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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

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VAERS ID: 1576860 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Condition aggravated, Death, Diarrhoea, Loss of consciousness, Rash
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (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), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   Days after onset: 34
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRMODERNATX, INC.MOD20212

Write-up: unconscious; condition got even worse at night; Death; Rash; Diarrhea with abdominal pain; Abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), LOSS OF CONSCIOUSNESS (unconscious), DIARRHOEA (Diarrhea with abdominal pain), ABDOMINAL PAIN (Abdominal pain), CONDITION AGGRAVATED (condition got even worse at night) and RASH (Rash) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DIARRHOEA (Diarrhea with abdominal pain) (seriousness criterion hospitalization) and ABDOMINAL PAIN (Abdominal pain) (seriousness criterion hospitalization). In July 2021, the patient experienced RASH (Rash) (seriousness criterion hospitalization). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (unconscious) (seriousness criteria hospitalization and medically significant) and CONDITION AGGRAVATED (condition got even worse at night) (seriousness criterion hospitalization). The patient died on 04-Aug-2021. The cause of death was not reported. An autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (unconscious), DIARRHOEA (Diarrhea with abdominal pain), ABDOMINAL PAIN (Abdominal pain), CONDITION AGGRAVATED (condition got even worse at night) and RASH (Rash) outcome was unknown. Concomitant product was not provided by the reporter. Lab data was not provided by the reporter. Treatment product was not provided y the reporter. Company Comment Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1576871 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-07-09
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2336 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Arthralgia, Arthritis, Cyanosis, Dyspnoea, Pulmonary embolism, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 16
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: Juvenile idiopathic arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVPFIZER INC202101010732

Write-up: Anxiety; Syncope; Cyanosis; Periodic shortness of breath, pronounced shortness of breath on 2021/07/25; Pulmonary thromboembolism; suspicion of arthritis flare; ankle arthralgia; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number LV-SAM-2021076347. This physician reported events for the same patient after 2 doses of the vaccine. This is the first of two reports for the second dose. Only this case is serious. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 15Jun2021 (Batch/Lot Number: FC2336) as 0.3ml, single dose for covid-19 immunisation. The patient''s medical history includes Juvenile idiopathic arthritis (seronegative juvenile idiopathic arthritis, start in 2006, rheumatologist last seen in 2013, On 09Jul2021 patient went to GP with complaint of ankle arthralgia. Due to suspicion of arthritis flare, patient sent for blood testing and consultation with a rheumatologist, which was not done). The patient''s concomitant medications were not reported. The patient received the 1st vaccination dose with Comirnaty (BioNTech, batch No. EW6126) 0,3 ml intramuscularly on 25May2021. After receiving the 1st vaccination dose on 25May2021 the patient experienced fatigue and body temperature increased (37.3 C). The events of fatigue and body temperature increased resolved after 2 days. The patient received the 2nd vaccination dose with Comirnaty (BioNTech, batch No. FC2336) 0,3 ml intramuscularly on 15Jun2021. The patient experienced no symptoms immediately after 2nd vaccination dose. On 09Jul2021 patient went to GP with complaint of ankle arthralgia. Due to suspicion of arthritis flare, patient sent for blood testing and consultation with a rheumatologist, which was not done. On 13Jul2021 (also reported on 15Jul2021) the patient started to experience periodic shortness of breath. On 25Jul2021 the patient experienced pronounced shortness of breath, cyanosis, anxiety, syncope. The emergency medical services were called at 12:00 and the patient was hospitalized at 13:02. On 25Jul2021 the patient was diagnosed with pulmonary thromboembolism. The outcome of the event pulmonary thromboembolism is fatal, the patient was pronounced dead on 25Jul2021 at 13:46. Autopsy is in progress. The outcome of other events was unknown.; Sender''s Comments: Linked Report(s) : LV-PFIZER INC-202101020906 same patient, different events after 1st/2nd dose; Reported Cause(s) of Death: Pulmonary thromboembolism


VAERS ID: 1576955 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003604 / 1 - / OT

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

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

Write-up: This case was received via Regulatory Authority (Reference number: 00646946) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003604) for COVID-19 vaccination. No Medical History information was reported. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 10-Jul-2021 The patient died on 10-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant products were not provided. Treatment medication were not reported. Company comment: This case refers to a 29-year-old male patient who died 4 days after receiving the dose 1 of mRNA-1273. Cause of death was not reported. Very limited information regarding the event has been provided at this time insufficient for causality assessment.; Sender''s Comments: This case refers to a 29-year-old male patient who died 4 days after receiving the dose 1 of mRNA-1273. Cause of death was not reported. Very limited information regarding the event has been provided at this time insufficient for causality assessment.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1576956 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-20
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101016141

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00650513. A 70-year-old male patient received 2nd dose of BNT162B2 (COMIRNATY, lot number FA8016) at single dose on 01Jun2021 via an unknown route for COVID-19 immunisation. Medical history and concomitant drug were not provided. Patient had no previous COVID-19 infection. Historical vaccine included 1st dose of BNT162B2 (COMIRNATY) at single dose on 27Apr2021 for COVID-19 immunisation. Serious adverse event was reported as fatigue, unclear: no obvious side effects reported beforehand with onset date of 20Jul2021 (also reported as 2 months after start) and seriousness criterion of death. Patient passed away on 20Jul2021 (also reported as 5 weeks after 2nd vaccination). No diagnostic procedures performed. The outcome of fatigue was fatal. It was unknown if autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: fatigue, unclear: no obvious side effects reported beforehand


VAERS ID: 1576957 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Blood pressure measurement, Blood test, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   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: HYDROCHLOORTHIAZIDE; LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal; Solitary kidney (donated a kidney 17 years ago)
Allergies:
Diagnostic Lab Data: Test Name: autopsy; Result Unstructured Data: Test Result:it could not be confirmed nor denied that she died; Comments: it could neither be confirmed nor denied that she died as a result of cardiac arrest. The brain was not examined. All other organs showed no evidence.; Test Date: 202104; Test Name: blood pressure; Result Unstructured Data: Test Result:was good; Test Date: 202104; Test Name: other blood results; Result Unstructured Data: Test Result:were good
CDC Split Type: NLPFIZER INC202101016145

Write-up: Death: Sudden death without awareness of underlying conditions/Cause could not be determined with certainty; This is a spontaneous report from a contactable consumer downloaded from the WEB, regulatory authority number NL-LRB-00650821. Safety Report Unique Identifier NL-LRB-00655495. A 70-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01May2021 (Lot Number: ET6956) as 0.3 mL single dose for covid-19 immunisation. Medical history included Solitary kidney: donated a kidney 17 years ago; Blood pressure abnormal. No Previous COVID-19 infection. Concomitant medications included hydrochlorothiazide and losartan for blood pressure. The patient experienced death: sudden death without awareness of underlying conditions on 03May2021. Cause could not be determined with certainty. Patient''s health prior to vaccination was good. She was working in her garden in the days before her death. A day before her death, reporter saw patient and she had no complaints/side effects. On the day of her death she took her car to a garage. Passing away. Diagnostic procedures: Autopsy excluding brain. 1. There were no complaints. The reporter saw and spoke to her on Sunday (02May). She was in normal shape. Monday morning, 03May, she brought her car to the garage. 2. No deterioration of health. The days before, the backyard was taken care of. She was still pulling conifers out of the garden herself. 3. Mother (patient) lived with her husband. There was no question of home care. 4. She was on blood pressure medication: Hydrochlorothiazide 12.5 and Losartankalium 50 mg. She had been for a check-up the week before her death (Apr2021) and at that time her blood pressure and other blood results were good. (She underwent this annual checkup because she donated a kidney 17 years ago). 5a. To present knowledge, it could not be confirmed nor denied that she died as a result of cardiac arrest. The brain was not examined. All other organs showed no evidence. 5b. That would follow as soon as the family doctor returns from vacation. They had not requested one yet. 6. No, she had no symptoms and so no test was taken. The outcome of sudden death was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death: sudden death without awareness of underlying conditions/Cause could not be determined with certainty.; Autopsy-determined Cause(s) of Death: To the best of knowledge it could not be confirmed nor denied that she died as a result of cardiac arrest.


VAERS ID: 1577034 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-26
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Chills, Decreased appetite, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre 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:
CDC Split Type: PHJNJFOC20210823970

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096825] concerned a 64 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A expiry: UNKNOWN) dose was not reported, 1 total administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUL-2021 at 10:00, the patient experienced fever, chills, body weakness and loss of appetite. On an unspecified date, the patient experienced covid-19. On an unspecified date, the patient died from fever, chills, weakness, appetite lost, and covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of body weakness and loss of appetite on an unspecified date. This report was serious (Death).; Sender''s Comments: V0: 20210823970-Covid-19 vaccine ad26.cov2.-Fever, chills, weakness, loss of appetite , and covid-19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FEVER; CHILLS; WEAKNESS; APPETITE LOST; COVID-19


VAERS ID: 1577039 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Chest pain, Dysphagia, Fatigue
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210824082

Write-up: CHEST PAIN; HYPERTENSION; DIFFICULTY OF SWALLOWING; FATIGUE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300096200] concerned a 59 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205C21A, expiry: unknown) dose was not reported, with frequency as 1 total administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021 at 04:00, the patient experienced chest pain, hypertension, difficulty of swallowing, fatigue and died. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210824082-covid-19 vaccine ad26.cov2.s -Chest pain, Hypertension, Difficulty of swallowing, fatigue. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FATIGUE; DIFFICULTY OF SWALLOWING; HYPERTENSION; CHEST PAIN


VAERS ID: 1577043 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21321A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210824177

Write-up: FATIGUE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA (PH-PHFDA-300097291)] concerned a 69 year old female of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 21321A, expiry: unknown) dose was not reported,1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, at 19:00 the patient experienced fatigue and was hospitalized on unknown date. On an unspecified date, the patient died from fatigue. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0.20210824177-covid-19 vaccine ad26.cov2.s -Fatigue. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: FATIGUE


VAERS ID: 1577047 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210824221

Write-up: ABDOMINAL PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096378] concerned a 77 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A and expiry: unknown) dose was not reported, frequency time 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021 at around 01:00 the patient experienced severe abdominal pain and at 01:15 the patient died from abdominal pain. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0; 20210824221-covid-19 vaccine ad26.cov2.s - Severe abdominal pain. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: ABDOMINAL PAIN


VAERS ID: 1577058 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210824371

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority (PHIFDA, PH-PHFDA-300096514) concerned an 80 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2. s (suspension for injection, intramuscular, batch number: 213C21A and expiry: unknown) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 02:00, the patient died from sudden attack of severe abdominal pain followed by loss of consciousness. It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2. s was not applicable. This report was serious (Death).; Sender''s Comments: V0- 20210824371-Covid-19 vaccine ad26.cov2.S- Abdominal pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: ABDOMINAL PAIN


VAERS ID: 1577079 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-28
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 20SC21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210824619

Write-up: SHORTNESS OF BREATH; FEVER; COUGH; NAUSEA; VOMITING; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095692] concerned a 36 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 20SC21A) dose was not reported, 1 total, administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, at 08:00, the patient experienced shortness of breath, fever, cough, nausea and vomiting. On an unspecified date, the patient died from shortness of breath, fever, cough, nausea and vomiting. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of shortness of breath, fever, cough, nausea and vomiting on an unspecified date. This report was serious (Death).; Sender''s Comments: V0: 20210824619-covid-19 vaccine ad26.cov2.s-shortness of breath, fever, cough, nausea and vomiting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COUGH; NAUSEA; VOMITING; FEVER; SHORTNESS OF BREATH


VAERS ID: 1577081 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213021A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210824684

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096036] concerned a 62 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213021A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 09:30, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210824684-Covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1577084 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210824738

Write-up: cough, loss of appetite, blood clot; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300097326] concerned a 69 year old male. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021 at 05:00, the patient experienced cough, loss of appetite, blood clot. On an unspecified date, the patient died from cough, loss of appetite, blood clot. It was unspecified if an autopsy was performed The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210824738-Covid-19 vaccine ad26.cov2.- Cough, loss of appetite, blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COUGH, LOSS OF APPETITE, BLOOD CLOT


VAERS ID: 1577101 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210824935

Write-up: FATIGUE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300097893] concerned an 81 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A,expiry: unknown) dose was not reported,1 total, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient experienced fatigue. On 2021, the patient died from fatigue. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0 20210824935-covid-19 vaccine ad26.cov2.s-Fatigue. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FATIGUE


VAERS ID: 1577105 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C214 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chest pain, Cough, Dyspnoea, Malaise, Oxygen saturation, Oxygen saturation decreased, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: Oxygen saturation; Result Unstructured Data: 63 %, low
CDC Split Type: PHJNJFOC20210824989

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA: PH-PHFDA-300097671] concerned a 63 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C214, and expiry: UNKNOWN) dose was not reported,1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, at 07:19, the patient experienced fever and body weakness (General malaise). On 04-AUG-2021, at 7:00, the patient experienced cough, chest pain and laboratory data Included oxygen saturation of 63 percent (low) and at 7:19, the patient experienced body weakness (weakness). On 05-AUG-2021, at 07:19, the patient experienced difficulty of breathing. On an unspecified date, the patient was hospitalized due to cough, chest pain, difficulty of breathing, body weakness (weakness) and oxygen saturation of 63 percent. On an unspecified date, the patient died from fever, cough, difficulty of breathing, body weakness (weakness), chest pain, 63 percent oxygen saturation, and body weakness (General malaise). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210824989-covid-19 vaccine ad26.cov2.s-fever, cough, difficulty of breathing, body weakness, chest pain, 63 percent oxygen saturation, and body weakness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FEVER; COUGH; DIFFICULTY OF BREATHING; BODY WEAKNESS; CHEST PAIN; 63% OXYGEN SATURATION; BODY WEAKNESS


VAERS ID: 1577110 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Pyrexia, Vaccination site pain
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: 2021-08-02
   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: Alcohol use (Someone saw him drinking liquor in the morning.)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210825036

Write-up: FEVER; CHILLS; PAIN ON INJECTION SITE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300097063] concerned a 95-year-old male of an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient''s concurrent conditions included: alcohol user (Someone saw him drinking liquor in the morning). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, frequency time was 1 total administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 31-JUL-2021, the patient experienced fever, chills and pain on injection site and treatment medication Included he took paracetamol 500 milligram. On 02-AUG-2021, the patient died from fever, chills and pain on injection site at around 3-4 AM, patient was found dead on his bed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of fever, chills and pain on injection site on 02-AUG-2021. This report was serious (Death).; Sender''s Comments: V0 20210825036-COVID-19 VACCINE AD26.COV2.S-fever, chills, pain on injection site. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FEVER; CHILLS; PAIN ON INJECTION SITE


VAERS ID: 1577146 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chest pain, Cough, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 antigen test; Result Unstructured Data: Positive
CDC Split Type: PHJNJFOC20210826579

Write-up: EPIGASTRIC PAIN; CHEST PAIN; COUGH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA,PH-PHFDA-300097363] concerned a 60 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212C21A, expiry: unknown) dose was not reported, one total, administered on 22-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced cough. On 05-AUG-2021, the patient experienced epigastric pain and chest pain. Laboratory data (dates unspecified) included: COVID-19 antigen test (NR: not provided) Positive. On an unspecified date, the patient died from cough, epigastric pain, and chest pain. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0 20210826579-COVID-19 VACCINE AD26.COV2.S-cough, epigastric pain, chest pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COUGH; EPIGASTRIC PAIN; CHEST PAIN


VAERS ID: 1577149 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101002325

Write-up: allegedly died due to complications; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included unspecified cardiac condition. The patient''s concomitant medications were not reported. The patient allegedly died due to complications on an unspecified date. It was unknown if an autopsy was performed. The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: allegedly died due to complications


VAERS ID: 1577169 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Dyspnoea, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 23
Permanent Disability? 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: 20210410; Test Name: Body temperature; Result Unstructured Data: Test Result:39.0-39.4; Test Date: 202104; Test Name: SARS-CoV-2 RT-PCR test; Test Result: Positive
CDC Split Type: PLPFIZER INC202101010736

Write-up: Fever; Dyspnea; Sars-Cov-2 Rt-PCR test was performed - positive; This is a spontaneous report received from a contactable physician downloaded from the WEB. The regulatory authority report number is PL-URPL-3-833-2021. A 54-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 10Apr2021 10:54 (Lot Number: EW2243; Expiration Date: 11Apr2021) (at age of 54-year-old) as dose 1, 0.3 mL, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Date of the reaction 10Apr2021 at 17:10. On the report of adverse reaction after vaccination, the following was noted: fever 39.0-39.4. After vaccination on 10Apr2021 fever and shortness of breath occurred. The patients condition worsened, and the Sars-Cov-2 Rt-PCR test was performed - positive. On 24Apr2021 the patient died. Therefore, the infection with COVID-19 immediately after the administration of the 1st dose, the infection could have started even before vaccination. The disease occurred in the time coincidence until vaccination. The person reporting adverse event following immunisation qualified it as serious. Agency for Registration of Medicinal Products assessed the adverse events following immunisation as serious (death). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Fever; Dyspnea; COVID-19


VAERS ID: 1577170 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC 1433 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse; Alcoholic seizure (The patient was not treated systematically for the disease.); Gastroesophageal reflux (The patient was not treated systematically for the disease.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202101010870

Write-up: patient was found dead in his house, laying naked on the floor; vomit; This is a spontaneous report received from a contactable physician downloaded from the Agency WEB. The regulatory authority report number is PL-URPL-3-835-2021. A 59-year-old male patient received second dose of BNT162B2 (COMIRNATY), via intramuscular, administered in left arm on 14Jul2021 14:19 (Lot Number: FC 1433; Expiration Date: 07Aug2021, at the age of 59-year-old ) as single dose for covid-19 immunisation. Medical history included alcohol-induced epilepsy (alcohol abuse) and gastric reflux disease. The patient was not treated systematically for the disease. The patient''s concomitant medications were not reported. On 15Jul2021 at 11:15 a post-vaccination reaction occurred. Patient was found dead in his house, laying naked on the floor in his own vomit. On 16Jul2021, the patient''s general practitioner (GP) was interviewed, and the following information was obtained: the patient suffered from alcohol-induced epilepsy (alcohol abuse) and gastric reflux disease. The patient was not treated systematically for the diseases mentioned. He was found in his own house naked on the floor in his own vomit. The called doctor declared death. The prosecutor present at the inspection did not order an autopsy. The outcome of the event "patient was found dead in his house, laying naked on the floor" was fatal, for event vomit was unknown. The patient died on 15Jul2021. An autopsy was not performed. The reporting person classified them as serious. Health Agency also classified the application as serious. Sender comment: Comirnaty are an mRNA vaccine against COVID-19 (with modified nucleosides). Vomiting was an expected side effect of Comirnaty. There was a time relationship between the administration of the vaccine and the occurrence of the reaction. However, due to the information about alcohol abuse by the patient and the lack of information about alcohol consumption (or not) after administration of the vaccine, the causal relationship has not been assessed. Relatedness of drug to event: vomiting, Result of Assessment: unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: patient was found dead in his house, laying naked on the floor


VAERS ID: 1577274 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial ischaemia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Other ischaemic heart disease (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: Bladder neoplasm; Coronary artery stenosis (constricted coronary arteries); Ischemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarct
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100996719

Write-up: Ischemic heart disease; Fever; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number SE-MPA-2021-061580. An 87-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on May2021 (Batch/Lot Number: EY2172) at the age of 87 years old, as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included ongoing ischemic heart disease, ongoing coronary artery stenosis (constricted coronary arteries), ongoing tumor of the bladder, myocardial infarction from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Historical vaccination included first dose of bnt162b2 (COMIRNATY) given on Mar2021 (batch# EY2172) for COVID-19 immunisation. Reported suspected adverse event was fatal ischemic heart disease in May2021, the same day as vaccination. The patient also had fever on May2021. The patient died on an unspecified date. An autopsy was performed, and results were not provided. The description includes information that allergy runs in the family on the man''s side, but not to what, nor whether the man himself had reacted to anything in the past. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Fever; Ischemic heart disease


VAERS ID: 1577311 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-05-01
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Sexual dysfunction (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101010759

Write-up: major brain haemorrhage; NUMBNESS IN HALF OF THE BODY; This is a spontaneous report from a contactable consumer downloaded from the WEB, regulatory authority number SE-MPA-2021-066026. A 69-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 19Apr2021 as single dose for COVID-19 immunizaiton. Medical history and concomitant medication were not reported. The patient was previously healthy. In May2021, two weeks after the first shot, the patient experienced numbness in one side of her body, went to the emergency room but this was dismissed as an adverse reaction to the vaccine and she was allowed to go home. Just over a week later the same numbness returned again and the woman took public transport to hospital and on the way she suffered a major brain haemorrhage and died a few hours later in hospital. The cause of death was cerebral bleeding. Autopsy was not reported. The outcome of events was fatal. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cerebral bleeding


VAERS ID: 1577326 (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: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101016256

Write-up: Malignant arrhythmia; This is a spontaneous report received from a contactable Physician downloaded from the WEB. The regulatory authority report number is SE-MPA-2021-069964. A 61-years-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular in May2021 (Lot Number: EX8680) as 0.3 ml single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatal malignant arrhythmia 4 days later in May2021. The patient died in May2021. An autopsy was performed that revealed mild arteriosclerosis but no signs of bleeding or thrombosis. The only real findings are enlarged heart and bilateral pulmonary edema as signs of acute circulatory disturbance. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: malignant arrhythmia; Autopsy-determined Cause(s) of Death: Mild arteriosclerosis


VAERS ID: 1577337 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure increased, Diarrhoea, Fatigue, Thrombosis
SMQs:, Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101026225

Write-up: Blood clot; lack of energy; tired; diarrhea; high blood pressure; This is a spontaneous report from a contactable consumer. An 83-years-old female patient (mother) received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date in Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 for COVID-19 immunisation. The patient experienced blood clot (death, hospitalization) on an unspecified date in 2021, lack of energy on an unspecified date in 2021 with outcome of unknown, tired on an unspecified date in 2021 with outcome of unknown, diarrhea on an unspecified date in 2021 with outcome of unknown, high blood pressure on an unspecified date in 2021 with outcome of unknown. Clinical course reported as follow: Patient got both doses and died of a blood clot the 06Jun2021. The reporter thought patient got the second dose in April. After that she felt tired some days. She had even told acquaintances that she had diarrhoea. She had a little high blood pressure and the reporter picked up her medication during these times. The blood clot that was building in her stomach have not just happened over one night. She was admitted to hospital on the 26May2021. The bowel had not gotten oxygen and when they investigated her after they said that she should have needed to operate away parts of the bowel. The patient died on 06Jun2021. It was not reported if an autopsy was performed. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Blood clot


VAERS ID: 1577683 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-03-19
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Sars-cov-2 test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101016139

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-39205. A 95 Years old Female patient received BNT162B2 (COMIRNATY), 1st dose on 08Jan2021 (batch/lot number EJ6796, expiration date 30Apr2021); 2nd dose on 29Jan2021 (batch/lot number EJ6134, expiration date 30Apr2021) at single dose for COVID-19 immunisation. No relevant medical history reported. No concomitant medication reported. On 19Mar2021 the patient experienced Vaccination failure, other, SARS-CoV-2 infection. The patient''s outcome was fatal. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6796. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6134. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1577684 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-05-11
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016114

Write-up: Vaccination failure, other, SARS-CoV-2 infection; Vaccination failure, other, SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-39261. A 93-year-old male patient received BNT162B2 (COMIRNATY), 1st dose on 01Apr2021(lot number ET7205, expiration date 31Jul2021), 2nd dose on 22Apr2021 (lot number EW4815, expiration date 31Jul2021), both at single dose for COVID-19 immunisation. Medical history and concomitant drug were not provided. Serious adverse event was reported as Vaccination failure, other, SARS-CoV-2 infection with onset date of 11May2021 and seriousness criterion of death. Outcome of SARS-CoV-2 infection was fatal. Quality investigation conclusion for lot ET7205: The complaint for adverse event/LOE of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ET7205. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Quality investigation conclusion for lot EW4815: The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EW4815. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Vaccination failure, other, SARS-CoV-2 infection; Vaccination failure, other, SARS-CoV-2 infection


VAERS ID: 1577685 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drowning, Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Accidents and injuries (narrow), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016215

Write-up: Epeleptic seizures every 2-3 days; Drowned in pool due to epileptic seizure; Drowned in pool due to epileptic seizure; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39286. A 56-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced drowned in pool due to epileptic seizure on Jul2021, epeleptic seizures every 2-3 days on 14Jul2021 with outcome of not recovered. Patient drowned in pool due to epileptic seizure. The patient died on Jul2021. It was not reported if an autopsy was performed. Sender''s comments: BASGAGES-comment: Follow-up information has been requested. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Drowned in pool due to epileptic seizure; Drowned in pool due to epileptic seizure


VAERS ID: 1577731 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101022719

Write-up: Cerebrovascular accident; This is a Spontaneous report from a contactable Consumer Or Other Non Health Professional. This is a report received from the Regulatory Authority via an on-line database search. Regulatory authority report number 000944395. This information was initially reported to Regulatory Authority on 02Apr2021 from the community. A female patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN which was reported as COVID-19 VACCINE), via unknown route 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 cerebrovascular accident (death) on an unspecified date 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: Cerebrovascular accident


VAERS ID: 1577732 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyslexia, Intellectual disability, Interchange of vaccine products, Mental disorder, Myocardial infarction, Neoplasm malignant, Off label use, Retinal degeneration, Retinal detachment, Retinal tear
SMQs:, Myocardial infarction (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (broad), Retinal disorders (narrow), Medication errors (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ECT (Duration of Hospitalization: 4. Hospitalization prolonged: yes. Treatment Received: unknown.); Meningitis meningococcal (Hospitalization Prolonged: Yes. Treatment received: No.); Mental disorder NOS (diagnostic and statistical manual of mental disorders)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101029604

Write-up: heart attack; retina tear; retina detachment; all dsm 5; retardation; cancer; retina thinning; dyslexia; Interchange of vaccine products; Interchange of vaccine products; This is a spontaneous report received from contactable consumers (patient''s parents) 29-year-old contactable male (patient) regarding Pfizer product Pfizer-BioNTech COVID-19 vaccine (BNT162b2) the following was reported. A 29-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 01May2021 (Batch/Lot Number: Unknown) as DOSE 2 (INITIAL PFIZER DOSE), SINGLE for covid-19 immunization, at the age at vaccination of 29 years. Medical history included ECT (electroconvulsive therapy) from 10Mar2020 (Duration of Hospitalization: 4. Hospitalization prolonged: yes. Treatment Received: unknown), Meningitis acwy from May2018 (Hospitalization Prolonged: Yes. Treatment received: No), whole dsm5 (diagnostic and statistical manual of mental disorders). The patient''s concomitant medications were not reported. Historical vaccine included first dose of Moderna (Batch/Lot number: not available) on May2021 (also reported as 31Jul2021, pending confirm). The patient experienced retina tear- retina detachment-heart attack-all dsm (diagnostic and statistical manual of mental disorders) 5-dyslexia-retardation-cancer-retina thinning, all on unknown date. Treatment received was unknown. The event heart attack with seriousness criteria of death, hospitalization, medically significant with fatal outcome, other events with seriousness criteria of medically significant with outcome of unknown. The adverse events result in: Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient also experienced interchange of vaccine products on an unspecified date with outcome of unknown. The patient died on 10Aug2021. It was not reported if an autopsy was performed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, unknown if the patient been tested for COVID-19. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: DEATH


VAERS ID: 1577783 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-17
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemoglobin, Leukopenia, Sepsis
SMQs:, Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 21
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: [IRON]
Current Illness: Hypothyreosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Haemoglobin; Result Unstructured Data: low
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Sepsis; This regulatory authority case was reported by a physician and describes the occurrence of SEPSIS (Sepsis) and LEUKOPENIA in a 79-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3001941) for COVID-19 vaccination. Concurrent medical conditions included Hypothyreosis. Concomitant products included [IRON] for Haemoglobinaemia. On 27-May-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 200 microgram. On 17-Jun-2021, the patient experienced SEPSIS (Sepsis) (seriousness criteria death, hospitalization and medically significant) and LEUKOPENIA (seriousness criteria death, hospitalization and medically significant). The patient died on 08-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Haemoglobin: 11.2 (Low) low. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered SEPSIS (Sepsis) and LEUKOPENIA to be possibly related. No treatment medication information was mentioned by reporter Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per overall case assessment by Authority. Low hemoglobin not captured as a separate event as it can be a symptom associated with sepsis and / or leukopenia; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per overall case assessment by Authority. Low hemoglobin not captured as a separate event as it can be a symptom associated with sepsis and / or leukopenia; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1577801 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   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: INVEGA SUSTENNA
Current Illness: Schizophrenia
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: COJNJFOC20210828762

Write-up: DEATH; This spontaneous report received from a health care professional concerned a 28 year old male. The patient''s weight was not reported and height was 144 centimeters. The patient''s concurrent conditions included: schizophrenia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 31-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included paliperidone palmitate for schizophrenia. On 07-AUG-2021, the patient died due to unknown cause. The patient was found with the top part (head) of the body on the bed and the lower part (the feet) towards the floor, the face looked like as patient was sleeping. There was nothing strange no sign of vomiting, no saliva and nor blood. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to unknown cause on 07-AUG-2021. This report was serious (Death).; Sender''s Comments: V0: 20210828762-COVID-19 VACCINE AD26.COV2.S-Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1577811 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987730

Write-up: Death; collapse; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company number DE-DCGMA-21189191, Safety Report Unique Identifier DE-PEI-202100089163. A 78-year-old male patient received (age at vaccination: 78-year-old) bnt162b2 (COMIRNATY also reported as mRNA TOZINAMERAN, lot ER9480), intramuscular on 07Apr2021 at unknown dose, 0.3ml single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on 07Apr2021. An autopsy was performed and results were not provided. The outcome of collapse was unknown. Reporter''s comments: 15 minutes after receiving the vaccine dose, the person collapsed requiring resuscitation. Event assessment : Comirnaty/ all events/PEI /Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reporter''s Comments: 15 minutes after receiving the vaccine dose, the person collapsed requiring resuscitation.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1577812 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-07
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987553

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB [DE-DCGMA-21189208], Safety Report Unique Identifier [DE-PEI-202100088783]. An 81-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3ml, Lot number was unknown), intramuscular on 30Mar2021 (at the age of 81-year-old) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 07Apr2021 the patient experienced death. Cause of death was unknown. The patient died on 07Apr2021. It was unknown if an autopsy was performed. The casual relationship of Comirnaty and death assessed as Unclassifiable by the Regulatory Authority. Reporter comment: =adverse drug reaction: Unexplained cause of death, Unknown. No follow-up attempts are possible; information on batch/lot number cannot be obtained. No further information is expected. Reporter''s Comments: Unexplained cause of death, Reported Cause(s) of Death: death.


VAERS ID: 1577813 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-03-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Dyspnoea, Restlessness
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Diabetic foot (Diabetic foot with toe inflammation); Hypertension; Inflammation.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987574

Write-up: Restlessness; Drop of blood pressure; Dyspnoea; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, DCGMA number DE-DCGMA-21189294. This report was forwarded via the Regulatory Authority number DE-PEI-202100097884. An 87-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 28Mar2021 (Lot Number: ER7812), at the age of 87-years-old, as dose 2, 0.3 ml, single for Prophylactic vaccination. Medical history included diabetic foot with toe inflammation, diabetes mellitus and hypertension, all from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included insulin taken for diabetes mellitus, start and stop date were not reported, drug for hypertension tablets 1-0-1 and antibiotics tablets 250mg 1-0-1 for 1 week against inflammation of the foot. The patient previously took first dose of bnt162b2 (COMIRNATY) on 07Mar2021 for COVID-19 vaccination. On 29Mar2021 the patient experienced Drop of blood pressure, dyspnoea and restlessness. This report is serious - death, hospitalization. The patient died on 01Apr2021. It was not reported if an autopsy was performed. Reporter''s comment: AEs: After 2nd vaccination 28Mar2021 dyspnoea, drop in blood pressure, restlessness. Hospitalization was carried out by ambulance. Died in hospital on 01Apr2021. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: AEs: After 2nd vaccination 28Mar2021 dyspnoea, drop in blood pressure, restlessness. Hospitalization was carried out by ambulance. Died in hospital on 01Apr2021.; Reported Cause(s) of Death: Drop of blood pressure; Dyspnoea; Restlessness


VAERS ID: 1577814 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   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: Adiposis; COPD; Hypertension; Sleep apnea syndrome (SAS).
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s encephalopathy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987661

Write-up: Death; This is as spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-DCGMA-21189296, Safety report unique identifier DE-PEI-202100095044. A 57-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 25Mar2021 (Batch/Lot Number: Unknown) (at age 57-years-old) as dose 2, single for covid-19 immunisation. Medical history included ongoing adiposis, ongoing sleep apnoea syndrome SAS, Hasimoto''s encephalopathy from Apr2020 to an unknown date, ongoing chronic obstructive pulmonary disease, and ongoing hypertension. The patient''s concomitant medications were not reported. On 26Mar2021, the patient experienced death. It was not reported if an autopsy was performed. Relatedness of drug to event: Source of assessment: Result of Assessment: D. Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death.


VAERS ID: 1577815 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-27
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET 3045 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (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: PANTOPRAZOL [PANTOPRAZOLE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastritis; Gastrooesophageal reflux disease; Hypermenorrhoea.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987562

Write-up: Death sudden; Especially fulminant pulmonary embolism; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-DCGMA-21189832. Safety Report Unique Identifier DE-PEI-202100083016. This report was forwarded via Regulatory authority. A 53-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on an unspecified date (Lot Number: ET 3045; at the age of 53-years (as reported)) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for COVID-19 immunisation. Medical history included gastritis, gastrooesophageal reflux disease, and hypermenorrhoea all from an unknown date and unknown if ongoing. Concomitant medication included (PANTOPRAZOL [PANTOPRAZOLE]) taken for gastritis. On 27Apr2021, the patient experienced especially fulminant pulmonary embolism, death sudden. Therapeutic measures were taken as the result of the events which included unsuccessful resuscitation. The outcome of the events was fatal. The patient died on 27Apr2021. An autopsy was not performed. Reporter''s comment: Measures: unsuccessful resuscitation. On 05May2021, it was reported that an autopsy was not carried out. There is no further information about the circumstances of death. Event assessment: / Comirnaty / All Events / Unclassifiable No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Measures: unsuccessful resuscitation. On 05May2021, it was reported that an autopsy was not carried out. There is no further information about the circumstances of death.; Reported Cause(s) of Death: Death sudden; Especially fulminant pulmonary embolism.


VAERS ID: 1577816 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatitis C
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987708

Write-up: Slight chills in the evening; This is a spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority (Regulatory Authority report number: number DE-DCGMA-21190050). A 74-year-old male patient received BNT162B2 (COMIRNATY, Lot Number: EX3599; Expiration date was not reported), intramuscular on 28Apr2021 as dose number unknown, 0.3 ml single, for COVID-19 immunization. Medical history included hepatitis C (not ongoing). The patient''s concomitant medications were not reported. On 29Apr2021, the patient had slight chills in the evening. The patient had died on 29Apr2021 due the slight chills. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Slight chills in the evening


VAERS ID: 1577817 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-19
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Base excess, Blood bicarbonate, Blood gases, Electrocardiogram, Fall, Heart rate, Hypotension, Oxygen saturation, PCO2, PO2, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPIN [AMLODIPINE]; TAMSULOSIN; ASS; CANDESARTAN; METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Exsiccosis; Hepatic steatosis; Hyponatraemia; Ileus of intestine (Colon ileus); Intestinal resection (Sigma resection); Prostatic hyperplasia; Sigmoid diverticulitis; Splenectomy.
Allergies:
Diagnostic Lab Data: Test Name: Base excess; Result Unstructured Data: Test Result:6.3 mmol/L; Test Name: H2CO3; Test Result: 20 mmol; Test Name: Arterial Blood Gas; Result Unstructured Data: Test Result:7.39 pH units; Test Name: ECG; Result Unstructured Data: Test Result: continuous SR with preserved circadian rhythm; Comments: sporadic (less than 1%) monomorphic premature ventricular contractions, once as a burst over 4 beats, No bradycardia, tachycardia, or pauses; Test Name: Heart rate; Result Unstructured Data: Test Result:76 (63-117) / min; Test Name: Oxygen saturation; Test Result: 81.4 %; Test Name: pCO2; Result Unstructured Data: Test Result:4.1; Comments: kPa; Test Name: pO2; Result Unstructured Data: Test Result:6.2; Comments: kPa.
CDC Split Type: DEPFIZER INC202100987635

Write-up: Syncope; Hypotension; Fall; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB (Regulatory authority report number is DE-DCGMA-21190275, Safety Report Unique Identifier DE-PEI-202100079887). A 68-year-old male patient received BNT162B2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot Number: Unknown) as dose number unknown, 0.3 mL, single for COVID-19 immunisation. Medical history included intestinal resection (Sigma resection) from an unknown date which was not ongoing; exsiccosis, hyponatraemia, arterial hypertension, hepatic steatosis, splenectomy, ileus of intestine, sigmoid diverticulitis, prostatic hyperplasia; all from an unknown date and unknown if ongoing. Concomitant medications included amlodipin [amlodipine] (AMLODIPIN [AMLODIPINE]) taken for hypertension, tamsulosin taken for benign prostatic hyperplasia, acetylsalicylic acid (ASS) taken for an unspecified indication, candesartan taken for hypertension, and metoprolol taken for hypertension, all start and stop date were not reported. The patient''s weight was 95 kg, and height was 180 cm. On 19May2021, the patient experienced syncope, hypotension and fall. The patient underwent lab tests and procedures on unspecified date which included base excess (BE): 6.3 mmol/l, H2CO3 (blood bicarbonate): 20 mmol, arterial blood gas (BGA): 7.39 pH units, electrocardiogram (ECG): continuous SR with preserved circadian rhythm, sporadic (less than 1%) monomorphic premature ventricular contractions, once as a burst over 4 beats, No bradycardia, tachycardia, or pauses, heart rate: 76 (63-117)/min, oxygen saturation (sO2): 81.4 %, pCO2: 4.1 kPa, pO2: 6.2 kPa. Therapeutic measures were taken as a result of syncope, hypotension, fall. This report was serious due to death, unknown cause of death. The outcome of the events was fatal. The patient died on an unspecified date. An autopsy was not performed. Reporter comment: Syncope clarification according to standard operating procedures Patient found in hospital with no signs of life, immediate reanimation according to Hospital Council guidelines and the hospitals standard operating procedures. It is not clear whether she only had her first vaccination or the second one. An upper inflow congestion during reanimation and subsequent autopsy was prominent. Event assessment between Comirnaty and all events was unclassifiable. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reporter''s Comments: Syncope clarification according to standard operating procedures Patient found in hospital with no signs of life, immediate reanimation according to Hospital Council guidelines and the hospitals standard operating procedures. It is not clear whether she only had her first vaccination or the second one. An upper inflow congestion during reanimation and subsequent autopsy was prominent.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 1577818 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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: Rheumatism
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987536

Write-up: Death; This is a spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority-WEB DCGMA number DE-DCGMA-21190822. This report was forwarded via the Regulatory Authority Safety Report Unique Identifier DE-PEI-202100105386. A 77-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on an unspecified date (Batch/Lot Number: Unknown) as single dose (at the age of 77-years-old) for COVID-19 immunization. Medical history included rheumatism from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced death on 02Jun2021. The patient died on 02Jun2021. It was not reported if an autopsy was performed. This report is serious - death. "Summary (full translation available upon request)". Reporter comment: The patient was found dead in bed in the emergency medical service. The day before, the second vaccination took place. Next to the bed was a bucket filled with water and on the bedside cabinet was a pack of Diclofenac 25mg, from which 1 tablet was missing. Only slight rheumatism was known from previous illnesses, no medication. Relatedness of drug to reaction/event: Source of assessment: Result of Assessment D. Unclassifiable Relatedness of drug to reaction/event: Source of assessment: Method of Assessment Regulatory Authority No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: The patient was found dead in bed in the emergency medical service. The day before, the second vaccination took place. Next to the bed was a bucket filled with water and on the bedside cabinet was a pack of Diclofenac 25mg, from which 1 tablet was missing. Only slight rheumatism was known from previous illnesses, no medication.; Reported Cause(s) of Death: Death.


VAERS ID: 1577819 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Head injury, Headache
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carcinoma liver; Hepatic cirrhosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987715

Write-up: Unknown cause of death; Pain head; Head injury; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-DCGMA-21190875. An 81-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 14Apr2021 (at the age of 81 years old) (Lot number was not reported) as dose number unknown, 0.3 ml single for COVID-19 immunisation. Medical history included hepatic cirrhosis and carcinoma liver; both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 16Apr2021 the patient experienced head injury, pain head and death (unknown cause of death). The patient''s outcome was fatal for all events. The patient died on 16Apr2021. An autopsy was performed and results were not provided. No follow-up attempts are possible. Information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death; Pain head; Head injury


VAERS ID: 1577820 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D018A / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN [METFORMIN HYDROCHLORIDE]; METOPROLOL; EXFORGE HCT; ALLOPURINOL; RIVAROXABAN; PANTOPRAZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; INEGY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis; Arterial hypertension; Atrial fibrillation; Carotid artery occlusion; Chronic kidney disease stage 2; COPD; Fatty liver; GERD; Hypertensive renal disease; Hyperuricaemia; Left ventricular failure; Lipid metabolism disorder NOS; Penile malignant neoplasm; Single vessel disease (Coronary artery disease); Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987731

Write-up: sudden collapse; Cyanosis; This is as spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority. Report number DE-DCGMA-21191052 with safety report unique identifier DE-PEI-202100112858. A 76-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 09Jun2021 (Batch/Lot Number: 1D018A) (at the age of 76 years old) as dose number unknown, single for COVID-19 immunisation. Medical history included single vessel disease (coronary artery disease), type 2 diabetes mellitus, arterial hypertension, hyperuricemia, atrial fibrillation, aortic valve stenosis, chronic kidney disease stage 2, penile malignant neoplasm, gastroesophageal reflux disease (GERD), lipid metabolism disorder NOS, carotid artery occlusion, left ventricular failure, chronic obstructive pulmonary disease (COPD), fatty liver and hypertensive renal disease, all unknown if ongoing. Concomitant medications included metformin hydrochloride (METFORMIN [METFORMIN HYDROCHLORIDE]) taken for type 2 diabetes mellitus, start and stop date were not reported; metoprolol taken for coronary artery disease, start and stop date were not reported; amlodipine besilate, hydrochlorothiazide, valsartan (EXFORGE HCT) taken for arterial hypertension, start and stop date were not reported; allopurinol taken for hyperuricaemia, start and stop date were not reported; rivaroxaban taken for atrial fibrillation, start and stop date were not reported; pantoprazole sodium sesquihydrate (PANTOPRAZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) taken for gastroesophageal reflux disease, start and stop date were not reported; and ezetimibe, simvastatin (INEGY) taken for lipid metabolism disorder NOS, start and stop date were not reported. The patient experienced sudden collapse (Collapse circulatory) and cyanosis on 10Jun2021. Admission to emergency room by ambulance, cardiopulmonary resuscitation. This report is serious - death, hospitalization. The patient died on an unspecified date. It was not reported if an autopsy was performed. Relatedness assessment (both events): D. Unclassifiable. Source of assessment: Regulatory Authority . Reporter''s comment: lethal outcome of unexplained cause; admission to emergency room by ambulance, cardiopulmonary resuscitation. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: lethal outcome of unexplained cause; admission to emergency room by ambulance, cardiopulmonary resuscitation; Reported Cause(s) of Death: Collapse circulatory; Cyanosis


VAERS ID: 1577821 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-04
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse; Arterial hypertension; Depression; Lumbar spine degeneration
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987722

Write-up: Lung embolism; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company report number DE-DCGMA-21191064. Additional case identifier includes DE-PEI-202100112859. A 70-year-old male patient received bnt162b2 (COMIRNATY), (strength: 0.3 mL), intramuscular on 16Jul2021 (Batch/Lot Number: Unknown), at the age of 70 years old, as 0.3 mL, single dose for COVID-19 immunisation. The patient''s medical history included depression unknown if ongoing, alcohol abuse (not ongoing), arterial hypertension unknown if ongoing and lumbar spine degeneration unknown if ongoing. Concomitant medications were not reported. The patient received the first dose of COMIRNATY on 07Apr2021 at 0.3 ml for COVID-19 immunization. On 04Jun2021, the patient experienced lung embolism. The event was considered serious requiring hospitalization, life-threatening and resulted in death according to the regulatory authority. Outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1577822 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Coronary disease; Myocardial infarction; Peripheral arterial occlusive disease; Type 1 diabetes mellitus.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987726

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DCGMA, company number DE-DCGMA-21191121. This report was forwarded via the regulatory authority, however no RA number was provided. A 69-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 10May2021 at 69-year-old (Batch/Lot Number: Unknown) as DOSE 2, 0.3ML SINGLE for covid-19 immunization. Medical history included Coronary disease from an unknown date and unknown if ongoing, Type 1 diabetes mellitus from an unknown date and unknown if ongoing , Peripheral arterial occlusive disease from an unknown date and unknown if ongoing, Myocardial infarction from an unknown date to unknown date, Atrial fibrillation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient took first dose of bnt162b2 (COMIRNATY), on 19Apr2021 at 69-year-old as dose 1, 0.3ml single for covid-19 immunization. The patient experienced death on 11May2021. The patient died on 11May2021. It was not reported if an autopsy was performed. This report is serious - death. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1577823 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-06
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cardiac failure chronic; Chronic renal insufficiency; Coronary artery disease; Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987530

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company number DE-DCGMA-21191248. An 81-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot Number: EX3599), at the age of 81 years old, as 0.3 ml single for covid-19 immunisation. Medical history included coronary artery disease, diabetes mellitus, arterial hypertension, cardiac failure chronic, chronic kidney disease, all from unspecified date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced death on 06May2021. Unknown cause of death. Autopsy was not performed. The patient''s outcome was fatal for death. Relatedness of drug to reaction death was Inconsistent causal association to immunization. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1577824 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration
SMQs:, Medication errors (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: Hypercholesterolaemia; Hypertension (Mild Hypertension)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987725

Write-up: Death/Unknown cause of death; 1st dose 01Apr2021, 2nd dose 13May2021; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company number DE-DCGMA-21191317. This report was forwarded via Regulatory Authority, however no regulatory authority number was provided. An 82-year-old male patient received bnt162b2 (COMIRNATY, lot number was not reported), via an unspecified route of administration on 13May2021 as dose 2, 0.3 mL single for covid-19 immunization. Medical history included ongoing hypercholesterolaemia and ongoing hypertension (mild hypertension). The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY), intramuscular, on 01Apr2021, as dose 1, 0.3 mL single for covid-19 immunization. The patient experienced death/ unknown cause of death on an unspecified date. The patient received the 1st dose on 01Apr2021, and 2nd dose on 13May2021. 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: Unknown cause of death


VAERS ID: 1578773 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-27
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Coronary artery disease; Infarct myocardial
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987777

Write-up: Death/Vaccination complication; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-DCGMA-21190008. A 72-year-old male patient received bnt162b2 (COMIRNATY, Lot number was unknown), via an unspecified route of administration on 06Apr2021 (at the age of 72-year-old) as dose number unknown, 0.3 ml, single for COVID-19 immunization. Medical history included coronary artery disease from 2001, cardiac failure from 2001 and infarct myocardial from 2001. The patient''s concomitant medications were not reported. On 27Apr2021, the patient experienced death/vaccination complication. The patient died on 27Apr2021. Cause of death was vaccination complication. It was unknown if an autopsy was performed. No follow-up attempts are possible; information on batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: vaccination complication


VAERS ID: 1578774 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: CANDESARTAN; ALLOPURINOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987789

Write-up: Sudden death, cause unknown; This is a spontaneous report downloaded from the Regulatory Authority; number DE-DCGMA-21191263, Safety Report Unique Identifier DE-PEI-202100127486. A 50-year-old male patient received bnt162b2 (COMIRNATY), dose 2 at the age of 50-years-old intramuscular on 07Jun2021 (Batch/Lot Number: Unknown) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included candesartan and allopurinol both taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (COMIRNATY) at the age of 50-years-old on 03May2021 (Bach/lot number: unknown) as dose 1, 0.3 ml, single for covid-19 immunisation. The patient experienced sudden death, cause unknown on an unspecified date in Jun2021. The patient died on an unspecified date in Jun2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Result of assessment per Regulatory Authority was unclassifiable (D.). Reporter''s comments: Found death, police turned on because the cause of death remained unexplained. No follow-up Information on batch/lot number cannot be obtained attempts are possible. No further information expected.; Reporter''s Comments: Found death, police turned on because the cause of death remained unexplained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1578775 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987629

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company number DE-DCGMA-21191316. A 76-year-old female patient received bnt162b2 (COMIRNATY, Strength: 0.3 mL; Lot number was not reported), intramuscular on 07May2021 (at the age of 76-years-old) as dose number unknown, 0.3 mL single for covid-19 immunisation. The patient medical history included ongoing chronic obstructive pulmonary disease (COPD). The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced death. The patient died on an unspecified date. It was unknown if an autopsy was performed. This report is serious - death. Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and event Death as D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1578780 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac failure, Chills, Fall, Interchange of vaccine products
SMQs:, Cardiac failure (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987587

Write-up: Decompensation cardiac; General debility; Fall; Rigors; Interchange of vaccine products; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority with regulatory authority number DE-PEI-202100133830. A 70-year-old male patient received bnt162b2 (COMIRNATY also reported as COMIRNATY (MRNA TOZINAMERAN); reported strength was 0.3 mL), dose 2 at vaccination age of 70-year-old via an unspecified route of administration on 02Jul2021 (Lot Number: FE6975) as dose 2 (initial PFIZER dose), single for covid-19 immunisation; and covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date at dose 1, single for covid-19 vaccination. The patient''s medical history and concomitant medications were not reported. On 03Jul2021 the patient experienced rigors, general debility, and fall which were considered as serious fatal. On 06Jul2021 the patient experienced decompensation cardiac which was considered as serious fatal. The report was considered as serious with seriousness criteria of death. The outcome of the vents was fatal. The patient died on 06Jul2021. An autopsy was not performed. Relatedness of drug to reactions/events with the source of the Regulatory Authority and the result of assessment was D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Decompensation cardiac; rigors; general debility; fall


VAERS ID: 1578781 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Inappropriate schedule of product administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (well adjusted)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987577

Write-up: Inappetence; first dose of COMIRNATY (strength: 0.3 mL) on 10May2021/second dose on 28Jun2021; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. The regulatory authority number is DE-PEI-202100133922. A 69-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3 mL), via an unspecified route of administration on 28Jun2021 (Batch/Lot Number: FE6975) as dose 2, 0.3 mL single (at the age of 69-years-old) for COVID-19 immunisation. Medical history included arterial hypertension: well adjusted. Concomitant medications were not reported. The patient received the first dose of COMIRNATY (strength: 0.3 mL) on 10May2021 for COVID-19 vaccination and the second dose on 28Jun2021. On an unspecified date, the patient experienced inappetence. The patient died on 12Jul2021. The regulatory authority assessed the event as serious, fatal; and unclassifiable by Regulatory Authority. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: inappetence


VAERS ID: 1578784 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-06-16
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987560

Write-up: Sudden cardiac death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. The regulatory authority number is DE-PEI-202100134130. An adult male patient of unspecified age received the dose of BNT162B2 (COMIRNATY; strength: 0.3 ml; lot number: EX8679), via an unspecified route of administration on 05May2021 (at an unspecified age) at dose number unknown, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Jun2021, the patient experienced sudden cardiac death. The patient died on 16Jun2021. No autopsy was done. Outcome of the event was fatal. Causality of BNT162B2 (COMIRNATY) to the event sudden cardiac death was unclassifiable.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1578797 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-11
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Cardiac failure acute, Pancytopenia, Platelet disorder, Prothrombin time, White blood cell disorder
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to nuts; Fruit allergy; Multiple sclerosis
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: thrombocytes; Result Unstructured Data: Test Result:27.000; Test Date: 20210711; Test Name: Spontaneous Quick value; Test Result: 10 %; Test Date: 20210711; Test Name: leukocytes; Result Unstructured Data: Test Result:2.5
CDC Split Type: DEPFIZER INC202100987738

Write-up: Anaphylactic shock; Acute heart failure; Pancytopenia; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100137297. An 88-year-old female patient received BNT162B2 (COMIRNATY, mRNA TOZINAMERAN), via an unspecified route of administration on 22Jun2021 (Batch/Lot Number: Unknown) at the age of 88 years old as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included Multiple sclerosis and allergy to nuts and apples. Concomitant medication included immunosuppressive medication about every two weeks. Three weeks after vaccination (on 11Jul2021), the patient experienced anaphylactic shock after eating, acute heart failure and pancytopenia (also reported duration 5 hours). 40 minutes after the anaphylactic shock, the patient underwent lab tests and procedures (11Jul2021) which included spontaneous quick value: 10 %, thrombocytes: 27.000, leukocytes: 2.5. The patient died on 11Jul2021. It was not reported if an autopsy was performed. This report is serious - death. Sender comment: Discharge report: Lethal outcome a.e. after anaphylactic shock with circulatory failure: Observed collapse after eating a grain roll... Fulminant aspiration with possibly rapidly developing Acute respiratory distress syndrome Severe cross-allergy to nuts and apples. Medical history: Presentation via Registered dietitian + NA. Patient. has a known nut allergy and is allergic to nuts after eating - of a bun syncopated in a manner requiring resuscitation. A doctor on site has immediately Resuscitation started. Massive aspiration in the field, suction by Registered dietitian, intubation, Fenistil, prednisolone and suprarenin. With continuation of the resuscitation measures Drive to us. Shortly before arrival return of spontaneous circulation with stable sustained release and not measurable respiratory rate. Patient ventilated by bag, difficult to ventilate. on 22Jun2021 Covid 9 vaccination (Biontech) received MS is pre-existing, currently no immunosuppressive therapy, however all 14 days of injection therapy with currently unclear active substance. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Anaphylactic shock; Pancytopenia; Acute heart failure


VAERS ID: 1578803 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-09
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987719

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100138666. A 67-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Jul2021 (Batch/Lot Number: FE6975) (at the age of 67 years) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 09Jul2021. The patient died on 09Jul2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1578815 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Inappropriate schedule of product administration, Lung infiltration, Lung transplant rejection
SMQs:, Interstitial lung disease (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 63
Permanent Disability? 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: Adiposis; Alpha-1 anti-trypsin deficiency; COPD; Lung transplant; Pneumothorax; Portopulmonary hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987668

Write-up: Lung transplant rejection; ARDS; Lung infiltration; 1st dose Comirnaty: 03Apr2021, 2nd dose: 15May2021; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100142237. A 61-year-old female patient received bnt162b2 (COMIRNATY; strength: 0.3 mL), dose 2 via an unspecified route of administration on 15May2021 (Lot Number: Unknown) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included alpha-1 antitrypsin deficiency, pneumothorax, chronic obstructive pulmonary disease (COPD), lung transplant from 01Jan2021 to an unknown date, portopulmonary hypertension, and adiposis. The patient''s concomitant medications were not reported. Historical vaccine included Comirnaty (1st dose, strength: 0.3 ml) on 03Apr2021 for COVID-19 immunisation. On 24Jun2021, the patient had lung transplant rejection, acute respiratory distress syndrome (ARDS), and lung infiltration. The patient died on 17Jul2021. The outcome of lung transplant rejection, acute respiratory distress syndrome (ARDS), and lung infiltration was fatal. It was not reported if an autopsy was performed. Relatedness of drug to events was assessed as being D. Unclassifiable. Reported dose of Comirnaty 2 (for clarification). Information about lot/batch number has been requested.; Reported Cause(s) of Death: Lung transplant rejection; ARDS; Lung infiltration


VAERS ID: 1578817 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Cardiomyopathy, Chills, Decreased appetite, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Pyrexia; Result Unstructured Data: Test Result: Pyrexia.
CDC Split Type: DEPFIZER INC202100987559

Write-up: Cardiomyopathy; Pyrexia; Chills; Appetite lost; Shoulder pain; Headache; This is a spontaneous report downloaded from the Regulatory Authority-WEB, Regulatory authority report number DE-PEI-202100142251, from a non-contactable physician. A 27-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 14Jul2021 (Batch/Lot Number: FD7958) (at the age of 27 years) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 on 16Jun2021 (Batch/Lot Number: Unknown) (at the age of 27 years) as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. The patient experienced cardiomyopathy, pyrexia, chills, appetite lost, shoulder pain, headache, all on 14Jul2021 with seriousness of death and life-threatening. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of all events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: shoulder pain; headache; appetite lost; cardiomyopathy; pyrexia; chills


VAERS ID: 1578826 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Dyspnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   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: Aortic valve replacement
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987765

Write-up: Shock cardiogenic; Dyspnoea; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company number DE-PEI-202100142663. An 80-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (also reported as 04Jun2021) (Batch/Lot Number: Unknown) as dose number unknown, 0.3 ml, single for COVID-19 immunization. The patient''s weight was not reported, and height was not reported. Medical history included aortic valve replacement. The patient''s concomitant medications were not reported. On 08Apr2021 the patient experienced dyspnoea, device failure, defect, shock cardiogenic. The patient died on 08Apr2021 due to the events. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardiogenic shock; dyspnoea


VAERS ID: 1578827 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   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: Medical History/Concurrent Conditions: Arterial hypertension; Atrial fibrillation; COPD; Emphysema pulmonary
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987677

Write-up: COPD exacerbation; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100142839. A 76-year-old male patient received bnt162b2 (COMIRNATY, Strength: 0.3 mL; Lot Number: EX3599), via an unspecified route of administration on 27Apr2021 (at the age of 76-years-old) as dose number unknown, 0.3 mL single for covid-19 immunisation. The patient medical history included COPD (chronic obstructive pulmonary disease), atrial fibrillation, arterial hypertension and emphysema pulmonary. The patient''s concomitant medications were not reported. On 28Apr2021, the patient experienced COPD exacerbation. The outcome of COPD exacerbation was fatal. The patient died on 17May2021. Cause of death was COPD exacerbation. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Chronic obstructive pulmonary disease


VAERS ID: 1578828 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D016A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Coronary disease.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987740

Write-up: Sudden cardiac death; Dose 1 on 28Apr2021/dose 2 on 09Jun2021; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100143128. A 69-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 09Jun2021 (Batch/Lot Number: 1D016A) (at the age of 68 years) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included aortic valve insufficiency and coronary disease. The patient''s concomitant medications were not reported. The patient had the first dose of bnt162b2 (COMIRNATY) on 28Apr2021 (at the age of 68 years) for covid-19 vaccination. The patient experienced sudden cardiac death on 21Jun2021. The patient died on 21Jun2021 due to sudden cardiac death. An autopsy was not performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1578829 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987695

Write-up: Cardiac failure (NOS); This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100143555. A 78-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Jul2021 (Batch/Lot Number: FE6975) (at the age of 78-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Jul2021, the patient experienced cardiac failure (NOS) which resulted to fatal outcome. The patient died on 14Jul2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac failure (NOS)


VAERS ID: 1578830 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   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: DEPFIZER INC202100987678

Write-up: Sudden death; Cold symptoms; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, (regulatory authority: DE-PEI-202100143558). A 54-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Strength: 0.3 ml, Batch/Lot Number: Unknown), via an unspecified route of administration on 14Jul2021 (received at the age of 54-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced cold symptoms on 15Jul2021 and sudden death on 17Jul2021. The patient died on 17Jul2021. It was not reported if an autopsy was performed. The casual relationship of Comirnaty and both events assessed as Unclassifiable by the RA. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cold symptoms; Sudden death


VAERS ID: 1578833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 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: DEPFIZER INC202100987532

Write-up: Death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100143727. This consumer reported similar events for two patients. This is the first of two reports. An elderly female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 17Mar2021 08:00 (Lot Number: ER7812) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced death. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Event assessment between Comirnaty and all events per RA was indeterminate. Sender''s comments: I would like to inform you that: My parents were vaccinated against SARS-CoV-2 on 17Mar2021 at 8:00 am. Neither of them had any acute health problems! Both have since passed away. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202100994641 same reporter/suspect drug/ event, different patient; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1578835 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Hypereosinophilic syndrome, Inappropriate schedule of product administration, Lung carcinoma cell type unspecified stage 0
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), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987660

Write-up: Hypereosinophilic syndrome; Bronchial carcinoma in situ; Acute respiratory failure; BNT162B2 dose 1: 01Ap2021, dose 2: 14May2021; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority DE-PEI-202100144672. A 79-year-old male patient received (age at vaccination: 79-year-old) bnt162b2 (COMIRNATY 0.3ml, lot unknown), via an unspecified route of administration on 14May2021 as dose 2, single for Covid-19 immunisation. The patient''s medical history was not reported, no concomitant medications. He had his dose 1 of bnt162b2 (lot unknown) on 01Apr2021. On 04Jun2021, the patient experienced acute respiratory failure, hypereosinophilic syndrome and bronchial carcinoma in situ all with fatal outcome. The patient died on an unspecified date. An autopsy was not performed. Relatedness of drug to reactions/events Comirnaty/ all events/ B. Indeterminate. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Hypereosinophilic syndrome; Bronchial carcinoma in situ; Acute respiratory failure


VAERS ID: 1578840 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-23
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy (Condition after several apoplexies); Diabetes mellitus; Hemiparesis; Hypertension; Struma (hypertensive struma).
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987799

Write-up: Infarct myocardial; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority number is DE-PEI-202100144865. A 73-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus, hypertension, condition after several apoplexies, hemiparesis, and hypertensive struma. Concomitant medications were not reported. On 23Apr2021, the patient experienced infarct myocardial. The patient died on 23Apr2021. It was unknown if an autopsy was performed. Sender comment: Heart attack with bypass operation 8 day after the vaccination, subsequently exitus letalis on account of complications. Base illness: diabetes mellitus, hypertension, condition after several apoplexies, hemiparesis, hypertensive struma. Year of birth given only. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Heart attack.


VAERS ID: 1578845 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FO30A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adiposis; Atrial fibrillation; Nicotine abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987791

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100145041. A 63-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FO30A, expiry date not reported), via an unspecified route of administration on 16Jul2021 (at the age of 63 years old) as dose 2, 0.3 ml, single for covid-19 immunization. Medical history included adiposis, nicotine abuse, and atrial fibrillation, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient received the first dose of Comirnaty for covid-19 vaccination on 18Jun2021 at 0.3 ml. The patient experienced unknown cause of death on an unspecified date in 2021. The event caused hospitalization from an unknown date in 2021. It was unknown if an autopsy was performed. Follow-up attempt are not possible. No expected further information.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1578846 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-16
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9758 / UNK - / -

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: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Stress
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987778

Write-up: Acute myocardial infarction; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100145048. An adult male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 25Jun2021 (Batch/Lot Number: FD9758) as dose number unknown, 0.3ml single for covid-19 immunisation. Medical history included hypertension and stress. The patient''s concomitant medications were not reported. The patient experienced acute myocardial infarction on 16Jul2021. The patient died on 16Jul2021 due to acute myocardial infarction. It was unknown if an autopsy was performed. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1578847 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-15
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular disorder, Decreased appetite, Fatigue, Hypoxia
SMQs:, Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure; COPD; Emphysema pulmonary; Hypertension; Sleep apnoea syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987727

Write-up: Hypoxia; Circulatory instability; Appetite lost; Tiredness; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. The regulatory authority number is DE-PEI-202100145066. A 68-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 01Jul2021 (Batch/Lot Number: FF0900) (at the age of 68-yrs-old) as dose 2, 0.3ml single for COVID-19 immunisation. The patient''s weight and height were not reported. Medical history and concurrent conditions included emphysema pulmonary, chronic respiratory failure, chronic obstructive pulmonary disease (COPD GOLD), sleep apnoea syndrome, hypertension. No concomitant medications were reported. Historical Vaccine included BNT162B2 (COMIRNATY), via an unspecified route of administration on 03Jun2021 (Batch/Lot Number was not reported) (at the age of 68-yrs-old) as dose 1, 0.3ml single for COVID-19 immunisation. On 15Jul2021, the patient experienced circulatory instability, appetite lost, and tiredness. On 18Jul2021, the patient experienced again tiredness. This report is serious - death. The outcome of the events was fatal. The patient died on 18Jul2021. Reported cause of death was hypoxia. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Hypoxia


VAERS ID: 1578848 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   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: Medical History/Concurrent Conditions: LDL increased; Lipid metabolism disorder NOS; Smoker.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Unknown cause of death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Unknown cause of death) in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Smoker, Lipid metabolism disorder NOS and LDL increased. Previously administered products included for an unreported indication: COVID-19 VACCINE ASTRAZENECA. On 11-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 14-Jul-2021 The patient died on 14-Jul-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant information was not provided. Treatment information was not provided. Company Comment: This is a case of death of an unknown cause in a 72-year-old female subject with hx of smoking and lipid metabolism disorder who died 3 days after receiving mRNA-1273. An autopsy was not performed. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death of an unknown cause in a 72-year-old female subject with hx of smoking and lipid metabolism disorder who died 3 days after receiving mRNA-1273. An autopsy was not performed. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1578851 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / UNK - / -

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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987552

Write-up: Acute myocardial infarction; This is a spontaneous report downloaded from the Regulatory Authority. Report number DE-PEI-202100146478. A non-contactable physician reported that a 74-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 24Jun2021 (at the age of 74-year-old) (Batch/Lot Number: FD7958) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 27Jun2021, the patient experienced acute myocardial infarction. The patient died on an unspecified date. It was not reported if an autopsy was performed. Source of assessment Result of Assessment C. Inconsistent causal association to immunization No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1578853 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987630

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100146521. A 58-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 vaccination. The patient experienced unknown cause of death on 16Jul2021. The patient died on 16Jul2021. An autopsy was performed and results were not provided. Causal relationship between the event and the administration of CORMINATY was assessed as "Unclassifiable" by the RA. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1578855 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-10
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D015A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987718

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100146645. A 52-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: 1D015A), via an unspecified route of administration on 01Jun2021 (at the age of 52-years-old) as dose 2, 0.3 mL single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 10Jul2021. This report is serious - death. The patient died on 10Jul2021. It was unknown if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1578857 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-11
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1440 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain injury, Computerised tomogram, Resuscitation
SMQs:, Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Post-traumatic stress disorder; Substance dependence
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: computerised tomography; Result Unstructured Data: Test Result:Pulmonary artery embolism; Comments: Pulmonary artery embolism ruled out by thorax computerized tomography on 11Jul2021; Test Date: 20210711; Test Name: computerised tomography; Result Unstructured Data: Test Result:Coronary heart disease; Comments: no pericardial effusion, no pathological tox-screening, no further specific causes recognisable so far; Test Name: reanimation procedure; Result Unstructured Data: Test Result:connection vaccination is assumed.; Comments: A genesis of the reanimation procedure in the tests s-far provides no indication, but a formal temporal connection with the vaccination is assumed.
CDC Split Type: DEPFIZER INC202100987605

Write-up: Hypoxic brain damage; This is a spontaneous report from a non-contactable pharmacist downloaded through the Regulatory Authority. Report number DE-PEI-202100148158. A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 05Jul2021 (Lot Number: FC1440) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included substance dependence, and post-traumatic stress disorder, all were unknown if ongoing. The patient received the first dose of bnt162b2 (COMIRNATY) on 25May2021 as dose 1, 0.3 mL single for prophylactic vaccination. The patient''s concomitant medications were not reported. On 11Jul2021, the patient experienced hypoxic brain damage which was considered as serious fatal with hospitalization. On 16Jul2021, the patient experienced death. It was reported that computerized tomography on 11Jul2021 included pulmonary artery embolism ruled out by thorax computerised tomography on 11Jul2021, and computerised tomography on 11Jul 2021 showed coronary heart disease ruled out by PRIVACY on 11Jul2021, no pericardial effusion, no pathological tox-screening, no further specific causes recognizable so far, implantation on 11Jul2021. A genesis of the reanimation procedure in the tests s-far provides no indication, but a formal temporal connection with the vaccination is assumed. An examination into an alleged irreversible brain function collapse following reanimation remains to be done. The outcome of the event was fatal. The patient died on 16Jul2021. It was not reported if an autopsy was performed. Sender comment: Computerised tomography on 11Jul2021, Pulmonary artery embolism ruled out by thorax computerised tomography on 11Jul2021, computerised tomography on 11Jul 2021, Coronary heart disease ruled out by PRIVACY on 11Jul2021, no pericardial effusion, no pathological tox-screening, no further specific causes recognizable so far, implantation on 11Jul2021. A genesis of the reanimation procedure in the tests s-far provides no indication, but a formal temporal connection with the vaccination is assumed. An examination into an alleged irreversible brain function collapse following reanimation remains to be done. Follow-up attempt are not possible. No expected further information.; Reported Cause(s) of Death: Hypoxic brain damage


VAERS ID: 1578861 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-23
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: skull CT; Result Unstructured Data: Test Result:complete medial and anterior infarction on the rig; Comments: complete medial and anterior infarction on the right, sec. Hemorrhage
CDC Split Type: DEPFIZER INC202100987776

Write-up: Right media infarction; This is a spontaneous report from a non-contactable healthcare professional downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100148269. A 65-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Apr2021 (at the age of 65-year-old) (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 23Apr2021, the patient experienced right media infarction (middle cerebral artery infarct). The patient was hospitalized due to the event on an unspecified date and event was considered as life threatening. The patient underwent lab test and procedure on 06Apr2021 which included skull computerised tomogram (CT) which showed complete medial and anterior infarction on the right, sec. hemorrhage. The patient died on an unspecified date. It was not reported if an autopsy was performed. Sender Comment: Skull CT 6Apr2021: complete medial and anterior infarction on the right, sec. Hemorrhage Comirnaty/ Middle cerebral artery infarct / unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Right media infarction


VAERS ID: 1578864 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7011 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pancreatic carcinoma, Sudden death, Weight, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: weight loss; Result Unstructured Data: Test Result: over 30 kg.
CDC Split Type: DEPFIZER INC202100987794

Write-up: suspected pancreatic cancer; Continuous weight loss over 30 kg; Death sudden; This is a spontaneous report received from a non-contactable healthcare professional downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100149322. A 69-year-old male patient received BNT162B2 (COMIRNATY; strength 0.3ml), via an unspecified route of administration on 15Jul2021 (Lot Number: FE7011, unknown expiration; at the age of 69 years old) as dose 2, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of COMIRNATY on 10Jun2021 (at the age of 69 years old) for prophylactic vaccination. The patient experienced continuous weight loss over 30 kg, suspected pancreatic cancer on unspecified dates. The patient experienced death sudden on 17Jul2021. The patient died on 17Jul2021. Outcome of the remaining events was unknown. It was unknown if an autopsy was performed. Sender''s comment: Continuous weight loss over 30 kg, suspected pancreatic cancer. Relatedness of the events were assessed by RA as "D. Unclassifiable". No follow-up attempts are possible; information about batch number was already obtained.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1578870 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E029A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987575

Write-up: Death sudden; This is a spontaneous report from a non-contactable physician, downloaded from the Regulatory Authority-WEB. The regulatory authority number is DE-PEI-202100149661. An 84-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, strength: 0.3 mL), via an unspecified route of administration on 22Jul2021 at the age of 84 years old (Batch/Lot Number: 1E029A, Expiration date: unknown) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death sudden on 27Jul2021. This report was considered serious due to death. The patient died on 27Jul2021. It was not reported if an autopsy was performed. The result of the assessment of relatedness of drug to the reaction/event, "death sudden," by the source of assessment, RA, was reported as "D. Unclassifiable." No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1578874 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-06-08
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Endocarditis, Intervertebral discitis, Multiple organ dysfunction syndrome, Staphylococcal sepsis, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic sclerosis; Atrial fibrillation; COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987753

Write-up: Thrombocytopenia; Staphylococcus aureus-Sepsis; the suspicion of spondylodiscitis; Mitral valve-endocarditis; Multi-organ failure with Lethal outcome; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100150829. An 85-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY), via an unspecified route of administration on 12May2021 (Lot Number: EX8680) as dose 2, single (at the age of 85 years old) for COVID-19 immunisation. Medical history included atrial fibrillation, chronic obstructive pulmonary disease (COPD), aortic sclerosis; all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took pneumovax on 20Apr2020 and experienced erythema on the abdominal wall, healed; COMIRNATY on 07Apr2021 as dose 1, 0.3 mL single for COVID-19 immunisation. The patient''s weight was not reported, and height was not reported. On 08Jun2021, the patient experienced multiorgan failure with lethal outcome, staphylococcus aureus sepsis (septicemia), mitral valve endocarditis, the suspicion of spondylodiscitis. The patient also experienced thrombocytopenia on an unspecified date. This report was serious due to death, hospitalization, life threatening. The outcome of all the events was fatal. The patient died on 01Jul2021. It was not reported if an autopsy was performed. Sender''s comments: After Pneumovax vaccination on 20Apr2020 as a reaction an erythema on the abdominal wall, healed. Info: Patient had previously seen cardiologist, was in very good General Condition, cared for a relative at home. Hospital document available. Relatedness of drug to reactions/events per was unclassifiable No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Multi-organ failure with lethal outcome; Thrombocytopenia; Staphylococcus aureus-Sepsis; the suspicion of spondylodiscitis; Mitral valve endocarditis


VAERS ID: 1578875 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987759

Write-up: Death (another history of myocardial infarction); This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100151658. A male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Jul2021 (Lot Number: FE9174), dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death (another history of myocardial infarction) on 28Jul2021. The patient was hospitalized on an unknown date in Jul2021. The event was reported as life threatening. The patient died on 28Jul2021 due to the event. It was not reported if an autopsy was performed. Event assessment for Comirnaty with the event (source of assessment: Regulatory Authority) was unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death (another history of myocardial infarction)


VAERS ID: 1578876 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1440 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Myocardial ischaemia
SMQs:, Other ischaemic heart disease (narrow), Medication errors (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   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: Addicted to amphetamine; Alcohol addiction; Coronary heart disease; Hyperlipidemia; Hypertension; Hyperuricaemia; Obesity; Smoker.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987619

Write-up: from Myocardial ischemia, Exitus letalis; first dose of Comirnaty on 29May2021/ on 10Jul2021 as dose 2, single; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100151748. A 35-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 10Jul2021 (Batch/Lot Number: FC1440) (at the age of 35 years old) as dose 2, single for COVID-19 immunisation. Medical history included hyperlipidemia from 06Mar2020, hyperuricemia from 06Mar2020, smoker from 06Mar2020, addicted to amphetamine from 06Mar2020, obesity from 06Mar2020, hypertension from 06Mar2020, coronary artery disease from 06Mar2020 and alcohol addiction from 06Mar2020, all were unknown if ongoing. The patient''s concomitant medications were not reported. The patient took the first dose of Comirnaty on 29May2021 for COVID-19 immunisation. The patient experienced ''Myocardial ischemia, exitus letalis'' on 12Jul2021. This report is serious - death, hospitalization, life threatening. The patient died on 12Jul2021. It was not reported if an autopsy was performed. Event assessment: RA / D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Myocardial ischemia, Exitus letalis


VAERS ID: 1578885 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-23
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016065

Write-up: Myocarditis; Sudden cardiac death with successful resuscitation; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB Worldwide unique case identification number DE-PEI-202100158148, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100158148. An 18-year-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular 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 myocarditis on 23Jul2021. The event was reported as life threatening and resulting hospitalization. Sudden cardiac death with successful resuscitation on unknown date. Therapeutic measures were taken as a result of events. The patient died on an unspecified date. It was unknown if an autopsy was performed. The patient was not recovered from myocarditis. Assessment: Comirnaty/ Myocarditis / RA: B. Indeterminate. Sender''s comments: Sudden cardiac death with successful resuscitation. No underlying disease. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Sudden cardiac death with successful resuscitation


VAERS ID: 1578887 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Muscle spasms, Myocardial infarction, Palpitations
SMQs:, Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016102

Write-up: Infarct myocardial; Accident cerebrovascular; Heart racing; Cramps; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority. Report number DE-PEI-202100158263. This consumer or other non hcp reported different doses and events for the same patient. This is the first of two reports-regarding the second dose. A 90-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: unknown, strength: 0.3 ml) (mRNA tozinameran), at the age of 90 years old, on 10Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown), at the age of 90 years old, on 20Jan2021 at single dose for COVID-19 immunisation and experienced heart racing. On 11Feb2021, the patient experienced heart racing and cramps. On an unspecified date, the patient also experienced infarct myocardial and accident cerebrovascular. This report was serious - death. The patient died on an unspecified date. It was not reported if an autopsy was performed. Relatedness of drug to events was assessed as D. Unclassifiable. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101027573 same patient, different doses, different events; Reported Cause(s) of Death: Infarct myocardial; Heart racing; Accident cerebrovascular; Cramps


VAERS ID: 1578888 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D020A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   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: Arterial hypertension; Chronic renal insufficiency; Hyperlipoproteinemia; Hyperuricaemia; Obesity; Proteinuria; Pulmonary granuloma; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101026379

Write-up: Lethal death after attempted resuscitation by air rescue; This is a spontaneous report from non-contactable physician downloaded from the Regulatory Authority. Report number DE-PEI-202100159263. A 69-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: 1D020A, strength: 0.3 ml) (mRNA tozinameran), at the age of 69 years old, on 28Jul2021 at single dose for COVID-19 immunisation. Medical history included arterial hypertension, chronic renal insufficiency, type 2 diabetes mellitus, hyperuricaemia, obesity, proteinuria, pulmonary granuloma and hyperlipidaemia (all were ongoing). The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown, strength: 0.3 ml), at the age of 69 years old, on 07Jul2021 at single dose for COVID-19 immunisation. On 02Aug2021, the patient experienced lethal death after attempted resuscitation by air rescue (unknown cause of death). On 02Aug2021, air rescue informed about the lethal outcome after unsuccessful resuscitation. This report was serious - death. The patient died on 02Aug2021. An autopsy was not performed. Relatedness of drug to the event was assessed as D. Unclassifiable by Regulatory Authority . The outcome of the event was fatal.; Reported Cause(s) of Death: Lethal death after attempted resuscitation by air rescue


VAERS ID: 1579069 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Body mass index, Glomerular filtration rate, Influenza, Low density lipoprotein, Platelet count, Pneumonitis
SMQs:, Interstitial lung disease (narrow), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness: Arrhythmia (cardiac arrhythmia, not further specified (I49.9G)); Cerebral infarction (results of a cerebral infarct (I69.3G)); Essential hypertension (essential hypertension, not further specified, without details of any hypertensive crisis (I10.90G)).
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy (years ago); Atrioventricular block (atrioventricular Block 1. Degree (I44.0G)); Brain stem infarction; Cardiac insufficiency (upper congestion (I87.1G)); Chronic pain; Gastroesophageal reflux (gastro-esophageal reflux with oesophagitis (K21.0G)); Heart failure (heart failure, unspecified (I50.9G)); Hypercholesterolaemia (LDL: 1.51 gl (04May2021)); Obesity (adipositas, BMI 30-35 (E66.90G)); Oesophagitis; Renal insufficiency (last glomerular filtration rate: 51 ml/min (04May2021)); Rosacea ((L71.8G)); Thrombocytopenia (for years: 47 Gpt/l gl. (04May2021)).
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:30-35; Test Date: 20210504; Test Name: glomerular filtration rate; Result Unstructured Data: Test Result:51 ml/min; Test Date: 20210504; Test Name: LDL; Result Unstructured Data: Test Result:1.51 gl.; Test Date: 20210504; Test Name: thrombocytopenia; Result Unstructured Data: Test Result:47 Gpt/l gl.
CDC Split Type: DEPFIZER INC202100987688

Write-up: Lung inflammation; Flu symptoms; pain in the back; This is a spontaneous report from a non-contactable consumer, downloaded from the Regulatory Authority-WEB. The regulatory authority number is DE-PEI-CADR2021114877. This is the first of two reports; the report for the second dose of Comirnaty. A 79-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 18May2021 at the age of 79 years old (Batch/Lot Number: EX8680, Expiration date: unknown) as dose 2, 0.3 mL single for COVID-19 immunization. Relevant medical history included obesity, further reported as adipositas with body mass index (BMI) of 30-35 on an unspecified date (E66.90G); ongoing hypertension, further described as essential hypertension, not further specified, without details of any hypertensive crisis (I10.90G); ongoing cerebral infarction, further described as results of a cerebral infarct (I69.3G); cardiac insufficiency, further described as upper congestion (I87.1G); brain stem infarction; gastro-esophageal reflux with oesophagitis (K21.0G); ongoing arrhythmia, further described as cardiac arrhythmia, not further specified (I49.9G); atrioventricular block, further reported as atrioventricular Block 1. Degree (I44.0G); heart failure, unspecified (I50.9G); apoplexy, years prior reporting; renal insufficiency with last glomerular filtration rate of 51 ml/min on 04May2021; hypercholesterolaemia with low-density lipoprotein (LDL) of 1.51 gl. on 04May2021; thrombocytopenia for years at 47 Gpt/l gl. on 04May2021; other rosacea and status after (L71.8G); and chronic (chr.) pain. The patient was on mobility without aids. Concomitant medications included apixaban (ELIQUIS) taken for an unspecified indication at 5 mg high dose, start and stop date were not reported and an unspecified antihypertensive therapy, which was well adjusted for years. The patient previously took valsartan and experienced allergies. The patient previously received bnt162b2 (COMIRNATY) on 06Apr2021 as dose 1, single for COVID-19 immunization and experienced increased body pain and was on hydromorphine (as reported) therapy in the short term. On 18May2021, the patient experienced pain in the back. On 31May2021, the patient experienced lung inflammation and flu symptoms. The patient was without pain therapy on 18May2021, and was then admitted to the clinic as an emergency on 31May2021. This report was considered serious, since the event "lung inflammation" led to hospitalization and death. The patient was hospitalized for lung inflammation from 31May2021 to an unknown date. The outcome of lung inflammation was fatal; the patient was not recovered from flu symptoms; while the outcome of pain in the back was unknown. The patient died on an unspecified date. An autopsy was not performed. Sender Comment: Do you or the person concerned have any allergies? If so, which ones? Valsartan. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101005564 same patient and product; different dose and event; Reported Cause(s) of Death: Lung inflammation


VAERS ID: 1579080 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Embolism, Myocardial infarction, Pulmonary embolism, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Weight gain (according to family doctor approx. 50 kg within one year).
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987601

Write-up: pulmonary embolism; thromboembolism; myocardial infarction; Respiratory failure; Arrest cardiac; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021124199, Safety Case Report Unique Identifier DE-PEI-202100120306. A 37-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 19May2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included weight increased from an unknown date and unknown if ongoing (according to family doctor approx. 50 kg within one year). The patient''s concomitant medications were not reported. The patient experienced arrest cardiac (death) on 20May2021. On 24May2021, Respiratory failure, resuscitation, death. Suspected diagnoses of the emergency doctor: pulmonary embolism, thromboembolism, myocardial infarction. The patient died on 24May2021. An autopsy was not performed. Senders comment: Information on risk factors or previous illnesses No, only strong weight gain (according to family doctor approx. 50 kg within one year) / on May 24th. Respiratory failure, resuscitation, death. Suspected diagnoses of the emergency doctor: pulmonary embolism, thromboembolism, myocardial infarction. Batch/lot number: Unknown. Comirnaty/ Arrest cardiac/ RA/ Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Arrest cardiac; Respiratory failure; pulmonary embolism; thromboembolism; myocardial infarction


VAERS ID: 1579082 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood lactic acid, Cardiac disorder, Dyspnoea, Extrasystoles, Lactic acidosis, Leukaemia, Multiple organ dysfunction syndrome, Pulmonary embolism, White blood cell count, pH body fluid
SMQs:, Anaphylactic reaction (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Hypokalaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: lactate; Result Unstructured Data: Test Result:29; Test Date: 20210703; Test Name: PH; Result Unstructured Data: Test Result:6.6; Test Date: 20210703; Test Name: Leukocytes; Result Unstructured Data: Test Result:314000; Comments: with Leukaemia.
CDC Split Type: DEPFIZER INC202100987670

Write-up: Lung embolism; Extrasystoles; Leukocytes of 314 thousand with Leukaemia; patient with dyspnie; right cardiac stress; Multiple organ failure; lactate acidosis; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, company number DE-PEI-CADR2021128714. A 90-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Jun2021 (Batch/Lot Number: Unknown) as dose 2, 0.3ml, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 03Jul2021, the patient experienced lung embolism, extrasystoles, leukocytes of 314 thousand with leukaemia, dyspnea and right cardiac stress. When taken to the clinic, the patient required reanimation with asystole. Reanimation cumulative 10 min. Death of patient with lactate acidosis ph 6.6 and lactate 29 and multiple organ failure. At the time of death, the outcome of the events lung embolism, extrasystoles, leukocytes of 314 thousand with leukaemia, dyspnea and right cardiac stress was not recovered. The patient died on 03Jul2021. An autopsy was not performed. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Multiple organ failure; lactate acidosis


VAERS ID: 1579084 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C007A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   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: Aortic valve stenosis; Arterial hypertension; Coronary heart disease; Heart valve replacement
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100988205

Write-up: Unknown cause of death; Tiredness; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021129130 and the safety report unique identifier is DE-CADRPEI-2021129130. A 79-year-old female patient received BNT162B2 (COMIRNATY, lot number: 1C007A), via an unspecified route of administration on 18May2021 (at the age of 79-years-old) at dose 2, 0.3 mL single for COVID-19 immunisation. Medical history included coronary artery disease, heart valve replacement NOS/ heart valve prothesis, arterial hypertension, and aortic stenosis/ aortic valve stenosis, which were all ongoing. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose 1, single for COVID-19 immunisation. It was reported that her first vaccination went well. On 19May2021, the patient experienced unknown cause of death which was reported as medically significant and tiredness. The outcome of the event tiredness was not recovered. The patient died on 19May2021. The cause of death was unknown. An autopsy was not performed. Sender''s Comment: Do you or the person concerned have any allergies? If so, which ones? Information on risk factors or previous diseases: Coronary heart disease, aortic valve stenosis, heart valve prothesis, arterial hypertension. Connection with vaccination?/Tired, exhausted on the first day after the second vaccination, died in the night. First vaccination went well. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579087 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-06-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987525

Write-up: Weakness; died with unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority number is DE-PEI-CADR2021130428. A 90-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as dose 2, 0.3ml single for COVID-19 immunisation. The patient''s weight was 80 kg, and height was 170 cm. Medical history included heart disorder. No concomitant medications were reported. On Jun2021, the patient experienced weakness. On 05Jun2021, the patient died from unknown cause. The outcome of the event weakness was not recovered/not resolved. This report is serious - hospitalization. The patient died on 05Jun2021. An autopsy was not performed. Sender comment: Information on risk factors or previous diseases: Heart. After the second vaccination, my father was seen by a doctor in the community practice and felt weaker every day, therefore he was admitted to hospital for 4 days! Moreover, after his discharge from the community practice, no one bothered to see him. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579092 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain oedema, Crush syndrome, Dyspnoea, Laboratory test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   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: Drug addict
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma; Coronary heart disease.
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: Laboratory test; Result Unstructured Data: Test Result: Crush Syndrome.
CDC Split Type: DEPFIZER INC202100987595

Write-up: Crush syndrome; Brain oedema; Dyspnoea; This is a spontaneous report downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021134443. A 40-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 29Jun2021 (Batch/Lot Number: FD7958) as dose number unknown, 0.3ml single for COVID-19 immunization. Medical history included ongoing drug addict, Bronchial Asthma, and coronary heart disease from an unknown date. Concomitant medications were not reported. The patient experienced crush syndrome on 04Jul2021, dyspnoea and brain oedema on 02Jul2021. The patient was hospitalized due to the events. The patient a laboratory test which confirmed crush syndrome on 04Jul2021. The patient died from crush syndrome on 04Jul2021. An autopsy was not performed. The outcome of the events dyspnoea and brain oedema was not recovered. Sender comment: Do you or the person concerned have any allergies? If so, which ones? No. Information on risk factors or previous diseases: Known bronchial asthma; drug use - for 20 years / initial shortness of breath, in the further course the patient required resuscitation; artificially ventilated; invasive exclusion of coronary heart disease; finding of massive cerebral oedema; laboratory constellation of Crush''s syndrome- on 04Jul2021- exitus letalis. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Crush syndrome


VAERS ID: 1579094 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Fatigue, International normalised ratio, Loss of consciousness, Mean cell haemoglobin, Mean cell haemoglobin concentration, Nausea, Pancytopenia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic erythropenia (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: international normalized ratio; Result Unstructured Data: Test Result: elevated; Test Name: mean corpuscular hemoglobin; Result Unstructured Data: Test Result: reduced; Test Name: mean cell hemoglobin concentration; Result Unstructured Data: Test Result: reduced.
CDC Split Type: DEPFIZER INC202100987711

Write-up: Sudden death; Pancytopenia; Anemia; Nausea; Unconsciousness; Tiredness; This is a spontaneous from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021134914. A 60-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 08Jul2021 (Batch/Lot Number: Unknown) as dose 1, 0.3 ml single for covid-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at an unspecified dose and frequency as prophylactic vaccination. The patient''s medical history and concomitant medications were not reported. The patient experienced pancytopenia, anemia, nausea, unconsciousness and tiredness on 08Jul2021 with outcome of not recovered prior to patient''s death. On 09Jul2021, the patient experienced sudden death. The patient underwent lab tests and procedures on an unspecified date which included international normalised ratio: elevated, mean cell haemoglobin: reduced, mean cell haemoglobin concentration: reduced. The patient died on 09Jul2021. It was unknown if an autopsy was performed. Sender''s comment: Do you or the person concerned have any allergies? If so, which ones? No Information on risk factors or previous diseases not available. None/ The patient has always been healthy according to the wife. He had received his first Corona vaccination with Astrazeneca four weeks ago and tolerated it well. Now, yesterday, there had been the possibility, regarding the newly recommended cross-immunisation to receive a Biontech vaccination, which was administered yesterday. Last night, her husband was tired and went to bed early. Slept until morning today, complained of nausea. Around noon, she said, he observed become unconscious, whereupon she began lay resuscitation. This was taken over by the emergency doctor and the admission of the patient took place under ongoing resuscitation with the mechanical resuscitation aid. Repeatedly No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579099 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-11
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Malaise, Physical examination
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   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: Arterial hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Appetite lost
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Comprehensive check-up; Result Unstructured Data: Test Result:normal
CDC Split Type: DEPFIZER INC202100987786

Write-up: Unknown cause of death; Malaise; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021137087. A 69-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 28Jun2021 (Lot Number: FE6975) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included ongoing arterial hypertension and slight loss of appetite. Patient had no allergies. The patient''s concomitant medications were not reported. On 11Jul2021, the patient experienced malaise. On 12Jul2021, unknown cause of death was reported. The patient died on 12Jul2021. An autopsy was not performed. The outcome of malaise was not recovered. Sender comment: Do you or the person concerned have any allergies: None. Information on risk factors or previous diseases: arterial hypertension well under control and had slight loss of appetite with no vomiting, diarrhea, or fever. On 10Jul2021 went to bed normally, on the morning of 12Jul2021 (also reported as 11Jul2021, possibly discrepant) patient found lifeless in bed. Family doctor said that only the blood pressure was well established. Comprehensive check-up prior to vaccination with Comirnaty completely normal. Family doctor can state no other cause of death. Follow-up attempts are not possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579104 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-26
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Blood test abnormal, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Mitral valve replacement
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: levels of inflammation in the blood; Result Unstructured Data: Test Result: high levels of inflammation in the blood.
CDC Split Type: DEPFIZER INC202100987567

Write-up: High levels of inflammation in the blood, renal insufficiency. Cause for this was not found in the one week until death in the intensive care unit.; High levels of inflammation in the blood; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021138193; other case identifier numbers DE-PEI-202100136175 and DE-CADRPEI-2021138193. An 84-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: EW8904, expiry date not reported), via an unspecified route of administration on 14Apr2021 as dose number unknown, single for covid-19 immunisation. Medical history included ongoing mitral valve replacement. The patient had no known allergies. The patient''s concomitant medications were not reported. On 26Apr2021, the patient experienced high levels of inflammation in the blood and renal insufficiency. Cause for this was not found in the one week until death in the intensive care unit. Patient was admitted to intensive care unit from an unknown date in 2021 and person unresponsive but not comatose. Therapeutic measures were taken as a result of the event reported as agitated broad-spectrum antibiotic, morphine, and oxygen administration. Patient no change in the one week until death. Mitral valve replacement could not be determined as the cause of the inflammatory values. This report is serious - death. The patient died on an unspecified date in 2021. The causes of death were renal insufficiency and high levels of inflammation in the blood. It was unknown if an autopsy was performed. Sender''s Comment: Do you or the person concerned have any known allergies? If yes, which ones? No. Information on risk factors or previous diseases: Mitral valve replacement, could not be determined as the cause of the inflammatory values. Intensive care unit: person unresponsive but not comatose, agitated broad-spectrum antibiotic, morphine, oxygen administration no change in the one week until death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: High levels of inflammation in the blood; renal insufficiency


VAERS ID: 1579107 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiovascular disorder, Circulatory collapse, Death, Dizziness, Drug ineffective, Dyspnoea, Peripheral vascular disorder, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), 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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: COVID-19 PCR test; Test Result: Positive.
CDC Split Type: DEPFIZER INC202100987540

Write-up: This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021139488, Safety Report Unique Identifier DE-PEI-202100138155. An elderly female patient received BNT162B2 (COMIRNATY, solution for injection, strength: 0.3 mL), via an unspecified route of administration on an unspecified date (lot number and expiry date were not reported) as dose 1, single and then via an unspecified route of administration on 09Mar2021 (lot number and expiry date were not reported) as dose 2, single for COVID-19 immunization. Medical history included ongoing arterial hypertension. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on an unspecified date, COVID-19 test pos. PCR, circulatory disorder peripheral, dizziness and circulatory problems, shortness of breath and collapse on 31Mar2021. The patient received unspecified intensive treatment. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 31Mar2021. The outcome of the event unknown cause of death was fatal while the outcome of all other events was not recovered. The patient died on an unspecified date. An autopsy was not performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses previously perfectly healthy mobile woman with arterial hypertension. Sudden symptoms after 2nd vaccination / intensive treatment with diagnosis of COVID-19 with positive PCR test. Causal relationship between the event(s) and the administration of CORMINATY was assessed as "Unclassifiable" by the PEI. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 1579111 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C008A / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death, Chest pain, Pain in extremity
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), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   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: DEPFIZER INC202100987750

Write-up: This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021144448, Safety Report Unique Identifier DE-PEI-202100144297. A 38-years-old male patient received bnt162b2 (COMIRNATY, solution for injection), dose 1 via an unspecified route of administration on 24May2021 (Batch/Lot Number: 1C008A) as DOSE 1, 0.3 ML SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 29May2021, the patient experienced cardiac death (death, medically significant). The patient died on 29May2021. Autopsy was not performed. On 27May2021, patient had pain in the chest and pain in the arm. Senders comment: Are you or the person concerned known of any allergies? If yes, which? Not known Information on risk factors or previous illnesses None. The outcome of cardiac death was fatal. The outcome of events pain in the chest and pain in the arm was not recovered. Event assessment: Comirnaty/ all events/PEI /Result of Assessment: D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infarct myocardial.


VAERS ID: 1579112 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D014A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 48
Permanent Disability? 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: Artificial cardiac pacemaker wearer
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987743

Write-up: Unknown cause of death; Malaise; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021144865. A 67-year-old male patient received BNT162B2 (COMIRNATY, strength: 0.3 mL, solution for injection, lot number: 1D014A), via an unspecified route of administration on 27May2021 as dose 2, 0.3 mL single for COVID-19 immunization. Medical history included artificial cardiac pacemaker wearer from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on 19Jul2021 and malaise on 01Jun2021. The outcome of the event unknown cause of death was fatal while the outcome of the event malaise was not recovered. The patient died on 19Jul2021 due to an unknown cause of death. An autopsy was not performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No Information on risk factors or previous illnesses Cardiac defibrillator / permanent malaise. Causal relationship between the event(s) and the administration of CORMINATY was assessed as "Unclassifiable" by the Regulatory Authority. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579114 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-05-26
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Pneumonitis
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: OXYGEN
Current Illness: COPD (permanent oxygen for 4 years).
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987653

Write-up: Unknown cause of death; severe pneumonia; This is a spontaneous report received from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021145708, Safety report unique identifier DE-PEI-202100145867. A 93-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease and permanent oxygen for 4 years. Concomitant medication included oxygen. On 26May2021 the patient experienced Lung inflammation, Unknown cause of death. The outcome of the event Lung inflammation was recovered, other event was fatal. The two pneumonia were treated with antibiotics and morphine. He recovered from both of them. The patient''s weight was 80 kg, and height was 170 cm. This report is serious - death. Relatedness of drug to reactions/events. Source of assessment: RA. Result of Assessment: D. Unclassifiable.Patient had his first dose of Comirnaty on an unspecified date for covid-19 immunisation and experienced Lung inflammation. No autopsy done. Patient died on 26May2021. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579115 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Anaphylactic shock
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016069

Write-up: Anaphylactic shock; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021149926, Safety Report Unique Identifier: DE-PEI-202100150260. A 55-year-old female patient (weight: 66 kg, height: 170 cm) received bnt162b2 (COMIRNATY, strength: 0.3 ml), dose 2 via an unspecified route of administration on 22Jul2021 (Lot Number: EL1491) at 0.3 ml single dose for COVID-19 immunisation. Medical history included allergy and anaphylactic shock. The patient''s concomitant medications were not reported. The patient experienced anaphylactic shock on 23Jul2021. This report is serious for death. The patient died on 27Jul2021. An autopsy was not performed. The outcome of the event was fatal. Sender''s comments: Do you or the concerned person have any known allergies? If yes, which ones? Yes Information on risk factors or previous illnesses Anaphylactic shock The Regulatory Authority assessment on relatedness of drug to the event anaphylactic shock is D. Unclassifiable. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Anaphylactic shock


VAERS ID: 1579117 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Serum ferritin
SMQs:, Cardiac failure (narrow), 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: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ferritin; Result Unstructured Data: Test Result:slight reduction of ferritin
CDC Split Type: DEPFIZER INC202101016095

Write-up: This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021153349. Safety Report Unique Identifier: DE-PEI-202100154208. A 79-year-old male patient received the second dose of bnt162b2 (COMIRNATY) on 11Jun2021 (lot number: unknown) via unknown route of administration at single dose for COVID-19 immunisation. Medical history included Hypertension from unknown date and ongoing. Concomitant medications were not reported. On 13Jun2021 (Time Interval between Beginning of Drug Administration and Start of Reaction / Event was also reported as 60 min) the patient experienced Death from heart failure. The patient died on 13Jun2021. It was not reported if an autopsy was performed. The event assessment between the events to the suspect drug was reported as Unclassifiable. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? : No. Information on risk factors or previous illnesses hypertension, controlled by medication slight reduction of ferritin / 60 hours after receiving the 2nd biotech vaccination death due to heart failure. No follow-up attempts possible. No further information expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death from heart failure.


VAERS ID: 1579118 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-16
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 77
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016094

Write-up: This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB regulatory authority number DE-PEI-CADR2021153552, Safety Report Unique Identifier DE-PEI-202100154781. A 79-year-old male patient received bnt162b2 (COMIRNATY) strength: 0.3 ml, dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EJ6789) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Mar2021 the patient experienced lung failure 12 days after the 1st vaccination with biontech/lung embolism and shortness of breath. Clinical course was as below: 12 days after the 1st vaccination, the person was admitted to the hospital due to shortness of breath. There he was given oxygen for about 5 weeks, at the beginning about 40 l / min with 90 percent oxygen. The medical team could not determine the cause, but ultimately suspected a shunt without being able to locate it. The condition improved 3 to 4 weeks after admission to the hospital, so that oxygen administration with mobile devices was possible. Patient was then discharged into short-term care for 3 weeks after 5 weeks of hospitalization. After the short-term care, he came back home for 4 weeks at his own request, where he unfortunately died in mid-June2021. An autopsy was not performed. The patient''s outcome was: fatal for Lung embolism and unknown for shortness of breath. This report is serious - death and hospitalization. Causality of events assessment with Comirnaty was D. Unclassifiable per PEI. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? Not known. / 12 days after the 1st vaccination, the person was admitted to the hospital due to shortness of breath. There he was given oxygen for about 5 weeks, at the beginning about 40 l / min with 90 percent oxygen. The medical team could not determine the cause, but ultimately suspected a shunt without being able to locate it. The condition improved 3 to 4 weeks after admission to the hospital, so that oxygen administration with mobile devices was possible. Patient was then discharged into short-term care for 3 weeks after 5 weeks of hospitalization. After the short-term care, he came back home for 4 weeks at his own request, where he unfortunately died in mid-June. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: lung failure 12 days after the 1st vaccination with biontech/lung embolism


VAERS ID: 1579120 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101026319

Write-up: Guillain Barre syndrome; Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021155945], Sender''s (Case) Safety Report Unique Identifier is DE-PEI-202100157926. A 78-year-old male patient received the first dose of BNT162B2 (COMIRNATY, strength 0.3 ml) at single dose on an unspecified date for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient had no allergies, no previous illnesses. The patient experienced Guillain Barre syndrome that resulting hospitalization, unknown cause of death. It was unknown if an autopsy was performed or not. The patient was not recovered from Guillain Barre syndrome, fatal for unknown cause of death. Relatedness of drug to reaction(s)/event(s) Source of assessment RA Result of Assessment D. Unclassifiable No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579121 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-22
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210827072

Write-up: HEART ATTACK RESULTING IN DEATH AFTER 6 WEEKS OF VACCINATION WITH JOHNSON&JOHNSON; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, DE-PEI-CADR2021156450] concerned a 65 year old male of unknown race and ethnicity. The patient''s weight was 84 kilograms, and height was 180 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported,1 total, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 22-JUL-2021, the patient had heart attack (infarct myocardial) resulting in death after 6 weeks of vaccination. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210827072-COVID-19 VACCINE AD26.COV2.S.-Heart attack resulting in death after 6 weeks of vaccination with Johnson & johnson. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: INFARCT MYOCARDIAL


VAERS ID: 1579123 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 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: DEPFIZER INC202100994641

Write-up: Death; This is a spontaneous report from a non-contactable consumer. This is the second of two reports. The first report is a report from the Regulatory Authority-WEB DE-PEI-202100143727. A elderly male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Mar2021 08:00 (Batch/Lot Number: ER7812) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced death. The patient died on an unspecified date. It was not reported if an autopsy was performed. Event assessment : Comirnaty/ all events/RA/Result of Assessment : B. Indeterminate. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202100987532 same reporter/suspect drug/ event, different patient; Reported Cause(s) of Death: Death


VAERS ID: 1579136 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Computerised tomogram head, Inappropriate schedule of product administration, Ruptured cerebral aneurysm, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   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: Aneurysm cerebral
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Angiography; Result Unstructured Data: Test Result:no results reported; Test Date: 20210726; Test Name: Head CT; Result Unstructured Data: Test Result:no results reported
CDC Split Type: DKPFIZER INC202101016258

Write-up: This is a spontaneous report downloaded from the Regulatory Authority-WEB [DK-DKMA-WBS-0081896] received from a contactable Physician with Safety Report Unique Identifier DK-DKMA-ADR 25736830. A 54-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 21Jul2021 (Lot Number: FE9174) at 54 years old as single dose for covid-19 immunisation. Medical history included ongoing Aneurysm cerebral. The patient''s concomitant medications were not reported. The patient was vaccinated with first dose of COMIRNATY (Batch number: FC2336) on 09Jun2021 for COVID-19 immunisation. On 26Jul2021, 5 days after the second vaccination, the patient developed bleeding from aneurysm (arteria basilaris) and subarachnoid haemorrhage from the basilar artery with following incarceration. The patient was treated with an attempt of endovascular treatment of the aneurysm (not specified). The ADRs(adverse drug reactions) were by the reporter reported as being fatal. The patient underwent lab tests and procedures which included on 26Jul2021 Head CT (computed tomogram) and angiography, both with no results reported. The patient died on 27Jul2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Bleeding from aneurysm (arteria basilaris); Subarachnoid haemorrhage from the basilar artery with following incarceration.


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