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

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



Case Details

This is page 139 out of 172

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VAERS ID: 1479790 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Computerised tomogram head, Computerised tomogram thorax, Conjunctival haemorrhage, Internal haemorrhage, Platelet count, Platelet count decreased, Pulmonary alveolar haemorrhage, Thrombocytopenic purpura
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Conjunctival disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: Head CT; Result Unstructured Data: Test Result:revealed multiple cerebral haemorrhage; Test Date: 20210618; Test Name: Chest CT; Result Unstructured Data: Test Result:pulmonary alveolar haemorrhage; Comments: revealed a complication of pulmonary alveolar hemorrhage; Test Date: 20210616; Test Name: Platelet level/Platelets; Result Unstructured Data: Test Result:6000 /mm3; Comments: low; Test Date: 20210618; Test Name: Platelet level/Platelets; Result Unstructured Data: Test Result:5000 or lower /mm3
CDC Split Type: JPPFIZER INC2021816507

Write-up: the platelet level was pointed out to be low at 6000/uL/platelets were 5000/uL or lower; left hyposphagma was noted; Thrombocytopenic purpura; internal haemorrhage of the vaccinated upper arm; Head computerised tomography (CT) revealed multiple cerebral haemorrhage; chest CT revealed a complication of pulmonary alveolar haemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21117122. The patient was an 85-year and 7-month-old female. Body temperature before vaccination, family history, medical history, and concomitant medications were not reported. It was not reported whether there were 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 05Jun2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date not reported) via an unspecified route of administration as a single dose (DOSE 1, SINGLE) for COVID-19 immunisation. On 08Jun2021 (3 days after the vaccination), the patient experienced internal haemorrhage of the vaccinated upper arm(thrombocytopenic purpura). On 15Jun2021 (10 days after the vaccination), the patient experienced left hyposphagma (thrombocytopenic purpura ). On 18Jun2021 (13 days after the vaccination), the patient experienced platelets 5000/uL or lower, multiple cerebral haemorrhage, pulmonary alveolar hemorrhage (thrombocytopenic purpura). On 18Jun2021 (13 days after the vaccination), the patient was admitted to the hospital. On 29Jun2021 (24 days after the vaccination), the patient was discharged with death, and the outcome of the events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: On 08Jun2021 (3 days after the vaccination), the patient noticed internal haemorrhage of the vaccinated upper arm. On 15Jun2021 (10 days after the vaccination), left hyposphagma was noted. On 16Jun2021 (11 days after the vaccination), the platelet level was pointed out to be low at 6000/uL at the local hospital. On 18Jun2021 (13 days after the vaccination), the patient was referred to the reporting hospital via a general hospital. The platelets were 5000/uL or lower. Head computerised tomography (CT) revealed multiple cerebral haemorrhage, and chest CT revealed a complication of pulmonary alveolar haemorrhage. The patient showed a poor response to platelet transfusion, gamma-globulin, and steroids. On 29Jun2021 (24 days after the vaccination), she died. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the events such as any other diseases.; Reported Cause(s) of Death: internal haemorrhage of the vaccinated upper arm; left hyposphagma was noted; the platelet level was pointed out to be low at 6000/uL/platelets were 5000/uL or lower; Head computerised tomography (CT) revealed multiple cerebral haemorrhage; chest CT


VAERS ID: 1479796 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Cardiac arrest, Cardiac failure congestive, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (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: JPPFIZER INC2021822318

Write-up: Respiratory failure; Cardiac arrest; Bronchial asthma attack; Cardiac failure congestive; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21117231. The patient was a 78-year and 5-month-old female. Body temperature before vaccination was not provided. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 26Jun2021 (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 28Jun2021 at 04:20 (2 days/4 hours/20 minutes after the vaccination), the patient experienced respiratory failure and cardiac arrest. On 28Jun2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 28Jun2021, at 04:20 (2 days, 4 hours, and 20 minutes after vaccination), the patient had dyspnoea. The patient was suspected to have asthmatic attack, and she received treatment of inhalation at her home. However, no improvement was observed, and an ambulance was called, and the patient was transferred to the reporting hospital. When the patient was transferred, she had coma, and 20 minutes later, she had cardiac arrest. Although the spontaneous circulation temporarily returned with resuscitation, immediately, the patient had cardiac arrest. Resuscitation was judged to be difficult, and the patient was confirmed to die at 06:04 (2 days, 6 hours, 4 minutes after vaccination). The patient was judged to have bronchial asthmatic attack and cardiac failure congestive. 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 some kinds of infection. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination was unknown.; Reported Cause(s) of Death: Respiratory failure; Cardiac arrest; Bronchial asthma attack; Cardiac failure congestive


VAERS ID: 1479802 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 26
Permanent Disability? 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 INC2021823073

Write-up: second dose of BNT162b2 was administered two weeks after administration of the first dose; Myocardial infarction/Heart attack; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 04Jun2021 15:00 (Batch/Lot number was not reported) as a single dose, dose 2 via an unspecified route of administration on 18Jun2021 15:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the second dose of BNT162b2 was administered two weeks after administration of the first dose. On an unspecified date in Jun2021, the patient experienced myocardial infarction/heart attack (death, medically significant). The clinical course was reported as follows: On 04Jun2021 at 15:00, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number: unknown, Expiration date: unknown). On 18Jun2021 at 15:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date not provided) via an unspecified route of administration for COVID-19 immunization. On 27Jun2021 (9 days after the vaccination), the patient died. The causality between the events and BNT162b2 and the seriousness criteria of the events were not provided. The course of the event was as follows: On 04Jun2021 at 15:00, the patient received the first dose of BNT162b2 vaccination. On 18Jun2021 at 15:00 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. The second dose of BNT162b2 was administered two weeks after administration of the first dose. On unknown date in Jun2021 (unknown days after vaccination), the patient had myocardial infarction/heart attack. On 27Jun2021 (9 days after vaccination), the patient died due to myocardial infarction/heart attack. The outcome of the event was fatal. The clinical outcome of the event, myocardial infarction/heart attack, was fatal. The clinical outcome of the event, inappropriate schedule of vaccine administered, was unknown. The patient died on 27Jun2021 due to myocardial infarction/heart attack. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Myocardial infarction/Heart attack


VAERS ID: 1479824 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-06-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Blood test, Body temperature, Bradycardia, Cardiac failure acute, Electrocardiogram, Heart rate, Hyporesponsive to stimuli, Pallor, Presyncope, Vomiting, White blood cell count
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cold sweat (at 11:35); Dementia; Ischaemic foot; Leg amputation; Type 2 diabetes mellitus; Vascular disorder NOS; Vomiting (at 11:35)
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:decreased; Comments: at 15:47; Test Date: 20210630; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:60s; Comments: at 17:15; Test Date: 20210630; Test Name: Blood collection; Result Unstructured Data: Test Result:only an increase of WBC; Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210630; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:sinus bradycardia and abnormal Q wave; Comments: at 17:15; Test Date: 20210630; Test Name: Pulse rate; Result Unstructured Data: Test Result:returned to 30s in about 15 minutes; Test Date: 20210630; Test Name: Pulse rate; Result Unstructured Data: Test Result:32; Comments: at 17:15; Test Date: 20210630; Test Name: Pulse rate; Result Unstructured Data: Test Result:temporarily became 60s; Comments: at 17:44; Test Date: 20210630; Test Name: white blood cell (WBC); Result Unstructured Data: Test Result:increase
CDC Split Type: JPPFIZER INC2021823632

Write-up: Bradycardia; patient''s response decreased; Pallor facial; Vagal reaction; Vomiting; Blood pressure decreased/Blood pressure was 60s; Cardiac failure acute; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21117985. An 86-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 30Jun2021 14:50 (Batch/Lot Number: EY3860; Expiration Date: 31Aug2021) at 86-years-old as a single dose for COVID-19 immunisation. The patient''s medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing, severe dementia from an unknown date and unknown if ongoing, left leg amputation due to severe ischaemic toe(s) from an unknown date and unknown if ongoing, cold sweat from 30Jun2021 to an unknown date (at 11:35), vomiting from 30Jun2021 to an unknown date (at 11:35), systemic vascular condition was extremely poor from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 30Jun2021 15:47, the patient experienced: cardiac failure acute (death, medically significant), vomiting (medically significant), blood pressure decreased/blood pressure was 60s (medically significant), and vagal reaction (medically significant). On 30Jun2021 17:15, the patient experienced: patient''s response decreased (medically significant), pallor facial (medically significant), bradycardia (medically significant). The clinical course was reported as follows: The patient was an 86-year-old male. Body temperature before vaccination was 36.4 degrees Centigrade. Family history was not reported. Medical history included type 2 diabetes mellitus, severe dementia, and left leg amputation due to severe ischaemic toe(s). On 30Jun2021 at 14:50 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 30Jun2021 at 15:47 (57 minutes after the vaccination), the patient experienced vomiting, blood pressure decreased, and cardiac failure acute. On 30Jun2021 at 17:15 (2 hours 25 minutes after the vaccination), the patient experienced hyporesponsive, pallor facial, and bradycardia. On 01Jul2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 30Jun2021 at 11:35, the patent had vomiting and cold sweat. Blood collection was performed and there was only an increase of white blood cell (WBC). Since the symptoms improved, the patient was placed under observation. In the afternoon, the patient had no symptom and it was judged that the patient could receive BNT162b2 intramuscular injection. At 14:50, the patient was vaccinated. At 15:47, the patient vomited again, and blood pressure decreased. A metoclopramide hydrochloride (PRIMPERAN) Injection 10 mg 0.5% 2 mL was administered. Vagal reaction was suspected, for which the patient''s lower extremities was elevated and placed in decubitus position; however, the symptoms did not improve, and fluid replacement was initiated. At 17:15, the patient''s response decreased and had pallor facial. Blood pressure was 60s and pulse rate was 32. Monitor was placed and 12-lead electrocardiogram showed sinus bradycardia and abnormal Q wave. At 17:44, an epinephrine (BOSMIN) Injection 1 mg 0.1% 0.5 mL was administered, and the pulse rate temporarily became 60s; however, it returned to 30s in about 15 minutes. Family member was consulted, and resuscitative measures were not requested. On 01Jul2021 at 06:03, the patient died. 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 as follows: The patient had a history of type 2 diabetes mellitus as well as left leg amputation due to severe ischaemic toe(s); thus, vascular condition was considered to have been aggravated. The reporting physician commented as follows: The patient had severe dementia, a history of type 2 diabetes mellitus for a long-term, and left leg amputation due to severe ischaemic toe(s); thus, systemic vascular condition was extremely poor. The patient had high risk of developing silent myocardial infarction. It was likely that the event occurred independently from the vaccination of COMIRNATY intramuscular injection; however, the case was reported since this was a death case occurred immediately after the vaccination. The patient underwent lab tests and procedures which included blood pressure measurement: decreased on 30Jun2021 at 15:47, blood pressure measurement: 60s on 30Jun2021 at 17:15, blood collection: only an increase of WBC on 30Jun2021, body temperature: 36.4 Centigrade on 30Jun2021 before vaccination, electrocardiogram: sinus bradycardia and abnormal Q wave on 30Jun2021 at 17:15, pulse rate: 32 on 30Jun2021 at 17:15, pulse rate: temporarily became 60s on 30Jun2021 at 17:44; pulse rate: returned to 30s in about 15 minutes on 30Jun2021, white blood cell (WBC): increase on 30Jun2021. Therapeutic measures were taken as a result of cardiac failure acute, vomiting, blood pressure decreased/blood pressure was 60s, patient''s response decreased, pallor facial, bradycardia, vagal reaction. The clinical outcome of the events: vomiting, blood pressure decreased/blood pressure was 60s, patient''s response decreased, pallor facial, bradycardia, vagal reaction, was unknown. The clinical outcome of the event, cardiac failure acute, was fatal. The patient died on 01Jul2021 due to cardiac failure acute. It was unknown if an autopsy was performed. ; Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1479827 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

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: 2021-06-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage; Dementia; Parkinson''s disease; Pneumonia aspiration
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021823671

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21117302. The patient was a 77-year and 5-month-old male. Body temperature before vaccination was 36.5 degrees Centigrade. Medical history included late effects of intracerebral hemorrhage, dementia, Parkinson''s disease and pneumonia aspiration. Concomitant medications and family history were not provided. On 08Jun2021 at 10:10 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot#: EY5420, Expiration date: 31Aug2021) via unspecified route of administration as a single dose for COVID-19 immunization. On 08Jun2021 at 17:35 (7 hours and 25 minutes after the vaccination), the patient developed cardio-respiratory arrest and died. It was not reported if an autopsy was performed. The course of the events was as follows: On 08Jun2021 (the day of vaccination), the patient''s condition was stable. After the vaccination, he was a good progress without any adverse reactions. However, at 17:35, the patient was found in cardio-respiratory arrest. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. It was unknown if there was possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient received the treatment for pneumonia aspiration at previous hospital. Since the patient was admitted to the reporter''s hospital, the amount of sputum was relatively large.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1479832 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Intraventricular haemorrhage, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Haemodialysis; Trochanteric femoral fracture; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: COVID-19 test (PCR); Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: JPPFIZER INC2021823705

Write-up: the third intraventricular haemorrhage; This is a spontaneous report from a contactable pharmacist received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was a elderly male (65 year-old or older). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent COVID-19 test (PCR) with nasal swab on 10Jun2021 and tested negative for COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included maintenance hemodialysis, epilepsy, type 2 diabetes mellitus, and femoral intertrochanteric fracture. On 25Jun2021 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via intramuscular route for COVID-19 immunization. On 27Jun2021 (2 days after the vaccination), the patient experienced the third intraventricular haemorrhage. On 28Jun2021 (3 days after the vaccination), the patient died. Cause of death was the third intraventricular haemorrhage. An autopsy was not performed. The patient did not any treatment for the event. The reporting pharmacist assessed the event as serious (death).; 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 event Intraventricular haemorrhage cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: The third intraventricular haemorrhage


VAERS ID: 1479838 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021823972

Write-up: died; This is a spontaneous report from a contactable physician received via Medical information team. The patient was an 89-year-old female. Medical history and concomitant medications were not provided. On 14Jun2021 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration as dose 1, single for COVID-19 immunization. On 01Jul2021 (17 days after the vaccination), the patient died. The reported course was as follows: On 14Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. The patient was to receive the second dose of BNT162b2 vaccination on 05Jul2021 (21 days after the first vaccination). On 01Jul2021 (17 days after the vaccination), the patient died. It was reported by the family that the patient died. Since 17 days had passed after the vaccination, the detailed situation on which the patient died was not heard. The reporting physician considered that the death was not caused by the vaccination. The autopsy was not provided.; 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: died


VAERS ID: 1479844 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-26
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   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: Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210617; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021824654

Write-up: acute myocardial infarction; This is a spontaneous report from a contactable physician (coroner) received from the regulatory authority report number is v21117304. The patient was a 70-year-old male. Body temperature before vaccination was 36.5 degrees centigrade. Medical history included rheumatoid arthritis. Concomitant medications and family history were not provided. The patient was living alone. On 17Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization (70-year-old at vaccination). On 26Jun2021 at around 16:00 (estimated date and time) (9 days after the vaccination), the patient died. The patient was found dead on the bed. A possible cause was acute myocardial infarction. It was not reported if an autopsy was performed. The reporting physician (coroner) classified the event as serious (fatal) and assessed the causality between the event and BNT162b2 as unassessable. Acute myocardial infarction was considered as a possible cause. The reporting physician commented that this was not anaphylaxis.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1479847 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Oesophageal carcinoma
Allergies:
Diagnostic Lab Data: Test Name: Oxygen saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC2021824703

Write-up: Death; breathing difficulty; Oxygen saturation decreased; This is a spontaneous report from a contactable physician via a Pfizer sales representative. On 05Jun2021, a 79-year-old male patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration at single dose at 79-year-old for COVID-19 immunisation. Medical history included terminal stage of oesophageal carcinoma and diabetes mellitus. Concomitant drug was not provided. On an unspecified date, the patient complained of breathing difficulty. Oxygen saturation decreased. The patient was transferred to a hospital by an ambulance, but he died. It was not reported if an autopsy was performed. The cause of death was not reported. There was no causal relationship with BNT162b2. Outcome of breathing difficulty and oxygen saturation decreased was unknown.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events "Death, breathing difficulty and Oxygen saturation decreased" cannot be completely excluded based on temporal association. Terminal stage of oesophageal carcinoma and diabetes mellitus may be contributory factors. This case will be re-assessed when 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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1479849 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hypoxia, Oxygen saturation, Pyrexia, Respiratory failure, SARS-CoV-2 test, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CILOSTAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Dementia; Disuse syndrome; Living in care; Poor feeding; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: Body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Test Date: 20210623; Test Name: SpO2; Test Result: 74 %; Test Date: 20210623; Test Name: COVID-19 antigen test; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: JPPFIZER INC2021827396

Write-up: Hypoxia at SpO2 74 %; Respiratory failure; Pyrexia at 37.9 degree C; Temporal wheezing; This is a spontaneous report from a contactable physician received via the Agency. The patient was a non-pregnant 84-year and 1-month-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received cilostazol (manufacture name not reported 50) at 50 (unit unknown) (1 tablet) twice daily after breakfast and supper within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included undernutrition, cardiac failure, disuse syndrome, dementia. The patient was wheelchair user, and in the condition requiring care for life. On 01Jun2021 at 10:00 at 84 years old, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) intramuscularly in the left arm for COVID-19 immunisation. On 21Jun2021 at 10:00 (the day of vaccination) at 84 years old, the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) intramuscularly in the left arm for COVID-19 immunization. On 23Jun2021 at 4:00 (2 days after the vaccination), temporal wheezing appeared. At 9:00, pyrexia at 37.9 degree C appeared. Hypoxia was noted at SpO2 74 %. Oxygen administration 5 L/min was started. The patient transferred to a hospital and was admitted for treatments. Since the vaccination, the patient was tested for COVID-19 antigen test using nasal swab on 23Jun2021, which showed negative result. However, the patient died of respiratory failure. The patient died on unspecified date. It was unknown if an autopsy was performed. Events resulted in physician office visit. The outcome of the respiratory failure and hypoxia at SpO2 74 % was fatal, and these events were classified as serious (death and hospitalization). Outcome of the temporal wheezing and pyrexia at 37.9 degree C was unknown. Causality assessment was not reported.; Sender''s Comments: Based on information provided, the events more likely related to underlying disease or represent intercurrent illnesses which are unrelated to BNT162b2 (COMIRNATY). 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: Hypoxia at SpO2 74 %; Respiratory failure


VAERS ID: 1479857 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration
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 INC2021828167

Write-up: physical condition deteriorated; This is a spontaneous report from a contactable physician received via Medical information group. A patient of unspecified age and gender received bnt162b2 (COMIRNATY Solution for injection), second dose (Lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Family history, medical history, and concomitant medication were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported) on an unspecified date. On an unspecified date (4 days after the vaccination), the patient experienced death. Seriousness criteria, causality assessment, and other possible cause of the event such as any other diseases were not provided. Event term death was updated to physical condition deteriorated later. After the patient received the second dose of COMIRNATY, physical condition deteriorated. Three days later, the patient visited a hospital. Four days later, on the following day, the patient died. Autopsy was conducted. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the limited available information, the causal association between the event general physical health deterioration with fatal outcome 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: physical condition deteriorated


VAERS ID: 1479861 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture, Aortic dissection, Blood pressure measurement, Cardio-respiratory arrest, Computerised tomogram, Condition aggravated, Lung neoplasm malignant, X-ray
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), Acute central respiratory depression (broad), Respiratory failure (broad), Non-haematological malignant tumours (narrow)

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DOCETAXEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer (N1M1); Metastases to liver
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:135/69 mmHg; Test Date: 20210627; Test Name: head-to-pelvis CT; Result Unstructured Data: Test Result:no intracranial lesion; Comments: at 13:32; left-side predominant pleural effusion was noted; Test Name: X-ray; Result Unstructured Data: Test Result:there was a suspicion of a descending thoracic aor; Comments: there was a suspicion of a descending thoracic aortic dissection and thoracic aortic aneurysm rupture
CDC Split Type: JPPFIZER INC2021828557

Write-up: thoracic aortic aneurysm rupture suspected; primary cancer with increased level of pleural effusion caused by aggravation of lung cancer; primary cancer with increased level of pleural effusion caused by aggravation of lung cancer; descending thoracic aortic dissection; CPA; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was a non-pregnant 72-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included inferior lobar cancer of the left lung (N1M1) diagnosed in Sep2020 and metastases to liver. In Sep2020, the patient was diagnosed with inferior lobar cancer of the left lung (N1M1). Primary lesion was reduced with KEYTRUDA; however, metastases to liver tended to increase, for which carboplatin (CBDCA) + docetaxel (DOC) were performed. Since adverse reaction was strong, only DOC was continued. On 08Jun2021, the patient received docetaxel intravenous infusion 60 mg, granisetron intravenous infusion 3 mg, and DEXART injection 6.6 mg. On the same day, blood pressure was 135/69 mmHg. On 25Jun2021 at 17:45 (the day of vaccination, at 72-year-old), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) intramuscular in the arm left for COVID-19 immunization. Concomitant medication included docetaxel for metastases to liver from an unspecified date and from 08Jun2021. On 27Jun2021 at 12:30 (1 day and 18 hours 45 minutes after the vaccination), the patient experienced cardiopulmonary arrest (CPA). And the patient experienced thoracic aortic aneurysm rupture suspected on unknown date. The event resulted in emergency room visit. On 25Jun2021 at 17:45, the patient received BNT162b2. On 27Jun2021 at 12:30, the patient suddenly fell while walking and had CPA, for which the patient was emergently transferred. At 12:38, emergency medical technician initiated CPR. At 12:50, the patient arrived at acute care hospital. The patient was intubated and epinephrine was administered; however, the patient had cardiac arrest. At 13:32, head-to-pelvis CT was conducted. There was no intracranial lesion, and left-side predominant pleural effusion was noted. It was considered that the death was due to primary cancer with increased level of pleural effusion caused by aggravation of lung cancer. At 13:52, death was confirmed. Autopsy was advised to family member, but they did not want it. At a later date, a radiologist read X-ray and pointed out that there was a suspicion of a descending thoracic aortic dissection and thoracic aortic aneurysm rupture. The cause of death was reported as thoracic aortic aneurysm rupture suspected. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events thoracic aortic aneurysm rupture suspected and primary cancer with increased level of pleural effusion caused by aggravation of lung cancer was fatal, while for other events was unknown. Treatment included cardiopulmonary resuscitation (CPR), intubation, and administration of epinephrine. The patient died on 27Jun2021. Autopsy was not performed. The reporting physician classified the event as serious (death).; Sender''s Comments: Based on available information as per narrative the causal relationship between BNT162B2 and the fatal events cardiac arrest and aggravated lung malignancy , aortic aneurysm leading to fatality , tcannot be excluded. 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.; Reported Cause(s) of Death: primary cancer with increased level of pleural effusion caused by aggravation of lung cancer; primary cancer with increased level of pleural effusion caused by aggravation of lung cancer; thoracic aortic aneurysm rupture suspected


VAERS ID: 1479867 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 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: 2021-06-16
   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: Chronic renal failure; Renal disease
Allergies:
Diagnostic Lab Data: Test Date: 20210613; Test Name: body temperature; Result Unstructured Data: Test Result:36.9; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021830079

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable other healthcare professional received from the Agency Regulatory Authority. Regulatory authority report number is v21117375. The patient was an 89-year-old male. Body temperature before vaccination was 36.9 degrees centigrade on 13Jun2021. The family history was not provided. The patient had medical history of renal disease, chronic renal failure. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 13Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 16Jun2021 at 19:15 (3 days after the vaccination), the patient experienced cardio-respiratory arrest. On 16Jun2021 (3 days after the vaccination), the outcome of the event was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: On 16Jun2021, at 19:15 (3 days, 19 hours, and 15 minutes after vaccination), the patient was found to have loss of consciousness while he was sitting on the toilet after supper. The patient had cardio-respiratory arrest. The patient seemed not to have vomiting. The patient ate 60% of the supper. He also orally took some drugs. The patient had no particular complaints, and his condition was as usual. The patient had chronic renal failure. The reporting physician classified the event as serious (death). The causality between the event and BNT162b2 vaccination was not provided. It was not reported whether there was other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1479877 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia aspiration, SARS-CoV-2 test
SMQs:, COVID-19 (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? Yes, 30 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Disuse syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: PCR; Test Result: Negative ; Comments: nasopharyngeal swab; Test Date: 202107; Test Name: tested for COVID-19; Result Unstructured Data: Test Result:test result was not provided
CDC Split Type: JPPFIZER INC2021830231

Write-up: Pneumonia aspiration; This is a spontaneous report from a contactable physician received through the COVID-19 Adverse Event Self-Reporting Solution. A 77-year-old [non-pregnant] elderly female received the first dose intramuscular of BNT162B2 (COMIRNATY, solution for injection, Lot FA7338 expiry 30Sep2021) as a single dose in the right arm on 01Jul2021 at 14:30 (at 77-years-old) for COVID-19 immunization. Relevant medical history included Disuse syndrome and Cerebral infarction. The patient had no allergies to medications, food, or other products. It was not reported whether the patient received any other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; PCR via nasopharyngeal swab was conducted on 03Jun2021 and was negative. The patient was not pregnant at the time of vaccination. On 01Jul2021 at 14:30 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) intramuscular in the arm right for COVID-19 immunization. On 02Jul2021 at 16:00 (the day following the vaccination), the patient experienced death; cause of death was pneumonia aspiration. The patient was treated with oxygen administration. The event resulted in hospitalization (duration of hospitalization was 30 days as reported) and death. Since the vaccination, the patient has been tested for COVID-19 (test result was not provided). The reporting physician classified the event as serious (death and hospitalization).; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available information and the known safety profile there is not a reasonable possibility that BNT162B2 contributed to the occurrence of the event.; Reported Cause(s) of Death: Pneumonia aspiration


VAERS ID: 1479878 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Respiratory failure
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), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   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: SYMMETREL; BAYASPIRIN; EXCEGRAN; MAGNESIUM OXIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia with Lewy bodies; Lacunar infarction; Oral intake reduced (improved in May); Parkinson''s syndrome; Pneumonia aspiration (treatment with antibacterial drugs was performed); Pyrexia; Sputum increased
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021830233

Write-up: Respiratory failure; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician from the COVID-19 Adverse Event Self-Reporting Solution (COVAES) and from the Regulatory authority report number is v21118003. The patient was a non-pregnant 95-year-old female. The most recent COVID-19 vaccine was administered at nursing home/senior living facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination or other medications within 2 weeks included amantadine hydrochloride (SYMMETREL), acetylsalicylic acid (BAYASPIRIN), zonisamide (EXCEGRAN), magnesium oxide. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no known allergies. There was no relevant past drug history. Other medical history included dementia with Lewy bodies, Parkinson''s syndrome, lacunar infarction, pyrexia and sputum increased were noted, and pneumonia aspiration (treatment with antibacterial drugs was performed). The patient had no family history in particular. Medical history included pyrexia and decreased oral intake because of pneumonia aspiration in late Apr2021, which improved in May. Concomitant medications included ongoing oral treatment with antiplatelets. On 12May2021 at 10:20 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ER9480, Expiration date 31Jul2021) at age of 95-year-old intramuscularly in the right arm at dose 1, single for COVID-19 immunisation. On 19May2021 (7 days after the vaccination), the patient experienced cardio-respiratory arrest and respiratory failure. The course of the events was as follows: Since around 20Apr2021, pyrexia and sputum increased were noted, and treatment with antibacterial drugs was performed for pneumonia aspiration. On 07May2021, an improvement was obtained, and oral intake became possible. On 12May2021, the patient whose general condition was stable. The patient received the vaccination. Shortly after this, no pyrexia or allergy was noted. On 19May2021 (7 days after the vaccination), the patient had a sudden aggravation of the respiratory state. On the same date, she had cardio-respiratory arrest and died. On 19May2021 at 14:44 (7 days after the vaccination), the patient experienced respiratory failure. The reporter stated that the adverse events resulted in life-threatening (risk for death due to the adverse events) and death. The death cause was respiratory failure. No autopsy was performed. No treatment was given for the adverse events. The reporting physician assessed the events as serious (life-threatening, death). The outcome of the events was fatal. The causality of the events was not reported. The reporting physician assessed the causality between the event respiratory failure and BNT162b2 as unassessable. Other possible cause(s) of the event respiratory failure such as any other diseases: Respiratory failure could be due to senility and pneumonia considering the repetitive episodes of pneumonia aspiration. The reporting physician commented as follows: As there were repetitive episodes of pneumonia due to senility, we basically considered this case as the course of senility. However, we also considered the potential relation with the vaccine because of the death due to the sudden aggravation of the respiratory state while pneumonia was improving, and we therefore reported this case.; Reported Cause(s) of Death: Cardio-respiratory arrest; Respiratory failure


VAERS ID: 1479879 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Chest discomfort, Chronic obstructive pulmonary disease, Computerised tomogram, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: RELVAR; MAGMITT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder cancer; Chronic obstructive pulmonary disease; Diabetes mellitus; Hypertension; Permanent atrial fibrillation; Varicose veins of lower extremities
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: CT; Result Unstructured Data: Test Result:revealed no aortic rupture findings; Comments: after vaccination
CDC Split Type: JPPFIZER INC2021830239

Write-up: Cardio-respiratory arrest; Strange feeling in the chest area; Mild wheezing; aggravation of chronic obstructive pulmonary disease (COPD); This is a spontaneous report from a physician via COVID-19 Adverse Event Self-Reporting Solution. The patient was an 85-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included fluticasone furoate/vilanterol trifenatate (RELVAR inhalant) and magnesium oxide (MAGMITT). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no known allergies. There was no relevant past drug history. Other medical history included chronic obstructive pulmonary disease, permanent atrial fibrillation, hypertension, varicose veins of lower extremities, diabetes mellitus, and bladder cancer. On 10May2021 at 15:15, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Lot number EW4811, Expiration date 31Jul2021) intramuscularly in the left arm for COVID-19 immunization. On 31May2021 at 15:15 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) intramuscularly in the left arm for COVID-19 immunization, at doctor''s office or urgent care. On 31May2021 (the day of vaccination), the patient received the second coronavirus vaccination at the reporting hospital. On 01Jun2021 (1 day after the vaccination), the patient experienced a strange feeling in the chest area and mild wheezing. Drip infusion of DEXART 3.3 mg was performed and produced an improvement of the symptoms, and the patient went home. A referral document was made because of suspected aggravation of chronic obstructive pulmonary disease (COPD). On 02Jun2021 (2 days after the vaccination), while heading to the respiratory medicine department of Hospital for consultation by bicycle, the patient experienced cardio-respiratory arrest. He was transported to the emergency department of Hospital and underwent cardiopulmonary resuscitation but died on the same day. Computerised tomography (CT) was performed but revealed no aortic rupture findings. The reporter stated that the adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and death. The death cause was unknown. No autopsy was performed. Cardiopulmonary resuscitation was performed as treatment for the adverse event. The reporting physician assessed the events as serious (death).; Sender''s Comments: Based on information provided, the events are more likely related to underlying disease but unrelated to BNT162b2 (COMIRNATY). 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 cause of death; Cardio-respiratory arrest


VAERS ID: 1479880 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood potassium, Body temperature, Computerised tomogram, Myocardial infarction, Troponin, X-ray
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   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: BAYASPIRIN
Current Illness: Heart disorder (treated with BAYASPIRIN 100 mg ; the attending physician said the patient could receive vaccination)
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Fruit allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210619; Test Name: Blood potassium concentration; Result Unstructured Data: Test Result:high; Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Comments: before vaccination; Test Date: 20210619; Test Name: CT test; Result Unstructured Data: Test Result:Coronary artery calcification positive; Comments: Coronary artery calcification positive, brain swelling positive.; Test Date: 20210619; Test Name: Troponin; Result Unstructured Data: Test Result:high; Test Date: 20210619; Test Name: X-ray test; Result Unstructured Data: Test Result:Coronary artery calcification positive; Comments: Coronary artery calcification positive, brain swelling positive.
CDC Split Type: JPPFIZER INC2021830258

Write-up: Myocardial infarction; This is a spontaneous report from a contactable other non-health professional received from the Regulatory Authority. Regulatory authority report number is v21117414. A 73-year and 9-month-old female patient received bnt162b2 (COMIRNATY; Lot Number: EY5420; Expiration Date: 31Aug2021), Dose 1 via an unspecified route of administration on 18Jun2021 at 14:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing cardiac disorder (treated with BAYASPIRIN 100 mg; the attending physician said the patient could receive vaccination), kiwi fruit allergy from an unknown date and unknown if ongoing , allergy to scales of moth from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (BAYASPIRIN) for cardiac disorder from an unspecified start date and ongoing. On 19Jun2021, the patient experienced myocardial infarction, a fatal event. The patient died on 19Jun2021. Cause of death was not reported. It was not reported if an autopsy was performed. On 18Jun2021 at 14:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 19Jun2021 in the afternoon (1 day after the vaccination), the patient experienced myocardial infarction. On 19Jun2021 (1 day after the vaccination), the outcome of the event was fatal. [Clinical course] On 19Jun2021 at around 11:30, the patient finished eating lunch at home and went to bedroom on the second floor to sleep. At around 13:50, family member went to wake up the patient but the patient was unconscious, for which ambulance was requested. At around 14:00, the patient was transferred to a hospital in the town. Life-saving measures were conducted; however, the patient was unresponsive to resuscitation and at 14:50, the patient died. [Examination, etc.] Blood test: Troponin high, blood potassium concentration high. X-ray and CT tests: Coronary artery calcification positive, brain swelling positive. The reporting other non-health professional classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not provided. The reporting other non-health professional commented as follows:The causality between the event and the vaccination was unassessable; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1479881 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-07
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Herpes zoster (dermatological treatment was given); Hypertension; Lower extremities ulcers of; Somnolence
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021830262

Write-up: Respiratory failure; Vomit was noted at the bedside; respiratory arrest; This is a spontaneous from a contactable physician via COVID-19 Adverse Event Self-Reporting Solution (COVAES) and from the Regulatory authority report number is v21118009. The patient was a non-pregnant 98-year-old female. The patient had no family history in particular. Medical history included cardiac failure, hypertension, lower extremities ulcers of in Feb2021, herpes zoster in Apr2021 (dermatological treatment was given), and somnolence tendency around May2021. The most recent COVID-19 vaccine was administered at nursing home/senior living facility. 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. Since the vaccination, the patient has not been tested for COVID-19. There was no past drug therapy. Concomitant medications only included oral laxatives. On 02Jun2021 at 14:35 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021), at same age, intramuscularly in the right arm for COVID-19 immunisation. On 02Jun2021 (the day of vaccination), the patient with a stable general condition received the vaccination. Shortly after this, no pyrexia or allergy was noted. On 07Jun2021 at 05:00 (5 days after the vaccination), vomit was noted at the bedside at visit to the room. The patient was in respiratory arrest. She was transported by ambulance but was confirmed dead at the destination. Treatment was not given for the adverse events. The reporting physician assessed the events as serious (death). On 07Jun2021 at 05:10 (5 days after the vaccination), the patient experienced respiratory failure. The reporting physician classified the event respiratory failure as serious (death) and assessed the causality between the event respiratory failure and BNT162b2 as unassessable. There was no other possible cause of the event respiratory failure such as any other diseases. The patient died on 07Jun2021. An autopsy was not performed. All events caused emergency room visit. The outcomes of events were fatal. The reporting physician commented as follows: Although the general condition had been worsening gradually because of senility, there were no obvious causes that could lead to sudden vomiting and respiratory failure. We reported this case because of the suspected relation with the vaccination.; Reported Cause(s) of Death: Vomit was noted at the bedside; respiratory arrest; Respiratory failure


VAERS ID: 1479884 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-02
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Decreased appetite, Ileus, Insomnia, Investigation, 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), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LIXIANA; LANSOPRAZOLE; YOKUKANSAN; MEMANTINE HYDROCHLORIDE; OLANZAPINE; BETANIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure chronic; Cognitive function abnormal; Dehydration; Dementia Alzheimer''s type; Hypertension; Inappetence; Renal disease
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination; Test Date: 20210603; Test Name: examination; Result Unstructured Data: Test Result:showed no obvious causes of vomiting; Comments: such as intestinal obstruction, pneumonia, pyelonephritis, or cerebral infarction other than dehydration, and thus, the causes of vomiting were unknown.
CDC Split Type: JPPFIZER INC2021830275

Write-up: Cardio-respiratory arrest; Bilious-like vomiting; ileus; Inappetence; Insomnia; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES) and received from the Regulatory authority report number is v21118005. The patient was a non-pregnant 92-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received edoxaban tosilate hydrate (LIXIANA), lansoprazole, YOKUKANSAN, memantine hydrochloride (MEMANTINE), olanzapine, and mirabegron (BETANIS) 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 dementia Alzheimer''s type, cardiac failure chronic, hypertension, renal disease chronic, and atrial fibrillation. Body temperature before vaccination was 36.9 degrees centigrade. Family history was nothing in particular. On 25May2021 at 10:46 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) via intramuscular route of administration in the arm right for COVID-19 immunization. On 08Jun2021 (13 days after the vaccination), the patient experienced cardio-respiratory arrest. The event resulted in hospitalization and death. The outcome of the event was fatal with treatment including peripheral fluid replacement. The reporting physician assessed the event as serious (hospitalization and death). The reported event course was as follows: Since around Feb2021, oral medications were adjusted because of inappetence associated with decreased cognitive function and of dehydration. The amount of oral intake was increasing since around May2021. On 25May2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. Immediately after the vaccination, no obvious allergic symptoms, pyrexia, or pain was observed. On 02Jun2021 (7 days after vaccination), the patient had inappetence and insomnia at night. On 03Jun2021, at 08:50 (8 days after vaccination), the patient suddenly had bilious-like vomiting. The patient was suspected to have ileus, and she was emergently transferred to another hospital on the same day. On 03Jun2021 (8 days after vaccination), the detailed examination after the transfer showed no obvious causes of vomiting such as intestinal obstruction, pneumonia, pyelonephritis, or cerebral infarction other than dehydration, and thus, the causes of vomiting were unknown. After the hospitalization, the oral intake was initiated, and the general condition tended to improve. On 08Jun2021 (13 days after vaccination), the patient died due to sudden cardio-respiratory arrest. On 08Jun2021, the outcome of the events vomiting and cardio-respiratory arrest was reported as fatal (for the other events was not reported). Since the vaccination, the patient has not been tested for COVID-19. The reporting physician assessed that the causality between the event vomiting and BNT162b2 as unassessable. The seriousness and causality of the other events were not reported. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: A week had passed since the vaccination on 25May2021, and considering the course, the relation with the vaccine was not suspected positively. Other than dehydration, no evident causes of vomiting such as intestinal obstruction, pneumonia, pyelonephritis, and cerebral infarction were noted on the close examination after the transport on 03Jun2021. The cause of vomiting was unknown. Oral intake was initiated after admission, and the general condition was improving, but the patient suddenly died of cardio-respiratory arrest on 08Jun2021. As there was no evident asphyxia or other factors, the cause of cardio-respiratory arrest was also unknown. We reported this case since the relation with the vaccination could not be denied as well. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest; Bilious-like vomiting


VAERS ID: 1479887 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood lactate dehydrogenase, Body temperature, C-reactive protein, Coma scale, Computerised tomogram, Depressed level of consciousness, Echocardiogram, Electrocardiogram, Gamma-glutamyltransferase, Myocardial infarction, Pyrexia, Somnolence, White blood cell count
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 14
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: 20210607; Test Name: GPT; Result Unstructured Data: Test Result:60; Test Date: 20210607; Test Name: GOT; Result Unstructured Data: Test Result:287; Test Date: 20210607; Test Name: CPK; Result Unstructured Data: Test Result:2229; Test Date: 20210608; Test Name: CK-MB; Result Unstructured Data: Test Result:31.4; Comments: high; Test Date: 20210607; Test Name: LD; Result Unstructured Data: Test Result:911; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 to 37.9 Centigrade; Test Date: 20210606; Test Name: CS; Result Unstructured Data: Test Result:III-200; Test Date: 20210607; Test Name: CT scan; Result Unstructured Data: Test Result:no obvious findings suggestive of infection; Comments: no obvious findings suggestive of infection; Test Date: 20210607; Test Name: CRP; Result Unstructured Data: Test Result:4.07; Test Date: 20210608; Test Name: echocardiogram; Result Unstructured Data: Test Result:EF 30-35% and wall thinning; Comments: EF 30-35% and wall thinning; Test Date: 20210203; Test Name: ECG; Result Unstructured Data: Test Result:no abnormal findings; Test Date: 20210607; Test Name: ECG; Result Unstructured Data: Test Result:abnormal Q waves in leads III and aVF; Comments: abnormal Q waves in leads III and aVF; Test Date: 20210607; Test Name: gamma-GTP; Result Unstructured Data: Test Result:19; Test Date: 20210607; Test Name: WBC; Result Unstructured Data: Test Result:14,590
CDC Split Type: JPPFIZER INC2021830291

Write-up: Inferior myocardial infarction recurrent; depressed level of consciousness (CS III-200); pyrexia; somnolence; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21117421. A 87-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 04Jun2021 at 14:28 (Batch/Lot Number: FA4597; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Body temperature before vaccination was 36.8 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Family history was not provided. Historical Vaccine: On 14May2021, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. After the first dose of vaccination, the patient made a good progress without any problems. On 07Jun2021 at 08:15 (3 days after the vaccination), the patient experienced inferior myocardial infarction recurrent, depressed level of consciousness (cs iii-200), pyrexia; 07Jun2021 somnolence. The patient was admitted to the hospital for inferior myocardial infarction recurrent, depressed level of consciousness and pyrexia from 07Jun2021 to an unknown date. The patient underwent lab tests and procedures which included alanine aminotransferase: 60 on 07Jun2021, aspartate aminotransferase: 287 on 07Jun2021,blood creatine phosphokinase: 2229 on 07Jun2021, blood creatine phosphokinase mb: 31.4 on 08Jun2021 high, blood lactate dehydrogenase: 911 on 07Jun2021, body temperature: 36.8 centigrade on 04Jun2021 Before vaccination, body temperature: 37.7 to 37.9 centigrade on 07Jun2021,coma scale: iii-200 on 06Jun2021, computerized tomogram: no obvious findings suggestive of infection on 07Jun2021 no obvious findings suggestive of infection , c-reactive protein: 4.07 on 07Jun2021, echocardiogram: ef 30-35% and wall thinning on 08Jun2021 EF 30-35% and wall thinning, electrocardiogram: no abnormal findings on 03Feb2021, electrocardiogram: abnormal q waves in leads iii and avf on 07Jun2021 abnormal Q waves in leads III and aVF, gamma-glutamyltransferase: 19 on 07Jun2021,white blood cell count: 14,590 on 07Jun2021. The patient died on 21Jun2021. It was not reported if an autopsy was performed. The clinical outcome of the event Inferior myocardial infarction recurrent was fatal while the remaining events was unknown. The course of the events was as follows: On 07Jun2021 in the morning, the patient was faint-hearted and she developed tendency toward somnolence. Since she had fever in the range of 37.7 to 37.9 degrees Centigrade, she visited a hospital as an outpatient. CT did not show obvious findings suggestive of infection. WBC (white blood cell) 14590, CRP (C-reactive protein) 4.07, GOT(AST [aspartate aminotransferase]) 287, GPT(ALT [alanine aminotransferase]) 60, gamma-GTP (gamma glutamyl transpeptidase) 19, LD (lactate dehydrogenase) 911, CPK (Creatine phosphokinase) 2229 were noted. ECG (electrocardiogram) showed abnormal Q waves in leads III and aVF. (ECG performed on 03Feb2021 did not show abnormal findings.) On 08Jun2021, echocardiogram showed EF (ejection fraction) 30-35% and wall thinning indicating the presence of obsolete inferior myocardial infarction (it was uncertain when it occurred). CK-MB (creatine phosphokinase isoenzymes) was high level of 31.4. It was considered that inferior myocardial infarction recurrent. The reporting physician classified the events as serious (fatal outcome and hospitalization) and assessed that the events were related to BNT162b2. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Inferior myocardial infarction


VAERS ID: 1479890 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living alone (details unknown/secondhand information)
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021830341

Write-up: Death; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21117413. The patient was a 71-year-old male. Body temperature before vaccination was 37.1 degrees centigrade. Family history included living alone (details unknown/secondhand information). Concomitant medications were not reported. 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) were unknown. On 28Jun2021 around 15:00 (secondhand information) (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7812, Expiration date 30Sep2021) via an unspecified route of administration as a DOSE 1, SINGLE (at the age of 71 years) for COVID-19 immunisation. On 29Jun2021 in the morning (estimated time) (1 day after the vaccination), the patient experienced death. On an unknown date, the outcome of the event was fatal. Autopsy was done. The course of the event was as follows: The patient was reportedly crouching down in front of the house after getting back from the vaccination (details unknown/secondhand information). The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable (currently unknown as examination is ongoing). It was not reported whether there were other possible causes of the event such as any other diseases. The reporting physician commented as follows: The Police Headquarters reported that an autopsy was performed for the case according to the Act for Investigations into the Cause of Death or Identity of Corpses Handled by the Police and Other Officials.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1479947 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral arterial aneurysm; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021834425

Write-up: Death; pyrexia; feeling queasy; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A 99-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, dose number, Lot number and Expiration date were not reported), via an unspecified route of administration on 28Jun2021, at dose number unknown, single dose for COVID-19 immunisation at the reporter''s hospital. Medical history included cerebral arterial aneurysm and hypertension. Concomitant medications and family history were not reported. On 01Jul2021 (3 days after the vaccination), the patient experienced feeling queasy. On 02Jul2021 (4 days after the vaccination), while the patient was being transferred to a hospital by an ambulance because of feeling queasy and pyrexia, she died before the ambulance arrived at a hospital. The cause of death was not reported. It was not reported if an autopsy was performed. The outcome of the events feeling queasy and pyrexia was unknown. The assessment of causality between the event and BNT162b2 was not provided.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event of death 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: Death


VAERS ID: 1479950 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-28
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   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: Medical History/Concurrent Conditions: Cardiac failure; Cervical spondylosis; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021841718

Write-up: Death; This is a spontaneous report from a contactable other healthcare professional and physician received via a Pfizer sales representative. A 76-year-old male received bnt162b2 (COMIRNATY, Solution for injection, lot number and expiration date were not reported) via intravenously on 22Jun2021 (at the age of 76 year) as dose number unknown, single for COVID-19 immunisation. Medical history included diabetes mellitus, hypertension, cardiac failure and cervical spondylosis. Family history was not reported. Concomitant medications were not provided. On 28Jun2021 (6 days after the vaccination), the patient died. The cause of death was unknown. It was not reported if an autopsy was performed. The outcome of the event was fatal. The course of the event was as follows: After receiving COMIRNATY, the patient died. At the time of this report, details were unknown. Seriousness criteria, causality assessment, and other possible cause of the event such as any other diseases were not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event death and the suspect drug BNT162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1479951 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dialysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021841960

Write-up: Cerebral haemorrhage; This is a spontaneous report from a contactable physician via a Pfizer sales representative. The patient was an 84-year-old male. The patient was on dialysis. Other medical history and concomitant medications were not provided. On 21Jun2021 at around 15:00, the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, Lot number and Expiration date were not reported), via an unspecified route of administration as a single dose for COVID-19 immunisation. On 21Jun2021 at night (the day of vaccination), the patient was admitted to a hospital (the department of neurosurgery) for cerebral haemorrhage. Several days after, the patient died in 2021. Cause of death was cerebral haemorrhage. It was not reported whether an autopsy was performed. The reporting physician classified the event as serious (fatal) and assessed that the event was possibly related to BNT162b2. Information about batch number has been requested.; Sender''s Comments: Based on temporal association, a causal association between the reported event cerebral haemorrhage and BNT162B2 cannot be fully 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 RAs, Ethics Committees, and investigators, as appropriate.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1479956 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Cardio-respiratory arrest, Chest X-ray, Idiopathic pulmonary fibrosis, Interstitial lung disease, Mouth breathing, Oxygen saturation decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Interstitial lung disease (narrow), 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), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SOLANAX; PIRESPA; CARBOCISTEINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Home care; Hyposthenia; Idiopathic interstitial pneumonia; Idiopathic pulmonary fibrosis; Respiratory disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Comments: decreased; Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210709; Test Name: Chest X-ray photography (Xp); Result Unstructured Data: Test Result:revealed a spread of bilateral diffuse ground glas; Comments: revealed a spread of bilateral diffuse ground glass opacity
CDC Split Type: JPPFIZER INC2021872344

Write-up: Acute aggravation of interstitial pneumonia; Acute aggravation of idiopathic pulmonary (IP); Maintaining SpO2 was not possible with oxygen administration at a maximum dose.; the blood pressure decreased simultaneously with respiratory and cardiac arrest; jaw breathing; the blood pressure decreased simultaneously with respiratory and cardiac arrest; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21119158. The patient was a 70-year and 12-month-old male. On 02Jul2021, the patient''s body temperature before vaccination was 36.5 degrees centigrade. Family history reported as follows: The patient had a subjective symptom of respiratory discomfort since around 2019. With a diagnosis of idiopathic interstitial pneumonia (idiopathic pulmonary fibrosis [IPF]) at 2 other hospitals, the patient began to have difficulty visiting hospitals, and since Dec2020, the reporting clinic had been providing home-visit medical care. The patient was on home care for idiopathic pulmonary fibrosis and was in a state of hyposthenia. Concomitant medications included alprazolam (SOLANAX tablet 0.4 MG) oral at 0.4 mg as needed (for the time of sleeplessness), pirfenidone (PIRESPA tablet 200 MG) oral at 600 mg thrice daily (morning, noon, and evening), and carbocisteine (manufactured by JG, tablet 500 MG) oral 500 mg thrice daily (morning, noon, evening). On an unknown date, the patient previously received the first dose of BNT162b2 (Lot number not reported, Expiration date not reported) for COVID-19 immunisation. On 02Jul2021 at 10:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) via an unspecified route of administration at the age of 70-year-old as the second single dose for COVID-19 immunisation. On 09Jul2021 at 7:30 (6 days after the vaccination), the patient experienced acute aggravation of interstitial pneumonia. At emergency house visit, jaw breathing was already noted. On 09Jul2021, Chest X-ray photography (Xp) was performed and revealed a spread of bilateral diffuse ground glass opacity. Acute aggravation of idiopathic pulmonary (IP) was considered. Maintaining SpO2 was not possible with oxygen administration at a maximum dose. It had been planned since before that the patient would be observed under home care. Even intubation was performed, recovery was unlikely, and observation under the present condition was decided with the consent of the family. Although steroids and fluid infusion were started, the blood pressure decreased simultaneously with respiratory and cardiac arrest, and death was confirmed on 09Jul2021. It was not reported whether autopsy was done. The reporting physician classified the events as serious (death) and assessed that the causality between the events and BNT162b2 as unassessable. Other possible cause(s) of the events such as any other diseases was acute aggravation of idiopathic pulmonary fibrosis.; Reported Cause(s) of Death: Acute aggravation of interstitial pneumonia


VAERS ID: 1479958 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute, Organ failure, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Pyrexia, Wheezing
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aphasia; Bedridden; Late effects of cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210617; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: Before vaccination; Test Date: 20210620; Test Name: SpO2; Test Result: 70 %
CDC Split Type: JPPFIZER INC2021873546

Write-up: Pneumonia; Cardiac failure acute; Mulitple organ faillure; SpO2 was 70%; wheezing; pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21118785. The patient was an 88-year and 9-month-old male. On 17Jun2021, the patient''s body temperature before vaccination was 37.0 degrees centigrade. The family history was not provided. The patient was bedridden due to late effects of right cerebral infarction, and he had difficulty in communicating due to aphasia. Since the patient received a gastrostomy feeding, the nutrition condition was favorable on the blood examination, and the general condition was also stable. On 27May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EX3617, Expiration date 31Aug2021) as single dose for COVID-19 immunization. Concomitant was not reported. On 17Jun2021 at 10:56 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5422, Expiration date 31Aug2021) via an unspecified route of administration at the age of 88-year-old as single dose for COVID-19 immunization. On 18Jun2021 at 15:10 (one day/4 hours/14 minutes after the vaccination), the patient experienced pneumonia, cardiac failure acute, and multiple organ failure. On 20Jun2021 (3 days after the vaccination), the patient was admitted to the hospital. On 23Jun2021 (6 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The side reactions to the BNT162b2 vaccination were explained to the family in advance, and they wished the vaccination. On 27May2021, the patient received the first dose of BNT162b2 vaccination. On 17Jun2021 (the day of vaccination), at 10:56, the patient received the second dose of BNT162b2 vaccination. On 18Jun2021, at 15:10 (one day, 4 hours, and 14 minutes after vaccination), the patient had pyrexia, and an antipyretic was administered. On the same day, the patient also had pneumonia and cardiac failure acute, which led to multiple organ failure. On 20Jun2021 (2 days, 13 hours, and 4 minutes after vaccination), the SpO2 was 70%, and the patient had wheezing. On 23Jun2021 (5 days, 13 hours, and 4 minutes after vaccination), the patient died. The events of pneumonia, cardiac failure acute and organ failure caused patient died. The reporting physician classified the event as serious (hospitalization and death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Pneumonia; Cardiac failure acute; Multiple organ failure


VAERS ID: 1479960 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021889156

Write-up: Death; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An 84-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (lot number, and expiration date were not reported) as a single dose for COVID-19 immunization. Medical history included atrial fibrillation, diabetes mellitus, and hypertension. On an unspecified date (4 to 5 days after the vaccination), the patient died. Cause of death, causality assessment and other possible cause of the event such as any other diseases were not provided. It was not reported if Autopsy Done. The outcome of the event was Fatal.; 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: 1479961 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Aortic valve insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021889168

Write-up: Death; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A 93-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), at the age of 93-year-old via an unspecified route of administration on unknown date in 2021 (Lot number unknown, Expiration date unknown) as single dose for COVID-19 immunization. The family history was not provided. The patient had medical histories of aortic valve insufficiency and abdominal aortic aneurysm. Concomitant medications were not reported. On unknown date in 2021 (14 days after the vaccination), the patient experienced death after the vaccination. The causality between the event and BNT162b2 was not provided. It was not reported if Autopsy Done. On unknown date in 2021 (unknown days after the vaccination), the outcome of the event was fatal.; 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: Unknown cause of death


VAERS ID: 1479962 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021889186

Write-up: Death; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A 76-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), on unknown date in 2021 (Lot number and Expiration date not reported) via an unspecified route of administration as single dose for COVID-19 immunization. The medical history was unknown because the patient visited the reporting hospital only for the vaccination. Concomitant medications were not reported. On unknown date in 2021 (unknown days after the vaccination), the patient experienced death within 1 week after BNT162b2 vaccination. The causality between the event and BNT162b2 was provided. It was not reported if Autopsy Done. On unknown date in 2021 (unknown days after the vaccination), the outcome of the event was fatal.; 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: unknown cause of death


VAERS ID: 1480117 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody, Blood albumin, Blood chloride, Blood creatinine, Blood glucose, Blood potassium, Blood sodium, Blood urea, Body temperature, Bronchoalveolar lavage, C-reactive protein, Cachexia, Computerised tomogram, Cytology, Delirium, Discomfort, Electromyogram, Fatigue, Glomerular filtration rate, Glomerulonephritis, HIV test, Haemoglobin, Hepatitis B virus test, Hepatitis C virus test, Hyponatraemia, Inflammation, Influenza A virus test, Influenza B virus test, Lung consolidation, Magnetic resonance imaging head, Muscle atrophy, Muscular weakness, Mycobacterium tuberculosis complex test, Neuropathy peripheral, Normocytic anaemia, Physical examination, Platelet count, Polyneuropathy, Positron emission tomogram, Pyrexia, Respiratory syncytial virus test, SARS-CoV-2 test, Urinary tract infection, Urine analysis, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haematopoietic erythropenia (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Vasculitis (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 50
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: CIPROFLOXACINE [CIPROFLOXACIN]; IRBESARTAN; NEBIVOLOL; SODIUM CHLORIDE
Current Illness: Hypertension; Post herpetic neuralgia (after herpes zoster infection)
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract operation; Depression; Ex-smoker; Fatigue (At admission on 22May2021 already 3 weeks of malaise and tired); Herpes zoster infection neurological; Humerus fracture (Humeral Plate Fixation); Irritable bowel syndrome; Malaise (At admission on 22May2021 already 3 weeks of malaise and tired); Osteopenia
Allergies:
Diagnostic Lab Data: Test Name: Na; Result Unstructured Data: Test Result:126; Comments: at discharge; Test Date: 20210616; Test Name: Na; Result Unstructured Data: Test Result:126; Comments: low; Test Date: 20210616; Test Name: urea; Result Unstructured Data: Test Result:12.6 mmol/L; Comments: elevated; Test Date: 20210521; Test Name: Body temperature; Result Unstructured Data: Test Result:39.3; Test Date: 20210525; Test Name: BAL; Result Unstructured Data: Test Result:BAL and bronchusbrush upper right: benign, no abno; Comments: BAL and bronchusbrush upper right: benign, no abnormalities. Quality: cell-rich, easy to assess.; Test Date: 20210605; Test Name: BAL; Result Unstructured Data: Test Result:BALL right; benign, no abnormalities. Quality: nor; Comments: BALL right; benign, no abnormalities. Quality: normocellular, easy to assess.; Test Name: CT scan; Result Unstructured Data: Test Result:no signs of malignancy; Test Name: C reactive protein; Result Unstructured Data: Test Result:high mg/l; Test Date: 202106; Test Name: C reactive protein; Result Unstructured Data: Test Result:100-150 mg/l; Comments: stable between 100-150 mg/L for several weeks; Test Date: 20210616; Test Name: C reactive protein; Result Unstructured Data: Test Result:17 mg/l; Comments: dropped to 17 mg/L after methylprednisolon treatment; Test Name: BAL RBK lung cytology; Result Unstructured Data: Test Result:benign cells; Test Name: BAL RBK lung cytology; Result Unstructured Data: Test Result:benign cells; Test Name: EMG; Result Unstructured Data: Test Result:neuropathy; Test Name: EMG; Result Unstructured Data: Test Result:In the vasculitis, the patient had a picture of de; Comments: In the vasculitis, the patient had a picture of demyelinating polyneuropathy, confirmed by EMG, expectant management.; Test Date: 20210616; Test Name: eGFR (CKD-EPI); Result Unstructured Data: Test Result:56 ml/min; Comments: decreased; Test Name: hemoglobin; Result Unstructured Data: Test Result:5.4; Comments: interpreted as anaemia of a chronic disease; Test Name: hemoglobin; Result Unstructured Data: Test Result:536; Comments: Known normocytic anemia (Hb 536) referred to as anemia of chronic disease in vasculitis.; Test Date: 20210609; Test Name: HepB; Test Result: Negative ; Test Date: 20210609; Test Name: HepC; Test Result: Negative ; Test Date: 20210602; Test Name: HIV test; Test Result: Negative ; Test Date: 20210522; Test Name: Influenza A PCR test; Test Result: Negative ; Test Date: 20210522; Test Name: Influenza B PCR test; Test Result: Negative ; Test Date: 20210615; Test Name: MRI brain; Result Unstructured Data: Test Result:no evidence of vasculitis; Test Date: 20210609; Test Name: quantiferon TB; Test Result: Negative ; Test Date: 20210529; Test Name: physical examination; Result Unstructured Data: Test Result:On readmission (patient had apparently gone home a; Comments: On readmission (patient had apparently gone home against advice, but was readmitted the same day): Not sick, no dyspnea, not confused. HH: pupils equal and reactive (PEARL) Circ: no chest pain, no palpitations, no edema, S1S2 no soufle.Resp: no cough, no nose cold, no dyspnea, VAG bdz, no noises.GI: Nausea from the sodium pills, no abdominal pain, unchanged defecation, abdomen supple, no pressure or release pain , no edema, no flank pain Uro: no micturition complaints Extr: no edema went home with his own advice, but was re-admitted the same day): Not sick, no dyspnea, not confused. HH: pupils equal and reactive (PEARL) Circ: no chest pain, no palpitations, no edema, S1S2 no soufle. Resp: no cough, no nose cold, no dyspnea, VAG bdz, no noises. GI: Nausea from the sodium pills, no abdominal pain, unchanged defecation, abdomen supple, no pressure or release pain, no edema, no flank pain. Uro: no micturition complaints. Extr: no edema.; Test Name: thrombo; Result Unstructured Data: Test Result:high; Test Name: PET CT; Result Unstructured Data: Test Result:moderately intense FDG accumulation mainly lateral; Comments: moderately intense FDG accumulation mainly lateral in the subpleural intrapulmonary consolidation of approximately 18 mm dorsally basal in the right upper lobe. Close relationship with the fissure. Impresses infectious especially, primary lung malignancy (especially adenocarcinoma) cannot be completely ruled out (however, seems to decrease slightly in size) Dubious lymph node right hilar / middle lobe. DD mainly reactive. No evidence of distant metastases. Side finding: conspicuous filled bladder with relatively little excretion of FDG. Clinical bladder retention; Test Name: PET CT; Result Unstructured Data: Test Result:no signs of malignancy; Test Name: PET CT; Result Unstructured Data: Test Result:consolidation right upper lobe; Test Date: 20210522; Test Name: RSV PCR test; Test Result: Negative ; Test Date: 20210522; Test Name: SARS CoV 2 PCR test; Test Result: Negative ; Test Date: 20210521; Test Name: urine dipstick; Result Unstructured Data: Test Result:suggestive for urinary tract infection; Test Name: leuco; Result Unstructured Data: Test Result:high; Test Name: anti MPO; Result Unstructured Data: Test Result:greater than 134; Comments: high; Test Name: albumin; Result Unstructured Data: Test Result:low; Test Date: 20210616; Test Name: chloride; Result Unstructured Data: Test Result:89; Comments: below normal; Test Date: 20210616; Test Name: creatinine; Result Unstructured Data: Test Result:86; Comments: normal; Test Date: 20210616; Test Name: glucose; Result Unstructured Data: Test Result:7.5 mmol/L; Comments: point of care testing; Test Date: 20210616; Test Name: kalium; Result Unstructured Data: Test Result:3.5; Comments: low end of normal; Test Name: Na; Result Unstructured Data: Test Result:118; Comments: at admission
CDC Split Type: NLPFIZER INC2021818104

Write-up: Polyneuropathy; Muscle atrophy; Anti-neutrophil cytoplasmic antibody positive vasculitis; Neuropathy; Inflammation; Lung consolidation; Fever; Glomerulonephritis; suspicion on urinary tract infection; postrenal kidney insufficiency/acute renal failure; chronic asymptomatic hypotonic hyponatremia; normocytic anaemia; possibly delirium; cachexia; everything feels heavy. It is difficult to bridge small distances. Heavy, not out of breath.; very tired/Fatigue aggravated; From then on weak and a lot of effort with exertion; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00586653, Sender''s (Case) Safety Report Unique Identifier NL-LRB-00598785, and Sender''s (Case) Safety Report Unique Identifier NL-LRB-00605032. A 76-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 05May2021 (Batch/Lot Number: EX7389) as dose 2, single for covid-19 immunisation. Dose 1 was received on an unknown date with strength: 0.3 ml for covid-19 immunisation, and experienced fatigue and malaise. Medical history included humerus fracture from 2013 (Humeral Plate Fixation), hypertension from 2015 and ongoing, irritable bowel syndrome from 2013, osteopenia from 2012, ongoing post herpetic neuralgia (after herpes zoster infection), herpes zoster infection, cataract operation from 2009, depression from 2013, fatigue and malaise both from 01May2021 (At admission on 22May2021 already 3 weeks of malaise and tired, remembers wanting to postpone injection because she is so tired), ex-smoker from an unknown date to 2010. No previous COVID-19 infection. Concomitant medications included ciprofloxacine [ciprofloxacin]; irbesartan; nebivolol; and sodium chloride, all taken for an unspecified indication, start and stop date were not reported. This physician concerns the patient with anti-neutrophil cytoplasmic antibody positive vasculitis, fever, inflammation, lung consolidation, glomerulonephritis, neuropathy, polyneuropathy, and muscle atrophy all on 22May2021, with seriousness reported as caused or prolonged hospitalization, other medically important condition, following administration of bnt162b2 solution for injection for covid 19 immunisation. The patient experienced delirium (life threatening, other medically important condition) on 20Jun2021. The patient experienced very tired/fatigue aggravated, from then on weak and a lot of effort with exertion; everything feels heavy/It is difficult to bridge small distances/Heavy, not out of breath on 06May2021. 17 days after vaccination (22May2021), the patient was hospitalized because of suspicion on urinary tract infection, without confirmation by urine culture and nonresponding on antibiotics. The patient experienced malaise for a while, the patient had long-lasting complaints of malaise and laboratory results indicated chronic inflammation and high ANCA (antineutrophil cytoplasmic antibodies) MPO (myeloperoxidase) titer levels ($g134). The patient was hospitalized for 4 weeks. Working diagnosis ANCA-vasculitis with possible pulmonary involvement as seen on PET-positive abnormalities (consolidation) in right upper lobe. Malignity could not be excluded because of refusing biopsy. Aspergilloses was excluded. No evidence for renal involvement. EMG showed neuropathy. Besides this, the patient had a postrenal kidney insufficiency for which a temporary catheter, followed by polyuria phase, renal function was completely recovered at discharge. An acute renal insufficiency was classified as postrenal requiring short-term urinary catheter. Polyure phase, but eventually kidney function fully restored. No evidence of renal vasculitis involvement. Also a chronic asymptomatic hypotonic hyponatremia (118 at admission), interpreted as SIADH (inappropriate antidiuretic hormone secretion) of unknown cause., DD possible matching pulmonal abnormalities. Recovering under fluidrestriction of 1.2 L per day. Sodium was 126 at discharge. The patient had chronic asymptomatic hypotonic hyponatremia of 118. Assessing a SIADH and improving with 1.2 liter fluid restriction. differential diagnosis not appropriate for vasculitis, more appropriate for a lung malignancy. Besides this a known normocytic anaemia (Hb (Hemoglobin) 5.4) interpreted as anaemia of a chronic disease. Known normocytic anemia (Hb 536) referred to as anemia of chronic disease in vasculitis. The patient had excluded new systolic soufle, endocarditis. Serological examination: no evidence of hep B or C infection and quantiferon TB negative. Also started preventive agents around immune-suppressive therapy (including cotrimoxazole, amphotericin B suspension). In the vasculitis, the patient had a picture of demyelinating polyneuropathy, confirmed by EMG, expectant management. Diagnostic procedures included: anti-MPO greater than 134, PET (Positron emission tomography) CT (computed tomogram) consolidation right upper lobe, EMG (Electromyography): neuropathy. The patient was treated with methylprednisone, prednisone and rituximab. The patient was recovering 4 weeks after onset. However, she deceased at home almost 5 weeks after the diagnosis ANCA vasculitis, despite treatment with methylprednisolone and the first treatment dose of rituximab. Reason for hospitalization: Suspected ANCA vasculitis with possible pulmonary involvement, acute renal failure, hyponatremia. Patient was admitted on 22May2021 but went home on 28May2021 against medical advice and came back on 29May021 because it was not going home. Conclusion: 1. Suspected ANCA vasculitis, MPA or GPA, with possible pulmonary involvement. No evidence of renal involvement. Polyneuropathy as a result: 10Jun2021 to 12Jun2021: methylprednisone 1000 mg daily. 13Jun2021 start prednisone 60 mg once daily. From 19Jun2021 40 mg once a day. Two courses of rituximab (both 100mg), planned 16Jun2021 and 02Jul2021. 2. Right upper lobe consolidation (PET dragged on), differential diagnosis lung focus vasculitis, differential diagnosis lung tumor not excluded, aspergillosis excluded by BAL. 3. Status after postrenal renal insufficiency, requiring temporary urinary catheter, followed by a polyuria phase, renal function fully recovered at discharge. 4. Chronic asymptomatic hypotonic hyponatremia (118 on admission), indicated by a SIADH of unknown cause, differential diagnosis in 2. Recovering under a fluid restriction of 1.2 liters. At discharge sodium 126. 5. Known normocytic anemia (Hb 5.4), indicated in anemia of chronic disease. As far as can be ascertained, the existing complaints before the vaccinations were more of a psychological nature. She was admitted on 22May2021 under suspicion of a urinary tract infection, but without confirmation in a culture and without a reaction to antibiotics. Afterwards, the serious inflammation turned out to be due to vasculitis. An ANCA associated vasculitis is usually not provoked by an infection. Strikingly, a case post COVID has been described (website). This increases the chance that this vasculitis can also be triggered by vaccination. Strikingly high antibody titres are more often seen in drug-luxated ANCA vasculitis. Patient died at home on 25Jun2021, despite treatment with methylprednisolone and a dose of rituximab. Later SIADH diagnosis was changed to possible "tea and toast" in causal relationship with renal insufficiency. Unlikely drug therapy related. The patient was recovering 4 weeks after onset. However, she passed away at home from cachexia, neuropathy, potential delirium and lost of wish to live, almost 5 weeks after the diagnosis ANCA vasculitis, despite treatment with methylprednisolone and the first treatment dose of rituximab. Physician deems it very unlikely patient would have passed away in the near future if ADRs from vaccination would not have occurred. 1. After discharge, bedridden because of cachexia and neuropathy, wish to die, no treatment result due to possible delirium, no readmission due to family, opted for palliative sedation. GP has probably reported vasculitis as cause of death. 2. Despite fluid restriction, sodium pills, the hyponatraemia at discharge was still significant - what is the meaning of this: Indeed conspicuous hyponatremia. Urine osmolarity varied, initially the hyponatremia was classified as SIADH, then also as "tea and toast", resulting in minor loss of renal function, no drug cause. 3. What were the CRP values and their course? Do you have any additional lab values, for example coagulation/thrombosis? Stable for several weeks between 100-150 mg/L (Jun2021), after methylprednsiolone drop to 17 mg/L (on 16Jun2021). 4. What is the explanation that despite the apparent improvement (e.g. recovery of kidney function), the patient died quickly? Improvement of renal function following catheterization in bladder retention and treatment of focal glomerulonephritis (kidney biopsy was refused by GP). 5. Could the existing anemia also be interpreted as supportive of malignancy? so, no, why not? No, not a smoker, twice BAL RBK lung cytology benign cells, CT and pet CT scan with no signs of malignancy. Normocytic anemia in combination with high CRP, high leuco, high thrombo and low albumin is consistent with severe chronic inflammation. 6. You indicated that the patient had problems of a psychological nature, are there indications that she could have suddenly stopped prednisone at home or that she could have otherwise negatively influenced the course? More psychosocial than psychiatric in nature, prednsion only stopped in final phase of palliative sedation, discontinuation did not adversely affect the course. 7. What is your estimate of the contribution that the side effects of the vaccine may have made to death? Not a single one, very unlikely, vaccine side effects may have accelerated death, vaccine side effects have likely accelerated death, it is extremely unlikely that this patient would have died in the short term without these side effects. The latter, without the consequences of this serious inflammatory disease, polyneuropathy, muscle atrophy, prolonged hospitalization recording, she would probably still be alive. 8. The diagnosis of ANCA vasculitis was made 17 days after vaccination. Do you know how long after vaccination the fever and the malaise symptoms arose? What was the course from vaccination to admission? Report set status 22May2021. Already 3 weeks in the rag basket. 05May2021, 2nd shot Pfizer. Can still remember that she preferred to postpone the jab that day because she was so tired. From then on weak and a lot of effort with effort. everything feels heavy. Short distances difficult to bridge. Heavy, not out of breath. HA diagnosed UTI yesterday based on strip, had 3xd tablet cipro, even measured 39.3 below that. So the alleged uwi is not confirmed, no reaction to antibiotics. 9. What was the patient''s situation before vaccination? Did she live independently? Home care? Nursing home resident, if yes, for which indication? Independent without home care. 10. What was the patient''s condition in the weeks/days up to vaccination? Was there a deteriorating health? If yes, what was the image? No evidence of a kink in her health before the vaccination. 11. Was a corona test taken around the time of vaccination and later on admission? If so, on what date and what was the result? When recording covid PCR negative on 22May2021. 12. When was the first vaccination and is it likely that the vasculitis was already caused by the first vaccination provoked? (Or vice versa: if not, would this contradict the diagnosis?) Please share your expertise on this. Possibly on the day of the second vaccination she was already a bit tired, with an increase in this and a short-term fever. Was an autopsy performed? If so, we would like to receive an (anonymous) report. No, died at home. Other lab tests and procedures which included on 16Jun2021: chloride: 89 below normal, creatinine: 86 normal, blood glucose: 7.5 mmol/l (point of care testing), kalium: 3.5 low end of normal, Na: 126 low, urea: 12.6 mmol/l elevated, eGFR (CKD-EPI): 56 ml/min decreased. Body temperature: 39.3 on 21May2021, BAL on 25May2021: BAL and bronchusbrush upper right: benign, no abnormalities. Quality: cell-rich, easy to assess. BAL on 05Jun2021: BALL right; benign, no abnormalities. Quality: normocellular, easy to assess. HIV test on 02Jun2021: negative. MRI brain on 15Jun2021: no evidence of vasculitis. Influenza A PCR test, Influenza B PCR test, RSV PCR test, and SARS CoV 2 PCR test on 22May2021: negative. HepB and HepC on 09Jun2021: negative. Urine dipstick on 21May2021: suggestive for urinary tract infection. Physical examination on 29May2021: On readmission (patient had apparently gone home against advice, but was readmitted the same day): Not sick, no dyspnea, not confused. HH: pupils equal and reactive (PEARL) Circ: no chest pain, no palpitations, no edema, S1S2 no soufle.Resp: no cough, no nose cold, no dyspnea, VAG bdz, no noises.GI: Nausea from the sodium pills, no abdominal pain, unchanged defecation, abdomen supple, no pressure or release pain , no edema, no flank pain Uro: no micturition complaints Extr: no edema went home with his own advice, but was re-admitted the same day): Not sick, no dyspnea, not confused. HH: pupils equal and reactive (PEARL) Circ: no chest pain, no palpitations, no edema, S1S2 no soufle. Resp: no cough, no nose cold, no dyspnea, VAG bdz, no noises. GI: Nausea from the sodium pills, no abdominal pain, unchanged defecation, abdomen supple, no pressure or release pain, no edema, no flank pain. Uro: no micturition complaints. Extr: no edema. PET CT on an unknown date: moderately intense FDG accumulation mainly lateral in the subpleural intrapulmonary consolidation of approximately 18 mm dorsally basal in the right upper lobe. Close relationship with the fissure. Impresses infectious especially, primary lung malignancy (especially adenocarcinoma) cannot be completely ruled out (however, seems to decrease slightly in size) Dubious lymph node right hilar / middle lobe. DD mainly reactive. No evidence of distant metastases. Side finding: conspicuous filled bladder with relatively little excretion of FDG. Clinical bladder retention. The outcome of event possibly delirium, anti-neutrophil cytoplasmic antibody positive vasculitis, neuropathy, and cachexia was fatal. The outcome of event postrenal kidney insufficiency/acute renal failure was recovered on an unknown date. the outcome of other event was unknown. The patient died on 25Jun2021. An autopsy was not performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: possibly delirium; neuropathy; ANCA vasculitis; cachexie


VAERS ID: 1480128 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-12
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Basilar artery thrombosis, Computerised tomogram
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   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: Ct scan; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021781623

Write-up: Basilar artery thrombosis; This is a spontaneous report from a contactable consumer downloaded from the WEB NL-LRB-00588272. A 72-years-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 01May2021 (Lot Number: ET6956) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient didn''t have previous COVID-19 infection. The patient experienced basilar artery thrombosis on 12May2021. Basilar artery thrombosis was treated with anticoagulation therapy and removing of thrombus. The patient underwent lab tests and procedures which included computerised tomogram(CT): unknown results. The patient died on 13May2021. It was not reported if an autopsy was performed. The outcome of basilar artery thrombosis was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Basilar artery thrombosis


VAERS ID: 1480132 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-23
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COLCHICINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021781627

Write-up: Cardiac arrest; This is a spontaneous report from a contactable consumer downloaded from the WEB NL-LRB-00589403. A 68-years-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 20Apr2021 (Batch/Lot Number: Unknown) as dose 1, 0.3 ml single for covid-19 immunisation. The patient medical history was not reported. No Past drug therapy. No Previous COVID-19 infection. Concomitant medication included colchicine. The patient experienced cardiac arrest (death) on 23May2021. The patient died on 23May2021. The outcome of cardiac arrest was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1480133 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chest pain, Chills, Malaise, Myalgia, Nausea, Pain in extremity
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (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), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021796320

Write-up: Cardiac arrest; Malaise; Chills; Myalgia; Chest pain; Nausea; Pain in arm; This is a spontaneous report from a contactable other health care professional downloaded from the regulatory authority number is NL-LRB-00590045. A 70-year-old female patient received bnt162b2 (COMIRANTY; Solution for injection; Lot number FD0785; expiration date: not reported) via an unspecified route of administration on 06Jun2021 as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included paracetamol. Patient historical vaccine included bnt162b2 (Lot number and expiration date was not reported) via an unspecified route of administration on 02May2021 as dose 1, single for covid-19 immunization with no adverse reaction. The patient experienced malaise, chills, myalgia, chest pain, nausea and pain in arm (1 day after start) on 07Jun2021, cardiac arrest on 08Jun2021. All adverse events occurred at the same time. It was reported that, the side effects have not worsened in severity, but patient did die from these side effects. Patient had no previous COVID-19 infection. No diagnostic procedures was performed because haven''t had a chance to do that anymore. The patient died of cardiac arrest on 08Jun2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. Reporter''s comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: no Date: 02May2021 Additional information ADR Chest pain and arm pain : All adverse events occurred at the same time. The side effects have not worsened in severity, but my mother did die from these side effects. Previous COVID-19 infection: No diagnostic procedures: no, we haven''t had a chance to do that anymore. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Ended up in cardiac arrest


VAERS ID: 1480144 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-05
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Cardiac arrest, Diarrhoea, Dyspnoea, Fatigue, Influenza like illness, Malaise, Muscle strain, Myalgia, Nausea, Pulmonary embolism, Pyrexia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (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), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUOXETINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive impairment (Was diagnosed with Mild Cognitive Impairment at the geriatrician in Jan2019); Depression
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: pyrexia; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Test Date: 20210609; Test Name: corona self test; Test Result: Negative
CDC Split Type: NLPFIZER INC2021804854

Write-up: cardiac arrest or lung embolism; cardiac arrest or lung embolism; Fever: 38 to 40.5 degrees Celsius; muscle strain; myalgia; Fatigue; Not feeling well; stuffy; pressure on the stomach, feeling like he was about to vomit; probably had a flu-like illness; Diarrhea; emptied.; Nausea; Back and shoulder pain; Back and shoulder pain/Pain in the joints; This is a spontaneous report from a contactable consumer from the WEB, regulatory authority number NL-LRB-00593139. Safety Report Unique Identifier NL-LRB-00595183. A 72-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 25May2021 (Batch/Lot Number: Unknown) as DOSE 2, 0.3ML SINGLE for COVID-19 immunisation. Medical history included depression, Cognitive impairment from Jan2019 (Was diagnosed with Mild Cognitive Impairment at the geriatrician in Jan2019). Concomitant medication included fluoxetine (FLUOXETINE). The patient previously received first dose of bnt162b2 on 20Apr2021 for COVID-19 immunisation and no adverse event reported. The patient experienced back and shoulder pain on 05Jun2021, fever: 38 to 40.5 degrees celsius on 08Jun2021 , muscle strain on 05Jun2021, myalgia on 05Jun2021, fatigue on 05Jun2021 , not feeling well on 05Jun2021 , stuffy on 05Jun2021 , pain in the joints on 05Jun2021 , pressure on the stomach, feeling like he was about to vomit on 05Jun2021 , probably had a flu-like illness on 05Jun2021, cardiac arrest or lung embolism on an unspecified date, diarrhea; emptied on 05Jun2021, nausea on 05Jun2021. Outcome of diarrhea and nausea was recovered on 07Jun2021. Outcome of other events was fatal. The patient died on 15Jun2021. An autopsy was not performed. The clinical course was reported as follows: This serious spontaneous report from a consumer concerns a male aged 72 years, with nausea, myalgia (death), generalized joint pain (death), malaise (death), fatigue (death), pyrexia (death), back pain (death), shoulder pain (death), abdominal discomfort (death), diarrhea, dyspnoea (death) following administration of covid-19 vaccin pfizer injvlst for covid 19 immunisation. Treatment: Patient was treated with ibuprofen. The patient recovered from diarrhea, recovered from nausea, the outcome of other events is fatal. On 05Jun2021- 06Jun2021, 12 days after vaccination patient develops: nausea, myalgia, arthralgia, malaise, dyspnoea, pain in back and shoulders, diarree, abdominal discomfort and fatigue. At that time he was on his own at a camp site. He called a general practioner if this could be caused by vaccination. Answer was: probaly not, patient probably had a flu-like illness. Adviced was to call his own GP(physician) if his complaints worsened. On 07Jun2021-06Jun2021 patient recovered from nausea and diarrhea. He developed a fever of 40.2 degrees Celsius. He was very sick and has severe fatigue, this continued for days. COVID self test on 09Jun2021 was negative. On 15Jun2021 in the morning patient send a message that he had no fever anymore, and that he was going to take a shower and going to the supermarket. 10 minutes later he passed away. Cause of death: cardiac arrest or lung embolism. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: back and shoulder pain; back and shoulder pain/pain in the joints; fever: 38 to 40.5 degrees celsius; muscle strain; myalgia; fatigue; not feeling well; stuffy; pressure on the stomach, feeling like he was about to vomit; probably had a flu-like illn


VAERS ID: 1480157 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-05
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Brain natriuretic peptide, Cardiac failure, Dyspnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 9
Permanent Disability? 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: 20210609; Test Name: Brain natriuretic peptide; Result Unstructured Data: BNP-2000 (Increased)
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Dyspnoea; Heart failure; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC FAILURE (Heart failure) and DYSPNOEA (Dyspnoea) in a 57-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 immunisation. No Medical History information was reported. On 24-May-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced CARDIAC FAILURE (Heart failure) (seriousness criteria death, medically significant and life threatening). On an unknown date, the patient experienced DYSPNOEA (Dyspnoea) (seriousness criteria death and life threatening). The patient died on 14-Jun-2021. The reported cause of death. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2021, Brain natriuretic peptide: 2000 (High) BNP-2000 (Increased). For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. This is a case of 57-year-old male patient who experienced Cardiac failure and Dyspnoea and subsequently died three weeks following a dose of mRNA-1273 vaccine. Very limited information regarding these events has been provided at this time. No information regarding patient''s relevant medical history nor concomitant medications was provided. Furthermore, it is unknown if an autopsy was performed.; Sender''s Comments: This is a case of 57-year-old male patient who experienced Cardiac failure and Dyspnoea and subsequently died three weeks following a dose of mRNA-1273 vaccine. Very limited information regarding these events has been provided at this time. No information regarding patient''s relevant medical history nor concomitant medications was provided. Furthermore, it is unknown if an autopsy was performed.; Reported Cause(s) of Death


VAERS ID: 1480161 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   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: NLPFIZER INC2021817992

Write-up: Death/Cardiac death; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number NL-LRB-00595253. A 46-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot Number: FC3098), via an unspecified route of administration on 19Jun2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced cardiac death on 21Jun2021. Cardiac death was treated with reanimeren. Death occurred after 40 min of resuscitation. The patient died on 21Jun2021. An autopsy was performed, and results were not provided. 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: Death occurred after 40 min of resuscitation. An autopsy is being performed. COVID19 Previous COVID-19 infection: No Other diagnostic procedures: Post-mortem examination: result unknown at the time of reporting; Reported Cause(s) of Death: Cardiac death


VAERS ID: 1480163 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NORTRIPTYLINE; TEMAZEPAM; FLURAZEPAM; LORAZEPAM; DOXAZOSIN; VENLAFAXINE; CLONAZEPAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021817972

Write-up: Sudden death; Fatigue; injection site pain; This is a spontaneous report from a contactable physician downloaded from the WEB NL-LRB-00595398. A 26-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: Unknown) via an unspecified route of administration on 07Jun2021 as dose1, single for COVID-19 immunization (at the age of 26 years old). The patient medical history was not reported. The patients concomitant medications includes lorazepam tablet (LORAZEPAM) 2.5 mg, temazepam (TEMAZEPAM) tablet 20 mg, doxazosine (DOXAZOSIN) Modified-release tablet 8 mg, nortriptyline (NORTRIPTYLINE) tablet 25 mg and 50 mg, venlafaxine Modified-release capsule (VENLAFAXINE ) 37.5 mg, flurazepam capsule (FLURAZEPAM ) 15 mg and clonazepam tablet (CLONAZEPAM ) 0.5 mg. The patient sudden death, fatigue and injection site pain following administration of covid-19 vaccine and found dead on Tuesday evening 15Jun2021. Autopsy was done but no results available. She was completely healthy. Obduction done, nothing could be found. Also toxicology clean. GP did not get the results but wanted to put us in touch with forensic medicine contact person. Patient had no previous heart problems. Brother goes to the cardiologist to see if there can be a genetic background. The outcome of events was fatal. Summary of reporter''s comments: Past Comirnaty: no passed away suddenly on 15Jun. Physically in good condition and has always been healthy. Previous COVID-19 infection: No No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: Found dead


VAERS ID: 1480170 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-19
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Cerebral infarction, Pulmonary embolism
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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), Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021818182

Write-up: brain infarct, pulmonary embolism and complications thereof; brain infarct, pulmonary embolism and complications thereof; brain hemorrhage; This is a spontaneous report from a contactable healthcare professional downloaded from the WEB, regulatory authority number is NL-LRB-00596024. A 77-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: ET3674) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 19April2021, the patient was found in his apartment with a brain hemorrhage. The patient probably lay for a few days. Later on, in the hospital he also had a pulmonary embolism, from which he died on 06May2021 after not having regained consciousness. It was also reported that patient had brain infarct, pulmonary embolism and complications thereof. Outcome of events was fatal. The patient died on 06May2021. 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: brain hemorrhage; brain infarct, pulmonary embolism and complications thereof; brain infarct, pulmonary embolism and complications thereof


VAERS ID: 1480177 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-05-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cerebral haemorrhage, Fatigue, Headache, Malaise, Nausea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), 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 INC2021817669

Write-up: Cerebral haemorrhage; Cardiac arrest; Not feeling well; Headache; Nausea; Fatigue; This is a spontaneous report from a contactable consumer or other non health care professional (patient''s partner), downloaded from the Agency Regulatory Authority-WEB NL-LRB-00597076. A 74-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number and Expiration date not reported) via an unspecified route of administration in an unspecified anatomical location on 16May2021 (at the age of 74-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number and Expiration date not reported) via an unspecified route of administration in an unspecified anatomical location on an unspecified date at 0.3 mL as single dose for COVID-19 immunisation. The patient had no previous COVID-19 infection. On an unspecified date, after administration of COVID-19 vaccine Pfizer injection fluid the patient experienced cerebral haemorrhage, cardiac arrest (latency unknown for both events). On 20May2021, 4 days after vaccination, the patient had fatigue. On 21May2021, the patient experienced headache, not feeling well, nausea; all 5 days after vaccination. It was reported that patient died a week after the second shot following cause of death as cardiac arrest due to a brain haemorrhage and could not have been an accident. The outcome of cardiac arrest, cerebral haemorrhage, fatigue, headache and malaise was reported as fatal and the outcome of nausea was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1480178 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Fatigue, Malaise, 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: 2021-04-14
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: ; This regulatory authority case was reported by a non-health professional and describes the occurrence of CARDIAC ARREST , NAUSEA, MALAISE and FATIGUE in an 84-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Bladder cancer. On 09-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced FATIGUE (seriousness criterion death). On 11-Apr-2021, the patient experienced CARDIAC ARREST (Haar lichaam/hart stopte er gewoon mee) (seriousness criteria death and medically significant), NAUSEA (seriousness criterion death) and MALAISE (seriousness criterion death). The patient died on 14-Apr-2021. The reported cause of death. An autopsy was not performed. Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death


VAERS ID: 1480182 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-23
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Platelet count, Pulmonary embolism, SARS-CoV-2 test, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATINE [ATORVASTATIN]; PERSANTIN; ASCAL BRISPER CARDIO-NEURO
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:No result; Test Name: platelet; Result Unstructured Data: Test Result:83; Test Name: covid-19 virus test; Test Result: Negative
CDC Split Type: NLPFIZER INC2021842926

Write-up: Thrombocytopenia; Lung embolism; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00598834. A 69-year-old female patient received second dose of BNT162B2 (Comirnaty; Solution for injection; Lot number: unknown), via an unspecified route of administration 27May2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Previous COVID-19 infection was reported as no. The patient Concomitant medications included ATORVASTATINE [ATORVASTATIN] tablet 40mg, carbasalate calcium effervescent tablet 100mg (ASCAL BRISPER CARDIO-NEURO), dipyridamole 150mg Modified Release Capsule (PERSANTIN). The patient previously received first dose of BNT162B2 (Comirnaty; Solution for injection; Lot number: unknown) on 26Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation and no side effects was reported. On 23Jun2021, 27 days after start, the patient experienced thrombocytopenia (death)and lung embolism (death). It was reported that Patient was resuscitated in the hospital emergency room with a large pulmonary embolism. It is of course not sure for me as a doctor whether it has to do with the vaccination, but by reporting I hope that this will be considered. The lab tests and diagnostic procedures included blood tests: no result, Platelet count: low platelets of 83, and a covid test: negative on an unspecified dates. Therapeutic measures were taken and treatment included Lung embolism is treated with trombolyse alteplase and thrombocytopenia is treated with trombolyse alteplase. The outcome of lung embolism is fatal and the outcome of thrombocytopenia is fatal.This CPR (with death) occurred on 23Jun. it was unknown whether autopsy was done. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Thrombocytopenia; pulmonary embolism


VAERS ID: 1480185 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-19
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Angiocardiogram, Blood bicarbonate, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood gases, Blood lactic acid, Blood test, Chest X-ray, Computerised tomogram head, Death, Glomerular filtration rate, Haemoglobin, International normalised ratio, Neck pain, PCO2, PO2, Platelet count, Prothrombin time, Troponin I, White blood cell count, pH body fluid
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210619; Test Name: aPTT; Result Unstructured Data: 60 sec; Test Date: 20210619; Test Name: CAG; Test Result: Inconclusive ; Result Unstructured Data: date was estimated most likely date, between start of events 19/6 and death 22/6; Test Date: 20210619; Test Name: bicarbonaat; Test Result: Inconclusive ; Result Unstructured Data: 19 mmol/L; Test Date: 20210619; Test Name: CK; Result Unstructured Data: 902 = high (<200= normal); Test Date: 20210619; Test Name: kreatinine; Result Unstructured Data: 97= normal for male; Test Date: 20210619; Test Name: fibrinogeen; Result Unstructured Data: 2.6 g/L = normal; Test Date: 20210619; Test Name: bloedgassen; Test Result: Inconclusive ; Result Unstructured Data: pH 7.28, pCO2 5.5 kPa, bicarbonaat 19 mmol/L. paO2 19.0 kPa.; Test Date: 20210619; Test Name: lactaat; Result Unstructured Data: 3.1 mmol/l; Test Date: 20210619; Test Name: Electrolyten; Result Unstructured Data: electrolytes normal; Test Date: 20210619; Test Name: Thorax X; Test Result: Inconclusive ; Result Unstructured Data: unknown; Test Date: 20210619; Test Name: CT Cerebrum; Test Result: Inconclusive ; Result Unstructured Data: unknown; Test Date: 20210619; Test Name: eGFR; Result Unstructured Data: $g90= normal; Test Date: 20210619; Test Name: hemoglobine; Result Unstructured Data: 11.3 mmlo/l = increased; Test Date: 20210619; Test Name: INR; Test Result: Inconclusive ; Result Unstructured Data: 1.2= normal; Test Date: 20210619; Test Name: pco2; Test Result: Inconclusive ; Result Unstructured Data: 5.5 kPa; Test Date: 20210619; Test Name: PH; Test Result: Inconclusive ; Result Unstructured Data: 7.28; Test Date: 20210619; Test Name: trombocyten; Result Unstructured Data: 454 = increased; Test Date: 20210619; Test Name: pao2; Test Result: Inconclusive ; Result Unstructured Data: 19 kPa; Test Date: 20210619; Test Name: PT; Result Unstructured Data: 16 sec = high; Test Date: 20210619; Test Name: Troponine I; Result Unstructured Data: 4319; Test Date: 20210619; Test Name: leukocyten; Result Unstructured Data: 19.6 = increased
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: ; This regulatory authority case was reported by a physician and describes the occurrence of DEATH in a 29-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced NECK PAIN (nekpijn). On 22-Jun-2021, NECK PAIN outcome was unknown. The patient died on 22-Jun-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, Activated partial thromboplastin time (30-40): 60 (High) 60 sec. On 19-Jun-2021, Angiocardiogram: inconclusive (Inconclusive) date was estimated most likely date, between start of events 19/6 and death 22/6. On 19-Jun-2021, Blood bicarbonate: 19 mmol/l (Inconclusive) 19 mmol/L. On 19-Jun-2021, Blood creatine phosphokinase: 902 (High) 902 = high (<200= normal). On 19-Jun-2021, Blood creatinine: normal (normal) 97= normal for male. On 19-Jun-2021, Blood fibrinogen: 2.6 (normal) 2.6 g/L = normal. On 19-Jun-2021, Blood gases: ph 7.28, pco2 5.5 kpa, bicarbonaat 19 mmol/l. (Inconclusive) pH 7.28, pCO2 5.5 kPa, bicarbonaat 19 mmol/L. paO2 19.0 kPa.. On 19-Jun-2021, Blood lactic acid: 3.1 (High) 3.1 mmol/l. On 19-Jun-2021, Blood test: normal (normal) electrolytes normal. On 19-Jun-2021, Chest X-ray: unknown (Inconclusive) unknown. On 19-Jun-2021, Computerised tomogram head: unknown (Inconclusive) unknown. On 19-Jun-2021, Glomerular filtration rate: normal (normal) $g90= normal. On 19-Jun-2021, Haemoglobin: 11.3 (High) 11.3 mmlo/l = increased. On 19-Jun-2021, International normalised ratio: 1.2 (Inconclusive) 1.2= normal. On 19-Jun-2021, PCO2: 5.5 kpa (Inconclusive) 5.5 kPa. On 19-Jun-2021, PO2: 19 kpa (Inconclusive) 19 kPa. On 19-Jun-2021, Platelet count: 454 (High) 454 = increased. On 19-Jun-2021, Prothrombin time (11-14): 16 sec (High) 16 sec = high. On 19-Jun-2021, Troponin I: 4319 (High) 4319. On 19-Jun-2021, White blood cell count: 19.6 (High) 19.6 = increased. On 19-Jun-2021, pH body fluid: 7.28 (Inconclusive) 7.28. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. Treatment drug information was not given. Company Comment : This is a case of sudden death in 29-year-old male with no hx provided and associated of AE of neck pain, who died 1 month after receiving the first dose of vaccine. Very limited information has been provided at this time; Sender''s Comments: This is a case of sudden death in 29-year-old male with no hx provided and associated of AE of neck pain, who died 1 month after receiving the first dose of vaccine. Very limited information has been provided at this time; Reported Cause(s) of Death


VAERS ID: 1480186 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021824706

Write-up: Was found dead on 27Jun, otherwise blank medical relevant history; Vomit traces were found in the house during the inspection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00598997. A 69-years-old male patient received first dose of BNT162B2 ((COMIRNATY), Formulation: Solution for injection, Lot number- unknown), via an unspecified route of administration on 23Jun2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had not been tested for covid-19 before the vaccination. No Previous COVID-19 infection. It was reported that the patient was found dead on 27Jun, otherwise blank medical relevant history. The patient was found death 4 days after vaccination, medical examiner has established death to have likely taken place 1 day after vaccination. Reporter has been informed that deceased did not have any relevant medical history to explain this death. Additional information ADR: A relationship with the vaccination cannot be ruled out, a forensic doctor was involved, who declared a natural death on the basis of the on-site investigation. presumably the person concerned had been dead for several days at the time of discovery. There was a blank medical relevant history, there have been no acute reactions after the first vaccination. Vomit traces were found in the house during the inspection. As far as is known, there has been no contact with the person concerned by family or general practitioner after the vaccination until the moment of discovery. Son has requested an autopsy through general practitioner. The outcome of the events was reported as fatal (death). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: According to the forensic doctor, there was a natural death, a relationship with vaccination cannot be ruled out


VAERS ID: 1480188 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-03-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Blood test, Computerised tomogram, Dizziness, Eye pruritus, Fall, Fatigue, Fear of falling, Feeling abnormal, Head injury, Headache, Inappropriate schedule of product administration, Limb injury, Malaise, Nausea, Oedema peripheral, Pain in extremity, Pruritus, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 64
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FINIMAL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:nothing found; Test Name: CT scan; Result Unstructured Data: Test Result:nothing found
CDC Split Type: NLPFIZER INC2021824690

Write-up: legs retain moisture; Sore legs (heavy legs)/pain (shoots) in the legs; Itching/scratching; itching behind the eyes; Nausea; Vomiting; Headache; Not feeling well; Fatigue; Dizziness; falling; Fear of falling; head and arms injured; head and arms injured; bad feeling; anxious; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority NL-LRB-00599920. A 93-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: ER9480) as dose 2, single at the age of 93-year-old for covid-19 immunisation. Dose 1 was received on 11Feb2021 for covid-19 immunisation and experienced nausea, dizziness, vomiting, fatigue, itching. The patient medical history was not reported. No previous COVID-19 infection. Concomitant medications included caffeine, paracetamol (FINIMAL) taken for an unspecified indication, start and stop date were not reported, and non-specified antibiotics. The patient experienced itching/scratching on 06Apr2021, vomiting on 01Apr2021, sore legs (heavy legs)/pain (shoots) in the legs on 13Apr2021, headache on 31Mar2021, nausea on 01Apr2021, not feeling well on 31Mar2021, fatigue on 31Mar2021, legs retain moisture on 13Apr2021, dizziness on 31Mar2021, falling on 31Mar2021, and fear of falling on 31Mar2021. Dizziness resulted in falling, head and arms injured. She was constantly dizzy and complained about it a lot. Due to the combination of dizziness/nausea, vomiting a lot during and after eating. Because of this side effect, a bad feeling and anxious to walk all day because of falling (on 31Mar2021). She always went to bed early to get rid of the bad feeling. Itching, continuous itching and scratching on the arms, legs. She also complained of itching behind the eyes (??) on 06Apr2021. Sore legs (heavy legs), pain (shoots) in the legs. Retain a lot of moisture. Not being able to stand much. Diagnostic procedures included blood test in hospital (nothing found), CT scan after falling (nothing found). Treatment: Headache is treated with paracetamol. Legs retain moisture is treated with ''Dewatering'' in the hospital (didn''t help) and antibiotics (didn''t help either). Sore legs (heavy legs)/pain (shoots) in the legs is treated with ''Dewater'' in the hospital (didn''t help) and antibiotics (didn''t help either). And Itching/scratching was treated with Cooling Ointment (which didn''t help). The outcome of event dizziness, itching/scratching, sore legs (heavy legs)/pain (shoots) in the legs, nausea, not feeling well, fatigue, headache, vomiting, legs retain moisture was death. The outcome of other event was unknown. The patient died on 02Jun2021. It was not reported if an autopsy was performed. Summary of reporter''s comments: description of events for the 1st dose, description of events for the 2nd dose, no previous COVID-19 infection and description of lab data and diagnostic procedures. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Summary of reporter''s comments: description of events for the 1st dose, description of events for the 2nd dose, no previous COVID-19 infection and description of lab data and diagnostic procedures.; Sender''s Comments: Based on the available , the causal relationship between BNT162B2 and the fatal events cannot be excluded. 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.; Reported Cause(s) of Death: Vomiting; Sore legs (heavy legs)/pain (shoots) in the legs; headache; nausea; Not feeling well; fatigue; legs retain moisture; dizziness; Itching/scratching


VAERS ID: 1480189 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Myalgia, Myocardial infarction, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021824686

Write-up: press the chest, My father passed away; Something with the heart / blood clot or heart attack according to the doctor; Muscle strain. My father passed away; In the morning, when he got up, he suffered from his arm where the injection was, in the afternoon pressure on the chest.; This is a spontaneous report from a contactable consumer or other non-HCP downloaded from the Regulatory Authority-WEB: NL-LRB-00599975. A 68-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 12Jun2021 at a dose of 0.3 ml as dose 2, single for COVID-19 immunization. Patient did not have previous COVID-19 infection. No diagnostic procedures were performed. Patient medical history included hypertension. The concomitant medications were not reported. Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration at a dose of 0.3 ml as dose 1, single for COVID-19 immunization. On 14Jun2021, the patient experienced muscle pain or strain, chest pain, heart attack, injection site pain 2 days following administration of COVID-19 vaccine Pfizer injectable solution for COVID-19 immunization. It was reported as something with the heart/blood clot or heart attack according to the doctor. The autopsy result was reported as unknown. When he got up in the morning, he suffered from his arm where the injection was, pressure on the chest in the afternoon. Confounding factors were reported to be high blood pressure. The outcome of the event injection site pain was unknown while that of the other events was fatal. No follow-up attempts are possible, No further information expected. Information on batch number cannot be obtained. Health Authority comments included muscle pain, chest pressure, father passed away.; Reported Cause(s) of Death: heart attack; Muscle strain; Something with the heart / blood clot or heart attack according to the doctor


VAERS ID: 1480193 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-28
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210711536

Write-up: PATIENT PASSED AWAY, FELT LIKE SHE WAS HAVING THE FLU FIFTEEN MINUTES BEFORE DEATH. WENT TO LIE DOWN ON THE COUCH, SOME SNORING AFTER WHICH SHE WAS FOUND DEAD, A SYSTOLE ENCOUNTERED DURING REANIMATION; This spontaneous report received from a physician via a Regulatory Authority [NL-LRB-00601596] concerned a 54-year-old male of unspecified race and ethnicity. The patient''s weight was 82 kilograms, and height was 174 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin, and batch number were not reported and expiry date not reported) 1 dosage forms (0.5 ml), 1 total, administered on 26-JUN-2021 for covid-19 immunization. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 28-JUN-2021, the patient was passed away, felt like she was having the flu fifteen minutes before death. She went to lie down on the couch, some snoring after which she was found dead, a systole encountered during reanimation. On 28-JUN-2021, the patient died from sudden death, during postmortem were indications of pneumonia, and cardiac disorder. An autopsy was performed on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event passed away, felt like she was having the flu fifteen minutes before death. went to lie down on the couch, some snoring after which she was found dead, a systole encountered during reanimation was fatal. This report was serious (Death).; Sender''s Comments: V0: 20210711536-covid-19 vaccine ad26.cov2.s-patient passed away, felt like she was having the flu fifteen minutes before death. went to lie down on the couch, some snoring after which she was found dead, a systole encountered during reanimation. 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: SUDDEN DEATH; Pneumonia; Cardiac disorder; Autopsy-determined Cause(s) of Death: Pneumonia; Cardiac disorder


VAERS ID: 1480194 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Depressed level of consciousness, Disturbance in attention, Fatigue, Inappropriate schedule of product administration, Malaise, Somnolence
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung disorder (one lung); Lung operation (lives with 1 lung)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021843497

Write-up: alertness deteriorated sharply; Fatigue; Concentration impaired; Not feeling well; even slept in the chair during the day; first dose on 05Mar2021, second dose on 26Apr2021; This is a spontaneous report from a contactable other health professional downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00603118. A 77-year-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number not reported), via an unspecified route of administration on 26Apr2021 as dose 2, single for COVID-19 immunisation. The medical history of the patient included lung disorder from an unknown date and lung operation on an unknown date. It was reported that patient lived healthy for 25 years, but with one lung. The concomitant medications of the patient were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY, solution for injection, 0.3mL, Batch/Lot number not reported), via an unspecified route of administration on 05Mar2021 and experienced extreme fatigue, difficulty concentrating, loss of strength and loss of appetite. There was no previous COVID-19 infection. On 27Apr2021 (1 day after vaccination) the patient experienced alertness deteriorated sharply, fatigue, concentration impaired, not feeling well and even slept in the chair during the day. The reporter stated that although his condition gradually deteriorated, after the 2 vaccinations he became extremely tired and even slept in the chair during the day, concentration and alert-ness deteriorated sharply and died within 3 months. It was unknown if autopsy was done and cause of death was unknown. The wife does not want to work on it further, but reporting was important, be-cause only 10% of the population does this, and that therefore a distorted picture was created about all side effects of the covid vaccines. The case was reported as serious. The outcome of the events was fatal on an unspecified date. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1480207 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-02
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperpyrexia, Illness, Injection site pain, Malaise, Myalgia, Nausea, Paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   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 Date: 20210703; Test Name: Hyperpyrexia; Result Unstructured Data: Fever 40.5 TO 42 Degrees Celsius.
CDC Split Type: NLJNJFOC20210723109

Write-up: PARALYZED; REACTION ON OR AROUND THE INJECTION SITE PAIN; SICK AS A DOG; NAUSEA; JOINT PAIN; COLD CHILLS; FATIGUE; MUSCLE PAIN; FEVER 40.5 TO 42 DEGREES CELSIUS; FEELING UNWELL; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority [NL-LRB-00612022] concerned a 48 year old female. The patient''s weight was 75 kilograms, and height was 175 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, at a frequency of 1 total, administered on 02-JUL-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 02-JUL-2021, the patient experienced fever 40.5 to 42 degrees celsius, feeling unwell, headache, joint pain, cold chills, fatigue and muscle pain. On 03-JUL-2021, the patient experienced paralyzed, sick as a dog, reaction on or around the injection site pain and nausea. Laboratory data included: Hyperpyrexia (NR: not provided) Fever 40.5 TO 42 Degrees Celsius. On 03-JUL-2021, the patient died from vaccination complication, fever 40.5 to 42 degrees celsius, paralyzed, feeling unwell, headache, joint pain, cold chills, fatigue, muscle pain, nausea, sick as a dog, and reaction on or around the injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of paralyzed on 03-JUL-2021. This report was serious (Death).; Sender''s Comments: V0 - 20210723109-covid-19 vaccine ad26.cov2.s-Paralyzed, Fever 40.5 to 42 degrees celsius, Feeling unwell, Headache, Joint pain, Cold chills, Fatigue, Muscle pain, Nausea, Sick as a dog, Reaction on or around the injection site pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: VACCINATION COMPLICATION; FEELING UNWELL; HEADACHE; JOINT PAIN; COLD CHILLS; FATIGUE; MUSCLE PAIN; NAUSEA; FEVER 40.5 TO 42 DEGREES CELSIUS; PARALYZED; SICK AS A DOG; REACTION ON OR AROUND THE INJECTION SITE PAIN


VAERS ID: 1480208 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cardiac arrest, Cardiac death, Chest pain, Fatigue, Head discomfort, Headache, Myocardial infarction, Nausea, Rhinorrhoea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 40
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE SODIUM; FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL FUMARATE]; ESOMEPRAZOLE; MACROGOL; DILANORM; VERAPAMIL; CETOMACROGOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain; Hypertension (Blood pressure medication and no cholesterol increase); Hypertrophic cardiomyopathy (Familial thickened heart muscle); Lung disorder; Thyroid disorder (1x p/year to a pulmonologist.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021864876

Write-up: light pressure feeling on the top of the chest and sometimes in head/ chest pain; light pressure feeling on the top of the chest and sometimes in head/weird feeling in her head; myocardial infarct or cardiac arrest; cardiac arrest or heart attack; a bit of nausea in the beginning; rhinorrhea; cardiac arrest or heart attack/ cardiac death; Fatigue; Headache; pain in the joints; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB NL-LRB-00612068 and Safety Report Unique Identifier NL-LRB-00613160. The contactable reporter described events for both doses of Comirnaty. This report describes events for the second dose. A 77-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EX0893), via an unspecified route of administration on 22Apr2021, as Dose 2, single for COVID-19 immunization. Medical history included hypertension (1x p/year to a pulmonologist. Blood pressure medication and no cholesterol increase), back pain, hypertrophic cardiomyopathy [Familial thickened heart muscle (indicated by GP and specialist), a few years ago, a heart rate monitor was taken by a cardiologist for 24 hours, after sending, the data was lost. Cardiologist paid little attention to it and conveniently dismissed it], thyroid disorder, and lung disorder. The patient did not test COVID-19 positive prior to vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM); beclometasone dipropionate, formoterol fumarate (FOSTER [BECLOMETASONE DIPROPIONATE; FORMOTEROL FUMARATE]); esomeprazole (ESOMEPRAZOLE); macrogol (MACROGOL); celiprolol hydrochloride (DILANORM); verapamil (VERAPAMIL); cetomacrogol (CETOMACROGOL) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EP9605), via an unspecified route of administration on 18Mar2021, as dose 1, single, for COVID-19 immunization and experienced headache (outcome: resolved), nausea (outcome: resolved) and rhinorrhea (outcome: not resolved). It was reported that they had great confidence in the Pfizer vaccine and were vaccinated on 18Mar and 22Apr. Perhaps wrongly, because in the course of time we have started to have some doubts. On 23Apr2021, after the second vaccination patient had fatigue, generalized joint pain, headache, and was still experienced rhinorrhea. On 02Jun2021 (a month after vaccination), the patient died in her sleep. As reported the walking was sometimes difficult, but she cycled for 45 minutes every day on her home trainer. Except for some physical discomfort, the patient was fine and live independently and 2.5 hours per week at home care. The patient was taking medication for Blood pressure, thyroid, antacid and 1x p/day inhaler. In the last week she had chest pain and a weird feeling in her head. Cause of death was myocardial infarct or cardiac arrest, but the Latency was unknown, but estimated at about a month after vaccination. It was reported that, in addition to headaches the patient was having a bit of nausea in the beginning, on an unspecified date and had complaints of nose colds (severe runny nose) that always occur intermittently. It was stated that the patient passed away suddenly in her sleep a month ago for no apparent reason, which made question the vaccine even more. The doctor thought it was a cardiac arrest or infarction. Perhaps similar reports had arrived. It was hard for her husband to accept that the vaccine, which should give them back their freedom, caused her death. He sincerely hopes that it was not caused by the Pfizer vaccine, but would like to report it. It was mentioned that Cardiopulmonary resuscitation (CPR) test taken at home by my GP but with negative result. Therapeutic measures were taken as a result of headache (treatment unspecified). No autopsy was performed. The outcome of the event myocardial infarct or cardiac arrest; cardiac arrest or heart attack/ cardiac death wad fatal; the outcome of the events chest pain, head discomfort, fatigue, headache, arthralgia, and nausea was resolved, on an unspecified date in 2021; while the outcome of the event Rhinorrhea was not resolved. No follow-up attempts possible. No further information expected. ; Reporter''s Comments: Summary of reporter''s comments: Past Comirnaty: yes ADRs: Headache and mild nausea, then permanent cold, runny nose. 1st vaccine number EP9605 Date: 18Mar2021 Previous COVID-19 infection: No No autopsy has been performed. My wife passed away on June 2nd I did have a CPR test taken at home by my GP. Result negative Assessor: FU received. Date of death added. Reactogenic complaints restored, except for a cold. Medical history added. Summary completed.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021892040 1st/2nd dose; Reported Cause(s) of Death: cardiac arrest or heart attack/ cardiac death; cardiac arrest or heart attack; myocardial infarct or cardiac arrest


VAERS ID: 1480256 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Blood lactic acid, Cardiac failure, Castleman's disease, Disseminated intravascular coagulation, Dyspnoea, Encephalitis, Fatigue, Haematology test, Haemolysis, Hemiplegia, Interleukin level, Interleukin level decreased, Investigation, Lactic acidosis, Lethargy, Low cardiac output syndrome, Magnetic resonance imaging head, Multiple organ dysfunction syndrome, Night sweats, Oxygen saturation, Oxygen saturation decreased, Platelet count, Procalcitonin, Procalcitonin increased, Pruritus, Renal failure, Serum ferritin, Serum ferritin increased, Splenomegaly, Thrombocytopenia, Venous oxygen saturation
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (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), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 47
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IMOVANE; MOVICOL READY TO TAKE; CETIRIZIN BLUEFISH; VITAMIN B12 [CYANOCOBALAMIN]; DUODART
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Ileus (Previously operated on for ileus); Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210612; Test Name: Lactate; Result Unstructured Data: Test Result:16 mmol/L; Test Date: 202105; Test Name: Haematology test; Result Unstructured Data: Test Result:Hemolysis, DIC.; Test Date: 202105; Test Name: Interleukin level; Result Unstructured Data: Test Result:increased; Test Name: investigation; Result Unstructured Data: Test Result:without findings; Comments: Investigated broadly with regard to hematological malignancy (leukemias, lymphoma, myeloproliferative disease), without findings that matched with any definite diagnosis; Test Date: 202105; Test Name: Head MRI; Result Unstructured Data: Test Result:similar to encephalitis.; Test Date: 202106; Test Name: Arterial oxygen saturation; Test Result: 98 %; Test Date: 202105; Test Name: Platelet count; Result Unstructured Data: Test Result:Thrombocytopenia.; Test Date: 202105; Test Name: Procalcitonin; Result Unstructured Data: Test Result:Increased.; Test Date: 202105; Test Name: Ferritin; Result Unstructured Data: Test Result:Increased.; Test Date: 202106; Test Name: Venous oxygen saturation; Result Unstructured Data: Test Result:Catastrophically low central venous oxygen sat...; Comments: Catastrophically low central venous oxygen saturation (ScvO2).
CDC Split Type: NOPFIZER INC2021818169

Write-up: multiorgan failure; low central venous oxygen saturation; SPLENOMEGALY; THROMBOCYTOPENIA; DISSEMINATED INTRAVASCULAR COAGULATION; RENAL FAILURE; LACTIC ACIDOSIS; TAFRO; low cardiac output; encephalitis; Procalcitonin increase; HEMOLYSIS; HEMIPLEGIA; HEART FAILURE; ATRIAL FIBRILLATION; interleukin 6 increase; ferritin increase; lethargy; NIGHT SWEATS; FATIGUE; DYSPNEA; ITCHY SKIN; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Umq78d. A 68-year-old male patient received BNT162B2 (COMIRNATY), 1st dose intramuscularly on 20Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. Medical history included ileus (Previously operated on for ileus), benign prostatic hyperplasia, vitamin b12 deficiency. Concomitant medications included zopiclone (IMOVANE) taken for Difficulty sleeping; macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL READY TO TAKE) taken for obstipation; cetirizine hydrochloride (CETIRIZIN BLUEFISH) taken for itching; cyanocobalamin (VITAMIN B12) taken for vitamin b12 deficiency; dutasteride, tamsulosin hydrochloride (DUODART) taken for benign prostatic hyperplasia. The patient experienced night sweats, fatigue, dyspnea, itchy skin, all (death) on 26Apr2021, hemolysis, hemiplegia, heart failure, atrial fibrillation, splenomegaly, thrombocytopenia, disseminated intravascular coagulation, renal failure, lactic acidosis, TAFRO, low cardiac output, encephalitis, all (death) in May2021, low central venous oxygen saturation (death) in Jun2021, multiorgan failure (death) on 12Jun2021, lethargy on 26Apr2021, interleukin 6 increase, ferritin increase, procalcitonin increase, all in May2021. The patient underwent lab tests and procedures which included Lactate: 16 mmol/l on 12Jun2021, haematology test: hemolysis, DIC in May2021, interleukin level: increased in May2021, investigation: Investigated broadly with regard to hematological malignancy (leukemias, lymphoma, myeloproliferative disease), without findings that matched with any definite diagnosis, Head MRI: similar to encephalitis in May2021, Arterial oxygen saturation: 98 % in Jun2021, platelet count: thrombocytopenia in May2021, procalcitonin: increased in May2021, ferritin: increased in May2021, venous oxygen saturation: Catastrophically low central venous oxygen saturation (ScvO2) in Jun2021. Therapeutic measures were taken as a result of TAFRO, low central venous oxygen saturation. The patient died on 12Jun2021. An autopsy was performed and results were not provided. The outcome of the events ''Lethargy, interleukin 6 increase, ferritin increase, Procalcitonin increase'' was unknown. Clinical course: Man in his late 60s receiving the first dose of covid-19 vaccine Comirnaty. Formerly known benign prostatic hyperplasia, vitamin b12 deficiency, Previously operated on for ileus. Hospitalized 20 days after vaccination with increasing fatigue and lethargy, shortness of breath, generalized intense skin itching and night sweats in the last 14 days before admission. According to the family, it is somewhat uncertain whether he had symptoms before the vaccine as well. Splenomegaly was detected during hospitalization. Investigated broadly with regard to hematological malignancy (leukemias, lymphoma, myeloproliferative disease), without findings that matched with any definite diagnosis. Eventually he developed hemolysis, a DIC-like condition with consumption of platelets and fibrinogen, and an increase in inflammatory parameters (ferritin, interleukin 6 and procalcitonin), and he developed dialysis-requiring renal failure. The symptoms matched TAFRO syndrome, which is a multifocal Castleman disease, but one was unable to find the trigger. He was treated with massive immunosuppression (tocelizumab, retuximab, high-dose steroids and immunoglobulins) without effect. He developed heart failure with right side dilation, atrial fibrillation and low cardiac output, hemiplegia with MRI findings similar to encephalitis, hemolysis, DIC, severe thrombocytopenia and severe lactic acidosis with catastrophically low central venous oxygen saturation (ScvO2) with concomitant SaO2 98% (indicating high oxygen consumption). The patient died 5 weeks after hospitalization (ie 8 weeks after vaccination) of multiorgan failure with lactic acidosis (16 mmol/l). A hospital autopsy has been performed where no definitive diagnosis has yet been found. The relatedness of drug to all events was reported as possible by Pharmacovigilance Center. Reporter comment: Regulatory Authority will request additional information from hospital. This is a preliminary report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Regulatory Authority will request additional information from hospital. This is a preliminary report.; Reported Cause(s) of Death: RENAL FAILURE; NIGHT SWEATS; FATIGUE; DYSPNEA; ITCHY SKIN; HEMOLYSIS; HEMIPLEGIA; HEART FAILURE; ATRIAL FIBRILLATION; SPLENOMEGALY; THROMBOCYTOPENIA; DISSEMINATED INTRAVASCULAR COAGULATION; TAFRO; low central venous oxygen saturation; encephalitis


VAERS ID: 1480257 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1436 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, General physical health deterioration, 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: 2021-06-24
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Life expectancy shortened; Living in nursing home; Lung cancer (advanced lung cancer in palliative phase); Palliative care; Pleural effusion recurrent
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021824246

Write-up: DYSPNEA; REDUCED GENERAL CONDITION; FEVER; This is a spontaneous report from a contactable physician downloaded from the WEB NO-NOMAADVRE-FHI-2021-Umq7a9. A 79-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 17Jun2021 12:54 (Batch/Lot Number: FC1436) as dose 1, single for covid-19 immunisation. Medical history included life expectancy shortened, advanced lung cancer in palliative phase, living in nursing home and pleural effusion recurrent. It was reported that the patient was hospitalized on 13Apr2021, very reduced at that time, considered to have a short life expectancy, recovered gradually and was planned to return home and considered dying on 21Jun2021. The patient''s concomitant medications were not reported. On 17Jun2021, same evening of vaccination, the patient had fever and gradual worsening of general condition the next few days with increasing dyspnea. The outcome of the events as fatal. The patient died on 24Jun2021 due to fever, dyspnea and reduced general condition. It was unknown if an autopsy was performed. Causality assessment by the Regional Pharmacovigilance Center for the events to the vaccine was reported possible.; Reporter''s Comments: * Advanced lung cancer in palliative phase and recurrent pleural effusion. * Admitted to a health center 13/Apr/2021, after hopitalization at the regional hospital. * The patient was very reduced at that time, considered to have a short life expectancy. * Then recovered gradually and it was planned for discharge. * Moved from the palliative care unit to the rehabilitation unit 17/Jun/2021, and due to a clear improvement in general condition with increasing level of function and planned discharge, the patient received the first dose of Comirnaty. * Fever the same evening as vaccination and gradual worsening of general condition the next few days with increasing dyspnea. * Considered dying 21/Jun/2021, after that only palliative treatment.; Reported Cause(s) of Death: Fever; Dyspnea; Reduced general condition


VAERS ID: 1480329 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Lethargy
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? 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 INC2021819548

Write-up: Lethargic; Dyspnea; This is a spontaneous report from a contactable other healthcare professional received via the Regulatory Authority. Regulatory authority report number PH-PHFDA-300087407. A 68-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EY4834), via intramuscular route on 20Jun2021 (68-year-old at vaccination) as a Dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 22Jun2021 at 17:00, the patient experienced lethargic, dyspnea. The patient was brought unresponsive to an emergency department. A few minutes prior, the patient was lethargic and had a sudden onset of dyspnea. The patient died on an unspecified date. It was not reported if an autopsy was performed or not. No follow-up attempts are possible. No further information was expected.; Reported Cause(s) of Death: Lethargic; Dyspnea


VAERS ID: 1480330 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-22
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pneumonia pneumococcal
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC2021819549

Write-up: Pneumococcal pneumonia; Difficulty of Breathing; This is a spontaneous report from a contactable other HCP. This is a report received from the Regulatory authority report number PH-PHFDA-300087687. A 80-years-old male patient received bnt162b2 (COMIRNATY, solution for injection), intramuscular on 12May2021(age at vaccination 80-years-old) (Batch/Lot Number: EY4834) as dose number unknown, single for covid-19 immunization. Medical history and concomitant medications were not reported. On 22May2021 at 17:00, the patient experienced pneumococcal pneumonia and difficulty of breathing. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of both the events were fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pneumococcal pneumonia; Difficulty of Breathing


VAERS ID: 1480354 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal behaviour, Cerebral disorder, Death, Delusion, Hallucination, visual, Headache, Loss of control of legs, Pain in extremity, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Hypertension; Nephrectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021814975

Write-up: The man started seeing things and people who are not there, he had delusions and hallucinations, he ran away.; The man started seeing things and people who are not there, he had delusions and hallucinations, he ran away.; The man started seeing things and people who are not there, he had delusions and hallucinations, he ran away.; After the vaccination there was a headache, pain in the legs, a feeling as if "the legs refused to obey"; After the vaccination there was a headache, pain in the legs, a feeling as if "the legs refused to obey"; After the vaccination there was a headache, pain in the legs, a feeling as if "the legs refused to obey"; This was followed by visual impairment.; probably something with the brain; At the hospital, the man died. The reporter did not know the official cause of death; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is first of two reports. A 77-year-old male patient received his second dose of BNT162B2 (COMIRNATY; lot number: unknown), via an unspecified route of administration on 16Apr2021 (at an unspecified age) at dose 2, single for COVID-19 immunisation. Medical history included hypertension, asthma, and kidney removal. The patient''s concomitant medications were not reported. On an unspecified date in 2021, after vaccination, the patient developed a headache, leg pain, and feeling as if his "legs refused to obey". This was followed by visual impairment and the patient started to see things and people who were not there, the patient had delusions and hallucinations, he was running away on 2021. Due to these, the patient was admitted to the hospital on an unspecified date in 2021 because the reporter could not cope with him. At the hospital, on 2021, the patient died. The reporter did not know the official cause of death and said that it was probably something with the brain. It was unknown if autopsy was done. Outcome of the event unknown cause of death was fatal, and for other events was unknown. Batch/lot number has been requested.; Sender''s Comments: Linked Report(s) : PL-PFIZER INC-2021825555 same reporter, same drug, another patient; Reported Cause(s) of Death: At the hospital, the man died. The reporter did not know the official cause of death


VAERS ID: 1480355 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Hallucination
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: PLPFIZER INC2021825555

Write-up: the woman had hallucinations and died after receiving the vaccine; the woman had hallucinations and died after receiving the vaccine.; This is a spontaneous report from a contactable consumer who reported events for 2 patients. This the second of 2 reports. An 88-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced the woman had hallucinations and died after receiving the vaccine. The patient died on an unspecified date. The cause of death was not reported. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : PL-PFIZER INC-2021814975 same reporter/drug, different events/patients; Reported Cause(s) of Death: the woman had hallucinations and died after receiving the vaccine.


VAERS ID: 1480363 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-02-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Diarrhoea, Gait disturbance, Malaise, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 5
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: 20210303; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: SARS-CoV-2 infection
CDC Split Type: PLPFIZER INC2021758718

Write-up: muscle aches; diarrhea; difficulty in walking; worse well-being and weakness; SARS-CoV-2 infection; worse well-being and weakness; This is a spontaneous report from a contactable physician downloaded from the WEB. The regulatory authority report number is PL-URPL-3-731-2021. An 88-year-old male patient received his first dose of BNT162B2 (COMIRNATY; lot number: EP2166), intramuscular on 26Feb2021 11:51 (at the age of 88-years-old) at dose 1, single in the left arm for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Feb2021 20:00, from the late evening hours, the patient experienced worse well-being and weakness. The next day, on 27Feb2021, the patient experienced difficulty in walking, muscle pain, diarrhea, and considerable weakness. The patient went to the emergency room on 03Mar2021, where the test showed SARS-CoV-2 infection. The patient was hospitalized on 03Mar2021 and died on 03Mar2021. It was unknown if autopsy was done. The patient underwent COVID-19 virus test on 03Mar2021 with positive result (SARS-CoV-2 infection). The reporter assessed the events as severe and the regulatory authority classified the report as severe (death). Outcome of the events was fatal. Sender''s comments: Weakness, malaise, muscle pain which may be associated with difficulty walking, diarrhea are all expected side effects of Comirnaty vaccine. It cannot be ruled out that these symptoms were related to Covid-19 infection, confirmed a few days later, which was assessed as a coincidence. An association with Covid-19 infection was assessed as unlikely. Association with the remaining side effects was assessed as possible. In this case, the lack of vaccine efficacy was not taken into account due to the time between the administration of the 1st dose and the onset of infection. However, due to the patient''s death, a severe course of COVID-19 after vaccination (VAED - vaccine assiociated enhanced disease), entered in as the theoretical risk associated with Comirnaty vaccination, cannot be ruled out. Currently, there is no confirmation of the occurrence of this phenomenon after vaccination with Comirnaty in humans, the database did not report the occurrence of VAED after vaccination with Comirnaty. There is a time relationship between the administration of the vaccine and the occurrence of complications. The reporting person assessed the side effects as severe. The regulatory authority also classified the report as severe (death). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: There is no reasonable possibility that the event COVID19 8hours after COMIRNATY use were related. It is more likely that the patient was already infected at or before the day of vaccination. 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: worse well-being and weakness; muscle aches; diarrhea; SARS-CoV-2 infection; worse well-being and weakness; difficulty in walking


VAERS ID: 1480364 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7842 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021817945

Write-up: Death (cause: unknown); This is a spontaneous report from a contactable physician downloaded from the WEB. The regulatory authority number is PL-URPL-3-738-2021. A 62-year-old male patient received BNT162B2 (COMIRNATY Solution for injection), intramuscular, administered in the left arm, on 27May2021 12:31 (Batch/Lot Number: FA7842; Expiration Date: 30Sep2021), as dose 2, 0.3 ml single, at age 62 years old, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 27May2021, the patient experienced death (cause: unknown). The patient died on 27May2021. It was not reported if an autopsy was done. The reporter assessed the event as serious. Sender''s comments: Comirnaty is a mRNA vaccine against COVID-19 (with modified nucleosides) The submitter has classified them as serious. Classified the report as "serious" due to the reporting person''s assessment and the Patient''s death. Due to the lack of additional information (potential other chronic diseases, medications used, allergies, etc.) to establish a cause and effect relationship, a non-classifiable relationship between vaccination and death was assigned. In addition, the adverse events were reported to have occurred on the day of vaccination at 08:00, which is a mistake (the vaccine was administered at 12:31). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death (cause: unknown)


VAERS ID: 1480365 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7842 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   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: SUVARDIO; NEBICARD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesteremia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021817960

Write-up: Sudden death - suspected pulmonary embolism; Sudden death - suspected pulmonary embolism; This is as spontaneous report received from a contactable physician downloaded from the WEB. The regulatory authority report number PL-URPL-3-740-2021. A 49-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 27May2021 11:34 (Batch/Lot Number: FA7842) as DOSE 2, 0.3ML SINGLE for covid-19 immunisation. Medical history included hypertension and hypercholesterolaemia from an unknown date an unknown if ongoing. Concomitant medication included rosuvastatin calcium (SUVARDIO) and nebivolol hydrochloride (NEBICARD); both taken for an unspecified indication, start and stop date were not reported. On 27May2021 at 11:34 was vaccinated with Comirnaty vaccine 0.3ml, second dose, left arm, intramuscular (lot FA7842, expiration date: absence). The description of the report stated: Sudden death - suspected pulmonary embolism. Additional information: an employee of the poviat sanitary and epidemiological station conducted a telephone conversation with the attending physician and the patient''s relative. The patient suffered from chronic hypertension and hypercholesterolaemia. Permanent medications: Nebicard and Suvardio. He was not allergic. Death occurred suddenly, while sleeping, after returning from work the day after vaccination against COVID-19 (2nd dose of Pfizer). The reporting person classified them as severe. Due to the assessment of the reporting person, the nature of the side effects and the patient''s death, classified the report as "severe". Health result: death (date: 28May2021 at 19:00, cause: unknown) The data contained in the electronic report are all available - in the case of obtaining additional information (for which the appropriate sanitary and epidemiological station was requested by e-mail) it will be sent another version. The patient died on 28May2021 at 19:00. It was not reported if an autopsy was performed. Sender''s comments: Comirnaty is an mRNA vaccine against COVID-19 (with modified nucleosides). Pulmonary embolism is not an expected adverse effect following administration of this vaccine. Until 10Jun2021, 1,298 cases of pulmonary embolism following Comirnata administration were reported in the database. The reporting person classified them as severe. Due to the assessment of the reporting person, the nature of the side effects and the patient''s death, classified the report as "severe". Due to the scarcity of data, the URPL has established an unclassifiable causal relationship between vaccination and death. Asked the appropriate sanitary and epidemiological station by e-mail whether an autopsy had been performed. It cannot be ruled out that the patient''s medical history contributed to his death. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: Sudden death - suspected pulmonary embolism; Sudden death - suspected pulmonary embolism


VAERS ID: 1480366 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021817963

Write-up: Death; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is PL-URPL-3-741-2021. An 81-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 18Mar2021 09:25 (Lot Number: ET3674; Expiration Date: 31Jul2021) as single dose (at the age of 81-years-old) for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death on 18Mar2021 19:00. The patient died on 18Mar2021. It was not reported if an autopsy was performed. Case narrative: The PL-URPL-3-741-2021 notification was sent to the Regulatory Authority on 08Jun2021 from the station. The patient with the initials PRIVACY, born PRIVACY, male, was administered on 18Mar2021 at 09:25 the vaccine: Comirnaty 0.3, first dose, left arm, i.m., series ET3674, exp. 31Jul2021 . The notification description indicates: death. Additional information: medical documentation received from the Primary Healthcare submitted to the relevant station. The notifier classified the notification as severe. Regulatory Authority, due to the assessment of the reporting person and the death of the Patient, classified the report as severe. Health outcome: death (date: 18Mar2021 at 19:00, cause: unknown)) The data contained in the electronic report are all the data available to the Regulatory Authority - in the case of obtaining additional information (which was requested by e-mail from the relevant station), another version will be sent. Sender Comment: Comirnaty is a mRNA vaccine against COVID-19 (with modified nucleosides) The notifier has classified it as severe. The Regulatory Authority classified the notification as severe due to the reporter''s assessment and the patient''s death. Due to the lack of additional information (potential other chronic diseases, medications used, allergies, etc.) to establish a cause and effect relationship, a non-classifiable relationship between vaccination and death was assigned). The Regulatory Authority asked the relevant station by e-mail for additional information, including medical records of the Patient mentioned in the notification. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1480367 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fall, Herpes zoster, Pain of skin, Rash, Skin burning sensation
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021824103

Write-up: weakness and death; fall from her own height; blistering skin lesions occupying 3 dermatomas, not exceeding the midline of the body. She was diagnosed with shingles.; symptoms of pain and burning of the skin in the area of the left back and left breast; symptoms of pain and burning of the skin in the area of the left back and left breast; symptoms of pain and burning of the skin in the area of the left back and left breast; This is a spontaneous report received from a contactable Physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is PL-URPL-3-778-2021. An 83-year-old female patient received BNT162B2 (COMIRNATY), first dose, intramuscularly, administered in arm left on 11Mar2021 12:50 (batch/Lot Number: ER7812; Expiration Date: 31Jul2021) at the age of 83 years old, as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced symptoms of pain and burning of the skin in the area of the left back and left breast on 13Mar2021, fall from her own height on 15Mar2021, blistering skin lesions occupying 3 dermatomas, not exceeding the midline of the body. she was diagnosed with shingles on 15Mar2021, symptoms of pain and burning of the skin in the area of the left back and left breast on 13Mar2021, weakness and death on 22Mar2021, symptoms of pain and burning of the skin in the area of the left back and left breast on 13Mar2021. On 11Mar2021 vaccination against COVID, on 13Mar2021 symptoms of pain and burning of the skin in the left area. back and left breast. On 15Mar2021 home visit - blistering skin lesions occupying 3 dermatomas, not exceeding the midline of the body. She was diagnosed with shingles. Acyclovir 5x800mg + Poltram Combo was included. Control home visit on 18Mar2021 then improvement in health. On 21Mar2021 according to the family report, a fall from her own height on 15Mar2021, a medical examiner was called - the patient was not hospitalized. 22Mar2021 weakness and death. The reporting person classified it as severe. Due to the assessment of the reporting person and the patient''s death, Regulatory Authority classified the report as severe. Health result: death (date: 22Mar2021 at 10:00) The data contained in the electronic report are all available to Regulatory Authority - in the case of obtaining additional information (for which the appropriate sanitary and epidemiological station was asked by e-mail), another version will be sent. The patient died on 22Mar2021. It was not reported if an autopsy was performed. Sender''s comments: Comirnaty is an mRNA vaccine against COVID-19 (with modified nucleosides). The reported side effects are unexpected for Comirnaty. Shingles is a viral disease caused by the chickenpox virus. The incubation period of the disease is usually 1-2 weeks. Accordingly, it is possible that the onset of disease brooding was prior to administration of Comirnaty. The reported skin lesions on 13Mar2021 and 15Mar2021 could be a symptom of developing shingles. Asthenia was not included in the report but was included as an expected malaise. It cannot be ruled out that the patient''s fall was associated with weakness and a potential malaise associated with herpes zoster. The reporting person classified them as severe. Due to the assessment of the reporting person and the patient''s death, Regulatory Authority classified the report as severe. There is no additional information in the notification (potential other chronic diseases, medications used, allergies, etc.) allowing to establish a causal relationship between vaccination and death. Regulatory Authority requested additional information by e-mail to the relevant sanitary and epidemiological station. The outcome of the all events was fatal. Relatedness of drug to reaction(s)/event(s): Localised rash, Shingles, Skin pain, Burning sensation skin, Source of assessment was Regulatory Authority expert. Method of assessment was WHO system for standardised case causality assessment. Result of Assessment was unlikely. Relatedness of drug to reaction(s)/event(s): Falling, Weakness, Source of assessment was Regulatory Authority expert. Method of assessment was WHO system for standardised case causality assessment. Result of Assessment was possible. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Falling; symptoms of pain and burning of the skin in the area of the left back and left breast; Shingles; symptoms of pain and burning of the skin in the area of the left back and left breast; Weakness; symptoms of pain and burning of the skin in the


VAERS ID: 1480368 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity, Laryngeal oedema, Laryngospasm, Platelet count, Respiratory failure, Thrombocytopenia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dystonia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Goitre; Respiratory disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210606; Test Name: level of platelets; Result Unstructured Data: Test Result:60000 /mm3
CDC Split Type: PLPFIZER INC2021824111

Write-up: respiratory failure; The lowest level of platelets: 60,000 / ul; vomiting; laryngospasm, laryngeal edema; allergic reaction: laryngospasm; laryngospasm, laryngeal edema; allergic reaction: laryngospasm; laryngospasm, laryngeal edema; allergic reaction: laryngospasm; This is a spontaneous report received from a contactable physician downloaded from the WEB. The regulatory authority report number is PL-URPL-3-779-2021. A 93-year-old female patient received bnt162b2 (COMIRNATY, (Batch/Lot Number: FD0932; Expiration Date: 29Jun2021), first dose intramuscular, administered in Arm Left on 05Jun2021 14:39 at the age of 93-year-old as single dose for covid-19 immunization. Medical history included narrowing of the respiratory tract and goitre of the thyroid gland both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced the lowest level of platelets: 60,000 / ul, vomiting, laryngeal edema; allergic reaction: laryngospasm all on 06Jun2021 07:30. The PL-URPL-3-779-2021 report was sent 07Jun2021 from the district sanitary and epidemiological station. A female patient, given on 05Jun2021 at 14:39 vaccine: Comirnaty, first dose, left arm. The following side effects are marked on the form: allergic reaction (laryngospasm), vomiting. Thrombocytopenia, respiratory failure, laryngospasm, laryngeal edema, the patient with multiple diseases including narrowing of the respiratory tract (goitre of the thyroid gland). The patient died despite the treatment on 06Jun2021. At 9.50 am. The lowest level of platelets: 60,000 /ul. In the past, the patient did not develop any post-vaccination reactions. The reporting person classified them as serious. Due to the assessment of the reporting person, the nature of the side effects and the patient''s death, classified the report as "serious". Health result: death (date: 06Jun2021, 09:50)). The patient underwent lab tests and procedures which included platelet count: 60000 /ul on 06Jun2021. The patient died on 06Jun2021. It was not reported if an autopsy was performed. Sender''s comments: Comirnaty is an mRNA vaccine against COVID-19 (with modified nucleosides). Vomiting is an expected side effect following vaccination with Comirnaty. Laryngospasm (allergic reaction) is not included in the Comirnaty Summary of product characteristics, however hypersensitivity reactions are expected. Thrombocytopenia is not an expected effect. However, there are scientific reports of observed thrombocytopenia after vaccination with anti covid-19 mRNA vaccines (bibliography). The reporting person classified them as serious. Due to the assessment of the reporting person, the nature of the side effects and the patient''s death, classified the report as "serious". There is no additional information in the notification (medications used, allergies, etc.). requested additional information by e-mail to the relevant sanitary and epidemiological station. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: The lowest level of platelets: 60,000 / ul; vomiting; Allergic reaction; laryngeal edema; laryngospasm; respiratory failure


VAERS ID: 1480369 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021824166

Write-up: Respiratory failure; Dyspnea; Malaise; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number PL-URPL-3-782-2021. A 98-year-old male patient received the first dose of BNT162B2 (COMIRNATY), intramuscular, administered in left arm on 17Mar2021 14:15 (Batch/Lot Number: ET3674; Expiration Date: 31Jul2021) at the age of 98 years old, at 0.3 mL single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 25Mar2021 at 01:11am, patient was feeling worse with dyspnea and malaise. He was hospitalized from 01Apr2021 to 03Apr2021. On 06Apr2021, patient had respiratory failure and was again hospitalized on the same day. The reporter assessed the events as medically significant. The patient died on 07Apr2021 due to respiratory failure, dyspnea, and malaise. It was not reported if an autopsy was performed. Additional information: No post-vaccination reaction in patient''s history. The reporting person classified it as severe. Regulatory Authority in consideration of the reporter''s assessment. The Regulatory Authority, based on the reporter''s assessment, the nature of the adverse reaction, the hospitalization, and the patient''s death, Regulatory Authority classified the report as "severe." Health outcome: death. (Date: 07Apr2021). The data contained in the electronic report were all the data available to Regulatory Authority. In case of obtaining additional information, another version will be sent. Sender''s comment: Comirnaty is an mRNA vaccine against COVID-19 (with modified nucleosides) Feeling worse is an expected adverse reactions to Comirnaty (in the other adverse reactions include those listed under the term "malaise" in the Summary of Product Characteristics. The other side effects are unexpected. Up to 23Jun2021 in the Regulatory Authority database, with the outcome Patient Death, there are 319 cases of dyspnoea and 94 respiratory failure after administration of Comirnaty. Regulatory Authority is not aware of any additional circumstances (medications, chronic diseases, allergies, etc.). Regulatory Authority asked by e-mail to the appropriate district sanitary-epidemiological station with a request for additional information. The temporal relationship speaks for a cause and effect relationship. The person making the report classified it as severe. Regulatory Authority due to assessment of the reporting person, the nature of the adverse reaction, the hospitalization, and the death of the patient The Regulatory Authority classified the report as "severe". No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Respiratory failure; Dyspnea; Malaise


VAERS ID: 1480370 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-10
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   Days after onset: 4
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: Chronic ischemic heart disease, unspecified; Essential hypertension; Obesity; Overweight; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: Body temperature; Result Unstructured Data: Test Result:38.0-38.4; Test Date: 20210315; Test Name: COVID-19 antigen test; Result Unstructured Data: Test Result:Positive
CDC Split Type: PLPFIZER INC2021857864

Write-up: Drug ineffective; SARS-CoV-2 infection; Fever (38.0-38.4 longer); Dyspnea; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number PL-URPL-3-789-2021. A 50-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EP2166; Expiration Date: 28Feb2021), via intramuscular route of administration, administered in left arm on 24Feb2021 at 21:45 (at the age of 50-years-old) as dose 1, 0.3ml single for COVID-19 immunisation. Medical history included obesity and overweight, type 2 diabetes mellitus, essential hypertension, chronic ischemic heart disease (unspecified); all from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 10Mar2021 (2-weeks after first dose), the patient had symptoms of dyspnea, fever (38.0-38.4 longer) and had SARS-CoV-2 infection. The events resulted in emergency room where rapid antigen test performed and death in the course of COVID-19 infection was confirmed. The events were serious (fatal and medically significant). It was confirmed that the death of the patient due to increased dyspnoea on 15Mar2021. The physician stated that the patient was infected with COVID-19, 2-weeks after the administration of the 1st dose, so the infection could have occurred when the patient had not yet developed immunity after vaccination. The disease occurred in the time coincidence until vaccination and there was a time relationship between vaccination and the occurrence of side effects. The patient underwent lab tests which included body temperature: 38.0-38.4 (units unspecified) on 10Mar2021, SARS-CoV-2 test: Positive (COVID-19 antigen test) on 15Mar2021. The patient was treated for other comorbidities: E11, I25, E66, I10 (as reported). Therapeutic measures were taken for events (unspecified). The patient died due to increased dypnoea on 15Mar2021. The patient family and the doctor had not asked for an autopsy. An autopsy was not performed. The person reporting vaccination undesirable reaction qualified it as severe. Regulatory Authority assessed the vaccination undesirable reaction as severe (death). The relatedness of drug to reaction(s)/event(s) was assessed as unlikely with Regulatory Authority as source of assessment done with WHO method of assessment. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: increased dyspnoea


VAERS ID: 1480372 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002333 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Dyspnoea, Erythema, Haemoptysis, Localised oedema
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   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:
CDC Split Type: PLMODERNATX, INC.MOD20212

Write-up: cough (blood in the discharge); redness and swelling in the abdominal area; dyspnoea; redness and swelling in the abdominal area; cough (blood in the discharge); This regulatory authority case was reported by a consumer and describes the occurrence of HAEMOPTYSIS (cough (blood in the secretion)), LOCALIZED OEDEMA (redness and swelling in the abdominal area), DYSPNOEA (shortness of breath), ERYTHEMA (redness and swelling in the abdominal area ) and COUGH (cough (blood in the secretion))in an elderly male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002333) for COVID-19 vaccination. No Medical History information was reported. On 12-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced HAEMOPTYSIS (cough (blood in the secretion)) (seriousness criterion death), LOCALISED OEDEMA (redness and swelling in the abdominal cavity) (seriousness criterion death), DYSPNOEA (dyspnoea) (seriousness criterion death), ERYTHEMA (redness and swelling in the cavity area abdominal) (seriousness criterion death) and COUGH (cough (blood in the discharge))(seriousness criterion death). The patient died on 14-May-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No concomitant medications were reported. No treatment information was provided. Company Comment Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1480373 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7015 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Diarrhoea, Dyspnoea, Heart rate, Heart rate increased, Lymphadenopathy, Nausea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: pulse; Result Unstructured Data: Test Result:very high
CDC Split Type: PLPFIZER INC2021804247

Write-up: dyspnoea; Enlargement of lymph nodes; Nausea; heart arrhythmia; Diarrhea; very high pulse; Fever; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB PL-URPL-DML-MLP.4401.2.408.2021 A 75-years-old male patient received bnt162b2 (COMIRNATY), at the age of 75-years-old intramuscular on 06May2021 (Batch/Lot Number: EY7015) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced dyspnoea, enlargement of lymph nodes, nausea, heart arrhythmia, diarrhea, very high pulse, fever on 10May2021 08:35. The patient was hospitalized for 14 days. The outcome was fatal. The patient died in May2021. It was not reported if an autopsy was performed. The person making the report indicated the criterion of severe reporting - death and hospitalization. Sender comments: The reporting person entered the incomplete name of the Pfizer vaccine in the reporting form. Taking into account the time of vaccination (pandemic period) and the data contained in the notification, Regulatory Authority assumed that the notification concerns the Comirnaty vaccine. Nausea, diarrhea, lymphadenopathy, pyrexia possibly accompanied by tachycardia are expected side effects of Comirnaty. Due to the time from vaccination to the onset of symptoms and additional disorders such as dyspnoea and arrhythmia (unexpected side effects) and insufficient information (including no information on diagnosis during hospitalization and the patient''s health status before vaccination), the relationship has not been established. cause and effect. There is a time relationship between the administration of the vaccine and the appearance of symptoms. The person making the report indicated the severe reporting criterion - death and hospitalization. Regulatory Authority classified the application as heavy. Relatedness of drug to reaction(s)/event(s) Source of assessment: Regulatory Authority expert Method of assessment: WHO system for standardised case causality assessment Result of Assessment: Unassessable/Unclassifiable Batch/lot number: EY7015 No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: dyspnoea; enlargement of lymph nodes; nausea; heart arrhythmia; diarrhea; very high pulse; fever


VAERS ID: 1480374 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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: TRITTICO
Current Illness: Insomnia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20212

Write-up: Suspicion of pulmonary embolism; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Suspicion of pulmonary embolism) and HEADACHE (Headache) in a 28-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Insomnia. Concomitant products included TRAZODONE HYDROCHLORIDE (TRITTICO) for Insomnia. On 26-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-Jun-2021 at 1:00 AM, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced HEADACHE (Headache) (seriousness criterion death). On 04-Jun-2021 at 11:33 AM, the patient experienced PULMONARY EMBOLISM (Suspicion of pulmonary embolism) (seriousness criteria death and medically significant). The patient died on 04-Jun-2021. The reported cause of death was suspicion of pulmonary embolism. An autopsy was not performed. No Treatment information was provided. This is a case of sudden death in a 28-year-old male subject, who died 9 days after receiving first dose of vaccine, cause of death was not specified, an autopsy was not performed, Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 28-year-old male subject,who died 9 days after receiving first dose of vaccine, cause of death was not specified an autopsy was not performed, Very limited information has been provided at this time.; Reported Cause(s) of Death: Suspicion of pulmonary embolism


VAERS ID: 1480396 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-06-15
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Cardiac failure, Enzyme level abnormal, Enzyme level test, Head injury, Hypoxia, International normalised ratio, International normalised ratio increased, Osteoarthritis, Platelet count, Platelet count abnormal, Pneumonia aspiration
SMQs:, Cardiac failure (narrow), Liver-related coagulation and bleeding disturbances (narrow), Asthma/bronchospasm (broad), Haematopoietic thrombocytopenia (broad), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMIODARONE; PANTOPRAZOLE; ATORVASTATIN; ENTRESTO; LASIX [FUROSEMIDE]; BISOPROLOL; ALPRAZOLAM; TAMSULOSIN; POTASSIUM CHLORIDE; VARFINE; ZYLORIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker user (Cardiac patient, underwent surgery in 1993. Patient with pacemaker.); Comments: Heart patient, underwent surgery in 1993. Pacemaker patient
Allergies:
Diagnostic Lab Data: Test Name: enzyme; Result Unstructured Data: Test Result:abnormal values; Test Name: INR; Result Unstructured Data: Test Result:10.21; Test Name: INR; Result Unstructured Data: Test Result:3.7; Test Name: INR; Result Unstructured Data: Test Result:1.8; Test Name: INR; Result Unstructured Data: Test Result:5.39; Test Name: platelets; Result Unstructured Data: Test Result:abnormal values
CDC Split Type: PTPFIZER INC2021817975

Write-up: aspiration pneumonia / very intense tiredness/ expectoration/ many breathing difficulties; lost his balance and cut his head; lost his balance and cut his head; hypoxia; INR value of 10.21; abnormal platelet; abnormal enzyme levels; arthrosis / disabling hip pain; heart failure; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, Safety Report Unique Identifier PT-INFARMED-B202106-2207. A 79-year-old male patient received the second dose of BNT162B2 (COMIRNATY), intramuscularly on 08Apr2021 at single dose (0.3 ML) for COVID-19 immunisation. Medical history included artificial cardiac pacemaker user (cardiac patient, underwent surgery in 1993. Patient with pacemaker). Concomitant medications included amiodarone, pantoprazole, atorvastatin, sacubitril valsartan sodium hydrate (ENTRESTO), furosemide (LASIX), bisoprolol, alprazolam, tamsulosin, potassium chloride, warfarin sodium (VARFINE), allopurinol (ZYLORIC). Patient previously received the first dose of BNT162B2 (COMIRNATY) on 11Mar2021 for COVID-19 immunisation. The patient experienced heart failure on 15Jun2021, and aspiration pneumonia/very intense tiredness/expectoration/many breathing difficulties, and arthrosis/disabling hip pain on an unspecified date. The cause of death was heart failure. Patient would have hypoxia, abnormal platelet and enzyme levels and that he had suffered from aspiration pneumonia. The patient had a pacemaker for about 28 years. As a clinical history, it was necessary to adjust the dosage of warfarin sodium (VARFINE), with weekly analyzes to control the international normalised ratio (INR), approximately two months before the patient''s death (that was, in the month in which the second dose of the vaccine; it was not specified whether before or after the second dose); in the following month, the patient started to feel disabling pain in the hips (he stopped leaving the house because he had great difficulty walking), with a diagnosis of arthrosis; at the end of that month, there was an INR value of 10.21 seconds; later, the patient became unbalanced and had a cut on his head, having been hospitalized for about 24 hours, with an INR of 3.7 at discharge (as indicated by the general practitioner, he did not take warfarin sodium in the following days); about 3 days after hospital discharge, he had an INR of 1.8; started taking half a tablet of warfarin sodium and there was an INR value of 5.39 about 5 days later; throughout this process, the patient began to lose mobility, began to feel very tired, presented with sputum and many difficulties in breathing; the patient was eventually transported to hospital, remaining in the OR for 2 days and then transferred to hospital, where he remained for 4 days until he died. No adverse drug reactions or known allergies were reported. The patient would never have been diagnosed with COVID-19. The patient died on 15Jun2021. Outcome of events heart failure, and aspiration pneumonia/very intense tiredness/expectoration/many breathing difficulties was fatal, and of other events was unknown. An autopsy was not performed. No follow-up attempts needed. No further information expected.; Reported Cause(s) of Death: aspiration pneumonia / very intense tiredness/ expectoration/ many breathing difficulties; heart failure


VAERS ID: 1480488 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-06-16
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Heart rate, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FILOTEMPO; TAMSULOSIN; RAMIPRIL; BUDESONIDE; UMECLIDINIUM BROMIDE;VILANTEROL; CARVEDILOL; FUROSEMIDE; ROSUVASTATIN; ALLOPURINOL; ACETYLSALICYLIC ACID; ESOMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: B-cell small lymphocytic lymphoma (with clinical stability.); Benign prostatic hyperplasia; Chronic respiratory failure; Dyslipidemia; Fibrillation atrial; Interstitial lung disease; Comments: It is unknown if there is a history of COVID-19 infection prior to vaccination
Allergies:
Diagnostic Lab Data: Test Date: 20210612; Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: 38,8?C Iu international unit(s); Test Date: 20210612; Test Name: Heart rate; Test Result: Inconclusive ; Result Unstructured Data: 110bpm Iu international unit(s); Test Date: 20210612; Test Name: Oxygen saturation; Test Result: Inconclusive ; Result Unstructured Data: 93% Iu international unit(s); Test Date: 20210616; Test Name: SARS-CoV-2 test; Result Unstructured Data: unknown
CDC Split Type: PTMODERNATX, INC.MOD20212

Write-up: Severe SARS-CoV-2 pneumonia; This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Severe SARS-CoV-2 pneumonia) in an 88-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001650 and 3001414) for COVID-19 vaccination. It is unknown whether there is a history of COVID-19 infection prior to vaccination. The patient''s past medical history included Interstitial lung disease, Fibrillation atrial, Dyslipidemia, B-cell small lymphocytic lymphoma (with clinical stability.), Benign prostatic hyperplasia and Chronic respiratory failure. Concomitant products included AMINOPHYLLINE (FILOTEMPO), TAMSULOSIN, RAMIPRIL, BUDESONIDE, UMECLIDINIUM BROMIDE;VILANTEROL, CARVEDILOL, FUROSEMIDE, ROSUVASTATIN, ALLOPURINOL, ACETYLSALICYLIC ACID and ESOMEPRAZOLE for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) 1 milliliter. On 19-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) dosage was changed to 1 milligram. On 16-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VACCINATION FAILURE (Severe SARS-CoV-2 pneumonia) (seriousness criteria death, hospitalization prolonged and life threatening). The patient died on 21-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jun-2021, Body temperature: 38.8 (Inconclusive) 38,8?C Iu international unit(s). On 12-Jun-2021, Heart rate: 110 (Inconclusive) 110bpm Iu international unit(s). On 12-Jun-2021, Oxygen saturation: 93% (Inconclusive) 93% Iu international unit(s). On 16-Jun-2021, SARS-CoV-2 test: unknown unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral), the reporter did not provide any causality assessments. No treatment information is provided. Previous history of COVID-19 infection prior to vaccination was unknown. Action taken with mRNA-1273 in response to the events were not applicable This fatal case concerns a 88-year-old male hospitalized with a serious unexpected event of severe SARS-CoV-2 pneumonia (vaccination failure). Event onset 59 days after second dose mRNA-1273. Event outcome death. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Translation document received on 06-JUL-2021, Other Relevant History updated, Concomitant medication (Filotempo-extended released tablet) added, Reporter''s comment updated.; Sender''s Comments: This fatal case concerns a 88-year-old male hospitalized with a serious unexpected event of severe SARS-CoV-2 pneumonia (vaccination failure). Event onset 59 days after second dose mRNA-1273. Event outcome death. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1480539 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-09
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SAPFIZER INC2021843595

Write-up: 2 days ago, one person died from Corona and he was immune; This is a spontaneous report from a from a non-contactable Physician via Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced 2 days ago (09May2021), one person died from corona and he was immune 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. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event Death and the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : SA-PFIZER INC-2021546178 Similar (Reporter, Product) different (Patient, Event); Reported Cause(s) of Death: 2 days ago, one person died from Corona and he was immune


VAERS ID: 1480696 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: Septic shock; D?DSFALL; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (D?DSFALL) and SEPTIC SHOCK (Septic shock) in an 86-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEPTIC SHOCK (Septic shock) (seriousness criteria death and medically significant). The patient died in May 2021. The reported cause of death was Septic shock. It is unknown if an autopsy was performed. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Company comment: Very limited information regarding the event has been provided.; Sender''s Comments: Very Limited information regarding the event has been provided.; Reported Cause(s) of Death: Septic shock


VAERS ID: 1480712 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 RA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]
Current Illness: Hypertension; Overweight
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021812661

Write-up: Felt all possible side effects resulting in death of the patient; Patient received the 2nd dose of BNT162B2 43 days after the 1st dose on 11May2021; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received BNT162B2 (COMIRNATY; solution for injection; lot number: FD4555), via an unspecified route of administration, administered in the right arm on 23Jun2021 13:15 (at the age of 50-years-old) as dose 2, single for COVID-19 immunization. Medical history included ongoing overweight, ongoing high blood pressure, and problems with atrial fibrillation from approximately 2016 (approximately 5 years ago). It was reported that the patient had no allergies (patient did not told the reporter of any allergies). Concomitant medications included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), and an unspecified blood pressure medication. The patient previously received BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in the right arm on 11May2021 13:15 (lot number: EX6537) as dose 1, single for COVID-19 immunization. On 23Jun2021, the patient received the 2nd dose of BNT162B2 43 days after the 1st dose on 11May2021. It was reported that the patient described in a post on Social Media that he felt all possible side effects on 23Jun2021 20:45, resulting in death of the patient. The patient took antipyretics to treat the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine, was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post-vaccination. The patient died due to unknown cause on 24Jun2021. An autopsy was not performed (awaiting autopsy). Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Felt all possible side effects resulting in death of the patient


VAERS ID: 1480752 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Laryngeal oedema, Myocardial infarction
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Myocardial infarction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZER INC2021824953

Write-up: myocardial infarction; Anaphylaxis; laryngeal edema; This is a spontaneous report received from a contactable physician based on information received by Pfizer from Biontech manufacturer control number 70351, license party for BNT162B2. A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at age of 46 years on 18Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced myocardial infarction, anaphylaxis, laryngeal edema, all on 18Jun2021. Clinical details indicated the patient returned to the hospital when got "stuck" on the road while returning home by car following the 1st dose vaccination with Pfizer-BioNTech COVID-19 on Friday, 18Jun2021. Patient came to the hospital with a preliminary diagnosis of anaphylaxis and laryngeal edema and died. Myocardial infarction was stated as the official cause of death. The outcome of event myocardial infarction was fatal, of other events was not recovered. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1483692 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-06
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronavirus test, Coronavirus test positive, Cough, Death, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: coronavirus test; Test Result: Positive
CDC Split Type: ZAPFIZER INC2021729339

Write-up: Shortness of breath; Coughing; coronavirus test: positive; patient died; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Jun2021 (Batch/Lot number and Expiration date were unknown), dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was reported to have started coughing 4 days after receiving the vaccine on 06Jun2021 and started having shortness of breath on 10Jun2021. The patient was hospitalized for coughing and shortness of breath from 10Jun2021 to an unknown date. The lab test on an unspecified date included coronavirus test: positive. The patient was reported to have died on the early hours of 18Jun2021. Therapeutic measures were taken as a result of shortness of breath, which was not specified. The patient was not recovered from coughing and shortness of breath, while the outcome of the event "coronavirus test: positive" was unknown. The patient died on 18Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: patient died


VAERS ID: 1483697 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, COVID-19, Cardiac arrest, Death, Fall, Haemoglobin, Haemoglobin decreased, Nasopharyngitis, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (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), Accidents and injuries (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Herpes zoster
Allergies:
Diagnostic Lab Data: Test Date: 20210619; Test Name: blood pressure; Result Unstructured Data: Test Result:started getting low; Test Name: haemoglobin; Result Unstructured Data: Test Result:7.5; Test Name: oxygen level; Test Result: 92 %; Test Date: 20210619; Test Name: Covid PCR test; Test Result: Positive
CDC Split Type: ZAPFIZER INC2021802503

Write-up: Collapsed; Passed away; Heart stopped for 12 minutes; Oxygen level 92%.; Low haemoglobin 7.5; Blood pressure started getting low; COVID PCR test was positive; Cold symptoms; This is a spontaneous report from a contactable consumer. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Jun2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included diabetes mellitus, herpes zoster. The patient''s concomitant medications were not reported. On 15Jun2021, the patient experienced cold symptoms, COVID PCR test was positive on 19Jun2021, the patient collapsed on 19Jun2021 5am, oxygen level 92%, low haemoglobin 7.5, heart stopped for 12 minutes, blood pressure started getting low on 23Jun2021. The patient passed away on 25Jun2021. It was not reported if an autopsy was performed. The outcome of event passed away was fatal, outcome of events was unknown.; Reported Cause(s) of Death: Passed away


VAERS ID: 1483700 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: tested positive for Covid-19; Test Result: Positive
CDC Split Type: ZAPFIZER INC2021814933

Write-up: He passed away this morning; Breathing difficulties; Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer. A male patient over 60-year-old received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 on 07Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. Medical history included an unspecified heart condition. The patient''s concomitant medications were not reported. On an unspecified date in Jun2021, the patient experienced breathing difficulties and tested positive for COVID-19; passed away on 30Jun2021. The patient was hospitalized due to these events. The patient died on 30Jun2021 due to COVID-19 related complications. It was unknown if an autopsy was performed, the official cause of death has not yet been confirmed. Information on the batch number has been requested.; Reported Cause(s) of Death: Passed away today of COVID-19 related complications


VAERS ID: 1483704 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-30
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Fatigue, Illness, Immobile, Malaise, Myalgia, Oxygen saturation decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (controlled)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021829935

Write-up: oxygen levels low; Rendered immobile; Coughing; sickness; Fatigue; Myalgia; Fell ill; Deceased; This is a spontaneous report from a contactable consumer or other non hcp. An 80-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient''s medical history included controlled hypertension. The patient''s concomitant medications were not reported. On an unknown date, the patient experienced fell ill, myalgia, fatigue, rendered immobile, oxygen levels low, coughing. The patient was hospitalized on an unspecified date due to the events. On 30Jun2021, the patient deceased. It was not reported if an autopsy was performed. The outcome of the event deceased was fatal and rest all other events was unknown. No further information was available at the time of this report.; Reported Cause(s) of Death: Deceased


VAERS ID: 1483707 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-16
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Pneumonia, SARS-CoV-2 test
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type 2 diabetes mellitus (on Metformin)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:positive
CDC Split Type: ZAPFIZER INC2021830883

Write-up: Covid 19 positive; Pneumonia; Death; This is a spontaneous report from a contactable other hcp. A 78-year-old male patient received first dose of BNT162b2 (COMIRNATY; Solution for injection; batch/lot number: FA5715; Expiration Date: Aug2021) administration on 01Jun2021 at 11:31 (at the age of 78-year-old) as single dose for COVID-19 immunization. The diluent batch number L19450; exp date May2023. The vaccine was reconstituted on 01Jun2021. Medical history included type 2 diabetes mellitus. Concomitant medication(s) included metformin (METFORMIN) taken for type 2 diabetes mellitus started on an unspecified date. On 11Jun2021, the patient experienced cough, shortness of breath, dizziness, loss of appetite. The patient tested positive for Covid-19 (COVID-19 virus test positive) on an unspecified date and was diagnosed with Pneumonia on an unspecified date. The patient was hospitalized on 15Jun2021. The patient died (death) on 16Jun2021. The autopsy was not done. Death is reported to be Natural cause. Outcome of the events cough, shortness of breath, dizziness, loss of appetite, COVID-19, pneumonia was unknown and for death was fatal. No further information was available at the time of this report.; Sender''s Comments: Based on the available information and known product profile, the causal relationship between the reported events Covid-19, Pneumonia and Death and the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Natural death


VAERS ID: 1484210 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 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: 2021-07-02
   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: Cardiac failure chronic; Eisenmenger''s syndrome (diagnosed with Eisenmenger''s syndrome associated with ventricular septal defect); End stage cardiac failure; Multiple cerebral infarction; Ventricular septal defect (diagnosed with Eisenmenger''s syndrome associated with ventricular septal defect)
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021831432

Write-up: Respiratory arrest; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21117502. The patient was a 78-year and 2-month-old female. Body temperature before vaccination was 37.1 degrees Centigrade on 01Jul2021. Medical history included follows: cardiac failure chronic, end stage cardiac failure, ventricular septal defect and Eisenmenger''s syndrome. In 2007, the patient was diagnosed with Eisenmenger''s syndrome associated with ventricular septal defect. Afterwards, she had cardiac failure chronic. In Apr2021, multiple cerebral infarction occurred. Family history was not provided. On 10Jun2021, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as a single dose (at the age of a 78-year-old) for COVID-19 immunization. On 01Jul2021 at 16:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FC3661, Expiration date 30Sep2021) (at the age of a 78-year-old) an unspecified route of administration as a single dose for COVID-19 immunization. On 02Jul2021 at 14:45 (1 day after the vaccination), the patient suddenly developed respiratory arrest and the patient''s death was confirmed. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Acute cardiac failure and cerebral infarction were considered as possible causes of the event. The reporting physician commented as follows: The patient had suffered end stage cardiac failure. Therefore, it was highly likely to consider that acute cardiac failure occurred which resulted in sudden death. ; Reported Cause(s) of Death: Acute cardiac failure; cerebral infarction; Respiratory arrest


VAERS ID: 1484301 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-12
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002339 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of COMPLETED SUICIDE in a 43-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002339) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced COMPLETED SUICIDE (seriousness criteria death and medically significant). The patient died on 12-Jun-2021. The reported cause of death was Suicide. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Suicide


VAERS ID: 1484325 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-12
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRJNJFOC20210732004

Write-up: SHORTNESS OF BREATH; ADVERSE REACTION TO THE VACCINE; This spontaneous report received from a consumer via a company representative concerned a 36 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on 12-JUL-2021 14:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-JUL-2021 (four hours after vaccination) at 18:00, the patient was hospitalized with shortness of breath, and some other unspecified symptoms and died on the same day due to unspecified adverse reaction to the vaccine. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of adverse reaction to the vaccine and shortness of breath on 12-JUL-2021. This report was serious (Death).; Sender''s Comments: V0: 20210732004-covid-19 vaccine ad26.cov2.s- Shortness of breath, adverse reaction to the vaccine. 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: ADVERSE REACTION TO THE VACCINE


VAERS ID: 1484336 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: variant
CDC Split Type: CAPFIZER INC2021846052

Write-up: COVID-19/variant/positive have very mild symptoms/one death has been reported; COVID-19/variant/positive have very mild symptoms/one death has been reported; This is a spontaneous report from two contactable healthcare professionals. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), dose 1, single and dose 2, single, both received via an unspecified route of administration on unspecified dates for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced COVID-19 on an unspecified date. The reporter stated that there was an outbreak of the variant after 2 doses of BNT162B2 was received. All residents were positive and have very mild symptoms although one death has been reported. The patient underwent a COVID-19 virus test on an unspecified date with the following result: positive (variant). The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . 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.,Linked Report(s) : CA-PFIZER INC-2021846051 Same reporter and drug, similar events, different patients; Reported Cause(s) of Death: COVID-19/variant/positive have very mild symptoms/one death has been reported; COVID-19/variant/positive have very mild symptoms/one death has been reported


VAERS ID: 1484362 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-21
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Coagulopathy
SMQs:, Haemorrhage laboratory terms (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   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: Coagulation factor V level abnormal
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of COAGULOPATHY in a 74-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Coagulation factor V level abnormal. On 07-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced COAGULOPATHY (seriousness criterion death). The patient died on 21-Apr-2021. The reported cause of death was Coagulation disorder. An autopsy was not performed. No concomitant medications were reported. No treatment information was reported by reporter. This is a case of sudden death in a 74-year-old female patient with a history of coagulation factor V level abnormal, who died of coagulation disorder 15 days after receiving a dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 74-year-old female patient with a history of coagulation factor V level abnormal, who died of coagulation disorder 15 days after receiving a dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Coagulation disorder


VAERS ID: 1484439 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-16
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Gynaecological examination, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: Pelvic exam; Result Unstructured Data: Test Result:Unknown result; Test Name: ultrasound; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: GBPFIZER INC2021843391

Write-up: inappropriate schedule of vaccine administered; Miscarriage; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the WEB, regulatory authority number GB-MHRA-WEBCOVID-202106281712381910-YY26L. Safety Report Unique Identifier is GB-MHRA-ADR 25556359. A 30-year-old female patient (non-pregnant and not currently breastfeeding) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 29Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. Patient relevant medical history included pregnancy, Patient no longer pregnant at the time of reporting, abortion spontaneous, Folic acid supplementation. The patient concomitant medication(s) included folic acid, 400 ug taken for Folic acid supplementation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. The patient was unsure, medicine have an adverse effect on any aspect of the pregnancy. Patient has not tested positive for COVID-19 since having the vaccine. The patient previously received first dose of BNT162B2 (Lot Number: Not Known) on 18Feb2021 for COVID-19 immunisation with reaction of prolonged periods. It was reported on 16May2021, the patient experienced miscarriage. On an unspecified date, maternal exposure during pregnancy. Prolonged and irregular periods after 1st vaccine ($g3 in 1 month). ongoing investigations. Unknown very early pregnancy after second vaccine. Miscarriage at 5.5 weeks. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab tests and procedures which included pelvic exam was unknown result, ultrasound scan was unknown result. The patient died on 16May2021. It was not reported if an autopsy was performed. Suspect Reactions. Please provide details of any relevant investigations or tests conducted: "Pelvic ex-am and referral for pelvic ultrasound for irreg periods. NAD " No follow up required. Information about Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: Miscarriage


VAERS ID: 1485721 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Computerised tomogram, Fall, Haemorrhage, Herpes zoster
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: CT scan of the whole body; Result Unstructured Data: Test Result:unknown results; Comments: Based on the result of CT scan of the whole body, it was assumed that he fell due to excessive haemorrhage
CDC Split Type: JPPFIZER INC2021830869

Write-up: fell down the stairs; herpes zoster; abdominal pain; Haemorrhage; This is a spontaneous report from a contactable physician received via the Agency. The patient was a 76-year-old male. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included hypertension. On 11Jun2021 at 10:00 (the day of vaccination, 76-year-old at vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration in the left arm for COVID-19 immunization. On 12Jun2021 (1 day after the vaccination), herpes zoster and haemorrhage occurred. On 01Jul2021 (20 days after the vaccination), the patient died of haemorrhage. The event resulted in clinic visit/death. The outcome of the event was fatal. The patient received the treatment for hypertension which the patient had suffered from before herpes zoster occurred. It was unknown if the patient has not been tested for COVID-19 since the vaccination. The course of the events according to the patient''s wife was as follows: On 12Jun2021 (1 day after the vaccination), the patient had abdominal pain. The test result showed the presence of herpes zoster. On 01Jul2021, the patient visited a different hospital for the treatment hypertension etc. He fell down the stairs and died. Based on the result of CT scan of the whole body, it was assumed that he fell due to excessive haemorrhage. (The patient was supposed to receive the second dose of the vaccination on 02Jul2021.) The causality assessment was not provided. The outcome of event haemorrhage was fatal and of other events was unknown. It was unknown if an autopsy was performed.; Sender''s Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of haemorrhage due to close temporal relationship and lack of other obvious cause. The fall was due to excessive haemorrhage. 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: Haemorrhage


VAERS ID: 1485725 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 LA / -

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

Life Threatening? Yes
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OLANZAPINE; ETODOLAC; MEMARY; MGO; YOKUKANSAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021831132

Write-up: She took three big breaths and stopped breathing; She complained severe pain in her back; This is a spontaneous report from a consumer, her family or other non-healthcare professional (HCP) via COVID-19 Adverse Event Self-Reporting Solution and from the Agency Regulatory Authority. Regulatory authority report number is v21118864. A non-pregnant 83-year-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot number EY5423, Expiration date 31Aug2021) via an unspecified route of administration, administered in left arm on 02Jul2021 13:45 (the day of vaccination) as dose 2, single for COVID-19 immunisation. The most recent COVID-19 vaccine was administered at the hospitality. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included olanzapine, etodolac, memantine hydrochloride (MEMARY), magnesium oxide (MGO), angelica acutiloba root, atractylodes lancea rhizome, bupleurum falcatum root, cnidium officinale rhizome, glycyrrhiza spp. root, poria cocos sclerotium, uncaria spp. hook (YOKUKANSAN). There was no relevant past drug history. There were no known allergies. Other medical history included dementia and osteoporosis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 11Jun2021 at 14:00, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Lot number EY5423, Expiration date 31Aug2021) via an unspecified route of administration in the left arm for COVID-19 immunisation. On 02Jul2021, she complained severe pain in her back at 15:20 (1 hour and 35 minutes after the vaccination) and took three big breaths and stopped breathing at 15:29 (1 hour and 44 minutes after the vaccination), and her death was noticed at 16:46 (3 hours and 1 minute after the vaccination). The course of the events was as follows: Just after 1.5 hours she had a corona vaccine. 3:20pm: She complained severe pain in her back, so her son laid down on the right side. 3:29pm: She took three big breaths and stopped breathing. 3:55pm: An ambulance arrived. 3:55pm: She arrived at University Hospital while having a cardiac massage. 4:46pm: Her death was noticed. The reporter stated that the adverse events resulted in emergency room/department or urgent care and life-threatening (risk for death due to the adverse events). The outcome of the event she complained severe pain in her back was not recovered with treatment including cardiac massage. The reporting consumer or other non-HCP assessed the events as serious (life-threatening). The causality of the events was not reported. The patient died on 02Jul2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: She took three big breaths and stopped breathing


VAERS ID: 1485731 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   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: PRAZAXA
Current Illness: Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Asphyxia; Aspiration; Respiratory arrest
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210704; Test Name: Vital signs; Result Unstructured Data: Test Result:no abnormal vital signs; Comments: at 15:35
CDC Split Type: JPPFIZER INC2021832047

Write-up: lethal arrhythmia; Cardio-respiratory arrest (anaphylaxis); Cardio-respiratory arrest (anaphylaxis); This is a spontaneous report from a contactable physician via Medical Information and from the Agency Regulatory Authority. Regulatory authority report number is v21117591. The patient was an 87-year and 6-month-old female. Body temperature before vaccination was 36.2 degrees centigrade. Family history was not reported. Medical history included prior aspiration, historical asphyxia due to aspiration, prior respiratory arrest of unknown cause, and admission to a group home for past medical history. Concomitant medications included dabigatran etexilate mesilate (PRAZAXA). On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported) for COVID-19 immunisation. On 04Jul2021 at 13:20 (the day of vaccination, at 87-year and 6-month-old), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC8736, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 04Jul2021 at 15:50 (2 hours and 30 minutes after the vaccination), the patient experienced cardio-respiratory arrest (anaphylaxis). On 04Jul2021 at 18:04 (4 hours and 44 minutes after the vaccination), the outcome of the events was fatal. Autopsy was done. The course of the events was as follows: The patient had background as mentioned above and was on follow-up at the reporting hospital as outpatient after admission to a group home. On 04Jul2021, the patient finished all her breakfast and lunch and had no pyrexia. Therefore, on 13:20, she received the BNT162b2 vaccination. Thereafter, she also ate all the snacks, and at 15:35, there were no abnormal vital signs. However, at 15:50 (2 hours and 30 minutes after the vaccination), the facility staff noticed her loss of consciousness and called an ambulance. Because of cardio-respiratory arrest, an intravenous route was secured, and cardiopulmonary resuscitation (CPR) with intravenous injection of adrenaline was performed. During these interventions, the patient was transported to Hospital with the reporter on the vehicle, but resuscitation was unsuccessful, and at 18:04 (4 hours and 44 minutes after the vaccination), she died. Although the reporting criteria was anaphylaxis because of the onset within 4 hours after the vaccination, the patient also had a past history of aspiration and respiratory arrest of unknown cause; the causal relationship was unknown according to the autopsy done by the Police, while the death cause recorded on the post-mortem certificate of the hospital was lethal arrhythmia. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause(s) of the events such as any other diseases included cardiac failure chronic and Alzheimer''s dementia (historical asphyxia due to aspiration).; Reported Cause(s) of Death: Cardio-respiratory arrest (anaphylaxis); Cardio-respiratory arrest (anaphylaxis); Lethal arrhythmia; Autopsy-determined Cause(s) of Death: Lethal arrhythmia


VAERS ID: 1485750 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / -

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

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: CILOSTAZOL; AMANTADINE; LINAGLIPTIN; METFORMIN; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic subdural haematoma; Diabetes mellitus; Subdural haematoma evacuation
Allergies:
Diagnostic Lab Data: Test Date: 20210625; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:132/82; Test Date: 20210624; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210625; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210625; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:92-94 %
CDC Split Type: JPPFIZER INC2021833472

Write-up: not breathing, sudden death of unidentifiable cause; Vomiting; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21118039. The patient was an 87-year-old female. Body temperature before vaccination was 36.5 degrees centigrade. Family history was not reported. Medical history included diabetes mellitus and surgery for chronic right subdural haematoma. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported). Concomitant medication included cilostazol, amantadine, linagliptin, metformin, and bisoprolol, all taken for unspecified indications, start and stop dates were not provided. On 24Jun2021 at 15:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 25Jun2021 at 10:00 (19 hours after the vaccination), the patient experienced vomiting. On 26Jun2021 at 07:10, the patient was found in the state of respiratory arrest/not breathing. On 26Jun2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient lived in a nursing home. On 24Jun2021 (Thursday), the patient received the second dose of the vaccine. The patient signed consent form on her own. Immediately after the vaccination, there was no abnormality. On 25Jun2021 (Friday) at 10:00, the patient vomited. In the evening, the patient vomited again. Blood pressure was 132/82, body temperature was 36.4 degrees centigrade, and oxygen saturation was 92-94%. On 26Jun2021 (Saturday) at 06:15, the patient talked with a staff and said that the patient was going to eat breakfast. At 07:10, when the patient was visited to be awakened, the patient was not breathing. A nurse at the facility was emergently called in and suction was conducted; however, nothing was suctioned. There was no foreign matter or vomitus in oral cavity. The course was explained to family member and autopsy imaging (AI) was recommended; however, family member did not request it, and examination was not conducted. The reporting physician classified the event as serious (medically significant) 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. The reporting physician commented as follows: On the following day of the vaccination, the patient vomited. On the following in the morning, the patient had no vomiting. Immediately after the patient expressed her will to eat breakfast, the patient experienced sudden death of unidentifiable cause. There were no findings suggestive of sudden cardiac death, intracranial lesion, or foreign matter in respiratory tract (asphyxia). Autopsy imaging was recommended but it was not requested and examination was not conducted; thus, the cause could not be identified. ; Reported Cause(s) of Death: sudden death of unidentifiable cause


VAERS ID: 1485770 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003190 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, 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: 2021-07-13
   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: CANDESARTAN CILEXETIL
Current Illness: Dyslipidaemia (Dyslipidemia (10 mg of atorvastatin calcium hydrate)); Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.5 degree celsius
CDC Split Type: JPTAKEDA2021TJP058475

Write-up: Subarachnoid hemorrhage; This spontaneous case was reported by a physician and describes the occurrence of SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) in a 53-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003190) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Dyslipidaemia (Dyslipidemia (10 mg of atorvastatin calcium hydrate)). Concomitant products included CANDESARTAN CILEXETIL for Hypertension. On 08-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) (seriousness criteria death and medically significant). The patient died on 13-Jul-2021. The reported cause of death was Subarachnoid haemorrhage. An autopsy was performed. The autopsy-determined cause of death was Subarachnoid haemorrhage. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 36.5 (Low) 36.5 degree celsius. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) to be possibly related. concomitant product included atorvastatin calcium hydrate. No treatment information was given. Very limited information regarding this event has been provided at this time. No further follow-up information is expected The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected; Reported Cause(s) of Death: Subarachnoid haemorrhage; Autopsy-determined Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1485869 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Cerebrovascular accident, Cough, Dementia, Scab, Visual impairment, Wound
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021838049

Write-up: Visual disturbances; Dementia; coughing while breathing; his mouth was full of wounds, his tongue and his mouth was full of scabs and live wounds; his mouth was full of wounds, his tongue and his mouth was full of scabs and live wounds; generalized atherosclerosis; vascular brain injury; This is a spontaneous report from a contactable consumer (reporting for the husband). This consumer reported different events for 2 vaccine doses. This is the second of 2 reports. A male patient of unspecified age received the second dose of BNT162B2 (COMIRNATY) via unspecified route of administration on an unspecified date as single dose 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) via unspecified route of administration on an unspecified date in May2021 as single dose for COVID-19 immunization and experienced knee pain. The patient experienced visual disturbances, dementia, vascular brain injury, and generalized atherosclerosis on unspecified date after the second dose. The events visual disturbances and dementia resulted to hospitalization while vascular brain injury and generalized atherosclerosis were fatal. Clinical course was reported as follows: At the beginning of May2021, the patient felt unwell after the first dose of the Pfizer vaccine. He had tremendous pain in his knees, making him unable to walk. Until that day, he had no health problems. After a few days, the pain subsided. When the patient received the second dose, it was reported that the patient suddenly went from being a healthy, intelligent person to a mentally ill person. The patient became delusional and told untold stories. He shouted out of the window that he was imprisoned in the house. He started defecating on the carpet. He also had visual disturbances. He suddenly became very aggressive towards the reporter and the reporter started to fear for the reporter''s life. The reporter called for an ambulance and took the patient to the hospital. For a month, the reporter called the attending physician and the nurses several times a day to get information about the patient''s condition. According to the information, the patient''s condition worsened every day. On several occasions, the reporter was asked to take the patient to a psychiatric hospital. The reporter described the patient as a very intelligent man and had never had any mental problems. The patient was given psychotropic medication. He was tied up because he was sometimes aggressive. Dementia was diagnosed. Per reporter''s opinion dementia takes years to develop and does not happen overnight. The day before the reporter was allowed to enter the hospital, the reporter was told that the patient had a 10 percent chance of survival. The doctor in-charge of the patient told the reporter that the patient was in an agonal condition. On unspecified date in Jun2021, the reporter was allowed to come in to visit the patient at the hospital. The reporter saw the patient lying, coughing while breathing, his mouth was full of wounds, his tongue and his mouth was full of scabs and live wounds. The patient did not respond to any of the reporter''s words or signals. When the reporter took the patient''s hand, he had an anxiety reflex along with a terrible facial grimace. The patient did not recognize the reporter. There was no contact with the patient at all. After the visit, the reporter received a phone call from the attending doctor, where during the conversation the doctor stated that the patient''s condition was most definitely a vaccine complication. The doctor said this with the kind of certainty that the reporter had been convincing him of since the patient''s month in hospital. It was the fault of the vaccine given. The reporter described the patient as a sober and healthy man. He also had no mental problems and declared that anyone could confirm this. The reporter added that the patient was killed by the second dose of the Pfizer vaccine. It was also reported that the patient was so afraid of the virus that he could not wait to be vaccinated to be safe and added "Unfortunately he was very wrong. It was the worst mistake we ever made in agreeing to this vaccination." It was reported that the hospital discharge card stated vascular brain injury as the secondary cause of death as the underlying cause generalized atherosclerosis. Outcome of visual disturbances and dementia was unknown while vascular brain injury and generalized atherosclerosis were fatal. It was not reported whether autopsy was performed.; Sender''s Comments: Linked Report(s) : PL-PFIZER INC-2021867179 same patient/drug (first dose), different events; Reported Cause(s) of Death: vascular brain injury as the secondary cause of death; underlying cause generalized atherosclerosis


VAERS ID: 1486381 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dependence on respirator, Suspected COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAJNJFOC20210724648

Write-up: PASSED AWAY; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; PATIENT PLACED ON VENTILATOR; This spontaneous report received from a consumer via a company representative concerned a 68 year old female of unspecified age. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, a month after receiving the vaccine, the patient contracted suspected covid-19 infection and suspected clinical vaccination failure. The patient was hospitalized on an unspecified date. On an unspecified date, the patient admitted to hospital, placed on a ventilator and passed away two days later. It was unknown, if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of passed away on an unspecified date, and the outcome of patient placed on ventilator, suspected covid-19 infection, suspected clinical vaccination failure and placed on ventilator was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening). This report was associated with product quality complaint: 90000185708 This case, from the same reporter is linked to 20210724671.; Sender''s Comments: V0: 20210724648-COVID-19 VACCINE AD26.COV2.S.- Passed away, Patient placed on ventilator, Suspected COVID-19 infection. This events is considered unassessable. The events 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 events. 20210724648-COVID-19 VACCINE AD26.COV2.S.- Suspected clinical vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1486384 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hyperkalaemia, Klebsiella sepsis, Renal failure, Urinary tract infection
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 (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
Permanent Disability? 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: Breast cancer; Chronic kidney disease; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021849445

Write-up: ESBL klebsiella septicaemia; UTI; Renal failure; Hyperkalemia; This is a spontaneous report from a contactable other hcp and a physician. A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 administration on 03Jun2021 (Batch/Lot number was not reported) as dose 1, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus, chronic kidney disease, hypertension, breast cancer. The patient''s concomitant medications were not reported. The patient had ESBL klebsiella septicemia, UTI, renal failureand hyperkalemia. The patient had ESBL klebsiella septicemia resulting from UTI and complicated by renal failure and hyperkalemia. The patient passed away (death) on 24Jun2021 09:50. The outcome of the events was fatal. It was not reported if an autopsy was performed. The exact source of the community-acquired ESBL is not clear as was intracerebral pathology (also considered relationship with previous breast cancer). The physician''s opinion is that there is no relationship between the vaccination and this event. No further information was provided at the time of this report.; Sender''s Comments: The unspecified age patient''s death is more likely related to the underlying serious disease unrelated to vaccine use; however, There is no information in the case suggesting a possible contribution of the Pfizer suspect product to the patient death, therefore the event does not meet reportability to Regulatory Authority. 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: UTI; Renal failure; Hyperkalemia; ESBL klebsiella septicemia resulting from UTI and complicated by renal failure and hyperkalemia


VAERS ID: 1486385 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-29
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0927 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Seizure
SMQs:, Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CVA (Left hemiplegia); Hypertension; Left hemiplegia; Prostate cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: SARS-CoV-2 PCR; Test Result: Positive
CDC Split Type: ZAPFIZER INC2021849466

Write-up: Seizures; SARS-CoV-2 PCR: positive; SARS-CoV-2 PCR: positive; This is a spontaneous report from a contactable physician. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jun2021 (Lot number: FD0927; Expiration Date: 11Jun2021) at dose number unknown, single for COVID-19 immunisation. Medical history included hypertension, prostate cancer, cerebrovascular accident (CVA), and left hemiplegia. The patient''s concomitant medications were not reported. The patient experienced seizures on an unspecified date, which required hospitalization on 28Jun2021. The patient underwent lab tests and procedures which included SARS-CoV-2 PCR: positive on 29Jun2021. The patient died due to seizures on 29Jun2021. An autopsy was not performed. The outcome of the event "SARS-CoV-2 PCR: positive" was unknown. This is the only information available at the time of this report. Additional information has been requested.; Sender''s Comments: As there is limited information in the case provided, the causal association between the seizures fatal case , and the suspect drug cannot be excluded. The case will be reassessed once new information is available.; Reported Cause(s) of Death: Seizures


VAERS ID: 1486386 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PC1436 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chest X-ray, Death, Malaise, Oxygen saturation, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   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: Medical History/Concurrent Conditions: Asthma; Diarrhoea; Lung mass (suspicious lesion on CXR); Prostate cancer
Allergies:
Diagnostic Lab Data: Test Name: CXR; Result Unstructured Data: Test Result:very suggestive of covid-19; Test Name: oxygen saturation; Test Result: 74 %; Test Date: 20210626; Test Name: SARS-CoV-2 Rapid antigen; Result Unstructured Data: Test Result:positive
CDC Split Type: ZAPFIZER INC2021849473

Write-up: feeling unwell; very suggestive of covid-19, sars-cov-2 rapid antigen test: positive on 26Jun2021; Death; This is a spontaneous report from a contactable physician. A 73-year-old male patient received BNT162B2 (BNT162B2) on 25Jun2021 (Batch/Lot Number: PC1436) (at the age of 73 years) as dose number unknown, single for covid-19 immunization. Medical history included asthma, diarrhoea, invasive prostate cancer, pulmonary mass (suspicious lesion on CXR). The patient''s concomitant medications were not reported. The patient experienced death on 29Jun2021, patient presented to the emergency unit with history of diarrhoea and feeling unwell on an unspecified date. The patient was hospitalized from 26Jun2021 to an unknown date. The patient underwent lab tests and procedures which included chest x-ray: very suggestive of covid-19, sars-cov-2 rapid antigen test: positive on 26Jun2021, oxygen saturation: 74%. The patient died on 29Jun2021. An autopsy was not performed. This is the only information available for this report. The outcome of events was fatal.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug 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 drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: feeling unwell; very suggestive of covid-19, sars-cov-2 rapid antigen test: positive on 26Jun2021; Death


VAERS ID: 1486387 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-19
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atypical pneumonia, Blood glucose, Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Heart rate increased, Lung infiltration, Oxygen saturation, Pneumonia, Respiratory rate, SARS-CoV-2 test, X-ray
SMQs:, Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   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: 20210619; Test Name: blood glucose; Result Unstructured Data: Test Result:6.3 mmol/L; Test Date: 20210619; Test Name: Blood pressure; Result Unstructured Data: Test Result:136/92 mmHg; Test Name: Temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210619; Test Name: Pulse rate; Result Unstructured Data: Test Result:103; Test Date: 20210619; Test Name: Oxygen Saturation; Test Result: 89 %; Test Date: 20210619; Test Name: Respiratory rate; Result Unstructured Data: Test Result:36; Test Date: 20210619; Test Name: IMG for COVID-19; Test Result: Negative ; Test Date: 20210620; Test Name: IMG for COVID-19; Test Result: Negative ; Test Date: 20210619; Test Name: PCR swab for COVID-19; Test Result: Negative ; Test Date: 20210620; Test Name: PCR swab for COVID-19; Test Result: Negative ; Test Date: 20210619; Test Name: x-ray; Result Unstructured Data: Test Result:Bilateral infiltration; Comments: suggestive of COVID-19 or atypical pneumonia
CDC Split Type: ZAPFIZER INC2021849487

Write-up: pneumonia; X-ray: bilateral infiltration suggestive of COVID-19 or atypical pneumonia; blood pressure: 136/92 mmHg; pulse rate: 103; X-ray: bilateral infiltration suggestive of COVID-19 or atypical pneumonia; This is a spontaneous report from a contactable physician. An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), 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. It was unknown if the patient was pregnant. The patient experienced pneumonia on an unspecified date which caused hospitalization from 19Jun2021. Therapeutic measures included INVANZE, morphine 4mg, dexamethasone, pantoprazole 40 mg, and EMITOP 4 mg. The patient underwent lab tests and procedures which included temperature: 36.4 Centigrade on an unspecified date; blood glucose: 6.3 mmol/L, blood pressure: 136/92 mmHg, pulse rate: 103, oxygen saturation: 89%, respiratory rate: 36, and X-ray: bilateral infiltration suggestive of COVID-19 or atypical pneumonia, all on 19Jun2021; and IMG (as reported) and PCR swab for COVID-19 which were both negative on 19Jun2021 and 20Jun2021. The patient died on 21Jun2021. The cause of death was pneumonia which was also reported as complications of pneumonia. It was unknown if an autopsy was performed. The outcome of all other events was unknown. No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: The advanced old patient''s death is more likely related to the underlying serious disease unrelated to vaccine use; however, There is no information in the case suggesting a possible contribution of the Pfizer suspect product to the patient death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: pneumonia/ complications of pneumonia


VAERS ID: 1486388 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-25
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Death, Drug ineffective, Fall, Oropharyngeal pain, Pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 9
Permanent Disability? 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; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: COVID PCR test; Test Result: Positive
CDC Split Type: ZAPFIZER INC2021849523

Write-up: Died; COVID PCR positive; COVID PCR positive; Cough; Mild pain/Mild body aches; Sore throat; Falls; This is a spontaneous report from a contactable nurse. An 89-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 14Jun2021 (at the age of 89-years-old) at dose 1, single for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension. The patient''s concomitant medications were not reported. On 25Jun2021, the patient experienced cough, mild pain, sore throat, mild body aches, and falls. On 30Jun2021, the patient was COVID PCR positive. On 04Jul2021, the patient died due to unknown reason. It was unknown if autopsy was performed. The patient underwent COVID PCR test on 30Jun2021 with positive result. Outcome of the event ''died'' was fatal, and for other events was unknown. No further information at the time of this report. Information on the lot/batch number has been requested.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events death, drug ineffective and covid-19 and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Died


VAERS ID: 1486390 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Disease complication, Headache, Heart rate, International normalised ratio, Oedema peripheral, Physical examination, Pulmonary oedema, Respiratory rate
SMQs:, Cardiac failure (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; CARVEDILOL; DIGOXIN; FUROSEMIDE; PANADO; SIMVASTATIN; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Congestive cardiac failure; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:152/99; Test Name: Temperature; Result Unstructured Data: Test Result:36.4=3; Test Name: Pulse; Result Unstructured Data: Test Result:90; Test Name: INR; Result Unstructured Data: Test Result:3.1; Test Name: Cardiac; Result Unstructured Data: Test Result:irregular pulse, gallop rhythm; Test Name: Resp; Result Unstructured Data: Test Result:Bibasal Creps; Test Name: Respiratory rate; Result Unstructured Data: Test Result:14
CDC Split Type: ZAPFIZER INC2021854384

Write-up: Natural disease; BP: 152/99; two days of headache; Bipedal oedema; Pulmonary oedema; This is a spontaneous report from a contactable physician. A 62-year-old male patient received BNT162B2, via an unspecified route of administration on 09Jun2021 (Batch/Lot number was not reported) at the age of 62 years old as dose number unknown, single for COVID-19 immunisation. Medical history included hypertension, atrial fibrillation and congestive cardiac failure, all from unknown dates and unknown if ongoing. Concomitant medication(s) included amlodipine; carvedilol; digoxin; furosemide; paracetamol (PANADO); simvastatin; warfarin; all taken for unspecified indications, start and stop dates were not reported. On 14Jun2021 the patient experienced two days of headache, bipedal oedema and pulmonary oedema. Also reported, natural disease on an unspecified date (cause of death). The patient underwent lab tests and procedures (unknown date) which included blood pressure measurement (BP): 152/99, temperature: 36.4=3 (as reported), pulse: 90, international normalised ratio (INR): 3.1 on, physical examination (Cardiac): irregular pulse, gallop rhythm; physical examination (Resp): bibasal creps on, respiratory rate: 14 on. Outcome of event BP: 152/99 was unknown. The patient died on 18Jun2021. It was not reported if an autopsy was performed. 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 headache, oedema peripheral, pulmonary oedema, disease recurrence 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: two days of headache; Bipedal oedema; Pulmonary oedema; Natural disease


VAERS ID: 1486391 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-24
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0927 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021858487

Write-up: Died; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection: Batch/Lot number: FD0927), via an unspecified route of administration on 09Jun2021 as dose number unknown, single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient died on 24Jun2021. The patient was hospitalized from 23Jun2021 to an unknown date. The patient died on 24Jun2021. It was unknown whether the autopsy was performed or not. Outcome of the event was fatal. No further information was provided at the time of this report. Follow-up (13Jul2021): New information reported includes: Batch number: FD0927. Name of vaccination site and vaccinator details.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event death and the suspect drug comirnaty 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.,Linked Report(s) : ZA-PFIZER INC-2021859212 Same reporter, Same product, Different patients, Same events;ZA-PFIZER INC-2021859213 Same reporter, Same product, Different patients, Different events; Reported Cause(s) of Death: Died


VAERS ID: 1486392 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1436 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Death, Fall, Muscular weakness, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   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: RIDAQ; ATENOLOL
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021858897

Write-up: Died; Mild body aches; Weakness of lower limbs; Back ache; Fell; This is a spontaneous report from a contactable pharmacist. An 89-year-old female patient received BNT162b2 (BNT162B2) dose 2 administration on 28Jun2021 10:33 (Batch/Lot Number: FC1436; Expiration Date: Oct2021) for covid-19 immunization at the age of 89-year-old. The Diluent batch details 55111, exp date May2023. The vaccine was reconstituted on 28Jun2021, 09:32. Medical history included ongoing hypertension. Concomitant medications included hydrochlorothiazide (RIDAQ) and atenolol (ATENOLOL). On 29Jun2021, the patient experienced mild body aches, weakness of lower limbs, back ache, stated that she fell. The patient is reported to have died on 04Jul2021. An autopsy was not performed. The outcome of other events was unknown. No further information was available at the time of this report; Sender''s Comments: As there is limited information in the case provided, the causal association between the death and the suspect drug cannot be excluded. The case will be reassessed once new information is available.; Reported Cause(s) of Death: Died


VAERS ID: 1486393 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021859212

Write-up: Died; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 via an unspecified route of administration on 17Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on 30Jun2021. The patient was hospitalized for the event from 28Jun2021 to an unknown date. It was not reported if an autopsy was performed. No further information was provided at the time of this report. The lot/batch number has been requested.; Sender''s Comments: Based on the limited information in the case a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported Unknown of Death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : ZA-PFIZER INC-2021859213 Same reporter, Same product, Different patients, Different events;ZA-PFIZER INC-2021858487 Same reporter, Same product, Different patients, Same events; Reported Cause(s) of Death: Died


VAERS ID: 1486412 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2021SA235381

Write-up: patient contracted [COVID-19] and died; This initial Information regarding this unsolicited and death case was received on 12-Jul-2021 from a non-healthcare professional (unknown relationship with patient) through Business Partner, which was forwarded on 13-Jul -2021. On 12/Jul/2021, received through social media a report of a serious adverse event after the use of influenza vaccine. The reporter, profession and demographics unknown, reports on Facebook, that the mother of a friend, female, demographics unknown, who received influenza vaccine, single dose, (lots, route of administration and expiry dates unknown) and received administration of adsorbed covid-19 (inactivated) vaccine on an unspecified date, the patient contracted [COVID-19] and died. No further details such as when the events started, intensity, duration, possible treatments, or any other information relevant to the case were provided. Since this report comes from social media, they are not authorized to contact the reporter, so no additional information is expected. The case has been closed and may be reopened in light of new data. Holder: Active ingredients trivalent influenza vaccine (fragmented and inactivated) Category: VACCINE Prescription: Not Informed Product with alterations: No Dosage: 0.5 ML; Sender''s Comments: This case concerns a female patient who presented with COVID-19 after vaccination with INFLUENZA VACCINE (TRIVALENT) (unknown manufacturer) and COVID-19 VACCINE (other manufacturer). The time to onset is unknown. There is, however, no information regarding patient''s condition at time of vaccination, past history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: patient contracted [COVID-19] and died


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