419450 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-31
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension (under treatment); Parkinson''s syndrome (under treatment)
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular disorder (untested); Epileptic seizure; Hemispatial neglect (left eye); Visual field defect (left eye)
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021710645

Write-up: Respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114248. An 81-year and 6-month-old male patient received 1st dose of BNT162B2 (COMIRNATY, Solution for injection, LOT number: FA2453, expiration date: 31Aug2021) via an unspecified route of administration on 25May2021 at 11:00 at age of 81-year and 6-month-old at single dose for COVID-19 immunisation. Medical history included epileptic seizure, suspected cerebrovascular disorder (untested), ongoing parkinson''s syndrome (under treatment), ongoing hypertension (under treatment), abnormal visual field and hemispatial neglect-like symptom of the left eye from 16May2021. Concomitant medications and family history were not provided. The patient was receiving the treatment for Parkinson''s syndrome and hypertension. Body temperature on 25May2021 before vaccination was 36.2 degrees Centigrade. On 31May2021 at 15:00 (6 days after the vaccination), the patient died of respiratory arrest. It was not reported if an autopsy was performed. The course of the events was as follows: From around 11May2021, epileptic seizure repeatedly occurred. On that day, the patient was prescribed phenytoin (ALEVIATIN). After the prescription, the epileptic seizure improved. On 16May2021, abnormal visual field and hemispatial neglect-like symptom of the left eye were noted, but the patient did not visit a hospital at his own wish, therefore, his clinical course for those symptoms was being monitored. On 25May2021, the patient received the vaccination. On 31May2021 at around 14:00, after lunch it was confirmed that the patient was alive. On 31May2021 at 15:00, he was found in respiratory arrest. Outcome of the event was fatal. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Epileptic seizure and suspected cerebrovascular disorder were considered as possible causes of the event.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1419451 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-30
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hyperlipidemia (stable); Hypertension (stable); Osteoporosis (stable)
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure acute; Living in nursing home
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021710674

Write-up: Cardiac failure acute; This is a spontaneous report from a contactable physician via a Pfizer representative. A 96-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021), via an unspecified route of administration on 19May2021 at single dose at the age of 96-year-old for COVID-19 immunisation. The patient had a history of cardiac failure acute. And also she had underlying diseases of hypertension, hyperlipidemia and osteoporosis, but the symptoms of the diseases were stable. The patient was living in nursing home. Concomitant medications and family history were not reported. After the vaccination, no change was noted in her condition. On 30May2021 at 21:30 (11 days after the vaccination), the patient was found in cardio-respiratory arrest in her room at the nursing home. An autopsy was performed, and the cause of death confirmed by autopsy was cardiac failure acute. The physician reported that the causal relationship with BNT162b2 was unknown.; Sender''s Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the event cardio-respiratory arrest onset. The medical history of cardiac failure acute may make a explanation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: cardiac failure acute; Autopsy-determined Cause(s) of Death: cardiac failure acute


VAERS ID: 1419452 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-10
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Disseminated intravascular coagulation, Escherichia test, Pyrexia, Sepsis, Viral test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 3
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: Hepatitis C; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Escherichia test; Test Result: Positive ; Test Date: 20210610; Test Name: SFTS reaction; Test Result: Positive
CDC Split Type: JPPFIZER INC2021710905

Write-up: pyrexia; Disseminated intravascular coagulation; Sepsis; Consciousness disturbed; This is a spontaneous report from the contactable physician. An 84-year-old female patient received second dose of BNT162B2 (COMIRNATY) Lot number EX3617, expiration date 31Aug2021, Intramuscular in left arm on 04Jun2021 11:30 at single dose (at the age of 84-year-old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient has been tested for COVID-19 after the vaccination. Medical history included hypertension and chronic hepatitis C (post therapy). Concomitant medications included antihypertensive drug, proton-pump inhibitor (PPI), vitamin D preparation and coronary dilator. On 14May2021 at 13:15, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Batch/Lot Number: EX3617; Expiration Date: 31Aug2021) intramuscular in the left arm for COVID-19 immunisation. On 04Jun2021 at 11:30 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Batch/Lot Number: EX3617; Expiration Date: 31Aug2021) intramuscular in the left arm for COVID-19 immunization at the health clinic. On 10Jun2021 (6 days after the vaccination), the patient experienced consciousness disturbed with prolonged pyrexia, sepsis and Disseminated intravascular coagulation (DIC). Pyrexia continued and consciousness disturbed was observed in the morning of 10Jun2021. Therefore the patient was urgently transported to the medical facility. Blood culture test performed after admission showed positive results for Escherichia coli and severe fever with thrombocytopenia symdrome (SFTS). The patient died of sepsis and disseminated intravascular coagulation (DIC) on 13Jun2021. The events resulted in emergency room/department visit or urgent care, hospitalization and death. The patient was hospitalized for four days. The outcome of the events was fatal with treatment including infusion and administration of antibiotic. Autopsy was not performed.; Sender''s Comments: Based on the temporal relationship, the association between the fatal events sepsis, disseminated intravascular coagulation, pyrexia, and altered state of consciousness with COMIRANTY use can not 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: pyrexia; Consciousness disturbed; Sepsis; DIC


VAERS ID: 1419453 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Pneumonia, Pneumothorax, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: 2021-06-04
   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: AMLODIPINE; AMBROXOL; LANSOPRAZOLE; QUETIAPINE; ENALAPRIL; CARBOCISTEINE; MIYA BM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage; Dementia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: CT; Result Unstructured Data: Test Result:bilateral pneumonia, right pneumothorax
CDC Split Type: JPPFIZER INC2021710915

Write-up: Acute pneumonia/ bilateral pneumonia; Right pneumothorax; Vomiting; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The 76-year-old male patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) intramuscular on 02Jun2021 at 14:30 at the age of 76-year-old (the day of vaccination) in the left arm for COVID-19 immunization. It was unknown if the patient had allergies to medications, food, or other products. Medical history included hypertension, dementia, and post cerebral haemorrhage. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received amlodipine; ambroxol; lansoprazole; quetiapine; enalapril; carbocisteine; clostridium butyricum within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Jun2021 at 21:00 (1 days 6 hours and 30 minutes after the vaccination), the patient experienced acute pneumonia, right pneumothorax, and vomiting. The event acute pneumonia resulted in death. The outcome of the event acute pneumonia was fatal with treatment including antibiotics. The outcome of the other events was unknown. On 04Jun2021, the patient died from acute pneumonia. Cause of death was acute pneumonia. An autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19. The course of the event was as follows: On the nighttime of the following day of the vaccination (03Jun2021), the patient vomited. In addition, bilateral pneumonia and right pneumothorax were diagnosed 2 days after the vaccination (as reported) based on the CT performed. Antibiotic administration was performed, however, the patient died 2 days after the vaccination(04Jun2021).; Sender''s Comments: The events pneumonia and pneumothorax were considered intercurrent conditions in this elderly patient and assessed to be unrelated to suspect product BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021).; Reported Cause(s) of Death: Acute pneumonia


VAERS ID: 1419538 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7823 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, General physical health deterioration, Localised infection, Magnetic resonance imaging, Nausea, Sepsis, Wound necrosis
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   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: Heart disorder; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Vascular shunt
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: blood exam; Result Unstructured Data: Test Result:hospital bacteria found; Test Date: 20210513; Test Name: MRI scan; Result Unstructured Data: Test Result:MRI scan was done on 13May of the left leg, due to; Comments: MRI scan was done on 13May of the left leg, due to known poor blood flow
CDC Split Type: NLPFIZER INC2021705082

Write-up: after 2nd vaccine also inflammation in healthy right leg with swelling sign of necrosis around wounds, followed by hospitalization, on 17May2021; after 2nd vaccine also inflammation in healthy right leg with swelling sign of necrosis around wounds, /also swelling and red spots on right leg; In hospital she again showed sign of infection in her blood and was treated with antibiotics; There was also continuous nausea; on 26May2021 her health had deteriorated so much that she died in the night of 26-27May.; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB NL-LRB-00566855. The contactable reporter described events for both doses of Comirnaty. This report describes events for the second dose. A 77-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 13May2021 (Lot Number: EX7823) as single dose for covid-19 immunisation. Medical history included vascular shunt, ongoing Heart disorder, ongoing hypertension. The patient''s concomitant medications were non specified antibiotics. The patient did not have Previous COVID-19 infection. The patient received 1st dose of BioNTech/Pfizer vaccine (COMIRNATY) on 06Apr2021 for covid-19 immunisation and experienced Swelling of legs, Neuralgia, sepsis In between vaccinations she had sepsis for which she was treated with antibiotics twice. The patient experienced there was also continuous nausea on 17May2021, after 2nd vaccine also inflammation in healthy right leg with swelling sign of necrosis around wounds, followed by hospitalization, on 17May2021, on unspecified date, after 2nd vaccine also inflammation in healthy right leg with swelling sign of necrosis around wounds, followed by hospitalization, on 17May2021/ after 2nd vaccination also swelling and red spots on right leg, on unspecified date, on 26May2021 her health had deteriorated so much that she died in the night of 26-27May. The patient was hospitalized for nausea, Wound necrosis, Leg infection, Septicemia from 17May2021. The patient died of nausea, Wound necrosis, Leg infection and health deteriorated. The patient underwent lab tests and procedures which included blood exam: hospital bacteria found in May2021, MRI scan: mri MRI scan was done on 13May of the left leg, due to known poor blood flow on 13May2021. Treatment: Patient is treated with antibiotics in hospital. The outcome of leg infection is fatal, the outcome of nausea is fatal, the outcome of neuralgia is fatal and the outcome of wound necrosis is fatal. After the first vaccination patient had neuralgia and swelling in her left leg. She already had a vascular shunt in her left leg, because of poor blood flow. In between vaccinations she had sepsis for which she was treated with antibiotics twice. After the second vaccination she also developed a leg infection in her right leg with swelling and signs of necrosis around wounds. She was hospitalized. In hospital she again showed sign of infection in her blood and was treated with antibiotics and had angioplasty in her leg. The blood flow recovered, but neuralgia did not recover. She also had nausea. Her health declined untill she passed away. The outcome of septicemia was unknown. The patient died on 27May2021. It was not reported if an autopsy was performed. Reporter''s comments: Reporter''s comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: nerve pains after 1st vaccination, thick leg left, after 2nd vaccination also swelling and red spots on right leg Date: 06Apr2021 nerve pain Additional information ADR: mother had plastic vein in left leg, nerve pain after 1st vaccine, blood infection treated with 2 antibiotics between vaccines, after 2nd vaccine also inflammation in healthy right leg with swelling sign of necrosis around wounds, followed by admission to hospital, on 17May2021, after this again traces of infection in blood, in hospital again antibiotics, and angioplasty. After surgery there was blood circulation in the leg but still nerve pain. There was also continuous nausea After a few days hospital bacteria found, on 26May2021 her health had deteriorated so much that she died in the night of 26-27May. Underlying diseases: were problems with heart, blood pressure. COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: MRI scan was done on 13May of the left leg, due to known poor blood flow No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: 2nd vaccine also inflammation in healthy right leg with swelling sign of necrosis around wounds, followed by admission to hospital, on 17May2021, after this again traces of infection in blood, in hospital again antibiotics, and angioplasty. After surgery there was blood circulation in the leg but still nerve pain. There was also continuous nausea After a few days hospital bacteria found, on 26May2021 her health had deteriorated so much that she died in the night of 26-27May.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021713774 The same patient, different dose of vaccine; Reported Cause(s) of Death: Nausea; Wound necrosis; Leg infection; health deteriorated; organ failure


VAERS ID: 1419540 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-04-11
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021687997

Write-up: Herpes zoster; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the WEB NL-LRB-00570472, received from Regulatory Authority. A 91-years-old female patient received BNT162B2 (Comirnaty; Solution for injection; Lot number: unknown) via an unspecified route of administration on 03Mar2021 as 2nd dose, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that patient had no previous COVID-19 infection. Historical vaccine included BNT162B2 (Comirnaty; Solution for injection; Lot number: unknown) via an unspecified route of administration on 27Jan2021 as 1st dose, 0.3 ml single for COVID-19 immunization and had no adverse event. On 11Apr2021 the patient experienced herpes zoster. On 12May2021 the patient died. It was not reported if an autopsy was performed. No follow-up attempts were possible, information on batch number could not be obtained.; Reported Cause(s) of Death: Herpes zoster


VAERS ID: 1419541 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   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: CYANOCOBALAMINE; SIMVASTATINE ACCORD; BISOPROLOL FUMARATE; PANTOPRAZOL PENSA; METFORMINE HCL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disorder NOS; COVID-19; Dementia; Diabetes mellitus; Heaviness in arm; Myocardial infarct (2013 heart attack Christmas Eve 2013 had myocardial infarction); Pain in arm; Stent placement
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: cholesterol; Result Unstructured Data: Test Result:too high; Test Date: 20210412; Test Name: diabetes; Result Unstructured Data: Test Result:too high; Test Date: 20210412; Test Name: blood pressure; Result Unstructured Data: Test Result:too high; Test Date: 20200320; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021698718

Write-up: Acute cardiac arrest at 1 a.m.; This is a spontaneous report from a contactable consumer from the WEB, regulatory authority number NL-LRB-00573324, Safety Report Unique Identifier NL-LRB-00575416. A 76-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 14Apr2021 at 14:00 (Lot Number: EW2243) as a 0.3 ml, single dose for covid-19 immunization. Medical history included diabetes mellitus, cardiovascular disorder, covid-19 from 20Mar2020 (disease symptoms: quite), left arm felt heavy, dementia from 10Mar2021, some pain in his left arm, Myocardial infarct from 2013, stent placement from 31Dec2013. Not worth mentioning, his left arm felt heavy. The patient would receive home care from Monday 19Apr2021. Dementia diagnosed March10 this year before the vaccination he had some pain in his left arm. Christmas Eve 2013 had myocardial infarction, placed stents on 31Dec2013, as in Feb2014. Concomitant medications included cyanocobalamine; simvastatin (SIMVASTATINE ACCORD, Film-coated tablet, strength: 20 mg); bisoprolol fumarate; pantoprazole sodium sesquihydrate (PANTOPRAZOL PENSA, Gastro-resistant tablet, strength: 40 mg); metformin hydrochloride (METFORMINE HCL, strength: 500 mg). The patient died within 12 hours after received the first dose vaccine, acute cardiac arrest (11 hours after start) on 15Apr2021 at 1 a.m. Confounding factors: Heart and Vascular, Disease-Diabetes. The patient underwent lab tests and procedures which included blood cholesterol: on 12Apr2021 he had a check-up at the doctor''s assistant: diabetes too high, blood pressure too high as well as cholesterol, take a pill. Corona, confirmed Positive with test on 20Mar2020. The patient died on 15Apr2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute cardiac arrest at 1 a.m.


VAERS ID: 1419563 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-05-22
   Days after vaccination:112
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, Infection, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: Cancer; COVID-19 immunization (Full vaccination); Heart failure; Hepatic cancer metastatic; Lung cancer metastatic; Parkinson''s disease; Polyneuropathy NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: NOPFIZER INC2021698909

Write-up: Became Covid-19 positive 22May21, asymptomatic with Covid-19 test; vaccination failure; Became Covid-19 positive 22May21, asymptomatic with Covid-19 test; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-U9p222. An 83-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 30Jan2021 as 2nd dose, single for covid-19 immunisation. Medical history included hepatic cancer metastatic from 2021 and ongoing, covid-19 immunisation from 30Jan2021 to 30Jan2021, full vaccination , ongoing parkinson''s disease , lung cancer metastatic from 2021 and ongoing, ongoing heart failure, cancer from 2021 and ongoing, ongoing polyneuropathy. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on an unspecified date for COVID-19 Immunization. On 22May2021, the patient developed asymptomatic BREAKTHROUGH INFECTION, COVID-19 VIRUS TEST POSITIVE, became Covid-19 positive in 22May2021, asymptomatic with Covid-19 test. Relevant laboratory findings and investigations included in the report ( COVID-19 VIRUS TEST, in May2021). The patient''s outcome was Fatal, at the time of the report. The case was considered to be serious. The patient died on 01Jun2021. It was not reported if an autopsy was performed. Reporter''s comment: RELIS: requested additional information regarding suspected events. Cancer was also reported as suspected event, but information in case summary pointed out asymptomatic infection as central event. Cancer was therefore added as concomitant disease. If new medical information is received, report will be updated. Sender''s comment: In the current report, we have assessed that it is an asymptomatic covid-19 disease that has been reported as a suspected side effect. We have assessed that cancer has been reported as a possible explanation for the outcome, but that cancer has not been reported as a suspected side effect. No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: outcome was Fatal


VAERS ID: 1419589 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Dysuria, Oedema
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified (The patient has heart disease for 40 years and has been on several medications.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021704644

Write-up: problems with urination, fluid retention in the body, heart failure, death; problems with urination, fluid retention in the body, heart failure, death; problems with urination, fluid retention in the body, heart failure, death; This is a spontaneous report from a non-contactable consumer downloaded from the-WEB, regulatory authority number NO-NOMAADVRE-PASRAPP-2021-Uyjrj5. A male patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY, Solution for injection), via intramuscular, administered in right arm on Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. Medical history included Heart disease, unspecified. The patient had heart disease for 40 years and has been on several medications. The patient''s concomitant medications were not reported. Immediately after vaccination on Mar2021, he was hospitalized for a week with oedema in body. He went home again, and then back to the hospital, home again and thereafter the patient was placed in a care center for 4 days before he died. The reporter (patient''s grandson) was unsure of the exact number of days from vaccination to hospitalization and death. The patient also developed urination difficulty and heart failure. Problems with urination, fluid retention in the body, heart failure, death. The outcome of the events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: OEDEMA; URINATION DIFFICULTY; HEART FAILURE


VAERS ID: 1419590 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Body temperature, Internal haemorrhage, Loss of consciousness, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   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: Medical History/Concurrent Conditions: Chemotherapy; Pancreatic cancer (no metastases); Radiotherapy (caused considerable scarring)
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Temperature; Result Unstructured Data: Test Result:39 degrees celsius
CDC Split Type: NZPFIZER INC2021666442

Write-up: lost consciousness; pain in her stomach; internal bleed; fever of 39 degrees Celsius; This is a spontaneous report from a contactable consumer (Pfizer colleague, reporting on their mother in law). A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included pancreatic cancer (no metastases), radiotherapy and chemotherapy. It was unknown if the patient was pregnant at the time of vaccination. The patient received the first dose of bnt162b2 (COMIRNATY) on an unspecified date for covid-19 immunisation. The patient''s concomitant medications were not reported. The reporter stated that the Pfizer colleague''s mother-in-law who was undergoing chemotherapy for pancreatic cancer (no metastases) had her second Comirnaty dose on the Thursday (03Jun2021) and passed away on the Friday (04Jun2021). She had a fever of 39 degrees Celsius following the vaccination (03Jun2021) and she had also had chemotherapy earlier in the week. Late on the Friday (04Jun2021), she had a pain in her stomach and within 5 minutes of complaining of the pain, she lost consciousness and was hospitalized on 04Jun2021. She died around 1 hour later. The father in law who was a GP suggested that it was an internal bleed on an unspecified date that may have been related to the radiotherapy that had been shown to have caused considerable scarring or that the tumour (which was wrapped around an artery) had invaded the artery. However, as she had so recently had her second dose of Comirnary and had suffered an adverse event related to this, hence the report. The outcome of the event internal bleed was unknown while the outcome of the other events was fatal. The patient died on 04Jun2021. It was not reported if an autopsy was performed. The following information on the batch/lot number has been requested.; Reported Cause(s) of Death: lost consciousness; pain in her stomach; fever


VAERS ID: 1419601 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-23
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: NZPFIZER INC2021702597

Write-up: death; This is a spontaneous report from a contactable other health professional. Regulatory authority report number is unknown. An elderly patient of an unspecified gender received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. It was not reported if an autopsy was performed. Death is considered by medical staff involved to be unrelated to the administration of BNT162B2 but were reported through an abundance of caution. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: deaths


VAERS ID: 1419602 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-23
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: NZPFIZER INC2021702634

Write-up: deaths; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. The regulatory authority report number is not provided. An elderly patient of unspecified gender received BNT162B2 (COMIRNATY) at single dose on an unspecified date for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient experienced deaths. The reporter was reporting the deaths of elderly individual this week. The death was considered by the Agency, the Regulatory Authority and medical staff involved to be unrelated to the administration of BNT162B2 but were reported through an abundance of caution. 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.; Sender''s Comments: Death with unknown cause is considered related to BNT162B2 for reporting purpose. Case will be reassessed once receiving additional information, including cause of death and clinical course. 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: deaths


VAERS ID: 1419673 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001942 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LAMOTRIGINE; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; THERALEN; KEPPRA [LEVETIRACETAM]; CIRCADIN; MIRTAZAPINE; LORATADINE
Current Illness: Epilepsy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 33-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001942) for COVID-19 vaccination. Concurrent medical conditions included Epilepsy. Concomitant products included LAMOTRIGINE, MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]), ALIMEMAZINE TARTRATE (THERALEN), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), MELATONIN (CIRCADIN), MIRTAZAPINE and LORATADINE for an unknown indication. In May 2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on May 2021 The patient died in May 2021. The cause of death was not reported. It is unknown if an autopsy was performed. Treatment information was not provided. Company Comment: This is a case of death not otherwise specified in a 33-year-old male patient with a medical history of epilepsy on antiepileptic therapy, that occurred on an unknown number of days after receiving second dose of vaccine (Lot number 3001942). Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Translated document contains no significant information.; Sender''s Comments: This is a case of death not otherwise specified in a 33-year-old male patient with a medical history of epilepsy on antiepileptic therapy, that occurred on an unknown number of days after receiving second dose of vaccine (Lot number 3001942). Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1419968 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-05
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Basophil count, Blood creatinine, Blood glucose, Blood thyroid stimulating hormone, Blood urea, C-reactive protein, C-reactive protein increased, COVID-19, Death, Drug ineffective, Eosinophil count, Fibrin D dimer, Fibrin D dimer increased, Glomerular filtration rate, Glomerular filtration rate decreased, Haematocrit, Haemoglobin, Immature granulocyte count, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Monocyte count, Neutrophil count, Platelet count, Red blood cell count, Red blood cell sedimentation rate, Red cell distribution width, SARS-CoV-2 test, Thyroxine free, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Lack of efficacy/effect (narrow), Haemorrhage laboratory terms (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: 20210605; Test Name: Absolute basophil; Result Unstructured Data: Test Result:0.04 x10 9/l; Test Date: 20210605; Test Name: basophils; Test Result: 0.6 %; Test Date: 20170622; Test Name: Creatinine; Result Unstructured Data: Test Result:62 umol/l; Test Date: 20180125; Test Name: Creatinine; Result Unstructured Data: Test Result:62 umol/l; Test Date: 20191224; Test Name: Creatinine; Result Unstructured Data: Test Result:72 umol/l; Test Date: 20210605; Test Name: Creatinine; Result Unstructured Data: Test Result:63 umol/l; Test Date: 20160921; Test Name: fasting glucose; Result Unstructured Data: Test Result:5.4 mmol/L; Test Date: 20170622; Test Name: fasting glucose; Result Unstructured Data: Test Result:4.7 mmol/L; Test Date: 20180125; Test Name: fasting glucose; Result Unstructured Data: Test Result:4.7 mmol/L; Test Date: 20180906; Test Name: fasting glucose; Result Unstructured Data: Test Result:4.6 mmol/L; Test Date: 20160921; Test Name: TSH; Result Unstructured Data: Test Result:5.71 MiU/L; Test Date: 20170622; Test Name: TSH; Result Unstructured Data: Test Result:0.39 MiU/L; Test Date: 20180125; Test Name: TSH; Result Unstructured Data: Test Result:2.59 MiU/L; Test Date: 20180906; Test Name: TSH; Result Unstructured Data: Test Result:1.87 MiU/L; Test Date: 20170622; Test Name: Urea; Result Unstructured Data: Test Result:4.7 mmol/L; Test Date: 20180125; Test Name: Urea; Result Unstructured Data: Test Result:4.9 mmol/L; Test Date: 20191224; Test Name: Urea; Result Unstructured Data: Test Result:6 mmol/L; Test Date: 20210605; Test Name: Urea; Result Unstructured Data: Test Result:3.8 mmol/L; Test Date: 20170622; Test Name: c-reactive protein; Result Unstructured Data: Test Result:2 mg/l; Test Date: 20180125; Test Name: c-reactive protein; Result Unstructured Data: Test Result:2 mg/l; Test Date: 20191224; Test Name: c-reactive protein; Result Unstructured Data: Test Result:3 mg/l; Test Date: 20210605; Test Name: c-reactive protein; Result Unstructured Data: Test Result:22 mg/l; Comments: high; Test Date: 20210605; Test Name: Absolute Eosinophil; Result Unstructured Data: Test Result:0.17 x10 9/l; Test Date: 20210605; Test Name: Eosinophils; Test Result: 2.5 %; Test Date: 20210605; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:0.86 mg/l; Comments: high; Test Date: 20170622; Test Name: eGFR (CKD-EPI); Result Unstructured Data: Test Result:90 ml/min; Test Date: 20180125; Test Name: eGFR (CKD-EPI); Result Unstructured Data: Test Result:89 ml/min; Test Date: 20191224; Test Name: eGFR (CKD-EPI); Result Unstructured Data: Test Result:73 ml/min; Test Date: 20210605; Test Name: eGFR (CKD-EPI); Result Unstructured Data: Test Result:86 ml/min; Comments: low; Test Date: 20210605; Test Name: Haematocrit; Test Result: 40.1 %; Test Date: 20210605; Test Name: Hemoglobin; Result Unstructured Data: Test Result:13.5 g/dl; Test Date: 20210605; Test Name: Immature Granuloctes abs; Result Unstructured Data: Test Result:0.01 x10 9/l; Test Date: 20210605; Test Name: Immature granulocytes; Test Result: 0.10 %; Test Date: 20210605; Test Name: Absolute lymphocytes; Result Unstructured Data: Test Result:1.09 x10 9/l; Test Date: 20210605; Test Name: Lymphocytes; Test Result: 16 %; Test Date: 20210605; Test Name: MCH; Test Result: 30.8 pg; Test Date: 20210605; Test Name: MCHC; Result Unstructured Data: Test Result:33.7 g/dl; Test Date: 20210605; Test Name: MCV; Result Unstructured Data: Test Result:91.3; Comments: fL; Test Date: 20210605; Test Name: Absolute monocytes; Result Unstructured Data: Test Result:0.88 x10 9/l; Test Date: 20210605; Test Name: Monocytes; Test Result: 12.9 %; Test Date: 20210605; Test Name: neutrophils; Test Result: 67.9 %; Test Date: 20210605; Test Name: Neutrophils abs; Result Unstructured Data: Test Result:4.63 x10 9/l; Test Date: 20210605; Test Name: Platelet count; Result Unstructured Data: Test Result:277 x10 9/l; Test Date: 20210605; Test Name: Red cell count; Result Unstructured Data: Test Result:4.39 x10 12/l; Test Date: 20210605; Test Name: ESR; Result Unstructured Data: Test Result:25; Comments: mm/hr; Test Date: 20210605; Test Name: RDW; Test Result: 13.9 %; Test Date: 20210605; Test Name: SARS-CoV-2 -PCR test; Test Result: Positive ; Test Date: 20180906; Test Name: Free T4; Result Unstructured Data: Test Result:17 pmol/L; Test Date: 20210605; Test Name: White blood cell count; Result Unstructured Data: Test Result:6.82 x10 9/l
CDC Split Type: ZAPFIZER INC2021664627

Write-up: Patient died post vaccination; SARS-CoV-2 RT-PCR positive; SARS-CoV-2 RT-PCR positive; C-Reactive Protein high; eGFR low; D-Dimer high; This is a spontaneous report from a contactable physician. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for covid-19 immunization. Medical history and concomitant medications were not reported. The patient died on an unspecified date post vaccination. On 05Jun2021, the patient had a SARS-CoV-2 -PCR test positive, C-Reactive protein high, eGFR low and D-dimer high. Lab tests included: On 21Sep2016: fasting glucose 5.4 mmol/L, TSH 5.71 MiU/L. On 22Jun2017: creatinine 62 umol/l, fasting glucose 4.7 mmol/L, TSH 0.39 MiU/L, urea 4.7 mmol/L, C-reactive protein 2 mg/l, eGFR (CKD-EPI) 90 ml/min. On 25Jan2018: creatinine 62 umol/l, fasting glucose 4.7 mmol/L, TSH 2.59 MiU/L, urea 4.9 mmol/L, C-reactive protein 2 mg/l, eGFR (CKD-EPI) 89 ml/min. On 06Sep2018: fasting glucose 4.6 mmol/L, TSH 1.87 MiU/L, free T4 17 pmol/L. On 24Dec2019: creatinine 72 umol/l, urea 6 mmol/L, C-reactive protein 3 mg/l, eGFR (CKD-EPI) 73 ml/min. On 05Jun2021: absolute basophil 0.04 x10 9/l, basophils 0.6 %, creatinine 63 umol/l, urea 3.8 mmol/L, C-reactive protein 22 mg/l (high), absolute eosinophil 0.17 x10 9/l, eosinophils 2.5 %, fibrin D dimer 0.86 mg/l (high), eGFR (CKD-EPI) 86 ml/min (low), haematocrit 40.1%, haemoglobin 13.5 g/dl, immature granuloctes abs 0.01 x10 9/l, immature granulocytes 0.10 %, absolute lymphocytes 1.09 x10 9/l, lymphocytes 16 %, MCH 30.8 pg, MCHC 33.7 g/dl, MCV 91.3 fL, absolute monocytes 0.88 x10 9/l, monocytes 12.9 %, neutrophils 67.9 %, neutrophils abs 4.63 x10 9/l, platelet count 277 x10 9/l, red cell count 4.39 x10 12/l, ESR 25 mm/hr, RDW 13.9 %, White blood cell count 6.82 x10 9/l. It was unknown if an autopsy was performed. The outcome of event patient died was fatal. The outcome of rest events was unknown.; Sender''s Comments: The causal relationship between BNT162B2 and the reported death for case unknown and the events drug ineffective and SARS-CoV-2 test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Patient died post vaccination


VAERS ID: 1419970 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Anaemia, Atrial fibrillation, Blood alkaline phosphatase, Blood alkaline phosphatase decreased, Blood calcium, Blood creatinine, Blood creatinine decreased, Blood glucose, Blood potassium, Blood pressure measurement, Blood sodium, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone decreased, Blood urea, Body temperature, C-reactive protein, C-reactive protein increased, Cardiac failure, Cardiomegaly, Cardiothoracic ratio increased, Chest X-ray, Death, Dizziness, Dyspnoea, Gait disturbance, Haematocrit, Haematocrit decreased, Haemoglobin, Haemoglobin decreased, Heart rate, International normalised ratio, Lymphocyte count decreased, Malaise, Mean cell haemoglobin concentration, Mean cell haemoglobin concentration decreased, Mean cell volume, Mean cell volume decreased, Nausea, Orthopnoea, Oxygen saturation, Pallor, Platelet count, Red blood cell count decreased, Reticulocyte count decreased, SARS-CoV-2 test, Thyroxine free, Ventricular failure, Vitamin B12, Vomiting, White blood cell count decreased
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: WARFARIN; OMEPRAZOLE; AMLODIPINE; LEVOTHYROXINE; SIMVASTATIN; ENALAPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (on warfarin); Chronic headaches (CT brain 01/21 revealed chronic left MCA infarcts); COPD; Dizzy; Haemorrhoids (previous haemorrhoidectomy); Hypertension; Hypothyroidism; Iron deficiency anaemia; Ischaemic heart disease; Osteoarthritis of cervical spine; Peptic ulcer (Gastroscopy ''07: Multiple pyloric erosions, ''13: Antral gastritis, ''20: Normal); Smoker; Unstable angina
Allergies:
Diagnostic Lab Data: Test Date: 20210527; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:14 IU/l; Test Date: 20210527; Test Name: Alkaline Phosphate; Result Unstructured Data: Test Result:33 U/L; Test Date: 20210527; Test Name: Calcium; Result Unstructured Data: Test Result:2,35 mmol/L; Test Date: 20210527; Test Name: Creatinine; Result Unstructured Data: Test Result:45 umol/l; Test Date: 20210527; Test Name: blood glucose; Result Unstructured Data: Test Result:level of 4,2; Test Date: 20210527; Test Name: Potassium; Result Unstructured Data: Test Result:4,2 mmol/L; Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Date: 20210527; Test Name: blood pressure; Result Unstructured Data: Test Result:128/75; Test Date: 20210527; Test Name: Sodium; Result Unstructured Data: Test Result:138 mmol/L; Test Date: 20210527; Test Name: TSH; Result Unstructured Data: Test Result:0.14 MiU/L; Test Date: 20210527; Test Name: Urea; Result Unstructured Data: Test Result:4,4 mmol/L; Test Date: 20210527; Test Name: temperature; Result Unstructured Data: Test Result:35,7 Centigrade; Comments: degrees Celsius; Test Date: 20210527; Test Name: chest x-ray; Result Unstructured Data: Test Result:showed increased CTI (cardio thoracic index); Test Date: 20210531; Test Name: c-reactive protein; Result Unstructured Data: Test Result:85 mg/l; Test Date: 20210527; Test Name: Haematocrit; Result Unstructured Data: Test Result:0.214 l/l; Test Date: 20210531; Test Name: Haematocrit; Result Unstructured Data: Test Result:0.282 l/l; Test Name: Haemoglobin; Result Unstructured Data: Test Result:5,9 L; Test Date: 20210527; Test Name: Haemoglobin; Test Result: 6 l; Test Name: pulse; Result Unstructured Data: Test Result:normal; Test Date: 20210527; Test Name: pulse; Result Unstructured Data: Test Result:72; Comments: beats per minute; Test Date: 20210527; Test Name: INR; Result Unstructured Data: Test Result:2,79; Test Date: 20210527; Test Name: MCHC; Result Unstructured Data: Test Result:29.1 g/dl; Test Date: 20210527; Test Name: Mean Cell Volume; Result Unstructured Data: Test Result:78,4 fL; Test Name: oxygen saturation; Result Unstructured Data: Test Result:normal %; Test Date: 20210527; Test Name: oxygen saturation; Test Result: 95 %; Test Date: 20210527; Test Name: Platelet count; Result Unstructured Data: Test Result:248 x10 9/l; Test Date: 20210531; Test Name: Platelet count; Result Unstructured Data: Test Result:220 x10 9/l; Test Date: 20210527; Test Name: RBC low; Test Result: 3.36 l; Test Date: 20210114; Test Name: Covid-19 test; Test Result: Positive ; Test Date: 20210601; Test Name: Covid-19 test; Test Result: Negative ; Test Date: 20210527; Test Name: Free T4; Result Unstructured Data: Test Result:21 pmol/L; Test Date: 20210527; Test Name: Vitamin B12; Result Unstructured Data: Test Result:367 pmol/L
CDC Split Type: ZAPFIZER INC2021706314

Write-up: Increased dizziness/ worsening dizziness; Unsteady gait; Nausea; Vomiting; left ventricular failure secondary to anaemia; atrial fibrillation; left ventricular failure secondary to anaemia; died; Heart failure; Cardiomegaly with the impression of new right sided infiltrates; Progressive dyspnoea,; Orthopnoea; Malaise; C-Reactive Protein high; Pale; Hemoglobin 5.9; Chest X-Ray showed increased CTI (cardio thoracic index); Creatinine low; Thyroid Stimulatig Hormones low; White Blood Cent Count low; Red Cell Count low; Haematocrit low; MCV low; MCHC low; Absolulte Recticulocyte Count low; Lymphocytes low; Alkaline Phosphatase low; This is a spontaneous report from a contactable other healthcare professional (HCP). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via unspecified route of administration on 25May2021 (Batch/Lot Number: EY4834; Expiration Date: 25May2021) for covid-19 immunization. Medical history included atrial fibrillation (on warfarin), iron deficiency anemia, hypothyroidism, unstable angina, peptic ulcer (Gastroscopy ''07: Multiple pyloric erosions, ''13: Antral gastritis, ''20: Normal), hypertension, dizzy from 24May2021, chronic obstructive pulmonary disease (COPD), smoker, ischaemic heart disease, haemorrhoids (previous haemorrhoidectomy), osteoarthritis of cervical spine and chronic headaches (CT brain 01/21 revealed chronic left MCA infarcts). Concomitant medications included warfarin; omeprazole; amlodipine; levothyroxine; simvastatin; enalapril; all from unspecified date for unspecified indication. On 25May2021 post vaccination, the patient experienced increased dizziness, had unsteady gait, nausea and vomiting. On the 27May2021, patient was hospitalized; he became pale, hemoglobin 5.9, chest x-ray showed increased CTI (cardio thoracic index), on 27May2021 - creatinine low, thyroid simulating hormones (TSH) low, white blood cent count low, red cell count low, hematocrit low, MCV (mean cell volume) low, MCHC (mean cell hemoglobin concentration) low, absolute reticulocyte count low, lymphocytes low, alkaline phosphatase low. On 31May2021, patient was found to have cardiomegaly with the impression of new right sided infiltrates, progressive dyspnoea and had heart failure, orthopnoea, malaise, C-reactive protein high. The patient was seen at Medical Outpatients in November 2019. She denied any chest pain, dyspnoea or palpitations. Her observations were normal, and she was discharged to her local clinic for further management of her chronic conditions. She presented to the Emergency Unit on the 27May2021 with complaints of dizziness and nausea. The referral letter from the clinic stated that she had similar symptoms since the 24May2021 but was not seen at the local clinic or at Hospital. She presented for her vaccination on 25May2021 at the Hospital vaccination site and went home afterwards. She volunteered worsening dizziness and an unsteady gait from the evening of 25May2021. She only attended her clinic on the 27May2021 for this problem. She was found to have an Hb of 5,9 with a normal blood pressure, pulse and oxygen saturation at her clinic. At triage in Hospital at 11:42 on the 27th of May, she had a blood pressure of 128/75, a pulse rate of 72 beats per minute, a temperature of 35,7 degrees Celsius, a blood glucose level of 4,2 and oxygen saturation on room air of 95%. A provisional diagnosis of left ventricular failure secondary to anaemia and atrial fibrillation was made. The patient was treated with Omeprazole 40mg/d, Cinnarazine, Lasix 40mg orally (changed to 80mg bd IV)and her chronic medication. The patient was reported to have died on 01Jun2021. It was unknown if an autopsy was performed. The patient underwent lab test included Lab data: Alanine aminotransferase 14 (normal 7-35) IU/l on 27May2021; Alkaline Phosphate 33 (normal 42-98) U/L on 27May2021; Calcium 2,35 (normal 2.20-2.55) mmol/L on 27May2021; Creatinine 45 (normal 49-90) umol/l on 27May2021; Potassium 4,2 (normal 3.5-5.1) mmol/L on 27May2021; Sodium 138 (normal 136-145) mmol/L on 27May2021; TSH 0.14 (normal 0.27-4.20) MiU/L on 27May2021; Urea 4,4 (normal 2.1-7.1) mmol/L on 27May2021; c-reactive protein 85 (normal <10) mg/l on 31May2021; Haematocrit 0.214 (normal 0.360-0.460) l/l on 27May2021 and 0.282 l/l on 31May2021; Haemoglobin 6 (normal 12-15) L on 27May2021 and 5,9 L on an unspecified date; INR 2,79 on 27May2021; MCHC 29.1 (normal 32.7-34) g/dl on 27May2021; Mean Cell Volume 78.4 (normal 78.9-98.5) L on 27May2021; Platelet count 248 (normal 186-454) x10 9/l on 27May2021 and 220 x10 9/l on 31May2021; RBC 3.36 (normal 3.80-4.80) L on 27May2021; Covid-19 test positive on 14Jan2021 and negative on 01Jun2021; free T4 21 (normal 12-22) pmol/L on 27May2021; Vitamin B12 367 (normal 145-569) pmol/L; blood pressure normal on an unspecified date and 128/75 on 27May2021; pulse normal on an unspecified date and 72 beats per minute on 27May2021; oxygen saturation normal on an unspecified date and 95% on 27May2021; temperature 35,7 degrees Celsius on 27May2021; blood glucose level of 4,2 on 27May2021; chest x-ray showed increased CTI (cardio thoracic index) on 27May2021. The outcome of the event died was fatal, while the other events were unknown.; Sender''s Comments: Based on the current available information and the plausible drug-events temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events dizziness, gait disturbance, nausea, vomiting, cardiac failure, ventricular failure and atrial fibrillation cannot be excluded. Additionally, medical history of multiple co-morbid conditions including, atrial fibrillation, iron deficiency anemia, peptic ulcer, chronic obstructive pulmonary disease (COPD) are risk factors for the reported events. Based on limited information, pertaining to the specific details of death and considering drug-events temporal association, the role of BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: died


VAERS ID: 1419971 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Heart rate, Investigation, Malaise, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN; NICOTINAMIDE; AMDOCIN; SALAZOPYRIN; CAPTOPRIL + HIDROCLOROTIAZIDA; CIPALAT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: BP; Result Unstructured Data: Test Result:100/54; Comments: 11h21; Pre-Vaccination; Test Date: 20210603; Test Name: BP; Result Unstructured Data: Test Result:112/62; Comments: 12h06; Post-Vaccination; Test Date: 20210603; Test Name: Pulse; Result Unstructured Data: Test Result:80; Comments: 11h21; Pre-Vaccination; Test Date: 20210603; Test Name: Pulse; Result Unstructured Data: Test Result:80; Comments: 12h06; Post-Vaccination; Test Date: 20210603; Test Name: Sats; Result Unstructured Data: Test Result:96; Comments: 12h06; Post-Vaccination
CDC Split Type: ZAPFIZER INC2021715846

Write-up: Not feeling well; Vomits after eating; Death; This is a spontaneous report from a contactable other HCP. A 91-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration at age of 91-years, on 03Jun2021 11:38 (Lot Number: FC3558; Expiration Date: 30Sep2021) as single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medications included metformin; nicotinamide; indometacin (AMDOCIN); sulfasalazine (SALAZOPYRIN); captopril, hydrochlorothiazide (CAPTOPRIL + HIDROCLOROTIAZIDA); nifedipine (CIPALAT). It was reported the patient was not feeling well and vomits after eating on 07Jun2021. The patient was hospitalized for not feeling well and vomits after eating from 10Jun2021 to an unknown date. It was also reported that patient died on 10Jun2021 at 16:30. The patient underwent lab tests and procedures which included Pre-Vaccination vitals BP 100/54 and Pulse 80 (11h21) on 03Jun2021; Post-Vaccination vitals BP 112/62 and Pulse 80 Sats 96 (12h06) on 03Jun2021. The outcome of events not feeling well and vomits was unknown. The patient died on 10Jun2021. Autopsy was done but result was not provided. Information on the lot/batch number has been requested.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. A causal association between administration of BNT162B2 and the onset of not feeling well and vomits cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. 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: 1419972 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Cardiac disorder; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021719302

Write-up: Death; This is a spontaneous report from a contactable nurse. An 82-year-old male patient received BNT162b2 (COMIRNATY) dose 1 administration on 31May2021 at 11:07, at patient age of 82-year-old, at single dose (Lot Number: FA5715; Expiration Date: Aug2021) for COVID-19 immunisation. The diluent batch details included lot number L1945; Expiration Date May2023. The vaccine was reconstituted on 31May2021. It is unknown if the patient had reactions after immunization; history of allergies unknown; the history of hospitalization in the last 30 days unknown; the patient has not tested positive for COVID-19 prior to vaccination. Medical history included hypertension, arthritis, cardiac disorder. The patient''s concomitant medications were not reported. The patient is reported to have died (death) on 02Jun2021. It was not reported if an autopsy was performed.; 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: Death


VAERS ID: 1419995 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210638405

Write-up: DEATH; This spontaneous report received from a health care professional via a media article, concerned a patient of unspecified age, sex, race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown, and expiry date: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died. The cause of death was unknown. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210638373, 20210638397, 20210638416 and 20210638382.; Sender''s Comments: V0: 20210638405-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered un-assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1419996 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210638416

Write-up: DEATH; This spontaneous report received from a health care professional via social media (media article) concerned a patient of unspecified age and sex. 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) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died 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. This report was serious (Death). This case, from the same reporter is linked to 20210638373, 20210638397, 20210638405 and 20210638382.; Sender''s Comments: V0 20210638416-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1419997 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-09
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 09-Jun-2021 The patient died on 09-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No treatment information was provided. No relevant concomitant medications were reported. Company comment: Very limited information regarding this event has been provided at this time. Details regarding the vaccine, cause of death is required for further assessment; Sender''s Comments: Very limited information regarding this event has been provided at this time. Details regarding the vaccine, cause of death is required for further assessment; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1420106 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002188 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Obstructive airways disorder
SMQs:, Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BUVENTOL
Current Illness: Asthma; Chronic obstructive pulmonary disease
Preexisting Conditions: Medical History/Concurrent Conditions: Opioid abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of OBSTRUCTIVE AIRWAYS DISORDER in a 44-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002188) for COVID-19 vaccination. The patient''s past medical history included Opioid abuse. Concurrent medical conditions included Asthma and Chronic obstructive pulmonary disease. Concomitant products included SALBUTAMOL SULFATE (BUVENTOL) for an unknown indication. In May 2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In May 2021, the patient experienced OBSTRUCTIVE AIRWAYS DISORDER (seriousness criteria death, hospitalization and life threatening). The reported cause of death was Airways obstruction. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of death in a 44-year-old male subject with a history of Asthma and Chronic obstructive pulmonary disease, who died after receiving second dose of vaccine Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Translation received on 18-Jun-2021.Description to be coded was updated(Severe obstruction).; Sender''s Comments: This is a case of death in a 44-year-old male subject with a history of Asthma and Chronic obstructive pulmonary disease, who died after receiving second dose of vaccine Very limited information has been provided at this time.; Reported Cause(s) of Death: Airways obstruction


VAERS ID: 1420902 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-06
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021703525

Write-up: adverse event following immunisation; This is a spontaneous report from a contactable other health professional. Regulatory authority report number is 564539. A 91-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose (dose number unknown) for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced adverse event following immunization with fatal outcome on 06Jun2021. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: adverse event following immunisation


VAERS ID: 1420924 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2236 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021668024

Write-up: Sudden death; Malaise; Unwell; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. The regulatory authority report number is BE-FAMHP-DHH-N2021-94691. A 67-year-old female patient received BNT162B2 (COMIRNATY, Lot FC2236, second dose) solution for injection intramuscular on 03Jun2021 at 09:48 (at the age of 67-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, first dose) for COVID-19 vaccination on an unknown date with no adverse effect reported. The patient experienced malaise, sudden death, feeling unwell on 03Jun2021. The patient was brought home from the vaccination center by a volunteer and became unwell in the car. The patient died suddenly while trying to enter the house on 03Jun2021. The mobile emergency group was immediately called in, but the patient had already passed away. Natural death according to mobile emergency group doctor. Time of death unknown. No treatment was provided for the events malaise, sudden death, feeling unwell. The outcome of the events malaise, sudden death, feeling unwell was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Natural death; Malaise; Sudden death


VAERS ID: 1420939 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0195 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Death, Dizziness, Headache, Malaise
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: 2021-05-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Hearing impaired; Speech impairment NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC2021670955

Write-up: died around 16:00 of the same day; stomachache; dizziness; headache; felt sick; This is a spontaneous report from a contactable other healthcare professional via COVAES. A 52-year-old male patient received the first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration and administered in left arm at age of 52-years, on 25May2021 09:15 (Lot Number: EW0195) as single dose for covid-19 immunisation. Medical history included that patient had COVID on the start of Mar2021; hearing and speech impaired. There were no concomitant medications. The patient was in great state of health, he received the vaccine at 09:15 in the morning of the day of 25May2021. The patient felt sick with headache, dizziness and stomachache at 10:00 and died around 16:00 of the same day (25May2021). There was no treatment received for the adverse event. The patient had not been tested for COVID-19 since the vaccination. The outcome of events felt sick with headache, dizziness and stomachache was unknown. The patient died on 25May2021. An autopsy was not performed. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: The information provided is too limited for a reasonable medical assessment for the event of Unknown cause of death. There was no information provided regarding the specific cause of death, detailed medical history and counteractive treatment measures. As per company causality guidance, the event of death with unknown cause is assessed as possibly related until the cause of death is clarified and re-assessed based on additional data. Queries are in place for the missing information. This case will be updated once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: died


VAERS ID: 1420953 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Death, Loss of consciousness, Myalgia, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINTROM; LISITRIL; METO ZEROK; PANTOPRAZOL NYCOMED; VICTOZA; TRESIBA; INSULIN HUMAN; TAMBOCOR; LYRICA; GLUCAGEN HYPOKIT; TEMESTA EXPIDET; NITROLINGUAL
Current Illness: Albuminuria (chronic relevant albuminuria (ACR 45.7 mg/mmol in 12/2019 (absolute albuminuria 915 mg/l in 2/2014)); Blood pressure high (Hypertensive heart disease with high blood pressure treated since 2003 and possibly ischemic with); Diabetic foot (diabetic foot with lesions in toes I bilaterally and mal perforans dig IV on the right, absence of relevant macroangiopathy (valid wrists up to periphery in 1/2020)); Diabetic maculopathy (OS diabetic maculopathy without edema); Diabetic polyneuropathy (diabetic polyneuropathy with status post therapy with Lyrica, pallesthesia); Diabetic retinopathy (initial diabetic retinopathy in 2/2020 with:); Fluorescein angiography normal; Gonalgia (AIS Duplex of 1/2017: Recurrence on left gonalgia proximal thigh perforating veins since 10/2016 w/on: or clinically lateral compartment arthritis and patellar ligament insertion on Quadriceps muscle shortening); Paroxysmal atrial fibrillation (currently symptoms suspect paroxysmal AF or intermittent tachycardic AF with BB and ACO. first diagnosis with paroxysmal AF in 2002 or coronarography 11/2008: normal or TTE 2008: mild IVS, moderate biatrial enlargement, examination otherwise normal); Type II diabetes mellitus (Metabolic syndrome with: or type II diabetes mellitus (diagnosed 2003) with insulin with)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Asthma NOS (Subclinical asthma with: or status post parainfective exacerbation in 10/2012 status post bilateral central pulmonary embolism with DVT of the left lower limb and discontinuation of ACO in 1/2014 with: or TTE of 1/2014: pulmonary hypertension (55 mmHg) on EP); Atrial fibrillation; Cardiomyopathy; Crossectomy (status post crossectomy and stripping of the left great saphenous vein in 1990 with:); Diabetes mellitus; Electrical cardioversion (status post electrical conversion 2008 status post tachycardization within EPs in 01/2014); Hypercholesteremia (hypercholesterolemia or adiposity (BMI 37 kg/m2) of the abdominal type or non-alcoholic fatty liver disease of the NASH type C4s chronic venous insufficiency (CEAP) on the right (C3a) on the left with:); Metabolic syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210519; Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: 38 degree Celsius
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Death; Fell unconscious; Fever; Myalgia; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), PYREXIA (Fever), MYALGIA (Myalgia) and LOSS OF CONSCIOUSNESS (Fell unconscious) in a 67-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Cardiomyopathy on 20-May-2021, Arterial hypertension on 20-May-2021, Atrial fibrillation on 20-May-2021, Metabolic syndrome on 20-May-2021, Diabetes mellitus on 20-May-2021, Hypercholesteremia (hypercholesterolemia or adiposity (BMI 37 kg/m2) of the abdominal type or non-alcoholic fatty liver disease of the NASH type C4s chronic venous insufficiency (CEAP) on the right (C3a) on the left with:) on 20-May-2021, Asthma NOS (Subclinical asthma with: or status post parainfective exacerbation in 10/2012 status post bilateral central pulmonary embolism with DVT of the left lower limb and discontinuation of ACO in 1/2014 with: or TTE of 1/2014: pulmonary hypertension (55 mmHg) on EP) on 20-May-2021, Electrical cardioversion (status post electrical conversion 2008 status post tachycardization within EPs in 01/2014) in 2008 and Crossectomy (status post crossectomy and stripping of the left great saphenous vein in 1990 with:). Previously administered products included for Product used for unknown indication: Tambocor. Past adverse reactions to the above products included No adverse event with Tambocor. Concurrent medical conditions included Blood pressure high (Hypertensive heart disease with high blood pressure treated since 2003 and possibly ischemic with) since 2003, Paroxysmal atrial fibrillation (currently symptoms suspect paroxysmal AF or intermittent tachycardic AF with BB and ACO. first diagnosis with paroxysmal AF in 2002 or coronarography 11/2008: normal or TTE 2008: mild IVS, moderate biatrial enlargement, examination otherwise normal), Type II diabetes mellitus (Metabolic syndrome with: or type II diabetes mellitus (diagnosed 2003) with insulin with) since 2003, Diabetic polyneuropathy (diabetic polyneuropathy with status post therapy with Lyrica, pallesthesia), Diabetic foot (diabetic foot with lesions in toes I bilaterally and mal perforans dig IV on the right, absence of relevant macroangiopathy (valid wrists up to periphery in 1/2020)), Albuminuria (chronic relevant albuminuria (ACR 45.7 mg/mmol in 12/2019 (absolute albuminuria 915 mg/l in 2/2014)), Diabetic retinopathy (initial diabetic retinopathy in 2/2020 with:) since February 2020, Fluorescein angiography normal since February 2020, Diabetic maculopathy (OS diabetic maculopathy without edema) and Gonalgia (AIS Duplex of 1/2017: Recurrence on left gonalgia proximal thigh perforating veins since 10/2016 w/on: or clinically lateral compartment arthritis and patellar ligament insertion on Quadriceps muscle shortening) since January 2017. Concomitant products included GLYCERYL TRINITRATE (NITROLINGUAL) for Chest pain, ACENOCOUMAROL (SINTROM), LISINOPRIL (LISITRIL), METOPROLOL SUCCINATE (METO ZEROK), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOL NYCOMED), LIRAGLUTIDE (VICTOZA), INSULIN DEGLUDEC (TRESIBA), INSULIN HUMAN, FLECAINIDE ACETATE (TAMBOCOR), PREGABALIN (LYRICA), GLUCAGON HYDROCHLORIDE (GLUCAGEN HYPOKIT) and LORAZEPAM (TEMESTA EXPIDET) for an unknown indication. On 19-May-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced PYREXIA (Fever) (seriousness criteria death and medically significant) and MYALGIA (Myalgia) (seriousness criteria death and medically significant). On 20-May-2021, the patient experienced DEATH (Death) (seriousness criterion death) and LOSS OF CONSCIOUSNESS (Fell unconscious) (seriousness criteria death and medically significant). The patient died on 20-May-2021. The reported cause of death was rhythm disturbance in the context of myocardial ischemia. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, Body temperature: 38 (Inconclusive) 38 degree Celsius. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered PYREXIA (Fever) and MYALGIA (Myalgia) to be probably related and DEATH (Death) to be unlikely related. No further causality assessment was provided for LOSS OF CONSCIOUSNESS (Fell unconscious). Patient was suffering from ischemic heart disease and it was on progress. After vaccination patent had a temperature of 38?C and while try to get up from bed patient fall unconscious and when 144 alerted patient found asystole. All the resuscitative maneuvers went vain No laboratory data was given. No treatment information was given. Based on reporter''s causality and multiple comorbidities, the event of death is assessed as unlikely related to mRNA-1273. Based on the current available information, reporter''s causality and temporal association between the use of the product and the start date of the events of pyrexia and myalgia, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Added medical histories and lab tests. Updated the dose information.; Sender''s Comments: Based on reporter''s causality and multiple comorbidities, the event of death is assessed as unlikely related to mRNA-1273. Based on the current available information, reporter''s causality and temporal association between the use of the product and the start date of the events of pyrexia and myalgia, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Rhythm disturbance in the context of myocardial ischemia


VAERS ID: 1420977 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-27
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001651 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure acute, Condition aggravated
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Asthma bronchial; Closed femur fracture
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100092398

Write-up: Condition worsened; Acute heart failure; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC FAILURE ACUTE (Acute heart failure) and CONDITION AGGRAVATED (Condition worsened) in an 81-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001651) for COVID-19 vaccination. Concurrent medical conditions included Closed femur fracture, Arterial hypertension and Asthma bronchial. On 17-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced CARDIAC FAILURE ACUTE (Acute heart failure) (seriousness criteria death and medically significant). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition worsened) (seriousness criterion death). The patient died on 27-Apr-2021. The reported cause of death was Acute heart failure. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were provided. No Treatment information was provided.; Sender''s Comments: This is a case of sudden death in an 81-year-old female with hx of Closed femur fracture, who died of Cardiac failure acute 10 days after receiving a dose of mRNA-1273 vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Acute heart failure


VAERS ID: 1421008 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bilateral blindness (glaucoma with blindness); Dementia; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Glaucoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699254

Write-up: suddenly died; This is a spontaneous report downloaded from the WEB number DE-CADRPEI-2021093888, Safety Report Unique Identifier DE-PEI-202100087552. An 87-year-old female patient received first dose of BNT162B2 (COMIRNATY) via unspecified route 0.3ml twice daily for COVID-19 immunisation on 22Mar2021. Medical history included ongoing hypertension, ongoing bilateral blindness (glaucoma with blindness), ongoing dementia. The patient''s concomitant medications were not reported. The patient suddenly died 5 days after the corona vaccination on 27Mar2021, with outcome of the event was not resolved. The patient died on 27Mar2021. No autopsy was performed. Sender Comment: Information on risk factors or previous illnesses dementia, glaucoma with blindness, known and treated high blood pressure. Otherwise physically healthy. / actually no reaction until sudden death. Event assessment : Comirnaty/ event/PEI /Result of Assessment : D. Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: suddenly died


VAERS ID: 1421009 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Aneurysm of aorta; Aortic valve stenosis; Infarct myocardial
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of DEATH in a 54-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Prophylactic vaccination: COVID-19 Vaccine COVID-19 Vaccine AstraZeneca suspension for injectionCOVID-19 Vaccine AstraZeneca. Concurrent medical conditions included Aortic valve stenosis, Infarct myocardial since 2020, Aneurysm of aorta and Asthma. On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was performed, but no results were provided. No concomitant medication was not reported. No treatment medication was not reported This is a case of sudden death in a 54-year-old male with medicatl history of aortic valve stenosis, infarct myocardial, asthma and aneurysm of aorta, who died after receiving second dose of vaccine. Autopsy results were not provided. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 54-year-old male with medicatl history of aortic valve stenosis, infarct myocardial, asthma and aneurysm of aorta, who died after receiving second dose of vaccine. Autopsy results were not provided. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1421010 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Cardiac arrhythmia; Diabetes mellitus, antepartum
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM and THROMBOSIS in an 80-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 in January 2021. Concurrent medical conditions included Arterial hypertension, Diabetes mellitus, antepartum and Cardiac arrhythmia. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (seriousness criteria death and medically significant) and THROMBOSIS (seriousness criterion medically significant). The patient died on 12-May-2021. The reported cause of death was Lung embolism. An autopsy was performed, but no results were provided. At the time of death, THROMBOSIS had not resolved. No concomitant medications were provided. No treatment was reported for the events. Action taken with the suspect product was not applicable. This is a case of an 80-year-old female patient with a history of arterial hypertension, diabetes mellitus, and cardiac arrhythmia who experienced thrombosis and lung embolism which resulted in fatal outcome three weeks following second dose of the vaccine. An autopsy was performed, but no results were provided. Very limited information has been provided at this time. Causality is confounded with patient''s advanced age and reported medical history.; Sender''s Comments: This is a case of an 80-year-old female patient with a history of arterial hypertension, diabetes melitus, and cardiac arrhytmia who experienced thrombosis and lung embolism which resulted in fatal outcome three weeks following second dose of the vaccine. An autopsy was performed, but no results were provided. Very limited information has been provided at this time. Causality is confouded with patient''s advanced age and reported medical history.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1421627 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-05-10
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2405 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Balance disorder, Blood cholesterol, Blood sodium, Blood urea, Cerebral infarction, Dysarthria, Electrocardiogram, Electrocardiogram ambulatory, Gait disturbance, Glycosylated haemoglobin, Low density lipoprotein, Magnetic resonance imaging head, Motor dysfunction, Platelet count
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROCORTISONE; FLORINEF
Current Illness: Diabetes; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenalectomy (Due to pheochromocytoma, patient is in substitution treatment for corticoadrenal insufficiency); Disease Addison''s; Pheochromocytoma
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: APTT; Result Unstructured Data: Test Result:32; Comments: Unit not specified; Test Date: 20210510; Test Name: Cholesterol total; Result Unstructured Data: Test Result:4.2; Comments: Unit not specified; Test Date: 20210510; Test Name: Sodium; Result Unstructured Data: Test Result:131; Comments: Unit not specified; Test Date: 20210510; Test Name: Urea; Result Unstructured Data: Test Result:11.6; Comments: Unit not specified; Test Date: 20210510; Test Name: ECG; Result Unstructured Data: Test Result:Sinus rhythm with frequency of 73; Test Date: 20210510; Test Name: ECG; Result Unstructured Data: Test Result:No signs of acute ischemia; Test Date: 20210510; Test Name: Holter monitoring; Result Unstructured Data: Test Result:32-93,49; Comments: Low frequency: 32 - 93 bpm, avg.: 49 bpm; Test Date: 20210510; Test Name: Holter monitoring; Result Unstructured Data: Test Result:Pauses up to 6.2 sec; Comments: Pauses up to 6.2 sec. No atrial fibrillation; Test Date: 20210510; Test Name: Holter monitoring; Result Unstructured Data: Test Result:ectopic atrial rhythm; Comments: 3 days monitoring: ectopic atrial rhythm; Test Date: 20210510; Test Name: Holter monitoring; Result Unstructured Data: Test Result:Nodal escapade rhythm; Test Date: 20210510; Test Name: HbA1C; Result Unstructured Data: Test Result:50; Comments: Unit not specified; Test Date: 20210510; Test Name: LDL; Result Unstructured Data: Test Result:2.1; Comments: Unit not specified; Test Date: 20210510; Test Name: MRI brain; Result Unstructured Data: Test Result:3 mm aneurysm; Comments: 3 mm aneurysm at the pericallosa artery, left side; Test Date: 20210510; Test Name: MRI brain; Result Unstructured Data: Test Result:Minor hemorrhagic; Comments: Minor hemorrhagic transformation at right frontal; Test Date: 20210510; Test Name: MRI brain; Result Unstructured Data: Test Result:Suspected Basilar aneurysm CTA; Test Date: 20210510; Test Name: MRI brain; Result Unstructured Data: Test Result:Late subacute infarction results at right frontal; Test Date: 20210510; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:129; Comments: Unit not specified
CDC Split Type: DKPFIZER INC2021669843

Write-up: Late subacute infarction diagnosed on MRI brain; Balance difficulty when standing/walking, no side difference; Unsteady walk, swayed from side to side; The patient could not buckle his belt, no side different in hands; Speech slurred; This is a spontaneous report from contactable physicians. This is the second report of two reports. The first report is a report downloaded from the WEB DK-DKMA-WBS-0067349. A 70-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 24Apr2021 (Lot Number: EX2405; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. Medical history included adrenalectomy from 2015 to 2015 (Due to pheochromocytoma, patient is in substitution treatment for corticoadrenal insufficiency), phaeochromocytoma, ongoing diabetes mellitus, ongoing hypertension, addison''s disease. Concomitant medications included hydrocortisone taken for adrenal insufficiency from 14Sep2014; fludrocortisone acetate (FLORINEF) taken for addison''s disease from 21Jul2012. On 10May2021, 16 days after the first vaccination, the patient developed balance difficulty, difficulty in walking, motor dysfunction, cerebral infarction and speech slurred. The patient underwent lab tests and procedures which included(10May2021): Cholesterol total: 4.2 (Unit not specified). LDL(low density lipoprotein): 2.1 (Unit not specified). HbA1C(glycosylated hemoglobin): 50 (Unit not specified). Sodium: 131 (Unit not specified). Thrombocyte count: 129 (Unit not specified). Urea: 11.6 (Unit not specified). APTT(activated partial thromboplastin time): 32 (Unit not specified). ECG(electrocardiogram): Sinus rhythm with frequency of 73, no signs of acute ischemia. MRI (Magnetic resonance image) brain: Late subacute infarction results at right frontal, minor hemorrhagic transformation at right frontal, basilar aneurysm CTA (computed tomography angiography)and 3 mm aneurysm at the pericallosa artery, left side. Holter monitoring: 3 days monitoring: ectopic atrial rhythm, nodal escapade rhythm, low frequency: 32 -93 bpm, avg.: 49 bpm, Pauses up to 6.2 sec. No atrial fibrillation. The patient received 2nd dose on 14May2021. The patient died on 17May2021 and the reported cause of death was aystolia. The reporter was not the one to confirm the death. The patient was autopsied on 20May2021 with no signs of macroscopic thrombi. Significant autopsy findings are available without explanation of the death and the primary autopsy statement and the supplementary statement is awaited. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DK-PFIZER INC-2021668350 same patient&different doses and events; Reported Cause(s) of Death: aystolia


VAERS ID: 1421660 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   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: Ischaemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021668120

Write-up: Cerebral haemorrhage; probable hypertensive crisis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-894138. A 74-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm (deltoid muscle) on 12May2021 (Batch/Lot Number: FA5715) as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included ischaemic heart disease. The patient''s concomitant medications were not reported. The day after administering the first dose of Pfizer''s COVID19 vaccine (13May2021), he was admitted to the Intensive Care Unit with a headache attributed to an acute brain stem hemorrhage. It was not a thrombo-embolic picture but a hemorrhagic one in the setting of a probable hypertensive crisis. Patient with a history of ischemic heart disease with numerous cardiovascular risk factors. Right now, he is brain dead. The faculty was informed, and it was agreed to record this event, although it does not seem attributable to the vaccination, but to his pathological history. Outcome of probable hypertensive crisis was unknown. The patient died on 19May2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Hemorragia cerebral


VAERS ID: 1421661 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-05-28
   Days after vaccination:109
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Base excess, Basophil count, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood calcium, Blood chloride, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood lactic acid, Blood potassium, Blood pressure measurement, Blood sodium, Body temperature, C-reactive protein, COVID-19 pneumonia, Carbon dioxide, Chest X-ray, Drug ineffective, Electrocardiogram, Eosinophil count, Gamma-glutamyltransferase, Glomerular filtration rate, Haematocrit, Haemoglobin, Heart rate, International normalised ratio, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet count, Procalcitonin, Prothrombin level, Prothrombin time, Red blood cell count, Red cell distribution width, Respiratory rate, SARS-CoV-2 test, Septic shock, White blood cell count, pH body fluid
SMQs:, Lack of efficacy/effect (narrow), Toxic-septic shock conditions (narrow), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Chronic gastritis; Decubitus ulcer; Dyslipidemia; Femoropopliteal artery occlusion; Ischemic heart disease; Mitral valve disease; Neuropsychiatric syndrome (Neuro-psychiatric disorders); Penicillin allergy; Pulmonary hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: pO2; Result Unstructured Data: Test Result:70.0 mmHg; Test Date: 20210528; Test Name: Procalcitonin; Result Unstructured Data: Test Result:7.19 ng/ml; Test Date: 20210528; Test Name: prothrombin activity; Test Result: 64.10 %; Test Date: 20210528; Test Name: prothrombin time; Result Unstructured Data: Test Result:14.90; Comments: sg; Test Date: 20210528; Test Name: red blood cells; Result Unstructured Data: Test Result:4.54; Comments: 10 e 6 / uL; Test Date: 20210528; Test Name: RDW; Test Result: 13 %; Test Name: respiratory rate; Result Unstructured Data: Test Result:35; Test Date: 20210528; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210528; Test Name: leukocyte count; Result Unstructured Data: Test Result:15.10; Comments: 10e3 / uL; Test Date: 20210528; Test Name: ALANINE AMINOTRANSFERASE; Result Unstructured Data: Test Result:36 IU/l; Test Date: 20210528; Test Name: ASPARTATE AMINOTRANSFERASE; Result Unstructured Data: Test Result:30 IU/l; Test Date: 20210528; Test Name: BEb; Result Unstructured Data: Test Result:0.5 mmol/L; Test Date: 20210528; Test Name: basophil count; Test Result: 0.00 %; Test Date: 20210528; Test Name: BASOPHILES; Result Unstructured Data: Test Result:0.00; Comments: 10e3 / uL; Test Date: 20210528; Test Name: Alkaline Phosphatase; Result Unstructured Data: Test Result:108 IU/l; Test Date: 20210528; Test Name: HCO3; Result Unstructured Data: Test Result:25.4 mmol/L; Test Date: 20210528; Test Name: bilirubin; Test Result: 0.43 mg/dl; Test Date: 20210528; Test Name: calcium; Test Result: 4.59 mg/dl; Test Date: 20210528; Test Name: blood chloride; Result Unstructured Data: Test Result:111 mmol/L; Test Date: 20210528; Test Name: creatinine; Test Result: 1.61 mg/dl; Test Date: 20210528; Test Name: Fibrinogen; Test Result: 740.00 mg/dl; Test Date: 20210528; Test Name: blood glucose; Test Result: 109 mg/dl; Comments: and 119; Test Date: 20210528; Test Name: LDH; Result Unstructured Data: Test Result:450 IU/l; Test Date: 20210528; Test Name: lactate; Result Unstructured Data: Test Result:6.7 mmol/L; Comments: Lactate in gases; Test Date: 20210528; Test Name: blood potassium; Result Unstructured Data: Test Result:5.1 mmol/L; Comments: and 4.4; Test Name: blood pressure; Result Unstructured Data: Test Result:97/47 mmHg; Test Name: blood pressure; Result Unstructured Data: Test Result:90/52 mmHg; Test Date: 20210528; Test Name: blood sodium; Result Unstructured Data: Test Result:150 mmol/L; Comments: and 144; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Test Date: 20210528; Test Name: TCO2; Result Unstructured Data: Test Result:26.7 mmol/L; Test Date: 20210528; Test Name: chest x-ray; Result Unstructured Data: Test Result:Bilateral interstitials Infiltrators; Comments: . Bilateral interstitials Infiltrators are observed with the presence of areas of consolidation in both upper lobes as lower left, with associated atelectasis. Occupation of both costophrenic sinuses; Test Date: 20210528; Test Name: C-reactive protein; Result Unstructured Data: Test Result:382.6 mg/l; Test Date: 20210528; Test Name: ECG; Result Unstructured Data: Test Result:Sinus tachycardia; Comments: Sinus tachycardia at 132 bpm, narrow QRS, neither supra nor under level of ST segment. Growth of T waves in precordial V4- V5.; Test Date: 20210528; Test Name: EOSINOPHILS; Result Unstructured Data: Test Result:0.02; Comments: 10 e3 / uL; Test Date: 20210528; Test Name: EOSINOPHILS; Test Result: 0.16 %; Test Date: 20210528; Test Name: GGT; Result Unstructured Data: Test Result:17 IU/l; Test Date: 20210528; Test Name: estimated glomerular filtration rate; Result Unstructured Data: Test Result:40.89 ml/min; Test Date: 20210528; Test Name: HEMATOCRIT; Result Unstructured Data: Test Result:44,7 %; Test Date: 20210528; Test Name: haemoglobin; Result Unstructured Data: Test Result:13.1 g/dl; Test Name: heart rate; Result Unstructured Data: Test Result:77; Comments: bpm; Test Name: heart rate; Result Unstructured Data: Test Result:112; Test Date: 20210528; Test Name: INR; Result Unstructured Data: Test Result:1.28; Test Date: 20210528; Test Name: Lymphocyte count; Test Result: 3.31 %; Test Date: 20210528; Test Name: LYMPHOCYTES; Result Unstructured Data: Test Result:0.50; Comments: 10 e3 / uL; Test Date: 20210528; Test Name: MCH; Result Unstructured Data: Test Result:29.1; Comments: pg; Test Date: 20210528; Test Name: MCHC; Result Unstructured Data: Test Result:29.4 g/dl; Test Date: 20210528; Test Name: MCV; Result Unstructured Data: Test Result:99.2; Comments: fl; Test Date: 20210528; Test Name: MPV; Result Unstructured Data: Test Result:9.47; Comments: fl; Test Date: 20210528; Test Name: monocytes; Test Result: 5.50 %; Test Date: 20210528; Test Name: MONOCYTES; Result Unstructured Data: Test Result:0.83; Comments: 10e3 / uL; Test Date: 20210528; Test Name: Neutrophil count; Test Result: 91.00 %; Test Date: 20210528; Test Name: NEUTROPHILES; Result Unstructured Data: Test Result:13.80; Comments: 10e3/ul; Test Name: oxygen saturation; Test Result: 98 %; Comments: with mask; Test Name: oxygen saturation; Test Result: 88 %; Test Date: 20210528; Test Name: oxygen saturation; Test Result: 93.8 %; Comments: % sO2c 93.8% (94 - 98) and sO2m 93.7% (80 - 99); Test Date: 20210528; Test Name: pCO2; Result Unstructured Data: Test Result:41.0 mmHg; Test Date: 20210528; Test Name: ph; Result Unstructured Data: Test Result:7.400; Comments: pH in Gases; Test Date: 20210528; Test Name: PLATELETS; Result Unstructured Data: Test Result:311.0; Comments: 10e3/ul
CDC Split Type: ESPFIZER INC2021688121

Write-up: Drug ineffective; COVID-19 pneumonia; Septic shock; This is a spontaneous report received from a contactable pharmacist downloaded from the Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-894150. A 85-year-old male patient received bnt162b2 (COMIRNATY, Formulation: solution for injection) via intramuscular route of administration on 08Feb2021 as 2nd dose, single (Lot Number: EL8723); on 18Jan2021 as 1st dose, single (Lot Number: EM0477) both for COVID-19 immunisation. Medical history Medical history included previous illnesses as ischemic heart disease, cognitive degenerative impairment, double mitral lesion, dyslipidemia, chronic gastritis, pulmonary hypertension, arterial hypertension, femoropopliteal occlusion, decubite ulcers, allergy to penicillin all were from an unknown date. The patient''s concomitant medications were not reported. The patient previously took sertraline [sertraline hydrochloride], bisoprolol, enalapril [enalapril maleate], Movicol [macrogol 3350; potassium chloride; sodium bicarbonate; sodium chloride]., OMEPRAZOLE 20 MG 1.0.0, CIPROFLOXACINO 750 MG 1.0. Since January 2021; it was unknown if the disease had previously passed. On 27May, 3 and a half months after the second vaccination dose, he began with respiratory symptoms, desaturation, and fever up to 38C, for which he was referred to the hospital with a negative antigen test and a subsequent positive PCR with bilateral pneumonia. On 28May2021, Reason for consultation was Fever and dyspnea. patient was institutionalized and referred from residence, with limited baseline status due to degenerative cognitive impairment, respiratory failure episode and fever of 12 hours of evolution. Residence physician attached evaluation report: Sat O2% basal 57%, with crackles on the left base. Physical exploration: Temperature (C): 37, Systolic pressure (mm Hg): 97, Diastolic pressure (mm Hg): 47, Pulse (beats / min): 77, Oxygen saturation in nasal glasses (%): 98, Oxygen saturation with mask (%): 98. BP: 90/52 Heart Rate: 112 Respiratory Rate: 35 T: 36.1 SatO2: 88 with reservoir 100% Poor general condition. Cachexia Good distal perfusion. Mucocutaneous paleness. Abdominal breathing, intense suprasternal, intercostal and subcostal work of breathing. Head and neck: No Jugular engorgement, rhythmic and symmetrical carotids, no goiter, no lymphadenopathy. Thorax: Cardiac auscultation: rhythmic heart tones, he does not hear murmurs. Pulmonary auscultation: Generalized Hypophonesis with diffuse rude crackles. Abdomen: hydro-noise positive. Soft, depressible, not painful on superficial and deep palpation, without signs of peritoneal irritation. He does not felt masses or megaly. Negative kidney percussion. Extremities: decubitus ulcers in both Lower limbs. Neurological: GCS 4/15. Isoreactive pupils, normocoria. Impossibility of the rest of the neurological examination. Upper and lower limbs stiffness, cervical. Blood tests performed on 28may2021. Biochemistry: Glucose 109 mg / dL (70 - 110), Creatinine 1.61 mg / dL (0.6 - 1.3), estimated glomerular filtration rate (MDRD 4 - IDMS) 40.89 mL / min (65 - 170), Sodium 150 mmol / L (135 - 145),Potassium 5.1 mmol / L (3.5 - 5.5), Chloride 111 mmol / L (98 - 110), Total Bilirubin 0.43 mg / dL (0.2 - 1.2), AST /GOT 30 U / L (4 - 50), ALT / GPT 36 U / L (5 - 40), GGT 17 U / L (10 - 50), LDH 450 U / L (140 - 240), Alkaline Phosphatase 108 U / L (53 - 128), flow redistribution: C-reactive protein 382.6 mg / L (0 - 5), Procalcitonin 7.19 ng / mL, ARTERIAL gasometry with reservoir 100%: PH in gases 7,400 (7.35 - 7.45), pco2 41.0 mmhg (32 - 45), po2 70.0 mmhg (60 - 95), hco3 25.4 (mmol / l) mm / l, TCO2 26.7 (mmol / l) mm / l, beb 0.5 (mmol / l) mm / l, BEECF 0.6 (mmol / l) mm / l, SBC 25.2 mm / l (22 - 26), % so2c 93.8% (94 - 98), so2m 93.7% (80 - 99), plasma sodium 144.0 mm / (135 - 145), potassium in plasma 4.4 mm / l (3.5 - 5.5), glucose in gases 119 mg / dl (70 -110), lactate in gases 6.70 mm / l (0.45 - 1.9), calcium ionic 4.59 mg / dl (4.2 - 5.4), hb in co-ox. 12.7 g / dl (12 - 16),hemogram: RBC 4.51 10 e 6 / ul (4.3 - 5.7), hemoglobin 13.1 g / dl (13.3 -16.7), hematocrit 44.7% (39 - 50), MCV 99.2 fl (82 - 98), MCH 29.1 PG (27.3 - 32.6), mchc 29.4 g / dl (31.6 - 34.9), RDW 13.0%, platelets 311.0 10e 3 / ul (140 - 440), MPV 9.47 FL, leukocytes 15.10 10e3 / ul (3.7 - 9.5), neutrophiles 13.80 10e 3 / ul (1.5 - 6.5),neutrophiles% 91.00%, lymphocytes 0.50 10 e3 / ul (1.1 - 3.5), lymphocytes% 3.31%,monocytes 0.83 10e3 / ul (0.21 - 0.92), monocytes% 5.50%, eosinophils 0.02 10 e3 / ul (0.02 - 0.67), eosinophils% 0.16%, basophiles 0.00 10e3 / ul (0 - 0.13), basophiles% 0.00%, coagulation: Prothrombin T. 14.90 sg (9 - 15), Prothrombin Activity 64.10% (65 -120), I.N.R. 1.28 (0.86 - 1.13), Cephalin T. 36.00 sg (24.6 - 40), Fibrinogen derivative 740.00 mg / dL (150 - 600) Chest X-ray: Image suboptimal quality; rotated and not clear. Bilateral interstitials Infiltrators are observed with the presence of areas of consolidation in both upper lobes as lower left, with associated atelectasis. Occupation of both costophrenic sinuses. There are no studies with which to make a comparison. Other tests included ECG: Sinus tachycardia at 132 bpm, narrow QRS, neither supra nor under level of ST segment. Growth of T waves in precordial V4- V5. Evolution and comments: The patient is admitted. Patient with General poor condition. laboured breathing with heavy abdominal breathing, audible rales noises without phonendoscope, neck and limb stiffness According to the critical state of the patient and exploration: Patient monitoring. Medical Assessment: Sepsis of possible respiratory origin in the context of probable aspiration. 28May2021. PCR Covid test received with positive result. Corticotherapy and bronchodilators are started upon arrival, resulting in a saturation of 88%, without. However, the patient again presents desaturation with clear worsening reservoir at 15 bpm to saturate at 80%. Given the patient''s history and poor response to the prescribed treatment, it was decided to limit the therapeutic effort by starting sedation perfusion with 30mg of morphic chloride + 20mg of midazolam. It was commented with internal medicine for admission of the patient until death, it was decided to remain in emergencies 18h from the beginning of the sedation perfusion. Without response to support measures and with poor evolution, he died in the hospital with a diagnosis of septic shock in relation to COVID-19 pneumonia. Therapeutic measures were taken as a result of COVID-19 pneumonia. The patient died on 30May2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. Medical assessment: Severe bilateral pneumonia due to SARS Cov2 Respiratory failure secondary to the above. Severe hypernatremia. Principal diagnostic: Septic shock in relation to COVID-19 pneumonia. Other diagnoses: Sacral pressure ulcers. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1421690 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Blood glucose abnormal, Cardiac failure, Condition aggravated, Death, Disorientation, Eye pain, Fatigue, Haemorrhage, Neuroendocrine carcinoma of the skin, Oedema peripheral, Pain in extremity, Varicose ulceration, Visual impairment
SMQs:, Cardiac failure (narrow), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Skin malignant tumours (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Merkel cell carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021668238

Write-up: Death; Condition aggravated; Blood glucose abnormal; Anxiety aggravated; Merkel cell carcinoma; Oedema lower limb; Pain of lower extremities; Cardiac failure aggravated; Varicose ulceration; Visual disturbance; Fatigue; Disorientation; Eye pain; Bleeding from leg wounds increased; This is a spontaneous report from a contactable other HCP, downloaded from the WEB regulatory authority number FI-FIMEA-20212970. An 88-years-old female patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunisation. Medical history included Merkel''s basal cell carcinoma. Concomitant medications were not reported. The patient experienced condition aggravated (death) on 12Mar2021; blood glucose abnormal (death) on 12Mar2021; anxiety aggravated (death) on 12Mar2021; Merkel cell carcinoma (death) on 12Mar2021; oedema lower limb (death) on 12Mar2021; pain of lower extremities (death) on 12Mar2021; death on 12Mar2021; cardiac failure aggravated (death) on 12Mar2021; varicose ulceration (death) on 12Mar2021; visual disturbance (death) on 12Mar2021; fatigue (death) on 12Mar2021; disorientation (death) on 12Mar2021; eye pain (death) on 12Mar2021. It was reported that patient managing at home care service was taken to hospital for treatment where she died 04May2021 (as reported), as a surprise to physicians. Bleeding from leg wounds increased, Merkel''s basal cell carcinoma went crazy in growing and surgery was required, eye pain and visual disturbances, fatigue, disorientation and anxiety increased, cardiac failure worsened and leg swelling and pain, blood sugar worsening, death. Outcome of the events was fatal. It was unknown if an autopsy was done or not. No follow-up attempts are possible; batch/lot number cannot be obtained.; Reported Cause(s) of Death: condition aggravated; Blood glucose abnormal; Anxiety aggravated; Merkel cell carcinoma; Oedema lower limb; Pain of lower extremities; Death; Cardiac failure aggravated; Varicose ulceration; Visual disturbance; Fatigue; Disorientation; Eye pain; Blee


VAERS ID: 1421711 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-05-10
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety depression; Bedridden; Macular degeneration; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: SARS-cov-2 pcr test; Test Result: Positive ; Comments: Screening: variant V1
CDC Split Type: FRPFIZER INC2021728673

Write-up: Patient died in a context of symptomatic COVID infection despite a complete vaccination with COMIRNATY; Patient died in a context of symptomatic COVID infection despite a complete vaccination with COMIRNATY; fever; deterioration of general condition; congestion; This is a spontaneous report received from a contactable other health care professional downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-2021056925. A 100-year-old female patient received the second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number: EJ6789), via an intramuscular route of administration on 10Feb2021 and first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number: EM0477) on 20Jan2021 as a single dose for COVID-19 immunisation. The patient medical history included macular degeneration, anxiety depression and vascular dementia. Concomitant medications were not reported. Patient was very bedridden before Covid infection and no evidence of a problem during the prior vaccination. On 10May2021, the patient experienced fever, deterioration of general condition and congestion. On the same day PCR test was performed which was positive, Screening: variant V1. Patient died in a context of symptomatic COVID infection despite a complete vaccination with Comirnaty on 12May2021 (no hospitalization, palliative care from the outset given the already altered condition of the patient). Patient did not receive any treatment for the events. The time interval between beginning of drug administration and start of event was 111 days and time interval between last dose of drug and start of event was 90 days. It was not reported whether if an autopsy was performed or not. Cluster in RA (10 cases including 2 asymptomatic; including 2 in 2 unvaccinated patients, 2 in patients having had 1 single dose (including 1 asymptomatic); 5 symptomatic cases reported to Regulatory Authority (DJ20211289; DJ20211290; DJ20211291; DJ20211292 and DJ20211293). 1 death (DJ20211289, the others are progressing favorably), all have a V1 screening, and all the patients having had 2 doses were vaccinated on the same dates, same batches.; Reported Cause(s) of Death: symptomatic COVID infection; fever; deterioration of general condition; congestion


VAERS ID: 1421751 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Influenza like illness, Musculoskeletal stiffness, Myocardial infarction, Thirst, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   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: EXFORGE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (Moderate)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021668045

Write-up: Infarct myocardial; Very strong feeling of thirst; Stiffness all over the body; Flu-like condition; Vomiting; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the WEB FR-AFSSAPS-2021066121. A 55-year-old male patient received the first dose of BNT162B2 (COMIRNATY; lot number: FC3558), intramuscular, administered in left arm on 22May2021 as single dose for COVID-19 immunisation. The patient''s medical history included arterial hypertension (moderate). The patient''s concomitant medications included amlodipine besilate, valsartan (EXFORGE). The patient had a bad experience after the injection on 22May2021 with a very strong feeling of thirst, stiffness all over the body, a flu-like condition, and vomiting. The patient died due to infarct myocardial on 24May2021. The outcome of the other events was unknown. An autopsy was performed and results were not provided (pending).; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1421782 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-05-21
   Days after vaccination:105
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   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: Medical History/Concurrent Conditions: CVA
Allergies:
Diagnostic Lab Data: Test Date: 20210527; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210521; Test Name: Covid-19 virus test; Test Result: Positive ; Comments: English variant.
CDC Split Type: FRPFIZER INC2021728762

Write-up: Vaccination failure; hyperthermia; dyspnoea; positive COVID-19 test; This is a spontaneous report from a contactable other health care professional downloaded from the WEB, regulatory authority number FR-AFSSAPS-2021067716. Case Summary and Reporter''s Comments Text: COVID-19 VACCINATION, Dose 1+Dose 2 , Confirmed vaccination failure. A 80-year-old male patient received second dose of BNT162B2 (COMIRNATY: Solution for injection, Lot Number: EJ6788, Expiration date: unknown), via intramuscularly, in right arm on 05Feb2021 as 2nd dose, single for COVID-19 immunization. Patient took his first dose of BNT162B2 (COMIRNATY: Solution for injection, Lot Number: EM0477, Expiration date: unknown), via intramuscularly, in right arm on 14Jan2021 as 1st dose, single for COVID-19 immunization. The patient medical history includes Cerebrovascular accident and concomitant medications were not reported. On 21May2021, the patient had PCR Covid-19 test positive (English variant) and on 27May2021 patient experienced, hyperthermia to 39 degree C and dyspnoea of sudden onset requiring 24-hour oxygen therapy. Later, the same day patient died with unknown cause of death. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as positive on 21May2021 and body temperature 39 degree centigrade on 27May2021. The outcome of the events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1421852 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100100886

Write-up: Anorexia; This regulatory authority case was reported by a physician and describes the occurrence of DECREASED APPETITE (Anorexia) in a 47-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced DECREASED APPETITE (Anorexia) (seriousness criterion death). The patient died on 28-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. This is a case of sudden death with unknown cause in a 47-year old female subject with reported unlisted event Anorexia, who died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death with unknown cause in a 47-year old female subject with reported unlisted event Anorexia, who died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1421853 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROCORTISONE; FLORINEF
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Addison''s disease; Adrenalectomy; Diabetes (medically induced); Hypertension; Pheochromocytoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021668350

Write-up: Asystolia; Cardiac arrhythmias got worse; Cardiac arrhythmias got worse; thrombi in the brain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority number is DK-DKMA-WBS-0067349 with Safety Report Unique Identifier DK-DKMA-ADR 25328534. A 70-year-old male patient received BNT162B2 (COMIRNATY), intramuscular on 14May2021 (Batch/Lot Number: EW6126; Expiration Date: Jul2021) as dose 2, single for COVID-19 immunisation. Patient''s medical history included pheochromocytoma which resulted in adrenalectomy in 2015 and as a consequence the patient is currently in substitution treatment for corticoadrenal insufficiency. Patient''s concurrent conditions included hypertension, medically induced diabetes and Addison''s disease. The patient is not known with previous cardiac disorders. There is no information regarding past medication. Concomitant medications included hydrocortisone for corticoadrenal insufficiency from 14Sep2014 to unspecified date and fludrocortisone acetate (FLORINEF) taken for Addison''s disease from 21Jul2012 to an unspecified date. Historical vaccine included BNT162B2 (COMIRNATY), intramuscular on 24Apr2021 (Batch/Lot Number: EX2405; Expiration Date: 31Aug2021) as dose 1, single for COVID-19 immunisation. On 17May2021, 3 days after the second vaccination, the patient developed asystolia and died. The patient died on 17May2021 and the reported cause of death was asystolia. The reporter was not the one to confirm the death. The patient was autopsied on 20May2021 with no signs of macroscopic thrombi. Significant autopsy findings are available without explanation of the death and the primary autopsy statement and the supplementary statement is awaited. Causality: The physician stated that the subacute infarctions found on MRI was compatible with the time of vaccination. He emphasized that all stroke patients should receive the second vaccination. Cardiac arrhythmias were already observed on 13May2021 based on the Holter monitoring, and after 14May2021 (the day of the 2nd vaccination) it got worse. The physician described that the death may be due to several scenarios. The vaccination can trigger arrhythmias that can lead to cardiac arrest. However, the physician cannot deny or confirm this. The frontal stroke cannot be the direct cause of death, since it was only a small thrombus in the brain, which would not be able to cause death. The physician think that the death is caused by the vaccination, but it may also have been the heart rhythm disturbances that led to thrombi in the brain. Autopsy was done. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Asystolia


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