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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: 1530163 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-21
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chills, Fatigue, Peripheral swelling, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARDIO ASPIRIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100948771

Write-up: After the administration of the first dose of the Pfizer vaccine, which occurred on June 10th, he felt tiredness, chills, pyrexia, chest oppression, swollen legs. The death occurs on 29 June; After the administration of the first dose of the Pfizer vaccine, which occurred on June 10th, he felt tiredness, chills, pyrexia, chest oppression, swollen legs. The death occurs on 29 June; After the administration of the first dose of the Pfizer vaccine, which occurred on June 10th, he felt tiredness, chills, pyrexia, chest oppression, swollen legs. The death occurs on 29 June; After the administration of the first dose of the Pfizer vaccine, which occurred on June 10th, he felt tiredness, chills, pyrexia, chest oppression, swollen legs. The death occurs on 29 June; After the administration of the first dose of the Pfizer vaccine, which occurred on June 10th, he felt tiredness, chills, pyrexia, chest oppression, swollen legs. The death occurs on 29 June; This is a spontaneous report from a contactable consumer downloaded from the Regulatory authority, regulatory authority number IT-MINISAL02-757832. A 79-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 10Jun2021 (Batch/Lot Number: FD1921) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient''s medical history was not reported. Concomitant medication included acetylsalicylic acid (CARDIO ASPIRIN) taken for an unspecified indication, start and stop date were not reported. After the administration of the first dose of the pfizer vaccine, the patient felt tiredness, chills, pyrexia, chest oppression and swollen legs. The patient died on 29Jun2021. It was not reported if an autopsy was performed. Therapeutic measures (Efferalgan) were taken as a result of the events. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: No known allergies. He was taking cardio aspirin; Reported Cause(s) of Death: Chills; Fatigue; Pyrexia; Chest discomfort; swollen legs


VAERS ID: 1530171 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac disorder, Pulmonary embolism
SMQs:, Supraventricular tachyarrhythmias (narrow), Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 95
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TRELEGY ELLIPTA; GEMCITABINE; FLUIMUCIL; DELTACORTENE; OMEPRAZEN [OMEPRAZOLE SODIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Cancer of lung; Chemotherapy; Emphysema pulmonary
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100948618

Write-up: Severe pulmonary embolism; degenerative heart disease; paroxysmal atrial fibrillation; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the Regulatory authority: IT-MINISAL02-759076. An 83-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 (Batch/Lot Number: ER9470) as a single dose for COVID-19 immunization. Medical history included lung cancer, emphysema, benign prostatic hyperplasia, and chemotherapy. Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA); gemcitabine on 22Mar2021; acetylcysteine (FLUIMUCIL); prednisone (DELTACORTENE); and omeprazole sodium (OMEPRAZEN). The patient experienced severe pulmonary embolism on 01Apr2021 21:00. Clinical course was reported as follows: The patient had pulmonary edema on 01Apr2021 with progressive worsening of general conditions until 05Jul2021. Access to the emergency room on 01Apr2021 with final diagnosis of pulmonary embolism in pulmonary cancer. Hospitalization in geriatrics from 02Apr2021 to 08Apr2021 with diagnosis at discharge of pulmonary embolism and degenerative heart disease with paroxysmal atrial fibrillation. Oncological check-up on 20Apr2021. The patient died due to the events on 05Jul2021. It was unknown if an autopsy was performed. Reporters comments: The adverse reaction led to another clinically relevant condition - Concomitant conditions: Lung cancer - Reaction time: 21:00 - Sent by Regulatory authority; Chemotherapy, then suspended due to embolism Death on 05Jul2021. Senders comments: 14Jul2021 Regulatory authority contacted signaler and oncologist asked for clinical documentation that is attached to the form. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The adverse reaction led to another clinically relevant condition - Concomitant conditions: Lung cancer - Reaction time: 21:00 - Sent by VigiCovid19-sheet Chemotherapy, then suspended due to embolism Death on 07May2021.; Reported Cause(s) of Death: Severe pulmonary embolism; degenerative heart disease; paroxysmal atrial fibrillation


VAERS ID: 1530178 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-22
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Esophageal reflux; Pulmonary embolism; Sarcoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100948908

Write-up: This is a spontaneous report from a contactable physician, downloaded from the Regulatory authority, Regulatory authority number: IT-MINISAL02-759613. An 86-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 08Apr2021 (Batch/Lot Number: EW2246) as DOSE 1, SINGLE for Covid-19 immunisation. Medical history included sarcoma from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, pulmonary embolism from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced (pulmonary embolism) on 22Apr2021. The patient died on 24Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1530200 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Gastric ulcer haemorrhage, Investigation, Shock haemorrhagic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Gastric ulcer haemorrhage; Glaucoma; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: consciousness level; Result Unstructured Data: Test Result:approximately 200
CDC Split Type: JPPFIZER INC202100942299

Write-up: Shock haemorrhagic due to haemorrhagic multiple gastric ulcers (name of injury or illness on admission); Shock haemorrhagic due to haemorrhagic multiple gastric ulcers (name of injury or illness on admission); Shock haemorrhagic due to haemorrhagic multiple gastric ulcers (name of injury or illness on admission); This is a spontaneous report from a contactable pharmacist received via Regulatory authority. An 85-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in left arm on 04Jul2021 10:00 (at the age of 85-year-old) (Batch/Lot Number: FA5765; Expiration Date: 30Sep2021) as dose 2, single for covid-19 immunisation. Medical history included cerebral infarction, glaucoma, osteoporosis and gastric ulcer haemorrhage. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 4 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient''s concomitant medications were not reported. The patient received first dose of bnt162b2 on 13Jun2021 for covid-19 immunisation. On 05Jul2021 at 12:00 (1 day and 2 hours after the vaccination), the patient experienced shock haemorrhagic due to haemorrhagic multiple gastric ulcers (name of injury or illness on admission). The event resulted in the emergency room. The outcome of the event was fatal with treatment including emergency medical care. The course of the event was as follows: on 04Jul2021, the patient''s condition was stable after the vaccination. On 05Jul2021, the patient went out for a relative''s funeral, and her condition suddenly changed in a car on her way hospital. The patient was able to return to the hospital; however, pallor facial was noted and the consciousness level was approximately 200. Treatment was started at the emergency outpatient department. The reporting pharmacist assessed the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19. The patient died on 05Jul2021. An autopsy was not performed.; Sender''s Comments: Based on available information and the drug temporal relationship, the causality between the events gastric ulcer haemorrhage, shock haemorrhagic and the suspect drug "BNT162B2" cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Shock haemorrhagic due to haemorrhagic multiple gastric ulcers (name of injury or illness on admission); Shock haemorrhagic due to haemorrhagic multiple gastric ulcers (name of injury or illness on admission)


VAERS ID: 1530209 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: Medical History/Concurrent Conditions: Interstitial pneumonia; Respiratory failure
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100943884

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21120878. The patient was a 77-year-old (at vaccination) male. Body temperature before vaccination was 36.9 degrees centigrade. The family history was unknown. The patient was being treated for interstitial pneumonia and respiratory failure at another hospital. The patient had no history of allergy or anaphylaxis. On 15Jul2021 at 14:29 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jul2021 (a day after the vaccination), the patient experienced unknown cause of death. The course of the event was as follows: On 15Jul2021 (the day of vaccination), the patient visited the reporting hospital for the first time for receiving the first dose of BNT162b2 vaccination. On 16Jul2021, in the middle of the day, when the patient''s neighbor visited the patient, the patient was found to collapse on the bed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were interstitial pneumonia and respiratory failure. The reporting physician commented as follows: It was informed that the patient was in the end stage of interstitial pneumonia and respiratory failure. Since the patient did not have anaphylaxis, the death caused by the underlying diseases was highly likely.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1530211 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Body temperature, Decreased appetite, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hyperlipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade
CDC Split Type: JPPFIZER INC202100943892

Write-up: Apnoea; Inappetence; Somnolence; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121383. The patient was a 96-year and 10-month-old male. Body temperature before vaccination was 36.8 degrees centigrade. Family history was not reported. Medical history included hypertension, hyperlipidaemia, and dementia, for which the patient was visiting the reporting hospital. There were no other diseases that required avoiding the vaccination. The first vaccination was performed on 26Jun2021 and developed no adverse reactions. On 26Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date unknown) as single dose for COVID-19 immunization. On 17Jul2021 at 13:58 (the day of vaccination), the patient received?the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EW0207, Expiration date: 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Medical history included hypertension, hyperlipidaemia, and dementia. The patient''s concomitant medications were not reported. The patient experienced apnoea on 23Jul2021 11:00, inappetence and somnolence on 22Jul2021. The patient underwent lab tests and procedures which included body temperature: 36.8 centigrade on 17Jul2021. Therapeutic measures were taken as a result of apnoea. On 22Jul2021 (5 days after the vaccination, as reported), the patient experienced inappetence and tendency of somnolence. On 23Jul2021 at 11:00 (6 days after the vaccination, as reported), the patient experienced apnoea. The course of the event was as follows: On 17Jul2021 at around 14:00 (as reported, also reported as 13:58), the patient received the second dose of BNT162b2. He spent the subsequent 6 days as usual, but from the afternoon of 22Jul2021, inappetence and tendency of somnolence appeared and led him to stay in bed. On 23Jul2021 at around 11:00, the patient''s family member noticed that the patient did not show spontaneous breathing and requested ambulance transportation. Cardiopulmonary resuscitation was performed at the hospital but the patient was confirmed dead. On 24Jul2021 (7 days after the vaccination), the outcome of the apnoea was fatal, and the outcomes of the inappetence and somnolence were unknown. The patient died on 24Jul2021. It was not reported if an autopsy was performed. The reporting physician classified the event of apnoea as serious (death) and considered that the causality between the event and BNT162b2 was unassessable. The reporting physician did not provide the seriousness and causaltity for the events of inappetence and somnolence. The reporting physician considered that other possible causes of the event such as any other diseases were unassessable due to the patient''s advanced age. The reporting physician commented as follows: The causality was unknown. Opinion hearing was held by the local police.; Reporter''s Comments: The causality was unknown. Opinion hearing was held by the local police.; Reported Cause(s) of Death: Apnoea


VAERS ID: 1530213 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Respiratory arrest, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hepatocellular carcinoma; Palliative care
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20210710; Test Name: SpO2; Test Result: 65 %
CDC Split Type: JPPFIZER INC202100943910

Write-up: Death; respiration arrested; Oxygen saturation (SpO2) decreased to 65%; wheezing breath; laboured respiration; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21120880. A 92-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 09Jul2021 14:10 (Batch/Lot Number: FC8736; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing hepatocellular carcinoma and palliative care. The patient''s concomitant medications were not reported. On unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EW4811, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 10Jul2021 at 21:38 (1 day after the vaccination), the patient died. Cause of death was not provided. The course of the event was as follows: After the second dose of the vaccination, there was nothing unusual about the patient''s symptoms, and the patient was able to eat all of her dinner with total assistance. On 10Jul2021 at approximately 0:10, ten hours after the vaccination, the patient experienced wheezing breath and laboured respiration when a nurse went the rounds. Oxygen saturation (SpO2) decreased to 65%. Although treatment with oxygen inhalation was performed, respiratory status deteriorated gradually. On 10Jul2021 at 21:10 (31 hours after the vaccination), respiration arrested. On 10Jul2021 at 21:38, the patient was confirmed dead. The outcome of the event death was fatal, other events was unknown.Body temperature on 09Jul2021 was 36.8 centigrade. The reporting physician classified the event as serious (Death) and assessed that the event was related to BNT162b2. Other possible causes of the event such as any other diseases were hepatocellular carcinoma and cardiac failure congestive. The reporting physician commented as follows: The patient suffered from hepatocellular carcinoma for which she had been admitted at the palliative care ward. However, the symptoms were slowly-progressive, and no sign of aspiration was noted. As the cause of the death, a possibility of the vaccination was considered. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1530227 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100944502

Write-up: Death; This is a spontaneous report from a contactable physician received via Pfizer sales representative. A 74-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection), intramuscular on 24Jul2021 (Batch/Lot Number: EY5423; Expiration Date: 31Aug2021) at the age of 74 years old as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number and Expiration date unknown) on 30Jun2021. The patient experienced death on 25Jul2021. The course of the event was provided as follows: On 24Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. After the vaccination, no abnormalities were observed, and the patient went home. On 25Jul2021 (one day after vaccination), in the morning, the patient was found to collapse at his home by his family. The patient was transferred to the nearby hospital; however, he was confirmed to die. The patient died on 25Jul2021. It was not reported if an autopsy was performed. The causality between the event and BNT162b2 vaccination was not provided. Cause of death was not provided.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1530228 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-13
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Interstitial lung disease, Pyrexia
SMQs:, Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatism
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100944805

Write-up: interstitial pneumonia acute; pyrexia; This is a spontaneous report from a non-contactable pharmacist received via a Pfizer sales representative. A 9-decade-old female patient received bnt162b2 (COMIRNATY; Batch/Lot number was not reported), via an unspecified route of administration, on 29Jun2021, as dose 2, single for COVID-19 immunisation. Medical history included rheumatism. The patient''s concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (COMIRNATY, Lot/Expiration date: unknown) on unspecified date in 2021, for COVID-19 immunisation. On 13Jul2021 (14 days after the vaccination), it was reported that the patient experienced pyrexia and interstitial pneumonia acute. On 22Jul2021 (23 days after the vaccination), the outcome of the events was fatal. The course of the events was as follows: On 29Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination at another institution (detail was unknown). On 13Jul2021 (14 days after vaccination), the patient experienced pyrexia. On 21Jul2021 (22 days after vaccination), the patient was admitted to the reporting hospital. On 22Jul2021 (23 days after vaccination), the patient died due to interstitial pneumonia acute. The outcome of the events was fatal. The event seriousness and causality between the event and BNT162b2 was not provided. Information on the lot/batch number has been requested.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events interstitial pneumonia , pyrexia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: interstitial pneumonia acute


VAERS ID: 1530230 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-03
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, CSF test, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210530; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination; Test Date: 20210603; Test Name: Cerebrospinal fluid examination; Result Unstructured Data: Test Result:showed no abnormality; Comments: after vaccination
CDC Split Type: JPPFIZER INC202100945793

Write-up: Unconscious; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121011. A 75-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 30May2021 (Batch/Lot Number: FA2453; Expiration Date: 31Aug2021) (at the age of 75 years old) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had been unconscious on 03Jun2021 10:35. The course of the event was as follows: On 03Jun2021 at 10:35 (3 days after the vaccination), the family member who was living separately found the patient unconscious in the bathtub at home. After a call (emergency call) was made, the emergency crews arrived and confirmed that the patient was clearly dead. Cerebrospinal fluid examination showed no abnormality. No autopsy was performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. The reporting physician commented that it was unknown whether there were other possible causes or not. The patient underwent lab tests and procedures which included body temperature: 36.0 centigrade on 30May2021 before vaccination and Cerebrospinal fluid examination (after vaccination) showed no abnormality on 03Jun2021. The patient died on 03Jun2021. An autopsy was not performed.; Reported Cause(s) of Death: Unconscious


VAERS ID: 1530232 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Autopsy, Decreased appetite, Diarrhoea, Dyspnoea, Oxygen saturation, Physical deconditioning, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: AI; Result Unstructured Data: Test Result:diffuse lesions in the lung were recognized.; Comments: diffuse lesions in the lung were recognized. Either interstitial pneumonia or pulmonary oedema could be considered as direct cause; Test Date: 20210720; Test Name: the level with a pulse oximeter; Result Unstructured Data: Test Result:70s
CDC Split Type: JPPFIZER INC202100951725

Write-up: Apnoea; physical deconditioning; inappetence; breathing difficulty; vomiting; diarrhoea; This is a spontaneous report from a contactable other health professional (patient''s family member) received from the Regulatory authority. Regulatory authority report number is v21121012. A 79-year and 3-month-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FD0889, Expiration date 30Sep2021) an unspecified route of administration on 19Jul2021 at around 15:00 (at the age of 79 years old) as dose 2, single for COVID-19 immunization. Body temperature before vaccination was not reported. Medical history, concomitant medications, and family history were not provided. The patient received the first dose of BNT162b2 (Lot# EW0207, Expiration date 30Sep2021) an unspecified route of administration on 28Jun2021, as a single dose for COVID-19 immunization. On 19Jul2021 at around 23:00 (around 8 hours after the vaccination), vomiting and diarrhoea were noted. On 20Jul2021 (1 day after the vaccination), physical deconditioning, inappetence and breathing difficulty were noted. At around 22:45, the patient developed apnoea. At 23:40, the patient died. The course of the events was as follows: The information was obtained from the patient''s family member. On 19Jul2021 at around 23:00, vomiting and diarrhoea appeared. The patient''s eldest son noticed that the patient went to the bathroom more frequently than usual at night (it was unknown how frequent times he went). On 20Jul2021 in the morning, physical deconditioning was noted. The patient did not eat breakfast. The level (SpO2 [oxygen saturation percutaneous]) measured with a pulse oximeter was in the range of 70. The patient himself said that he was fine. At 09:00, the patient''s wife had something to do and went out. The eldest son stated that the patient seemed to have difficulty in breathing. The patient said that he had diarrhoea twice. Although the eldest son advised him to go to a hospital, he said that he was fine. At 15:00, when the wife returned home, it seemed that the patient still felt sick. He ate a small amount of jelly but seemed to spit it on the tissue later. At around 22:00, the patient could have a conversation, however, at around 22:45, it was found the patient did not breathe. Therefore, an emergency service was requested. While transferring the patient to a hospital, the emergency service team performed cardiopulmonary resuscitation. After arrived at a hospital, cardiopulmonary resuscitation was continuously performed, but it did not work. At 23:40, the patient''s death was pronounced. The outcome of the event ''apnoea'' was fatal, for the rest of the events was unknown. The patient died on 20Jul2021. An autopsy was performed that revealed diffuse lesions in the lung were recognized. either interstitial pneumonia or pulmonary oedema could be considered as direct cause. The reporting other health professional classified the event ''apnoea'' as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Reporter''s comment: Based on the results of AI (autopsy imaging) which performed after the patient died, diffuse lesions in the lung were recognized. Either interstitial pneumonia or pulmonary oedema could be considered as direct cause. The patient''s previous lung state was uncertain, but given the fact that his physical condition worsened and he made a poor progress after 19Jul2021, it was considered that the causal relationship with BNT162b2 could not be ruled out. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Based on the results of AI (autopsy imaging) which performed after the patient died, diffuse lesions in the lung were recognized. Either interstitial pneumonia or pulmonary oedema could be considered as direct cause. The patient''s previous lung state was uncertain, but given the fact that his physical condition worsened and he made a poor progress after 19Jul2021, it was considered that the causal relationship with BNT162b2 could not be ruled out.; Reported Cause(s) of Death: Apnoea; Autopsy-determined Cause(s) of Death: diffuse lesions in the lung were recognized. Either interstitial pneumonia or pulmonary oedema could be considered as direct cause; diffuse lesions in the lung were recognized. Either interstitial pneumonia or pulmonary oedema could be considered as


VAERS ID: 1530234 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-07-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-07-02
   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: Hospitalisation; Transient ischaemic attack
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100951751

Write-up: Sudden cardiac death; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121146. The patient was a 92-year-old female. Body temperature before vaccination was 36.2 degrees centigrade. Family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Medical history included patient had been hospitalized for transient ischaemic attack. The patient''s concomitant medications were not reported. On an unknown date at unknown time, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, lot number not reported, expiration date not reported) for COVID-19 immunisation. On 18Jun2021 at 13:15 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as DOSE 2, SINGLE (single dose) for COVID-19 immunisation. On 02Jul2021 at 14:38 (14 days after the vaccination), the patient experienced sudden cardiac death. On 02Jul2021 (14 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had been hospitalized for transient ischaemic attack. Patient improved and suddenly died during preparation for discharge. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported whether there were other possible causes of the event such as any other diseases. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1530235 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100951815

Write-up: Death; This is a spontaneous report from a non-contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 62-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified antihypertensive drug within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19: Unknown. The patient had no allergies to medications, food, or other products. Other medical history included hypertension. On 03Jul2021 at 13:30, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY3860, Expiration date 31Aug2021) at the age of 62-year-old, intramuscular, left arm for COVID-19 immunisation. On 24Jul2021 at 13:30 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FD1945, Expiration date 31Oct2021) at the age of 62-year-old, via intramuscular route of administration in the arm left for COVID-19 immunisation. On 26Jul2021 (one day/10 hours/30 minutes after the vaccination), the patient experienced death. The event resulted in death. It was unknown if the autopsy was performed. The outcome of the event was fatal with unknown treatment. The reporting physician assessed the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19: Unknown. The reported event was as follows: On 26Jul2021, the patient died. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on current convention, the reported death is assessed as related to BNT162b2 until sufficient information is available to confirm an unrelated cause of death. Case will be reassessed once receiving additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Death


VAERS ID: 1530248 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-28
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy; Forearm fracture; Hip prosthesis user
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100963618

Write-up: Died at home; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A non-pregnant 73-year-old female patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via intramuscular in the arm right on 16Jul2021 at 14:00 for COVID-19 immunization at the age of 73-year-old. Medical history included bilateral hip prosthesis and forearm fracture right (the details were unknown). The patient had allergy to kelp. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 28Jul2021 (12 days after the vaccination), the patient died at home. The event resulted in death. The outcome of the event was fatal without treatment. The reporting physician assessed the event as serious (death). Cause of death was reported as unknown at the time of report. It was unknown that autopsy was performed or not.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: unknown at the time of report


VAERS ID: 1530251 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-06-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral disorder, Computerised tomogram, Hydrocephalus, Investigation, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (Chronic rheumatoid arthritis was reported.)
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: Before vaccination; Test Date: 20210630; Test Name: computed tomography; Result Unstructured Data: Test Result:subarachnoid haemorrhage and acute hydrocephalus; Comments: subarachnoid haemorrhage and acute hydrocephalus was diagnosed; Test Date: 20210630; Test Name: first medical examination; Result Unstructured Data: Test Result:unknown results; Comments: patient was already in comatose
CDC Split Type: JPPFIZER INC202100964346

Write-up: Bilateral cerebral disorder; Subarachnoid haemorrhage; Acute hydrocephalus; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121646.?? An 86-year-old female patient received 2nd dose of BNT162B2 (COMIRNATY, lot number FC5947, expiration date 30Sep2021) at single dose on 30Jun2021 13:58 via an unknown route at 86-year-old for COVID-19 immunisation. Body temperature before vaccination was 37.0 degrees centigrade. Medical history included chronic rheumatoid arthritis. Family history was not reported. Concomitant drugs included acetylsalicylic acid (BAYASPIRIN). On 30Jun2021 at 13:58 (the day of vaccination), the patient BNT162b2 (COMIRNATY). On 30Jun2021 at around 23:00 (around 9 hours 2 minutes after the vaccination), the patient presented with the symptoms that were diagnosed as subarachnoid haemorrhage, and acute hydrocephalus. On 18Jul2021 (18 days after the vaccination), the patient experienced bilateral cerebral disorder. On 19Jul2021 at 03:30 (19 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 30Jun2021 at around 18:00, the patient completed the preparation of supper (this was assumed by the patient''s family member), but at around 23:00, the patient''s oldest son found her lying unconscious. She was then transferred to medical center A. According to the referral provided by the medical center A, the patient was already in comatose at the first medical examination. Based on the results of head computed tomography, subarachnoid haemorrhage and acute hydrocephalus was diagnosed, for which external ventricular drainage was performed. On 18Jul2021, the patient''s condition suddenly changed, with rehaemorrhage and diffuse damage in the bilateral cerebral hemisphere noted. On 19Jul2021 at 15:30, the patient died. Outcome of the events subarachnoid haemorrhage, acute hydrocephalus, and bilateral cerebral disorder was fatal. The reporting physician classified the event as serious(death) and assessed that the causality between the event and BNT162b2 was unassessable. Other possible cause of the event such as any other diseases was not reported.; Reported Cause(s) of Death: Subarachnoid haemorrhage; Acute hydrocephalus; bilateral cerebral disorder


VAERS ID: 1530253 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Marasmus
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100964597

Write-up: Death due to senility; Blood pressure dropped transient; This is a spontaneous report from a contactable physician received via a company representative. The patient was a 90-year-old female. Underlying disease/complication was unknown. Other medications were not reported. On 25Jun2021 at unknown time, the patient aged 90 previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) for COVID-19 immunisation. On 16Jul2021 at unknown time (the day of vaccination), the patient aged 90 received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 17Jul2021 (1 day after the vaccination), the patient experienced blood pressure dropped transient; the outcome of this event was recovered on an unknown date. On 23Jun2021 at unknown time (7 days after the vaccination), the patient experienced death due to senility. On 23Jun2021 (7 days after the vaccination), the outcome of the event death due to senility was fatal. The course of the event was as follows: On 25Jun2021, the first vaccination was given. On 16Jul2021 (the day of vaccination), the second vaccination was given. On 17Jul2021 (1 day after the vaccination), the blood pressure temporarily decreased but spontaneously recovered. On 23Jun2021 (7 days after the vaccination), the patient experienced death due to senility. The dietary intake had been gradually decreasing since before the vaccination, and there were no unusual points for the cause of death. The reporting physician classified the event death due to senility as serious (death) and blood pressure dropped transient was serious but not provided seriousness criteria. The reporting physician reported that the vaccine was possibly related to blood pressure dropped transient and unrelated to death. The reporting physician commented that a direct causal relationship with the vaccine was unlikely.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Marasmus and Blood pressure decreased cannot be totally excluded.; Reported Cause(s) of Death: Death due to senility


VAERS ID: 1530255 (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: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   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: Chemotherapy; Lung cancer; Oxygen therapy (home oxygen therapy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100966299

Write-up: Respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121858. An 85-year and 4-month-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0583, Expiration date 31Oct2021) on 27Jul2021 at single dose for COVID-19 immunisation. Body temperature before vaccination was 36.1 degrees centigrade. Family history was not reported. Medical history included ongoing lung cancer, ongoing receiving home oxygen therapy (HOT) and ongoing chemotherapy/under treatment with anticancer drug. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot number unknown, Expiration date unknown) on an unspecified date at single dose for COVID-19 immunisation. On 27Jul2021 at an unknown time (the day of vaccination), the patient received the second dose of BNT162B2. On the morning of 28Jul2021 (1 day after the vaccination), the patient experienced respiratory arrest. On 28Jul2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 27Jul2021, the patient with no significant change went home after the vaccination. On the morning of 28Jul2021, the family found the patient was not breathing. The death was confirmed at a destination. The patient died on 28Jul2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were lung cancer and receiving HOT and chemotherapy.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1530256 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Myotonic dystrophy
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100966359

Write-up: Death 3 hours after the vaccination; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121763. The patient was a 55-year and 11-month-old male. Body temperature before vaccination was 36.2 degrees Centigrade. The patient had no family history. Medical history included myotonic dystrophy and diabetes mellitus. On 05Jul2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FD1945, Expiration date 31Oct2021) via unspecified route single dose for COVID-19 immunisation. On 26Jul2021 at 15:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection) via unspecified route single dose for COVID-19 immunisation. On 26Jul2021 at 18:30 (the same day of the vaccination), the patient died. The course of the event was as follows: The patient regularly went to another hospital for treatment of myotonic dystrophy and diabetes mellitus. On 05Jul2021, the patient received the first dose of COVID-19 vaccine. Then, clinical course was uneventful. On 26Jul2021, the day of the second dose of COVID-19 vaccine, his body temperature before vaccination was 36.2 degrees Centigrade. Although the patient had difficulty in moving his body from the primary disease, it was considered that the patient was able to be vaccinated on the basis of vaccine screening questionnaire and general condition. After consent was obtained, the patient received the second dose of COVID-19 vaccine at 15:30 (26Jul2021). Then, the patient returned home, and he couched soon. At 18:30 (26Jul2021), his family found the patient was down. The patient died. On 27Jul2021, autopsy was performed. On 28Jul2021, the reporting physician was informed by phone; there was no obvious abnormality. The reporting physician classified the event as serious (Death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was unassessable as the reporting physician described above. The reporting physician commented as follows: The symptom of anaphylaxis was not noted. There was no obvious abnormality at postmortem inspection (autopsy), but the results would be obtained 60 days after the intramuscular vaccination. The causal relationship was unassessable; however, causality with the vaccine could not be denied, because the patient died suddenly just 3 hours after the vaccination. Thus, this case was reported here.; Reported Cause(s) of Death: Death 3 hours after the vaccination


VAERS ID: 1530258 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 55
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100966981

Write-up: Cellulitis; Geromarasmus; This is a spontaneous report from a contactable physician received from the Regulatory authority. The regulatory authority report number is v21121887. A 95-year and 4-month-old male patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular at single dose in the left deltoid on 01Jun2021 at the age of 95-year-old for COVID-19 immunization. Body temperature before vaccination was not provided. The first dose was in 2021. Medical history and concomitant medication were not reported. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 02Jun2021 (one day after the vaccination), the patient experienced cellulitis. On 08Jun2021 (7 days after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 01Jun2021 (the day of vaccination), the patient received the second dose of BNT162B2 vaccination. On 02Jun2021 (one day after vaccination), in the morning, the patient had redness, swelling, feeling hot, and pain from the left elbow joint to the hand. The patient visited another clinic, where he was diagnosed with cellulitis, and oral administration of potassium clavulanate/amoxicillin hydrate (AUGMENTIN) and amoxicillin hydrate (SAWACILLIN) was initiated. However, no improvement was observed, and since several days before, the patient became unable to take meals. Thus, the patient was referred to and visited the reporting hospital on 08Jun2021 (7 days after vaccination). On 08Jun2021 (7 days after vaccination), no redness and pain on the left upper arm was noted. Oedema remained. It was diagnosed that the cellulitis was improving. Thereafter, the patient experienced geromarasmus in Jun2021. On 26Jul2021 (one month and 25 days after vaccination), the patient died due to geromarasmus. It was unknown if an autopsy was performed or not. The outcome of events was fatal. The reporting physician classified the events as serious (hospitalization and death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not reported. The lot number for the vaccine BNT162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cellulitis; Geromarasmus


VAERS ID: 1530260 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100970145

Write-up: Suicide; This is a spontaneous report from a non-contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A 39-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 21Jul2021 16:30 at age of 39-year-old as dose 1, single for COVID-19 immunisation. Medical history included schizophrenia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had allergies. The patient''s concomitant medications were not reported. On 28Jul2021 at 16:30 (7 days after the vaccination), the patient experienced suicide. The event resulted in death. The patient died on 28Jul2021. It was not reported if an autopsy was performed. The outcome of the event was fatal without treatment. The reporting physician assessed the event as serious (death). No causality assessment was provided. Since the vaccination, the patient has not been tested for COVID-19. Information on lot/batch number has been requested.; Sender''s Comments: Fatal event suicide represents an intercurrent medical condition and unrelated to bnt162b2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Suicide


VAERS ID: 1530261 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100970163

Write-up: acute myocardial infarction; This is a spontaneous report from a non-contactable physician received via Regulatory authority. A non-pregnant 65-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 02Jul2021 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included carcinoma. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications were not reported. On 02Jul2021 at unspecified time (the day of vaccination), the patient received?the first single dose of BNT162b2. On 10Jul2021 at unspecified time (eight days after the vaccination), the patient experienced acute myocardial infarction. On 17Jul2021 at unspecified time (fifteen days after the vaccination), the patient died from acute myocardial infarction. Autopsy was not performed. The outcome of the event was fatal with unspecified treatment. The reporting physician assessed the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Limited information can not support a complete medical assessment. A possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of acute myocardial infarction due to temporal relationship. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1530262 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Body temperature, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   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: Medical History/Concurrent Conditions: Cardiac failure; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100970223

Write-up: Apnoea; Shortness of breath; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121888. A 93-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration at the age of 93-year-old on 24Jul2021 14:00 (Lot Number: FC3661; Expiration Date: 30Sep2021) as single dose for COVID-19 immunisation. Medical history included cardiac failure and hypertension. The patient was a 93-year and 7-month-old female. Body temperature before vaccination was 36.8 degrees centigrade on 24Jul2021. The family history was not provided. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY) in 2021 for COVID-19 immunisation. On 27Jul2021 (3 days after the vaccination), the patient experienced shortness of breath. On 28Jul2021 (4 days after the vaccination), the patient experienced apnoea. On 29Jul2021 (5 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient visited a hospital regularly for cardiac failure, hypertension, and others. On 24Jul2021 at 14:00 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 27Jul2021 (3 days after vaccination) (as reported), the patient experienced shortness of breath, and she went to the duty at night, and she went home without abnormalities. On 28Jul2021 (4 days after vaccination) (as reported), the patient was found to have apnoea at dinner by her family. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was cardiac failure. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination was considered unlikely considering the length of time that has elapsed after the vaccination, and the patient''s age. However, this case was reported. The patient underwent lab tests and procedures which included body temperature: 36.8 centigrade on 24Jul2021 (Before vaccination). The patient died on 29Jul2021. It was not reported if an autopsy was performed. The outcome of events was fatal.; Reported Cause(s) of Death: Apnoea; shortness of breath


VAERS ID: 1530263 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-11
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood fibrinogen, Blood urea, Body temperature, C-reactive protein increased, Deep vein thrombosis, Disseminated intravascular coagulation, Fibrin D dimer, Fibrin degradation products, Haemoglobin, Peripheral artery occlusion, Platelet count, Pyrexia, Skin exfoliation, Vomiting, White blood cell count
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210611; Test Name: CRP; Result Unstructured Data: Test Result:12.2; Test Date: 20210616; Test Name: fibrin d dimer; Result Unstructured Data: Test Result:138.4 mg/ml; Test Date: 20210616; Test Name: FDP; Result Unstructured Data: Test Result:164.0 mg/ml; Test Date: 20210611; Test Name: Hb; Result Unstructured Data: Test Result:12.6; Test Date: 20210616; Test Name: platelet count; Result Unstructured Data: Test Result:3,6000 uL; Test Date: 20210611; Test Name: PLT; Result Unstructured Data: Test Result:8,0000; Test Date: 20210611; Test Name: WBC; Result Unstructured Data: Test Result:8600; Test Date: 20210611; Test Name: Creatinine; Result Unstructured Data: Test Result:4.06; Test Date: 20210616; Test Name: fibrinogen; Test Result: 46.4 mg/dl; Test Date: 20210611; Test Name: BUN; Result Unstructured Data: Test Result:62.2; Test Date: 20210611; Test Name: body temperature; Result Unstructured Data: Test Result:39 to 40 Centigrade
CDC Split Type: JPPFIZER INC202100970246

Write-up: skin peeling; Disseminated intravascular coagulation; deep vein thrombosis of the right lower limb; arterial occlusion of the right lower limb; pyrexia of 39 to 40 degrees Celsius; vomiting; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121902. A 95-year-old and 10-month-old female patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 24May2021 (Lot number unknown, Expiration date unknown) at the age of 95-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Body temperature before vaccination was not provided. The family history was not provided. The patient received the first dose of BNT162B2 via an unspecified route of administration on 30Apr2021 (Lot Number: unknown; Expiration date: unknown) as single dose for COVID-19 immunization. The clinical course was as follows: On 13Jun2021 (20 days after the vaccination), the patient experienced disseminated intravascular coagulation, deep vein thrombosis of the right lower limb, and arterial occlusion of the right lower limb. The outcome of the event was fatal. On 30Apr2021, the patient received the first dose of COVID-19 vaccine. On 11Jun2021 (18 days after vaccination), since the patient had pyrexia of 39 to 40 degrees Celsius and vomiting, fluid replacement was administered at her nearby hospital. On 13Jun2021 (20 days after vaccination), the patient had oedema right lower limb. On 15Jun2021 (22 days after vaccination), the patient had discoloration of the right lower limb, and she visited the reporting hospital on 16Jun2021 (23 days after vaccination). The platelet count was 3,6000/uL, the FDP was 164.0 mg/mL, D-dimer was 138.4 mg/mL, and the fibrinogen was 46.4 mg/dL. Thus, the patient met the diagnostic criteria of disseminated intravascular coagulation. The intravascular ultrasound showed deep vein thrombosis of the right lower limb, and moreover, the arterial blood flow below the right knee decreased. Subcutaneous bleeding was noted in a wide range of the right lower limb. The discoloration of the skin was aggravated, and the tip of the toe became black. The patient had skin peeling on the whole legs. Although the patient was treated, she died on 21Jun2021 (28 days after vaccination). (On 11Jun2021, the blood examination at her nearby hospital showed WBC of 8600, Hb of 12.6, PLT of 8,0000, BUN of 62.2, Cr of 4.06, and CRP of 12.2.). The reporting physician classified the event as serious (death) and assessed that the causality between the event and COVID-19 vaccine as unassessable. Other possible cause of the event such as any other diseases was as follows: The possibility could not be ruled out that the event was caused by other infection. The reporting physician commented as follows: It was considered important that thrombosis was noted both on the arteries and veins. The event of disseminated intravascular coagulation caused patient died. It was not reported about autopsy. The outcome of pyrexia, vomiting and skin peeling was unknown. The outcome of other events was fatal. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Disseminated intravascular coagulation


VAERS ID: 1530264 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure reading high
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100970406

Write-up: Death due to heart attack; falling; cardiopulmonary arrest; This is a spontaneous report from a contactable physician via a sales representative. The patient was a 91-year-old male. Medical history included mild high blood pressure. Body temperature before vaccination, family history, and concomitant medication were not reported. On 09Jul2021 (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number, Expiration date and Dose number were not reported) via an unspecified route of administration at single dose for COVID-19 immunization. On 19Jul2021 (10 days after the vaccination), the patient experienced death due to heart attack. Around noon, the patient was found falling and being in cardiopulmonary arrest while cutting the grass. The patient had no trauma. The reporting physician determined that the patient died from heart attack. The outcome of the event death due to heart attack was fatal, outcome of other events were unknown. The cause of death was heart attack. It was unknown if autopsy was done. The reporting physician reported that the event was unrelated to BNT162b2. The reporting physician commented that the patient was elderly; however, he had few underlying diseases and only had mild high blood pressure. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: based on the avaialable information the causality between the suspect vaccine BNT162B2 and the fatal events heart attack , cardiopulmonary arrest cannot be completely ruled out , case can be assessed once the further information is available . patient also suffers from underlying medical conditions which could also be possible additive factor for the fatal event .; Reported Cause(s) of Death: Death due to heart attack


VAERS ID: 1530265 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 34
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: RELVAR ELLIPTA [FLUTICASONE FUROATE;VILANTEROL TRIFENATATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma; Hypertension; Interstitial pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: body temperature; Result Unstructured Data: Test Result:normal; Comments: before vaccination; Test Date: 20210720; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 degrees Celsius
CDC Split Type: JPPFIZER INC202100970410

Write-up: possible interstitial pneumonia aggravated; Unknown cause of death; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121907. The patient was an 82-year and 1-month-old female. On 16Jun2021 (as reported) at unknown time (the day of vaccination) (at age of 82-year-old), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a dose2, single dose for COVID-19 immunization. Body temperature before vaccination was normal. The patient family history was not reported. Medical history included interstitial pneumonia, hypertension and bronchial asthma. Concomitant medication included fluticasone furoate/vilanterol trifenatate (RELVAR200ELLIPTA). On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not reported). On 20Jun2021 at unknown time (four days after the vaccination), the patient experienced interstitial pneumonia. On 23Jun2021 (seven days after the vaccination), the patient was admitted to the hospital. On 24Jul2021 (about one month and one week after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was regularly going to hospital for interstitial pneumonia and bronchial asthma. She was under the treatment of Home Oxygen Therapy (HOT) at 0.5 liter/min. On 16Jun2021, the patient received the vaccination. On 20Jul2021 (as reported), the patient started to have pyrexia at 37.5 degrees Celsius. Malaise aggravated. On 23Jun2021, the patient presented to hospital due to the worsening of breathing difficulty, and she was hospitalized with interstitial pneumonia aggravated. Steroid pulse therapy was performed. Oxygenation showed a shift to improve, but general physical condition worsened gradually, and the patient died on 24Jul2021 at 13:24. The reporting physician classified the event as serious (fatal) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was possible interstitial pneumonia aggravated. The reporting physician commented as follows: It was a case that interstitial pneumonia aggravated after receiving the COVID-19 vaccine. The causal relationship was unknown.; Reporter''s Comments: It was a case that interstitial pneumonia aggravated after receiving the COVID-19 vaccine. The causal relationship was unknown.; Reported Cause(s) of Death: Unknown cause of death; possible interstitial pneumonia aggravated


VAERS ID: 1530321 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100948862

Write-up: not feeling well; muscle pain; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00632378. A 77-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration (at the age of 77-years-old) on 13Jun2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient received first dose of Comirnaty on an unspecified date at 0.3 ml, single dose for covid-19 immunisation. On 13Jun2021, the patient experienced malaise and myalgia following administration of covid-19 vaccine. The event was treated with placing a stent. The patient died on an unspecified date. It was not reported if an autopsy was performed. Sender''s comments: Due to inconsistency between latency time and start of reaction, latency time was removed. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information expected.; Reporter''s Comments: Previous COVID-19 infection: No Diagnostic procedures: yes; Reported Cause(s) of Death: Myalgia; Malaise


VAERS ID: 1530323 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100948791

Write-up: Nausea; Fatigue; Headache; Cardiac arrest; This is a spontaneous report from a contactable consumer downloaded from the Regulatory authority, regulatory authority number NL-LRB-00632999 reporting the similar events for the 2 patients. This is one of 2 reports. A 77-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 24May2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had the first dose of bnt162b2 (COMIRNATY) on 19Apr2021 (batch/lot # not provided) for COVID-19 immunization and had headache and nausea. Then, the 2nd dose on 24May2021. On 25May2021, the patient had nausea, fatigue, headache. Then, the patient had cardiac arrest on that same day, then resuscitation (CPR) was provided. The patient then died due to the events on unknown date in 2021. The outcome of the events was considered as fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. Information on lot and batch numbers cannot be obtained; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202100961707 same patient/ drug, different event/doses; Reported Cause(s) of Death: cardiac arrest, then CPR, then died; nausea; fatigue; headache


VAERS ID: 1530324 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
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? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 8
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100949036

Write-up: Severe CVA, death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB. The regulatory authority number is NL-LRB-00633770. A 78-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Jul2021 (Batch/Lot Number: Unknown) as single dose (at the age of 78-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 13Jul2021, the patient experienced severe cerebrovascular accident (CVA), death. The event was considered serious, death, life threatening, disabling or incapacitating by the regulatory authority. The patient died on 21Jul2021 with cause of death reported as "Because of the vaccination!! Result of severe CVA". It was not reported if an autopsy was performed. Reporter comment: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine(Comirnaty): unknown No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine(Comirnaty): unknown; Reported Cause(s) of Death: Because of the vaccination!! Result of severe CVA


VAERS ID: 1530327 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Inappropriate schedule of product administration, Oedema peripheral, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Angioedema (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 58
Permanent Disability? 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: Heart failure; Renal disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100967105

Write-up: Heart failure; Had poor kidneys; lot of fluid in the legs/leg edema; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer or other non-HCP downloaded from the Regulatory authority NL-LRB-00637747. This is first of two reports, for the second dose. An 81-year-old female patient received the 2nd dose of BNT162B2 (COMIRNATY, lot number: unknown) via an unspecified route of administration on 14Apr2021 at age of 81 year old as single dose for COVID-19 immunisation. Medical history renal disorder and heart failure. Concomitant medications included non-specified diuretic. The patient previously received the 1st dose of BNT162B2 (COMIRNATY) on 18Feb2021 for COVID-19 immunisation, experienced leg oedema. The patient experienced lot of fluid in the legs/leg edema on 16Apr2021, heart failure and had poor kidneys on an unspecified date; inappropriate schedule of vaccine administered on 14Apr2021. Treatment: Leg edema was treated with morphine. Heart failure and had poor kidneys were reported as cause of death. It was unknown if autopsy was performed. Confounding factors: Kidney problems. The patient had no previous COVID-19 infection. The outcome of heart failure, had poor kidneys and lot of fluid in the legs/leg edema was fatal. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202100972363 same patient/drug, different dose of vaccine, different events; Reported Cause(s) of Death: lot of fluid in the legs/leg edema; Heart failure; Had poor kidneys


VAERS ID: 1530328 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Asthenia, Dysphagia, Investigation, Pain in extremity
SMQs:, Anticholinergic syndrome (broad), Dementia (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), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: many examinations; Result Unstructured Data: Test Result: Nothing came out of scans.
CDC Split Type: NLPFIZER INC202100967103

Write-up: lose power/loss of strength; swallow problems; Speech loss; Sore legs; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00639577. A 78-years-old female patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 12Apr2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. No previous COVID-19 infection. One week after starting vaccination, the patient experienced lose power/loss of strength, swallow problems, speech loss, sore legs. The patient had many examinations in hospital. Nothing came out of scans. Likely neurological side effects of Pfizer. They didn''t want to be examined. Outcome of the events was fatal. The patient died on 11Jul2021. It was not reported if an autopsy was performed. Sender Comment: Due to an inconsistency between latency time and started date of the reactions, the start date was removed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: lose power/loss of strength; swallow problems; Speech loss; Sore legs


VAERS ID: 1530329 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cough, Fatigue, Haemoptysis, Hyperpyrexia, Malaise, Myalgia, Pneumonia, SARS-CoV-2 test, Sepsis, Vaccination site pain, Vaccination site pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (allergy test has led to severe rash on arms,); Allergy to antibiotic (allergy: various antibiotics); Allergy to arthropod bite (hypersensitive reactions to mosquito bites); Hay fever
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: hyperpyrexia; Result Unstructured Data: Test Result:40.5 to 42 Centigrade; Test Date: 20210701; Test Name: coronatest negative; Test Result: Negative
CDC Split Type: NLPFIZER INC202100987893

Write-up: Muscle pain; Coughing blood; Cough; Suspected pneumonia; Not feeling well; resulting in sepsis; Fatigue; Fever: 40.5 to 42 degrees Celcius; Reaction at or around the injection site: pain; Reaction at or around the injection site: itching; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory authority, regulatory authority number NL-LRB-00644523. This is first of two reports. A 66-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 09Jun2021 (age at vaccination: 66-year-old) as single dose for covid-19 immunization. Medical history included allergy to various antibiotics, hypersensitive reactions to mosquito bites, allergy test has led to severe rash on arms, hay fever all from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included first dose of Comirnaty on 05May2021 as 0.3 ml single dose for covid-19 immunization and experienced Arm discomfort. Patient did not diagnose with covid-19 prior to vaccination. Other diagnostic procedures was reported as no. It was reported within 1 day patient experienced injection site pain and injection site pruritus. On 29Jun2021 patient experienced cough, suspected pneumonia, not feeling well, resulting in sepsis, fatigue, fever: 40.5 to 42 degrees Celsius and on 30Jun2021 patient experienced coughing blood. It was reported Suspected pneumonia resulting in sepsis: From 29Jun2021 high fever and cough, 30Jun2021 corona test was advised, 01Jul2021 tested negative. Coughing up blood 30Jun2021. 02Jul2021 called GP again, advised to watch as fever decreased a bit and to contact him if fever increased. 05 or 06Jul deceased. The patient underwent lab tests and procedures which included body temperature: 40.5 to 42 centigrade on 29Jun2021, sars-cov-2 test: negative on 01Jul2021. The patient died on 06Jul2021. It was not reported if an autopsy was performed. The outcome for the event injection site pain, injection site pruritus was resolved on 2021. Reporter Comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Rigid arm Date: 05May2021. Suspected pneumonia resulting in sepsis: Additional information ADR: From 29Jun high fever and cough, 30Jun coronatest advised, 01Jul tested negative. Coughing up blood 30Jun. 02Jul called GP again, advised to watch as fever decreased a bit and to contact him if fever increased. 05/06Jul deceased No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Rigid arm Date: 05May2021 Suspected pneumonia resulting in sepsis: Additional information ADR: From 29Jun high fever and cough, 30Jun coronatest advised, 01Jul tested negative. Coughing up blood 30Jun. 02Jul called GP again, advised to watch as fever decreased a bit and to contact him if fever increased. 05/06Jul deceased; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202100996461 same patient, different dose; Reported Cause(s) of Death: Pneumonia + sepsis; Pneumonia + sepsis


VAERS ID: 1530338 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-07-07
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2083 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure systolic, Coma scale, Computerised tomogram head, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:more than 200 mmHg; Comments: At the first pre-hospital examination he had high systolic blood pressure, $g 200 mmHg; Test Date: 20210707; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:7; Comments: At the first pre-hospital examination he was unconscious with a GCS score of 7; Test Date: 20210707; Test Name: CT brain scan; Result Unstructured Data: Test Result:severe subarachnoid and parenchymal haemorrhage; Comments: CT scan revealed severe subarachnoid and parenchymal haemorrhage after rupture of aneurism in arteria cerebri media left side in M2.
CDC Split Type: NOPFIZER INC202100966982

Write-up: Subarachnoid hemorrhage from the left side of the cerebral artery; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority. Report number; NO-NOMAADVRE-FHI-2021-Un27x5. Safety Report Unique Identifier is NO-NOMAADVRE-E2B_00039012. A 67-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot no FE2083) on 24Jun2021 12:00 intramuscular in left arm on 24Jun2021 12:00 for COVID-19 immunisation. Medical history and concomitant drug were not provided. The patient was previously healthy. Historical vaccine included the first dose BNT162B2 (COMIRNATY, lot no EX6564) on 12May2021 for COVID-19 immunisation. Thirteen days after the second dose, on 07Jul2021, he developed subarachnoid haemorrhage from arteria cerebri media left side. At the first pre-hospital examination he was unconscious with a GCS score of 7 and high systolic blood pressure, $g 200 mmHg. He was acutely hospitalized and still unconscious on arrival at the hospital. CT scan revealed severe subarachnoid and parenchymal haemorrhage after rupture of aneurism in arteria cerebri media left side in M2. The patient died two days later, 09Jul2021. Outcome of the event was fatal. The reactions are serious, and the outcome was fatal. The causality assessment was possible. The reporter will forward the discharge journal, and try to get information on any possible risk factors. The report was assessed as serious with death, hospitalization, and life-threating. The Regional Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Subarachnoid hemorrhage from the left side of the cerebral artery


VAERS ID: 1530346 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202100968149

Write-up: death; This is a spontaneous report from a contactable other health professional via the Regulatory authority (Regulatory authority number unknown). A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced death on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1530347 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202100968201

Write-up: death; This is a spontaneous report from a contactable other health professional via the Regulatory authority (Regulatory authority number unknown). A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. The patient died on an unspecified date. The outcome of the event was fatal. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1530348 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202100968209

Write-up: death; This is a spontaneous report from a contactable other health professional via the Regulatory authority (Regulatory authority number unknown). A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for an unspecified indication. The medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1530352 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-21
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202100970919

Write-up: sudden death; This is a spontaneous report from a contactable HCP. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300093386. A 58-year-old male patient received an unknown dose of BNT162B2 (COMIRNATY) via intramuscular on 05Jul2021 (Batch/Lot Number: FD5996) at the age of 58-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 21Jul2021 at 22:30, the patient experienced sudden death. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1530353 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202100970920

Write-up: Fever; cough; colds; Shortness of breath; body malaise; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory authority. Regulatory authority report number PH-PHFDA-300093397. A 72-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly on 24Jun2021 (at the age of 72 years old) (Lot Number: FD5996) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever (death) on 28Jun2021, cough (death) on 28Jun2021, colds (death) on 28Jun2021, shortness of breath (death) on 28Jun2021, body malaise (death) on 28Jun2021. The patient died on 28Jun2021. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever; cough; colds; shortness of breath; body malaise


VAERS ID: 1530354 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat
SMQs:, Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202100970921

Write-up: cold and clammy skin; This is a spontaneous report from a contactable other health professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300093403. A 53-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 30Jun2021 (at the age of 53 years old) (Lot Number: FD5996) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cold and clammy skin (death) on 07Jul2021. It was reported that the patient usually woke up at 3am in the morning but on 07Jul2021, when the helper tried to wake her up. She noticed that the patient was not moving and has cold and clammy skin. The patient died on 07Jul2021. It was unknown if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: cold and clammy skin


VAERS ID: 1530355 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-07
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Cough, Dyspnoea, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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: PHPFIZER INC202100970922

Write-up: difficulty of breathing; cough; fever; abdominal pain; vomiting; This is a spontaneous report from a contactable other HCP. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300093416. A 85-year-old female patient received bnt162b2 (COMIRNATY), via intramuscular on 28Jun2021 (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 cough (death) and fever (death) both on 09Jul2021, difficulty of breathing (death) on 11Jul2021, abdominal pain (death) and vomiting (death) both on 07Jul2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: cough; fever; difficulty of breathing; Abdominal pain; Vomiting


VAERS ID: 1530356 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-15
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cough, Nasopharyngitis
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad)

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202100970923

Write-up: general weakness; cough and colds; cough and colds; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300093569. A 76-years-old male patient received bnt162b2 (COMIRNATY), at the age of 76-years-old intramuscular on 30Jun2021 (Lot Number: FD5996) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced general weakness, cough and colds on 15Jul2021, all resulted in death. The patient died on 15Jul2021. 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: general weakness; cough and colds; cough and colds


VAERS ID: 1530357 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Dysarthria, Haematoma, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202100970924

Write-up: Slight fever; Back pain; Vomiting; Slurred speech; Hematoma on both thighs; This is a spontaneous report from a contactable other healthcare professional, received from the Regulatory Authority. The regulatory authority report number is PH-PHFDA-300093707. A 64-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FD5996) via intramuscular on 14Jul2021 (at the age of 63-year-old) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 15Jul2021, the patient experienced slight fever, back pain, vomiting, slurred speech, hematoma on both thighs. The outcome of the events was fatal. The patient died on 15Jul2021. 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 fever; Back pain; Vomiting; Slurred speech; Hematoma on both thighs


VAERS ID: 1530361 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-05-24
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7015 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain stem infarction, Headache, Ischaemic stroke, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 16 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EFECTIN; ATYWIA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202100949245

Write-up: Breathing arrested/respiratory arrest.; Ischaemic stroke; Brain stem infarction/brainstem ischemic stroke; Headache, back part of the head; This is a spontaneous report from a contactable consumer (fiance of the patient) downloaded from the Regulatory authority. Report number PL-URPL-DML-MLP.4401.2.460.2021. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 09May2021 (at the age of 30-year-old)(Batch/Lot Number: EY7015) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included venlafaxine hydrochloride (EFECTIN) taken as antidepressant therapy from Sep2019 to 05Jun2021; and dienogest, ethinylestradiol (ATYWIA) taken as contraception from Oct2015 to 05Jun2021. The patient received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. The patient received two doses approximately 30 days. On 24May2021, the patient experienced headache at back part of the head which was persisting for 12 days (24May2021 to 05Jun2021). On 05Jun2021, the patient experienced brain stem infarction/brainstem ischemic stroke. On 12Jun2021, the patient had another ischemic stroke. The patient was hospitalized from 05Jun2021 to 21Jun2021. The reporter marked the criterion for reporting a severe death and hospitalization. The patient died on 21Jun2021. The cause of death given by the reporter was respiratory arrest. An autopsy was not performed. Sender''s comments: ischemic stroke, which can manifest as headache and result in respiratory arrest, is an unexpected effect of the Comirnaty vaccine. There is currently no correlation between Comirnaty vaccine administration and thromboembolic events. Although headache is included in the Comirnaty Summary of Product Characteristics, it should be associated with the occurrence of stroke in this case. There is a temporal relationship between the administration of the vaccine and the onset of symptoms. The submitter marked the criterion for severe notification death and hospitalization. Regulatory authority classified the notification as severe. Reaction(s) / Event(s) Assessed by Regulatory authority. Method of assessment: WHO, Result of Assessment: unlikely. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on limited information in the case , the reported events and the suspect drug BNT162B2 cannot be totally excluded or assess. Case reassess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Breathing arrested/respiratory arrest


VAERS ID: 1531183 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH VTAE15MQMZANPE / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100954406

Write-up: died; This is a spontaneous report from a non-contactable consumer. A 73-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: VTAE15MQMZANPE) administration on 03Jun2021 (at age of 73 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on 04Jun2021. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: died


VAERS ID: 1531184 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Local reaction
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100954591

Write-up: Local reaction; This is a spontaneous report from a non-contactable consumer. A 61-years-old female patient received BNT162b2 (COMIRNATY) via unknown route of administration at age of 61 years on 19May2021 (Batch/Lot Number: EY4834) as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced local reaction (death) on 25May2021. The patient died on 25May2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: local reaction


VAERS ID: 1531185 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100954592

Write-up: Death; Weakness; Vomiting; This is a spontaneous report from a non-contactable consumer. A 57-year-old female patient received BNT162b2 (COMIRNATY) via an unspecified route of administration on 26May2021 at age of 57 years old (Batch/Lot Number: EY4834) at dose number unknown, single for covid-19 immunization. The patient''s medical history and concomitant medications was not reported. The patient experienced weakness and vomiting, both on 04Jun2021. The patient died on an unspecified date. It is unknown if autopsy was performed or not. The outcome of weakness and vomiting was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1531186 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0297 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100954593

Write-up: Death; This is a spontaneous report from a non-contactable consumer. A 68-year-old female patient received BNT162b2 (COMIRNATY) via an unspecified route of administration on 08Jun2021 (Lot Number: FD0297) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient died on 15Jun2021. An autopsy was not performed. The outcome of event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1531187 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anuria, Death, Dyspnoea, Headache
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100954594

Write-up: Death; Anuria; Dyspnoea; Headache; This is a spontaneous report from a non-contactable consumer. A 67-years-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 10Jun2021 (Batch/Lot Number: FA7812), at the age of 67-years-old, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced dyspnoea, headache and anuria on 18Jun2021. The patient died on an unspecified date. The cause of death is not reported. It was not reported if an autopsy was performed. The outcome of the events dyspnoea, headache and anuria was unknown. No further information was provided at the time of this report.; Reported Cause(s) of Death: Death


VAERS ID: 1531188 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0921 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Febrile convulsion, Local reaction
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100956432

Write-up: Febrile seizure; Local reaction; This is a spontaneous report from a non-contactable consumer. An 86-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 14Jul2021 (Lot Number: FD0921), dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced febrile seizure and local reaction on 14Jul2021. The patient died due to febrile seizure and local reaction on an unspecified date. An autopsy was not performed. No further information was available at the time of this report.; Reported Cause(s) of Death: Febrile seizure; Local reaction


VAERS ID: 1531203 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-07-19
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Inappropriate schedule of product administration
SMQs:, Guillain-Barre syndrome (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100972859

Write-up: General body weakness; died; first dose on 04Jun2021 10:27/second dose on 19Jul2021 15:22; This is a spontaneous report from a contactable nurse. A 70-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 04Jun2021 10:27 (Batch/Lot Number: FC3558; Expiration Date: 29Jun2021, at the age of 70-year-old) as single dose, and second dose via an unspecified route of administration on 19Jul2021 15:22 (Batch/Lot Number: FE2090; Expiration Date: 07Aug2021, at the age of 70-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was reported to have complained of general body weakness on an unspecified date. The patient died on 21Jul2021 before she could be taken to hospital. The outcome of the event died was fatal, for event general body weakness was unknown. Autopsy was performed; report not provided.; Sender''s Comments: Based on the limited information the causal association between the event unknown cause of death with the usage of the vaccine BNT162B2 can neither be meaningfully assessed nor excluded. The case will be reassessed if there is new information available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: died


VAERS ID: 1531206 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOXAIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (On Foxair 50/250 Inhaler)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100994950

Write-up: Patient was found dead at home; This is a spontaneous report from a contactable Other Health Professional. A 46-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 22Jul2021 11:00 (lot number: FE9174; expiration date: 22Jul2021), at single dose for covid-19 immunisation. Medical history included asthma (on Foxair 50/250 Inhaler). Concomitant medication included fluticasone propionate, salmeterol xinafoate (FOXAIR) for asthma. Diluent lot number was L1955D; Expiration Date was May2023. Date and time of reconstitution was on 22Jul2021 at 09:00. The patient was found dead at home on 25Jul2021. As reported, the patient was a known asthma patient and received the COVID-19 vaccine on 22Jul2021. She came back home, the patient was stable at home and she was staying with her 3 year old daughter. They slept on Saturday 24Jul2021. In the morning the following day at about 15:00; The daughter was seen by the tenant through the window inside the room with the mother who had already demised. The daughter stated her mother didn''t wake up. The case was reported to the police immediately and the body taken to forensic. It was not reported if an autopsy was performed.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease of asthma may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Patient was found dead at home, day after they were vaccinated


VAERS ID: 1531348 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-13
Submitted: 0000-00-00
Entered: 2021-08-06
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: AUPFIZER INC202100999543

Write-up: Cerebrovascular accident; This is a spontaneous report from a contactable other health professional via the Goods Administration (GA). Regulatory authority report number is 593330. A 64-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cerebrovascular accident on 13May2021. Onset Time in Days: 22days. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Cerebrovascular accident


VAERS ID: 1531349 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
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: AUPFIZER INC202100999545

Write-up: Cerebrovascular accident; This is a spontaneous report from a contactable other health professional via the Goods Administration (GA). Regulatory authority report number is 593828. A patient of unspecified age and gender received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cerebrovascular accident on an unspecified date. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cerebrovascular accident


VAERS ID: 1531350 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100999547

Write-up: Myocardial infarction; This is a spontaneous report from a contactable other health professional via the Goods Administration (GA). Regulatory authority report number is 593870. A male patient of an unspecified age received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced myocardial infarction on an unspecified date. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1531428 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-10
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G 26761 A; LOT / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood cholesterol, Blood creatine phosphokinase, Blood glucose, Glycosylated haemoglobin, Granulocytes abnormal, Haemoglobin, Lymphocyte count, Myocardial infarction, Platelet count, Troponin T
SMQs:, Haematopoietic leukopenia (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   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: METFIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lumbar spine compression fracture Type II diabetes mellitus; Comments:
Allergies:
Diagnostic Lab Data: Test Date: 20201028; Test Name: Cholesterin; Result Unstructured Data: 4.94 mmol/l,; Test Date: 20201028; Test Name: CK; Result Unstructured Data: 1643 U/L; Test Date: 20210310; Test Name: Glucose; Result Unstructured Data: 18,2; Test Date: 20201028; Test Name: HbA1c; Result Unstructured Data: 4.8%; Test Date: 20210310; Test Name: Granulocytes; Test Result: Inconclusive ; Result Unstructured Data: 84; Test Date: 20201028; Test Name: HB; Result Unstructured Data: 15.1; Test Date: 20210310; Test Name: HB; Result Unstructured Data: 16,4; Test Date: 20201028; Test Name: LC; Result Unstructured Data: 8.5; Test Date: 20210310; Test Name: LC; Result Unstructured Data: 23,5; Test Date: 20201028; Test Name: Platelets; Result Unstructured Data: 313 G/L; Test Date: 20210310; Test Name: Troponin T; Result Unstructured Data: 886
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION in a 77-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. G 26761 A; LOT 300042723) for COVID-19 vaccination. The patient''s past medical history included Type II diabetes mellitus, Adipositas and Lumbar spine compression fracture on 21-Dec-2020. Concomitant products included METFORMIN HYDROCHLORIDE (METFIN) from 01-Jan-2021 to 10-Mar-2021 for Type 2 diabetes mellitus. On 03-Mar-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 200 microgram. On 10-Mar-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced MYOCARDIAL INFARCTION (seriousness criteria death and medically significant). The patient died on 10-Mar-2021. The cause of death was not reported. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2020, Blood cholesterol: 4.94 (normal) 4.94 mmol/l. On 28-Oct-2020, Blood creatine phosphokinase: 1643 (High) 1643 U/L. On 28-Oct-2020, Blood glucose:. On 28-Oct-2020, Glycosylated hemoglobin: 4.8% (normal) 4.8%. On 28-Oct-2020, Granulocytes abnormal:. On 28-Oct-2020, Hemoglobin: 15.1 (normal) 15.1. On 28-Oct-2020, Lymphocyte count: 8.5 (Low) 8.5. On 28-Oct-2020, Platelet disorder: 313 (normal) 313. On 28-Oct-2020, Troponin T:. On 10-Mar-2021, Blood glucose: 18,2 (High) 18,2. On 10-Mar-2021, Granulocytes abnormal: 84 (Inconclusive) 84. On 10-Mar-2021, Hemoglobin: 16,4 (normal) 16,4. On 10-Mar-2021, Lymphocyte count: 23,5 (normal) 23,5. On 10-Mar-2021, Troponin T: 886 (High) 886. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Blood test was conducted on 28-NOV-2020 & 10-MAR-2021. Lab test was conducted on 28.10.2020 Kreatinin 68,Lc 8.5, Tc 313. Treatment information not provided.; Sender''s Comments: COVID-19 Vaccine Moderna das SARS-CoV-2-Virus verursachten Coronavirus-2019-Erkrankung (COVID-19). COVID-19 Vaccine Moderna. 2021 Case Safety Reports, ?Anterior myocardial infarction (LLT)?. COVID-19 Vaccine Moderna. CO-VID-19 Vaccine Moderna, Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 1531430 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Blood creatinine, C-reactive protein, Chills, Cold sweat, Dyspnoea, Emotional distress, Feeling cold, Feeling hot, Feeling of body temperature change, Glycosylated haemoglobin, Micturition urgency, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Pyrexia, Respiratory arrest, Sepsis, Troponin T, White blood cell count
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes (uncontrolled)
Allergies:
Diagnostic Lab Data: Test Name: creatinine; Result Unstructured Data: Test Result:174 umol/l; Test Name: CRP; Result Unstructured Data: Test Result:285; Test Name: HbA1c; Result Unstructured Data: Test Result:146; Test Name: Neutrophils; Result Unstructured Data: Test Result:19.4 x10 9/l; Test Name: proBNP; Result Unstructured Data: Test Result:22527; Test Name: TROPONIN T; Result Unstructured Data: Test Result:28; Test Name: WBC; Result Unstructured Data: Test Result:28.1 x10 9/l
CDC Split Type: CKPFIZER INC202100971002

Write-up: Acute pulmonary oedema; sepsis; insisted on using the bathroom; Pyrexia; chills; hot body; distress; Dyspnoea; stopped breathing at that time; clammy skin; cold; Feeling of body temperature change; This is a spontaneous report from a contactable other health professional. Regulatory authority report number is AEFI-A-004936. A 41-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 29May2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus uncontrolled. The patient''s concomitant medications were not reported. The patient experienced dyspnoea (death) on 30May2021, stopped breathing at that time (death, medically significant) on 30May2021, acute pulmonary oedema (death, medically significant) on an unspecified date, sepsis (death, medically significant) on an unspecified date, insisted on using the bathroom on 30May2021 with outcome of unknown, pyrexia on 30May2021 with outcome of unknown, feeling of body temperature change on 29May2021 with outcome of unknown, chills on 30May2021 with outcome of unknown, hot body on 29May2021 with outcome of unknown, distress on 30May2021 with outcome of unknown, cold on 30May2021 with outcome of unknown, clammy skin on 30May2021 with outcome of unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. The clinical course was reported as follows: A few hours after vaccination (29May21), she developed a "hot body" and chills. She took paracetamol and seemed to be well. She didn''t report nor notify health provider at that time. Next day (30May21), she had with chills and fever again but again seemed to improve, then husband was not worried. He left the house to do something. Upon his return he discovered she was in distress, he called for the ambulance she was cold and with clammy skin and insisted on using the bathroom, when she came back to the room she was unable to get onto the bed and stopped breathing at that time. When ambulance arrived, CPR attempted. Death on arrival at ED. Blood tests showed CREATININE 174 ?mol/L, HbA1c 146, CRP 285, TROPONIN T 28, proBNP 22,527, WBC 28.1 x109/L , Neutrophils 19.4 x109/L. Cause of death- Not decided yet. Vaccine related vs. sepsis and diabetes related complications. Probable cause: Sepsis (source of infection??) & Acute pulmonary oedema (secondary to uncrontrolled diabetic, acute sepsis) No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Sepsis; Dyspnoea; stopped breathing at that time; Acute pulmonary oedema


VAERS ID: 1531795 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / 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; Artificial cardiac pacemaker wearer; Cardiac failure; Coronary artery disease; Diabetes; Infarct myocardial
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987589

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB DE-DCGMA-21191315, Safety Report Unique Identifier DE-PEI-202100133929 . A 74-year old male patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular on 04Jun2021 (Lot Number: Unknown) at the age of 74-year old as 0.3 ml dose for COVID-19 immunization. Medical history included coronary artery disease, diabetes, artificial cardiac pacemaker wearer, cardiac failure, arterial hypertension, all unknown ongoing and not ongoing infarct myocardial. No concomitant medication reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 14May2021 at the age of 74-year old as single dose for COVID-19 immunization. On an unspecified date, the patient experienced death. Autopsy was unknown whether had done. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1532292 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza like illness, Myocarditis, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
Permanent Disability? 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: Lipoedema
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987703

Write-up: Myocarditis; Groggy; Flu-like symptoms; This is a spontaneous report from a non-contactable Physician downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100133875. A 26-years-old female patient received unspecified dose of bnt162b2 (COMIRNATY. Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 04Jun2021 as dose number unknown, single for COVID-19 immunisation. Medical history included lipoedema from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On an unspecified date the patient experienced also Flu-like symptoms, grogg and myocarditis. The patient died on 06Jul2021. An autopsy was performed and results were not provided. Outcome of the events was fatal. Patient notes: pathologically and anatomically unclear, macroscopically conspicuous cardiac findings, suspected myocarditis (histology still pending). No follow-up attempts possible. No further information expected. Batch/Lot numbers cannot be obtained.; Reported Cause(s) of Death: Myocarditis


VAERS ID: 1532294 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-07
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 2021-07-07
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210808959

Write-up: ACUTE MYOCARDIAL INFARCTION; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP] concerned a 51 year old male of unknown race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD974 expiry: unknown) dose was not reported, one total frequency, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the patient experienced acute myocardial infarction. On 07-JUL-2021, the patient died from acute myocardial infarction. It was unknown if the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210808959-covid-19 vaccine ad26.cov2.s-acute myocardial infarction. 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: ACUTE MYOCARDIAL INFARCTION


VAERS ID: 1532305 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea exertional, Limb discomfort, Nightmare, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   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: Cardiac insufficiency; Complex regional pain syndrome; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987596

Write-up: Confused dreams, body aches, exertional dyspnea, lower leg edema; Confused dreams, body aches, exertional dyspnea, lower leg edema; Confused dreams, body aches, exertional dyspnea, lower leg edema; Confused dreams, body aches, exertional dyspnea, lower leg edema; Confused dreams, body aches, exertional dyspnea, lower leg edema; This is a spontaneous report from a non-contactable consumer and downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021141475. Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100140049. A 88-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 13Apr2021 (Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included hypertension, complex regional pain syndrome and cardiac insufficiency, all ongoing. No known allergy. No concomitant medication reported. On 14Apr2021 the patient experienced nightmares, limb discomfort, dyspnoea exertional, edema. On 17Apr2021 the patient experienced unknown cause of death. Autopsy was none. The outcome of unknown cause of death was fatal, the outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1532424 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-07-16
   Days after vaccination:162
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

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: 2021-07-23
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Aortic valve stenosis; Gout; Hypertension arterial; Slipping rib syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202100987917

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-CN20212454. A 95-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscular on 04Feb2021 (Batch/Lot Number: EJ6788) as dose 2, single, and dose 1 intramuscular on 14Jan2021 (Batch/Lot Number: EM0477) as dose 1, single for covid-19 immunisation. Medical history included Alzheimer disease, aortic valve stenosis, hypertension arterial, gout, recent slipping syndrome. The patient''s concomitant medications were not reported. Identical screening profile E484K - / E484Q - / L452R +. This profile was strongly suggestive of an Indian variant. Sequencing was underway in the laboratory, but results will not be available for several days. The patient contracted covid-19 infection (positive test on 16Jul2021) lead to his death on 23Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Jul2021. Vaccination failure reported stop date 23Jul2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1532584 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-21
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiac murmur, Coma scale, Computerised tomogram, Intestinal infarction, Large intestine perforation, Oxygen saturation, Physical examination, Radial pulse
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal perforation (narrow), Pulmonary hypertension (broad), Ischaemic colitis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 0
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: ALDACTONE A; PAROXETINE; AMANTADINE; STALEVO [CARBIDOPA MONOHYDRATE;ENTACAPONE;LEVODOPA]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Digestion impaired; Disease Parkinson''s; Obsessive-compulsive disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: blood pressure; Result Unstructured Data: Test Result:100/80 mmHg; Comments: blood pressure is initially impregnable/The blood pressure is unbearable.; Test Date: 20210521; Test Name: heart murmur; Result Unstructured Data: Test Result:no perceived; Comments: The vesicular murmur is symmetrical without added noise.; Test Date: 20210521; Test Name: Glasgow score; Result Unstructured Data: Test Result:8; Test Date: 20210521; Test Name: CT scan; Result Unstructured Data: Test Result:Gastrointestinal perforation; Comments: digestive perforation with parietal pain in the right colon and a right inguinal hernia. There is a significant pneumatosis, an airborne, a major diffuse gas and fluid effusion; there is also a hepatic tumor syndrome of the right liver and the left liver/with evidence of hepatic tumor syndrome on CT scan; Test Date: 20210521; Test Name: saturation; Test Result: 50 %; Comments: under 9 liters / min of oxygen; Test Date: 20210521; Test Name: Abdominally; Result Unstructured Data: Test Result:extremely distended; Comments: exhibits generalized defense. A scrotal hernia is suspected.; Test Date: 20210521; Test Name: radial pulse; Result Unstructured Data: Test Result:not perceived
CDC Split Type: FRPFIZER INC202100973541

Write-up: Colonic perforation; mesenteric infarction; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB FR-AFSSAPS-RS20212455. A 69-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular, administered in Arm Left on 11May2021 (Lot Number: EX6537) as single dose for COVID-19 immunisation. Medical history included obsessive-compulsive disorder, parkinson''s disease, digestive discomfort. Concomitant medications included spironolactone (ALDACTONE A); paroxetine; amantadine; carbidopa monohydrate, entacapone, levodopa (STALEVO). The patient experienced colonic perforation (death) on 21May2021, mesenteric infarction (death) on 21May2021. The clinical course was reported as follows: Undesirable effect: The case is reported by a doctor at the vaccination center. 11May2021: patient received Dose1 COMIRNATY, lot EX6537, left arm; his wife is vaccinated the same day. In Jun2021: the declaring doctor sees the patient''s wife for her 2nd dose in the vaccination center. She reports that her husband died of a mesenteric infarction after the first dose. The reporting physician has no additional information on this subject. Additional information obtained by the CRPV from the attending physician and the hospital where the patient was treated: - call to the attending physician: for her, death has nothing to do with vaccination. - Report from hospital: 10 days after vaccination, that is 21May2021, Urgent Medical is contacted for acute abdominal pain in this patient; this pain follows a digestive discomfort that appeared 3 weeks ago. When help arrives, the patient is in respiratory distress. blood pressure is 100/80 mmHg, saturation is about 50% under 9 liters / min of oxygen. The Glasgow score is 8. The patient is therefore intubated and sedated. Hemodynamically, the patient is mottled up to the thorax with a greatly increased recoloration time. Radial pulses are not perceived. The blood pressure is initially impregnable. There is no perceived heart murmur. The vesicular murmur is symmetrical without added noise. Hemodynamic support by NORADRENALINE 1 mg / H. During hospitalization: On entering the ward, shocked with marbling and a recoloration time of more than 5 seconds. The blood pressure is unbearable. Respiratory, patient intubated in assisted ventilation. The oxygen saturation is impregnable. Neurologically, patient sedated by MIDAZOLAM and SUFENTANIL. Abdominally, the abdomen is extremely distended and exhibits generalized defense. A scrotal hernia is suspected. Patient immediately transferred to the scan which shows a Gastrointestinal perforation with parietal pain in the right colon and a right inguinal hernia. There is a significant pneumatosis, an airborne, a major diffuse gas and fluid effusion; there is also a hepatic tumor syndrome of the right liver and the left liver which cannot be labeled as content of incomplete iodine dynamics. The surgical treatment seems unreasonable in the context of refractory shock with extensive digestive distress. The patient is then transferred to intensive care where he dies a few minutes later. No platelet value available. In total, fatal digestive perforation in a 69-year-old patient, 10 days after Dose1 COMIRNATY, in a context of digestive discomfort prior to vaccination, with evidence of hepatic tumor syndrome on CT scan. Emergency Room Visit and Physician Office Visit for events. Therapeutic measures were taken as a result of events. The patient died on 21May2021. An autopsy was not performed. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Colonic perforation; mesenteric infarction


VAERS ID: 1532612 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bronchospasm, Candida test, Corynebacterium test, Cytomegalovirus test, Escherichia bacteraemia, Herpes simplex test, Multiple organ dysfunction syndrome, Staphylococcal abscess, Staphylococcus test
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: candida albicans; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Candida glabrata; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Candida tropicalis; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Corynebacterium striatum; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Cytomegalovirus; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Escherichia coli; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Herpes simplex virus type 1; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Staphylococcus epidermidis; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Staphylococcus capitis; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission
CDC Split Type: GBPFIZER INC202100969128

Write-up: multi-organ failure; Bronchospasm; This is a spontaneous report from a contactable other hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-ADR 25720260. Safety Report Unique Identifier GB-MHRA-ADR 25720260. A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Dec2020 (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 bronchospasm, multi-organ failure on an unspecified date. 56-year-old male patient receiving extracorporeal membrane oxygenation. 61 days from vaccination to extracorporeal membrane oxygenation treatment. 58 days after vaccination admitted hospital and then to severe respiratory failure Centre 3 days later. Patient experienced bronchospasm. Discharged from severe respiratory failure Centre alive 15 days later. Subsequently died, cause of death believed to be multi-organ failure. Pathogens detected during extracorporeal membrane oxygenation admission include candida albicans, Candida glabrata, Candida tropicalis, Corynebacterium striatum, Cytomegalovirus, Escherichia coli, Herpes simplex virus type 1, Staphylococcus capitis and Staphylococcus epidermidis. Case was reported as serious, other medically important condition. Outcome of bronchospasm was unknown and multi-organ failure was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: multi-organ failure


VAERS ID: 1532622 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-03-30
   Days after vaccination:75
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: B-cell lymphoma, Lymphadenopathy, Medication error
SMQs:, Malignant lymphomas (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 114
Permanent Disability? 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: GBPFIZER INC202100943262

Write-up: medication error; Enlarged B-Cell Lymphoma /Enlarged Lymph nodes; Enlarged B-Cell Lymphoma /Enlarged Lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-EYC 00256933, Safety Report Unique Identifier GB-MHRA-ADR 25699099. An 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via parenteral on 14Jan2021 (Batch/Lot Number: el0141) 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 enlarged b-cell lymphoma /enlarged lymph nodes on 30Mar2021, medication error on an unspecified date. Medication Error Details: the patient was firsted diagnosed with Enlarged B Lymph Nodes - Before he was confirmed with Blood Cancer The patient was taking BNT162b2 for: Government suggested to take as was told was vulnerable to covid. The patient died on 22Jul2021. It was not reported if an autopsy was performed. The outcome of the event enlarged b-cell lymphoma /enlarged lymph nodes was fatal, while the other event was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Enlarged B-Cell Lymphoma /Enlarged Lymph nodes; Enlarged B-Cell Lymphoma /Enlarged Lymph nodes


VAERS ID: 1533246 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1471 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Bleeding time, Bleeding time prolonged, Chest pain, Confusional state, Pneumonia
SMQs:, Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain; Enlarged prostate; Pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Bleeding time; Result Unstructured Data: Test Result:prolonged
CDC Split Type: GBPFIZER INC202100976645

Write-up: Pneumonia NOS; Bleeding time prolonged; Confusion; Loss of balance; Chest pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number (GB-MHRA-WEBCOVID-202107301258141360-VSNYS), Safety Report Unique Identifier (GB-MHRA-ADR 25732878). An 88-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Er1471), via an unspecified route of administration on 01Jul2021 as second dose, single for COVID-19 immunization. Medical history included chest pain, pneumonia, enlarged prostate. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with covid-19 and not had a covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On unspecified date in Jul2021, the patient experienced pneumonia nos, bleeding time prolonged, confusion, loss of balance and chest pain. Outcome of all the events was fatal (also reported as not recovered for the events confusion, loss of balance, chest pain while unknown for the event bleeding time prolonged). The patient died on 28Jul2021. 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: Pneumonia NOS; Bleeding time prolonged; Confusion; Loss of balance; Chest pain


VAERS ID: 1533309 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Congenital anomaly
SMQs:, Congenital, familial and genetic disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? Yes
Birth Defect? Yes
Died? Yes
   Date died: 2021-04-02
   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: GBPFIZER INC202100951112

Write-up: Congenital anomaly/birth defect; Early miscarriage; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory Authority report number is GB-MHRA-WEBCOVID-202107241955066220-YERYI, Safety Report Unique Identifier GB-MHRA-ADR 25703364. This physician reported information for both mother and fetus. This is a fetal report. A fetus of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via transplacental route on 30Mar2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history was not reported. There were no concomitant medications. It was reported that the patient''s mother became pregnant on an unspecified date in 2021 (between Mar2021 to Apr2021) while taking BNT162B2. Patient experienced congenital anomaly further reported as birth defect and early miscarriage on 02Apr2021. The events were reported as serious (death, medically significant, life threatening, congenital anomaly). The patient died on 02Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100943362 maternal case; Reported Cause(s) of Death: Congenital anomaly/birth defect; Early miscarriage


VAERS ID: 1533335 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Encephalitis viral
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100975640

Write-up: Viral encephalitis; This is a spontaneous report from a contactable consumer via medical information team. An 87-year-old male patient (reporter''s father) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose on 19Mar2021 for COVID-19 immunisation. The first dose was on 08Jan2021 (Lot number: BN ej1688). Medical history and concomitant medications were not reported. The reporter''s father died after the second dose of the COVID-19 vaccine due to viral encephalitis. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of event was fatal. The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Viral encephalitis


VAERS ID: 1533357 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-11
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Atrial fibrillation, Blood pressure measurement, Cardiac arrest, Death, Hypotension, Myocardial infarction, Pulmonary oedema
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart valve replacement; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: Blood pressure; Result Unstructured Data: Test Result:8/3.5
CDC Split Type: GRPFIZER INC202100973441

Write-up: Cardiac arrest/heart attack; Cardiac arrest/heart attack; Acute renal insufficiency; Atrial fibrillation; fluid in lungs; Hypotension, blood pressure 8/3.5; Death; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number GR-GREOF-20216067. A senior male patient of an unspecified age received the first dose of BNT162B2 (COMIRNATY, lot number: unknown) on 03Apr2021 at single dose for COVID-19 immunisation. Medical history included heart valve replacement from 2009 and hypertension. Concomitant medication included rivaroxaban (XARELTO). On 11Apr2021, the patient experienced hypotension. The patient went to the hospital where he was diagnosed with atrial fibrillation and fluid in lungs. On 12Apr2021 at 08:00 in the morning, the doctors told us that the patient had had two heart attacks, that they brought him back to life and intubated him. Two hours later the patient died, because after the second cardiac arrest, the patient had acute renal failure, and the artificial kidney couldn''t endure the low pressure. The patient underwent lab tests and procedures which included blood pressure: 8/3.5 on 11Apr2021. The outcome of the events cardiac arrest, acute kidney insufficiency and death was fatal. The outcome of other events was unknown. The patient died on 12Apr2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest/heart attack; Acute renal insufficiency; Death


VAERS ID: 1533359 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-05-01
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Neoplasm malignant, Neoplasm progression, Skin disorder
SMQs:, Malignancy related conditions (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 42
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202100985177

Write-up: Skin and subcutaneous tissue disorder; initial and metastatic cancer(aggravation/cause); initial and metastatic cancer(aggravation/cause); This is a spontaneous report from a contactable consumer. This is second of two reports. The first report was downloaded from the Regulatory Authority-WEB GR-GREOF-20216150. A 73-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced skin and subcutaneous tissue disorder and initial and metastatic cancer(aggravation/cause) on 01May2021. The events were reported serious with criteria of death and medically significant. The patient died on 12Jun2021. 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: initial and metastatic cancer(aggravation/cause); skin and subcutaneous tissue disorder; initial and metastatic cancer (aggravation/cause)


VAERS ID: 1533365 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 125
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Esophageal carcinoma; Operation NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRPFIZER INC202100982628

Write-up: tightness around the heart; This is a spontaneous report from a contactable consumer. This is second of two reports. The first report wad downloaded from the Regulatory Authority-WEB regulatory authority number HR-HALMED-300049723. A 78-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), intramuscular on 23Feb2021 (at unknown age) as 0.3 ML SINGLE for COVID-19 immunisation. The person was healthy before vaccination, had a history of oncological disease (Esophageal carcinoma, operated on in the initial stage in 2014, without metastases) which was considered cured in 2014, regularly monitored at the Hospital, all findings regarding this tumor are in order. Good psychophysical condition, active, no cardiac symptoms before, never taking any chronic therapy. The patient''s concomitant medications were not reported. After the first dose he noticed tightness around the heart (death, hospitalization, life threatening) on Feb2021 that he had never felt before, but it did not intensify. The patient died on 07Jun2021. It was unknown if an autopsy was performed. Due to good health before the vaccine and the sudden onset of symptoms and rapid deterioration, there is a suspicion of an association. A casual relationship between COMIRNATY and event Chest pressure was assessing: Unassessable/Unclassifiable. Source of assessment: Regulatory Authority. Method of assessment: WHO- Causality. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : HR-PFIZER INC-202100974257 same reporter/patient/drug, different dose/events; Reported Cause(s) of Death: tightness around the heart


VAERS ID: 1533398 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Death, Medication error
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210801314

Write-up: DEATH; HEART PROBLEMS; POTENTIAL MEDICATION ERROR; This spontaneous report received from a patient via a company representative from social media concerned a male of unspecified age, race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect vaccine included: MRNA 1273 ( form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination; and BNT 162 ( form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient dies for heart problems after the third dose. The patient experienced potential medication error as he received first had first J&J vaccine then MRNA and then BNT 162. It was unknown if an autopsy was performed. As heart problems was not the cause of death. On an unspecified date, the subject died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of heart problems and potential medication error was not reported. This report was serious (Death).; Sender''s Comments: V0:20210801314- Covid-19 vaccine ad26.cov2.s - Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1533571 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-21
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Loss of personal independence in daily activities, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE; ALLOPURINOL; TAMSULOSIN; BISOPROLOL FUMARATE; ATORVASTATIN; LASIX [FUROSEMIDE]; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aphasia; Chronic renal failure (moderate); Dysphagia; Hypertensive heart disease NOS (severe heart disease); Stroke (2020 resulting in aphasia and dysphagia); Unilateral leg swelling
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100973358

Write-up: total loss of autonomy until death within 1 month and a half; already had a swollen leg, both swollen in the days; already had a swollen leg, both swollen in the days; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB IT-MINISAL02-761751. A 78-year-old male patient (reporter''s father) received the first dose of BNT162B2 (COMIRNATY, lot number: FC3558), via intramuscular in left arm (also reported as left shoulder) on 25May2021 at single dose for COVID-19 immunisation. Medical history included stroke (resulting in aphasia and dysphagia in 2020), aphasia from 2020, dysphagia from 2020, chronic renal failure (moderate), hypertensive heart disease NOS (severe heart disease) and swollen leg. Concomitant medications included lansoprazole (strength: 30 mg) at 30 mg; allopurinol; tamsulosin; bisoprolol fumarate; atorvastatin (strength: 40 mg) at 40 mg; furosemide (LASIX, strength: 25 mg) at 25 mg; clopidogrel (strength: 75 mg) at 75 mg. The patient had a severe heart disease, and he already had a swollen leg. The patient experienced both swollen in the days following the vaccination, total loss of autonomy until death within 1 month and a half on 21Jun2021. The reporter decided not to give the patient the second dose but it was useless, he didn''t make it. The reporter cannot say that it was the vaccine but the aggravation was clear. The outcome of the events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Sender''s comments: 26Jul2021 added concomitant drugs. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: already had a swollen leg, both swollen in the days; total loss of autonomy until death within 1 month and a half; already had a swollen leg, both swollen in the days


VAERS ID: 1533591 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   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: TAKEPRON; BI SIFROL; MENESIT; MUCODYNE-DS; LULLAN; CRAVIT; CALONAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastrostomy; Parkinson''s disease; Pneumonia aspiration; Pyrexia
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Test Date: 20210621; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade
CDC Split Type: JPPFIZER INC202100942657

Write-up: Cardio-respiratory arrest; Suspicion of upper airway obstruction due to sputum; This is a spontaneous report from a contactable physician received via COVID-19 Regulatory Authority. Regulatory authority report number is V21121594. An 88-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection), intramuscular, administered in left arm on 21Jun2021 at 16:30 (Batch/Lot Number: FC3661; Expiration Date: 30Sep2021) (at the age of 88-years-old) as dose 1, single for COVID-19 immunisation. Medical history included Parkinson''s disease (classification of severity: Hoehn and Yahr 5), state of gastrostomy. As for diseases within one month before the report, from 04Jun2021 to 11Jun2021, the patient had pneumonia aspiration, for which intravenous drip infusion of sulbactam/ampicillin (SBT/ABPC) was administered. On 18Jun2021, pyrexia of 38.1 degrees Centigrade developed, and administration of levofloxacin (LVFX) 500 mg was started by a tube. On 19Jun2021, the patient had a slight fever. On 20Jun2021, fever was reduced. On 21Jun2021, body temperature was 37 degrees Centigrade. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the following medications within 2 weeks of vaccination: lansoprazole (TAKEPRON OD Tablets 15), pramipexole dihydrochloride (BI SIFROL Tablets 0.5mg), carbidopa, levodopa (MENESIT Combination Tablets 100), carbocisteine (MUCODYNE-DS 50%), perospirone hydrochloride (LULLAN Tablets 8mg), levofloxacin (CRAVIT Tablets 500 mg), and paracetamol (CALONAL Fine granules 50%). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Since the vaccination, the patient has not been tested for COVID-19. On 22Jun2021 at 08:30 (1 day after the vaccination), the next morning after the vaccination, the patient was found in cardio-respiratory arrest. The patient died. The cause of death was unknown but upper airway obstruction due to sputum and association with the vaccination were suspected. The patient received no treatments for the event. The reporting physician assessed the event as serious (death). Autopsy was not performed. The reporting physician assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was a possibility of upper airway obstruction due to sputum. The reporting physician provided the following comment: Although sputum was not noted at the pharynx or larynx on consultation, this observation was done after aspiration operation. The reporting physician thus considered that upper airway obstruction due to sputum was highly suspected as the cause of death. However, there was no fact of increased amount of sputum after the vaccination specifically, and the event occurred within 24 hours of the vaccination. Therefore, it was reported that the adverse reaction due to the vaccine also could not be denied as the cause of death.; Reporter''s Comments: Upper airway obstruction due to sputum was highly suspected as the cause of death. However, there was no fact of increased amount of sputum after the vaccination specifically, and the event occurred within 24 hours of the vaccination. Therefore, it was reported that the adverse reaction due to the vaccine also could not be denied as the cause of death.; Reported Cause(s) of Death: possibility of upper airway obstruction due to sputum; cardio-respiratory arrest


VAERS ID: 1533593 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Body temperature, Cardio-respiratory arrest, Foaming at mouth, Multiple organ dysfunction syndrome, Pallor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREDONINE [PREDNISOLONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anti-neutrophil cytoplasmic antibody positive vasculitis
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.9 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202100943885

Write-up: Multi-organ failure resulting from asphyxia due to vomiting; Multi-organ failure resulting from asphyxia due to vomiting; Multi-organ failure resulting from asphyxia due to vomiting; cardio-respiratory arrest; Complexion ill; Foaming at mouth; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120990. A 96-year and 3-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 21Jul2021 at 14:17 (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) (at the age of 96-years-old) as dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.9 degrees centigrade. Family history was unknown. Medical history included antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Concomitant medications included prednisolone (PREDONINE) orally ongoing at 6 mg/day taken for an unspecified indication, start and stop date were not reported. On 21Jul2021, the patient experienced complexion ill and foaming at mouth at 14:22 (5 minutes after the vaccination). On 21Jul2021, the patient died with multi-organ failure resulting from asphyxia due to vomiting. The course of the events was as follows: On 21Jul2021 at 14:17 (the day of vaccination), the patient received the coronavirus vaccination. At 14:22 (5 minutes after the vaccination), complexion ill was noted. The patient was found foaming at the mouth. At 14:25 (8 minutes after the vaccination), medical review was done in a sitting position. The carotid artery was not palpable at that time. At 14:28 (11 minutes after the vaccination), the reporting physician was called, went to hospital. The physician assessed the patient was in cardio-respiratory arrest. At 14:30 (13 minutes after the vaccination), cardiac massage was started by another person. At 14:33 (16 minutes after the vaccination), an ambulance was called. At 14:35 (18 minutes after the vaccination), an automated external defibrillator (AED) was used, but no improvement was obtained. The reporting physician classified the events as serious (hospitalization) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases included asphyxia due to vomiting. The patient died on 21Jul2021. It was not reported if an autopsy was performed. The reporting physician commented as follows: The information was from Primary care. There was a contact from the hospital where the patient was urgently taken, and it notified that the death cause was multi-organ failure resulting from asphyxia due to vomiting.; Reporter''s Comments: The information was from Hospital. There was a contact from the hospital where the patient was urgently taken, and it notified that the death cause was multi-organ failure resulting from asphyxia due to vomiting.; Reported Cause(s) of Death: Multi-organ failure resulting from asphyxia due to vomiting; Multi-organ failure resulting from asphyxia due to vomiting; Multi-organ failure resulting from asphyxia due to vomiting


VAERS ID: 1533626 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Atrial fibrillation paroxysmal; Renal impairment; Thoracic aortic aneurysm.
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: Body Temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210721; Test Name: imaging results; Result Unstructured Data: Test Result: Aortic dissection.
CDC Split Type: JPPFIZER INC202100951721

Write-up: Cardio-respiratory arrest; Aortic dissection; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121082. A 93-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 20Jul2021 09:40 (Batch/Lot Number: EY0573; Expiration Date: 30Sep2021) as dose 2, single for COVID-19 immunisation. Medical history included Atrial fibrillation paroxysmal, Thoracic aortic aneurysm, Aortic valve insufficiency, and Renal impairment. The patient had no family history. The patient''s concomitant medications were not reported. The patient took the first dose of BNT162B2 (COMIRNATY) on an unspecified date for COVID-19 immunization. Body temperature before vaccination was 36.6 degrees centigrade on 20Jul2021. On 21Jul2021 (1 day after the vaccination), the patient experienced cardio-respiratory arrest. On 21Jul2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 21Jul2021, the patient experienced cardio-respiratory arrest and was transferred to medical center. The patient''s heartbeat did not return and he was confirmed dead. Aortic dissection was suspected based on the imaging results. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 was unassessable. Other possible causes of the event such as any other diseases were aortic valve insufficiency and aortic dissection.; Reported Cause(s) of Death: Cardio-respiratory arrest; Aortic dissection


VAERS ID: 1533631 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Anuria, Aspartate aminotransferase, Base excess, Blood albumin, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood creatinine, Blood gases, Blood lactate dehydrogenase, Blood potassium, Blood pressure decreased, Blood pressure measurement, Blood urea, Body temperature, C-reactive protein, Cardiac failure, Cerebral infarction, Chest X-ray, Computerised tomogram head, Creatinine renal clearance, Cyanosis, Dyspnoea, Electrocardiogram, Gamma-glutamyltransferase, Generalised oedema, Glomerular filtration rate, Haemoglobin, Hemiplegia, Hypokalaemia, Liver disorder, Malnutrition, Oxygen saturation, Oxygen saturation decreased, PCO2, PO2, Platelet count, Pleural effusion, Protein total, Prothrombin time, Pyrexia, Renal failure, Respiratory alkalosis, Tachycardia, Urine output, Weight increased, White blood cell count, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WYSTAL; HEPARIN; TAKECAB; BAYASPIRIN; CLOPIDOGREL; ACETAMINOPHEN; ANHIBA; HANP; FUROSEMIDE; SOLDACTONE; EDARAVONE; PASIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bile duct cancer; Biliary stent placement; Catheterisation venous (500 mL of infusion per day was continued since 04Jun2021); Cholangitis; Dementia; Device related infection; Inappetence; Pyrexia.
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: ALT; Result Unstructured Data: Test Result:328; Test Date: 20210715; Test Name: AST; Result Unstructured Data: Test Result:849; Test Date: 20210715; Test Name: BE; Result Unstructured Data: Test Result:0.0; Test Date: 20210715; Test Name: Alb; Result Unstructured Data: Test Result:2.4; Test Date: 20210715; Test Name: ALP; Result Unstructured Data: Test Result:475; Test Date: 20210715; Test Name: HCO3; Result Unstructured Data: Test Result:21.2; Test Date: 20210715; Test Name: TB; Result Unstructured Data: Test Result:1.2; Test Date: 20210715; Test Name: Cr; Result Unstructured Data: Test Result:2.75; Test Date: 20210715; Test Name: Blood gas; Result Unstructured Data: Test Result: respiratory alkalosis; Test Date: 20210715; Test Name: LD; Result Unstructured Data: Test Result:891; Test Date: 20210715; Test Name: K; Result Unstructured Data: Test Result:2.45; Test Date: 20210717; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result: decreased; Test Date: 20210715; Test Name: UN; Result Unstructured Data: Test Result:43.4; Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0-36.8 Centigrade; Comments: before vaccination; Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: at 14:00; Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Comments: at 16:00; Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: at 20:00; Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Comments: at 14:55; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Comments: at 14:00; Test Date: 20210708; Test Name: Body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Test Date: 20210709; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Test Date: 20210712; Test Name: Body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Test Date: 20210713; Test Name: Body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:38.9 Centigrade; Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:39.0 Centigrade; Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Test Date: 20210713; Test Name: Chest roentgenogram; Result Unstructured Data: Test Result: right pleural effusion; Test Date: 20210702; Test Name: Head CT test; Result Unstructured Data: Test Result: left-predominant old Lacunar infarction; Comments: left-predominant old Lacunar infarction and chronic ischemic change; disorder involving Broca''s area was suspected; Test Date: 20210705; Test Name: Head CT test; Result Unstructured Data: Test Result: no new lesion; Comments: the same as before and no new lesion could be pointed out; Test Date: 20210715; Test Name: CRP; Result Unstructured Data: Test Result:5.0; Test Date: 20210702; Test Name: CCR; Result Unstructured Data: Test Result:27.2; Test Date: 20210702; Test Name: Electrocardiogram; Result Unstructured Data: Test Result: no atrial fibrillation; Comments: pacemaker rhythms and there was no possibility of cardiogenic cerebral infarction as the same as before; Test Date: 20210715; Test Name: gamma GT; Result Unstructured Data: Test Result:336; Test Date: 20210702; Test Name: eGFR; Result Unstructured Data: Test Result:38.6; Test Date: 20210715; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.0; Test Date: 20210715; Test Name: O2S; Test Result: 96.7 %; Test Date: 20210715; Test Name: PCO2; Result Unstructured Data: Test Result:26.2; Test Date: 20210715; Test Name: pH; Result Unstructured Data: Test Result:7.526; Test Date: 20210715; Test Name: Platelets; Result Unstructured Data: Test Result:13.8; Test Date: 20210715; Test Name: PO2; Result Unstructured Data: Test Result:76.0; Test Date: 20210715; Test Name: TP; Result Unstructured Data: Test Result:5.9; Test Date: 20210715; Test Name: PT (INR); Result Unstructured Data: Test Result:2.2; Test Date: 20210712; Test Name: Urine output; Result Unstructured Data: Test Result:1600 mL mL; Comments: a day; Test Date: 20210713; Test Name: Urine output; Test Result: 2000 mL; Comments: a day; Test Date: 20210714; Test Name: Urine output; Test Result: 660 mL; Comments: a day; Test Date: 20210715; Test Name: Urine output; Test Result: 55 mL; Comments: a day; Test Date: 20210716; Test Name: Urine output; Test Result: 135 mL; Comments: a day; increased a little; Test Date: 20210715; Test Name: WBC; Result Unstructured Data: Test Result:10500.
CDC Split Type: JPPFIZER INC202100951740

Write-up: dyspnoea; decrease in oxygenation; tachycardia; blood pressure decreased; cyanosis of extremities; anuria; renal failure; hypokalaemia; respiratory alkalosis; undernutrition; high grade liver disorder; right pleural effusion; gained 6.7 kg in a week; generalised oedema (complicated by cardiac failure); generalised oedema (complicated by cardiac failure); hemiplegia (flaccid); Cerebral infarction; Pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory Authority (Regulatory authority report number is v21121095) with information received from the same contactable physician received via a Pfizer sales representative. An 83-year and 9-month-old (at vaccination) female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 01Jul2021 10:45 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) as dose 2, 0.3 mL single for covid-19 immunisation; Edaravone, via an unspecified route of administration from 02Jul2021 (Batch/Lot number was not reported) to an unspecified date, at 30 mg, twice a day for cerebral infarction; pazufloxacin mesilate (PASIL), via an unspecified route of administration from 09Jul2021 (Batch/Lot number was not reported) to an unspecified date, at 0.5 g, twice a day for an unspecified indication. Medical history included complication of pyrexia possibly due to catheter-related bloodstream infection or retrograde cholangitis from 25Jun2021 to 30Jun2021, biliary metallic stent placement for middle bile duct cancer, oral intake was inadequate due to dementia (inappetence due to dementia), for which total parenteral nutrition (TPN) catheter was inserted via the right groin for water and nutrition control. 500 mL of infusion per day was continued since 04Jun2021. Concomitant medication included cefoperazone sodium, sulbactam sodium (WYSTAL) 1 g twice daily taken for pyrexia started on 29Jun2021 and from 02Jul2021 to 08Jul2021, heparin 10.000 unit/day from 02Jul2021 to 09Jul2021, vonoprazan fumarate (TAKECAB) 20 mg started on 02Jul2021, which was changed to 10 mg on 08Jul2021, acetylsalicylic acid (BAYASPIRIN) 200 mg started on 02Jul2021, which was changed to 100 mg on 08Jul2021, clopidogrel 75 mg started on 02Jul2021, acetaminophen 400 mg as needed taken for pyrexia on 01Jul2021, paracetamol (ANHIBA) suppository (200) 2 DFs taken for pyrexia on 02Jul2021 and 03Jul2021, carperitide (HANP) started on 12Jul2021, furosemide 20 mg started on 12Jul2021, and potassium canrenoate (SOLDACTONE) 100 mg started on 12Jul2021. On 10Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number and expiration date were not reported) 0.3 mL intramuscular. On 25Jun2021, the patient had complication of pyrexia possibly due to catheter-related bloodstream infection or retrograde cholangitis. On 29Jun2021, WYSTAL 1 g twice daily was added for pyrexia. On 30Jun2021 (2 days before 2nd vaccination), pyrexia resolved and general condition was good. Body temperature before vaccination was 37.0 to 36.8 degrees centigrade. On 02Jul2021 at around 17:00 (around 1 day 6 hours 15 minutes after the vaccination), the patient experienced cerebral infarction. The course of the event cerebral infarction was as follows: On 01Jul2021 at 10:45, the patient received the second dose of COMIRNATY intramuscular injection 0.3 mL in arm left. Body temperature before vaccination was 37.0-36.8 degrees centigrade. On the same day at 14:00, the patient developed pyrexia of 37.5 degrees centigrade. At 16:00, body temperature was 37.9 degrees centigrade, which was treated with acetaminophen 400 mg as needed. At 20:00, pyrexia resolved to 36.8 degrees centigrade. On 02Jul2021 at 14:55, body temperature rose again to 38.2 degrees centigrade, for which ANHIBA suppository (200) two dosage forms were inserted into the rectum. At 17:00, paralysis of right upper limb and aphasia appeared. The patient had no consciousness disturbed. Head CT test was emergently conducted, which showed left-predominant old Lacunar infarction and chronic ischemic change, for which disorder involving Broca''s area was suspected. Electrocardiogram showed no atrial fibrillation. It showed pacemaker rhythms and there was no possibility of cardiogenic cerebral infarction as the same as before. The patient was diagnosed with cerebral infarction and treatment was initiated which included 1) infusion at a total volume of 1400 mL/day, 2) heparin 10.000 unit/day, 3) EDARAVONE 30 mg twice daily, and 4) WYSTAL 1 g twice daily. Renal function was creatinine clearance (CCR) 27.2 and estimated glomerular filtration rate (eGFR) 38.6. TAKECAB 20 mg and BAYASPIRIN 200 mg/clopidogrel 75 mg (dual anti-platelet therapy [DAPT]) were concurrently initiated. On 03Jul2021, aphasia and paralysis of right upper limb were unchanged. At 14:00, the patient developed high fever of 38.8 degrees centigrade, which resolved with ANHIBA suppository (200) two dosage forms. On 05Jul2021, the condition progressed to right hemiplegia (flaccid), for which head CT test was conducted again. CT finding was the same as before and no new lesion could be pointed out. On 07Jul2021, the patient spoke and paralysis of right lower limb improved to some extent. There was a chance of improvement. On 08Jul2021, body temperature was 38.4 degrees centigrade. The patient was barely able to move right lower limb. Oral medications were changed to BAYASPIRIN 100 mg/clopidogrel 75 mg (DAPT) and TAKECAB 10 mg. On 09Jul2021, since the patient had pyrexia of 38.1 degrees centigrade, antibiotic was changed from WYSTAL to PASIL 0.5 g twice daily. Heparin was discontinued and treatment with DAPT was continued. Infusion volume per day was 1900 mL. On 12Jul2021, body temperature was 38.2 degrees centigrade. The patient gained 6.7 kg in a week and had generalised oedema (complicated by cardiac failure), for which 24-hour HANP therapy and injection of diuretic (furosemide 20 mg and SOLDACTONE 100 mg) via the side tube were initiated. Infusion volume per day was decreased to 1200 mL. Ureteral catheter was inserted. Urine output a day was 1600 mL. On 13Jul2021, body temperature was 38.3 degrees centigrade. Chest roentgenogram showed right pleural effusion. Urine output a day was 2000 mL. On 14Jul2021, body temperature was 38.9 degrees centigrade. Urine output a day was 660 mL. On 15Jul2021, body temperature was 39.0 degrees centigrade and urine output a day was 55 mL. TPN catheter in the right groin was removed and a catheter was newly inserted via the left groin. Blood gas showed respiratory alkalosis. (Oxygen 3 L, ph: 7.526, oxygen partial pressure [PO2]: 76.0, carbon dioxide partial pressure [PCO2]: 26.2, bicarbonate [HCO3]: 21.2, base excess [BE]: 0.0, and oxygen saturation [O2S]: 96.7%). White blood cell (WBC): 10500, haemoglobin: 11.0, platelets: 13.8, C-reactive protein (CRP): 5.0, prothrombin time (PT) (international normalized ratio [INR]): 2.2, potassium: 2.45, total protein (TP): 5.9, albumin (Alb) : 2.4, aspartate aminotransferase (AST): 849, alanine aminotransferase (ALT): 328, LD: 891, ALP: 475, gamma-glutamyl transpeptidase (gamma GT): 336, total bilirubin (TB): 1.2, urea nitrogen (UN): 43.4, and creatinine (Cr): 2.75. Thus, undernutrition, hypokalemia, renal failure, and high grade liver disorder. NEOPHAGEN 80 mL injection via the side tube was added for liver disorder. On 16Jul2021, body temperature was 38.2 degrees centigrade, the patient was in a state of anuria. Dopamine 3 ug/kg/minute was also initiated. Urine output a day increased a little to 135 mL, possibly due to the effect of the treatment. On 17Jul2021 in the early hours, dyspnoea, decrease in oxygenation, tachycardia, etc., appeared. At 02:00, blood pressure decreased, laboured respiration, and cyanosis of extremities appeared. At 03:30, death was confirmed. The patient died on 17Jul2021 due to cerebral infarction. The outcome of other events was unknown. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. Other possible causes of the event such as any other diseases includes middle bile duct cancer and catheter-related bloodstream infection. The reporting physician comment: It was considered that the patient had complication of cerebral infarction which was triggered by pyrexia due to the second vaccination and liver disorder and renal disorder in the clinical course were caused by adverse effect due to therapeutic drug (EDARAVONE or PASIL). Causal relationship between the vaccine and the onset of cerebral infarction could not be denied.; Reported Cause(s) of Death: cerebral infarction


VAERS ID: 1533659 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bacterial sepsis, Bacterial test, Disseminated intravascular coagulation, Malaise, Pneumonia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: blood: gram-negative rod; Test Result: Positive.
CDC Split Type: JPPFIZER INC202100971377

Write-up: severe pneumonia; sepsis (blood: gram-negative rod positive); DIC; malaise; This is a spontaneous report from a contactable physician received via the Regulatory Authority. A 72-year and three-month-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, lot number FC3661, expiration date 30Sep2021) at the age of 72-years, intramuscularly in the left arm on 03Jul2021 at unspecified time (the day of vaccination) at single dose for COVID-19 immunization. The patient previously received the first single dose of BNT162b2 (COMIRNATY, lot number FC3661, expiration date 30Sep2021) at the age of 72-years, intramuscularly in the left arm on 12Jun2021 for COVID-19 immunization. Body temperature before vaccination was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included chronic obstructive pulmonary disease. Concomitant medications were not reported. On 04Jul2021 at unspecified time (one day after the vaccination), the patient started to experience malaise, outcome of unknown. On 06Jul2021 at unspecified time (three days after the vaccination), the patient experienced pyrexia and respiratory condition worsening and was referred to the reporter hospital by the inoculation/consultation hospital. The events resulted in hospitalization. On 06Jul2021 at unspecified time (three days after the vaccination), the patient experienced severe pneumonia. On 06Jul2021 (three days after the vaccination), the patient was admitted to the hospital. On 07Jul2021 (four days after the vaccination), the patient died from severe pneumonia, sepsis (blood: gram-negative rod positive) and disseminated intravascular coagulation (DIC). On 07Jul2021 (four days after the vaccination), the patient died and was discharged from the hospital. The patient received treatment for pneumonia, sepsis and DIC, but did not recover. The course of the event was as follows: on 03Jul2021, the patient received the second dose of COMIRNATY. No past medical history. On 04Jul2021, the patient started to experience malaise. On 06Jul2021, the patient experienced pyrexia and respiratory condition worsening and was transported from the inoculation/initial consultation hospital to the reporter hospital. On 07Jul2021, the patient died after he experienced severe pneumonia, sepsis and DIC. The reporting physician classified the event as serious (fatal, hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: the causal relationship was unknown. No past medical history meant there was no history of visit/treatment. Since the vaccination, the patient has not been tested for COVID-19. It was unknown if an autopsy was done or not.; Sender''s Comments: Based on information provided. the events are more likely represent intercurrent medical conditions or related to underlying disease but unrelated to BNT162b2. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: severe pneumonia; sepsis (blood: gram-negative rod positive); DIC


VAERS ID: 1533660 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN; NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastrointestinal stromal tumor; Lung cancer recurrent (postoperative recurrent).
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100971452

Write-up: died at home; This is a spontaneous report from a contactable physician received via the Regulatory Authority. A 78-year-old male patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) intramuscular in the left arm on 05Jul2021 at 11:15 at age of 78 years old as single dose for COVID-19 immunization. Medical history included postoperative recurrent lung cancer and gastrointestinal stromal tumor (GIST) of stomach. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received acetylsalicylic acid (BAYASPIRIN), esomeprazole magnesium hydrate (NEXIUM) and other unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unspecified date in July2021 at unspecified time (unknown days after the vaccination), the patient died at home, and local police telephoned the reporter. The event resulted in death. It was unknown if the patient received any treatment for the event. The reporting physician assessed the event as serious (death). The cause of death was reported as unknown (the causal relationship could not be denied) lung cancer, the patient had GIST of stomach. It was unknown if autopsy was performed. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on current convention, the reported death is assessed as related to BNT162b2 until sufficient information is available to confirm an unrelated cause of death. The patient''s underlying risk factors/predisposing condition postoperative recurrent lung cancer and gastrointestinal stromal tumor (GIST) of stomach have been assessed to provide an alternative explanation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1533661 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Dementia; Gastric fistula; Hepatic cirrhosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100971454

Write-up: Assumed acute myocardial infarction; cardiopulmonary arrest; This is a spontaneous report from a contactable physician received via the Regulatory Authority. The patient was a non-pregnant 90-year-old female. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medical history included cerebral infarction, dementia, hepatic cirrhosis, gastric fistula, and bedridden. On 11Jun2021 at an unknown time, the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) intramuscular for COVID-19 immunization. On 09Jul2021 at an unknown time (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) at the age of 90-year-old intramuscular at dose 2, single for COVID-19 immunization. On 12Jul2021 at an unknown time (3 days after the vaccination), the patient experienced assumed acute myocardial infarction and cardiopulmonary arrest. The events resulted in emergency room and death. The outcome of the events was fatal with treatment including cardiopulmonary resuscitation (CPR). The course of the events was as follows: The patient had a medical history of dementia, cerebral infarction, and cirrhosis. The patient had nutritional dependence of gastric fistula, and she was bedridden. On 11Jun2021, the patient received the first single dose of BNT162b2 in another hospital. On 09Jul2021, the patient received the second single dose of BNT162b2. On 12Jul2021, the patient was urgently transferred to the reporting hospital due to cardiopulmonary arrest. The patient did not respond to CPR and died. The cause of lesion could not be identified by autopsy imaging (AI). No autopsy was performed. The cause was considered as acute myocardial infarction and cardiopulmonary arrest. The reporting physician assessed the events as serious (death). Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events of Acute myocardial infarction and cardiopulmonary arrest cannot be totally excluded/assessed. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: cardiopulmonary arrest; Assumed acute myocardial infarction


VAERS ID: 1533662 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100971860

Write-up: Sudden death; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is V21121947. A 88-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 24Jul2021 (the day of vaccination) (Batch/Lot Number: EY0583; Expiration Date: 31Oct2021) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Body temperature before vaccination was not provided. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 25Jul2021 (one day after the vaccination), the patient experienced sudden death. On 25Jul2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 24Jul2021 (the day of vaccination), in the morning, the patient received the first dose of BNT162b2 vaccination, at a dose of 0.3 mL at the reporting hospital, and he went home. After the patient went home, the course was observed without abnormalities. On 25Jul2021 (one day after vaccination), no particular abnormalities were observed. The patient told his family member that he would take a bath, and he took a bath. After a while, when the family member went to see how the patient dosing, he had death on arrival (DOA). The patient was transferred to the general hospital, and he was confirmed to die. An arrangement for an autopsy was made, and as of this date, the cause of death was unknown. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were underling disease and advanced age. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1533663 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-12
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood lactate dehydrogenase, Body temperature, C-reactive protein, Computerised tomogram, Interstitial lung disease, Oxygen saturation, Pneumonia bacterial, White blood cell count
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: LDH; Result Unstructured Data: Test Result:311; Test Date: 20210612; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210613; Test Name: Body temperature; Result Unstructured Data: Test Result:38s Centigrade; Test Date: 202106; Test Name: CT; Result Unstructured Data: Test Result: ground glass opacity in the entire lung field; Test Date: 202106; Test Name: CRP; Result Unstructured Data: Test Result:7.11; Test Date: 20210614; Test Name: SpO2; Result Unstructured Data: Test Result:60s %; Comments: room air; Test Date: 202106; Test Name: WBC; Result Unstructured Data: Test Result: 8900.
CDC Split Type: JPPFIZER INC202100971886

Write-up: interstitial pneumonia aggravated accompanying infection; interstitial pneumonia aggravated accompanying infection; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121965. A 77-year-old female (age at vaccination was 77 years old) received the first dose of COVID-19 vaccine (Product name, Lot number and expiration date were not unknown) via an unspecified route of administration as a single dose on 31May2021 at unknown time (the day of vaccination) for COVID-19 immunization. Body temperature before vaccination was unknown. Family history and medical history were unknown. On 12Jun2021 (12 days after the vaccination), the patient experienced interstitial pneumonia aggravated. On 18Jun2021 (18 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows:On 31May2021, the patient received COVID-19 vaccine (trade name was unknown) at another medical institution. On 12Jun2021, the patient developed pyrexia of 37.7 degrees centigrade. On 13Jun2021, the patient developed pyrexia of 38s degrees centigrade and dyspnoea. On 14Jun2021, the patient visited a nearby hospital. SpO2 was 60s % (room air [RA]), for which the patient was transported to the reporting hospital. CT revealed ground glass opacity in the entire lung field. White blood cell (WBC) was 8900, C-reactive protein (CRP) was 7.11, and lactate dehydrogenase (LDH) was 311. It was assessed as interstitial pneumonia aggravated accompanying infection (as reported).The reporting physician classified the event as serious (death) and assessed that the causality between the event and COVID-19 vaccine as unassessable. Other possible cause of the event such as any other diseases was pneumonia bacterial. The reporting physician commented as follows:The symptoms occurred more than 1 week after the vaccination; thus, causality was considered unlikely related. The case was reported at the strong request of family member. Information on the lot/batch number has been requested.; Sender''s Comments: Based on known disease pathophysiology, the events of Interstitial pneumonia aggravated and pneumonia bacterial is assessed as not related to COVID-19 vaccine, and more likely due to underlying medical condition of pneumonia bacterial.The case will be reassessed if additional information becomes available.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Interstitial pneumonia aggravated


VAERS ID: 1533664 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pneumonia bacterial
SMQs:, Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   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: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Hypopharyngeal cancer; Pneumonia aspiration.
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result: 37.0 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202100971967

Write-up: Pneumonia bacterial; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121931. The patient was an 86-year and 1-month-old female. Body temperature before vaccination was 37.0 degrees centigrade. The family history was not provided. The patient had medical history of hypopharyngeal cancer, cerebral infarction, for which she was orally taking acetylsalicylic acid (BAYASPIRIN), and bilateral pneumonia aspiration (from03Jul2021 to 06Jul2021). On 08Jul2021 at 15:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5829, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization at the age of 86-year and 1-month-old . On 12Jul2021 (4 days after the vaccination), the patient experienced pneumonia bacterial. On 26Jul2021 at 14:25 (18 days after the vaccination), the outcome of the event was fatal. It was unknown if autopsy was performed. The course of the event was as follows: On 12Jul2021 (4 days after vaccination), the patient experienced pneumonia bacterial (it was diagnosed on the chest X-ray and the blood examination). On 26Jul2021 at 14:25 (18 days after vaccination), the patient died. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Pneumonia bacterial


VAERS ID: 1533665 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: body temperature; Result Unstructured Data: Test Result: 36.5 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202100972077

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121966. The patient was a 74-year and 0-month-old male. Body temperature before vaccination was 36.5 degrees centigrade. The family history was not described. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 18Jul2021 at 09:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 21Jul2021 (3 days after the vaccination), the patient experienced unknown cause of death. On 21Jul2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The course was unknown. An autopsy was performed at another hospital. Only the vaccination was performed at the reporting hospital. The reporting physician classified the event as serious (death). The causality between the event and BNT162b2 vaccination was not provided. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination was unknown.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1533666 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Cardiac failure acute, Cardio-respiratory arrest, Chest pain, Cyanosis, Oxygen saturation, Oxygen saturation decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; FUROSEMIDE; LIXIANA; BISOPROLOL FUMARATE; DIGOXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Aortic stenosis; Aortic valve repair; Atrial fibrillation paroxysmal; Cardiac failure chronic.
Allergies:
Diagnostic Lab Data: Test Name: SpO2; Result Unstructured Data: Test Result: latter half of 80%; Comments: it was usually latter half of 80; Test Date: 20210625; Test Name: SpO2; Result Unstructured Data: Test Result: latter half of 70%.
CDC Split Type: JPPFIZER INC202100972115

Write-up: cardiac failure acute; Cardio-respiratory arrest; consciousness disturbed; cyanosis; chest pain; the SpO2 was latter half of 70%; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121932. An 86-year and 7-month-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) via an unspecified route of administration on 25Jun2021 at 15:00 at 86 years old as a single dose for COVID-19 immunization. Body temperature before vaccination was not provided. The patient had medical histories of aortic stenosis, cardiac failure chronic, angina pectoris, aortic valve surgery and atrial fibrillation paroxysmal. The family history was not provided. The concomitant medications included clopidogrel (tablet 75 mg) orally at 75 mg, furosemide (tablet 40mg) orally at 40 mg, edoxaban tosilate hydrate (LIXIANA, Orodispersible tablet 30 mg) orally at 30 mg, bisoprolol fumarate (tablet 2.5 mg) orally at 2.5 mg , and digoxin (tablet 0.125 mg) orally at 0.0625 mg (0.5 tablet). On 26May2021, the patient previously received the first dose of BNT162b2 (Lot number EX3617, Expiration date 31Aug2021) for COVID-19 immunization at 86 years old. On 25Jun2021 (the day of the vaccination), the patient experienced chest pain. On 26Jun2021 (one day after the vaccination), the patient experienced consciousness disturbed, cyanosis, and cardio-respiratory arrest. The course of the event was as follows: On 25Jun2021 (the day of vaccination), at 15:00, the patient received the second dose of BNT162b2 vaccination. After the patient went home, he experienced chest pain, and the SpO2 was latter half of 70% (it was usually latter half of 80%). On 26Jun2021 (one day after vaccination), in the morning, the patient was found to have consciousness disturbed, and he had cyanosis. While the patient was being transferred, he had cardio-respiratory arrest. At 07:15 (one day after vaccination), the patient was confirmed to die. The cause of death was considered as cardiac failure acute (as reported). The patient originally had medical histories of aortic valve surgery and angina pectoris. These symptoms were considered to be aggravated. On 26Jun2021 at 7:15 (one day after the vaccination), the outcome of the events was fatal. It was unknown if autopsy was performed. The reporting physician classified the events as serious (death) and assessed that the events were unrelated to BNT162b2. Other possible causes of the events such as any other diseases were cardiac valvulopathy and angina pectoris. The reporting physician commented as follows: The patient originally had cardiac diseases and he was an elderly. Thus, it was considered that the events was unrelated to BNT162b2 vaccination.; Sender''s Comments: There is no reasonable possibility of causal association between the event of Cardiac failure acute, Chest pain, Oxygen saturation decreased , Cardio-respiratory arrest, Altered state of consciousness , Cyanosis and the drug BNT162b2 . The reported events are confounded by patient''s history of aortic stenosis, cardiac failure chronic, angina pectoris, aortic valve surgery and atrial fibrillation paroxysmal.; Reported Cause(s) of Death: chest pain; the SpO2 was latter half of 70%; Cardio-respiratory arrest; consciousness disturbed; cyanosis; cardiac failure acute


VAERS ID: 1533667 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Blood potassium, Body temperature, Cardiac arrest, Dehydration, Hyperkalaemia, Ileus, Loss of consciousness, Renal failure, Small intestinal obstruction, Subileus, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), 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), 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), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease; Renal failure
Allergies:
Diagnostic Lab Data: Test Name: K; Result Unstructured Data: Test Result: 7.4; Test Date: 20210727; Test Name: body temperature; Result Unstructured Data: Test Result: 36.8 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202100972170

Write-up: Small intestinal obstruction; had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K of 7.4), and thus, the patient had cardiac arrest.; had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K of 7.4), and thus, the patient had cardiac arrest.; had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K of 7.4), and thus, the patient had cardiac arrest.; had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K of 7.4), and thus, the patient had cardiac arrest.; had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K of 7.4), and thus, the patient had cardiac arrest.; vomiting due to ileus, and she aspired the vomit; Since the patient was an elderly and had Parkinson''s disease, she inhaled the vomit and had asphyxia; vomiting; loss of consciousness; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121993. The patient was an 84-year-old female. Body temperature before vaccination was 36.8 degrees centigrade. The family history was unknown. The patient had medical histories of renal failure and Parkinson''s disease. On 06Jul2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EW0201, Expiration date 30Sep2021), and no side reactions were observed after the vaccination. On 27Jul2021 at unknown time (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) at 84-year-old, via intramuscular as a single dose for COVID-19 immunization. On 28Jul2021 (one day after the vaccination), the patient had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K of 7.4), and thus, the patient had cardiac arrest. The patient had vomiting due to ileus, and she aspired the vomit. Since the patient was an elderly, and she had Parkinson''s disease, she inhaled the vomit, and she had asphyxia. On 28Jul2021 (one day after the vaccination), the outcome of the events were fatal. The course of the event was as follows: On 21Jul2021, the patient had no appetite, and she did not move, and thus, the family recommended her to take fluid. On 27Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination via intramuscular route. On 28Jul2021 (one day after vaccination), in the morning, the patient experienced vomiting, and thereafter, she was unable to move, and she was sleeping all the time. On the same day at 18:45, the patient was found to be exhausted by her family. The patient had a large amount of vomiting (it was black, but no fresh blood was observed). Thereafter, the patient experienced loss of consciousness, and cardiac massage was initiated. An ambulance was called. At 18:58 , an ambulance service arrived. Electrocardiogram showed cardiac arrest, and cardiopulmonary resuscitation (CPR) was initiated, and adrenaline was administered; however, no electrocardiographic waveform appeared. At 19:25, the patient arrived at the reporting hospital. CPR was continued. Approximately 20 minutes had passed; however, no return of spontaneous circulation was obtained. CPR was continued until the patient''s husband arrived at the hospital at the family''s wish. At 20:10, the family arrived at the reporting hospital. The patient had cardio-respiratory arrest and pupils dilated, and light reflex disappeared. Thus, the patient was confirmed to die. After the death was confirmed, an autopsy imaging (AI) was performed, which showed small intestinal obstruction, and accumulation of vomit in the bronchus was confirmed. Based on the results of the AI and the blood examination, the direct causes of death were explained to the family as follows: 1) the patient had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K 7.4), and thus, the patient had cardiac arrest. 2) the patient had vomiting due to ileus, and she aspired the vomit. Since the patient was an elderly and had Parkinson''s disease, she inhaled the vomit and had asphyxia. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was small intestinal obstruction. The reporting physician commented as follows: According to the attending physician, although the patient died the following day after the BNT162b2 vaccination, the patient had physical deconditioning before the vaccination. Thus, it was considered that ileus occurred independently of the vaccination, and ileus could not be said as the direct cause of death. However, it could not be said that the death was not affected by the ileus, which was not mentioned at the time of explanation to the family. Causality was unknown. Patient die on 28Jul2021.; Sender''s Comments: Based on information provided, the event ileus more likely represents an intercurrent medical condition which is unrelated to BNT162b2. The case will be reassessed once more information become available.; Reported Cause(s) of Death: had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K of 7.4), and thus, the patient had cardiac arrest.; subileus; asphyxia; Hyperkalaemia; loss of consciousness; Small intestinal obstructio; Autopsy-determined Cause(s) of Death: small intestinal obstruction.


VAERS ID: 1533669 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Breast cancer; Bronchial asthma; Cholecystolithiasis; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100973859

Write-up: found the patient dead in the toilet; This is a spontaneous report from a contactable physician received via COVID-19 Regulatory Authority. The patient was a non-pregnant 87-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Other medical history included hypertension, bronchial asthma, breast cancer, angina pectoris and cholecystolithiasis. On 26Jul2021 at 11:00 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0572, Expiration date 31Oct2021) intramuscularly in the left upper arm for COVID-19 immunization. After 15 minutes of resting, there was no problem and the patient went home. On 28Jul2021 (two days after the vaccination), a caretaker visited the patient and found the patient dead in the toilet. The event resulted in death. The cause of death was unknown. Autopsy was not performed. The outcome of the event was fatal without treatment. The reporting physician did not provide any assessment of the event seriousness or the causal relationship to the vaccine. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: found the patient dead in the toilet


VAERS ID: 1533670 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-22
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-07
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: 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: TACROLIMUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency secondary to chemotherapy (Treated with Tacrolimus)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100976373

Write-up: Death; This is a spontaneous report from a contactable physician (coroner) received via Regulatory Authority. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 22Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; tacrolimus (TACROLIMUS), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication . The patient medical history included immunocompromised patient. Concomitant medications were not reported. On 01Jun2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced death on an unspecified date. The action taken in response to the event(s) , for tacrolimus was not applicable. The patient died on an unspecified date. An autopsy was performed and results were not provided. Course of the event. On 01Jun2021, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were unknown) as single dose for COVID-19 immunization. On 22Jun2021 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were unknown) via an unspecified route of administration as single dose for COVID-19 immunization. On an unspecified date (1 month and 10 days after the second dose of the vaccination), the patient died. An autopsy was performed by the reporter. The cause of death was not reported. The reporter inquired if it was appropriate that the vaccination was given to the patient who was using immunosuppressants (tacrolimus) and if the vaccination should be given to such patients hereafter. The reporter also inquired if there was a causal relationship between the BNT162b2 and the patient''s death, if there was a possibility that the vaccination influenced the death, and if adverse reaction could occur 1 month and 10 days after the vaccination. Information on the lot/batch number has been requested.; Sender''s Comments: The causal relationship between bnt162b2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: Death


VAERS ID: 1533671 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

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

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: AMLODIPINE BESILATE; RABEPRAZOLE SODIUM; DROXIDOPA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Large intestine carcinoma; Thoracic aortic aneurysm
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100976483

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician received via COVID-19 Regulatory Authority. The patient was a non-pregnant 84-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received amlodipine besilate (AMLODIPINE), rabeprazole sodium (RABEPRAZOLE), and droxidopa (DROXIDOPA) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included ascending thoracic aortic aneurysm and large intestine carcinoma. On 16Jun2021 at 17:15 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via intramuscular route of administration in the arm left at single dose for COVID-19 immunization (84-year-old at vaccination). On unknown date in Jun2021 (unknown days/hours/minutes after the vaccination), the patient experienced unknown cause of death. The event resulted in death. The outcome of the event was fatal with without treatment. The reporting physician assessed the event as (death). It was contacted that the patient died at his home (the details were unknown). On 29Jul2021 (one month, 12 day, 6 hours, and 45 minutes after vaccination), the death was revealed by the contact from the police. However, the following day after the vaccination, the patient had no physical deconditioning, and he visited the reporting hospital (at that time, no abnormalities were observed at all). Since the patient did not visit the reporting hospital on 01Jul2021 (14 days, 6 hours, and 45 minutes after vaccination) which was the day of the second dose of BNT162b2 vaccination. Although the physician called the patient and visited his home, no response was obtained. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1533672 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   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: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion
Allergies:
Diagnostic Lab Data: Test Date: 20210626; Test Name: Body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100977603

Write-up: cardiopulmonary arrest (CPA); This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is V21122006. A 78-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY5422, Expiration date 31Aug2021) on 26Jun2021 at single dose for COVID-19 immunization. Body temperature before vaccination was 35.7 degrees centigrade. Family history was not reported. Medical history included cardiac pacemaker insertion. Concomitant medication included rivaroxaban (XARELTO, strength: 10 mg) at 10 mg taken orally and ongoing. On an unspecified date, the patient previously received the first dose of BNT162B2 (lot number: unknown, expiration date: unknown) at single dose for COVID-19 immunization. On 26Jun2021 (the day of vaccination), the patient received the second dose of BNT162B2. On 27Jun2021 in early morning (1 day after the vaccination), the patient experienced cardiopulmonary arrest (CPA). On 27Jun2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 27Jun2021 in early morning, family member found that the patient had CPA in the bedroom at home. The patient died on 27Jun2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. Reporter''s comment: Causality between the second vaccination and the cause of death could not be estimated.; Reporter''s Comments: Causality between the second vaccination and the cause of death could not be estimated.; Reported Cause(s) of Death: cardiopulmonary arrest (CPA)


VAERS ID: 1533675 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis coronary artery, Cardiac failure acute, Computerised tomogram, Left ventricular dysfunction
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: CT; Result Unstructured Data: Test Result:advanced coronary artery calcification
CDC Split Type: JPPFIZER INC202100977613

Write-up: advanced coronary artery calcification; cardiac failure acute due to marked low left ventricular function; cardiac failure acute due to marked low left ventricular function; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is V21122465. A 93-year and 0-month-old female patient received the second dose of COVID-19 vaccine (Lot number and expiration date were not reported) via an unspecified route of administration on 24Jul2021, at patient age of 93-year-old, as a single dose for COVID-19 immunization. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Family history was not reported. Concomitant medications were not reported. On an unspecified date, the patient previously received COVID-19 vaccine (Lot# and expiration date were not reported). On 24Jul2021 (the day of vaccination), the patient received the second dose of COVID-19 vaccine. Body temperature before vaccination was not reported. On 26Jul2021 at 00:45 (2 days after the vaccination), the patient experienced cardiac failure acute due to marked low left ventricular function. The event resulted in hospitalization. Probably 36 hours after receiving the vaccine at facility, the patient developed pyrexia, blood pressure decreased, and respiratory failure. The patient was transported to emergency center of the reporting hospital. The patient was diagnosed with cardiac failure acute due to marked low left ventricular function. Due to advanced age, invasive therapy was not requested; thus, only drug therapy was initiated. Despite the therapy, on 29Jul2021 (5 days after the vaccination), the patient died. The reporting physician classified the event as serious (death) and assessed that the causality between the event and COVID-19 vaccine as un-assessable. Other possible cause of the event such as any other diseases was follows: Computer tomography (CT) revealed advanced coronary artery calcification. There was a possibility of low left ventricular function due to chronic coronary artery disease. The reporting physician commented as follows: Although the event was considered probably unrelated to COVID vaccine, the case was reported since the patient experienced the event about 36 hours after the vaccination and eventually died.; Reported Cause(s) of Death: cardiac failure acute due to marked low left ventricular function; cardiac failure acute due to marked low left ventricular function; advanced coronary artery calcification


VAERS ID: 1533677 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100977642

Write-up: death; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A 7-decade-old (reported as 60s) female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown), via an unspecified route of administration on 2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date in 2021 (2 days after the vaccination), the patient experienced death. The course of the event was as follows: On unknown date in 2021, the patient died 2 days after the vaccination. Since the physician was not her attending physician, and the physician examined the patient for the first time, the details were unknown. An autopsy was performed by the police. The causality between the event and BNT162b2 was not provided. The outcome of the event was fatal. The patient died on 2021. An autopsy was performed and results were not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1533678 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Body temperature, Computerised tomogram, Condition aggravated, Ruptured cerebral aneurysm, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   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: DEPAKENE-R; IMIDAPRIL HYDROCHLORIDE; REBAMIPIDE; MARZULENE S; CELECOX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Hypertension; Subarachnoid haemorrhage
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Autopsy; Result Unstructured Data: Test Result:Subarachnoid haemorrhage; Comments: Subarachnoid haemorrhage due to ruptured cerebral aneurysm (right internal carotid artery to posterior communicating artery bifurcation), performed in the morning; Test Date: 20210728; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Name: CT; Result Unstructured Data: Test Result:intraventricular haemorrhage; Comments: Left and right intraventricular haemorrhage and haemorrhage around the right thalamus were pointed out.; Test Date: 20210729; Test Name: CT; Result Unstructured Data: Test Result:Haemorrhage intracranial
CDC Split Type: JPPFIZER INC202100977649

Write-up: Subarachnoid haemorrhage due to ruptured cerebral aneurysm; Subarachnoid haemorrhage due to ruptured cerebral aneurysm; Subarachnoid haemorrhage due to ruptured cerebral aneurysm; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122468. A 73-year-old female patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021), via an unspecified route of administration on 28Jul2021 at 15:03 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.2 degrees centigrade. It was unknown whether the patient had a family history. Medical history included hypertension, epilepsy, and subarachnoid haemorrhage. Allergy, vaccination and disease within one month, past history of adverse reaction was none. Concomitant medications included oral valproate sodium (DEPAKENE-R), oral imidapril hydrochloride, oral rebamipide, oral levoglutamide/sodium gualenate (MARZULENE S) and oral celecoxib (CELECOX). On an unspecified date, the patient previously received the first dose of BNT162b2 for COVID-19 immunisation. On 29Jul2021 at an unknown time (1 day after the vaccination), the patient experienced subarachnoid haemorrhage due to ruptured cerebral aneurysm. The course of the event was as follows: On 28Jul2021 at 15:03, the patient was vaccinated (COVID-19 vaccine manufactured by Pfizer, COMIRNATY). The patient went home with no acute adverse reaction. On the same day at 16:02, the patient reported the family that she had no symptoms. On 29Jul2021 around 09:50, the patient was found dead in her bedroom. On the same day, a computed tomography (CT) performed at the time of necropsy and examination showed haemorrhage intracranial. On the morning of 30Jul2021, subarachnoid haemorrhage due to ruptured cerebral aneurysm (right internal carotid artery to posterior communicating artery bifurcation) was found in an autopsy performed to determine the cause of haemorrhage intracranial. A CT (on unknown date) showed left and right intraventricular haemorrhage and haemorrhage around the right thalamus; however, a detailed examination was scheduled to be performed for details at a later date. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was possibility of pathologic subarachnoid haemorrhage due to ruptured cerebral aneurysm (not related to the vaccination). The reporting physician commented as follows: At the autopsy of this case, the cause of death with naked eyes was diagnosed as subarachnoid haemorrhage due to ruptured cerebral aneurysm. The causal relationship between the vaccination and the ruptured cerebral aneurysm could not be completely ruled out because of the temporal proximity of death within 24 hours after the second dose of the COVID-19 vaccination. However, at the time of this report, there was no literature or report that clearly had a causal relationship between the COVID-19 vaccine and haemorrhage intracranial. In addition, since it still took time to examine the histological findings of this case (presence or absence of vasculitis, etc.), the causal relationship should be considered as unassessable at the time of this report. On 29Jul2021 (1 day after the vaccination), the outcome of the events was fatal.; Reported Cause(s) of Death: Subarachnoid haemorrhage due to ruptured cerebral aneurysm; Subarachnoid haemorrhage due to ruptured cerebral aneurysm; Subarachnoid haemorrhage due to ruptured cerebral aneurysm


VAERS ID: 1533679 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-03
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Cardio-respiratory arrest, Haematemesis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Respiratory failure (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Hepatic function disorder; Hepatopathy alcoholic
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: blood examination; Result Unstructured Data: Test Result: mild hepatic function disorder; Test Date: 20210611; Test Name: body temperature; Result Unstructured Data: Test Result: 36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100977652

Write-up: haematemesis; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119409. A 28-year-old (reported as 28-year and 11-month-old) female patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) at 28-year-old, via an unspecified route of administration on 11Jun2021 at 14:00 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees centigrade. The family history was not provided. The patient had medical history of mild hepatic function disorder, hepatopathy alcoholic, and drinking alcohol. Concomitant medications were not reported. On an unspecified date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EW4811, Expiration date 31Jul2021) for COVID-19 immunisation. On 03Jul2021 (21 days and 10 hours after the vaccination), the patient experienced cardio-respiratory arrest. The course of the event was as follows: On 03Jul2021 (21 days and 10 hours after vaccination), when the patient''s relative (her elder brother) visited the patient''s home, she was found to have cardio-respiratory arrest. It was considered that the patient had cardio-respiratory arrest while she was drinking alcohol and eating snacks, and she also had haematemesis. An autopsy was being performed by the police (the details were unknown). The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was hepatopathy alcoholic. The reporting physician commented as follows: In Feb2021, the blood examination was performed at the reporting hospital, which showed mild hepatic function disorder. However, considering the underlying disease and her age, the involvement of BNT162b2 vaccination was suspected to be one of the causes of sudden death. On 03Jul2021 (22 days after the vaccination), the outcome of the event cardio-respiratory arrest was fatal, and of event haematemesis was unknown.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1533680 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-30
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100977658

Write-up: acute aortic dissection; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is V21119433. Local reference # V21119433_20210731. The patient was an 86-year and 10-month-old female. Body temperature before vaccination was unknown. Reported unknown to the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 04Jun2021, the patient previously received the first dose of COVID-19 Vaccine (Lot # and Expiration date were not reported). On 28Jun2021 at unspecified time (the day of vaccination), the patient received the second dose of COVID-19 Vaccine (Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 30Jul2021 at 10:57 (two days after the vaccination), the patient experienced acute aortic dissection. On 30Jul2021 at 13:04 (two days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 30Jul2021 at 13:04, the patient died from acute aortic dissection. The reporting physician classified the event as serious (death) and assessed that the causality between the event and COVID-19 Vaccine as unassessable. Other possible cause(s) of the event such as any other diseases was stenosis aortic valve. The reporting physician did not provide any further comment. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: acute aortic dissection


VAERS ID: 1533701 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Lung disorder, Pulmonary alveolar haemorrhage, Pulmonary hypertension, Right ventricular hypertrophy, Thrombosis
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTPFIZER INC202100973171

Write-up: After II dose - heavy dyspnea; pulmonary hypertension; right ventricular hypertrophy; focal blood vessel thrombosis; intra-alveolic hemorrhages; hypertrophy of smooth muscle of lungs; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number LT-SMCA-4213. A 63-year-old male patient received bnt162b2 (COMIRNATY), second single dose via an unspecified route of administration on 05May2021 (Batch/Lot Number: EX6537) for covid-19 immunisation. The patient previously received first single dose of bnt162b2 (batch# EW9127) on 14Apr2021 and experienced dyspnea on15Apr2021, which was worsening. The patient''s medical history and concomitant medications were not reported. After the second dose, the patient experienced heavy dyspnea and lack of air, and died on 06May2021 in less than 24 hours after vaccination. Autopsy performed included morphological test in May2021 and found pulmonary hypertension, right ventricular hypertrophy, hypertrophy of smooth muscle of lungs, focal blood vessel thrombosis with intra-alveolic hemorrhages. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: After II dose - heavy dyspnea; Autopsy-determined Cause(s) of Death: pulmonary hypertension; right ventricular hypertrophy; focal blood vessel thrombosis; intra-alveolic hemorrhages; hypertrophy of smooth muscle of lungs


VAERS ID: 1533778 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   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: OMEPRAZOLE; DICLOFENAC SODIUM; BRICANYL TURBUHALER; FLUOXETINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100948850

Write-up: death/becoming unwell and asystole; Fatigue; generalized joint pain/pain in the joints; malaise/not feeling well; shortness of breath/dyspnoea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00632862. A 68-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Apr2021 (Batch/Lot Number: EX0893) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history was not reported. No previous COVID-19 infection. Concomitant medications included omeprazole; diclofenac sodium; terbutaline sulfate (BRICANYL TURBUHALER); fluoxetine; all taken for an unspecified indication, start and stop date were not reported. On an unspecified date in 2021 (latency unknown), patient experienced shortness of breath/dyspnoea. On 29Apr2021 (3 days after start), patient experienced fatigue, generalized joint pain/pain in the joints and malaise/not feeling well. On 30Apr2021 (4 days after start), patient experienced death/becoming unwell or suddenly unwell and asystole on arrival ambulance. Treatment for asystole is treated with BLS (basic life support) and pace and adrenaline but no benefit. The outcome of the events was fatal. The patient died on 30Apr2021. It was unknown if autopsy was done. This case was reproted as serious. Reporter''s comment: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no death Additional information ADR: suddenly unwell on 30Apr on arrival ambulance asystole. no benefit from pacing adrenaline and BLS. already complaints of shortness of breath, fatigue and joint pain COVID-19 Previous COVID-19 infection: No No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no death Additional information ADR: suddenly unwell on 30Apr on arrival ambulance asystole. no benefit from pacing adrenaline and BLS. already complaints of shortness of breath, fatigue and joint pain COVID-19 Previous COVID-19 infection: No; Reported Cause(s) of Death: death/becoming unwell and asystole; shortness of breath/dyspnoea; generalized joint pain/pain in the joints; fatigue; malaise/not feeling well


VAERS ID: 1533873 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: SKPFIZER INC202100981008

Write-up: sudden cerebrovascular hemorrhagic accident; This is a spontaneous report from a contactable physician received via COVAES. A 66-year-old male patient received a dose of BNT162b2 (COMIRNATY), via an unspecified route of administration in Mar2021 (Batch/Lot Number was not reported) (at the age of 66-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. It was reported that: two days after vaccination (in Mar2021) with Pfizer vaccine the patient experienced sudden cerebrovascular hemorrhagic accident and as a consequence of which he died. The patient died on an unspecified date. It was not reported if an autopsy was performed. The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.; Sender''s Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: sudden cerebrovascular hemorrhagic accident


VAERS ID: 1534544 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0297 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Pyrexia, Respiration abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100956269

Write-up: Fever; Abnormal breathing; Weakness; This is a spontaneous report from a non-contactable consumer. An 82-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administration on 21Jun2021 (Lot Number: FD0297) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever, abnormal breathing and weakness on 21Jun2021. The outcome of events was fatal. The patient died on 21Jun2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever; abnormal breathing; weakness


VAERS ID: 1534545 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0297 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Dyspnoea, Nausea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100956428

Write-up: Shortness of breath; Nausea; Diarrhea; Vomiting; This is a spontaneous report from a non-contactable consumer. A 61-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Jun2021 at age of 61-year-old (Batch/Lot Number: FD0297) at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced shortness of breath, nausea, diarrhea and vomiting on 28Jun2021. The patient died on 28Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number and expiry date cannot be obtained. ; Reported Cause(s) of Death: Shortness of breath; nausea; diarrhea; vomiting


VAERS ID: 1534546 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-16
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH VVC7UC39XCVL / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dry mouth, Fatigue, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100956429

Write-up: Extreme fatigue; Dry mouth; Fever; This is a spontaneous report from a non-contactable consumer. An 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28May2021 (Batch/Lot Number: VVC7UC39XCVL) as single dose for covid-19 immunization at age of 81 years old. The patient''s medical history and concomitant medications were not reported. The patient experienced fever on 16Jun2021, extreme fatigue and dry mouth on 28Jun2021. The outcome of the events was fatal. The patient died on 28Jun2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Dry mouth; Extreme fatigue; Fever


VAERS ID: 1534547 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-07-02
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100956430

Write-up: Kidney failure; This is a spontaneous report from a non-contactable consumer. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administration on 28May2021 (Batch/Lot number was not reported) at age of 71-year-old at single dose for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced kidney failure on 02Jul2021. The patient died of kidney failure 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: Kidney failure


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