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

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



Case Details

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VAERS ID: 1429015 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Late effects of cerebral infarction; Living in care
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021693602

Write-up: Heat illness; The patient was unconscious; Pyrexia; This is a spontaneous report from a contactable other health professional (Other HCP) received from the Regulatory Authority. The regulatory authority report number is v21113760. The patient was an 86-year and 8-month-old female. Body temperature before vaccination was 36.9 degrees centigrade on 10Jun2021. Medical history included late effects of cerebral infarction and the patient was living while being cared by her younger sister in her 80s at home (care level 5). There were no other points to be considered. Family history and concomitant medications were not reported. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY). On 10Jun2021 at 15:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, solution for injection, Lot number: FC3661, Expiration Date: 30Sep2021) via an unspecified route of administration at single dose for COVID-19 immunisation. On 11Jun2021 at 08:20 (1 day after the vaccination), the patient experienced heat illness. On 11Jun2021 (1 day after the vaccination), the patient experienced pyrexia and the patient was unconscious. On 11Jun2021 (1 day after the vaccination), the outcome of the event heat illness was fatal, while for the other events was unknown. It was not provided whether autopsy was done. The course of the events was as follows: On 11Jun2021 (1 day after the vaccination), the patient experienced pyrexia. The patient had been observed at home until around late afternoon, but because the fever did not decline, her family contacted the care manager in charge. The care manager called the reporting hospital. At visit of the physician, the patient was unconscious and was confirmed dead. After confirming the insufficient fluid intake, the indoor environment (no air conditioner or air conditioning equipment), and the patient''s condition, a diagnosis of heat illness and death was made. The reporting other HCP classified the event heat illness as serious (death) and assessed the causality between the event heat illness and BNT162B2 as unassessable. The seriousness and causality of the other events were not reported. Other possible cause of the event heat illness such as any other diseases: present. The reporting other HCP commented as follows: The causality with the vaccine was unknown because it was difficult to perform a close examination, but the heat illness was very likely due to the environment.; Reported Cause(s) of Death: Heat illness


VAERS ID: 1429037 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-29
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardio-respiratory arrest, Coma scale, Heart rate, Investigation, Marasmus, Oxygen saturation
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: 2021-04-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Disuse syndrome; Pneumonia aspiration
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalisation
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: blood pressure; Result Unstructured Data: Test Result:111/94 mmHg; Test Date: 20210423; Test Name: body temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Comments: Before vaccination; Test Date: 20210423; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Name: CONS; Result Unstructured Data: Test Result:I-2 to III-100; Test Date: 20210423; Test Name: pulse rate; Result Unstructured Data: Test Result:76; Comments: beats/minute; Test Name: activities daily living (ADL) score; Result Unstructured Data: Test Result:24 points; Test Date: 20210423; Test Name: SpO2; Test Result: 99 %; Comments: room air
CDC Split Type: JPPFIZER INC2021716961

Write-up: geromarasmus; cardiopulmonary arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21114468. The patient was a 91-year and 3-month-old female. Body temperature before vaccination was 37.4 degrees Centigrade. The family history was not provided. The patient was hospitalized for pneumonia aspiration, dementia, and disuse syndrome. It was also reported that 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 23Apr2021 at 13:45 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ET9096, Expiration date 31Jul2021) via an unspecified route of administration as dose 1, single for COVID-19 immunization. On 29Apr2021 at 06:48 (6 days after the vaccination), the patient experienced cardiopulmonary arrest. On 29Apr2021 (6 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was an oldest old who was being admitted to the hospital with diagnoses of pneumonia aspiration, dementia, and disuse syndrome. The patient was bedridden (lank C2) with total assistance. The activities daily living (ADL) score was 24 points. CONS (consciousness) was I-2 to III-100. The patient had large amount of sputum daily, and frequent suction was required. Oxygen 0 to 10 L was also administered. The patient was on total parenteral nutrition. On 23Apr2021 (the day of vaccination), at the time of vaccination, the vital signs were stable as follows: the body temperature was 36.8 degrees Celsius, the pulse rate was 76 beats/minute, the SpO2 was 99% in room air, and the blood pressure was 111/94 mmHg. The course was observed without significant changes after the vaccination. However, on 29Apr2021 (on Day 6 after the vaccination), in the early morning, the patient had cardiopulmonary arrest (CPA). It was considered as geromarasmus. A death certificate was made. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. It was reported that there was other possible cause(s) of the event such as any other diseases, but that cause(s) was not specified. The reporting physician commented as follows: The CPA was unrelated to the BNT162b2 vaccination.; Sender''s Comments: Based on available information, the event cardiopulmonary arrest was attributed to the patient''s underlying medical conditions and geromarasmus, thus unrelated to BNT162B2 vaccine. 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: Cardio-respiratory arrest; Geromarasmus


VAERS ID: 1429039 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Sudden death
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: 2021-06-16
   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: Acute renal failure; Influenza A virus infection; Rhabdomyolysis; Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021718074

Write-up: confirmed dead/Sudden death with unknown cause of death; found in a state of cardio-respiratory arrest in the toilet; This is a spontaneous report from a contactable physician via a company representative via the Agency. The patient was a non-pregnant 71-year-old female. Underlying disease/complication included schizophrenia. Other medical history included influenza A, rhabdomyolysis, and acute renal failure. 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 antipsychotic drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies. On 15Jun2021 at 11:10 (at age of 71 years old, no pregnant, the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) intramuscularly into the left arm as a single dose for COVID-19 immunization. On 16Jun2021 at 15:30 (1 day after the vaccination), the patient was found in a state of cardio-respiratory arrest in the toilet. On 16Jun2021 at 15:45 (1 day after the vaccination), the patient experienced sudden death with unknown cause of death. Autopsy was performed with unknown results. The outcome of the event was fatal. The course of the event was as follows: On 16Jun2021 at 15:30 (1 day after the vaccination), the patient was found in a state of cardio-respiratory arrest in the toilet. Cardiac massage was immediately started. A transfusion route was secured, and oxygen was administered. The patient was placed with an automated external defibrillator (AED) but was unresponsive, and at 15:45, she was confirmed dead. As it was considered as sudden death with unknown cause of death, a contact was made to the police. After a questioning, the corpse was transported. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unknown.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events cardiorespiratory arrest (Fatal) and sudden death 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: found in a state of cardio-respiratory arrest in the toilet; confirmed dead/Sudden death with unknown cause of death


VAERS ID: 1429074 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   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: Arterial hypertension; Epilepsy
Preexisting Conditions: Medical History/Concurrent Conditions: Exposure to COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVPFIZER INC2021680677

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority LV-SAM-2021065932. A 46-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 28May2021 (Batch/Lot Number: Unknown) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included ongoing epilepsy, ongoing arterial hypertension and exposure Covid-19 from 16May2021 to an unknown date and did not exhibit any symptoms. The patient did not have SARS-CoV-2 testing done. The patient was advised to quarantine. The patient did not fully quarantine themselves, went to receive the 2nd vaccination dose on 28May2021 and subsequently - to work. The patient''s GP notes that the patient rarely went in for consultations. The patient''s concomitant medications were not reported. The patient previously received dose 1 of Comirnaty on unspecified date for Covid-19 immunization. The patient experienced death on 29May2021. It was reported that the patient was found dead. An autopsy was performed however results were not provided. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1429124 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 51
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: DABIGATRAN ETEXILATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021681921

Write-up: Cerebral infarction; Thrombosis; Fatigue; Not feeling well; This is as spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00567598. A 98-year-old female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Mar2021 (Lot Number: ER7812) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included dabigatran etexilate. The patient previously received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 19Feb2021 (Lot Number unknown) as 0.3 ml, single for covid-19 immunisation. The patient experienced cerebral infarction and thrombosis (both resulted in death, hospitalization) on 14May2021, fatigue and not feeling well on 30Mar2021. The events appeared suddenly. Diagnostic procedures included CT-scan. The outcome of the events Thrombosis and cerebral infarction was fatal, other events was recovered on 06Apr2021. The patient died on 20May2021 due to events Thrombosis and cerebral infarction. 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: thrombosis; cerebral infarction


VAERS ID: 1429126 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Cystitis, Hypoxia, Inappropriate schedule of product administration, Malaise, Palpitations, Pneumonia, Sepsis
SMQs:, Cardiac failure (narrow), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 48
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: Cystitis; Pneumonia; Recurrent infection (cystitis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021681904

Write-up: suspicion of sepsis; Pneumonia; Cystitis/bladder infections; palpitations; Oxygen deficiency; heart failure/she only deteriorated further until she was rushed to hospital on 19May2021 due to deteriorating heart function; felt very sick after the second shot, about 4 to 5 days; Second dose on 07Apr2021/first dose on 24Feb2021; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00569076. A 79-year-old female patient received second dose of BNT162B2 (COMIRNATY, strength: 0.3ml), via an unspecified route of administration on 07Apr2021 (at the age of 79-year-old) as single dose for covid-19 immunisation. Medical history included pneumonia from 1997, recurrent infection (cystitis). The patient''s concomitant medications were not reported. The patient took first dose of BNT162B2 (COMIRNATY, strength: 0.3ml), via an unspecified route of administration on 24Feb2021 as single dose for covid-19 immunisation. 9 days after 2nd shot on 16Apr2021, patient was rushed to the hospital for palpitations/heart failure. It was known that patient was prone to bladder infections. In 1997 she had pneumonia for the last time, she was inside because of corona. The heart failure was completely unexpected and was now "dismissed" as age, but no one knows for sure. Patient was sent home with medication and with extra oxygen (2 l per day), patient was oxygen deficiency, she also had a bladder infection and starting pneumonia. Despite medication for this, she only deteriorated further until she was rushed to hospital on 19May2021 due to deteriorating heart function. The emergency doctor reported a suspicion of sepsis and heart values that were too high. Despite treatment and partly succeeding treatments for the cystitis, there remained an inflammation somewhere in the body that could not be found. The heart continued to deteriorate and on 24May2021 the decision was made to administer morphine. The exact details of the treatment are available through general practitioner (GP). It was continuously reported to the GP and to the hospital that she had had a second shot of Pfizer. What surprised was that until 16Apr2021 there was no mention of heart failure or problems with the heart. This report should therefore be made to Pfizer anyway because of possible other reports. The examination of the heart failure revealed the onset of pneumonia. Patient regularly had cystitis, but not to the extent that it occurred now. From the time of heart failure until death she needed extra oxygen, about 2 liters a day. Confounding factors reported as susceptibility to cystitis, but that was not the cause of the hospitalization and deterioration. There was a suspected sepsis, which however could not be found. Fluid at the heart and heart failure were not correctable. Reporter thought that the cause of death was seen to be due to age. However, the heart failure, was completely out of the blue. It could be an underlying problem of course, but the combination with oxygen deficiency, pneumonia and cystitis surprised they all and cannot be explained medically (in terms of cause, where did it start?). She indicated that patient felt very sick after the second shot, 1 days after on 08Apr2021 and also about 4 to 5 days. Treatment received included cystitis was treated with antibiotics, heart failure was treated with unknown treatment, hypoxia was treated with oxygen support ( 2 l per day), palpitations was treated with unknown treatment, pneumonia was treated with antibiotics and oxygen and sepsis was treated with antibiotics. Patient previous was not COVID-19 infection. The outcome of the events "heart failure/she only deteriorated further until she was rushed to hospital on 19May2021 due to deteriorating heart function", "suspicion of sepsis", "Pneumonia" was fatal, for event "Cystitis/bladder infections" and "Oxygen deficiency" was not recovered, for event "felt very sick after the second shot, about 4 to 5 days" was recovering, for event palpitations was unknown. Patient died on 25May2021. 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: suspicion of sepsis; she only deteriorated further until she was rushed to hospital on 19May2021 due to deteriorating heart function/heart failure; Pneumonia


VAERS ID: 1429129 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-08
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute myocardial infarction, Base excess, Blood bicarbonate, Blood bilirubin, Blood calcium, Blood chloride, Blood creatinine, Blood glucose, Blood lactic acid, Blood magnesium, Blood phosphorus, Blood potassium, Blood sodium, Blood urea, Body temperature, Body temperature decreased, C-reactive protein, Chest X-ray, Echocardiogram, Electrocardiogram, Fibrin D dimer, Glomerular filtration rate, Haemoglobin, Investigation, Lymphocyte count, Monocyte count, Nausea, Oxygen saturation, PCO2, PO2, Platelet count, Prothrombin time, Pyrexia, Ultrasound scan, White blood cell count, pH body fluid
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   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: SULFASALAZINE; FOLIC ACID; PERINDOPRIL ERBUMINE; PANTOPRAZOLE; HYDROXYCHLOROQUINE; CALCI CHEW D3; SIMVASTATIN; RISEDRONIC ACID; ETORICOXIB; METHOTREXATE; CLOPIDOGREL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: APTT; Test Result: 34 s; Test Name: base excess; Test Result: 10.0 mmol; Test Name: HCO3; Test Result: 20 mmol; Test Name: Bilirubin total; Result Unstructured Data: Test Result:22 umol/l; Test Date: 20210607; Test Name: Bilirubin total; Result Unstructured Data: Test Result:22 umol/l; Test Date: 20210607; Test Name: Calcium; Result Unstructured Data: Test Result:2.24 mmol/L; Test Date: 20210607; Test Name: calcium heart; Result Unstructured Data: Test Result:2.5 mmol/L; Test Name: Chloride; Result Unstructured Data: Test Result:100 mmol/L; Test Name: creatinine; Result Unstructured Data: Test Result:213 umol/l; Test Date: 20210607; Test Name: creatinine; Result Unstructured Data: Test Result:213 umol/l; Test Name: Glucose; Result Unstructured Data: Test Result:7.3 mmol/L; Test Name: lactate; Result Unstructured Data: Test Result:5.3 mmol/L; Test Date: 20210607; Test Name: Magnesium; Result Unstructured Data: Test Result:1.4 mmol/L; Test Date: 20210607; Test Name: Phosphate; Result Unstructured Data: Test Result:2.2 mmol/L; Test Name: Potassium; Result Unstructured Data: Test Result:5.1 mmol/L; Test Name: Sodium; Result Unstructured Data: Test Result:134; Test Date: 20210607; Test Name: Urea; Result Unstructured Data: Test Result:19.5 mmol/L; Test Date: 20210608; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 to 38 Centigrade; Comments: fever; Test Name: body temperature; Result Unstructured Data: Test Result:35.4 Centigrade; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Veil ring right; Test Date: 20210607; Test Name: C-reactive protein; Result Unstructured Data: Test Result:396 mg/l; Test Name: echo cor; Result Unstructured Data: Test Result:still heart; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm 111/min, intermed axis, ST elevation; Comments: sinus rhythm 111/min, intermed axis, ST elevation V1-V2, ST-depression V3-V6, I aVL, elevation aVR.; Test Name: D-dimer; Result Unstructured Data: Test Result:more than 5000 ng/ml; Test Date: 20210607; Test Name: D-dimer; Result Unstructured Data: Test Result:more than 5000 ng/ml; Test Date: 20210607; Test Name: estimated glomerular filtration rate (CKD-EPI); Result Unstructured Data: Test Result:26; Comments: 26 ml/min/area; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.3 mmol/L; Test Date: 20210607; Test Name: baso; Result Unstructured Data: Test Result:0.0 x10 9/l; Test Date: 20210607; Test Name: Ethylene oxide; Result Unstructured Data: Test Result:0.0 x10 9/l; Test Name: iCa++; Test Result: 1.21 mmol; Test Date: 20210607; Test Name: ingot; Result Unstructured Data: Test Result:1.5 x10 9/l; Test Name: pO2/FIO2 ratio; Result Unstructured Data: Test Result:48 mmHg; Test Date: 20210607; Test Name: segment; Result Unstructured Data: Test Result:26.8 x10 9/l; Test Name: t O2; Test Result: 6.2 mmol; Test Date: 20210607; Test Name: vacuoles; Result Unstructured Data: Test Result:1+; Test Date: 20210607; Test Name: lympho; Result Unstructured Data: Test Result:0.9 x10 9/l; Test Date: 20210607; Test Name: mono; Result Unstructured Data: Test Result:0.3 x10 9/l; Test Name: O2; Test Result: 100 %; Test Name: Oxygen saturation; Test Result: 75 %; Test Name: pCO2; Result Unstructured Data: Test Result:55 mmHg; Test Name: ph; Result Unstructured Data: Test Result:7.15; Test Name: platelets; Result Unstructured Data: Test Result:218 x10 9/l; Test Date: 20210607; Test Name: platelets; Result Unstructured Data: Test Result:218 x10 9/l; Test Name: pO2; Result Unstructured Data: Test Result:48 mmHg; Test Date: 20210607; Test Name: Prothrombin time; Test Result: 18.0 s; Test Name: echo lung; Result Unstructured Data: Test Result:Many B-lines on both sides; Test Date: 20210607; Test Name: Leukocytes; Result Unstructured Data: Test Result:29.5 x10 9/l
CDC Split Type: NLPFIZER INC2021688031

Write-up: STEMI; Fever: 37.5 to 38 centigrade inclusive; Nausea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00571244. A 70-year-old male patient received second dose of BNT162B2 (COMIRNATY, strength: 0.3ml), via an unspecified route of administration on 29May2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included sulfasalazine; folic acid; perindopril erbumine; pantoprazole; hydroxychloroquine; calcium carbonate, colecalciferol (CALCI CHEW D3); simvastatin; risedronic acid; etoricoxib; methotrexate; clopidogrel. The patient previously took first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On 08Jun2021, the patient experienced ST-elevation myocardial infarction (STEMI), fever: 37.5 to 38 centigrade inclusive, nausea. The seriousness criteria for event STEMI was death. The patient underwent lab tests and procedures which included: On unspecified date, Bilirubin total 22 umol/l, Creatinine 213 umol/l, D-Dimer more than 5000 ng/ml, Platelets 218 x10 9/l, Electrocardiogram (ECG): sinus rhythm 111/min, intermed axis, ST elevation V1-V2, ST-depression V3-V6, I aVL, elevation aVR. Echo lung: Many B-lines on both sides. Echo heart: still heart, Chest X-ray: Veil ring right. Hemoglobin 8.3 mmol/l. Body temperature 35.4 Centigrade, O2 100%, pH 7.15, pCO2 55 mm Hg, HCO3 20 mmol/l, base excess 10.0 mmol/l, pO2 48 mm Hg, saturation O2 75%, t O2 6.2 mmol/l, pO2/FIO2 ratio 48 mmHg. Glucose 7.3 mmol/l, Sodium 134 mmol/l, Potassium 5.1 mmol/l, Chloride 100 mmol/l, iCa++ 1.21 mmol/l, Lactate 5.3 mmol/l. On 07Jun2021, Platelets 218 x10 9/l, Leukocytes 29.5 x10 9/l, segment 26.8 x10 9/l, Lymphocytes 0.9 x10 9/l, Monocyte 0.3 x10 9/l, Ethylene oxide 0.0 x10 9/l, baso 0.0 x10 9/l, ingot 1.5 x10 9/l, vacuoles 1+, Prothrombin time 18.0 sec, Activated partial thromboplastin time (APTT 34) sec, D-Dimer more than 5000 ng/ml. C-reactive protein (CRP) 396 mg/l, Calcium 2.24 mmol/l, calcium heart 2.50 mmol/l, Phosphate 2.2 mmol/l, Magnesium 1.4 mmol/l, Urea 19.5 mmol/l, Creatinine 213 umol/l, estimated glomerular filtration rate(CKD-EPI) 26 ml/min/area, Bilirubin total 22 umol/l. On 08Jun2021, body temperature: 37.5 to 38 centigrade, fever. Patient previous was not COVID-19 infection. The outcome of the event STEMI was fatal, for other events was unknown. The patient died on 08Jun2021. 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: STEMI


VAERS ID: 1429136 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-04-25
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living in nursing home (DNR code minus Evaluated as preterminal before positive corona test)
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Increasing; Comments: Strongly increasing values (not specified); Test Date: 20210427; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: NOPFIZER INC2021681967

Write-up: detected COVID-19 and died; detected COVID-19 and died; Sepsis; This is a spontaneous report from a contactable other Health Care Professional downloaded from the Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-00297-U8e7rq. A 102-year-old male patient received bnt162b2 (COMIRNATY), intramuscular in Jan2021 (Batch/Lot Number: Unknown) as dose 1, single and intramuscular on 27Jan2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunisation. Medical history included living in residential institution (DNR code minus; Evaluated as preterminal before positive corona test). The patient''s concomitant medications were not reported. The patient was living in a nursing home (DNR code minus) was vaccinated with both doses of Comirnaty in Jan2021 and had no adverse effects from the vaccinations. About three months later, on 25Apr2021, he became ill and felt weak. He was diagnosed with sepsis and treatment with antibiotics was started due to strongly increasing CRP values on 26Apr2021. He was evaluated as preterminal. An outbreak of COVID-19 disease was discovered in his ward on the following day and all patients and staff were tested. The disease started in an unvaccinated employee. The patient tested positive for COVID-19 on 27Apr2021 (Variants of Concern unknown). On 27Apr2021, patient experienced drug ineffective and COVID-19. He was isolated and was ill for about a week before he died. Antibiotics were stopped two days before he died and palliative care was started on the day before his death. The institution had been followed all COVID-19 routines closely. On 27Apr2021, the patient was detected with COVID-19 and died. The patient underwent lab tests and procedures which included c-reactive protein: increasing on 26Apr2021 (Strongly increasing values (not specified)) and SARS-CoV-2 PCR test: positive on 27Apr2021. The patient died on 30Apr2021. It was not reported if an autopsy was performed. The Agency assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. Reporter''s comments: Reporter''s qualification: Physiotherapist. 07Jun2021 Agency: information about Variants of Concern requested. No follow-up attempts are possible; Information on batch/lot number cannot be obtained. No further information expected.; Reporter''s Comments: Physiotherapist. Reporter''s qualification: Physiotherapist 07Jun2021 Agency: information about Variants of Concern requested; Reported Cause(s) of Death: Sepsis; COVID-19; Drug ineffective


VAERS ID: 1429137 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, Pulmonary hypertension
SMQs:, Pulmonary hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD (Grade 3)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021681942

Write-up: Admission with severe COPD exacerbation 08APR2021, death from unspecified exacerbation of COPD and pulmonary hypertension 17APR2021.; Admission with severe COPD exacerbation 08APR2021, death from unspecified exacerbation of COPD and pulmonary hypertension 17APR2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-00322-Uxz91y, Safety Report Unique Identifier NO-NOMAADVRE-FHI-2021-00322. A 70-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 07Apr2021 (Lot Number: EW8904) as single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing (3). The patient''s concomitant medications were not reported. The patient experienced admission with severe COPD exacerbation on 08Apr2021, death from unspecified exacerbation of COPD and pulmonary hypertension on 17Apr2021. The patient died on 17Apr2021. It was unknown if an autopsy was performed. It was also reported as follows: the patient was admitted to hospital due to COPD exacerbation on the day after she was vaccinated with the first dose. She died from unspecified COPD exacerbation and secondary pulmonary hypertension 10 days after the vaccination. The patient had serious COPD and secondary pulmonal hypertension. Before the vaccination she was living at home with her husband, grade 3, but not frequent hospitalizations. The Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as possible. No follow-up attempts possible. No further information expected. ; Reporter''s Comments: Notifier qualification: Doctor.; Reported Cause(s) of Death: PULMONARY HYPERTENSION SECONDARY; COPD EXACERBATION


VAERS ID: 1429144 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX 6564 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, General physical health deterioration
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021681971

Write-up: Diarrhea, abdominal pain; Diarrhea, abdominal pain; reduced general condition; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uyj358, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00031004. A 72-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: EX 6564, expiry date not reported), intramuscular, administered in left arm on 19May2021 10:00 as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received the first dose of Comirnaty on an unknown date for COVID-19 immunisation. The day after vaccination, 20May2021, patient got diarrhea, abdominal pain and reduced general condition. Events had fatal outcome 14 days after vaccination. The patient died on 01Jun2021. The causes of death were diarrhea, abdominal pain and reduced general condition. It was unknown if an autopsy was performed. For the events relatedness of drug per source of assessment Regulatory Authority was possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: diarrhea; abdominal pain; reduced general condition


VAERS ID: 1429150 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein increased, General physical health deterioration, Oxygen saturation, Oxygen saturation decreased, Pneumonia
SMQs:, Acute central respiratory depression (broad), Eosinophilic pneumonia (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: 2021-03-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Living in nursing home
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: C-reactive protein increased; Result Unstructured Data: Test Result:Increased; Test Date: 20210305; Test Name: O2 saturation; Result Unstructured Data: Test Result:severe saturation drop
CDC Split Type: NOPFIZER INC2021688740

Write-up: Pneumonia; severe saturation decrease; an already weakened general condition was further weakened; This is a spontaneous report from a contactable consumer, received via a lawyer from Regulatory Authority. This is the first of two reports for this patient. This is for the second dose. An 86-year-old female patient received BNT162b2 (COMIRNATY), dose 2, via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose (at age of 86 years old) for COVID-19 immunisation. The patient medical history included living in nursing home. The patient previously received first dose of BNT162b2 (unknown batch/lot number) in the first week of Jan2021 for COVID-19 immunisation and experienced pneumonia, COVID-19 and reduced general condition. The patient''s concomitant medications were not reported. The patient had been diagnosed with COVID-19 on 18Jan2021 after the first dose of vaccination (reported in 2021693239) and in the continuation of the course of COVID, she developed pneumonia. She came out of isolation on 11Feb2021. She was severely weakened after long-term sick leave. She was given dose 2 of the vaccine on 04Mar2021, exactly 3 weeks after isolation, despite that the guidelines from National Institute of Public Health clearly state that dose 2 should not be administered after dose 1 and subsequent COVID infection. The next of kin was neither consulted nor informed that dose 2 was administered, despite the fact that they had expressed both orally and in writing skepticism about further vaccination given the patient''s situation and health, and at least repeatedly asked to be kept closely informed. Despite this, dose 2 was still administered on 04Mar2021 without a doctor present to assess her health and whether she at all was suitable for receiving such a vaccine. Such an assessment must be in accordance with the authorities'' guidelines routine for frail patients. The day after vaccine dose 2, on 05Mar2021, the patient had a severe saturation drop and was put on oxygen. An already weakened general condition weakened additionally. Then on day 6 after vaccination, 10May2021, she got increased CRP (C-reactive protein). New pneumonia was confirmed. Day 7, 11May2021, the patient was put on antibiotics. "Pneumonia is high on the list of side effects of Corona vaccine", as reported. Day 9 (13Mar2021) after vaccination 2, the patient died. It was reported as that the patient died as a result of COVID-19 and Vaccination at a health institution. The outcome of saturation drop and general condition weakened was not reported. 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: pneumonia


VAERS ID: 1429179 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Body temperature, Cardiac failure, Death, Loss of consciousness, Pyrexia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 15
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: ENTRESTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure (treated by three stents for acute events); Stent insertion NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: Body temperature; Result Unstructured Data: Test Result:increased; Comments: as fever adverse event reported; Test Date: 20210514; Test Name: SARS-CoV-2 infection test; Test Result: Negative
CDC Split Type: ROPFIZER INC2021696778

Write-up: suspension of consciousness; Heart failure; Fever; Acute pulmonary edema; Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB RO-NMA-2021-SPCOV11177. A 60-years-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EY2172 and expiration date not provided), via intramuscular, on 13May2021, at single dose, for COVID-19 immunization. Medical history included heart failure in treatment with three stents for acute events. Concomitant medication included sacubitril valsartan sodium hydrate (ENTRESTO) taken for cardiac failure from 15Jul2020. The patient experienced heart failure (death, hospitalization) on 14May2021, fever (death, hospitalization) on 14May2021, acute pulmonary edema (death, hospitalization) on 14May2021, death (death) on 29May2021. On 14May2021, the patient developed fever, heart failure, acute pulmonary edema and death. The physician comments were: According to the family, 24 hours after the vaccination, patient had fever that gave way to antipyretics initially, but the fever reappeared intermittently for 4 days. On 17May2021 (reported as "the fourth day"), the patient presented an episode of suspension of consciousness, which was why he was referred to the emergency room. In the reporter''s opinion the events were related to Comirnaty. The adverse reaction was assessed as "results in death" by the primary reporter. The patient underwent lab tests and procedures which included body temperature was increased (as fever adverse event reported) on 14May2021; Sars-Cov-2 test was negative on 14May2021. Therapeutic measures were taken as a result of event fever. The outcome of the events was fatal. The patient died on 29May2021 (also reported as "the night of 28-29May 2021"). It was not reported if an autopsy was performed. Sender''s comments: The Agency requested the investigation of the case at the Regulatory Authority, to no result yet. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown; Heart failure; Fever; Acute pulmonary edema; suspension of consciousness


VAERS ID: 1429187 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Contusion, Haemorrhage, Platelet count, Thrombocytopenia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRONOLACTONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Unspecified congenital anomaly of heart
Allergies:
Diagnostic Lab Data: Test Name: thrombocyte count; Result Unstructured Data: Test Result:33; Comments: thrombocytopenia on 33 (units not specified)
CDC Split Type: SEPFIZER INC2021696309

Write-up: cardiac arrest; Thrombocytopenia; small bleedings like mestruation; Bruises; This is a spontaneous report from a contactable nurse reporting about her twin sister. A 55-years-old female patient received BNT162B2 (COMIRNATY), second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; apixaban (ELIQUIS), unknown from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. Medical history included Unspecified congenital anomaly of heart/ congenital heart defect. Concomitant medication(s) included spironolactone. Historical vaccine included first dose of BNT162B2 (COMIRNATY) for for covid-19 immunisation. Reporter was a nurse and had received first dose Pfizer covid vaccine. Reporter and her twin sister were identical twins, i.e. They were like one person divided into two people. Reporter sister has had a congenital heart defect. She took both doses of Pfizer covid vaccine. After 2-3 weeks she started to get bruises and had very small bleedings like menstruations. They are 55 so it could not be normal. First they thought that it was due the Eliquis she was taking. Then they gave her spironolactone. She had thrombocytopenia on 33. But the physicians could not explain and were not considering it to be an adverse event of the vaccine. She got heart stop and now she has passed away. The event outcome for cardiac arrest was fatal, for other events was unknown. Follow-up (11Jun2021): This is a follow-up spontaneous report from a contactable nurse based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number SE-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-058268), license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: 2021696309) on 11-Jun-2021 and was forwarded to BMS on 14-Jun-2021. This spontaneous case was reported by a nurse and describes the occurrence of fatal CARDIAC ARREST, THROMBOCYTOPENIA and HAEMORRHAGE (small bleedings like mestruation) in 55-year-old female patient who received apixaban (Eliquis) for an unknown indication. The occurrence of additional non-serious events is detailed below CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19 immunisation. The patient''s past medical history included Unspecified congenital anomaly of heart. On an unknown date, the patient started Eliquis (unknown route) and Covid-19 Vaccine (unknown route) 1st dose. On an unknown date, the dose was changed to 2nd dose. On an unknown date, the patient experienced CARDIAC ARREST (seriousness criteria death and medically significant), THROMBOCYTOPENIA (seriousness criterion medically significant), HAEMORRHAGE (seriousness criterion medically significant) and CONTUSION (Bruises). The action taken with Eliquis(Unknown) was unknown. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. At the time of death, THROMBOCYTOPENIA, HAEMORRHAGE and CONTUSION outcome was unknown. The patient took both doses of covid vaccine. After 2-3 weeks she started to get bruises and had very small bleedings like menstruations. First, they thought that it was due the Eliquis she was taking. Then they gave her spironolactone. She had thrombocytopenia on 33. But the physicians could not explain and were not considering it to be an adverse event of the vaccine. She got heart stop and passed away. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 33 units not specified. For Eliquis(Unknown), the reporter considered HAEMORRHAGE and CONTUSION to be related. No further causality assessments were provided for CARDIAC ARREST and THROMBOCYTOPENIA. Causality Assessment for drug: apixaban of Bruise, Minor bleed per reporter was related, per company (Bristol-Myers Squibb) was related. For drug: APIXABAN of Thrombocytopenia, Cardiac arrest per reporter was No Information, per company (Bristol-Myers Squibb) was Not Related. Information about lot/batch number has been requested.; Sender''s Comments: BMS Medical Evaluation Comment: This patient died due to cardiac arrest after receiving apixaban therapy. This patient also vaccinated for COVID-19. Based on the anticoagulant action of apixaban, its role in the event hemorrhage is considered as possible. Based on the etiology of the reported event, cardiac arrest is considered as not related to apixaban. Based on the limited information available regarding the therapy details, event onset date, action taken with the suspect and outcome of the event, it cannot be as Pfizer Medical Evaluation Comment: Based on the temporal relationship that events started 2-3 weeks after Pfizer COMIRNATY vaccination, all events are not considered likely related to COMIRNATY. The events may represent intercurrent conditions or related to co-suspect product apixaban. Contribution factors may also include patient''s congenital heart defect, especially to the event cardiac arrest.certained with the reasonable possibility that the apixaban could have contributed to the event thrombocytopenia.,Linked Report(s) : SE-PFIZER INC-2021696169 Same reporter and product, different patient and event.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1429203 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Gout; Hyperlipidaemia; Hypertension; Obesity ((BMI 31) since several years (concluded by reporter as metabolic syndrome))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: artery blood gasometry; Result Unstructured Data: Test Result:Lactate 17; Comments: Checking artery bloodgases, Lactate 17; Test Name: ECG; Result Unstructured Data: Test Result:still heart inspite of repeated doses of adrenalin; Comments: ECG shows still heart inspite of repeated doses of adrenaline and compressions.
CDC Split Type: SEPFIZER INC2021688250

Write-up: Deceased unknown cause, cardiac arrest; acute MI; Chest Pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This physician reported different events for both doses of Comirnaty for the same patient. This is the first of two reports. The regulatory authority report number for the first, serious report is [SE-MPA-2021-045669]. A 61-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on Jun2021 (Batch/Lot Number: unknown) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes from 2016 and ongoing, ongoing obesity: (BMI 31) since several years (concluded by reporter as metabolic syndrome), hyperlipidaemia from 2010 and ongoing, ongoing gout, hypertension from 2009 and ongoing. Historical vaccine included Comirnaty (covid-19 vaccines; batch/lot not provided), first dose administered on unknown date in 2021 and experienced chest pain on unknown date after the first dose of Comirnaty. The patient''s concomitant medications were not reported. The patient experienced deceased unknown cause, cardiac arrest, acute MI and chest pain (approx 1 hr after the second dose), all on Jun2021 with fatal outcome. The patient underwent lab tests which included blood gases: lactate 17 (Checking artery bloodgases, Lactate 17) on unknown date, electrocardiogram: shows still heart inspite of repeated doses of adrenaline and Lucas compressions on unknown date. The patient died on an unspecified date. An autopsy was not performed. Reported on the same day the patient experienced cardiac arrest in his home. Bystander CPR initiatally, initial rythm VF (ventricular flutter), defibrillated x6 and then asystolic. CPR continued for i 55 min. At admission to hospital intubated without spontaneous circulation an asystole on ECG. Ultrasound led pinprick in A. Femoralis and V.Femoralis and dministring 6F introducer. Checking artery bloodgases, Lactate 17. ECG shown still heart inspite of repeated doses of adrenaline and Lucas compressions. Patient was deceased on the same day as vaccination with dose two.According to the rapporteur several risk factors for cardiovascular disease are present, most likely cause of death is acute MI, but ECG was not assessable (no bearing rythm). Autopsy was not yet concluded. Report assessed as serious, death. Cause of Death was set as cardiac arrest, pending autopsy result. Treatment received for cardiac arrest and acute MI. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-2021691873 the same patient, different dose and event; Reported Cause(s) of Death: Acute myocardial infarction; Cardiac arrest


VAERS ID: 1429204 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7842 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Respiratory insufficiency (The report states that the cause of death may probably be due to severe lung disease)
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Ischemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021688305

Write-up: respiratory failure (severe lung disease); respiratory failure (severe lung disease); Deceased; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-045788. A 76-year-old male patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on an unknown date in May2021 (Lot Number: FA7842) as single dose for covid-19 immunisation. Medical history included ongoing respiratory failure (The report states that the cause of death may probably be due to severe lung disease), Ischemic heart disease and not ongoing; diabetes mellitus and not ongoing. The patient''s concomitant medications were not reported. The patient was found dead in his home two days after receiving dose 2 of the vaccine. According to the physician, it was unclear if there was any connection to the vaccine but the physician reported that it might probably be due to the man''s severe lung disease which the reporter also stated as the cause of death. The physician also informed that an autopsy will not be performed on the man. There was no further information stated in the report regarding the man''s death. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Respiratory insufficiency


VAERS ID: 1429467 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Circulatory collapse, Death, Palpitations
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 (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), 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: Atrial fibrillation; Congestive cardiac failure; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021696269

Write-up: No heart beat; Collapsed; Complaint of heart palpitations; Death; This is a spontaneous report from a contactable physician. A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: FC3558 and Expiration Date: Sep2021) via an unspecified route of administration on 08Jun2021 10:39 as dose 1, single, for COVID-19 immunization. Diluent batch number#4945; Expiry date May2023. The vaccine was reconstituted on 08Jun2021. Medical history included hypertension, cardiac failure congestive, atrial fibrillation all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was reported that on 08Jun2021 22:00, patient complained of heart palpitations, at 22:10, collapsed and at 22:55, the patient was assessed by EMS found no breathing and no heart beat. The patient died on 08Jun2021. No further information was available at the time of this report.; Sender''s Comments: Based on the temporal relationship and the information provided in the narrative, the causal association between the suspect drug and the events 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: Assessed by EMS found no breathing and heart beat


VAERS ID: 1429468 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3588/495/5 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Asthenia, Chills, Diarrhoea, Dyspnoea, Hypoaesthesia oral, Loss of consciousness, Pain, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Venous ulcer NOS (Admitted three months back)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021709436

Write-up: Fever; pain; she was weak; Then she pass out; Diarrhea; Shortness of breath; loss of taste; vomiting yellowish stuff.; Shivering; numbness of mouth; This is a spontaneous report from a contactable other Health care professional. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection,), dose 1 on 31May2021 12:06 (at the age of 76 years old) (Batch/Lot Number: FC3588/495/5; Expiration Date: Sep2021) as dose 1, single for COVID-19 immunisation. Medical history included Venous ulcer and admitted three months back. The patient''s concomitant medications were not reported. On an unspecified date the patient experienced fever, pain, on 01Jun2021 experienced shivering, numbness of mouth, on 02Jun2021 experienced loss of taste, vomiting yellowish stuff. On 03Jun2021 experienced Diarrhea, Shortness of breath, and on 04Jun2021 she was weak, and diarrhea continued then she passed out. The patient died on 04Jun2021. It was not reported if an autopsy was performed. Therapeutic measures were taken as a result of pain, loss of taste and vomiting yellowish stuff. The outcome of the events was fatal. No further information was available at the time of this report.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events pyrexia,vomiting,pain,Ageusia,diarrhoea,loss of consciousness,dyspnoea,Hypoaesthesia oral,chills and asthenia cannot be totally 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: 1429470 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021710066

Write-up: Headache post vaccination; This is a spontaneous report from a contactable physician. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FA7812) via unspecified route single dose for COVID-19 immunisation on 02Jun2021 13:20 at 77-year-old. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced headache post vaccination on 02Jun2021 with outcome of fatal. The patient died on 04Jun2021. It was unknown if an autopsy was performed. No further information was available at the time of this report.; Sender''s Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: Headache


VAERS ID: 1430783 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-31
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Tod; Tod; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Tod) and CARDIAC FAILURE ACUTE (Tod) in a 77-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Coronary heart disease. On 01-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced DEATH (Tod) (seriousness criteria death and medically significant) and CARDIAC FAILURE ACUTE (Tod) (seriousness criteria death and medically significant). The patient died on 31-Mar-2021. The reported cause of death was Acute heart failure. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Tod) and CARDIAC FAILURE ACUTE (Tod) to be unlikely related. No concomitant medications were reported. Treatment information was not provided. This fatal case concerns a 77-year-old male with serious unexpected events cardiac failure acute with outcome death. Event latency 2 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This fatal case concerns a 77-year-old male with serious unexpected events cardiac failure acute with outcome death. Event latency 2 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Acute heart failure


VAERS ID: 1430808 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-08
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Hypothyreosis; Nicotine abuse
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210650031

Write-up: PULMONARY EMBOLISM; DEEP VEIN THROMBOSIS LEG; This spontaneous report received from a physician via a Regulatory Authority concerned a 57 year old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included nicotine abuse, arterial hypertension, and hypothyreosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: X0985 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The drug start period was 10 days. No concomitant medications were reported. On 08-JUN-2021, the patient experienced deep vein thrombosis leg. On 13-JUN-2021, the patient experienced pulmonary embolism. On same day patient died from lung embolism. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of deep vein thrombosis leg and pulmonary embolism on 13-JUN-2021. This report was serious (Death).; Sender''s Comments: V0: 20210650031-Covid-19 vaccine ad26.cov2.s-Pulmonary embolism, Deep vein thrombosis leg. 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: LUNG EMBOLISM


VAERS ID: 1430838 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-19
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021751178

Write-up: died one day after the second vaccination; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Biontech [manufacturer control number: 66632], license party for Comirnaty. A female patient of an unknown age received 2nd dose BNT162B2 (COMIRNATY) at single dose on an unknown date via an unknown route for COVID-19 immunisation. Medical history and concomitant drug were not provided. Historical vaccine included 1st dose BNT162B2 (COMIRNATY) for COVID-19 immunisation. It was reported that a "very fit" woman died on19Jun2021, one day after the second vaccination. It was unknown if autopsy was performed. Lot/batch number has been requested.; Reported Cause(s) of Death: died one day after the second vaccination


VAERS ID: 1430839 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-20
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-28
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: 2021-05-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021751207

Write-up: got Pfizer vaccine on 14May and died on 20May2021; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 66646], license party for Comirnaty. Patien''s parent (contactable) reported his/her 21-year-old son received BNT162B2 (COMIRNATY) at single dose for COVID-19 immunisation on 14May2021. Relevant history and concomitant drugs were unknown. The patient died on 20May2021. Cause of death was not reported. Unknown if autopsy performed or not. Lot/batch number has been requested.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1431589 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fall
SMQs:, Accidents and injuries (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: ESJNJFOC20210647447

Write-up: DEATH; FELL TO GROUND; This spontaneous report received from a patient via social media company representative concerned a 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, and batch number were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The woman who was walking along the road she fell to the ground. On an unspecified date, the patient experienced death. On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of fell to ground was not reported. This report was serious (Death). This case, from the same reporter is linked to 20210647442 and 20210647445.; Sender''s Comments: V0:20210647447-COVID-19 VACCINE AD26.COV2.S-DEATH. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1431597 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002186 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation, Cerebral artery thrombosis, Cerebral infarction
SMQs:, Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: GALANTAMINE; LOSATRIX; PLAVIX; NITROSID; PIOGLITAZONE; PARACETAMOL; SIMVASTATIN; ATENBLOCK; TRAJENTA
Current Illness:
Preexisting Conditions: Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20212

Write-up: Atrial fibrillation; Cerebral infarction; Middle cerebral artery thrombosis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021. This regulatory authority case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation), CEREBRAL INFARCTION (Cerebral infarction) and CEREBRAL ARTERY THROMBOSIS (Middle cerebral artery thrombosis) in an 86-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002186) for COVID-19 vaccination. No medical history was provided. Concomitant products included GALANTAMINE, LOSARTAN POTASSIUM (LOSATRIX), CLOPIDOGREL BISULFATE (PLAVIX), ISOSORBIDE DINITRATE (NITROSID), PIOGLITAZONE, PARACETAMOL, SIMVASTATIN, ATENOLOL (ATENBLOCK) and LINAGLIPTIN (TRAJENTA) for an unknown indication. On 28-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria death and medically significant), CEREBRAL INFARCTION (Cerebral infarction) (seriousness criteria death and medically significant) and CEREBRAL ARTERY THROMBOSIS (Middle cerebral artery thrombosis) (seriousness criteria death and medically significant). The patient died on 01-Jun-2021. The reported cause of death was Cerebral infarction. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the events was not applicable since the patient died. This fatal case concerns an 86-year-old female with serious unexpected events of atrial fibrillation, cerebral infarction, and cerebral artery thrombosis. Event latency 2 days after first 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.; Sender''s Comments: This fatal case concerns an 86-year-old female with serious unexpected events of atrial fibrillation, cerebral infarction, and cerebral artery thrombosis. Event latency 2 days after first 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: Cerebral infarction


VAERS ID: 1431600 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-05-10
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Ileus paralytic, Intestinal ischaemia, Mesenteric artery thrombosis, Pseudomembranous colitis
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal obstruction (narrow), Ischaemic colitis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20212

Write-up: death; Intestinal ischaemia; Mesenteric artery thrombosis; Pseudomembranous colitis; Paralytic ileus; This regulatory authority case was reported by a physician and describes the occurrence of INTESTINAL ISCHAEMIA (Intestinal ischaemia), MESENTERIC ARTERY THROMBOSIS (Mesenteric artery thrombosis), PSEUDOMEMBRANOUS COLITIS (Pseudomembranous colitis), ILEUS PARALYTIC (Paralytic ileus) and DEATH (death) in a 74-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 27-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced INTESTINAL ISCHAEMIA (Intestinal ischaemia) (seriousness criteria death and medically significant), MESENTERIC ARTERY THROMBOSIS (Mesenteric artery thrombosis) (seriousness criteria death, medically significant and life threatening), PSEUDOMEMBRANOUS COLITIS (Pseudomembranous colitis) (seriousness criteria death and medically significant) and ILEUS PARALYTIC (Paralytic ileus) (seriousness criteria death and medically significant). The patient died on 22-May-2021. The reported cause of death was Intestinal ischaemia and Mesenteric artery thrombosis. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information was not provided. This is a case of sudden death in a 74-year-old male subject with no known Medical History , who died 25 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 74-year-old male subject with no known Medical History , who died 25 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Intestinal ischaemia; Mesenteric artery thrombosis


VAERS ID: 1431604 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-04-17
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Fatigue, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Dementia
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728875

Write-up: having contracted COVID-19; drug ineffective; Appearance of desaturation; Fatigue extreme; Pyrexia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number is FR-AFSSAPS-2021057655. A 95-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EK9788), intramuscular route, administered in arm left on 04Feb2021 as dose 2 single and via intramuscular route, administered in arm left on 14Jan2021 (Lot Number: EM0477) as dose 1, single for COVID-19 immunisation. Medical history included advanced dementia and covid-19. The patient''s concomitant medications were not reported. On 17Apr2021, the patient experienced, appearance of desaturation, fever and intense fatigue. The patient lab test included sars-cov-2 test: positive result on an unspecified date. The patient was put on antibiotics, anticoagulants, antipyretics and oxygen. Evolution: Death of the patient as a result of the adverse effects without further details. Hence cause of death was considered because of appearance of desaturation, fever and intense fatigue. The patient died on an unknown date in 2021. It was not reported if an autopsy was performed. The outcome of the events was fatal.; Reported Cause(s) of Death: Fatigue extreme; Pyrexia; Appearance of desaturation


VAERS ID: 1431781 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-06-09
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Cardiac arrest, Myocarditis, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypothyreosis; Variant angina
Preexisting Conditions: Medical History/Concurrent Conditions: Gastritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100100794

Write-up: Myocarditis; Cardiac arrest; Cardiac arrhythmia; Ventricular fibrillation; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis), CARDIAC ARREST (Cardiac arrest), ARRHYTHMIA (Cardiac arrhythmia) and VENTRICULAR FIBRILLATION (Ventricular fibrillation) in a 65-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002620) for COVID-19 vaccination and Prophylactic vaccination. The patient''s past medical history included Gastritis. Concurrent medical conditions included Hypothyreosis and Variant angina. On 27-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria death, hospitalization and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death, hospitalization and medically significant), ARRHYTHMIA (Cardiac arrhythmia) (seriousness criteria death, hospitalization and medically significant) and VENTRICULAR FIBRILLATION (Ventricular fibrillation) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized on 09-Jun-2021 due to ARRHYTHMIA, CARDIAC ARREST, MYOCARDITIS and VENTRICULAR FIBRILLATION. The reported cause of death was Heart arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not provided. Treatment included cardiopulmonary resuscitation for the cardiac arrest. The action taken with mRNA 1273 with the events was considered as not applicable. This is a case of death in a 65-year-old male patient, that occurred 1 day after receiving the second dose of vaccine (Lot number 3002620). Based on the provided information, the patient had cardiac arrest and expired. A possible confounding factor is the patient''s medical history of variant angina. No further information is expected.; Sender''s Comments: This is a case of death in a 65-year-old male patient, that occurred 1 day after receiving the second dose of vaccine (Lot number 3002620). Based on the provided information, the patient had cardiac arrest and expired. A possible confounding factor is the patient''s medical history of variant angina. No further information is expected.; Reported Cause(s) of Death: Heart arrest


VAERS ID: 1431782 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient suffered from unspecified previous pathologies.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210647445

Write-up: HEART ATTACK; This spontaneous report received from social media platform reported via a company representative concerned a 76 year old male patient. The patient''s height, and weight were not reported. The patient had suffered from unspecified previous pathologies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose, start therapy date were not reported 1 total administered on JUN-2021 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 an unspecified date in JUN-2021, the patient died from heart attack after few hours of being vaccinated. Although medical services tried to resuscitate him, it was not possible. The patient was a prisoner and was serving time in the prison. The patient died on an unspecified date in JUN-2021. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210647442 and 20210647447.; Sender''s Comments: V0: 20210647445-covid-19 vaccine ad26.cov2.s-heart attack. 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: HEART ATTACK


VAERS ID: 1432162 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Congenital anomaly, Maternal exposure during pregnancy
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021745377

Write-up: maternal exposure during pregnancy; Congenital Anomaly; This is a spontaneous report. This is the second of two reported. The first report was received from a contactable consumer from the Regulatory Agency (RA). The regulatory authority report number is (GB-MHRA-WEBCOVID-202106121548503420-OGSAK), Safety Report Unique Identifier GB-MHRA-ADR 25466169 A fetus patient of an unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), dose 2 via transplacental on 29May2021 as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced maternal exposure during pregnancy and congenital anomaly(assessed as serious as congenital anomaly) on an unspecified date. The outcome of the event was fatal No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1432262 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-08
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Death, Sudden death
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: 2021-06-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of CARDIAC ARREST, SUDDEN DEATH and DEATH in a 53-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Cutaneous) 1 dosage form. On 08-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (seriousness criteria death and medically significant), SUDDEN DEATH (seriousness criteria death and medically significant) and DEATH (seriousness criteria death and medically significant). The patient died on 08-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided. Treatment information was not reported. This fatal case concerns a 53-year-old male with a serious unexpected event of cardiac arrest, sudden death, and death. Event latency 7 days after mRNA-1273. Case of death unknown. 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.; Sender''s Comments: This fatal case concerns a 53-year-old male with a serious unexpected event of cardiac arrest, sudden death, and death. Event latency 7 days after mRNA-1273. Case of death unknown. 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: 1432401 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Malaise
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021703073

Write-up: Death; The patient felt unwell when eating; This is a spontaneous report from a contactable consumer (patient wife) received via a contactable reporter. The case refers to a patient of unknown gender and age. Medical history and concomitant medications were not reported. On unknown date at unknown time (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. On unknown date at unknown time (after an unknown time gap from the vaccination), the patient felt unwell when eating an experienced death. Onan unknown date, the outcome of the events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: After waiting following the vaccination, the patient felt unwell when eating and was transported by ambulance. Thereafter, the patient died. The medical facility assessed that the causal relationship with the vaccine was unknown because a meal had been taken. The medical facility assessed the causality between the events and BNT162b2 as unknown.; Reported Cause(s) of Death: Unknown cause of death; The patient felt unwell when eating


VAERS ID: 1432411 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Drowning
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021739595

Write-up: Drowning; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21115230. The patient was an 86-year and 1-month-old female. Body temperature before vaccination was 36.3 degrees Centigrade. The family history was not provided. The patient had medical history of anaemia. On 19May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA4597, Expiration date 31Aug2021). On 10Jun2021 at 14:15 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 11Jun2021 at 21:00 (18 hours and 45 minutes after the vaccination), the patient experienced drowning. On 11Jun2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was visiting another hospital regularly for anaemia. The patient lived alone, and her activity of daily living (ADL) was independent. On 10Jun2021 (the day of vaccination), at 14:15, although the patient received the second dose of BNT162b2 vaccination, she complained of no changes in the physical condition on the day of the vaccination. On 11Jun2021 (one day after vaccination), the patient met with nobody. Home security system was placed in her home. There was a specification that if the patient would not move for 12 hours, safety confirmation would be made. On 12Jun2021, at around 08:00 (one day, 17 hours, and 45 minutes after vaccination), the staff member of the home security system visited the patient, and the patient was found drowning in the bathtub. 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 anaemia. The patient died on 11Jun2021. It was unknown if an autopsy was performed. The cause of death was drowning.; Reported Cause(s) of Death: Drowning


VAERS ID: 1432412 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Incontinence, Investigation, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Effusion pleural bloody (the possibility of a malignant disease was suggested)
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: detailed examination for right pleural effusion bloody; Result Unstructured Data: Test Result:possibility of a malignant disease; Comments: On unknown date in Dec2020, the patient underwent detailed examination for right pleural effusion bloody in the advanced hospital, and the possibility of a malignant disease was suggested.
CDC Split Type: JPPFIZER INC2021749328

Write-up: Cardio-respiratory arrest; seizure; incontinence; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21115359. The patient was an 87-year and 3-month-old male. Body temperature before vaccination was not provided. The patient had family histories of hypertension, diabetes mellitus, and tongue carcinoma. 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). In the morning of 11Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 12Jun2021 at 14:00 (one day after the vaccination), the patient experienced cardio-respiratory arrest. On 12Jun2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 11Jun2021 (the day of vaccination), in the morning, the patient received the first dose of BNT162b2 vaccination. At that time, no abnormalities were observed in the physical condition. On 12Jun2021, at around 14:00 (one day after vaccination), at the time of assisted bathing, the patient had incontinence while he was sitting in the chair in the undressing room, and he had cardio-respiratory arrest after seizure. 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 right pleural effusion. The reporting physician commented as follows: On unknown date in Dec2020, the patient underwent detailed examination for right pleural effusion bloody in the advanced hospital, and the possibility of a malignant disease was suggested. The causality between the event and BNT162b2 vaccination was unknown. The outcome of cardio-respiratory arrest was fatal; outcome of other events was unknown. The patient died on 12Jun2021. It was not reported if an autopsy was performed. The cause of death was cardio-respiratory arrest. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1432413 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Computerised tomogram, Near drowning
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ascites (the patient was hospitalized from 27May2021 to 02Jun2021); Gastric cancer; Hospitalization; Hypertension; Pleural effusion (the patient was hospitalized from 27May2021 to 02Jun2021); Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210620; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: before vaccination; Test Date: 20210620; Test Name: Postmortem CT; Result Unstructured Data: Test Result:findings of near drowning only; Comments: Findings of near drowning in the lung and paranasal sinus only. There was no abnormality other than known finding(s) in the head and thoracoabdominal part.
CDC Split Type: JPPFIZER INC2021749331

Write-up: Near drowning; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES) and from the regulatory authority. Regulatory authority report number is v21115449. The patient was a 91-year-old male. Body temperature before vaccination was 35.6 degrees centigrade. The patient''s family history was unknown. Medical history of pleural effusion and ascites, for which the patient was hospitalized from 27May2021 to 02Jun2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received hypotensive 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 the status after the surgery for gastric cancer, and hypertension. On 20Jun2021 at 10:45 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) intramuscular at the age of 91-year-old in the left arm for COVID-19 immunization at other facility. On 20Jun2021 at 20:28 (9 hours and 43 minutes after the vaccination), the patient experienced near drowning. The event resulted in death (The cause of death was near drowning). The patient did not receive any treatment for the event. An autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19. The course of the event was as follows: At 19:30, the patient was bathing alone and did not come out. At 20:28, family member went to found out that the patient sank in the bathtub. Emergency medical service performed cardiopulmonary resuscitation and the patient was transferred to a hospital. However, at 21:08, the patient was confirmed to be dead. Postmortem CT (on 20Jun2021) revealed findings of near drowning in the lung and paranasal sinus only. There was no abnormality other than known finding(s) in the head and thoracoabdominal part. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The outcome of event was fatal. The reporting physician commented as follows: On 02Jun2021, at the time when the patient was discharged from the hospital, activities of daily living (ADL) including eating meals and walking were more or less maintained. Causality between near drowning and the vaccination was unknown.; Reporter''s Comments: On 02Jun2021, at the time when the patient was discharged from the hospital, activities of daily living (ADL) including eating meals and walking were more or less maintained. Causality between near drowning and the vaccination was unknown.; Reported Cause(s) of Death: Near drowning


VAERS ID: 1432414 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Anuria, Blood test, Computerised tomogram abdomen, Computerised tomogram head, Intestinal ischaemia, Investigation, Multiple organ dysfunction syndrome, Skin discolouration, Thrombosis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Generalised arteriosclerosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: Blood test; Result Unstructured Data: Test Result:multi organ failure; Test Date: 20210612; Test Name: Abdomen CT; Result Unstructured Data: Test Result:intestinal ischaemia; Test Date: 20210612; Test Name: Head CT; Result Unstructured Data: Test Result:No apparent cerebrovascular disease.; Test Date: 20210614; Test Name: Lower extremity arterial echo; Result Unstructured Data: Test Result:obstruction below the superficial femoral artery
CDC Split Type: JPPFIZER INC2021749335

Write-up: intestinal ischaemia; multi organ failure; color change in the right lower limb; anuria; Thromboembolism multiple; disturbed consciousness; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21115291. The patient was a 95-year and 7-month-old male. 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 09Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 12Jun2021 (3 days after the vaccination), the patient experienced thromboembolism multiple. On 15Jun2021 (6 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 12Jun2021 (3 days after vaccination), in the morning, the patient was emergently transferred to the reporting hospital for disturbed consciousness. Head CT showed no obvious cerebrovascular disorder. On 13Jun2021 (4 days after vaccination), the patient had color change in the right lower limb. He also had anuria. On 14Jun2021 (5 days after vaccination), an echo of the artery of the lower limb showed obstruction below the superficial femoral artery. Abdominal CT showed intestinal ischaemia, and the blood examination showed multi organ failure. On 15Jun2021 (6 days after vaccination), the patient died. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were as follows: The patient was an oldest old, and he had generalised arteriosclerosis. The reporting physician commented as follows: Since the possibility of side reactions caused by the vaccine could not be ruled out, this case was reported.; Reported Cause(s) of Death: Thromboembolism multiple; disturbed consciousness; color change in the right lower limb; anuria; intestinal ischaemia; multi organ failure


VAERS ID: 1432415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Blood glucose, Body temperature, Chest discomfort, Chest pain, Coma scale, Computerised tomogram, Heart rate, Oxygen saturation, Pulmonary congestion, Pulmonary embolism
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Infective pneumonia (broad)

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Multiple myeloma (under treatment and permission for vaccination was given by primary care physician)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210619; Test Name: BS; Result Unstructured Data: Test Result:120; Comments: at 19:24; Test Date: 20210616; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: before vaccination; Test Date: 20210619; Test Name: CS; Result Unstructured Data: Test Result:10; Comments: at 19:24; Test Date: 20210619; Test Name: CS; Result Unstructured Data: Test Result:300; Comments: at 19:38; Test Date: 20210619; Test Name: Postmortem CT; Result Unstructured Data: Test Result:could not identify causative lesion; Comments: Pulmonary congestion was present; Test Date: 20210619; Test Name: Pulse; Result Unstructured Data: Test Result:52; Comments: at 19:24; Test Date: 20210619; Test Name: SpO2; Test Result: 97 %; Comments: at 19:24
CDC Split Type: JPPFIZER INC2021749344

Write-up: chest tightness/the patient held the chest, leaned forward, and complained of pain; chest tightness/the patient held the chest, leaned forward, and complained of pain; acute coronary syndrome, suspected; pulmonary embolism, suspected; Pulmonary congestion; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21115360. The patient was an 80-year-old female. Body temperature before vaccination was 37.0 degrees centigrade. Family history was unknown. Medical history included ongoing multiple myeloma, for which the patient was under treatment and permission for vaccination was given by primary care physician. On 26May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA2453, Expiration date 31Aug2021). On 16Jun2021 at 16:10 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 19Jun2021 at 19:00 (3 days 2 hours 50 minutes after the vaccination), the patient experienced chest tightness. On 19Jun2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 19Jun2021 at 19:00, during supper, the patient held the chest, leaned forward, and complained of pain, for which ambulance was requested. At 19:24, emergency medical service arrived. Pulse was 52, Coma Scale (CS) was 10, SpO2 was 97%, and blood sugar (BS) was 120. At 19:38, CS was 300 and the patient had asystole. Cardiopulmonary resuscitation (CPR) was initiated; however, spontaneous circulation and respiration did not return. At 21:05, the patient arrived at the reporting hospital. Postmortem CT could not identify causative lesion. Pulmonary congestion was present. Consent to perform autopsy could not be obtained. Outcome of pulmonary congestion was unknown. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was acute heart disorder. The reporting physician commented as follows: Considering sudden onset and the symptoms, acute coronary syndrome, pulmonary embolism, etc. were suspected; however, it could not be identified whether these were the related cause.; Reported Cause(s) of Death: Chest tightness; the patient held the chest, leaned forward, and complained of pain; acute coronary syndrome, suspected; pulmonary embolism, suspected; Pulmonary congestion


VAERS ID: 1432416 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Decreased appetite, Movement disorder, Pneumonia, Pyrexia, Sepsis, Shock
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Old tuberculosis
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021749386

Write-up: Shock; Consciousness disturbed; possibility of pneumonia and sepsis; possibility of pneumonia and sepsis; Pyrexia; Inappetence; Difficulty moving body; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21115326. The patient was a 95-year-old female. Body temperature before vaccination was 36.6 degrees centigrade. Family history was not reported. Medical history included old tuberculosis. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not provided) for COVID-19 immunisation. On 16Jun2021 (the day of vaccination), the patient received the second 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 17Jun2021 (1 day after the vaccination), the patient experienced pyrexia, inappetence, and difficulty moving body. On 20Jun2021 (4 days after the vaccination), the patient was admitted to the hospital. On 20Jun2021 (4 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 16Jun2021, the patient received the second vaccination. On the following day on 17Jun2021, the patient developed pyrexia and inappetence, and the patient became bedridden. On 20Jun2021, the patient had consciousness disturbed and emergently transferred to a hospital. The patient was in shock state. The patient was unresponsive to treatment and on 20Jun2021 at 22:16, the patient died. It was not reported if autopsy was done or not. The patient was admitted to the hospital from 20Jun2021 to 20Jun2021. The reporting physician classified the events as serious (death and hospitalization) and assessed that the events was related to BNT162b2. Other possible cause of the events such as any other diseases was possibility of pneumonia and sepsis. The reporting physician commented as follows: Right lung field originally showed shadow due to old tuberculosis and it was difficult to assess whether it was complicated by pneumonia. From the clinical course, the patient developed pyrexia which occurred and continued after the vaccination and died without improvement; thus, causality between the event and the vaccine was highly likely.; Reported Cause(s) of Death: Pyrexia; Inappetence; Difficulty moving body; possibility of pneumonia and sepsis; possibility of pneumonia and sepsis; Consciousness disturbed; Shock


VAERS ID: 1432419 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Diarrhoea, Hyperhidrosis, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: body temperature; Result Unstructured Data: Test Result:35.0 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021749426

Write-up: chills; Diarrhoea; Vomiting; sweat; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21115231. The patient was an 83-year and 10-month-old male. Body temperature before vaccination was 35.0 degrees centigrade. The patient had no particular family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 18Jun2021 at 11:45 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021), at the age of 83 years old, via an unspecified route of administration as a single dose for COVID-19 immunization. On 18Jun2021 at 20:00 (8 hours 15 minutes after the vaccination), the patient experienced diarrhoea and vomiting. On 20Jun2021 (2 days after the vaccination), the outcome of the events was fatal. The course of the event was as follows: On 18Jun2021, the patient received the first dose of BNT162b2 vaccination and went home. Until the patient had supper, no significant changes were observed. At around 20:00 (8 hours and 15 minutes after vaccination), the patient had frequent vomiting. He had a large amount of sweat. At 21:00 (9 hours and 15 minutes after vaccination), the patient changed his cloths, and he complained of chills. The patient pulled a blanket and a cotton blanket over his head, and the vomiting persisted. At 23:00 (11 hours and 15 minutes after vaccination), the patient had diarrhoea twice. On 19Jun2021 at 03:00 (15 hours and 15 minutes after vaccination), the patient slept for a short time. At 07:00 (19 hours and 15 minutes after vaccination), the patient had vomiting again. The patient called the Vaccine Call Center once, and his consciousness seemed to be alert, and thus, he was instructed to visit the healthcare facility. At 10:00 (22 hours and 15 minutes after vaccination), the patient had difficulty in visiting the hospital, and the reporting physician gave his wife domperidone (NAUZELIN), loperamide hydrochloride (LOPEMIN), and acetaminophen. However, his wife was instructed to request something illegible when the patient was unable to take fluid. Thereafter, the diarrhoea persisted. On 20Jun2021 at 2:00 (one day, 14 hours, and 15 minutes after vaccination), the patient took a little fluid, and he slept. Around 06:00 (one day, 18 hours, and 15 minutes after vaccination), his wife contacted that the patient stopped breathing when she went to see how the patient was doing. At 07:00 (one day, 19 hours, and 15 minutes after vaccination), the patient was confirmed dead. At around 8:00 (one day, 20 hours, and 15 minutes after vaccination), his wife contacted the police. The wife reported that the patient continued to have no pyrexia during the course, and his fingertips were cold in the afternoon and at night on 19Jun2021. The reporting physician classified the events 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 possibility of other infection which the patient might have was not zero. The reporting physician commented as follows: The patient was suspected to have side reactions after the vaccination according to the time course. However, it was considered that the possibility was not zero that the events were caused by other infection than the virus of the vaccine. Although a large amount of sweat was temporarily observed during the course, no pyrexia was confirmed, and the body temperature at the time of vaccination was 35 degrees Celsius. In addition, the hands were cold at night on 19Jun2021. Thus, the possibility that the patient had peripheral circulatory failure (DIC was suspected) could not be ruled out. At the pre-examination before the vaccination, the patient complained of nothing, and he said that he had seldom seen a doctor before. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Diarrhoea; Vomiting; sweat; chills


VAERS ID: 1432420 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-12
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-29
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: 2021-06-12
   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: Diabetes mellitus; Hypercholesterolaemia
Preexisting Conditions: Medical History/Concurrent Conditions: Mood disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021750181

Write-up: unknown cause of death; This is a spontaneous case from a contactable physician via a Pfizer sales representative. The patient was an 80-year-old. The patient''s gender was unknown. Body temperature before vaccination was not provided. The patient family history was not provided. The patient had medical histories of ongoing diabetes mellitus; ongoing hypercholesterolaemia; mood disorder. On 29May2021 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, solution for injection) intramuscularly at single dose for COVID-19 immunization. On 12Jun2021 (14 days after the vaccination), the patient experienced unknown cause of death. On 12Jun2021 (14 days after the vaccination), the outcome of the event was fatal. It was unknown if an autopsy was performed. The course of the event was as follows: On 29May2021 (the day of vaccination), the patient received a dose of BNT162b2 vaccination via intramuscular route. On 05Jun2021 (7 days after vaccination), the patient visited the reporting hospital for treatment for diabetes mellitus and hypercholesterolaemia which were the underlying diseases. The patient complained of no side reactions after the BNT162b2 vaccination, and the course was uneventful. On 12Jun2021 (14 days after vaccination), the police called with a question, and it was reported that the patient died. Thus, when the status at diagnosis was confirmed, the physician told the police that the patient received BNT162b2 vaccination. The reporting physician classified the event as serious (death) and assessed that the event was possibly related to BNT162B2. There was no other possible cause of the event such as any other diseases. Information on the lot/batch number has been requested.; Sender''s Comments: Based on information provided, as a cautionary measure and for reporting purposes, the Company considers that a causal association between the event Death (Unknown cause of death) and the administration of the Covid-19 Vaccine (BNT162b2, COMIRNATY) cannot be completely excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1432421 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-11
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain stem 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: 2021-06-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Spinal stenosis of lumbar region
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021751289

Write-up: Brain stem haemorrhage; This is a spontaneous case from a contactable physician and consumer received via a Pfizer sales representative and Medical information group. The patient was a 92-year-old male. Body temperature before vaccination was not provided. The patient family history was not provided. The patient had a medical history of spinal stenosis of lumbar region. On 31May2021 (at the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an intramuscular route of administration 0.3 ml for COVID-19 immunization. On 11Jun2021 (11 days after the vaccination), the patient experienced brain stem haemorrhage. On 11Jun2021 (11 days after the vaccination), the outcome of the event was fatal (as reported). On 11Jun2021, the patient collapsed at home. On 12Jun2021, the patient died. According to the patient''s wife, the cause of death was brain stem haemorrhage. It was not reported if an autopsy was performed. The physician considered the event to be serious (fatal outcome) and possibly related to BNT162b2. Information about the lot/batch number has been requested.; Sender''s Comments: Despite limited information provided, due to a plausible drug-event temporal association, the company cannot completely exclude a contributory role of Comirnaty in the occurrence of the reported brain hemorrhage. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Brain stem haemorrhage


VAERS ID: 1432609 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-17
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Guillain-Barre syndrome, Lung disorder, Pneumonia, Pyrexia
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021749027

Write-up: her lungs were weak; Pneumonia; fever due to infection; was diagnosed Guillain Barre syndrome; This is a spontaneous report from a non-contactable consumer. Received from an Online Marketing website. A female patient of an unspecified age received BNT162B2, dose 2 on Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included diabetes. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 on Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient was vaccinated with the Pfizer vaccine with its 2 doses at the end of April, on 15May she was hospitalized for mobility problems in extremities (movement impairment), on 17May, she was diagnosed with Guillian Barre Syndrome, she had to be intubated because her lungs were weakening, she was diabetic and blemished. Her health was complicated and she presented pneumonia and fever due to infection, she died on 23May, apparently it was her vaccine that caused the syndrome. The reporter hoped to take action and review the vaccine so that these things happen, it did not cause the same to all people, but the reporter did not want some of the consequences of the vaccine that can be fatal to be left lightly. The patient was hospitalized for all the events from 15May2021 to an unknown date. The patient died on 23May2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained. ; Reported Cause(s) of Death: Guillain Barre syndrome; lungs were weak; Pneumonia; fever


VAERS ID: 1432644 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Malaise
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: 2021-06-11
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholic; Bowel cancer; Heavy smoker (still smoked occasionally); Prostate cancer; Stress (under continuous stress)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021699436

Write-up: Death. Patient died on June 11th most likely due to cardiac arrest but not confirmed.; Patient felt unwell for a week after the second dose of COVID vaccine.; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 59-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on Jun2021 (Batch/Lot Number: Unknown) as single dose (at the age of 59-years old) for COVID-19 immunization. Medical history included alcoholic, prostate cancer, bowel cancer, stressed (under continuous stress), heavy smoker from an unknown date to 2013 (still smoked occasionally, not ongoing as reported). The patient''s concomitant medications were not reported. Historical vaccine was bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. It was reported as unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported as unknown if the patient received any other medications within 2 weeks of vaccination. The patient died on 11Jun2021 most likely due to cardiac arrest but not confirmed, on Jun2021. The patient also felt unwell for a week after the second dose of COVID vaccine on an unspecified date. The patient refused to go to the doctor after advice from friends. The patient was not treated for the events. The outcome of the event unwell was unknown. The patient died on 11Jun2021. An autopsy was not performed. Prior to vaccination, the patient was not diagnosed with COVID-19. It is unknown if the patient was tested for COVID-19 after vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1432684 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: TROMBYL
Current Illness: Arthrosis; Overweight
Preexisting Conditions: Medical History/Concurrent Conditions: Transient ischaemic attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021752346

Write-up: pulmonary embolism; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB SE-MPA-2021-046868. A 76-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on May2021 (at unknown age) as single dose for COVID-19 immunisation. Medical history included Arthrosis ongoing, Overweight ongoing, TIA-Transient ischaemic attack. Concomitant medication included acetylsalicylic acid (TROMBYL). The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Report from a consumer regarding a 76-year-old female. Reported suspect vaccine was COMIRNATY dose 2 (covid-19 vaccines). Reported suspect adverse event was Pulmonary embolism on May2021. The reporter states in accordance with the autopsy report that pulmonary embolism was the cause of Death. Report assessed as serious, death. The man died on unknown date 14 days after receiving dose two. The patient died on an unspecified date. An autopsy was performed that revealed pulmonary embolism. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1432984 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021752084

Write-up: Four days later he was dead in his apartment; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-32141. A 74-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 08May2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced four days later he was dead in his apartment on 11May2021. The patient died on 11May2021. 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: Four days later he was dead in his apartment


VAERS ID: 1432997 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Fatigue
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021749810

Write-up: Decreased appetite; Fatigue; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 569819. A 97-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced decreased appetite, fatigue on an unspecified date. The outcome of the patient was died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Decreased appetite; Fatigue


VAERS ID: 1432998 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Decreased appetite, Fatigue, Pneumonia aspiration
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021749811

Write-up: Pneumonia aspiration; Confusional state; Decreased appetite; Fatigue; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 569816. An 86-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced pneumonia aspiration, confusional state, decreased appetite, fatigue all on an unspecified date. The outcome of events was death. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pneumonia aspiration; Confusional state; Decreased appetite; Fatigue


VAERS ID: 1432999 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-09
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021749812

Write-up: Haemorrhage intracranial; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 569553. A 60-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced haemorrhage intracranial on 09May2021. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Haemorrhage intracranial


VAERS ID: 1433055 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Death, Disease progression, Hepatic cirrhosis, Illness, Somnolence, Ultrasound scan
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 28
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: LASIX [FUROSEMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cirrhosis liver (in treatment for six months, under control)
Allergies:
Diagnostic Lab Data: Test Name: blood samples; Result Unstructured Data: Test Result:unknown results; Test Name: CT scan; Result Unstructured Data: Test Result:unknown results; Test Name: ultrasound; Result Unstructured Data: Test Result:unknown results
CDC Split Type: BEPFIZER INC2021752152

Write-up: That morning he was almost impossible to wake up and very drowsy; He got sick the night after the vaccination; liver cirrhosis/ had liver problems but after his vaccination it seems to have deteriorated a lot; liver cirrhosis/ had liver problems but after his vaccination it seems to have deteriorated a lot; died 3 weeks later; This is as spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is BE-FAMHP-DHH-N2021-96040. An elderly male patient of unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 23Apr2021 as single dose for covid-19 immunisation. Medical history included always very healthy, he had been in treatment for cirrhosis of the liver for six months (he didn''t drink) but was under control. Concomitant medication(s) included furosemide (LASIX). Patient already had liver problems but after his vaccination it seems to have deteriorated a lot. The reporting consumer did not know if it''s the vaccine, but it''s strange that he got so sick (Illness) right after his vaccine. Patient experienced Illness on 23Apr2021, that morning he was almost impossible to wake up and very drowsy on 24Apr2021, died on 21May2021. Patient was hospitalized the day after his 2nd vaccination and died 3 weeks later on 21May2021 from liver cirrhosis. He didn''t drink. The patient underwent lab tests and procedures which included Ct scan, blood samples, ultrasound. The patient died on 21May2021. 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: died 3 weeks later; liver cirrhosis; That morning he was almost impossible to wake up and very drowsy; He got sick the night after the vaccination; liver cirrhosis/ had liver problems but after his vaccination it seems to have deteriorated a lot


VAERS ID: 1433056 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-05-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Cardiovascular disorder
SMQs:, Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021752156

Write-up: Cardiovascular disorder; Aortic dissection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB BE-FAMHP-DHH-N2021-96265. An 84-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 07May2021 (Lot Number: EW6126) 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 cardiovascular disorder and aortic dissection, both on 13May2021. Patient received treatment, was hospitalization and surgery for treatment of aortic dissection. Evolution of the ADR: Death. The events resulted hospitalization and death. Patient died on 16May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Aortic dissection; Cardiovascular disorder


VAERS ID: 1433057 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Coma, Death, Haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholism; Heart disorder; Liver cirrhosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021752159

Write-up: Death; Coma; heavy unstoppable bleeding; Cardiac arrest; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-96464. A 64-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 15May2021 (Lot Number: EW6126) as single dose for covid-19 immunisation. Medical history included alcoholism, liver cirrhosis and heart problems. The patient''s concomitant medications were not reported. Patient was a risk patient (liver cirrhosis and heart problems) died two weeks after receiving the pfizer vaccine, during a visit to the dentist, heavy unstoppable bleeding (hemorrhage), cardiac arrest and coma on 26May2021, death on 29May2021. The reporting consumer asked was this a coincidence? His weakened and sick body could not cope with the second injection in reporter''s opinion. Outcome of the events was fatal. The patient died on 29May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death; unstoppable bleeding; cardiac arrest; coma


VAERS ID: 1433101 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Retching, SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: CZPFIZER INC2021752148

Write-up: Sudden death; Stomach issues; Retching; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB CZ-CZSUKL-21006784. A 78-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 26May2021 at the age of 78-years-old as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included omeprazole (OMEPRAZOL) and antihypertensives. On 26May2021, the patient had stomach problems, stomachache, felt like vomiting, but did not (retching), the patient did not feel good. The events stomachache, felt like vomiting, but did not (retching) were assessed as serious, medically significant. The patient was sudden death on an unknown date for an unknown reason. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on Jun2021. The patient died on an unspecified date. The outcome of the events stomachache and retching was unknown. An autopsy was performed and results were not available. Information about lot/batch number was requested.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1433102 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 626761A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   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: SORTIS; ANOPYRIN; TROMBEX; MILURIT; TRITACE; CORYOL [CARVEDILOL]; EZEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarct (stents used); Myocardial infarct (bypasses used)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION and BACK PAIN in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 626761A) for COVID-19 vaccination. The patient''s past medical history included Myocardial infarct (bypasses used) from 2002 to 2016 and Myocardial infarct (stents used) in 2002. Concomitant products included CLOPIDOGREL BISULFATE (TROMBEX) for Anticoagulant therapy, ACETYLSALICYLIC ACID (ANOPYRIN) for Antiplatelet therapy, RAMIPRIL (TRITACE) for Arterial hypertension, ALLOPURINOL (MILURIT) for Gout, ATORVASTATIN CALCIUM (SORTIS) for Hypercholesterolaemia, EZETIMIBE (EZEN) for Hyperlipidemia, CARVEDILOL (CORYOL [CARVEDILOL]) for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced BACK PAIN (seriousness criterion life threatening). On 09-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (seriousness criteria death, medically significant and life threatening). The patient died on 09-Apr-2021. The reported cause of death was myocardial infarction. An autopsy was performed, but no results were provided. At the time of death, BACK PAIN had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. No treatment information was provided by the reporter. The patient consulted Cardiologist and was observed as everything was normal. Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. However patient?s medical history could be a confounder.; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. However patient?s medical history could be a confounder.; Reported Cause(s) of Death: myocardial infarction


VAERS ID: 1433120 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-29
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Circulatory collapse, Dizziness, Dyspnoea, Gait disturbance, Nausea
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Chronic bronchitis; Hypothyroidism; Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Cardiovascular collapse; Gait instability; Dyspnea; Light headedness; Nausea; This regulatory authority case was reported by a physician and describes the occurrence of CIRCULATORY COLLAPSE (Cardiovascular collapse), GAIT DISTURBANCE (Gait instability), DYSPNOEA (Dyspnea), DIZZINESS (Light headedness) and NAUSEA (Nausea) in a 39-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for Prophylactic vaccination. Concurrent medical conditions included Hypothyroidism, Chronic bronchitis, Arterial hypertension and Obesity. On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced GAIT DISTURBANCE (Gait instability) (seriousness criterion death), DYSPNOEA (Dyspnea) (seriousness criterion death), DIZZINESS (Light headedness) (seriousness criterion death) and NAUSEA (Nausea) (seriousness criterion death). On 01-May-2021, the patient experienced CIRCULATORY COLLAPSE (Cardiovascular collapse) (seriousness criteria death and medically significant). The patient died on 01-May-2021. The reported cause of death was Acute heart failure. An autopsy was performed. The autopsy-determined cause of death. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product were not provided/unknown. Treatment medication were not reported/unknown. Very limited information regarding these events have been provided at this time. No further information is expected at this time. Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Acute heart failure; Autopsy-determined Cause(s) of Death.


VAERS ID: 1433123 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Arterial occlusive disease; Dementia; Diabetes mellitus (badly adjusted)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021752720

Write-up: Sudden cardiac death; Dyspnoea; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, Safety Report Unique Identifier DE-PEI-202100101095. A 87-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Apr2021 (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included ongoing Arterial hypertension, ongoing Arterial occlusive disease, ongoing Diabetes mellitus, ongoing Dementia. The patient''s concomitant medications were not reported. On 01Apr2021 the patient experienced Dyspnoea, Sudden cardiac death. The patient died on an unspecified date. An autopsy was not performed. Outcome of events was fatal. This report is serious as death. Relatedness of drug to reaction(s)/event(s) was Unclassifiable. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Suspected acute myocardial infarction


VAERS ID: 1434104 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021752715

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, Safety Report Unique Identifier DE-PEI-202100101097.A 69-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 10May2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. No relevant medical history reported. Patient previously received the first dose of Comirnaty on 19Apr2021 for COVID-19 immunization.On 11May2021 the patient experienced Unknown cause of death. The patient died on 11May2021.It was not reported if an autopsy was performed. Outcome of event was fatal.Relatedness of drug to reaction(s)/event(s) was Unclassifiable. 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: 1434108 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D018A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021752729

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, Safety Report Unique Identifier DE-PEI-202100102422.A 79-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 10Jun2021 (Batch/Lot Number: 1D018A) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of bnt162b2 (COMIRNATY) on 29Apr2021 for COVID-19 immunization. The patient experienced also unknown cause of death. This report is serious as death. The patient died on 13Jun2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1434109 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-08
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C006A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ileus, Mesenteric vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Gastrointestinal obstruction (narrow), Thrombophlebitis (broad), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021752734

Write-up: Ileus; Mesenteric vein thrombosis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-PEI-202100102429. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 19May2021 (Batch/Lot Number: 1C006A) as DOSE 2, SINGLE for covid-19 immunisation. No relevant medical history reported. The patient''s concomitant medications were not reported. Patient previously received the first dose of Comirnaty (strength: 0.3 ml) on 15Apr2021 for COVID-19 immunisation. On 08Jun2021 the patient experienced Ileus, Mesenteric vein thrombosis. The patient died on 10Jun2021. It was not reported if an autopsy was performed. Outcome of events was fatal.For both events: Relatedness of drug to reaction(s)/event(s): Source of assessment: Regulatory Authority, Result of Assessment: D. Unclassifiable. Stop date of both events of Ileus, Mesenteric vein thrombosis reported was 10Jun2021. This report is serious as death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Mesenteric vein thrombosis; Ileus


VAERS ID: 1434114 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-03-04
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021753261

Write-up: Lung embolism; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB [DE-PEI-202100105350]. An 82-year-old female patient received the second dose of BNT162B2 (COMIRNATY, strength: 0.3 ml) at single dose on 16Feb2021 at age of 82-year-old for COVID-19 immunisation. The first dose was on 19Jan2021 at age of 82-year-old and no adverse event. Medical history and concomitant medication were not reported. The patient experienced lung embolism on 04Mar2021 that resulting death. It was unknown if an autopsy was performed. The outcome of event was fatal. Relatedness of drug to reaction(s)/event (s) Source of assessment Regulatory Authority; Result of Assessment D. Unclassifiable No follow up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1434115 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-18
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   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: DEJNJFOC20210660106

Write-up: THROMBOSIS OF VENOUS SINUSES; This spontaneous report received from a physician via a Regulatory Authority DE-PEI-202100110773 concerned a 44 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XB985) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the patient experienced thrombosis of venous sinuses and died. It was unknown if an autopsy was performed. Outcome of the event was fatal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: This spontaneous report received from a physician via Regulatory Authority DE-PEI-202100110773 concerns a 44 year old female who had thrombosis of venous sinuses and died 11 days after receiving the Janssen Covid-19 vaccine. Patient''s height and weight were not reported. Patient''s concurrent conditions and concomitant medications were not reported. Information regarding past smoking history, illicit drug use and alcohol abuse were not provided. Information is limited in this case. The relationship of the thrombosis of the venous sinuses to vaccination is considered unclassifiable due to insufficient information. Additional information has been requested.; Reported Cause(s) of Death: THROMBOSIS OF VENOUS SINUSES


VAERS ID: 1434156 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D014A / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Nausea, Tachycardia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Accident cerebrovascular; Arterial hypertension; Arterial occlusive disease; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699370

Write-up: Unknown cause of death; Tachycardia; Nausea; retrosternal tenderness; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the WEB DE-PEI-CADR2021092222, Safety Report Unique Identifier DE-PEI-202100085748. A 98 Years old female patient received the first dose of (COMIRNATY, Lot number 1D014A) at single dose for COVID-19 immunisation on unknown date. The patient''s medical history included: type 2 diabetes mellitus, arterial hypertension, arterial occlusive disease, accident cerebrovascular, all were ongoing. No concomitant medication was reported. The patient experienced also nausea, tachycardia, retrosternal tenderness, unknown cause of death. The outcome of events Nausea and Tachycardia was not resolved. The outcome of event retrosternal tenderness was unknown. No autopsy was performed. Senders comments: Do you or the person concerned have any known allergies? If yes, which ones? no. Details of risk factors or previous illnesses Long-standing diabetes mellitus type II, arterial hypertension, condition after multiple cerebral insults, AVK / 3 h after vaccination, the patient complains of nausea after taking a meal. A short time later, she complains of retrosternal tenderness. Relatives call the emergency medical service, during their journey the patient dies at home. Relatedness of drug to reaction(s)/event(s) for all events D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1434170 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-05-13
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Type 1 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699366

Write-up: Death from pulmonary embolism, probably from leg vein thrombosis; Death from pulmonary embolism, probably from leg vein thrombosis; This is a spontaneous report received from a non-contactable consumer downloaded from the WEB number DE-PEI-CADR2021100556, Safety Report Unique Identifier DE-PEI-202100093332. A 66 Years old Male patient received 1st dose of BNT162B2 (COMIRNATY, lot# EX3510) on 22Apr2021 at single dose for covid-19 immunization. The patient''s medical history and concurrent conditions included Type 1 diabetes mellitus. No allergies reported. No concomitant medication reported. On 13May2021, the patient experienced Deep vein thrombosis leg, Lung embolism. The patient''s outcome was not recovered/not resolved for Deep vein thrombosis leg, fatal for Lung embolism. The death date was 13May2021. No Autopsy was Done. Information on risk factors or previous illnesses: Diabetes mellitus type 1. As a general practitioner, I would like to suspect a serious vaccination side effect with fatal consequences Report.This report is serious - death. Event assessment: Comirnaty/all events/PEI /Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death from pulmonary embolism, probably from leg vein thrombosis


VAERS ID: 1434214 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aortic dissection, Dyspnoea, Dyspnoea exertional, Fibrin D dimer, Malaise, Oxygen saturation, Pulmonary embolism, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 33
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: AMLODIPIN ACCORD; LOSARTAN MEDIC VALLEY; DURAPHAT
Current Illness: Aortic dissection (Small possibility of Aortic dissection (small OBS)); Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Fibrin D dimer; Test Result: Inconclusive ; Result Unstructured Data: Unknown; Test Date: 20210603; Test Name: Oxygen saturation; Test Result: Inconclusive 95 %; Result Unstructured Data: Oxygen saturation-95%; Test Date: 20210603; Test Name: Respiratory rate; Test Result: Inconclusive ; Result Unstructured Data: Unknown
CDC Split Type: DKMODERNATX, INC.MOD20212

Write-up: Acute unwell; Possible lung embolism with fatal ourcome; Hospitalised due to progressive dyspnoea through 4 weeks; Dyspnoea exertional; aortic dissection.; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Possible lung embolism with fatal ourcome), AORTIC DISSECTION (aortic dissection.), DYSPNOEA (Hospitalised due to progressive dyspnoea through 4 weeks), DYSPNOEA EXERTIONAL (Dyspnoea exertional) and MALAISE (Acute unwell) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Aortic dissection (Small possibility of Aortic dissection (small OBS)). Concomitant products included SODIUM FLUORIDE (DURAPHAT) from 20-May-2020 to an unknown date for Caries dental, AMLODIPINE BESILATE (AMLODIPIN ACCORD) from 08-Mar-2016 to an unknown date and LOSARTAN POTASSIUM (LOSARTAN MEDIC VALLEY) from 20-Feb-2018 to an unknown date for Hypertension. On 07-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In May 2021, the patient experienced PULMONARY EMBOLISM (Possible lung embolism with fatal ourcome) (seriousness criteria death, hospitalization prolonged and medically significant), AORTIC DISSECTION (aortic dissection.) (seriousness criteria death and medically significant), DYSPNOEA (Hospitalised due to progressive dyspnoea through 4 weeks) (seriousness criteria death and hospitalization prolonged) and DYSPNOEA EXERTIONAL (Dyspnoea exertional) (seriousness criteria death and hospitalization prolonged). On 03-Jun-2021, the patient experienced MALAISE (Acute unwell) (seriousness criteria death and hospitalization prolonged). The patient died on 03-Jun-2021. The reported cause of death was Lung embolism and Aortic dissection. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Fibrin D dimer: unknown (Inconclusive) Unknown. On 03-Jun-2021, Oxygen saturation: 95 percent (Inconclusive) Oxygen saturation-95%. On 03-Jun-2021, Respiratory rate: unknown (Inconclusive) Unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Patients treatment product details was not provided by reporter. This fatal case concerns a 79-year-old male hospitalized with serious unexpected events of pulmonary embolism, aortic dissection, dyspnea, dyspnea exertional and malaise. Event latency x days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This fatal case concerns a 79-year-old male hospitalized with serious unexpected events of pulmonary embolism, aortic dissection, dyspnea, dyspnea exertional and malaise. Event latency x days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Lung embolism; Aortic dissection


VAERS ID: 1434216 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-05-07
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2405 / 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: 2021-05-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUVENTOL EASYHALER; CLOPIDOGREL ACTAVIS [CLOPIDOGREL BESYLATE]; RAMIPRIL; LITAREX [LITHIUM CITRATE]; METOPROLOL SUCCINATE; SIMVASTATIN; HJERTEMAGNYL [ACETYLSALICYLIC ACID]
Current Illness: Artificial cardiac pacemaker user; Bipolar disorder; Chronic obstructive pulmonary disease; Crohn''s disease
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; Apoplexy; Bronchial spasm; Cardiac arrhythmia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021752510

Write-up: Cardiac arrest after 1st vaccine. Found dead by spouse at. 15:50. Was through long resuscitation and the heart started beating but the patient ended up dying; This is a spontaneous report received from a contactable physician downloaded from the WEB. The regulatory authority report number is DK-DKMA-WBS-0070543. A 74-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 22Apr2021 (Lot Number: EX2405; Expiration Date: 31Aug2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included acute myocardial infarction not ongoing, apoplexy not ongoing, ongoing chronic obstructive pulmonary disease, ongoing Artificial cardiac pacemaker user, ongoing crohn''s disease, ongoing bipolar disorder, bronchial spasm, cardiac arrhythmia and hypertension. Concomitant medication(s) included salbutamol sulfate (BUVENTOL EASYHALER) taken for Bronchial spasm from 14Nov2018 to an unspecified stop date; clopidogrel besylate (CLOPIDOGREL ACTAVIS) taken for thrombosis prophylaxis from 2019 to an unspecified stop date; ramipril taken for hypertension from 03Sep2018 to an unspecified stop date; lithium citrate (LITAREX) taken for mood swings from 26Jun2020 to an unspecified stop date; metoprolol succinate taken for cardiac arrhythmia from 12Aug2014 to an unspecified stop date; simvastatin taken for cardiovascular event prophylaxis from 08Feb2018 to an unspecified stop date; acetylsalicylic acid (HJERTEMAGNYL) taken for anticoagulant therapy from 2019 to an unspecified stop date. On 07May2021 15:50, the patient experienced cardiac arrest after 1st vaccine. Found dead by spouse at. 15:50. Was through long resuscitation and the heart started beating but the patient ended up dying. The ADRs were by the physician reported as being Fatal. Reported cause of death was cardiac arrest. The patient died on 07May2021. It was not reported if an autopsy was performed. Causality: The death is reported as being a possible causal link with the vaccine because he cannot rule out a link. In addition, it is reported in accordance with stricter reporting obligations. The physician was not the one to confirm the death, and is not aware if the Police are informed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1434238 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-01-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Decreased appetite, Depressed mood, Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN/HYDROCHLOROTHIAZIDE; TRAZODONE; OMEPRAZOLUM; FASLODEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; Breast cancer; Dyslipidaemia; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021753312

Write-up: dead, the cause is unknown; Low mood; Anorexia; Diarrhea; This is a spontaneous report from a contactable other healthcare professional, received from regulatory authority, downloaded from the Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-810527. An 88-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Batch/Lot number: EK9788), via an unspecified route of administration on 30Jan2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. Medical history included dyslipidaemia, hypertension arterial, arthrosis, and breast cancer. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN/HYDROCHLOROTHIAZIDE); trazodone (TRAZODONE); omeprazolum (OMEPRAZOLUM); fulvestrant (FASLODEX). The patient previously received the first dose of BNT162B2 (COMIRNATY, Lot/batch number: EM0477) on 09Jan2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. The patient experienced anorexia and diarrhea on 31Jan2021; low mood on 14Feb2021. Verbatim: Has COVID-19 passed?: Unknown. Patient with the background described above, they notify the nursing home for decay for a few days. They refer anorexia. They do not report nausea or vomiting or diarrhea. They do not report abdominal pain. They do not refer voiding syndrome. They do not refer respiratory symptoms. Not refers to chest pain. They do not report other accompanying symptoms. The 2nd dose of Comirnaty was vaccinated on 31Jan2021. Four days after that she is found dead, the cause is unknown. The outcome of diarrhea was recovered (duration: 1 day); outcome of anorexia and low mood was unknown. The patient died on 18Feb2021. It was unknown if an autopsy was performed. The cause of death is unknown.; Reported Cause(s) of Death: dead, the cause is unknown


VAERS ID: 1434335 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood creatinine, Blood pressure measurement, Body temperature, Chest X-ray, Condition aggravated, Heart rate, Nephrotic syndrome, Oxygen saturation, Respiratory failure, Urine protein/creatinine ratio
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Proteinuria (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 21
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: AFib; Chronic kidney disease (CKD G3bA3 in a functional single-kidney with right agenesis); Chronic liver disease; Hypertension arterial; Nephrotic syndrome (previous admission, probable minimal change nephropathy.)
Allergies:
Diagnostic Lab Data: Test Name: auscultation; Result Unstructured Data: Test Result:CA: arrhythmic heart sounds, auscultation systolic; Comments: CA: arrhythmic heart sounds, auscultation systolic murmur in aortic focus. PA: Right basal hypophonesis and up to left midfield with crackles up to midfields.; Test Name: creatinine; Test Result: 4 mg/dl; Test Name: creatinine; Result Unstructured Data: Test Result:2.7-3 mg/dl; Comments: previous 2.7-3; Test Name: blood pressure; Result Unstructured Data: Test Result:149/87 mmHg; Test Name: temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Name: chest x-ray; Result Unstructured Data: Test Result:right pleural effusion; Test Name: heart rate; Result Unstructured Data: Test Result:85; Comments: bpm; Test Name: 02 saturation; Test Result: 86 %; Test Name: protein creatinine ratio; Result Unstructured Data: Test Result:10.4
CDC Split Type: ESPFIZER INC2021751830

Write-up: Respiratory insufficiency; Condition worsened; Nephrotic syndrome worsened; This is a spontaneous report from a contactable physician downloaded from the WEB ES-AEMPS-906088. A 94-year-old male patient received bnt162b2 (COMIRNATY) dose 1 intramuscular on 19Apr2021 (Lot Number: EW4815) as single dose for COVID-19 immunisation. Medical history included hypertension arterial, chronic liver disease, anticoagulated AF with syndromes and chronic kidney disease (CKD) G4A3 (functional single-kidney with right agenesis) with previous admission in September / 2020 for unknown nephrotic syndrome (probable minimal change nephropathy. No biopsy was performed by patient characteristics). The patient''s concomitant medications were not reported. The patient experienced respiratory insufficiency, condition worsened, nephrotic syndrome worsened on 20Apr2021. Serious criteria were reported as death, hospitalized. The patient attended the emergency room on 06May2021 referred by his Primary Care Physician due to a progressive increase in his usual dyspnea associated with an increase in edema of the eyelids and lower limbs (roots of the limbs) in the last 10 days. He was vaccinated with 1st dose of bnt162b2 (19Apr2021) and the clinical picture began 24 hours later. The patient presented general malaise, hyporexia and progressive increase in dyspnea with orthopnea. Denied voiding syndrome, denied gastrointestinal disturbances. A family member reported that for 2-3 weeks he had presented symptoms of greater dyspnea, with episodes of paroxysmal nocturnal dyspnea and orthopnea. At this time presented 2-3 days of more greenish expectoration, but antibiotic treatment was not performed because it was self-limited. The diuretic treatment was adjusted to 2-1-0 and initially presented improvement but for a week he had worsened again. No episodes of bronchial aspiration or choking at home. Normal general condition, tachypneic at rest at about 24 rpm. Eyelid edema. TA: 149/87 mmHg. HR: 85 bpm. SatO2: 86% baseline. T: 36.8 ? C. CA: arrhythmic heart sounds, auscultation systolic murmur in aortic focus. PA: Right basal hypophonesis and up to left midfield with crackles up to midfields. Abdomen: Soft, not painful on palpation, without signs of peritoneal irritation. Extermity: Edemas up to the roots of the limbs with fovea. In complementary tests, deterioration of renal function stands out with creatinine: 4 mg / dl (previous 2.7-3 mg / dl), hypoproteinemia and protein/creatinine: 10.4. Chest X-ray with right pleural effusion. Admission to Nephrology was decided given the clinical and analytical findings that correspond to nephrotic syndrome in the probable context of relapse of minimal change nephropathy (vaccination may be a probable trigger, despite the fact that it began with the clinic a few days before it). During his admission, oral corticosteroid therapy and depletive treatment were started, with little diuretic response. He therefore presents a progressive deterioration from the respiratory point of view, with subsequent respiratory failure refractory to non-invasive measures, finally dying on 11May2021. Main diagnosis was reported as "exitus". Other diagnoses included nephrotic syndrome (Probable relapse of minimal change nephropathy). Severe respiratory failure. Chronic Kidney Disease G4A3. It was unknown if autopsy was done. The outcome of events respiratory insufficiency, condition worsened, nephrotic syndrome worsened was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Nephrotic syndrome; Respiratory insufficiency


VAERS ID: 1434339 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-26
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001939 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATINA; ADIRO
Current Illness: Cardiovascular event prophylaxis
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST and MYOCARDIAL ISCHAEMIA in a 56-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001939) for COVID-19 vaccination. The patient''s past medical history included Angina pectoris. Concurrent medical conditions included Cardiovascular event prophylaxis. Concomitant products included ACETYLSALICYLIC ACID for Cardiovascular event prophylaxis, ATORVASTATINA [ATORVASTATIN] for an unknown indication. On 12-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced CARDIO-RESPIRATORY ARREST (seriousness criteria death and medically significant) and MYOCARDIAL ISCHAEMIA (seriousness criteria death and medically significant). The patient died on 26-May-2021. The reported cause of death was respiratory arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided by the reporter Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death:


VAERS ID: 1434349 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 51
Permanent Disability? 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: ESPFIZER INC2021756258

Write-up: herpez zoster; severe headaches; This is a spontaneous report from a contactable consumer via sales representative through the Agency. An 88-year-old male patient received bnt162b2 (COMIRNATY), the second dose via intramuscular in left arm on 31Mar2021 (lot number: EW2239) as single dose for COVID-19 immunisation. The relevant medical history was not reported. Concomitant medications included unspecified medications. The patient previously received first dose of bnt162b2 (COMIRNATY, lot number: ET1831) via intramuscular on 09Mar2021 at the age of 88 years old as single dose for COVID-19 immunisation. The patient experienced herpez zoster on 06Apr2021, severe headaches on 02Apr2021. Reported Event: Two days after administration of the second dose, the patient developed severe headaches. On 06Apr2021, external signs of herpes zoster are observed on the right side of the head. Neurological involvement due to herpes and death of the patient. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The patient died on 23May2021. It was unknown if an autopsy was performed. The outcome of the event herpez zoster was fatal, while the other events were unknown.; Reported Cause(s) of Death: Herpes zoster


VAERS ID: 1434359 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN; SOMAC; BRILIQUE; BISOPROLOL; DIURAMIN; DISPERIN; SEPRAM; ATORVASTATIN
Current Illness:
Preexisting Conditions: Comments: No significant medical history reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20212

Write-up: Cerebral haemorrhage; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) in a 65-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No significant medical history reported. Concomitant products included LOSARTAN from 04-Jan-2021 to an unknown date for Blood pressure high, TICAGRELOR (BRILIQUE) from 04-Jan-2021 to an unknown date and BISOPROLOL from 04-Jan-2021 to an unknown date for Coronary artery disease, Acetylsalicylic acid (DISPERIN) for Thrombosis prophylaxis, PANTOPRAZOLE SODIUM SESQUIHYDRATE (SOMAC), AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE (DIURAMIN), CITALOPRAM HYDROBROMIDE (SEPRAM) and ATORVASTATIN for an unknown indication. On 20-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 21-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) (seriousness criteria death and medically significant). The patient died in 2021. The reported cause of death was Cerebral haemorrhage. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Date of death was not reported . The action taken with mRNA-1273 was not applicable. This is a case of sudden death in a 63-year-old male subject on medications for high blood pressure, coronary artery disease, thrombosis prophylaxis, who died after receiving first dose of vaccine, the date of death is Unknown. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 63-year-old male subject on medications for high blood pressure, coronary artery disease, thrombosis prophylaxis, who died after receiving first dose of vaccine, the date of death is Unknown. Very limited information has been provided at this time.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1434367 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bacterial infection, Computerised tomogram, Cytomegalovirus viraemia, General physical health deterioration, Idiopathic pulmonary fibrosis, Muscular weakness, Myocardial infarction, Respiratory distress
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Interstitial lung disease (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 77
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Cerebral infarction; Coronary artery disease; Dry cough; Hypercholesterolemia; Hypertension; Hypoxemia; Pulmonary fibrosis; Shortness of breath
Allergies:
Diagnostic Lab Data: Test Date: 20210227; Test Name: CT scan; Result Unstructured Data: Test Result:pulmonary fibrosis changes; Comments: ruled out pulmonary embolism, found pulmonary fibrosis changes for which referral to pulmonary clinic.
CDC Split Type: FIPFIZER INC2021752889

Write-up: Lower extremities weakness of; General physical health deterioration; Exacerbation of idiopathic pulmonary fibrosis; Bacterial infection; Cytomegalovirus viraemia; Myocardial infarction; respiratory distress; This is a spontaneous report from a contactable physician downloaded from Agency Regulatory Authority-WEB, Safety Report Unique Identifier FI-FIMEA-20213221. A 72-years-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 09Mar2021 (Lot Number: ET1831) as dose 1, single for covid-19 immunisation. Medical history included hypertension, hypercholesterolemia, coronary artery disease, abdominal aortic aneurysm, one side symptoms due to cerebral infarction. Since Dec2020, worsening shortness of breath and dry cough. In the emergency room on 27Feb2021 due to shortness of breath and hypoxemia, CT scan ruled out pulmonary embolism, found pulmonary fibrosis changes for which referral to pulmonary clinic. The patient''s concomitant medications were not reported. The patient experienced lower extremities weakness of (death, hospitalization) on 11Mar2021, general physical health deterioration (death, hospitalization) on 11Mar2021, exacerbation of idiopathic pulmonary fibrosis (death, hospitalization) on 11Mar2021, bacterial infection (death, hospitalization) on 11Mar2021, cytomegalovirus viraemia (death, hospitalization) on 11Mar2021, myocardial infarction (death, hospitalization) on 11Mar2021, respiratory distress (hospitalization) on 11Mar2021. COMIRNATY 1st dose on 09Mar2021, two days later hospitalized due to respiratory distress, idiopathic pulmonary fibrosis and acute exacerbation noted. Interstitial lung disease of course a more protracted process, diagnosis was confirmed. Received treatment for exacerbation, no obvious infection was found but due to high dose cortisone therapy antibiotic protection was given. With cortisone treatment mild cytomegalovirus, for which she received a couple of weeks of intensive care to control the infection, continued prophylaxis, cortisone was withdrawn. At follow-up on 04May2021 again there were more interstitial lung disease-exacerbation findings, cortisone had to be increased. Due to worsening of the situation hospitalized again on 25May2021, on that occasion pulse steroid therapy for exacerbation of interstitial lung disease under antibiotic protection, after a delay of a couple of days clear CRP increase consistent with concomitant acute bacterial infection. Mild cardiac enzyme pollution consistent with mild myocardial infarction due to oxygen deficiency. The patient died on 28May2021. The underlying cause of death was considered to be acute exacerbation of interstitial lung disease with contributory unspecified bacterial infection and myocardial infarction. The patient repeatedly reported a decrease in lower limb strength and general well-being after Comirnaty vaccination. The hospice service staff reported symptoms apparently in the past, which is why I did not consider a probable suspected vaccine injury at the time. Acute exacerbations are certainly part of interstitial lung disease, severe exacerbations of interstitial lung disease in a short period of time, with a temporal relationship to the Comirnaty vaccine - the pattern of exacerbations is abnormal. This raised the idea of the possibility of vaccine causing the event and delayed notification. The patient died on 28May2021. It was not reported if an autopsy was performed. Outcome of the event respiratory distress was unknown, of the other events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Exacerbation of idiopathic pulmonary fibrosis; Bacterial infection; Myocardial infarction


VAERS ID: 1434434 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-30
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cerebral haemorrhage, Haemorrhage, Hypertension, Intentional product use issue, Meningorrhagia, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Drug abuse and dependence (broad), Hypertension (narrow), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EUTHYROX; LOGIMAX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Arterial hypertension
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:13-14 / 80 mmHg; Comments: Blood pressure balanced according to the objectives at 13-14 / 80 mmHg.; Test Date: 20210430; Test Name: Blood pressure; Result Unstructured Data: Test Result:between 15 and 16 mmHg; Comments: increased
CDC Split Type: FRPFIZER INC2021752740

Write-up: intentional use beyond labelled duration; Meningeal bleeding; probable subarachnoid hemorrhage; brain bleeding; blood present in the ears, in the nose, on the face; Hypertension aggravated; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-2021069105. A 90-year-old female patient received bnt162b2 (COMIRNATY), intramuscularly on 06Apr2021 (Lot Number: EW2239) as DOSE 2, SINGLE for covid-19 immunisation; apixaban (ELIQUIS, strength: 2.5 mg), orally from an unspecified date (Batch/Lot Number: Unknown) and ongoing, at 2 dosage form, daily (in the long term) for atrial fibrillation (AFib). Medical history included arterial hypertension from an unknown date, atrial fibrillation from an unknown date. Concomitant medication(s) included levothyroxine sodium (EUTHYROX) for an unspecified indication; felodipine, metoprolol succinate (LOGIMAX, felodipine/metoprolol strength: 5 mg/47.5 mg) for hypertension and atrial fibrillation, all taken in the long term, start and stop date were not reported. On 06May2021, the patient experienced brain bleeding. On 30Apr2021, the patient experienced hypertension increase. Therapeutic measures taken as a result of the reaction. The patient had not yet recovered from hypertension aggravated. The patient died from meningeal bleeding on 06May2021. No autopsy was performed. Long-term treatment for hypertension and atrial fibrillation with LOGIMAX and ELIQUIS. Blood pressure balanced according to the objectives at 13-14 / 80 mmHg. On 06Apr2021, second injection of COMIRNATY batch EW2239 vaccine against COVID-19. On 30Apr2021, routine consultation with the general practitioner. Blood pressure increased between 15 and 16 mmHg. Specialized consultation scheduled a few days later. No corrective action taken. 06May2021, patient found at home, sitting, (no reported fall context) blood present in the ears, in the nose, on the face. Emergency services call and death certificate. Conclusion: 90-year-old female patient, long-term treated with ELIQUIS (apixaban) having presented an increase in blood pressure, observed approximately three weeks after vaccination with COMIRNATY batch EW2239 (D2), as well as a probable subarachnoid hemorrhage occurring one month after vaccination and which may have resulted in her death. The patient underwent lab tests and procedures which included blood pressure measurement: Blood pressure balanced according to the objectives at 13-14 / 80 mmHg on unknown date, blood pressure measurement: increased between 15 and 16 mmhg on 30Apr2021. The action taken in response to the event(s) for apixaban was dose not changed. Apixaban rechallenge was done. The patient died on 06May2021. The outcome of the event hypertension increase was not recovered, the outcome of blood present in the ears, in the nose, on the face and brain bleeding was unknown. An autopsy was not performed. No follow-up attempts possible. No further information expected. Follow-up (17Jun2021): This is a follow-up spontaneous report from a contactable physician (regulatory authority reference number: FR-AFSSAPS-2021069105) based on information received by Pfizer (manufacturer control number FR-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-059428), license party for apixaban (ELIQUIS). This case was received (Reference number: FR-AFSSAPS-2021069105) on 17-Jun-2021 and was forwarded on 17-Jun-2021. This spontaneous case was reported by a physician and describes the occurrence of fatal meningorrhagia (Meningeal bleeding) in 90-year-old female patient who received apixaban (Eliquis) for Cerebrovascular accident prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included tozinameran (Comirnaty) for COVID-19 vaccination. Product or product use issues identified: intentional product use issue (intentional use beyond labelled duration). The patient''s past medical history included AFib. On an unknown date, the patient started Eliquis (Oral) 2 dosage form, daily. On 06-Apr-2021, the patient started Comirnaty (Intramuscular) 1 dosage form, total. On 30-Apr-2021, an unknown time after starting Eliquis, the patient experienced hypertension (Hypertension aggravated). On 06-May-2021, the patient experienced meningorrhagia (seriousness criteria death and medically significant). The dose of Eliquis(Oral) was not changed. On 06-May-2021, hypertension did not resolve. The patient died on 06-May-2021. The reported cause of death was Meningeal bleeding. An autopsy was not performed. Patient received apixaban for atrial fibrillation. For Eliquis(Oral), the reporter did not provide any causality assessments.; Sender''s Comments: Medical Evaluation Comment: This patient died due to meningeal bleeding after receiving apixaban therapy. Based on the anticoagulant nature of apixaban , its role in this fatal event is considered possible.; Reported Cause(s) of Death: probable subarachnoid hemorrhage; meningeal bleeding


VAERS ID: 1434438 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Angiogram, Aspartate aminotransferase, Blood alcohol, Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood chloride, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood lactic acid, Blood potassium, Blood pressure measurement, Blood sodium, C-reactive protein, Carbon dioxide, Cardio-respiratory arrest, Chest X-ray, Coagulation factor V level, Coagulation factor VII level, Coagulation factor X level, Coma scale, Echocardiogram, Electrocardiogram, Fibrin D dimer, Fraction of inspired oxygen, Full blood count, Haematocrit, Haemoglobin, Heart rate, Investigation, Laboratory test, Myocardial infarction, Neutrophil count, Oxygen saturation, Platelet count, Procalcitonin, Protein total, Prothrombin level, Prothrombin time, Respiratory rate, SARS-CoV-2 test, Troponin, White blood cell count, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypothyroidism; Obesity (BMI: 40.26)
Preexisting Conditions: Medical History/Concurrent Conditions: Cannabis use (Occasional); Chest discomfort; Graves-Basedow disease (With orbitopathy, treated with Thyrozol and Levothyrox); Neck pain; Pulmonary embolism (With negative thrombophilia assessment (Proteins C and S not measured)); Thymectomy (For thymoma with global follicular lymphoid hyperplasia); Thymoma; Tobacco user (10 pack-years)
Allergies:
Diagnostic Lab Data: Test Date: 20210522; Test Name: alanine aminotransferase; Result Unstructured Data: Test Result:181; Test Date: 20210522; Test Name: alanine aminotransferase; Result Unstructured Data: Test Result:13.7; Comments: At 11:42 p.m.; Test Name: coronary angiography; Result Unstructured Data: Test Result:sub-occlusion of the proximal anterior ventricular; Test Date: 20210522; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:504; Test Date: 20210522; Test Name: Alcohol; Result Unstructured Data: Test Result:0.12 g/l; Test Date: 20210522; Test Name: PAL; Result Unstructured Data: Test Result:95; Test Date: 20210522; Test Name: bilirubin; Result Unstructured Data: Test Result:Normal; Test Date: 20210522; Test Name: calcium; Test Result: 1.8 mmol; Test Date: 20210522; Test Name: chlorine; Result Unstructured Data: Test Result:103; Test Date: 20210522; Test Name: creatine phosphokinase; Result Unstructured Data: Test Result:4437 IU/l; Test Date: 20210522; Test Name: creatinine; Test Result: 89 umol; Test Date: 20210522; Test Name: fibrinogen; Result Unstructured Data: Test Result:1.58 g/l; Test Date: 20210522; Test Name: Lactates; Result Unstructured Data: Test Result:14.1 mmol/L; Test Date: 20210522; Test Name: potassium; Result Unstructured Data: Test Result:4.6; Test Date: 20210522; Test Name: Blood pressure; Result Unstructured Data: Test Result:73/58; Comments: on noradrenaline; Test Date: 20210522; Test Name: sodium; Result Unstructured Data: Test Result:140; Test Date: 20210522; Test Name: partial pressure of carbon dioxide; Result Unstructured Data: Test Result:96; Test Date: 20210522; Test Name: partial pressure of carbon dioxide; Result Unstructured Data: Test Result:34; Comments: At 11:42 p.m.; Test Date: 20210522; Test Name: Chest radiograph; Result Unstructured Data: Test Result:cardiomegaly; Comments: interstitial infiltrate predominant on the left; Test Date: 20210522; Test Name: factor V; Test Result: 28 %; Test Date: 20210522; Test Name: factor VII; Test Result: 85 %; Test Date: 20210522; Test Name: factor X; Test Result: 69 %; Test Date: 20210522; Test Name: Glasgow; Result Unstructured Data: Test Result:3; Comments: not sedated; Test Date: 20210504; Test Name: CRP; Result Unstructured Data: Test Result:3.30 mg/l; Test Date: 20210522; Test Name: CRP; Result Unstructured Data: Test Result:0.6 mg/l; Test Date: 20210522; Test Name: Clearance TTE; Result Unstructured Data: Test Result:LVEF 5 to 10%, akinetic LV, undilated RV; Comments: Systolic function OK visually, venous ECMO cannula visualized in the IVC.; Test Date: 20210522; Test Name: Clearance TTE; Result Unstructured Data: Test Result:LVEF 5 to 10%, akinetic LV, undilated RV, systolic; Comments: LVEF 5 to 10%, akinetic LV, undilated RV, systolic function OK visually, venous ECMO cannula visualized in the IVC; Test Name: ECG; Result Unstructured Data: Test Result:extensive left ventricular necrosis; Comments: almost akinetic; Test Date: 20210521; Test Name: ECG; Result Unstructured Data: Test Result:Probable left anterior hemiblock; Comments: Sinus rhythm, left axis with probable left anterior hemiblock. Repolarization is normal.; Test Date: 20210522; Test Name: ECG; Result Unstructured Data: Test Result:asystole on admission; Comments: sinus, extended anterior ST + with inferior shift; multiple passages in FV; switch to TV 180 / min at 00:17; Test Date: 20210504; Test Name: D-dimers; Result Unstructured Data: Test Result:Normal ng/ml; Test Date: 20210522; Test Name: D-dimers; Result Unstructured Data: Test Result:less than 24,000 ng/ml; Test Date: 20210522; Test Name: fraction of inspired oxygen; Test Result: 100 %; Test Date: 20210522; Test Name: fraction of inspired oxygen; Test Result: 456 %; Comments: At 11:42 p.m.; Test Date: 20210504; Test Name: CBC; Result Unstructured Data: Test Result:Normal; Test Date: 20210522; Test Name: hematocrit; Test Result: 36.3 %; Test Date: 20210522; Test Name: hemoglobin; Result Unstructured Data: Test Result:11.5; Test Date: 20210522; Test Name: Heart rate; Result Unstructured Data: Test Result:112/min; Test Date: 20210504; Test Name: pulmonary radiological assessment; Result Unstructured Data: Test Result:Normal; Test Date: 20210504; Test Name: clinical examination; Result Unstructured Data: Test Result:normal; Test Date: 20210522; Test Name: PNN; Result Unstructured Data: Test Result:18,760; Test Date: 20210522; Test Name: oxygen saturation; Test Result: 9.4 %; Test Date: 20210522; Test Name: oxygen saturation; Test Result: 96.9 %; Comments: At 11:42 p.m.; Test Date: 20210522; Test Name: pH; Result Unstructured Data: Test Result:less than 6.8; Test Date: 20210522; Test Name: pH; Result Unstructured Data: Test Result:7.7; Comments: At 11:42 p.m; Test Date: 20210522; Test Name: platelets; Result Unstructured Data: Test Result:167,000; Test Date: 20210522; Test Name: Procalcytonin; Result Unstructured Data: Test Result:0.02 ng/ml; Test Date: 20210522; Test Name: protein; Result Unstructured Data: Test Result:49 g/l; Test Date: 20210522; Test Name: factor II; Test Result: 79 %; Test Date: 20210522; Test Name: prothrombin time; Test Result: 54 %; Test Date: 20210522; Test Name: Respiratory rate; Result Unstructured Data: Test Result:25; Test Date: 20210504; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210522; Test Name: SARS-CoV-2 test; Test Result: Negative ; Comments: At 11:42 p.m.; Test Name: Troponin; Result Unstructured Data: Test Result:459,000 ng/ml; Comments: maximum; Test Date: 20210522; Test Name: Troponin; Result Unstructured Data: Test Result:37,986 ng/ml; Test Date: 20210522; Test Name: WBC; Result Unstructured Data: Test Result:26,800 /mm3
CDC Split Type: FRPFIZER INC2021699868

Write-up: Cardio-respiratory arrest; Myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority Report Number : FR-AFSSAPS-2021069222. A 31-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular on 19May2021 (Lot Number: FA4598) as single dose for COVID-19 immunisation. Medical history included ongoing obesity (BMI: 40.26), ongoing hypothyroidism, Graves disease (With orbitopathy, treated with Thyrozol and Levothyrox ), Smoking (10 pack-years ), Cannabis use (Occasional), pulmonary embolism from Aug2015 (With negative thrombophilia assessment (Proteins C and S not measured) ), thymectomy (For thymoma with global follicular lymphoid hyperplasia (thymoma discovered in the aftermath of pulmonary embolism) ), thymoma with global follicular lymphoid hyperplasia, neck pain from 04May2021, chest discomfort from 04May2021. No diabetes, no hypertension, no dyslipidemia, no family cardiovascular history, no contraception. The patient''s concomitant medications were not reported. The patient previously took thiamazole (THYROZOL) for basedow''s disease, levothyroxine sodium (LEVOTHYROX) for basedow''s disease. The patient experienced cardio-respiratory arrest (death, medically significant) on 22May2021, myocardial infarction (death, medically significant) on 22May2021. On 04May2021: consultation for neck pain and chest discomfort on deep inspiration in supine position. No dyspnea. The clinical examination is normal. Normal pulmonary radiological assessment. COVID test negative. Normal D-dimers. CRP 3.30 mg / l. CBC normal.On 07May2021: symptom improvement. On 19May2021: first dose Comirnaty (lot FA4598).On 21May2021: new consultation for neck pain radiating to the upper limbs, no fever, no symptoms. The ECG finds a sinus rhythm, left axis with probable left anterior hemiblock. Repolarization is normal.On 22May2021: Emergency medical services call at 8:02 pm by the mother for chest pain without respiratory distress with headache and pain in the jaw and left arm. Concept of occasional cannabis use during the day.8:46 pm: second call to the Emergency medical services for loss of consciousness: presence of gasp and cyanosis; witnesses at the request of the regulator. Arrival of firefighters at 8:55 pm: Arrival at 9:02 pm: asystole, urine loss, areactive bilateral mydriasis, intubation, intraosseous insertion in the humeral and tibia. Duration of noflow unknown (PC around 8:30 pm): Injection of 12 mg adrenaline in total. Transfer.In intensive care unit at 10 pm: heart rate at 112 / min; respiratory rate at 25; Glasgow at 3 not sedated; Bilateral areactive mydriasis, ROT (stretch reflex) abolished. Blood pressure at 73/58 on noradrenaline, BDC (heart murmurs) inaudible, pulse not perceived no sign of cardiac insects; cyanosis of the face, mottling up to mid-thigh, re-coloring time more than 3 seconds. ECG: asystole on admission. Post-sheave ECG: sinus, extended anterior ST + with inferior shift; multiple passages in FV; switch to TV 180 / min at 00:17. RP (chest radiograph): cardiomegaly, interstitial infiltrate predominant on the left. Clearance TTE (transthoracic echocardiography): LVEF 5 to 10%, akinetic LV, undilated RV, systolic function OK visually, venous ECMO cannula visualized in the IVC. WBC 26,800 / mm?, 18,760 PNN, hematocrit 36.3%, hemoglobin 11.5, platelets 167,000, TP (prothrombin time) 54%, factor II 79% factor V 28% factor VII 85% factor X 69%, D-dimers less than 24,000 ng / ml, anti-Xa UFH 0.09, fibrinogen 1.58 g / l, sodium 140, potassium 4.6, chlorine 103, protein 49 g / l, calcium 1.80 mmol, creatinine 89 ?mol, GOT (aspartate aminotransferase ) 504, GPT (alanine aminotransferase) 181, PAL 95, GGT (gamma glutamyl aminotransferase) 148, normal bilirubin, CPK (creatine phosphokinase) 4437 IU / L, troponin 37,986 ng / ml; CRP 0 6 mg / l, alcohol 0.12 g / l PCT (procalcytonin) 0.02 ng / ml.Blood gas under 100% FIO2 (fraction of inspired oxygen) on arrival: pH less than 6.8, PCO2 (partial pressure of carbon dioxide) 96, SaO2 (oxygen saturation) 9.4%, lactates 14.1 mmol / l.At 11:42 p.m .: pH 7.7, PCO2 34, PO2 456, SaO2 96.9%, ALAT at 13.7.PCR SARS-CoV-2 negative.At 10:30 p.m .: Right femoro-femoral ECMO-VCA pose; surgical reperfusion route; vasopressor support by noradrenaline and DOBUTAMINE IVSE; filling with NaCl, GELOFUSIN and albumin; sedation with midazolam and Fentanyl.Evolution: Emergency coronary angiography: sub-occlusion of the proximal anterior ventricular. Stenosis IVA 1:70 to 99%; Successful angioplasty with placement of a steel stent. Installation in refractory shock with collapse of the ECMO flow despite massive filling, large doses of amines; glypressin failure; initiation of a DIC, metabolic acidosis. Attempt of extra-renal purification without repercussions on hemodynamics. Echocardiography found extensive left ventricular necrosis, almost akinetic. The maximum troponin and dosed at 459,000 ng / ml. The evolution is unfavorable with inability to maintain an ECMO flow rate, ischemia of the lower limbs, major hemodynamic instability. The patient died the same day at 11 a.m.In total, refractory cardiopulmonary arrest on subocclusion of the proximal anterior ventricular vein with extensive necrosis of the left ventricle, complicated by post-resuscitation vasoplegic shock and multiorgan failure at D3 of Comirnaty in a young woman, having complained of chest discomfort without an ECG abnormality a few days before the injection. Therapeutic measures were taken as a result of events. Emergency Room Visit for the events. The patient died on 23May2021. An autopsy was not performed. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction; Cardio-respiratory arrest


VAERS ID: 1434441 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-05-29
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test, 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: 2021-06-07
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic respiratory failure (Person considered at risk); COPD (under 1.5L of O2 at home)
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer of prostate; COVID-19; Hip prosthesis insertion (right hip prosthesis); Hypertension arterial (high blood pressure); Radiotherapy; Silicosis
Allergies:
Diagnostic Lab Data: Test Date: 20210530; Test Name: Covid-19 serology; Result Unstructured Data: Test Result:IgM + IgG negative; Test Date: 20210530; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: PCR test shows positive SARS CoV2 detection (SARS CoV2 RNA detected) Conclusion: profile compatible with a 20l / 501y variant
CDC Split Type: FRPFIZER INC2021752933

Write-up: Vaccination failure; serious covid; This is a spontaneous report from a contactable physician downloaded from the WEB FR-AFSSAPS-2021069690. An 82-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via intramuscular, administered in Arm Left on 02Apr2021 (Lot Number: ET7205), dose 1 via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported), both at single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing (as reported), chronic obstructive pulmonary disease (under 1.5L of O2 at home), silicosis, prostate cancer, radiotherapy (Mar2021), right hip prosthesis (2014) and high blood pressure/hypertension arterial. The patient was considered as at risk for chronic respiratory failure. The patient''s concomitant medications were not reported. On 29May2021 (day 57 of Dose 2), the patient experienced vaccination failure: serious COVID, putting on optiflow (in intensive care). The event was serious for hospitalization and fatal. IgM + IgG negative serology on 30May2021 despite two injections. The PCR test on 30May2021 showed positive SARS CoV2 detection (SARS CoV2 RNA detected), conclusion: profile compatible with a 20l / 501y variant (says English). The patient died on 07Jun2021. It was not reported if an autopsy was performed. NB: Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. Information on the batch number has been requested. ; Reported Cause(s) of Death: serious covid; Vaccination failure


VAERS ID: 1434462 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-31
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7823 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholism; Hypertension (under treatment but not taken regularly); Tobacco user
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021752000

Write-up: cardiac arrest; This is a spontaneous report from a contactable other hcp downloaded from the WEB, regulatory authority number FR-AFSSAPS-2021074781. A 64-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 12May2021 (Batch/Lot Number: EX7823) as single for covid-19 immunisation. Medical history included smoking, alcoholism, hypertension under treatment but not taken regularly. No overweight. The patient''s concomitant medications were not reported. The patient presented malaise on 31May2021 on chest pain followed by a cardiac arrest supported by the firefighters - intubation failure during resuscitation - reported by his children today - after having seen with the attending physician was asked to make an adverse reaction report in doubt of a cause and effect relationship. The patient died on 31May2021. 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: cardiac arrest


VAERS ID: 1434463 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Altered state of consciousness, Aphasia, Bacterial test, Bladder dilatation, Blood albumin, Blood culture, Blood sodium, C-reactive protein, Cardiopulmonary exercise test, Chest discomfort, Confusional state, Creatinine renal clearance, Dysarthria, Electrocardiogram, Hemiparesis, Hyponatraemia, Hypoxia, Inflammation, Ischaemic stroke, Leukocytosis, Leukoencephalopathy, Malnutrition, Multiple organ dysfunction syndrome, Muscular weakness, Myocardial necrosis marker, Physical examination, Restlessness, Scan brain, Ultrasound Doppler, Urinary retention, Urinary tract infection, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial; Ischial neuralgia; Polymyalgia rheumatica
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: cytobacteriological examination of urine; Result Unstructured Data: Test Result:presence of Escherichia coli.; Test Date: 202105; Test Name: albuminemia; Result Unstructured Data: Test Result:34 g/l; Test Date: 202105; Test Name: Blood cultures; Test Result: Negative ; Test Date: 202105; Test Name: hyponatremia; Result Unstructured Data: Test Result:125 mmol/L; Test Date: 202105; Test Name: cardiopulmonary examination; Result Unstructured Data: Test Result:normal; Test Date: 202105; Test Name: CRP; Result Unstructured Data: Test Result:141; Test Date: 202105; Test Name: clearance; Result Unstructured Data: Test Result:17 ml/min; Test Date: 202105; Test Name: ECG; Result Unstructured Data: Test Result:absence of repolarization and conduction disturban; Comments: absence of repolarization and conduction disturbance.; Test Date: 202105; Test Name: ECG; Result Unstructured Data: Test Result:diffuse brain distress.; Test Date: 202105; Test Name: cardiac enzymes; Result Unstructured Data: Test Result:no increase; Test Date: 202105; Test Name: Clinical examination; Result Unstructured Data: Test Result:aphasia of expression, no facial paralysis, no ocu; Comments: aphasia of expression, no facial paralysis, no oculomotor disorder, no homonymous lateral hemi-anopsia. No obvious deficit.; Test Date: 202105; Test Name: Brain CT scan; Result Unstructured Data: Test Result:absence of ischemic lesion constituted.; Comments: absence of ischemic lesion constituted. There is microvascular leukopathy.; Test Date: 202105; Test Name: Brain CT scan; Result Unstructured Data: Test Result:absence of vascular accident and signs of hemorrha; Comments: absence of vascular accident and signs of hemorrhage.; Test Date: 202105; Test Name: cerebral scanner; Result Unstructured Data: Test Result:without abnormality; Test Date: 202105; Test Name: Doppler; Result Unstructured Data: Test Result:no argument in favor of vasculitis; Comments: no argument in favor of vasculitis of the large and medium vessels. Absence of stenosis.; Test Date: 202105; Test Name: leukocytosis; Result Unstructured Data: Test Result:16000
CDC Split Type: FRPFIZER INC2021752473

Write-up: Hemiparesis (right); Aphasia; Dysarthria; Ischemic stroke; loss of strength in the lower limbs; feeling of tightness in her chest; undernutrition; leukocytosis; hyponatremia; inflammatory syndrome; confusion; restlessness; acute retention of urine; bladder distention; acute renal failure; urinary E coli infection; multi organ failure; disturbances of consciousness; hypoxia; microvascular leukopathy; This is a spontaneous report received from a contactable physician downloaded from the WEB. The regulatory authority report number is FR-AFSSAPS-2021075531. A 95-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 10May2021 (Lot Number: EX6537) as single dose for covid-19 immunisation. Medical history included hypertension arterial, polymyalgia rheumatica and ischial neuralgia. The patient''s concomitant medications were not reported. The patient experienced hemiparesis (right), aphasia, dysarthria and ischemic stroke on 16May2021, acute retention of urine, multi organ failure and urinary E coli infection in May2021. Clinical course: On 16May2021, patient had dysarthria, aphasia, right hemiparesis. Patient had consultation of the attending physician. On 18May2021, the patient was hospitalized. In front of these signs of stroke, realization of a cerebral scanner which appears without abnormality in May2021. Patient had worsening of general condition with restlessness, confusion, acute renal failure and bladder distention in May2021. Evolution toward death. On 18May2021, hospitalization of this 95-year-old female patient in good general condition, presenting for 48 hours with dysarthria and loss of strength in the lower limbs. She was aphasic in the morning when she woke up and complained of a feeling of tightness in her chest on 16May2021. In May2021, clinical examination: aphasia of expression, no facial paralysis, no oculomotor disorder, no homonymous lateral hemi-anopsia. No obvious deficit. Normal cardiopulmonary examination. Supple and depressible abdomen, without a globe. ECG (electrocardiogram): absence of repolarization and conduction disturbance. Brain CT scan: absence of ischemic lesion constituted. There was microvascular leukopathy. The patient was put on acetylsalicylate lysine (KARDEGIC), strict rest in bed. Doppler: no argument in favor of vasculitis of the large and medium vessels. Absence of stenosis. Biology: albuminemia at 34 g / l in favor of undernutrition. Subsequently, the patient presented episodes of confusion with discovery of a 750 ml globe with the bladder. Placement of a urinary catheter. cytobacteriological examination of urine: presence of Escherichia coli. Treatment with ceftriaxone sodium (ROCEPHINE) 1 g for 8 days. Patient had appearance of more and more restlessness and confusion. Patient had placement of abdominal compression, oxazepam (SERESTA) 10 at bedtime. New brain scan: absence of vascular accident and signs of hemorrhage. EEG: diffuse brain distress. Rapid deterioration of the clinical state with disturbances of consciousness, signs of poor tolerance with mottling and hypoxia. Biology: leukocytosis at 16,000, hyponatremia at 125 mmol / l, acute renal failure with clearance at 17 ml / min, no increase in cardiac enzymes, significant inflammatory syndrome with CRP (C-reactive protein) at 141; blood cultures negative. Faced with the clinical deterioration of the patient and the disturbances of consciousness, introduction of midazolam (HYPNOVEL) with an electric syringe. Death of the patient was on 29May2021. The patient had no autopsy. In total: occurrence of a frank right hemiparesis evoking an ischemic stroke of the brainstem, 6 days after a first injection of the bnt162b2 vaccine, in a 95-year-old woman in good general condition (little / no fragility objectified to the geriatric assessment carried out on 18May2021). Imaging did not confirm the suspicion of stroke. Death in a context included deteriorating clinical condition with acute renal failure, urinary E coli infection, acute retention of urine, worsening with agitation, confusion, bladder distention and multi organ failure. Outcome of feeling of tightness in her chest, undernutrition, loss of strength in the lower limbs, disturbances of consciousness, leukocytosis, hypoxia, microvascular leukopathy, hyponatremia and inflammatory syndrome was unknown, outcome of other events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Multi organ failure; acute renal failure; urinary E coli infection; acute retention of urine; confusion; bladder distention; Hemiparesis (right); Aphasia; Dysarthria; Ischemic stroke; restlessness


VAERS ID: 1434464 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 - / OT

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

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: Alcoholism; Bypass surgery (bypass valve insertion); Colon cancer (in 2020 in remission; treatment with chemotherapy, surgery, radiotherapy, in complete remission.); Colon operation (in 2020 in remission; treatment with chemotherapy, surgery, radiotherapy, in complete remission.); CSF shunt operation NOS; Meningitis (Cranial trauma with loss of consciousness, then meningitis); Skull trauma (Cranial trauma with loss of consciousness, then meningitis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021770476

Write-up: Death unexplained; died in his chair without a sneer of pain; This is a spontaneous report from a contactable pharmacist downloaded from the WEB, regulatory authority number FR-AFSSAPS-2021078067. A 39-years-old male patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular on 16Jun2021 09:11 (Batch/Lot Number: FD0168, Expiry date was not reported) as single dose for covid-19 immunisation. Medical history included alcoholism (chronic consumer alcohol, and possibly drugs), Cranial trauma, with loss of consciousness, then meningitis, Colon cancer in 2020 (treatment with chemotherapy, surgery, radiotherapy, in complete remission), installation of bypass valve in 2019 and CSF shunt operation. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular on 07May2021 (Batch/Lot Number and Expiry date was not reported) as single dose for covid-19 immunisation. There was no information on tolerance of dose 1. On 16Jun2021, 12:00 the patient died in his chair without a sneer of pain, death unexplained. After administration of the second dose of vaccine at 9:11 AM, the patient was monitored for 15 minutes at the vaccination centre and was presented with no symptoms during monitoring, there was no headache pain and no allergic reaction. The patient was accompanied with his father and who did not notice any reaction at this time and dropped him home at around 10:00 AM and before leaving, everything was fine. His father came back home at around 5:30 PM and noticed that his son has died in his chair without a sneer of pain. The doctor noted a rigidity and a cadaverous lividity which made him think that the time of death goes back to 12:00 and he also noted that the patient did not take his lunch. It was reported as sudden death of the patient, without any associated complaint within one hour of the injection of the 2nd dose of the vaccine. The death would have occurred approximately 3 hours after the vaccination according to the doctor who noted the death. Faced with the complexity of the situation, it was important to take into account the patient''s comorbidities and history. It was unknown if autopsy was performed or not. Outcome of the event was fatal. NB: Imputation made without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death unexplained; died in his chair without a sneer of pain


VAERS ID: 1434467 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-23
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Asthenia, Atrial thrombosis, Blood creatine phosphokinase, Blood culture, C-reactive protein, Cardiomegaly, Cardiovascular examination, Chest X-ray, Computerised tomogram, Embolism arterial, Gait inability, General physical health deterioration, Limb injury, Lower respiratory tract congestion, Mobility decreased, Myoglobin blood, Necrosis, Peripheral ischaemia, Pneumonia, Radial pulse abnormal, SARS-CoV-2 test, Troponin, Ultrasound Doppler, White blood cell count
SMQs:, Cardiac failure (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 43
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: FUROSEMIDE; ZOPICLONE; DIGOXINE; PRADAXA; INSPRA; NEBIVOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Arthrosis; Bradyarrhythmia; Bradycardia NOS (benefiting from a pacemaker insertion); Hyperuricaemia; Implantable defibrillator insertion
Allergies:
Diagnostic Lab Data: Test Date: 20210520; Test Name: CT angiography; Result Unstructured Data: Test Result:embolic occlusion of the left axillary artery; Comments: embolic occlusion of the left axillary artery, hypodense image of the left atrium in favour of a thrombus, major cardiomegaly and calcified pleural plaques.; Test Date: 20210520; Test Name: CPK; Result Unstructured Data: Test Result:6500 IU/l; Test Date: 20210528; Test Name: blood culture; Result Unstructured Data: Test Result:no germs; Test Date: 20210520; Test Name: Cardiac examination; Result Unstructured Data: Test Result:normal; Comments: No left radial, pedal or posterior tibial pedious and weak right radial pulse.; Test Date: 20210518; Test Name: radiography; Result Unstructured Data: Test Result:showing a suspicious lesion; Test Date: 20210520; Test Name: radiography; Result Unstructured Data: Test Result:consistent with infectious pneumonitis; Test Date: 20210520; Test Name: CT scan; Result Unstructured Data: Test Result:consistent with infectious pneumonitis; Test Date: 20210518; Test Name: CRP; Result Unstructured Data: Test Result:38 mg/l; Test Date: 20210520; Test Name: CRP; Result Unstructured Data: Test Result:95 mg/l; Test Date: 20210528; Test Name: CRP; Result Unstructured Data: Test Result:201 mg/l; Test Date: 20210520; Test Name: myoglobin; Result Unstructured Data: Test Result:2700 ug/L; Test Date: 20210520; Test Name: SARS-COV-2 test; Test Result: Negative ; Test Date: 20210520; Test Name: troponin cycle; Test Result: Negative ; Test Date: 20210520; Test Name: Arterial doppler ultrasound of the lower limbs and abdominal aorta; Result Unstructured Data: Test Result:critical ischaemia of the lower limbs; Comments: critical ischaemia of the lower limbs with thrombosis of the femoral and popliteal arteries.; Test Date: 20210520; Test Name: wbc; Result Unstructured Data: Test Result:normal sup; Test Date: 20210528; Test Name: wbc; Result Unstructured Data: Test Result:17.5; Comments: Giga per liter
CDC Split Type: FRPFIZER INC2021752909

Write-up: Limb ischemia; Embolism arterial; necrosis and abolition of the radial pulse; necrosis and abolition of the radial pulse; Atrial thrombosis; deterioration in general condition; the need for a walker to move around/inability to walk; bronchial congestion; inability to move his left hand; major cardiomegaly; infectious pneumonitis; severe asthenia; right foot trauma; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-AM20211704. Safety Report Unique FR-AFSSAPS-2021074866. A 90-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection), dose 2 intramuscular, administered in Deltoid Left on 12Apr2021 (Lot Number: EW2246) as dose 2, single for covid-19 immunisation. Medical history included Arthrosis, Implantable defibrillator insertion, Hyperuricaemia, Arterial hypertension, Bradycardia NOS (benefiting from a pacemaker insertion), paroxysmal brady-arrhythmia. Concomitant medications included furosemide; zopiclone; digoxine; dabigatran etexilate mesilate (PRADAXA); eplerenone (INSPRA); nebivolol. Historical Vaccine included the first dose of BNT162B2 (COMIRNATY, lot number: EP9598, in the left deltoid) on 15Mar2021 for COVID-19 immunisation without any particularity. The patient experienced limb ischemia (death, hospitalization) on 20May2021, embolism arterial (death, hospitalization) on 20May2021, necrosis and abolition of the radial pulse (death, hospitalization) on 20May2021, atrial thrombosis (death, hospitalization) on 20May2021, infectious pneumonitis on 20May2021, right foot trauma on 23Apr2021, severe asthenia on 10May2021, deterioration in general condition on 10May2021, the need for a walker to move around on 10May2021. On 23Apr2021 notion of trauma to the right foot. Biological check-up normal. Consultation on 10May2021, at Day28 (D28), for severe asthenia and altered general condition with the need for a walker to get around. No functional complaint. On 18May2021, at day 36, hospitalization for 48 hours due to inability to walk and worsening of her general condition. CRP at 38 mg/L, chest X-ray showing a suspicious lesion. Re-hospitalization on 20May2021, at D38, due to crepitants on the right, an inability to move his left hand and ischemia of the left upper limb with necrosis and abolition of the radial pulse, noted by the attending physician. Clinical cardiac examination normal. No left radial, pedious or posterior tibial pulses and weak right radial pulse. Biological workup shows an inflammatory syndrome with CRP 95mg/L (normal WBC sup), CPK 6500 IU/L, myoglobin 2700 ?g/L and a negative troponin cycle. SARS COV2 PCR negative. Initiation of amoxicillin-ac clavulanic and curative anticoagulation.Upper extremity angioscanner was performed showing embolic occlusion of the left axillary artery, hypodense image of the left atrium in favour of a thrombus, major cardiomegaly and calcified pleural plaques. Arterial Doppler ultrasound of the lower limbs and abdominal aorta revealed critical ischaemia of the lower limbs with thrombosis of the femoral and popliteal arteries. Chest X-ray and CT scan were consistent with infectious pneumonitis. CRP 201mg/L and WBC 17.5G/L on 28May2021. No germs found on blood culture and cytobacteriological urine test. No ETT performed. Deterioration of general condition with development of bronchial congestion. Initiation of scopolamine and level 3 analgesic. Decision of therapeutic limitation. Outcome of the events infectious pneumonitis, right foot trauma, severe asthenia, deterioration in general condition, the need for a walker to move around, inability to move his left hand, cardiomegaly, bronchial congestion was unknown; of the other events was fatal. The patient died on 05Jun2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Limb ischemia; Embolism arterial; necrosis and abolition of the radial pulse; necrosis and abolition of the radial pulse; Atrial thrombosis


VAERS ID: 1434471 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-05-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood bicarbonate, Blood creatinine, Blood urea, Chronic obstructive pulmonary disease, Computerised tomogram, Delirium, Hypercapnic coma, PCO2, Pulmonary embolism, Respiratory acidosis, Right ventricular dilatation, Urine output, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (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), Dementia (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 19
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: Anemia iron deficiency; Anxiodepressive syndrome; Aortic stenosis; Arthrosis; Asthma; COPD; Hypertension arterial; Osteoporosis; Peripheral arterial occlusive disease; Sigmoid diverticulosis
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: Bicarbonates; Result Unstructured Data: Test Result:43 mmol/L; Test Date: 202105; Test Name: Serum creatinine; Result Unstructured Data: Test Result:143 umol/l; Comments: Maximum serum creatinine; Test Date: 20210518; Test Name: Serum creatinine; Result Unstructured Data: Test Result:70 umol/l; Test Date: 20210518; Test Name: Urea; Result Unstructured Data: Test Result:10 mmol/L; Test Date: 20210510; Test Name: CT scan; Result Unstructured Data: Test Result:pulmonary embolism; Comments: segmental and subsegmental lower right lobar pulmonary embolism with dilation of the right cardiac chambers; Test Date: 20210511; Test Name: PCO2; Result Unstructured Data: Test Result:133 mmHg; Test Date: 20210511; Test Name: PCO2; Result Unstructured Data: Test Result:221 mmHg; Test Date: 20210511; Test Name: pH; Result Unstructured Data: Test Result:7.12; Comments: hypercapnic acidosis; Test Date: 20210518; Test Name: Urine output; Result Unstructured Data: Test Result:580 ml per 24h; Comments: Oliguria
CDC Split Type: FRPFIZER INC2021752130

Write-up: Embolism pulmonary; Chronic obstructive airways disease exacerbated; hypercapnic acidosis; dilation of the right cardiac chambers; hypercapnic coma; acute renal failure; delirium; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-BR20212161. Safety Report Unique Identifier: FR-AFSSAPS-2021075243. An 87-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 14Apr2021 (Lot Number: EW2246) as single dose for covid-19 immunisation. Medical history included anemia iron deficiency, arthrosis, asthma, anxiodepressive syndrome, sigmoid diverticulosis, chronic obstructive pulmonary disease (COPD), osteoporosis, aortic stenosis, peripheral arterial occlusive disease, hypertension arterial. The patient''s concomitant medications were not reported. Patient previously received bnt162b2 (COMIRNATY), dose 1 on 20Mar2021 (Lot Number: ET3620) as single dose for covid-19 immunisation. On 01May2021, hospitalization due to respiratory deterioration following a decrease in corticosteroid therapy. On 09May2021, hospitalization for a new decompensation of COPD (chronic obstructive airways disease exacerbated). Treatment with ceftriaxone sodium (ROCEPHINE), bronchodilator aerosols, corticosteroids and furosemide (LASILIX) is introduced initially. On 10May2021, a CT scan was finally performed in front of respiratory deterioration showing a segmental and subsegmental lower right lobar pulmonary embolism with dilation of the right cardiac chambers. Anticoagulation with rivaroxaban (XARELTO) 15 mg twice a day is then introduced. On 11May2021, appearance of a vigilance disorder on hypercapnic acidosis (pH 7.12, PCO2 133 mmHg, PCO2 221 mmHg, bicarbonates 43 mmol/L). The patient was then intubated and transferred to the intensive care unit. In intensive care: Initial hemodynamic instability with the need to introduce noradrenaline up to 1.2 mg / hour, weaned quickly. Mechanical ventilation from 11May2021 to 13May2021 with relay by non-invasive ventilation due to episodes of hypercapnic acidosis during extubation. Antibiotic therapy stopped in the absence of evidence for an infectious etiology. Relay from XARELTO to heparin calcium (CALCIPARINE) in a context of acute renal failure, then to LOVENOX. Acute functional renal failure improved after increased intake. Maximum serum creatinine at 143 ?mol/L. Intensive care delirium. In the aftermath of resuscitation, transfer to another hospital. During the intensive care stay, it had been decided, taking into account the age and the respiratory history, not to reintubate the patient if further deterioration. Evolution in the service: Respiratory: the patient remains eupneic in ambient air, however, bronchial congestion persists. Neurological: He persists in intensive care delirium (positive CAM-CIU test). Metabolic: Progressive regression of acute functional renal failure. On 18May2021, urea is 10 mmol/L and serum creatinine is 70 ?mol/L. Oliguria persists at 580 ml per 24 hours. On 20May2021, appearance of vigilance disorders with respiratory congestion despite the resumption of the non-invasive ventilation. The evolution is unfavorable and the patient dies in the evening. Conclusion: 88-year-old patient hospitalized for a hypercapnic coma on decompensation of COPD in a context of right lower lobar segmental pulmonary embolism. In total : Decompensation of COPD occurring at 17 days of a 2nd dose of COMIRNATY and in a context of decrease in corticosteroid therapy. New decompensation approximately 1 week later and evidence of pulmonary embolism. Hospitalization in intensive care. Death of the patient on 20May2021 in a context of vigilance disorders with respiratory congestion despite the resumption of the NIV (non-invasive ventilation). Patient died on 20May2021 from chronic obstructive airways disease exacerbated and embolism pulmonary. Outcome of the event acute renal failure was recovering, other events were unknown. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: chronic obstructive airways disease exacerbated; Embolism pulmonary


VAERS ID: 1434474 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-05-01
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, COVID-19, Hypothermia, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Respiratory failure (broad), 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: 8
Permanent Disability? 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: 20210501; Test Name: body temperature; Result Unstructured Data: Test Result:hypothermia; Test Date: 20210501; Test Name: oxygen saturation; Result Unstructured Data: Test Result:desaturation; Test Date: 20210506; Test Name: SARS-COV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021758488

Write-up: Vaccination failure; COVID-19 aggravated; hypothermia; asthenia; desaturation; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-BS20211005. Safety Report Unique FR-AFSSAPS-2021074926. A 91-year-old female patient received bnt162b2 (COMIRNATY COVID-19 vaccine, Solution for injection, Batch/Lot Number: EM0477), dose 2 intramuscular, administered in arm on 02Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY COVID-19 vaccine, Solution for injection, Batch/Lot Number: EM0477, Expiry date: unknown), dose 1 intramuscular, administered in arm on 12Jan2021 as single for covid-19 immunisation. Patient resident of a retirement home in which several cases of COVID-19 infection were observed. The patient was not in a double room. The patient had no history of COVID-19. The patient had not tested with COVID-19. The was considered at risk of developing a severe form of COVID-19 disease. Day 88 (01May2021) the patient experienced, appearance of symptoms such as hypothermia, asthenia and desaturation. A severe alteration of the patient''s general condition was observed within 24 hours. Day 93 (06May2021) a positive PCR (polymerase chain reaction) test was performed. On 06May2021, the patient experienced vaccination failure and covid-19 aggravated. Day 96 (09May2021): Death of the patient due to her COVID-19 infection. Confirmed vaccine failure with COVID-19 aggravated with indeterminate variant in an elderly subject at D88 (01May2021) of COMIRNATY dose 2 with patient death at Day 96 (09May2021). On 01May2021, the patient lab tests included body temperature was hypothermia, oxygen saturation was desaturation. On 06May2021, the patient lab data included sars-cov-2 test (PCR test) was positive. The patient died on 09May2021 and the cause of death was vaccination failure and COVID-19, An autopsy was not performed. The outcome of the events vaccination failure and COVID-19 aggravated was fatal. The outcome of the events hypothermia, asthenia and desaturation was resolved on an unknown date 2021. No follow-up attempts possible. No further information expected. ; Sender''s Comments: Linked Report(s) : FR-AFSSAPS-2021074837 ;FR-AFSSAPS-2021074856 ;FR-AFSSAPS-2021074849 ;FR-AFSSAPS-2021074891 ;FR-PFIZER INC-2021758495 Same reporter, different patient, different events, same vaccine;FR-PFIZER INC-2021761330 Same reporter, different patient, different events, same vaccine;FR-PFIZER INC-2021761343 Same reporter, different patient, different events, same vaccine;FR-PFIZER INC-2021761348 Same reporter, different patient, different events, same vaccine; Reported Cause(s) of Death: COVID-19 aggravated; vaccination failure


VAERS ID: 1434478 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-03-03
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0641 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Stress echocardiogram, Ultrasound Doppler
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioplasty (Bilateral iliac kissing-balloon angioplasty); Angioplasty (Angioplasty and lateral Cx bridge stent and apical IVA stent); Cardiac disorder; Coronary artery surgery (Bilateral carotid surgery.); Coronary bypass; Coronary stent user (Saphenous-cd and distal right coronary bridge stent. Distal sub-occlusion latero bridge Cx.); Paroxysmal atrial fibrillation (No change in coronary angiography). Medical treatment. Paroxysmal AF.); Comments: Cardiopathie
Allergies:
Diagnostic Lab Data: Test Date: 201609; Test Name: stress echo; Test Result: Negative ; Test Date: 2015; Test Name: TSA and MI Doppler; Result Unstructured Data: Test Result:no significant stenosis
CDC Split Type: FRPFIZER INC2021752073

Write-up: Death; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority FR-AFSSAPS-CF20211489, Safety Report Unique Identifier FR-AFSSAPS-2021074971. An 85-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in left arm on 19Feb2021 (Lot Number: ER0641) at single dose for COVID-19 immunisation. Medical history included Heart disease, Quadruple bypass in 1991 (see detail in History of the disease): 2004: Saphenous-cd and distal right coronary bridge stent. Distal sub-occlusion latero bridge Cx. 2006: No change. 2009: Bilateral carotid surgery. 2010: Angioplasty and lateral Cx bridge stent and apical IVA stent. 2010: Bilateral iliac kissing-balloon angioplasty. 2014: No change in coronary angiography. Medical treatment. Paroxysmal AF. 2015: The supra-aortic trunk echo-Doppler (TSA) and MI Doppler: no significant stenosis. September 2016: Negative stress echo. The patient''s concomitant medications were not reported. The patient experienced death on 03Mar2021. The patient underwent lab tests and procedures which included stress echo: Negative on Sep2016, TSA and MI Doppler: no significant stenosis in 2015. The patient died on 03Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1434481 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Diabetes mellitus inadequate control, Pneumonia, Renal failure, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 75
Permanent Disability? 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: Embolism pulmonary; Hypertension arterial; Non-insulin-dependent diabetes mellitus; Oligophrenia
Allergies:
Diagnostic Lab Data: Test Date: 20201023; Test Name: Covid-19 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021752934

Write-up: Diabetes imbalance; bronchopulmonary infection; renal failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-LL20213978, Safety Report Unique Identifier FR-AFSSAPS-2021072790. An 83-year-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 18Mar2021 (Lot Number: ET3620) as single dose for COVID-19 immunisation. Medical history included oligophrenia, embolism pulmonary, non-insulin-dependent diabetes mellitus and hypertension arterial. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) in Feb2021 for COVID-19 immunisation. On 19Mar2021, 18h after the injection, appearance of a bronchopulmonary infection with diabetes imbalance and renal failure. Patient died on 02Jun2021. The patient underwent lab tests and procedures which included Covid-19 test: negative on 23Oct2020. The patient died on 02Jun2021. It was unknown if an autopsy was performed. Additional information obtained by the Regional Pharmacovigilance Center on 2/6 after 3 reminders: in the aftermath of the vaccination (Day1Dose2), fever and deterioration of the general condition probably at the origin of a false route which led to pneumopathy, with imbalance of diabetes and acute renal failure, progression to death.; Reported Cause(s) of Death: diabetes imbalance; bronchopulmonary infection; renal failure


VAERS ID: 1434492 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7823 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021752198

Write-up: Intra-cerebral haemorrhage; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-MA20212305, Safety report unique identifier FR-AFSSAPS-2021075527. A 29-year-old male patient received bnt162b2 (COMIRNATY) at the age of 29-year-old, dose 1 intramuscular on 10Jun2021 (Batch/Lot Number: EX7823) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced intra-cerebral haemorrhage on 12Jun2021. The patient died on 12Jun2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: 29-year-old male patient who presented with a cerebromeningeal hemorrhage two days after the first dose of COMIRNATY lot EX7823. The patient had no medical history, we noted a jogging session the day before the event, on 11Jun. On 12Jun, at home feeling unwell in the toilets with cardiopulmonary arrest. He was brought to the emergency room, diagnosed with cerebromeningeal hemorrhage with commitment. The declaring doctor suspected a ruptured aneurysm, but did not rule out the hypothesis of a surge in blood pressure following the vaccination. He died as a result of this hemorrhage. Time Interval between Beginning of Drug Administration and Start of Reaction / Event 3 days Did reaction recur on readministration? (NO -- N/A (no rechallenge was done, recurrence is not applicable)) No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Intra-cerebral haemorrhage


VAERS ID: 1434533 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombotic thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, arterial (narrow), Renovascular disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021777467

Write-up: vaccine-related TTP (2 fatal); This is a report from an episode associated with an mRNA-based anti-COVID-19 vaccination". A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccine-related thrombotic thrombocytopenic purpura (TTP) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of event was fatal. The Vaccine Adverse Event Reporting system (VAERS) co-managed by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), contains six cases of vaccine-related TTP (2 fatal) as of the first of January 2021, all after the anti-COVID-19-vaccine produced by Pfizer- BioNTech. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency.; Sender''s Comments: The contributory role of the suspect product to reported thrombotic thrombocytopenic purpura (TTP) cannot totally 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: Thrombotic thrombocytopenic purpura


VAERS ID: 1434534 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombotic thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, arterial (narrow), Renovascular disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021777468

Write-up: vaccine-related TTP (2 fatal); This is a report associated with an mRNA-based anti-COVID-19 vaccination". A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccine-related thrombotic thrombocytopenic purpura (TTP) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of event was fatal. The Vaccine Adverse Event Reporting system (VAERS) co-managed by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), contains six cases of vaccine-related TTP (2 fatal) as of the first of January 2021, all after the anti-COVID-19-vaccine produced by Pfizer- BioNTech. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency.; Sender''s Comments: The contributory role of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to reported thrombotic thrombocytopenic purpura (TTP) cannot totally 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: Thrombotic thrombocytopenic purpura


VAERS ID: 1434561 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-16
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 84
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILLIN MYLAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholangitis NOS (cholangitis on gallbladder lithiasis); Cognitive disturbance (major cognitive disorders); Cystoprostatectomy; Deglutition disorder (swallowing disorders); Gallstones (cholangitis on gallbladder lithiasis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021160475

Write-up: Death; Shingles; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB. This is a report received from the Regulatory Authority, regulatory authority report number: FR-AFSSAPS-RE20210054. An 82-year-old male patient received the first dose of BNT162b2 (COMIRNATY) (lot number EM0477, expiry date unknown) on 13Jan2021 at single dose intramuscularly into his right arm for COVID-19 immunisation. Other suspect drug included amoxicillin (AMOXICILLIN MYLAN), received from Jan2021 (date prior to vaccination) to 17Jan2021 orally at 3 g once daily (1g x3 per day), for acute bronchitis. The patient''s medical history included major cognitive disorders, cholangitis on gallbladder lithiasis, swallowing disorders and cystoprostatectomy. The patient did not have a test and did not developed COVID-19, at risk of developing a severe form of COVID-19 disease due to his age. Concomitant medication was not reported. The patient experienced shingles on 16Jan2021. On 16Jan2021, appearance of urticarial lesions with area of necrosis on the right arm and the posterior face of the neck. On 17Jan2021, the patient stopped amoxicillin Mylan and switch to rocephine. On 19Jan2021, the patient had a dermatological consultation, on examination erythematous plaques surmounted by vesicles in the upper right limb. Some umbilicated lesions in their center. A lesion of the neck. No other lesion on the rest of the integument. No scratching lesion. No sign of superinfection. Very probable diagnosis of herpes zoster in the right upper limb. Treatment with valaciclovir hydrochloride (ZELITREX) 1g x3 / d for 7 days. The evolution of the event was recovering. Upon follow up on 15Jun2021, it was reported that Death of male patient after change in their general wellbeing that pre-existed the vaccination on 11Apr2021. Vaccination in a patient whose state of health was in decline at the time of the vaccination. It was not reported if an autopsy was performed. Outcome of the event Shingles was recovered on 23Jan2021. Other reference from the regulatory authority: subject to other elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible; information about lot/batch number already obtained. Follow-up (15Jun2021): New information downloaded from the Regulatory Authority-WEB FR-AFSSAPS-RE20210054 (Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021026672) includes: New event (death) added, outcome of event shingles updated, stop date added. No follow-up attempts are possible; information about lot/batch number already obtained. ; Reported Cause(s) of Death: Death


VAERS ID: 1434707 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-13
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angiocardiogram, Cardiovascular evaluation, Death, Disease progression, Echocardiogram
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN CARDIO; BELOC ZOK; OLMESARTAN MEPHA; TOREM [TORASEMIDE]; METOLAZON; EUTHYROX; ATORVASTATIN MEPHA; ACIDUM FOLICUM STREULI; ALUCOL [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE]; ROCALTROL; HUMALOG; MAGNESIOCARD CITRON
Current Illness: Triple vessel disease; Type 1 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure (Chronic kidney failure CKD stage G3b-4A3. Dialysis-dependent kidney failure); Diabetic nephropathy (Not histologically confirmed); Dialysis (worsening of kidney failure.); Elective hospitalization (Hospitalized for double organ (combined pancreas and kidney) transplantation clarification. Patient was diagnosed with triple vessel disease with cardiac decompensation with significant dyspnea and need for oxygen.); Hashimoto''s thyroiditis; Left heart failure (Predominantly left-sided cardiac decompensation NYHA IV for coronary triple vessel disease (HFpEF), initial diagnosis Feb 23); Polyglandular autoimmune syndrome type I (Polyglandular autoimmune syndrome)
Allergies:
Diagnostic Lab Data: Test Date: 20210223; Test Name: Coronary angiography; Result Unstructured Data: triple vessel disease; Test Date: 2021; Test Name: Cardiological assessment; Test Result: Inconclusive ; Result Unstructured Data: LVEF of 65% without detectable changes; Test Date: 2021; Test Name: Transthoracic echocardiography; Test Result: Inconclusive ; Result Unstructured Data: LVEF of 65% without detectable changes
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of DEATH and DISEASE PROGRESSION in a 55-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 immunization. The patient''s past medical history included Left heart failure (Predominantly left-sided cardiac decompensation NYHA IV for coronary triple vessel disease (HFpEF), initial diagnosis Feb 23) on 23-Feb-2021, Polyglandular autoimmune syndrome type I (Polyglandular autoimmune syndrome), Chronic renal failure (Chronic kidney failure CKD stage G3b-4A3. Dialysis-dependent kidney failure), Diabetic nephropathy (Not histologically confirmed) in 1985, Hashimoto''s thyroiditis, Elective hospitalization (Hospitalized for double organ (combined pancreas and kidney) transplantation clarification. Patient was diagnosed with triple vessel disease with cardiac decompensation with significant dyspnea and need for oxygen.) from 22-Feb-2021 to 26-Feb-2021 and Dialysis (worsening of kidney failure.) on 12-Mar-2021. Concurrent medical conditions included Type 1 diabetes mellitus since 1973 and Triple vessel disease since 23-Feb-2021. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), METOPROLOL SUCCINATE (BELOC ZOK), OLMESARTAN MEDOXOMIL (OLMESARTAN MEPHA), TORASEMIDE (TOREM [TORASEMIDE]), METOLAZONE (METOLAZON), LEVOTHYROXINE SODIUM (EUTHYROX), ATORVASTATIN CALCIUM (ATORVASTATIN MEPHA), FOLIC ACID (ACIDUM FOLICUM STREULI), ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE (ALUCOL [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE]), CALCITRIOL (ROCALTROL), INSULIN LISPRO (HUMALOG) and MAGNESIUM ASPARTATE HYDROCHLORIDE (MAGNESIOCARD CITRON) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISEASE PROGRESSION (seriousness criterion death). The patient died on 13-Mar-2021. The reported cause of death was Disease progression, Type 1 diabetes mellitus, dialysis-dependent kidney failure and Triple vessel disease. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Angiocardiogram: abnormal (abnormal) triple vessel disease. In 2021, Cardiovascular evaluation: unknown (Inconclusive) LVEF of 65% without detectable changes. In 2021, Echocardiogram: unknown (Inconclusive) LVEF of 65% without detectable changes. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH and DISEASE PROGRESSION to be possibly related. It was reported that the patient was scheduled for a cardiac MRI (magnetic resonance imaging) on 09-Mar-2021, after which an aortic coronary bypass surgery was planned. It was reported that the rapid progression of the underlying diseases, after 22-Feb-2021, was presumed as the primary factor for the patient''s death. No treatment information was provided. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event/s, a causal relationship cannot be excluded Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Translated document uploaded. Added additional causes of death (as per sender''s comments), medical history, lab data, frequency of con-meds, causality as reported.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event/s, a causal relationship cannot be excluded; Reported Cause(s) of Death: Disease progression; type 1 diabetes mellitus; dialysis-dependent kidney failure; Triple vessel disease


VAERS ID: 1435132 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-06-15
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis, Cerebral venous sinus thrombosis, Computerised tomogram, Fibrin D dimer, Heparin-induced thrombocytopenia, Inappropriate schedule of product administration, Platelet count, SARS-CoV-2 test, Suicide attempt
SMQs:, Suicide/self-injury (narrow), Ischaemic 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), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypersensitivity (narrow), Medication errors (narrow), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: CT; Result Unstructured Data: Test Result:large intraparenchymal haemorrhage; Test Name: D-dimer; Result Unstructured Data: Test Result:Unknown; Test Name: anti-PF4 antibodies; Result Unstructured Data: Test Result:Unknown; Test Name: platelet count; Result Unstructured Data: Test Result:Unknown; Test Date: 20201108; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021772900

Write-up: Inappropriate schedule of vaccine administered; Cerebral thrombosis; cortical venous thrombosis; attempted anticoagulation; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106211424254930-78XYV, Safety Report Unique Identifier GB-MHRA-ADR 25511468. A 44-year-old male patient had received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 30Mar2021 as dose 2 single for COVID-19 immunisation. Patient medical history included depression. Concomitant medications included citalopram taken for depression from 19Sep2019. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 22Jan2021 as dose 1 single for COVID-19 immunisation. The patient previously took heparin. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. On an unspecified date in 2021, the patient experienced cortical venous thrombosis, attempted anticoagulation "(suicide attempt)" and inappropriate schedule of vaccine administered. On 15Jun2021, the patient had cerebral thrombosis. It was reported that patient had cortical venous thrombosis with haemorrhagic transformation, attempted anticoagulation, no improvement. Reaction report was related to possible blood clots or low platelet counts. Suspect Reactions details any relevant investigations or tests conducted included ''CT - large intraparenchymal haemorrhage'' ''cerebral venous sinus thrombosis with haemorrhagic transformation''. Event was diagnosed by ''CT'' on ''15Jun21'' the date of diagnosis. The platelet count <150 A-109/L; D-dimer $g4000: anti-PF4 antibodies identified was Unknown. Patient had none additional medical history, not already provided, that relates to previous venous or arterial thromboses. The patient had no any previous reactions to medications, especially heparin or anticoagulants. The patient was not confirmed or suspected autoimmune or inflammatory disease, including vasculitis. The patient had no history of or current malignancy. It was unknown whether patient currently smoke. It was unknown the lowest platelet count after vaccine (usual normal range 150-450) and the last platelet count before vaccine. The patient was not reviewed by a haematologist and had no diagnosis or differential diagnoses. The intraparenchymal haemorrhage was identified. The patient had no history of, or concurrent, intracranial malignancy and no concurrent or recent intracranial infections. Patient had no recent surgical or medical interventions to the central nervous system (including lumbar puncture) and recent trauma/head injury. The patient underwent lab tests and procedures which included computerised tomogram: large intraparenchymal haemorrhage on 15Jun2021, fibrin d dimer: unknown on an unspecified date, heparin-induced thrombocytopenia: unknown on an unspecified date, platelet count: unknown on an unspecified date, Negative COVID-19 virus test on 08Nov2020. The clinical outcome of cortical venous thrombosis, attempted anticoagulation, cerebral thrombosis was fatal and the patient died on 17Jun2021. The cause of death was cortical venous thrombosis, attempted anticoagulation, cerebral thrombosis. 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: cortical venous thrombosis; attempted anticoagulation; Cerebral thrombosis


VAERS ID: 1435188 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-05-01
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, Bedridden, COVID-19 pneumonia, Chest X-ray, Chronic kidney disease, Disease progression, Drug ineffective, Fluid intake reduced, Hydrothorax, Hyponatraemia, Hypophagia, Laboratory test, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Lack of efficacy/effect (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic arteriosclerosis; Brain infarction; Hyperlipidaemia; Hypertension; Ischemic heart disease; Kidney failure chronic; NIDDM; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20210501; Test Name: Chest X-ray; Result Unstructured Data: Test Result:COVID-19 pneumonia; Comments: COVID-19 pneumonia, hydrothorax; Test Name: Laboratory test; Result Unstructured Data: Test Result:mild hyponatremia, elevated inflammatory parameter; Comments: mild hyponatremia, elevated inflammatory parameters and progression of his chronic kidney failure; Test Date: 20210501; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210503; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021752046

Write-up: vaccination failure; COVID-19 pneumonia; Asymptomatic COVID-19; hyponatremia; progression of his chronic kidney failure; progression of his chronic kidney failure; hydrothorax; Bedridden; Did not drink or eat much; Did not drink or eat much; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority number is HU-OGYI-415221. This spontaneous, serious, medically confirmed case was reported on 31May2021 by a physician and concerns the occurrence of vaccination failure, Covid-19 pneumonia and asymptomatic Covid-19 infection resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. On 05Mar2021 the 78-years-old male patient received the first dose (lot number: EP2163) and on 09Apr2021 received the second dose of 0.3 ml COMIRNATY concentrate for dispersion for injection (tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), lot number: EW9127, expiry date: unknown, MAH: BioNTech Manufacturing GmbH/Pfizer) intramuscularly in the left arm to prevent Covid-19. The patient was hospitalized on 01May2021 after finding him lying on the floor in his home. According to the patients relative, he was bedridden and did not drink or eat much. The patient did not have Covid-19 symptoms and his PCR tests were also negative. Laboratory results showed mild hyponatremia, elevated inflammatory parameters and progression of his chronic kidney failure. Chest X-ray showed hydrothorax and pneumonia. The patient received therapy, but his general condition worsened and passed away on 03May2021 22:00. Medical history included hypertension, ischemic heart disease, aortic atherosclerosis, hyperlipidemia, NIDDM, chronic kidney failure, brain infarction and pulmonary embolism in May2020. Concomitant drugs were not reported. Further information is not expected. Sender Comment: The patient had negative Covid-19 PCR tests, but laboratory results implied Covid-19 infection. The patient also received both doses of the vaccine and passed away 24 days after the second those, therefore vaccination failure is possible. The case is serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Asymptomatic COVID-19; vaccination failure; COVID-19 pneumonia


VAERS ID: 1435189 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-21
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Disease progression, Haematemesis, Laboratory test, Metastases to central nervous system, Muscular weakness, Renal impairment, SARS-CoV-2 test, Speech disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal haemorrhage (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder neoplasm; COPD; Dementia; Lung infiltration malignant; Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210421; Test Name: Brain CT; Result Unstructured Data: Test Result:cerebellar metastasis left side,; Comments: cerebellar metastasis left side, left lung tumor in the upper lung field, metastasis in the same lobe; Test Date: 20210421; Test Name: Laboratory test; Result Unstructured Data: Test Result:Decreased renal function; Test Date: 20210421; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210421; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021752047

Write-up: underlying malignant diseases; Haematemesis; weakness in his right lower limb.; anointed speech; Decreased renal function; cerebral metastasis was confirmed on the left side by cranial; This is as spontaneous report received from a contactable Physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is HU-OGYI-415421. This spontaneous, serious case was reported by a physician on 31May2021, concerning death after the administration of Comirnaty concentrate for dispersion for injection (30 micrograms of COVID-19 mRNA Vaccine, MAH: BioNTech Manufacturing/Pfizer). On 12Apr2021 at 07:42 a.m., the 89-year-old male patient received the second dose of Comirnaty (COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran) concentrate for dispersion for injection (1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine, intramuscularly, left arm, lot number: EW9127). First dose was given on 08Mar2021, lot number: EP2163. On 21Apr2021, the patient was admitted to the hospital due to anointed speech and weakness in his right lower limb. Decreased renal function showed in laboratory tests, cerebral metastasis was confirmed on the left side by cranial computed tomography (CT), and left lung tumor with the same lobe metastasis was considered in the upper lung field. The patient received infusion, dexamethasone, glycerin-, and preventive LMWH treatment. After two negative COVID-19 PCR tests, the patient was placed in the Pulmonology Department for further treatment. Cerebellar metastasis caused by malignant pulmonological disease was considered in the background of the patient''s complaints. Given the patient''s general condition and the previous request from the patient and relatives, no invasive examination was considered. Haematemesis occurred, which disappeared after maximal conservative treatment and did not cause hemodynamic fluctuations or anemia. The general condition of the patient declined continuously despite the applied symptomatic therapy. Due to his underlying malignant diseases, the patient died at 6:15 a.m. on 11May2021. Autopsy was not requested. Medical history included bladder neoplasm, Chronic obstructive pulmonary disease (COPD), dementia, smoking, and malignant lung infiltration. No further information is expected. Sender''s Comments: The 89-year-old patient died 29 days after Comirnaty vaccination due to his underlying diseases. The event and the suspect vaccine is not related. The case is serious due to hospitalization and fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: underlying malignant diseases


VAERS ID: 1435190 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cachexia, Disease progression
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
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: Bone cancer; Cachexia; Hyperlipidaemia; Hypertension; Intestinal adenocarcinoma; Ischemic heart disease; Paralytic ileus; Prostate cancer; Pulmonary embolism; Stomach cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021752049

Write-up: cancer cachexia; cancer cachexia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-416021. This spontaneous, serious, medically confirmed case was reported on 31May2021 by a physician and concerns the occurrence of death after COMIRNATY injection for active immunization to prevent COVID-19. On 01Apr2021 the 75-years-old male patient received the first dose (batch number: EW2239) and on 06May2021 received the second dose of 0.3 ml COMIRNATY concentrate for dispersion for injection (tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), lot number: FA5829, expiry date: unknown, MAH: BioNTech Manufacturing Pfizer) intramuscularly in the left arm to prevent Covid-19. The patient was hospitalized on 12May2021 after experiencing nausea, vomiting and abdominal discomfort. The symptoms were assessed as paralytic ileus. Surgery was not performed due to the patients general condition as he had malign prostate cancer, stomach, intestinal adenocarcinoma and bone metastases. The patient received parenteral liquid supplement and comfort care. He passed away on 16May2021 17:15 due to cancer cachexia. Medical history included Prostate cancer, Paralytic ileus, hypertension, ischemic heart disease, Intestinal adenocarcinoma, Stomach cancer, Cachexia, Bone cancer, pulmonary embolism and hyperlipidemia. Past drugs included Taxotere (docetaxel) from Aug2016 to Dec2016 and Xtandi (enzalutamide). Concomitant drugs were not reported. Further information is not expected. Sender Comment: The reporter physician assessed the event of death as related to the patients primary diseases (cancer with metastases), therefore the causal relationship is unlikely between the suspected drug and the adverse event. The case is serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cachexia cancer; Cachexia cancer


VAERS ID: 1435191 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-23
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anuria, Bronchitis chronic, Confusional state, Electrocardiogram, General physical health deterioration, Heart rate, Hypotonia, Pneumonia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Cardiac operation; Mitral valve repair
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:wide QRS; Test Name: Heart rate; Result Unstructured Data: Test Result:30 / min; Test Date: 20210527; Test Name: COVID-19 rapid POC test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021752051

Write-up: bilateral pneumonia; exacerbation of chronic bronchitis; No diuresis; general condition had greatly deteriorated; confused, hypotonic; confused, hypotonic; This is a spontaneous report from a contactable physician downloaded from the WEB, the Regulatory Authority number is HU-OGYI-416521. This spontaneous, serious case was reported by a physician on 31May2021, concerning bilateral pneumonia after the administration of Comirnaty concentrate for dispersion for injection (30 micrograms of COVID-19 mRNA Vaccine, MAH: BioNTech Manufacturing GmbH/ Pfizer). On 23May2021, the 44-year-old female patient received the second dose of Comirnaty (COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran) concentrate for dispersion for injection ( 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine, intramuscularly, left arm, lot number: FA4598). First dose was given on 15Apr2021, batch number: EW4815). On 27May2021, the patient was transported to the hospital due to dyspnoea started a few days before, diarrhea complaints started 2 months before, and her general condition had greatly deteriorated. COVID-19 rapid test was negative. Due to superficial spontaneous respiration, non-invasive ventilation was started with mild sedation. The patient was confused, hypotonic, for which she received norepinephrine; she also had no diuresis. In the absence of compliance, the patient was intubated, ventilated, and given dobutamine. ECG showed wide QRS, heart rate was 30 / min, the patient was hypotonic. Tonogen (epinephrine) and atropine were given, but her heart rate did not change. Complete cardiopulmonary resuscitation was initiated, unsuccessfully. At 12:35, the patient died. According to the autopsy, the cause of death was bilateral pneumonia due to the exacerbation of chronic bronchitis. Medical history included unspecified cardiac operation when the patient was 3 years old, aortic valve replacement and mitral valve repair in //2017. The patient did not attend regular treatments. No further information is expected. Sender Comment: The patient died 4 days after the second dose of Comirnaty. The cause of death was bilateral pneumonia due to the exacerbation of chronic bronchitis. The causal relationship between the event and Comirnaty is considered unlikely. The case is serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Bilateral pneumonia; exacerbation of chronic bronchitis


VAERS ID: 1435192 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-05-13
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Chronic obstructive pulmonary disease, Disease progression, Lung cancer metastatic
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), Hypersensitivity (broad), Respiratory failure (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   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: SEEBRI BREEZHALER; BERODUAL; VENTOLIN [SALBUTAMOL]; FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL FUMARATE]; RETAFYLLIN
Current Illness: Advanced lung cancer (with multiple metastases); COPD; Decompensation cardiac
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021752052

Write-up: acute respiratory failure; advanced lung cancer with multiple metastases; advanced lung cancer with multiple metastases; COPD; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number is HU-OGYI-424021. This serious, spontaneous case was reported by a physician on 01Jun2021, concerning the occurrence of death after the use of Comirnaty concentrate for dispersion for injection (MAH: BioNTech Manufacturing). On 22Apr2021, the 65-year-old female patient received 0.3 ml Comirnaty concentrate for dispersion for injection (tozinameran; Lot number: ET6956, expiry date: Aug2021, intramuscularly, in the left upper arm) for COVID-19 immunisation. On 13May2021, the patient''s asphyxiation symptoms increased and was sent to the hospital. The patient was hospitalized. In the hospital, the patient was treated for respiratory failure but the fatal outcome of advanced lung cancer was unavoidable. The patient died on 15May2021 in the early hours. According to the autopsy report, the cause of death was acute respiratory failure. The patient''s primary diseases that contributed to the death was COPD and advanced lung cancer with multiple metastases. In the patient''s medical history, there is advanced lung cancer, COPD and cardiac decompensation. The patient''s concomitant medicinal products were Berodual (fenoterol, ipratropium bromide), Foster (beclometasone, formoterol), Seebri Breezhaler (glycopyrronium bromide), Retafyllin (theophylline) and Ventolin (salbutamol). No further information is expected. Senders comments: Death after vaccination with Comirnaty is not expected. TTO is 3 weeks until hospitalization. Dechallenge and rechallenge were not applicable. Due to the patient''s primary diseases, the causal relationship between the suspected drug and the events is considered not related. The case is considered serious due to hospitalization and fatal outcome Batch/ lot number: ET6956 No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: acute Respiratory failure; COPD; advanced lung cancer with multiple metastases; advanced lung cancer with multiple metastases; Autopsy-determined Cause(s) of Death: acute Respiratory failure


VAERS ID: 1435194 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-05-07
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cerebral haemorrhage, Computerised tomogram head, Computerised tomogram thorax, Death, Loss of consciousness, Nervous system disorder, Oxygen saturation, Oxygen saturation decreased, Pleural effusion
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Nephropathy (since 2018); Type I diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Acetabulum fracture (After car accident); Automobile accident; Diabetic retinopathy; Jaw fracture (After car accident); Maxillary antrum fracture (After car accident); Non STEMI
Allergies:
Diagnostic Lab Data: Test Date: 20210507; Test Name: blood pressure; Result Unstructured Data: Test Result:hypertension; Test Date: 20210507; Test Name: chest CT; Result Unstructured Data: Test Result:circulatory stagnation and pleural fluid in both s; Comments: circulatory stagnation and pleural fluid in both sides of the lung; Test Date: 20210507; Test Name: skull CT; Result Unstructured Data: Test Result:large haemorrhage in four cerebral ventricles in t; Comments: large haemorrhage in four cerebral ventricles in the brain; Test Date: 20210507; Test Name: oxygen saturation; Result Unstructured Data: Test Result:low oxygenation levels
CDC Split Type: HUPFIZER INC2021752055

Write-up: died; disturbed and unconscious/coma-like state; low oxygenation levels; large haemorrhage in four cerebral ventricles in the brain; chest circulatory stagnation and pleural fluid in both sides of the lung; severe neurological damage; This is a spontaneous report from a contactable physician downloaded from the WEB HU-OGYI-456321. A 36-year-old male patient received second dose of bnt162b2 (COMIRNATY) intramuscularly in the left arm on 27Apr2021 at 0.3 ml single (lot number: ET6956) for COVID-19 immunisation. Medical history included ongoing type I diabetes mellitus, diabetes retinopathy, nephropathy since 2018 and ongoing, non-STEMI in 2020, ongoing hypertension. In 2021, the patient had a car accident, which resulted in maxillary antrum fracture, mandibular fracture and acetabulum fracture. The patient''s concomitant medicinal products were not reported. The patient previously received first dose of bnt162b2 intramuscularly in the left arm on 23Mar2021 at 0.3 ml single (lot number: ET3620) for COVID-19 immunisation. The patient experienced died on 09May2021. The clinical course was reported follows: On 07May2021, in his home, the patient became disturbed and unconscious. The ambulance was called and the patient was found in a coma-like state with hypertension and low oxygenation levels. The patient received respiratory support and was transported to the hospital. In the hospital, skull CT and chest CT was initiated. The skull CT test results showed large haemorrhage in four cerebral ventricles in the brain. The chest CT showed chest circulatory stagnation and pleural fluid in both sides of the lung. The patient was sedated and intensive medicinal treatment was initiated. On 08May2021, the patient''s severe neurological damage was reported. On 09May2021, the patient died. Outcome of other events was unknown. It was unknown if autopsy was performed. Sender Comment: Death after vaccination with Comirnaty is not expected. TTO is 10 days until hospitalization. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered not assessable per lack of information. The case is considered serious due to hospitalization and fatal outcome. No follow-up attempts possible. No further information expected.; Sender''s Comments: There was no information provided regarding cause of death, autopsy results and diagnostic studies. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified and will be re-assessed based on additional data. Event death and the other reported events causal relationship with the patient underlying condition cannot be excluded and is therefore not related to the suspect drug BNT162B2. This case will be updated once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: died


VAERS ID: 1435207 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-08
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Cold sweat, Death, Depressed level of consciousness, Discomfort
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   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: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021752726

Write-up: Consciousness decreased; Discomfort; Cold sweat; Chest pain; death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB IS-IMA-3090.This case was received via the Agency from a physician. A 94-year old female with hypertension was vaccinated for the second time with Comirnaty on 21Jan2021 for COVID-19 immunisation.The patient has hypertension and no other history of cardiovascular diseases.Concomitant medication was not reported.On 08FEB2021, 18 days after the second administration of the Comirnaty vaccine, the patient experienced sudden discomfort, chest pain, cold sweat and impaired consciousness. Patient passed away 30 minutes later. Outcome of events was fatal. No follow-up attempts possible. No further information expected. Information on batch number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1435208 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-09
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   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: ISPFIZER INC2021752730

Write-up: death; stomach ache; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, Regulatory authority number is IS-IMA-3091. A 103-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 21Jan2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Feb2021, 19 days after the second administration of Comirnaty, the patient experienced stomach ache at 9 o''clock in the morning. Outcome of events was fatal.The patient died at 20 in the evening.The patient died on 09Feb2021. It was not reported if an autopsy was performed. 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: 1435266 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-06-09
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 31946 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Alanine aminotransferase, Blood creatinine, Blood glucose, C-reactive protein, Cardiac arrest, Fibrin D dimer, Lipase, Pulmonary embolism, Pulmonary infarction, Troponin
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: EFFIPREV [DIENOGEST;ETHINYLESTRADIOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiopulmonary resuscitation; Comments: No medical history was reported by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: Alanine aminotransferase; Test Result: Inconclusive ; Result Unstructured Data: 106 INTERNATIONAL UNIT(S)-(UNDER 1000) 50/5; Test Date: 20210609; Test Name: Blood creatinine; Test Result: Inconclusive ; Result Unstructured Data: 1.74 MILLIGRAM(S) 1.18/0.55; Test Date: 20210609; Test Name: Blood glucose; Test Result: 321 mg; Result Unstructured Data: 321; Test Date: 20210609; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 18.1 MILLIGRAM(S) 5/0; Test Date: 20210609; Test Name: Fibrin D dimer; Test Result: Inconclusive ; Result Unstructured Data: 29.30 MILLIGRAM(S) 0.5/0; Test Date: 20210609; Test Name: Lipase; Test Result: Inconclusive ; Result Unstructured Data: 115 INTERNATIONAL UNIT(S)-(UNDER 100) 67/5; Test Date: 20210609; Test Name: Troponin; Test Result: Inconclusive ; Result Unstructured Data: 878 NANOGRAM(S) 11.6/2.3
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST; PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST; PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST), CARDIAC ARREST (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST) and PULMONARY INFARCTION (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST) in a 24-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 31946) for COVID-19 immunisation. No medical history was reported by the reporter. The patient''s past medical history included Cardiopulmonary resuscitation on 09-Jun-2021. Concomitant products included DIENOGEST, ETHINYLESTRADIOL (EFFIPREV [DIENOGEST;ETHINYLESTRADIOL]) for an unknown indication. On 15-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) at an unspecified dose. On 09-Jun-2021, the patient experienced PULMONARY EMBOLISM (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST) (seriousness criteria death and medically significant), CARDIAC ARREST (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST) (seriousness criteria death and medically significant) and PULMONARY INFARCTION (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST) (seriousness criteria death and medically significant). The patient died on 09-Jun-2021. The reported cause of death was cardiac arrest. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2021, Alanine aminotransferase: 106 (Inconclusive) 106 INTERNATIONAL UNIT(S)-(UNDER 1000) 50/5. On 09-Jun-2021, Blood creatinine: 1.74 (Inconclusive) 1.74 MILLIGRAM(S) 1.18/0.55. On 09-Jun-2021, Blood glucose (74-106 milligram): 321 milligram (abnormal) 321. On 09-Jun-2021, C-reactive protein: 18.1 (Inconclusive) 18.1 MILLIGRAM(S) 5/0. On 09-Jun-2021, Fibrin D dimer: 29.30 (Inconclusive) 29.30 MILLIGRAM(S) 0.5/0. On 09-Jun-2021, Lipase: 115 (Inconclusive) 115 INTERNATIONAL UNIT(S)-(UNDER 100) 67/5. On 09-Jun-2021, Troponin: 878 (Inconclusive) 878 NANOGRAM(S) 11.6/2.3. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route) and mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route), the reporter did not provide any causality assessments. Patient was arrived emergency room at 11:24 AM patient was experienced lacking consciousness, pulse and absence of spontaneous breathing and pronounced extreme cyanosis and marble veined. No treatment information was provided by the reporter. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. CT REPORTS AND COPIES OF BLOOD TESTS ARE AVAILABLE, CLINICAL DIARY FROM THE EMERGENCY ROOM AVAILABLE. REQUESTED TODAY DETAILED CLINICAL REPORT TO THE REPORTER This is a case of death in a 24-year-old female patient, that occurred 26 days after receiving first dose of vaccine (Lot number 31946)). Based on the provided information, the patient had cardiac arrest and expired. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Translation uploaded for initial SD containing narrative case summary and further information. On 18-Jun-2021: Follow-up received on 18-JUN-2021 Contains No new information. On 21-Jun-2021: Follow-up received on 21-JUN-2021 Contains No new information.; Sender''s Comments: This is a case of death in a 24-year-old female patient, that occurred 26 days after receiving first dose of vaccine (Lot number 31946)). Based on the provided information, the patient had cardiac arrest and expired. No further information is expected.; Reported Cause(s) of Death: CARDIAC ARREST


VAERS ID: 1435274 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-20
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 22
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: Basilar artery stenosis; Unspecified cerebrovascular disease (Cerebral vasculopathy with vertebrobasilar stenosis); Vascular encephalopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021752975

Write-up: symptoms attributable to complete occlusion of the basilar artery, hospitalization with consequent death on 11Jun2021.; This is a non-interventional study report from a contactable physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-743110. A 71-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via intramuscular on 29Apr2021 (Batch Number: EX7389; Expiration Date: 31Aug2021) at 0.3 ML, single for COVID-19 immunisation. Medical history included unspecified cerebrovascular disease, cerebral vasculopathy with vertebrobasilar stenosis, from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced symptoms attributable to complete occlusion of the basilar artery on 20May2021, hospitalization with consequent death on 11Jun2021. It was not reported if an autopsy was performed. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the information available and the known MH the reported event is considered not related to suspect drug BNT162B2 .; Reported Cause(s) of Death: complete occlusion of the basilar artery


VAERS ID: 1435281 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-05-23
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6327 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Fibrin D dimer, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Fibrin D dimer high; Phlebitis lower limb
Allergies:
Diagnostic Lab Data: Test Name: D dimer; Result Unstructured Data: Test Result:higher than the threshold
CDC Split Type: ITPFIZER INC2021753207

Write-up: Sudden loss of consciousness due to massive cerebral hemorrhage; Sudden loss of consciousness due to massive cerebral hemorrhage; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-743318. An 83-year-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular, administered in arm right on 24Apr2021 (Batch/Lot Number: EW6327) as dose 2, single for COVID-19 immunisation. The patient medical history included D-Dimer value higher from 2020 and phlebitis. The patient''s concomitant medications were not reported. The patient previously took acetylsalicylate lysine (CARDIRENE) for D-Dimer value higher. The patient experienced sudden loss of consciousness due to massive cerebral hemorrhage on 23May2021. The clinical status at the time of vaccination was normal. Patient was not taking any type of medication and was not prone to any cardiovascular, oncological or infectious disease. He had no history of COVID-19, reporter did not believe that there may have been other causes that contributed to the death as the patient had never had symptoms of problems relating to the cardiovascular system. The relationship between the intake of the vaccine and death was a suspicion. As additional information reporter can say that a little over a year ago (2020), following blood tests, the D-Dimer value higher than the threshold was detected. The doctor never said he was worried and prescribed two cycles of acetylsalicylate lysine. At the end of the second cycle of treatment the patient made a further sample and the value of the D-Dimer was lower even if still above the threshold. The doctor continued not to show concern and therefore linked the still high value to a phlebitis (according to him already healed) to a vein in the right leg, he prescribed the use of an elastic stocking and a further cycle of acetylsalicylate lysine following which an additional blood sample should have been taken for control. The blood sample was not done for the death. At the time of access to the emergency room the doctors were informed of this and told us that in their opinion there was no link between the value of D-Dimer and the massive cerebral hemorrhage that affected the patient. No autopsy examination was performed. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reporter''s Comments: None; Reported Cause(s) of Death: Sudden loss of consciousness due to massive cerebral hemorrhage; Sudden loss of consciousness due to massive cerebral hemorrhage


VAERS ID: 1435291 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002917 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Cardiac arrest, Respiratory arrest, Terminal state
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), 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 (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carotid artery atheroma; Cerebral atrophy; Cognitive deterioration; Diabetes mellitus; Hypertensive cardiomyopathy; Hypoxic-ischaemic encephalopathy; Nephropathy; Peripheral obliterative arteriopathy; Retinopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: Concurrent medical conditions included Carotid artery atheroma on 01-Jan-2015, Hypoxic-ischaemic encephalopathy on 11-Oct-2019, Nephropathy, Cerebral atrophy on 11-Oct-2019, Peripheral obliterative arteriopathy on 11-Jun-2021, Cognitive deterioration on 24-Jul-2019, Hypertensive cardiomyopathy on 25-Jun-2018, Diabetes mellitus on 01-Jan-2015 and Retinopathy. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information was not provided. This is a case of a 72-year-old female patient with medical history of carotid artery atheroma, hypoxic-ischaemic encephalopathy, nephropathy, cerebral atrophy, peripheral obliterative arteriopathy, cognitive deterioration, hypertensive cardiomyopathy, diabetes mellitus and retinopathy who developed Terminal state, Abdominal pain upper, Cardiac arrest and Respiratory arrest. The patient died due to events and it is unknown if autopsy was performed. Very limited information regarding these events has been provided at this time. No further information is expected. The patient''s advanced age and underlying medical history confound causality.; Sender''s Comments: This is a case of a 72-year-old female patient with medical history of carotid artery atheroma, hypoxic-ischaemic encephalopathy, nephropathy, cerebral atrophy, peripheral obliterative arteriopathy, cognitive deterioration, hypertensive cardiomyopathy, diabetes mellitus and retinopathy who developed Terminal state, Abdominal pain upper, Cardiac arrest and Respiratory arrest. The patient died due to events and it is unknown if autopsy was performed. Very limited information regarding these events has been provided at this time. No further information is expected. The patient''s advanced age and underlying medical history confound causality.; Reported Cause(s) of Death: Arrest cardiac; Epigastralgia; Arrest respiratory


VAERS ID: 1435294 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-20
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea exertional, Gastrointestinal haemorrhage, Renal failure, Sepsis, Skin ulcer
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemorrhage terms (excl laboratory terms) (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), Gastrointestinal haemorrhage (narrow), Pulmonary hypertension (broad), Ischaemic colitis (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 15
Permanent Disability? 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; Decompensation cardiac; Implantable defibrillator user; Prostatic carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE, SEPSIS, RENAL FAILURE, DYSPNOEA EXERTIONAL and SKIN ULCER in a 73-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001655) for COVID-19 vaccination. The patient''s past medical history included Implantable defibrillator user, Atrial fibrillation, Decompensation cardiac and Prostatic carcinoma. On 08-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced GASTROINTESTINAL HAEMORRHAGE (seriousness criteria death and medically significant), SEPSIS (seriousness criteria death and medically significant), RENAL FAILURE (seriousness criteria death and medically significant), DYSPNOEA EXERTIONAL (seriousness criterion death) and SKIN ULCER (seriousness criterion death). The patient died on 04-Jun-2021. The reported cause of death was gastrointestinal haemorrhage, sepsis, renal failure, dyspnoea exertional and skin ulcer. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was not provided. No Treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: gastrointestinal haemorrhage, sepsis, renal failure, dyspnoea exertional and skin ulcer


VAERS ID: 1435336 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Body temperature, Oxygen saturation
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), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   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: Pneumonia
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:36.7; Comments: before vaccination; Test Date: 20210606; Test Name: SpO2; Test Result: 60 %; Comments: 60% range
CDC Split Type: JPPFIZER INC2021699586

Write-up: This is a spontaneous report from a contactable physician. Regulatory authority report number is v21114220. The patient was an 87-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medical history included pneumonia. Body temperature before vaccination was 36.7 degrees centigrade. There was no notable family history. The patient had no allergies to medications, food, or other products. On 03Jun2021 at 14:00 (the day of vaccination), the patient received?the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration Date 31Aug2021), intramuscular in the arm left for COVID-19 immunization. On 06Jun2021 at 01:20 (2 days, 11 hours and 20 minutes after the vaccination), the patient experienced acute respiratory failure. Dyspnea suddenly developed. SpO2 was 60% range. Oxygen administration was started at 10 L/min. The patient received treatment including hydrocortisone sodium succinate (SOLU-CORTEF) 100 mg and aminophylline hydrate (NEOPHYLLIN) 250 mg were administered via intravenous drip. On 07Jun2021 at 14:18, death was confirmed. An autopsy was not performed. The reporting physician assessed the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19. The reporting physician assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was geromarasmus. The reporting physician commented as follows: It was considered due to geromarasmus; however the possibility that the event was caused by the vaccine could not completely be ruled out.; Reported Cause(s) of Death: Acute respiratory failure


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