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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: 1389383 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Food refusal, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Adiposity; Anemia; Gout; Hypertension; Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627653

Write-up: Food refusal; Coughing; Pain in limb; Pyrexia; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, Safety Report Unique Identifier DE-PEI-202100079086. A 84-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06May2021 (Batch/Lot Number: EX8679) at 84-years-old as UNKNOWN, SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Hypertension, ongoing Type II diabetes mellitus, ongoing Adiposity, ongoing Anemia, ongoing Gout. The patient''s concomitant medications were not reported. The patient experienced food refusal, coughing, pain in limb, pyrexia on 06May2021, the events were serious due to death. The patient died on 06May2021. It was not reported if an autopsy was performed. 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: Coughing; Pyrexia; Pain in limb; Food refusal


VAERS ID: 1389385 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-03-17
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Bronchitis, COVID-19, COVID-19 pneumonia, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   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: Atrial fibrillation; Chronic renal insufficiency; COPD; Kidney failure chronic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210317; Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: Sequencing showed the mutant B.1.1.7.
CDC Split Type: DEPFIZER INC2021627862

Write-up: Fever, Covid pneumonia, congestive bronchitis and ARDS; COVID-19; Fever, Covid pneumonia, congestive bronchitis and ARDS; Fever, Covid pneumonia, congestive bronchitis and ARDS; Fever, Covid pneumonia, congestive bronchitis and ARDS; Vaccination failure; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB DE-PEI-CADR2021078045, Safety Report Unique Identifier DE-PEI-202100071274. An 85-year-old female patient received bnt162b2 (COMIRNATY, strength: 0.3 ml), dose 2, via an unspecified route of administration on 19Feb2021 at single dose(Lot number: EP9598), dose 1, via an unspecified route of administration on 28Jan2021 at single dose(Lot number unknown), all at the age of 85 years old for covid-19 immunisation. The patient''s medical history included chronic renal insufficiency, COPD, atrial fibrillation, chronic kidney failure, all ongoing. Concomitant medications were not reported. The patient experienced fever, Covid pneumonia, congestive bronchitis, ARDS, COVID-19 on 17Mar2021. The patient was hospitalized due to Covid pneumonia, COVID-19, congestive bronchitis and ARDS. The patient died on 23Mar2021 at the sanatorium. The cause of death was Covid pneumonia. It was not reported if an autopsy was performed. The patient underwent lab test included Covid-19 PCR test: positive on 17Mar2021(Sequencing showed the mutant B.1.1.7.). The outcome of the event Covid pneumonia was fatal, of the other events was not recovered. Senders comment: Information on risk factors or previous illnesses: COPD, chronic kidney failure, atrial fibrillation / *Privacy. The affected person received both vaccinations with Comirnaty, about one month after the second vaccination, a Covid-19 infection was detected by means of PCR on 17Mar2021. Sequencing showed the mutant B.1.1.7. Symptoms were fever, Covid pneumonia, congestive bronchitis and acute respiratory distress syndrome. The person concerned died on 23Mar2021 at the sanatorium.Relatedness of drug to events for all events was unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Covid pneumonia


VAERS ID: 1389389 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-24
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000489 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Colonoscopy, Multiple organ dysfunction syndrome, Myocardial infarction
SMQs:, Myocardial infarction (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), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELTROXIN; AMLODIPIN ACCORD; METFORMIN; LOSARTAN / HYDROCHLOROTHIAZIDE; VITAMIN D [VITAMIN D NOS]; VITAMIN B NOS; TRAJENTA
Current Illness: Diarrhea (Long-term diarrhea diagnosed as Lymphocytic colitis); Lymphocytic colitis; Polymyalgia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: Colonoscopy; Result Unstructured Data: Lymphocytic colitis
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: Cardiac infarction; Multi organ failure; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION (Cardiac infarction) and MULTIPLE ORGAN DYSFUNCTION SYNDROME (Multi organ failure) in an 84-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001531 and 3000489) for COVID-19 vaccination. Concurrent medical conditions included Lymphocytic colitis since 31-Mar-2021, Diarrhea (Long-term diarrhea diagnosed as Lymphocytic colitis) and Polymyalgia. Concomitant products included AMLODIPINE BESILATE (AMLODIPIN ACCORD) from 18-Jan-2021 to an unknown date and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN / HYDROCHLOROTHIAZIDE) from 24-Apr-2018 to an unknown date for Hypertension, LEVOTHYROXINE SODIUM (ELTROXIN) from 17-Jun-2014 to an unknown date for Hypometabolism, METFORMIN from 10-Mar-2014 to an unknown date and LINAGLIPTIN (TRAJENTA) from 09-Oct-2014 to an unknown date for Type 2 diabetes mellitus, VITAMIN D [VITAMIN D NOS] and VITAMIN B NOS for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced MYOCARDIAL INFARCTION (Cardiac infarction) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced MULTIPLE ORGAN DYSFUNCTION SYNDROME (Multi organ failure) (seriousness criteria death and medically significant). The patient died on 04-May-2021. The reported cause of death was Myocardial infarct and Multi organ failure. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Colonoscopy: colonoscopy (abnormal) Lymphocytic colitis. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Treatment medication not reported. Company Comments Very limited information regarding the events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding the events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: Myocardial infarct; Multi organ failure


VAERS ID: 1389399 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aspiration, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KETOCONAZOL CINFA; BUSCOPAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: ESPFIZER INC2021096374

Write-up: Aspiration into bronchus; Febricula; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-729918. An 87-years-old female patient received BNT162B2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EM0477), dose 2 intramuscular on 17Jan2021 as 2nd dose, 0.3 ml single dose (at the age of 87-years-old) for covid-19 immunisation. The patient medical history included Severe vascular dementia. The patient''s concomitant medications included ketoconazole (KETOCONAZOL CINFA, Gel, 2%) from 18Jan2021 to 14Feb2021 and hyoscine butylbromide (BUSCOPAN, Solution for injection) from 22Sep2020 to 14Feb2021. Historical Vaccine included the first dose of BNT162B2 (COMIRNATY witch batch/lot number: EM0477) Intramuscular on 27Dec2020 for COVID-19 immunisation. The patient experienced febricula on 17Jan2021, Aspiration into bronchus on 14Feb2021. The patient died on 14Feb2021; the cause of death was aspiration. It was unknown if an autopsy was performed. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 19Jan2021. The event febricula was assessed as non-serious by health authority outcome of event febricula was recovered on 18Jan2021. Outcome of the event aspiration into bronchus was fatal. Causation assessment (Regulatory Authority algorithm): Chronology compatible with the vaccine. The participation of the vaccine in death cannot be ruled out or confirmed, since according to the notifying doctor, due to her history, the trigger for her death may have been natural. No follow up attempts are possible. No further information is expected. Follow-up (31May2021): New information downloaded from the Agency Regulatory Authority-WEB (vES-AEMPS-729918) includes: medical history informaiton, Historical Vaccine data, concomitant medications information, new event (Aspiration into bronchus), event causality assessment.; Reporter''s Comments: CAUSATION ASSESSMENT (Regulatory Authority algorithm): Chronology compatible with the vaccine. The participation of the vaccine in death cannot be ruled out or confirmed, since according to the notifying doctor, due to her history, the trigger for her death may have been natural.; Reported Cause(s) of Death: Aspiration


VAERS ID: 1389404 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-05-03
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001177 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood glucose, Diarrhoea, Disorientation, Hyperglycaemia, Pain, Pyrexia, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVETIRACETAM ACCORD; TRAZODONA [TRAZODONE]; REXER FLAS; OMEPRAZOLE
Current Illness: Cognitive deterioration; Diabetes mellitus; Permanent atrial fibrillation
Preexisting Conditions: Medical History/Concurrent Conditions: Cranioencephalic trauma
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: Blood glucose; Result Unstructured Data: Hyperglycemia
CDC Split Type: ESMODERNATX, INC.MOD20211

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RESPIRATORY DISTRESS (Distress respiratory), DISORIENTATION (Disorientation), HYPERGLYCAEMIA, DIARRHOEA (Diarrhea), PYREXIA (Fever) and PAIN (Ache) in an 83-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001177 and 3001937) for COVID-19 vaccination. The patient''s past medical history included Cranioencephalic trauma in 2017. Concurrent medical conditions included Diabetes mellitus since 1997, Permanent atrial fibrillation and Cognitive deterioration since 2012. Concomitant products included LEVETIRACETAM (LEVETIRACETAM ACCORD), TRAZODONA [TRAZODONE], MIRTAZAPINE (REXER FLAS) and OMEPRAZOLE for an unknown indication. On 03-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced RESPIRATORY DISTRESS (Distress respiratory) (seriousness criteria death and medically significant), DISORIENTATION (Disorientation) (seriousness criterion death), DIARRHOEA (Diarrhea) (seriousness criterion death), PYREXIA (Fever) (seriousness criterion death) and PAIN (Ache) (seriousness criterion death). On 14-May-2021, the patient experienced HYPERGLYCAEMIA (seriousness criterion death). The patient died on 20-May-2021. The reported cause of death was Disorientation, Distress respiratory and Hyperglycaemia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Blood glucose: high (High) Hyperglycemia. Treatment information was not provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Disorientation; Distress respiratory; Hyperglycaemia


VAERS ID: 1389408 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acidosis, Activated partial thromboplastin time, Alanine aminotransferase, Aspartate aminotransferase, Base excess, Basophil count, Basophil percentage, Blood albumin, Blood bicarbonate, Blood bilirubin, Blood calcium, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood sodium, Blood urea, Brain oedema, C-reactive protein, Carbon dioxide, Cardio-respiratory arrest, Computerised tomogram, Differential white blood cell count, Eosinophil count, Eosinophil percentage, Fibrin D dimer, Haematocrit, Haemoglobin, Haemoglobin distribution width, Hepatic failure, International normalised ratio, Lymphocyte count, Lymphocyte percentage, Mean cell haemoglobin, Mean cell volume, Mean platelet volume, Monocyte count, Monocyte percentage, Neutrophil count, Neutrophil percentage, Oxygen saturation, PCO2, PO2, Platelet anisocytosis, Platelet count, Prothrombin level, Prothrombin time, Red blood cell count, Red cell distribution width, Renal failure, SARS-CoV-2 antibody test, Serum ferritin, White blood cell count, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: APIXABAN; ALOPURINOL; MANIDON; ATORVASTATIN; URAPLEX; CO VALS FORTE; OMEPRAZOLE; TRELEGY ELLIPTA; ACETYLCYSTEINE; PARACETAMOL; DISTRANEURINE [CLOMETHIAZOLE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (anticoagulated with apixaban); Blood glucose abnormal; Bronchiectasis; Cane user; Cardiovascular disease, unspecified (cardiovascular disease (excluding HTA)); Chronic kidney disease (A1 discharged by Nephrology in 2017. Baseline creatinine around 1.5mg/dL); Claudication; COPD (Moderate-severe COPD, Admitted on 19Apr2021 for COPD exacerbation.); COVID-19 pneumonia (Admitted to inpatient ward 2-8 January 2021, did not require intensive care centre (ICU). Diagnosis by antigenic test); Epistaxis; Ex-smoker; Hip replacement (total hip replacement, left); Hypertension (HTA); Ischaemia peripheral; Leukocytosis; Mitral insufficiency; Obesity; Pulmonary hypertension; Respiratory infection; Comments: Cardiovascular disease (excluding hypertension) EPOC Chronic kidney disease HTA COVID-19 has passed
Allergies:
Diagnostic Lab Data: Test Name: APTT; Test Result: 34.5 s; Comments: T. Cephalin; Test Name: gpt; Result Unstructured Data: Test Result:629 IU/l; Test Name: got; Result Unstructured Data: Test Result:724 IU/l; Test Name: BECF; Result Unstructured Data: Test Result:19.6 mmol/L; Test Name: Excess blood bases; Result Unstructured Data: Test Result:21.2 mmol/L; Test Name: Basophils; Result Unstructured Data: Test Result:0.5 10*6/mL; Test Name: Basophils; Test Result: 1.4 %; Test Name: albumin; Result Unstructured Data: Test Result:3.7 g/dl; Test Name: BICARBONATE; Result Unstructured Data: Test Result:14.2 mmol/L; Test Name: STANDARD BICARBONATE; Result Unstructured Data: Test Result:9.0 mmol/L; Test Name: total billirubin; Test Result: 0.5 mg/dl; Test Name: calcium; Test Result: 9.0 mg/dl; Test Name: Calcium corrected (albumin); Test Result: 9.5 mg/dl; Test Name: cpk; Result Unstructured Data: Test Result:207 IU/l; Test Name: creatinine; Test Result: 2.00 mg/dl; Test Name: Derived fibrinogen; Test Result: 688.0 mg/dl; Test Name: Glucose; Test Result: 155 mg/dl; Test Name: ldh; Result Unstructured Data: Test Result:1408 IU/l; Test Name: potassium; Result Unstructured Data: Test Result:7.3 mmol/L; Test Name: sodium; Result Unstructured Data: Test Result:145 mmol/L; Test Name: urea; Test Result: 80 mg/dl; Test Name: TCO2; Result Unstructured Data: Test Result:16.8 mmol/L; Test Name: CT scan; Result Unstructured Data: Test Result:in notes; Comments: Radiological report: non-contrast cranial CT scan complete with multiplanar reconstructions: Loss of differentiation between white and grey matter, diffuse, both supra- and infratentorial parenchyma, with decreased cortical sulci. Findings in relation to diffuse cerebral oedema given the clinical context. No signs of intra- or extra-axial bleeding. Basal cisterns patent. No midline shift. Calcified atheromatosis of carotid siphons. No relevant bone alterations. Conclusion: Findings related to diffuse cerebral oedema given the clinical context.; Test Name: c-reactive protein; Result Unstructured Data: Test Result:15.35 mg/l; Test Name: Differential white blood cell count; Test Result: 2.90 %; Test Name: LUC; Result Unstructured Data: Test Result:0.96 10*6/mL; Test Name: Eosinophils; Result Unstructured Data: Test Result:0.2 10*6/mL; Test Name: Eosinophils; Test Result: 0.7 %; Test Name: Fibrin d dimer; Result Unstructured Data: Test Result:22389.0 ng/ml; Comments: high sensitivity; Test Name: Haematocrit; Test Result: 46.8 %; Test Name: Haemoglobin; Result Unstructured Data: Test Result:13.1 g/dl; Test Name: HDW; Result Unstructured Data: Test Result:2.41 g/dl; Test Name: INR; Result Unstructured Data: Test Result:1.55; Test Name: Lymphocyte count; Result Unstructured Data: Test Result:12.1 10*6/mL; Test Name: Lymphocyte; Test Result: 35.9 %; Test Name: MCH; Test Result: 25.3 pg; Test Name: MCHC; Result Unstructured Data: Test Result:27.9 g/dl; Test Name: MCV; Result Unstructured Data: Test Result:90.5 fL; Test Name: Mean platelet volume; Result Unstructured Data: Test Result:9.6 fL; Test Name: Monocyte count; Result Unstructured Data: Test Result:1.1 10*6/mL; Test Name: Monocytes; Test Result: 3.4 %; Test Name: Neutrophils; Result Unstructured Data: Test Result:18.8 10*6/mL; Test Name: neutrophils; Test Result: 55.7 %; Test Name: O2 SATURATION; Test Result: 62 %; Test Name: PCO2; Result Unstructured Data: Test Result:84.5 mmHg; Test Name: pH; Result Unstructured Data: Test Result:6.84; Test Name: PDW; Test Result: 51.6 %; Test Name: platelet count; Test Result: 0.16 %; Test Name: Platelets; Result Unstructured Data: Test Result:169 10*6/mL; Test Name: PO2; Result Unstructured Data: Test Result:56.2 mmHg; Test Name: Prothrombin activity; Test Result: 48.3 %; Test Name: Prothrombin time; Test Result: 17.6 s; Test Name: Red blood cell; Result Unstructured Data: Test Result:5.17 10*6/uL; Test Name: RDW; Test Result: 17.4 %; Test Name: sars-cov-2 antibody test; Test Result: Positive ; Comments: Serological determinations Antibodies SARS-CoV2 IgG: Positive against Spicule (S1-RBD) Antibodies. SARS-CoV2 IgG against Spicule (S1-RBD): Positive Quantification Antibodies. SARS-CoV2 IgG S (S1-RBD): 40000.00 AU/ml ( 50.00);; Test Name: ferritin; Result Unstructured Data: Test Result:108 ng/ml; Test Name: Leukocyte; Result Unstructured Data: Test Result:33.86 10*6/mL
CDC Split Type: ESPFIZER INC2021616444

Write-up: Cardio-respiratory arrest; Mixed acidosis, hepatic and renal failure; Mixed acidosis, hepatic and renal failure; Mixed acidosis, hepatic and renal failure; Diffuse cerebral oedema; This is as spontaneous report received from a contactable Physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-876580. A 77-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 19May2021 (Batch/Lot Number: FC3558) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included Bilateral SARSCOV2 pneumonia from Jan2021 (Admitted to inpatient ward 2-8 January 2021, did not require intensive care centre (ICU). Diagnosis by antigenic test), Cardiovascular disease, unspecified (cardiovascular disease (excluding HTA)), ex-smoker, Hip replacement on 01Dec2020 (total hip replacement, left), No known drug allergies. Cardiovascular risk factor: hypertension (HTA), obesity. Altered basal glycaemia, CKD 3a A1 discharged by Nephrology in 2017. Baseline creatinine around 1.5mg/dL. Moderate-severe COPD. Bronchial hyperresponsiveness and air trapping. Panlobar centrolobulillar emphysema. Exacerbations with respiratory infection. Bronchiectasis. FEV1/CVF 69%. atrial fibrillation anticoagulated with apixaban. Transthoracic echocardiogram 2018 Normal Left ventricular ejection fraction (LVEF), grade III mitral insufficiency, mild pulmonary hypertension. Claudication and chronic ischaemia of lower limbs (Stenosis at the origin of the left external iliac artery, apparently significant. Critical stenosis (vs focal obstruction) of right superficial femoral artery. Obstruction of distal left superficial femoral artery) not anti-aggregate due to episode of epistaxis. The patient ruled out endovascular treatment. Studied in 2014 in Internal Medicine for moderate leukocytosis of very long evolution. No atypia in the absence of pathology. No involvement of the rest of the series. No adenopathies. Latent tuberculous infection. Assessed 10Apr2021 in relation to COPD exacerbation. Admitted on 19Apr2021 for COPD exacerbation. SURGICAL HISTORY; total hip replacement left on 01Dec2020. BASELINE SITUATION: Independent for Basic Activities of Daily Living. Lives with wife (now also with daughter and grandson). Double continent. Walks with cane. Concomitant medications included apixaban (APIXABAN); alopurinol (ALOPURINOL); verapamil hydrochloride (MANIDON) taken for hypertension; atorvastatin (ATORVASTATIN); trospium chloride (URAPLEX); hydrochlorothiazide, valsartan (CO VALS FORTE) taken for hypertension; omeprazole (OMEPRAZOLE); fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA); acetylcysteine (ACETYLCYSTEINE); paracetamol (PARACETAMOL); clomethiazole (DISTRANEURINE [CLOMETHIAZOLE]) . The patient previously took comirnaty for covid-19 immunisation (1st dose, IM Batch/lot number: EY3014) on 27Apr2021, apixaban for atrial fibrillation. The patient experienced cardio-respiratory arrest, mixed acidosis, hepatic and renal failure, diffuse cerebral oedema on 20May2021. The events were serious due to hospitalization on 20May2021 and death. The patient died on 20May2021. An autopsy was performed and results were not provided. Detail clinical course was provided as Patient''s reasons for vaccination: Over 65 years of age, Cardiovascular disease (excluding AHT), COPD, Chronic kidney disease, HTA. The patient had passed COVID-19. Additional adverse events information: Cardio-respiratory arrest of undiagnosed origin. Intracranial haemorrhage ruled out. Coronary or intracranial ischaemic origin not ruled out. Pending clinical autopsy. Reason for consultation: Pre-notification for recovered arrest of a 77 year-old male with the following. CURRENT ILLNESS: The patient''s wife reports that he spends the night restless, without being able to specify specific symptoms. When he got up in the morning, he fell from his height. They tried to get him up but were unable to do so, and he reported a loss of strength and a decrease in the level of consciousness, which he lost a few minutes later. The emergency services were called and the daughter began basic cardiopulmonary resuscitation (CPR). On arrival of the mobile intensive care centre (5 minutes), they observed asystole and began advanced resuscitation manoeuvres, intubating the patient without complications. After 12 minutes, the patient recovered spontaneous circulation. Output in atrial fibrillation with rapid ventricular response. During transfer another cardiorespiratory arrest of approximately 3 minutes duration. The patient receives a total of 4 mg of adrenaline. No sedation. No recovery of consciousness or movement of any kind is observed at any time. Mydriatic pupils are reactive at all times. He was transferred to reporter center and we received him at the Emergency Department. Complementary examinations (date unknown): BLOOD ANALYSIS IN THE CRITICAL CARE UNIT: Haemogram. White Series Leukocytes: 33.86 10^3/uL (3.50 - 11.00); Neutrophils: 18.8 10^3/uL (2.0 - 7.5); Lymphocytes: 12.1 10^3/uL (1.0 - 4.5); Monocytes: 1.1 10^3/uL (0.2 - 0.8); Eosinophils: 0.2 10^3/uL (0.0 - 0.5); Basophils: 0.5 10^3/uL (0.0 - 0.2); LUC: 0.96 10^3uL ( 0.40); Neutrophils %: 55.7 % (40.0 - 75.0); Lymphocytes %: 35.9 % (20.0 - 45. 0); Monocytes %: 3.4 % (2.0 - 10.0); Eosinophils %: 0.7 % (1.0 - 6.0); Basophils %: 1.4 % ( 2.0); %LUC: 2.90 % ( 4.00); Haemogram. Red cells Red cells: 5.17 10^6/uL (4.30 - 5.90); Haemoglobin: 13.1 g/dL (13.0 - 17.0); Haematocrit: 46.8 % (39.0 - 50.0); Mean cell volume: 90.5 fL (78. 0 - 100.0); Mean cell haemoglobin: 25.3 pg (27.0 - 32.0); Mean cell haemoglobin concentration: 27.9 g/dL (31.5 - 34.5); Red cell distribution width (CV): 17.4 % (11.6 - 14.0); Haemoglobin distribution width 2.41 g/dL (2.20 - 3.20); Haemogram.Platelets Platelets: 169 10^3/uL (130 - 450); Platelet count: 0.16 % (0.12 - 0.36); PDW (platelet anisocytosis ): 51.6 % (25.0 - 65.0); Mean platelet volume: 9.6 fL (9.0 - 13.0); Coagulation Study Prothrombin time: 17.6 seconds (9.0 - 13.0); Prothrombin activity: 48.3 % ( 80.0); I.N.R.: 1.55 ( 1.15); APTT (T. Cephalin): 34.5 sec (25.0 - 35.0); Derived fibrinogen: 688.0 mg/dL (150.0 - 400.0); D-Dimer (high sensitivity): 22389.0 ng/ml ( 500.0); Venous blood sample pH (v): 6.84 (7.35 - 7.45); Not possible to test due to insufficient sample pCO2: 84.5 mmHg (38.0 - 48.0); pO2: 56.2 mmHg (20.0 - 45.0); HCO3: 14.2 mmol/l (23.0 - 28.0); TCO2: 16. 8 mmol/l O2 saturation (calculated): 62 % (20 - 80); BEb (Excess blood bases): -21.2 mmol/l BEecf (Excess extracellular lipid bases): -19.6 mmol/l SBC (Standard bicarbonate): 9.0 mmol/l Venous blood gas interpretation: Blood gas results compatible with mixed acidosis. Serum/plasma biochemical determinations Glucose: 155 mg/dl (70 - 110); Urea: 80 mg/dl (10 - 50); Creatinine: 2.00 mg/dl (0.70 - 1.30); Albumin: 3.7 g/dl (3.5 - 5.2); Calcium: 9.0 mg/dl (8.5 - 10.5); Calcium corrected (albumin): 9. 5 mg/dl (8.6 - 10.2); Sodium: 145 mmol/L (135 - 147); Potassium: 7.3 mmol/L (3.5 - 5.0); Checked and noted Total bilirubin: 0.5 mg/dl (0.2 - 1.0); CPK: 207 U/L (190); LDH: 1408 U/L (80 - 235); GPT (ALT): 629 U/L (41); GOT (AST): 724 U/L (37); C-reactive protein: 15.35 mg/L (5.00); Ferritin: 108 ng/ml (20 - 300); Serological determinations Antibodies SARS-CoV2 IgG: Positive against Spicule (S1-RBD) Antibodies. SARS-CoV2 IgG against Spicule (S1-RBD): Positive Quantification Antibodies. SARS-CoV2 IgG S (S1-RBD): 40000.00 AU/ml ( 50.00). CRANIAL CT SCAN WITHOUT CONTRAST: Radiological report: non-contrast cranial CT scan complete with multiplanar reconstructions: Loss of differentiation between white and grey matter, diffuse, both supra- and infratentorial parenchyma, with decreased cortical sulci. Findings in relation to diffuse cerebral oedema given the clinical context. No signs of intra- or extra-axial bleeding. Basal cisterns patent. No midline shift. Calcified atheromatosis of carotid siphons. No relevant bone alterations. Conclusion: Findings related to diffuse cerebral oedema given the clinical context. INITIAL ACTION / EVOLUTION: The patient was admitted to the Emergency Department. The patient arrived intubated, with poor perfusion and lividity in the limbs. Mydriatic pupils were reactive. On arrival at the critical care unit, slow Atrial Fibrillation, extreme bradycardia and asystole on changing stretcher. Advanced CPR manoeuvres were performed and ventricular fibrillation was observed; shock could not be administered due to device failure and massage was continued, with subsequent recovery of spontaneous circulation and exit in Atrial Fibrillation with rapid ventricular response. Total duration of the episode 10-12 minutes and administration of 3mg of adrenaline. The patient''s pupils remained mydriatic and the decision was made to perform a cranial CT scan in which bleeding was ruled out, drawing attention to diffuse cerebral oedema. IV contrast was not administered, so we cannot rule out an ischaemic event. During the CT scan, slow Atrial Fibrillation and hypotension improved after administration of 1mg of atropine and 1 mg of adrenaline. Venous blood gases showed significant mixed acidosis, so 100mEq of sodium bicarbonate was administered. The patient was transferred to the intensive care unit, and an echocardiogram was attempted, which only revealed a non-dilated right ventricle and no pericardial effusion, as well as complete akinesia of both ventricles in the context of a new cardiorespiratory arrest. Advanced CPR manoeuvres were started again and continued for 25 minutes without any return of spontaneous circulation. Subsequently, the results of laboratory tests showed acute renal failure with urea 80mg/dL and creatinine 2mg/dL, as well as hyperkalaemia 7.3, in addition to liver failure with hypertransaminasemia and increased Lactate Dehydrogenase. The initial ECG showed no abnormalities related to hyperkalaemia. Ischaemic origin, either cardiac or intracranial, cannot be ruled out as the origin of the PCR. An arrhythmogenic/metabolic cause is less likely. The patient received yesterday (19May2021, no record in database) the second dose of SARSCOV2 vaccine (Pfizer). Given the absence of thrombopenia (169,000/mm3), the episode does not appear to be related to thrombotic thrombocytopenia induced by the vaccine. The patient did present significant elevation of D-dimer. No anti-heparin antibodies were requested. Given the diagnostic doubts, the family was offered the possibility of a clinical autopsy, which they accepted. CLINICAL JUDGEMENT: Cardiorespiratory arrest, Mixed acidosis, hepatic and renal failure. Diffuse cerebral oedema. No follow-up attempts possible. No further information expected. Information on lot and batch numbers already obtained.; Reported Cause(s) of Death: Cardio-respiratory arrest; Diffuse cerebral oedema; Mixed acidosis, hepatic and renal failure; Mixed acidosis, hepatic and renal failure; Mixed acidosis, hepatic and renal failure


VAERS ID: 1389421 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram cerebral, Anti-platelet antibody, Aphasia, Cerebral artery stenosis, Electrocardiogram, Fibrin D dimer, Investigation, Ischaemic stroke, Language disorder, Muscular weakness, Perfusion brain scan, Platelet count, SARS-CoV-2 test, Scan brain, Thrombotic stroke
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 18
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: Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210517; Test Name: Angiogram cerebral; Result Unstructured Data: Test Result:ANGIOTC OF SUPRAORTIC TRUNKS:; Comments: Replenishment defect in the M1 segment of the left Middle Cerebral Artery MCA. Findings compatible with acute ischemic lesion in the territory of the left Middle Cerebral Artery MCA, with an infarct established in the territory of the left lateral lenticulostriate branches (head of the caudate and left lenticular nucleus), secondary to a filling defect in the M1 segment of the Left Middle Cerebral Artery ACM.; Test Date: 20210517; Test Name: Anti-platelet antibodies; Test Result: Negative ; Comments: Anti FP4 Negative. do not know the method of determination.; Test Date: 20210517; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Sinus rhythm at 75 bpmk, normal PR (160 ms), left; Comments: Sinus rhythm at 75 bpmk, normal PR (160 ms), left axis, narrow QRS interval, Left branch anterosuperior hemiblock (from His bundle) (LBAH), without other significant alterations in repolarization.; Test Date: 20210519; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:confirmed the diagnosisof brain death; Test Date: 20210517; Test Name: Fibrin D dimer high; Result Unstructured Data: Test Result:3382.0 ng/ml; Comments: D-Dimero 3382.0 ng/mL 0.0 - 500.0; Test Date: 20210517; Test Name: NIH Stroke Scale/Score (NIHSS); Result Unstructured Data: Test Result:7; Test Date: 20210517; Test Name: Perfusion brain scan; Result Unstructured Data: Test Result:Alterations are observed in the maps of blood brai; Comments: Alterations are observed in the maps of blood brain volume in the left lenticular and caudate nucleus, suggestive of established infarction, together with an alteration in the Tiempo de tromboplastina parcial TTP map in the rest of the territory of the left Middle Cerebral Artery MCA suggestive of ischemic penumbra.; Test Date: 20210517; Test Name: Platelet count; Result Unstructured Data: Test Result:180 x10 9/l; Comments: Plaquetas 180 x10E9/L 120 - 500; Test Date: 20210517; Test Name: COVID-19 antigen test negative; Test Result: Negative ; Comments: Rapid antigenic test COVID19 Negative 17May2021; Test Date: 20210517; Test Name: COVID-19 PCR test negative; Test Result: Negative ; Comments: PCR n-Cov-2019 Negative nasopharyngeal exudate; Test Date: 20210519; Test Name: COVID-19 PCR test negative; Test Result: Negative ; Comments: PCR COVID-19 in negative BAL.; Test Date: 20210519; Test Name: COVID-19 PCR test negative; Test Result: Negative ; Comments: NPCR n-Cov-2019 egative nasopharyngeal exudate; Test Date: 20210517; Test Name: Scan brain; Result Unstructured Data: Test Result:CT SKULL WITHOUT Intravenous contrast:; Comments: CT SKULL WITHOUT Intravenous contrast: There are no signs of intracranial or extra-axial intracranial bleeding. Hypodensity in the lenticular nucleus, left caudate head and external capsule and left posterior parietal corticosubcortical focal point in relation to an ischemic lesion established in the territory of the left Middle Cerebral Artery MCA (lateral lenticulostriate branches and M5 territory). Conserved cortical sulcus pattern. Normal size ventricular system. Differentiation between conserved white and gray matter. BASAL ASPECTS: 7.
CDC Split Type: ESPFIZER INC2021639204

Write-up: decreased of language fluency; a lot of jargon and semantic paraphasia, unable to emit or understand language; a lot of jargon and semantic paraphasia, unable to emit or understand language; severe global aphasia; Ischaemic stroke; Atherothrombotic stenosis in left M1 segment; Atherothrombotic stenosis in left M1 segment; subtly lose strength in the right upper limb; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-886037. A 58-years-old male patient received 1st dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 14May2021 (Lot Number: FA4598) at 58-years-old as single dose for covid-19 immunisation. Medical history included smoker of 1 pack a day from an unknown date and unknown if ongoing. Patient had no known adverse drug reactions. The patient''s concomitant medications were not reported. The patient experienced ischaemic stroke on 14May2021 , decreased of language fluency on 14May2021, a lot of jargon and semantic paraphasia, unable to emit or understand language on 17May2021, severe global aphasia on 17May2021. ischaemic stroke was reported as serious with seriousness criteria of death. Decreased of language fluency was reported as serious with seriousness criteria of hospitalization. Other events were reported as non-serious. Outcome of ischaemic stroke and Atherothrombotic stenosis in left M1 segment was fatal. The patient died on 19May2021. It was not reported if an autopsy was performed. Outcome of the other events was unknown. The clinical course was reported as follows: CV Risk Factor: No AHT. No dyslipidemia. No diabetes mellitus. Smoker 1 pack a day. No personal background of interest. No regular medication. After being vaccinated with the first dose of Pfizer on 14May2021, his family noticed a decrease in language fluency and went to the emergency department on 17May2021, due to a 3-day evolution of language disorder, really striking and severe on the day of the entry. After two days the patient could say a phrase, although it was Monday (17May2021) that he started with a lot of jargon and semantic paraphasia, without being able to emit or understand language. Upon arrival at the emergency room, stable, with severe global aphasia without another location. A multimodal CT scan was performed where a stop was observed in the proximal left M1 with hypodensity and dropped volume in the caudate head, internal capsule and lenticular. The rest of the territory dependent on the left Middle Cerebral Artery (MCA) is in semi-darkness, so primary Mecanic Thrombectomy (MT) is decided, in addition to the fact that the patient was beginning to subtly lose strength in the right upper limb. The ICU service is advised that they assess the patient and perform orotracheal intubation (OTI). The procedure in the first instance proceeds without incident, M1 is released and flow is restored. However, there is a stenosis in M1 segment of atheromatous origin that after a few minutes causes the entire vessel to close again, so Inyesprim 1 amp IV + Tirofiban IV is prescribed (bolus 10 ml in 5 minutes and the following 14-18 hours to 4 ml / h) + intracranial plaque stent, with partial improvement at first but later rethrombosis, also associating thrombosis of the left internal carotid artery in successive series. An attempt has been made by means of a stent retriever and continuous aspiration to re-establish flow, being impossible at the intracranial level. Other Diagnostics included Ischemic stroke in the territory of the left Middle Cerebral Artery (MCA) (segment M1) of probable atherothrombotic etiology. Atherothrombotic stenosis in left M1 segment. Monitor hypercoagulability status (hidden neoplasia?). Physical exploration included neurological exploration upon admission to Neurology: NIH Stroke Scale/Score (NIHSS) of 7 due to global aphasia without the possibility of speaking or understanding anything (2 + 2 + 3). Dysarthria cannot be assessed. No motor weakness, no HH, no apparent sensory alteration or involvement of parietal cortical functions. No cerebellum disease. Supplementary tests included ECG: Sinus rhythm at 75 bpmk, normal PR (160 ms), left axis, narrow QRS interval, Left branch anterosuperior hemiblock (from His bundle) (LBAH), without other significant alterations in repolarization. CT skull without Intravenous contrast: There are no signs of intracranial or extra-axial intracranial bleeding. Hypodensity in the lenticular nucleus, left caudate head and external capsule and left posterior parietal corticosubcortical focal point in relation to an ischemic lesion established in the territory of the left Middle Cerebral Artery MCA (lateral lenticulostriate branches and M5 territory). Conserved cortical sulcus pattern. Normal size ventricular system. Differentiation between conserved white and gray matter. BASAL ASPECTS: 7. perfusion study included: Alterations are observed in the maps of blood brain volume in the left lenticular and caudate nucleus, suggestive of established infarction, together with an alteration in the Tiempo de tromboplastina parcial TTP map in the rest of the territory of the left Middle. Angiogram cerebral /angiotc of supraortic trunks: Replenishment defect in the M1 segment of the left Middle Cerebral Artery MCA. diagnostic impression: Findings compatible with acute ischemic lesion in the territory of the left Middle Cerebral Artery MCA, with an infarct established in the territory of the left lateral lenticulostriate branches (head of the caudate and left lenticular nucleus), secondary to a filling defect in the M1 segment of the Left Middle Cerebral Artery ACM. Analytics upon admission.D-Dimer: 3382.0 ng / mL 0.0 - 500.0.Platelets 180 x10 ^ 9 / L 120 - 500.Anti FP4 : Negative (unknown know the method of determination).PCR n-Cov-2019 17May2021: Negative nasopharyngeal exudate.Rapid antigenic test 17May2021: COVID19 Negative.PCR n-Cov-2019 Broncolavado19May2021: Negative. PCR COVID-19 in negative BAL.PCR n-Cov-2019 19May2021: Negative nasopharyngeal exudate.Evolution: Left Middle Cerebral Artery MCA ischemic stroke (M1) with established infarction in the territory of the left lateral lenticulostriate branches (NIH Stroke Scale/Score NIHSS 7). Prolonged thrombectomy procedure with placement of Pharmacoactive stent, migration of thrombus to the pericallosal region and finding of a large number of thrombus in the left carotid with thrombus aspiration. Need for high doses of norepinephrine, he remains sedated, intubated and connected to mechanical ventilation.At 8h, bilateral arreactive mydriasis and Transcranial Doppler TCD with reverberant flow - hemorrhagic transformation and diffuse edema, ruled out surgical intervention.One-off episode of diabetes insipidus with a single dose of 1 mcgr of desmopressin on 18May2021 at 7:00 p.m. On 19May2021 of brain death, with an Electroencephalogram EEG that confirmed the diagnosis. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: ischaemic stroke; Atherothrombotic stenosis in left M1 segment; Atherothrombotic stenosis in left M1 segment


VAERS ID: 1389454 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-07
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood pressure decreased, Blood pressure measurement, Brachiocephalic artery stenosis, Bradycardia, Carotid artery stenosis, Coma scale abnormal, Computerised tomogram head, Hemiparesis, International normalised ratio, International normalised ratio decreased, Musculoskeletal stiffness, Pain in extremity, Thrombosis, Vertebral artery stenosis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MAREVAN FORTE; BISOPROLOL ACTAVIS; FURESIS; ZANIDIP; PANADOL FORTE [CAFFEINE;PARACETAMOL]; DIGOXIN ORION MITE; MEMANTINE MERZ; SALAZOPYRIN EN; LOSARTAN ORION; ISANGINA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Arteriosclerosis; Atrial fibrillation
Allergies:
Diagnostic Lab Data: Test Name: CT angiography; Result Unstructured Data: Test Result:the stent was open; Comments: the stent was open but there was a critical narrowing in the distal end; Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Name: head CT; Result Unstructured Data: Test Result:no bleeding and the stent was open; Test Name: head CT; Result Unstructured Data: Test Result:no bleeding or large infarctions; Test Name: INR; Result Unstructured Data: Test Result:1.1
CDC Split Type: FIPFIZER INC2021645305

Write-up: Hemiparesis (left); Limbs stiffness; Blood pressure decreased; Bradycardia; Glasgow coma scale abnormal; Thrombectomy; International normalised ratio decreased; Leg pain; Brachiocephalic artery stenosis; Internal carotid artery stenosis; Vertebral artery stenosis; This is a spontaneous report from a contactable consumer from the Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20212912. An 89-year-old female patient received bnt162b2 (COMIRNATY), dose 2, via an unspecified route of administration on an unspecified date (Batch/Lot Number: UNKNOWN) as DOSE, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation, Arteriosclerosis, Alzheimer''s disease. Concomitant medication(s) included warfarin sodium (MAREVAN FORTE); bisoprolol fumarate (BISOPROLOL ACTAVIS) taken for hypertension; furosemide (FURESIS) taken for hypertension; lercanidipine hydrochloride (ZANIDIP); caffeine/paracetamol (PANADOL FORTE) taken for pain; digoxin (DIGOXIN ORION MITE) taken for cardiac failure; memantine hydrochloride (MEMANTINE MERZ) taken for dementia alzheimer''s type; sulfasalazine (SALAZOPYRIN EN) taken for rheumatoid arthritis; losartan potassium (LOSARTAN ORION) taken for cardiac failure; isosorbide mononitrate (ISANGINA). The patient experienced leg pain (death) on 07May2021, brachiocephalic artery stenosis (death) on 07May2021, internal carotid artery stenosis (death) on 07May2021, vertebral artery stenosis (death) on 07May2021, hemiparesis (left) (death) on 13May2021, limbs stiffness (death) on 13May2021, international normalised ratio decreased (death) on 10May2021, blood pressure decreased (death) on 13May2021, thrombectomy (death) on 12May2021 , bradycardia (death) on 13May2021, glasgow coma scale abnormal (death) on 13May2021. The patient died on 13May2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: "My mother developed a very severe pain in the right leg 07May2021 due to which she was transferred to hospital for investigations by ambulance. Veins of the leg was investigated, nothing was found and she was sent home by a taxi. There was no pain. On Monday morning 10May2021, the hospital called as there had been some inconsistency with the test results of anti-bodies from Friday. A nurse came to take the tests at home. On that same day a few hours later the patient developed pain in both legs and she was taken by ambulance to the hospital for venography/arteriogram. She was admitted to the hospital ward of the health center because her INR was only 1.1 and she had pain in her legs. During a visit to the hospital ward I noted that her legs turned purple when she was sitting up and I called for a physician. Because no clear reason was found at the hospital the physician decided to treat the pain primarily and she was given cortisone orally. On 12May2021 the patient developed a "brain event" at the health center and was taken to hospital again. The rest is from the death certificate Acute left hemiparesis. Right ICA blocked at the stem, also right brachiocecphalica artery was blocked chronically and a tight stenosis at the stem of a. vertablis. Thrombectomy performed and right ICA stented successfully radiologically. No thrombolysis. After procedure head CT showed no bleeding and the stent was open. On 13May2021 at 16:40 the right arm was stiff, GCS 3, blood pressure low, bradycardia. The head CT showed no bleeding or large infarctions. In CT angiography the stent was open but there was a critical narrowing in the distal end. The left carotid status was also weak. DNAR and quick exitus. Underlying illnesses: atrial fibrillation, ASO disease, and Alzheimer. This was the second dose of the vaccine. Follow-up attempts not possible. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Hemiparesis (left); Leg pain; Brachiocephalic artery stenosis; Internal carotid artery stenosis; Vertebral artery stenosis; Limbs stiffness; International normalised ratio decreased; Blood pressure decreased; Thrombectomy; Bradycardia; Glasgow coma s


VAERS ID: 1389456 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-10
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: 2021-05-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (oesophageal)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021611617

Write-up: died; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 20May2021 (Batch/Lot number was not reported) as unknown, single for COVID-19 immunisation. Medical history included reflux. Concomitant medication included medication for reflux. The patient died on 23May2021, three days later. The patient had no illnesses. The outcome of event, died was fatal. It was not reported if an autopsy was performed. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: died


VAERS ID: 1389461 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Alanine aminotransferase, Aspartate aminotransferase, Asphyxia, Asthenia, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood calcium, Blood chloride, Blood creatinine, Blood glucose, Blood lactic acid, Blood magnesium, Blood phosphorus, Blood sodium, Blood urea, Body mass index, Brain natriuretic peptide, Cardio-respiratory arrest, Chest X-ray, Chest pain, Coma scale, Dyspnoea, Echocardiogram, Electrocardiogram, Gamma-glutamyltransferase, Haemoglobin, Investigation, Myocardial ischaemia, Myocarditis, Nausea, PCO2, PO2, Platelet count, Protein total, Prothrombin time, Respiratory disorder, Rheumatoid arthritis, SARS-CoV-2 test, Troponin, Vomiting, White blood cell count, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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 (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Arthritis (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LERCAN; MONOPROST
Current Illness: Glaucoma (Chronic); Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse, episodic drinking behavior; Ex-tobacco user (Weaned for 40 years)
Allergies:
Diagnostic Lab Data: Test Name: BNP; Result Unstructured Data: Test Result:15338; Test Name: Chest x-ray; Result Unstructured Data: Test Result:bilateral alveolar interstitial opacities; Comments: bilateral alveolar interstitial opacities with a clear predominance of the peri-hilar; Test Name: glasgow; Result Unstructured Data: Test Result:3; Test Name: echocardiographic; Result Unstructured Data: Test Result:abnormalities; Test Name: Trans-thoracic echography; Result Unstructured Data: Test Result:LVEF globally impaired visually estimated between; Comments: LVEF globally impaired visually estimated between 15 and 20%. Gobal hypokinesia predominant in septo-apical. Sub-aortic integral time speed of 12 cm. Straight cavities not dilated. Dry pericardium.; Test Name: ECG; Result Unstructured Data: Test Result:regular sinus rhythm; Comments: regular sinus rhythm, fine QRS, ST segment shift in inferior (D2-D3-aVF), left branch blockage; Test Name: gammaGT; Result Unstructured Data: Test Result:40 IU/l; Test Name: hemoglobin; Result Unstructured Data: Test Result:14.8; Test Name: clinical examination; Result Unstructured Data: Test Result:patient intubated ventilated, cold extremities, no; Comments: patient intubated ventilated, cold extremities, no mottling, no cyanosis. Patient on IV electric syringe epinephrine 5 mg / h, glascow score at 3 without sedation, bilateral areactive mydriasis. Abolition of the corneal reflex. regular heart sounds, no sign of right or left heart failure. Supple, depressible abdomen. Soft calves, no signs of Homans; Test Name: FiO2; Result Unstructured Data: Test Result:100%; Test Name: PaCO2; Result Unstructured Data: Test Result:81.8 mmHg; Test Name: pH; Result Unstructured Data: Test Result:6.79; Test Name: Platelet count; Result Unstructured Data: Test Result:237000 /mm3; Test Name: PaO2; Result Unstructured Data: Test Result:113 mmHg; Test Name: protidemia; Result Unstructured Data: Test Result:68; Test Name: Prothrombin Time; Result Unstructured Data: Test Result:57%; Test Name: RA Test; Result Unstructured Data: Test Result:12.4 mmol/L; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Name: troponin; Result Unstructured Data: Test Result:831; Test Name: white blood cell; Result Unstructured Data: Test Result:32000 mmol/L; Test Name: Alanine aminotransferase; Test Result: 75 [iU]; Test Name: Aspartate aminotransferase; Test Result: 133 [iU]; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:177 IU/l; Test Name: HCO3; Result Unstructured Data: Test Result:12.4 mmol/L; Test Name: total bilirubin; Result Unstructured Data: Test Result:12 umol/l; Test Name: calcemia; Result Unstructured Data: Test Result:2.44; Test Name: chloride; Result Unstructured Data: Test Result:92 mmol/L; Test Name: creatinine; Result Unstructured Data: Test Result:128 umol/l; Test Name: glucose; Result Unstructured Data: Test Result:24.4 mmol/L; Test Name: lactate; Result Unstructured Data: Test Result:15 mmol/L; Test Name: magnesium; Result Unstructured Data: Test Result:1.32; Test Name: phosphorus; Result Unstructured Data: Test Result:4.75 mmol/L; Test Name: sodium; Result Unstructured Data: Test Result:130 mmol/L; Test Name: urea; Result Unstructured Data: Test Result:7.3 mmol/L; Test Name: Body mass index; Result Unstructured Data: Test Result:25.78 kg/m2
CDC Split Type: FRPFIZER INC2021645551

Write-up: Hypoxic cardio-respiratory arrest on probable pulmonary acute oedema. Possible myocarditis or coronary ischemia; Acute oedema of lung, unspecified; Hypoxic cardio-respiratory arrest on probable pulmonary acute oedema. Possible myocarditis or coronary ischemia; Hypoxic cardio-respiratory arrest on probable pulmonary acute oedema. Possible myocarditis or coronary ischemia; asthenia; respiratory discomfort; mid-thoracic pain; crescendo dyspnea; asphyxia; nausea and vomiting; nausea and vomiting; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-2021050107. A 74-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EX0893), intramuscular, administered in Arm Left on 26Apr2021 (at unknown age) as single dose for COVID-19 immunisation. Medical history included ongoing glaucoma (Chronic), ongoing Hypertension arterial, ex-tobacco user (weaned for 40 years), alcohol very occasionally. No history of COVID-19 disease. Concomitant medications included lercanidipine hydrochloride (LERCAN) taken for Hypertension arterial; latanoprost (MONOPROST). The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: ET7205) Intramuscular on 30Mar2021 as single dose for COVID-19 immunisation. On 29Apr2021, nausea and vomiting. On 30Apr2021, in the morning, the patient presented with a general state alteration with asthenia, respiratory discomfort, mid-thoracic pain. The patient''s husband described a crescendo dyspnea over about fifteen minutes rapidly progressing to asphyxia. The patient was in cardio-respiratory arrest between 1:30 p.m. and 1:35 p.m. with a no-flow between 7 and 12 minutes. Initiating an extern cardiac massage, the defibrillator identified a non-shockable rhythm. Firefighters arrived at 01:42 pm. The patient experienced acute oedema of lung, unspecified (death) on 30Apr2021. On admission to intensive care at 4:00 p.m. In total on admission: cardio-respiratory arrest of hypoxic appearance on probable asphyxial pulmonary acute oedema which appears to be asphyxiant in front of echocardiographic abnormalities and ECG repolarization disorders. Cardiogenic shock secondary to cardio-respiratory arrest and lactic acidosis favored by adrenaline in high doses. Outcome: On the circulatory level: state of shock due to post-resuscitation syndrome and severe myocardial incompetence estimated between 10 and 15% with ransthoracic echocardiogram. 2 attempts to initiate an inotropic treatment that was very poorly tolerated on the blood pressure level and quickly stopped. Increased dose of noradrenaline in connection with intense vasoplegia. Hypovolemic part treated with 6L of crystalloid filling. Progressive regression of lactic acidosis without recourse to extra-renal purification. Acute renal failure KDIGO 2 without known reference creatinemia (no previous assessment). On the neurological level: severe neurological condition from the outset with spontaneous Glasgow 3 coma without brainstem reflex but in hypothermia at 34 ? C. After rewarming in a patient who has never been sedated, the diagnosis of clinical brain death is made on 30Apr2021 at 10 p.m. in front of a Glasgow 3 coma, the absence of a brainstem reflex and the absence of spontaneous ventilation confirmed by a hypercapnia test performed on 01May2021. In Total, acute pulmonary oedema flash in a 74-year-old woman with no history of heart disease and taking lercanidipine for hypertension. In front of the severe and global dysfunction, without dilation of the left ventricle, two hypotheses persist with this hypoxic cardiorespiratory arrest on probable acute pulmonary oedema flash: myocarditis with a possible link with the Dose 2 of the Comirnaty vaccine (the complete myocarditis assessment could not be carried out but there were no prodromes leading to a myocarditis of disease of the system, in particular negative COVID PCR) but global and severe myocardial dysfunction with acute pulmonary oedema without thoracic gene in a non-diabetic patient. The patient underwent lab tests and procedures which included on unspecified date: SARS-CoV-2 test negative, Body mass index: 25.78 kg/m2. Chest x-ray: bilateral alveolar interstitial opacities with a clear predominance of the peri-hilar. ECG: regular sinus rhythm, fine QRS, ST segment shift in inferior (D2-D3-aVF), left branch blockage. Trans-thoracic echography (under Noradrenaline 2mg / h in Assisted ventilation controlled by positive expiratory pressure 5 cm H2O): LVEF globally impaired visually estimated between 15 and 20%. Gobal hypokinesia predominant in septo-apical. Sub-aortic integral time speed of 12 cm. Straight cavities not dilated. Dry pericardium. Biology: WBC 32000mmol/l, Hb 14.8, platelets 237000/mm3, Prothrombin Time 57%, urea 7.3mmol/l, creatinine 128?mol/l, glucose 24.4mmol/l, Sodium 130 mmol/l, Chloride 92mmol/l, RA Test 12.4 mmol/l, protidemia 68, calcemia 2.44, magnesium 1.32, phosphorus 4.75mmol/, troponin 831, BNP (Brain natriuretic peptide) 15338, total bilirubin: 12 ?mol/l, ASAT/ALAT 133/75 IU/l, gammaGT 40 IU/l, ALP (Alkaline phosphatase) 177 IU/L, lactate 15 mmol/l. Clinical examination: patient intubated ventilated, cold extremities, no mottling, no cyanosis. Patient on IV electric syringe epinephrine 5 mg / h, glascow score at 3 without sedation, bilateral areactive mydriasis. Abolition of the corneal reflex. regular heart sounds, no sign of right or left heart failure. Supple, depressible abdomen. Soft calves, no signs of Homans. Blood gas under Assisted ventilation controlled by positive expiratory pressure FiO2 100%, pH 6.79, PaCO2 81.8mmHg, PaO2 113 mmHg, HCO3 12.4 mmol/l. All events had emergency room visit. The patient died on 30Apr2021. An autopsy was not performed. No FU attempts are possible. No further information is expected.; Reported Cause(s) of Death: Hypoxic cardio-respiratory arrest on probable pulmonary acute oedema. Possible myocarditis or coronary ischemia; Acute oedema of lung, unspecified; Hypoxic cardio-respiratory arrest on probable pulmonary acute oedema. Possible myocarditis or corona


VAERS ID: 1389477 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Blood pressure measurement, Body temperature, Cardiac failure, Chills, Electrocardiogram, Heart rate, Hyperhidrosis, Hypertension, Hyperthermia, Hypovolaemic shock, Hypoxia, Influenza, Myocardial ischaemia, Oedema peripheral, Oxygen saturation, Respiratory distress, Respiratory rate, SARS-CoV-2 test, Ultrasound scan, Urinary tract infection
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Hypovolaemic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMINE B12; ZANEXTRA; MEDIATENSYL [URAPIDIL HYDROCHLORIDE]; CORDARONE; PANTOPRAZOLE; ERYTHROPOIETIN HUMAN; LASILIX [FUROSEMIDE]; STAGID; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; FEROGRAD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib (arrhythmic valvular heart disease (Afib)); Arrhythmia; Valvular heart disease NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210429; Test Name: blood pressure; Result Unstructured Data: Test Result:190/54; Test Date: 202104; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 202104; Test Name: ECG; Result Unstructured Data: Test Result:Afib at116 bpm; Test Date: 202104; Test Name: heart beat; Result Unstructured Data: Test Result:130 / min; Test Date: 202104; Test Name: heart beat; Result Unstructured Data: Test Result:116; Test Date: 20210429; Test Name: heart beat; Result Unstructured Data: Test Result:130; Test Date: 202104; Test Name: oxygen saturation; Test Result: 97 %; Test Date: 202104; Test Name: oxygen saturation; Test Result: 96 %; Test Date: 20210424; Test Name: oxygen saturation; Test Result: 83 %; Test Date: 20210429; Test Name: oxygen saturation; Test Result: 83 %; Test Date: 202104; Test Name: respiratory rate; Result Unstructured Data: Test Result:26 / min; Test Date: 202104; Test Name: PCR covid; Test Result: Negative ; Test Date: 202104; Test Name: ultrasound; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC2021639391

Write-up: blood pressure surge at 190/54; cardiac decompensation; infectious urinary; Ischemia myocardial; Hyperthermia; Transient nocturnal oxygen desaturation; Hypovolaemic shock; respiratory distress; Afib; flu syndrome; chills to chattering teeth; sweating to soak sheets; Lower limbs were edema; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-2021059594. An 85-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY) intramuscular administered in left arm on 17Apr2021 (Lot Number: EW4815) at single dose for covid-19 immunisation. Medical history included arrhythmic valvular heart disease (Afib) from an unknown date and unknown if ongoing. Concomitant medications included cyanocobalamin (VITAMINE B12), enalapril maleate, lercanidipine hydrochloride (ZANEXTRA), urapidil hydrochloride (MEDIATENSYL) , amiodarone hydrochloride (CORDARONE) , pantoprazole, erythropoietin human, furosemide (LASILIX) ,metformin embonate (STAGID) ,macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL), and ascorbic acid, ferrous sulfate (FEROGRAD), all for an unspecified indication, start and stop date were not reported. Historical vaccine included 1st dose of bnt162b2 (COMIRNATY) for covid-19 immunisation. On 24Apr2021, the patient experienced ischemia myocardial, hyperthermia, transient nocturnal oxygen desaturation, and hypovolaemic shock. Seriousness criteria for the events was death. The lab tests included oxygen saturation: 83 % on 24Apr2021, 97 % on an unknown date, 83 % on 29Apr2021, 96 % on an unknown date, heart rate: 130 / min on an unknown date, 116 on an unknown date, 130 on 29Apr2021, body temperature: 39 centigrade on an unknown date, respiratory rate: 26 / min on an unknown date, blood pressure measurement: 190/54 on 29Apr2021. The patient died on 01May2021. It was not reported if an autopsy was performed. Outcome of the events was fatal. The clinical course was reported as follows: on 24Apr2021, ie 1 week after vaccination, the patient presented with hyperthermia, 83% desaturation, hypovolemic shock and myocardial ischemia. Patient was in respiratory distress with significant dyspnea, found at 83% sat in ambient air with thoraco-abdominal rocking, tachycardia at 130 / min, febrile at 39 degrees, and chest pain. Since the dose 2 injection of the vaccine, flu syndrome with chills to chattering teeth and sweating to soak sheets, no temperature taken because thermometer defective. Cardiologic work up ruled out sign of shock, mottling, paleness. Patient had irregular heart sounds, no audible murmur, no acute right heart signs: no Turgescence of the Jugular veins and, Hepato-Jugular Reflux. Lower limbs were edema white, soft and painless, reaching up to the thighs, peripheral pulses perceived up to the distality. Patient had no TD, no dyspnea. pneumologic work up revealed speech dyspnea, had difficulty finishing sentences, saturation at 97% under 2L, bilateral cracklings of the bases, predominant on the right, no auscultatory focus, no suprclavicular indrawing, polypnea at 26 / min, no cyanosis, no sweating, no BTA. clinical ultrasound/ ECG: Afib at116 bpm, normoaxed. On 28Apr2021, cardiac decompensation on an infectious urinary trigger in a heart disease patient with thoracic and troponin increased. On 29Apr2021, cardiac decompensation with blood pressure surge at 190/54, tachycardia at 130 bpm, 83% desaturation under 3L, thoraco abdominal swing, feeling of imminent death, teeth chattering chills, bilateral crackles at the bases, risordan and furosemide help lower blood pressure and respiratory rate. It was reported that the conclusion was cardiac decompensation on an infectious urinary trigger in a patient with valvular and rhythmic heart disease. PCR covid was negative. Patient received lasilix then IVSE then PO relay. Patient had dyspnea at the slightest effort under 2L of oxygen 96%: decrease to 1L with good clinical improvement with depletion. Patient transferred from the emergency room on 30Apr2021 at 9:58 am and referral to a clinic death in the morning of 01May2021 despite the adapted resuscitation measures. Patient was in precarious respiratory state, and died in the morning of 01May2021 despite the adapted resuscitation measures.; Reported Cause(s) of Death: respiratory distress; Afib; blood pressure surge at 190/54; cardiac decompensation; infectious urinary; Ischemia myocardial; Hyperthermia; Transient nocturnal oxygen desaturation; Hypovolaemic shock


VAERS ID: 1389478 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-27
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Disseminated intravascular coagulation, Dyspnoea, Headache, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cholangitis; Cholecystitis; Cognitive disorders; Ischemic stroke
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021639058

Write-up: cephalgia; dyspnea; Disseminated intravascular coagulation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021059601. An 88-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in arm right on 17Apr2021 (Batch/Lot Number: EW2246) as 2nd dose, single for covid-19 immunisation. The patient received the 1st dose of bnt162b2 by intramuscular route in Mar2021 (Batch/Lot Number: EW2246). Medical history included arterial hypertension, ischaemic stroke, cholecystitis, cholangitis, and cognitive disorder. The patient was considered "at risk" (having risk factors). He had never had Covid-19. Sars-cov-2 test performed on unspecified date was negative. Concomitant medications were not reported. The patient experienced disseminated intravascular coagulation (death, hospitalization prolonged) on 27Apr2021, cephalgia and dyspnea of sudden onset on an unspecified date with outcome of unknown. The patient was hospitalized on 22Apr2021 due to cephalgia and dyspnea of sudden onset. On 27Apr2021, the patient developed disseminated intravascular coagulation leading to his death on the same day. 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: Disseminated intravascular coagulation


VAERS ID: 1389479 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-04-28
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Ischaemic stroke, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TAMSULOSIN HYDROCHLORIDE; RAMIPRIL
Current Illness: Arterial hypertension; Hypercholesteremia; Type 2 diabetes mellitus; Vascular dementia (Iso-Resource Groups score (dependence level): 2)
Preexisting Conditions: Medical History/Concurrent Conditions: Pacemaker insertion (cardiac) (Unspecified indication)
Allergies:
Diagnostic Lab Data: Test Date: 20210506; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Positive (mutation N50Y1)
CDC Split Type: FRPFIZER INC2021638994

Write-up: ischemic stroke; Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-2021059716. A 94-year-old male patient received bnt162b2 (COMIRNATY), the first dose via intramuscular in the right arm on 21Jan2021 (Batch/Lot Number: unknown) at 0.3 mL, single and the second dose via intramuscular in the right arm on 11Feb2021 (Batch/Lot Number: EJ6789) at 0.3 mL single for covid-19 immunisation. Medical history included ongoing hypercholesterolaemia, ongoing arterial hypertension, ongoing type 2 diabetes mellitus, ongoing vascular dementia (Iso-Resource Groups score (dependence level): 2), pacemaker user (Unspecified indication) from unspecified date. Concomitant medications included tamsulosin hydrochloride (unspecified trade name) and ramipril (unspecified trade name). On 06May2021, positive SARS COV 2 test (N50Y1 mutation) detected in the context of a cluster at the establishment for dependent elderly people. The patient developed a form of covid-19 that was not very symptomatic (onset of symptoms estimated on 28Apr2021). On 19May2021, occurrence of an ischemic stroke with hemiplegia and swallowing disorders, according to the referring physician, related to the ongoing covid19 infection. Outcome: Death of the patient on 22May2021 following the stroke. in Total, confirmed vaccine failure associated with the onset of a stroke (attributed to low-symptomatic SARS-CoV-2 infection) leading to death in a 94-year-old patient. The patient died on 22May2021. Reported cause of death was ischemic stroke. An autopsy was not performed. The outcome of the event ischemic stroke was fatal, while the other events were unknown. No Follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Ischaemic stroke


VAERS ID: 1389480 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Chest X-ray, Computerised tomogram, Electrocardiogram, Fall, Oxygen saturation, Pleural effusion, Pneumonia, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (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: 2021-05-19
   Days after onset: 40
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN; ELIQUIS; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib (treated with Eliquis); Cardiac insufficiency (stable); Cognitive disorder (moderated); Depression (moderate, following death of his wife, AGGIR GIR score rated 3); Diabetes (treated with metformin); Hypertension arterial (treated with Bisoprolol); Ischemic stroke (per coronary angiography in 2018)
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: chest X-ray; Result Unstructured Data: Test Result:small effusion on the left side; Comments: and signs of pneumonia on the right side; Test Date: 202105; Test Name: Computed tomography; Result Unstructured Data: Test Result:in favor of both pulmonary infection and COVID-19; Test Date: 202105; Test Name: electrocardiogram; Result Unstructured Data: Test Result:Mild lateral ST-depression; Test Date: 20210412; Test Name: Oxygen saturation; Test Result: 70 %; Comments: desaturation; Test Date: 20210509; Test Name: Oxygen saturation; Test Result: 70 %; Comments: desaturation; Test Date: 20210511; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021645758

Write-up: chest X-ray showed small effusion on the left side, and signs of pneumonia on the right side; chest X-ray showed small effusion on the left side, and signs of pneumonia on the right side; fall at home; Decompensation cardiac; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-2021060245. An 83-years-old male patient received bnt162b2 (COMIRNATY), dose 1 on 08Apr2021 (Lot Number: ET7205) and dose 2 on 29Apr2021 (Lot Number: ET6956), both via intramuscular as single dose for COVID-19 immunisation. Medical history included ischaemic stroke per coronary angiography in 2018, moderate depression following death of his wife, AGGIR (Autonomie Gerontology Groupes Iso-Ressources) score rated GIR 3, moderated cognitive disorder, AFib treated with Eliquis, diabetes treated with metformin, stable cardiac insufficiency, Hypertension arterial treated with Bisoprolol. No COVID-19 history. Concomitant medications included metformine taken for diabetes; apixaban (ELIQUIS) taken for atrial fibrillation; bisoprolol taken for hypertension arterial. The patient experienced decompensation cardiac on 13Apr2021. Course of the event: On 06Apr2021, the patient was discharged home from rehabilitation unit. On 08Apr2021, a first dose of bnt162b2 (COMIRNATY) was administered (lot number ET7205). On 09Apr2021, the patient experienced a fall at home. On 12Apr2021, the patient was admitted to nursing home. Oxygen desaturation was 70%. On 13Apr2021, the patient developed cardiac decompensation with lower limbs edema. Oxygen therapy was initiated with furosemide (unspecified trade name). On 19Apr2021, chest X-ray showed small effusion on the left side, and signs of pneumonia on the right side. Amoxicillin, potassium clavulanate (AUGMENTIN) was then initiated. Gradual clinical and biological improvement ensued, with resumption of walking, mood improved even it stayed low (due to his wife death less than 6 months earlier - the patient wanted to die). Falls on clumsiness persisted. The patient still required oxygen at night. On 29Apr2021, the second dose of COVID-19 mRNA Vaccine (nucleoside modified) was administered (lot number ET6956). On 09May2021, the patient experienced a second oxygen desaturation episode (70%). Diuretics and oxygen were then increased. Oxygen dependence lasted 24 hours, followed by transient intakes. On 11May2021, the patient suffered generalized pain, hallucinations, and presented with unusual aggressiveness. He asked to be killed. On 12May2021, the patient developed retro-cardiac chest pain. In May2021, mild lateral ST-depression was detected on electrocardiogram with atrial fibrillation and incomplete left bundle branch block, relieved by glyceryl trinitrate (unspecified trade name), while cardiac decompensation persisted. The patient was transferred to cardiac intensive care unit, then to infectious diseases unit. Computed tomography was in favor of both pulmonary infection and COVID-19. The patient was managed like a COVID-19 patient. Reverse transcriptase polymerase chain reaction was done. The patient had SARS-CoV-2 test: negative on 11May2021. On 19May2021, the patient died. The cause of death was decompensation cardiac. It was unknown if an autopsy was performed. The outcome of the event decompensation cardiac was fatal, the outcome of the other events was unknown.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1389482 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 2 - / OT

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: 2021-05-07
   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:
Current Illness:
Preexisting Conditions: Comments: ATCD cardiovascular
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021645741

Write-up: Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-2021062177. An 87-year-old female patient received BNT162B2 (COMIRNATY), second dose intramuscularly on 06May2021 (Lot Number: EX7389) as single dose for covid-19 immunisation. The patient medical history was not reported. No medical history of COVID-19. The patient previously took the first dose of BNT162B2 (COMIRNATY), on an unspecified date for covid-19 immunisation. No information about tolerance of first dose of COMIRNATY. The patient''s concomitant medications were not reported. The patient experienced infarct myocardial on 07May2021. The patient died on 07May2021. It was not reported if an autopsy was performed. The outcome of the event infarct myocardial was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1389483 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Blood bicarbonate, Blood potassium, Blood sodium, Brain natriuretic peptide, C-reactive protein, Carbon dioxide, Chest scan, Electrocardiogram, International normalised ratio, Investigation, Neutrophil count, Oxygen saturation, PCO2, PO2, Physical examination, Pleural effusion, Respiratory acidosis, Scan brain, Troponin I, White blood cell count, pH body fluid
SMQs:, Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   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: SPECIAFOLDINE; PERMIXON; IRBESARTAN; XARELTO; MODOPAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Arrhythmia; Arterial hypertension; Atrial fibrillation; Parkinson''s disease; Prostate adenoma
Allergies:
Diagnostic Lab Data: Test Name: Prothrombin rate; Test Result: 43 %; Comments: (NL = 70-100); Test Name: HCO3-; Result Unstructured Data: Test Result:29.6 mmol/L; Comments: (NL = 21-28); Test Name: Potassium; Result Unstructured Data: Test Result:4.92 mmol/L; Comments: (NL = 3.4-4.5 mM); Test Name: Sodium; Result Unstructured Data: Test Result:141 mmol/L; Comments: (NL = 136-146 mM); Test Name: BNP; Result Unstructured Data: Test Result:427 ng/L; Comments: (NL < 100); Test Name: total carbon dioxide; Result Unstructured Data: Test Result:32.1 mmol/L; Comments: (NL = 22-28); Test Name: Thoracic scan; Result Unstructured Data: Test Result:pleural effusion; Comments: revealed a bilateral pleural effusion of moderate abundance associated with ventilated parenchymal collapse, two sub subpleural nodules of malicious aspect, and a cardiomegaly; Test Name: C-reactive protein; Result Unstructured Data: Test Result:85 mg/l; Comments: Normal limits (NL): <5; Test Date: 20210514; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:revealed a known atrial fibrillation and presence; Comments: revealed a known atrial fibrillation and presence of Q wave at V1 V2; Test Name: INR; Result Unstructured Data: Test Result:1.8; Comments: (NL = 2-3); Test Name: EBvt; Result Unstructured Data: Test Result:-0.4 mmol/L; Comments: (-23-3); Test Name: Neutrophil count; Result Unstructured Data: Test Result:8.69 x10 9/l; Comments: (NL = 1.50-7.50); Test Date: 20210514; Test Name: Oxygen saturation; Test Result: 77 %; Comments: Desaturation; Test Date: 20210514; Test Name: Oxygen saturation; Test Result: 92 %; Comments: under 5 L of oxygen; Test Name: Oxyhemoglobin; Test Result: 90.38 %; Comments: (NL = 94-98); Test Name: pCO2; Result Unstructured Data: Test Result:80.2 mmHg; Comments: (NL = 35-48); Test Name: pH; Result Unstructured Data: Test Result:7.18; Comments: (NL = 7.35-8.45); Test Date: 20210514; Test Name: Physical examination; Result Unstructured Data: Test Result:The patient was confused and drowsy, Glasgow score; Comments: The patient was confused and drowsy, Glasgow score 12, he had no fever and did not talk. His eyes were open, and he had a motor response to pain. Saturation of peripheral oxygen was at 97% under 3 L of oxygen. The patient had irregular heart sounds, no chest pain, known oedema of the lower limbs and soft calves. He had rattles, crackles heard in both basis, which were more marked for the right lung and no thoraco-abdominal balancing. The abdomen was soft, no guarding or tenderness nor distended bladder were described. No fecaloma was retrieved on digital rectal examination.; Test Name: pO2; Result Unstructured Data: Test Result:77.9 mmHg; Comments: (NL = 83-108); Test Name: Brain scan; Result Unstructured Data: Test Result:cortico-subcortical atrophy; Test Name: Troponin I; Result Unstructured Data: Test Result:18.6 ng/L; Comments: (NL < 17.5); Test Name: White blood cells; Result Unstructured Data: Test Result:11.9 x10 9/l; Comments: (NL = 4-11)
CDC Split Type: FRPFIZER INC2021645202

Write-up: Acidosis respiratory; Effusion pleural; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-2021062422. A 95-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 06May2021 (Lot Number: ET6956) as 1st single dose, 0.3 ml for covid-19 immunization. Medical history included complete arrhythmia with atrial fibrillation, atrial fibrillation, prostatic adenoma, arterial hypertension, parkinson''s disease, anaemia. The patient had no history of COVID-19 infection. Concomitant medications included folic acid (SPECIAFOLDINE); serenoa repens extract (PERMIXON); irbesartan (IRBESARTAN); rivaroxaban (XARELTO); benserazide hydrochloride, levodopa (MODOPAR). The patient experienced acidosis respiratory (death) on 14May2021, effusion pleural (death) on 14May2021. On 06May2021, the patient was vaccinated for the first time with BNT162B2. Patient had no symptoms until 14May2021. According to the general practitioner, the patient was autonomous until his admission to a nursing home on 26Apr2021. He had no desire to leave his home. On 14May2021 the patient experienced crackles heard and had an oxygen desaturation at 77% in ambient air and at 92% under 5 L of oxygen. Physical examination: The patient was confused and drowsy, Glasgow score 12, he had no fever and did not talk. His eyes were open, and he had a motor response to pain. Saturation of peripheral oxygen was at 97% under 3 L of oxygen. The patient had irregular heart sounds, no chest pain, known oedema of the lower limbs and soft calves. He had rattles, crackles heard in both basis, which were more marked for the right lung and no thoraco-abdominal balancing. The abdomen was soft, no guarding or tenderness nor distended bladder were described. No fecaloma was retrieved on digital rectal examination. Electrocardiogram (ECG) revealed a known atrial fibrillation and presence of Q wave at V1 V2. On 15May2021, the patient was drowsy, presented with retraction and seemed uncomfortable (facial expression). Non-invasive ventilation did not work, and a collective decision was taken to apply palliative cares. The patient was administered Morphine (unspecified trade name) by electric syringe pump to relieve dyspnea. Blood tests: C-reactive protein 85 mg/L, Troponine I 18.6 ng/L (NL: <17.5), B natriuretic peptide 427 ng/L (NL: <100), Leukocytes 11.9 G/L (NL: 4-11), Neutrophils 8.69 G/L (NL: 1.50-7.50), Prothrombin time ratio was 43 (NL: 70-100), International normalised ratio was 1.8 (NL: 2-3), pH was 7.18 (NL: 7.35-8.45), pO2: 77.9 mmHg (NL: 83-108), pCO2: 80.2 mmHg (NL: 35-48), Blood bicarbonate (HC03-) 29.6 mM (mmol/L) (NL: 21-28), TCO2: 32.1 mM (NL: 22-28), EBvt = -0.4 mM (NL: -23-3), Oxyhemoglobin: 90.38 (94-98 %), Blood sodium: 141 mM (NL: 136 - 146 mM), Blood potassium: 4.92 mM (NL: 3.4 - 4.5). Brain computerized tomography (CT) revealed a cortico-subcortical atrophy. Thoracic CT revealed a bilateral pleural effusion of moderate abundance associated with ventilated parenchymal collapse, two sub subpleural nodules of malicious aspect, and a cardiomegaly. Discharge diagnosis was described as respiratory acidosis with hypercapnia at 80 mmHg and biological inflammatory syndrome. The final outcome was death. Awaiting for further information. The patient died on 16May2021. An autopsy was not performed. No follow-up attempt possible. No further information expected.; Reported Cause(s) of Death: Acidosis respiratory; effusion pleural


VAERS ID: 1389484 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7082 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Blood potassium, Blood sodium, Blood test, Cardiac failure, Creatinine renal clearance, Decreased appetite, International normalised ratio, Malaise, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PREVISCAN [FLUINDIONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Arrhythmia; Diabetes mellitus; Eschar; Hypokalemia; Hyponatremia; Hypothyroidism; Insufficiency cardiac; International normalized ratio increased; Malnutrition; Renal insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Blood potassium; Result Unstructured Data: Test Result:hypokalemia; Test Date: 20210508; Test Name: Blood sodium; Result Unstructured Data: Test Result:hyponatremia; Test Date: 20210508; Test Name: blood tests; Result Unstructured Data: Test Result:hyponatremia, hypokalemia, renal insufficiency; Comments: hyponatremia, hypokalemia, renal insufficiency with creatinine clearance at 20 mL/min; Test Date: 20210508; Test Name: Creatinine clearance; Result Unstructured Data: Test Result:20 ml/min; Test Date: 20210508; Test Name: INR; Result Unstructured Data: Test Result:4
CDC Split Type: FRPFIZER INC2021645189

Write-up: malaise in the toilet; Death sudden; cardio-respiratory arrest (possible diagnosis of cardiac decompensation in connection with acute pulmonary edema); cardio-respiratory arrest (possible diagnosis of cardiac decompensation in connection with acute pulmonary edema); anorexia; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021062507. An 87-year-old male patient received the second dose of BNT162B2 (COMIRNATY) (Batch/Lot Number: FA7082), at the age of 87-year-old, via intramuscular on 19May2021 in the morning at single dose for COVID-19 immunisation. Medical history included Insufficiency cardiac, Complete arrhythmia with atrial fibrillation, Malnutrition, Hypothyroidism, Eschar, Diabetes mellitus, hyponatremia from 08May2021, hypokalemia from 08May2021, renal insufficiency with creatinine clearance at 20 mL/min from 08May2021, international normalized ratio (INR) of 4 from 08May2021. Concomitant medications included fluindione (PREVISCAN) taken for international normalized ratio (INR) of 4. The patient previously received the first dose of BNT162B2 (COMIRNATY) on an unspecified date for COVID-19 immunisation. The patient was recently admitted to the nursing home. The patient experienced death sudden on 20May2021, cardio-respiratory arrest (possible diagnosis of cardiac decompensation in connection with acute pulmonary edema) on 20May2021, anorexia on 19May2021, malaise in the toilet on 20May2021 05:00. The events (death sudden, cardio-respiratory arrest (possible diagnosis of cardiac decompensation in connection with acute pulmonary edema) and malaise in the toilet) resulted in emergency room visit. Clinical course: On 19May2021 in the morning, the patient received the second dose of BNT162B2. During the next meal anorexia was noted. In the night following the vaccination (20May2021 around 05:00 am) the patient had a malaise in the toilet. Upon the arrival of emergency medical service, the patient had cardio-respiratory arrest (possible diagnosis of cardiac decompensation in connection with acute pulmonary edema). The patient could not be resuscitated. Overall, sudden death (simultaneously with cardiac decompensation signs) of a very old patient with comorbidities and a priori in a poor general condition less than 24 hours after the second dose of BNT162B2 vaccine. The patient underwent lab tests and procedures which included blood potassium: hypokalemia on 08May2021, blood sodium: hyponatremia on 08May2021, Creatinine clearance: 20 ml/min on 08May2021. On 08May2021, blood tests revealed hyponatremia, hypokalemia, renal insufficiency with creatinine clearance at 20 mL/min and international normalized ratio (INR) of 4. The outcome of the events (anorexia and malaise) was unknown, of other remain events was fatal. The patient died on 20May2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death; cardio-respiratory arrest (possible diagnosis of cardiac decompensation in connection with acute pulmonary edema); cardio-respiratory arrest (possible diagnosis of cardiac decompensation in connection with acute pulmonary edema)


VAERS ID: 1389485 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-23
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Lumbar scoliosis
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Infection urinary tract
Allergies:
Diagnostic Lab Data: Test Date: 20200402; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive
CDC Split Type: FRJNJFOC20210619012

Write-up: CARDIO-RESPIRATORY ARREST; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, FR-AFSSAPS-2021062586] concerned an 82 year old female. The patient''s weight was 39 kilograms, and height was 135 centimeters. The patient''s past medical history included infection urinary tract, and covid-19 in APR-2020, and concurrent conditions included lumbar scoliosis, and arterial hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-02 expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 22-MAY-2021 for covid-19 vaccination. No concomitant medications were reported. On 02-APR-2020, the patient''s laboratory data included: SARS-CoV-2 test positive. On 23-MAY-2021, the patient experienced cardio-respiratory arrest. On the same day, the patient died due to cardio-respiratory arrest. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210619012-COVID-19 VACCINE AD26.COV2.S -Cardio-respiratory arrest. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: CARDIO-RESPIRATORY ARREST


VAERS ID: 1389492 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Fall, Insomnia, Musculoskeletal pain, Pain in extremity, Physical examination, Ultrasound Doppler, Wound, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 34
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; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: clinical examination; Result Unstructured Data: Test Result:no sign of phlebitis; Test Date: 20210429; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result:returns to normal; Test Date: 20210505; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210505; Test Name: X-ray; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021645272

Write-up: fall; occipital wound; Death unexplained; severe pain in the left lower limb; preventing the patient from sleeping; the pain went up to the buttock; This is a spontaneous report from a contactable consumer and a physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PS20211134. A 75-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: ER9470), intramuscularly in arm left on 24Apr2021 at single dose for COVID-19 immunisation. Medical history included hypertension arterial, and COVID-19. The patient''s concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunisation. The patient experienced death unexplained on 05May2021. Around 26 or 27Apr2021, severe pain in the left lower limb occurred, preventing the patient from sleeping. The patient also complained at one point to his wife that the pain went up to the buttock. On 28Apr2021 in the morning, the patient consulted his GP and underwent on 29Apr2021 a doppler ultrasound which returned to normal. On clinical examination no sign of phlebitis. No notion of dyspnea. No treatment (no anti-coagulation) prescribed. On 04May2021, the patient came to see his daughter. He told her of very severe pain in his left leg. She thought about a possible phlebitis, listening to the pain he was describing to her and she asked him to consult quickly, even to go to the emergency room. But the patient told that he would have the doppler ultrasound results the next day (05May2021) and that he would also do an X-ray, so he did not consult. On 05May2021 in the morning, an X-ray of the leg was normal. Subsequently, on 05May2021, the patient did his shopping at the supermarket: Sudden onset at 12:55 p.m. of a fall backwards with occipital wound. The patient did not get up. Emergency ambulance call: attempt at resuscitation impossible. Statement of death. Patient died on 05May2021. Outcome of the other events was unknown. Autopsy not desired by the family. An autopsy was not performed.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1389493 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNK / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse; Alcohol addiction; Bipolar I disorder; Cannabis addiction; Chronic bronchitis; Degenerative disc disease; Drug addiction; Hepatitis B (cured); Hepatitis C (cured); Heroin addiction (from his 20 years old to his 40 years old); HIV infection; Low back pain; Manic episode; Neuropathy peripheral (probably multifactorial); Psychotic episode; Sciatica
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Post-mortem whole body CT scan; Result Unstructured Data: Test Result:two abdominal thromboses (venous or arterial?)
CDC Split Type: FRPFIZER INC2021645261

Write-up: Thrombosis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-PS20211139. A 57-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: UNK), administered in arm right at single dose for COVID-19 immunisation on 02Apr2021. The patent previously received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: ER2659) for COVID-19 immunisation on 05Mar2021. Medical history included low back pain on degenerative disc disease with sciatica, lower limb neuropathy probably multifactorial, human immunodeficiency virus infection (HIV), treated Hepatitis B virus and C virus infections, chronic bronchitis, bipolar I disorder, several manic episodes with psychotic features in 2001, 2010 and 2014. The patient presented with alcohol misuse and multiple addictions including heroin use from his 20 years old to his 40s, alcohol, cannabis and drugs addiction. No history of SARS-Cov-2 infection. The patient''s concomitant medications were not reported. The patient experienced thrombosis (thrombosis) (death) on 2021. The clinical course was reported as: On 20Apr2021 the patient was seen in psychiatric consult and his psychiatrist indicated that he was in good health and that they had a good discussion. The patient had just received his second injection of the Pfizer vaccine on 02Apr and wanted to return to day care center starting from this week. He had wanted to leave our center, where he had been going regularly, and stayed at home since last December for fear of SARS-Cov-2. On 29Apr2021, i.e. 28 days after the 2nd dose, the patient was found dead by his home help. Whole body imaging was performed (exact date was not provided) identified two abdominal thromboses (venous or arterial?). An autopsy was requested (not performed yet). On 18May2021 the patient''s brother appealed to the public prosecutor''s office to obtain the documents from the medico-legal institute. The brother will send the documents when they are available. To summarize, death occurred 28 days after the 2nd injection of COVID-19 mRNA Vaccine (nucleoside modified) in a 57 year-old patient whose main medical history was HIV infection, bipolar disorder type 1 and multiple addictions and in whom post-mortem imaging identified 2 abdominal thromboses (venous or arterial?). Discussion/conclusion: From a chronological point of view, the death occurred 28 days after vaccination by COVID-19 mRNA Vaccine (nucleoside modified) , the role of the vaccine in the occurrence of this death cannot be ruled out. From a semiology point of view, the whole-body CT scan found two abdominal thrombosis (venous or arterial?). From a bibliographical point of view, the pharmacovigilance report No. 15 on the vaccine lists the deaths declared since the beginning of the follow-up page 14-15. Cases of arterial and venous thrombosis have been recorded since the beginning of the vaccination campaign. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: THROMBOSIS


VAERS ID: 1389528 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-05-12
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anti-cyclic citrullinated peptide antibody, Anti-neutrophil cytoplasmic antibody positive vasculitis, Antinuclear antibody, Antiphospholipid antibodies, Beta-2 glycoprotein antibody, Blood bilirubin, Blood cholesterol, Blood fibrinogen, Blood triglycerides, Borrelia test, CSF pressure, Cardiolipin antibody, Coagulation factor V level, Coagulation factor VIII level, Computerised tomogram, Computerised tomogram head, Cytomegalovirus test, Echocardiogram, Electrocardiogram, Epstein-Barr virus test, Fundoscopy, Glomerular filtration rate, HIV test, HTLV-1 test, HTLV-2 test, Haemoglobin, Hepatitis B virus test, Hepatitis C virus test, High density lipoprotein, Investigation, Ischaemic stroke, Low density lipoprotein, Magnetic resonance imaging head, Platelet count, Protein C, Protein S, Prothrombin time, Rheumatoid factor, SARS-CoV-2 test, Toxoplasma serology, Treponema test, Ultrasound Doppler, Vascular imaging, White blood cell count, Whole body scan
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 11
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: KARDEGIC; SERESTA; NEBIVOLOL; PERINDOPRIL; INSPRA
Current Illness: Tabaquism (active)
Preexisting Conditions: Medical History/Concurrent Conditions: Acute coronary syndrome (treated with thrombolysis and drug-eluting stents insertion); Chronic alcoholism (active smoking); Dyslipidaemia; Infarct myocardial; Left anterior descending coronary artery occlusion; Sensory polyneuropathy axonal (of lower limbs, followed-up since 2006); ST segment elevation (treated with thrombolysis and drug-eluting stents insertion); Stent placement (drug-eluting stents insertion in left anterior descending coronary artery); Thrombolysis
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: Encephalo-thoraco-abdomino-pelvic CT scan; Result Unstructured Data: Test Result:no hemorrhagic transformation of ischemic lesion; Comments: no hemorrhagic transformation of the ischemic stroke from left middle cerebral artery territory, no deep vein thrombosis in chest, abdomen or pelvis. A probable right renal infarction was found (emboligenic etiology given the context?). Mild pleural effusions were observed with ventilatory impairment at their level; Test Date: 20210521; Test Name: Brain CT scan; Result Unstructured Data: Test Result:hemorrhagic transformation of ischemic stroke; Comments: hemorrhagic transformation of left superficial middle cerebral artery territory stroke with severe hematoma, intraventricular bleeding, dilatation of ventricular system and subfalcine herniation; Test Date: 20210522; Test Name: Intracranial pressure; Result Unstructured Data: Test Result:uncontrollable; Comments: Intracranial hypertension was refractory, uncontrollable; Test Date: 202105; Test Name: CMV test; Test Result: Negative ; Test Date: 20210517; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210517; Test Name: Echocardiography; Result Unstructured Data: Test Result:normal; Test Date: 20210513; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:normal; Test Date: 20210513; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm; Test Date: 202105; Test Name: EBV test; Test Result: Negative ; Test Date: 20210514; Test Name: Fundoscopy; Result Unstructured Data: Test Result:normal; Test Date: 20210514; Test Name: Glomerular filtration rate; Result Unstructured Data: Test Result:99; Test Date: 20210520; Test Name: Glomerular filtration rate; Result Unstructured Data: Test Result:99; Test Date: 20210522; Test Name: Glomerular filtration rate; Result Unstructured Data: Test Result:109; Test Date: 20210523; Test Name: Glomerular filtration rate; Result Unstructured Data: Test Result:107; Test Date: 20210514; Test Name: Hemoglobin; Result Unstructured Data: Test Result:15.5; Test Date: 20210520; Test Name: Hemoglobin; Result Unstructured Data: Test Result:15.2; Test Date: 20210522; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.2; Test Date: 20210523; Test Name: Hemoglobin; Result Unstructured Data: Test Result:12; Test Date: 202105; Test Name: Hepatitis B test; Test Result: Negative ; Test Date: 202105; Test Name: Hepatitis C test; Test Result: Negative ; Test Date: 20210514; Test Name: HDL cholesterol; Result Unstructured Data: Test Result:1.04 mmol/L; Test Date: 202105; Test Name: HIV test; Test Result: Negative ; Test Date: 202105; Test Name: HTLV-1 test; Test Result: Negative ; Test Date: 202105; Test Name: HTLV-2 test; Test Result: Negative ; Test Date: 202105; Test Name: Molecular biology for thrombogenic mutation; Result Unstructured Data: Test Result:pending; Test Date: 20210514; Test Name: LDL cholesterol (calculated); Result Unstructured Data: Test Result:4.34 mmol/L; Test Date: 20210513; Test Name: Brain MRI; Result Unstructured Data: Test Result:left sylvian ischemic stroke; Comments: in FLAIR sequence revealed ischemic stroke ($g4h30) in whole middle cerebral artery territory associated with bilateral parietal punctiform ischemias. Perfusion diffusion mismatch with abnormal mean transfer time in left occipital lobe. Cerebral blood volume drop in the left middle cerebral artery territory.; Test Date: 20210514; Test Name: Platelet count; Result Unstructured Data: Test Result:241; Test Date: 20210520; Test Name: Platelet count; Result Unstructured Data: Test Result:199; Test Date: 20210522; Test Name: Platelet count; Result Unstructured Data: Test Result:175; Test Date: 20210523; Test Name: Platelet count; Result Unstructured Data: Test Result:184; Test Date: 202105; Test Name: Protein C; Result Unstructured Data: Test Result:normal; Test Date: 202105; Test Name: Protein S; Result Unstructured Data: Test Result:normal; Test Date: 20210514; Test Name: Prothrombin time; Result Unstructured Data: Test Result:98; Test Date: 20210517; Test Name: Prothrombin time; Result Unstructured Data: Test Result:100; Test Date: 20210522; Test Name: Prothrombin time; Result Unstructured Data: Test Result:90; Test Date: 20210523; Test Name: Prothrombin time; Result Unstructured Data: Test Result:90; Test Date: 202105; Test Name: Rheumatoid factor; Test Result: Negative ; Test Date: 20210509; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210513; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210514; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210521; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210522; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210523; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 202105; Test Name: Toxoplasmosis test; Test Result: Negative ; Test Date: 202105; Test Name: Syphilis test; Test Result: Negative ; Test Date: 20210513; Test Name: Neck Doppler; Result Unstructured Data: Test Result:unremarkable; Test Date: 20210514; Test Name: Vascular explorations; Result Unstructured Data: Test Result:no significant disorder at the level of neck arter; Comments: no significant disorder at the level of neck arteries; no visible abnormality of Willis''s circle (partial exam due to unusable left temporal window); no evidence for high intensity transient signal, thus no indirect sign of intra or extra cardiac right-left shunt; Test Date: 20210514; Test Name: White blood cell count; Result Unstructured Data: Test Result:9.56; Test Date: 20210520; Test Name: White blood cell count; Result Unstructured Data: Test Result:7.2; Test Date: 20210522; Test Name: White blood cell count; Result Unstructured Data: Test Result:13.6; Test Date: 20210523; Test Name: White blood cell count; Result Unstructured Data: Test Result:10.3; Test Date: 20210523; Test Name: Whole body scan; Result Unstructured Data: Test Result:stability of right renal infarct; Comments: stability of right renal infarct and benign bilateral renal cortex microcysts. Lesion was detected in the fourth hepatic segment, with peripheral arterial enhancement, and venous portal enhancement, suggestive of benign hemangioma. A benign calcified 3-mm nodule was found in the right inferior lung lobe, with distal endobronchial congestion. Bronchiolitis in right superior and inferior lobes was probably secondary to aspiration. Ventilatory impairment in both bases. Probable sequela of anteroseptal myocardial infarction. No evidence for SARS-Cov-2 infection; Test Date: 202105; Test Name: anti-cyclic citrullinated peptides antibodies; Test Result: Negative ; Test Date: 20210514; Test Name: anti-neutrophil cytoplasmic antibodies (ANCA); Test Result: Negative ; Test Date: 202105; Test Name: Antinuclear antibodies; Test Result: Negative ; Test Date: 202105; Test Name: circulating anticoagulant as lupus type; Test Result: Negative ; Test Date: 202105; Test Name: circulating anticoagulant as anti B2GP1 type; Test Result: Negative ; Test Date: 20210514; Test Name: Total bilirubin; Result Unstructured Data: Test Result:7.6 umol/l; Test Date: 20210514; Test Name: Total cholesterol; Result Unstructured Data: Test Result:6.17 mmol/L; Test Date: 202105; Test Name: Fibrinogen; Result Unstructured Data: Test Result:increased; Test Date: 20210514; Test Name: Triglycerides; Result Unstructured Data: Test Result:1.74 mmol/L; Test Date: 202105; Test Name: Borrelia test; Test Result: Negative ; Test Date: 202105; Test Name: circulating anticoagulant as anticardiolipines type; Test Result: Negative ; Test Date: 20210522; Test Name: Factor V; Result Unstructured Data: Test Result:148; Test Date: 202105; Test Name: Factor VIII; Result Unstructured Data: Test Result:increase; Comments: increased in the context of inflammation (increased fibrinogen).; Test Date: 20210522; Test Name: Brain and thoracic CT scan; Result Unstructured Data: Test Result:significant increase of hematoma; Comments: significant increase of left intraparenchymal temporal hematoma (89 mm vs 73), as well as peripheral edema related to hemorrhagic transformation; significant increase of associated intraventricular bleeding (4 ventricles involved vs 3 on previous exam); left frontal parietal temporal subarachnoid hemorrhage had also worsened at the same level. Impingement had markedly worsened with aggravation of subfalcine herniation (median line shift of 18 mm to the right vs 10 previously), onset of left temporal engagement, basal cisterns were not visible. Cortical sulci were not visible, suggestive of intracranial hypertension; obstructive hydrocephalus; Test Date: 20210521; Test Name: CT scan; Result Unstructured Data: Test Result:hemorrhagic transformation of ischemic stroke; Comments: hemorrhagic transformation of previous stroke with severe hematoma, intraventricular bleeding and dilation of ventricular system. Subfalcine herniation was also observed. hemorrhagic transformation of left superficial middle cerebral artery territory stroke with severe hematoma, intraventricular bleeding, dilatation of ventricular system and subfalcine herniation
CDC Split Type: FRPFIZER INC2021645219

Write-up: Ischemic stroke; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number FR-AFSSAPS-SE20211242. A 52-year-old male patient received his first dose of bnt162b2 (COMIRNATY), as an intramuscular single dose, administered in left arm, on 23Apr2021 (Lot Number: EX0893), for covid-19 immunisation. Medical history included infarct myocardial in 2015, ST elevation acute coronary syndrome treated with thrombolysis and drug-eluting stents insertion in left anterior descending coronary artery in 2015, sensory polyneuropathy of lower limbs under follow-up from 2006, dyslipidemia, active smoking/ ongoing tabaquism, alcohol consumption. Concerning COVID-19: the patient was not a risk to develop a severe COVID-19 (history of infection and testing, if any, was unknown). Chronic treatment/ concomitant medications included DL-lysine acetylsalicylate (KARDEGIC, strength 75), oxazepam (SERESTA, strength 50 mg) in the evening, nebivolol (strength 5), perindopril (strength 4), eplerenone (INSPRA, strength 25) once daily. Course of the event: On 23Apr2021, the patient was vaccinated for the first time with COVID-19 mRNA Vaccine (nucleoside modified) (COMIRNATY), by intramuscular route in the left arm. On 12May2021 in the evening, the patient developed right upper arm paresis, considered as not significant by the patient. On 13May2021, aphasia prompted visit to the emergency room. Brain magnetic resonance imaging revealed ischemic stroke in the left middle cerebral artery territory. Transthoracic echocardiography returned normal. Electrocardiogram showed sinus rhythm. Neck Doppler ultrasound was unremarkable. DL-lysine acetylsalicylate was continued. The initial course was favorable. On 21May2021, the patient experienced consciousness impairment with meningeal irritation. Computed tomography disclosed hemorrhagic transformation of previous stroke with severe hematoma, intraventricular bleeding and dilation of ventricular system. Subfalcine herniation was also observed. On 22May2021, neurological condition rapidly worsened, required surgical management with hematoma drainage, placement of external ventricular drain in the left frontal horn and intracranial pressure sensor. During and after procedure, the patient presented with bilateral mydriasis. Following discharge from the intensive care unit, intracranial pressure was uncontrollable. No more surgery was indicated given the poor clinical condition and the severity of cerebral lesions. Intracranial hypertension was refractory, uncontrollable. On 23May2021, the patient died. The final diagnosis and cause of death was Ischemic stroke. It was unknown if an autopsy was performed. Blood tests: On 14May2021, glomerular filtration rate was 99, hemoglobin 15.5, leukocytes 9.56, platelets 241, prothrombin time ratio 98. Metabolism: total bilirubin was 7.6 umol/l (upper limit of the normal: 21.0), total cholesterol 6.17 mmol/l (normal range: 4.30-5.20), triglycerides 1.74 mmol/l (upper limit of the normal: 1.70), high density lipoprotein cholesterol 1.04 mmol/l (lower limit of the normal: 1.00), calculated low density lipoprotein cholesterol 4.34 mmol/l (upper limit of the normal: 4.12). On 17May2021, prothrombin time ratio was 100. On 20May2021, glomerular filtration rate was 99, hemoglobin 15.2, leukocytes 7.2, platelets 199. On 22May2021, glomerular filtration rate was 109, hemoglobin 14.2, leukocytes 13.6, platelets 175, prothrombin time ratio 90, coagulation factor V 148. On 23May2021, glomerular filtration rate was 107, hemoglobin 12, leukocytes 10.3, platelets 184, prothrombin time ratio 90. Coagulation profile: coagulation factor VIII increased in the context of inflammation (increased fibrinogen). No circulating anticoagulant as lupus type, anticardiolipines or anti B2GP1. Protein S and protein C levels were normal. Molecular biology for thrombogenic mutation was pending. Infectious work-up: SARS-CoV-2 tests returned negative on 09May2021, 13May2021, 14May2021, 21May2021, 22May2021 and 23May2021. Testing returned negative for human immunodeficiency virus, hepatitis B, hepatitis C, syphilis, cytomegalovirus, Epstein Barr virus, toxoplasmosis, Human T-cell lymphotropic virus types 1and 2. Serology was negative for borreliosis. Immune work-up was negative for rheumatoid factor, anti-cyclic citrullinated peptides antibodies, anti-nuclear antibodies (anti-neutrophil cytoplasmic antibodies (ANCA), anti-nuclear antibodies). Additional examinations: Brain magnetic resonance imaging done on 13May2021 in FLAIR sequence revealed ischemic stroke ($g4h30) in whole middle cerebral artery territory associated with bilateral parietal punctiform ischemias. Perfusion diffusion mismatch with abnormal mean transfer time in left occipital lobe. Cerebral blood volume drop in the left middle cerebral artery territory. Brain chest abdomen pelvis computed tomography performed on 14May2021 found no hemorrhagic transformation of the ischemic stroke from left middle cerebral artery territory, no deep vein thrombosis in chest, abdomen or pelvis. A probable right renal infarction was found (emboligenic etiology given the context?). Mild pleural effusions were observed with ventilatory impairment at their level. Vascular explorations done on 14May2021 revealed no significant disorder at the level of neck arteries; no visible abnormality of Willis''s circle (partial exam due to unusable left temporal window); no evidence for high intensity transient signal, thus no indirect sign of intra or extra cardiac right-left shunt; fundoscopy done on 14May2021 returned normal; Echocardiography done on 17May2021 returned normal; Cardiac ultrasound on 17May2021 showed no abnormality. CT scan/ Brain computed tomography was realized on 21May2021 found hemorrhagic transformation of left superficial middle cerebral artery territory stroke with severe hematoma, intraventricular bleeding, dilatation of ventricular system and subfalcine herniation. Brain and chest computed tomography performed on 22May2021 showed significant increase of left intraparenchymal temporal hematoma (89 mm vs 73), as well as peripheral edema related to hemorrhagic transformation; significant increase of associated intraventricular bleeding (4 ventricles involved vs 3 on previous exam); left frontal parietal temporal subarachnoid hemorrhage had also worsened at the same level. Impingement had markedly worsened with aggravation of subfalcine herniation (median line shift of 18 mm to the right vs 10 previously), onset of left temporal engagement, basal cisterns were not visible. Cortical sulci were not visible, suggestive of intracranial hypertension; obstructive hydrocephalus. Whole body computed tomography performed on 23May2021 revealed stability of right renal infarct and benign bilateral renal cortex microcysts. Lesion was detected in the fourth hepatic segment, with peripheral arterial enhancement, and venous portal enhancement, suggestive of benign hemangioma. A benign calcified 3-mm nodule was found in the right inferior lung lobe, with distal endobronchial congestion. Bronchiolitis in right superior and inferior lobes was probably secondary to aspiration. Ventilatory impairment in both bases. Probable sequela of anteroseptal myocardial infarction. No evidence for SARS-Cov-2 infection. Conclusion: Patient who developed ischemic stroke in the left middle cerebral artery territory 20 days after the first injection of COVID-19 mRNA Vaccine (nucleoside modified), with secondary hemorrhagic transformation resulting in death. Cardioembolic etiology was strongly suspected given history of heart disorder, bilateral cerebral lesions, renal infarct, while under anti-platelet therapy, and also in the context of atheroma. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: ischemic stroke with hemorrhagic transformation


VAERS ID: 1389564 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-15
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, COVID-19, Oxygen saturation, Respiratory distress, Respiratory rate, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Hernia hiatal; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: Blood pressure; Result Unstructured Data: Test Result:171/77 mmHg; Comments: at 04:01 am; Test Date: 20210515; Test Name: Blood pressure; Result Unstructured Data: Test Result:122/43 mmHg; Comments: at 05:53 am; Test Date: 20210515; Test Name: Oxygen saturation; Test Result: 97 %; Comments: at 04:01 am; Test Date: 20210515; Test Name: Oxygen saturation; Test Result: 75 %; Comments: at 05:53 am; Test Date: 20210515; Test Name: Respiratory rate; Result Unstructured Data: Test Result:43; Comments: at 04:01 am; Test Date: 20210515; Test Name: Respiratory rate; Result Unstructured Data: Test Result:13; Test Date: 20210515; Test Name: Sars-CoV2 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021639357

Write-up: Vaccination failure; COVID-19; Respiratory distress; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-ST20211980. An 89-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscularly on 11Mar2021 (lot number: only partial provided (6905)) at 0.3 mL, single, and the first dose on an unspecified date at single dose for COVID-19 immunisation. Medical history included Alzheimer''s disease, hypertension arterial, and hiatus hernia. The patient''s concomitant medications were not reported. The patient experienced vaccination failure, and COVID-19 on 15May2021. Dyspnea, bronchial congestion evolving to respiratory distress. On admission in ICU at 02:53 am the patient presented with comatose and respiratory distress with indrawing and thoracoabdominal asynchrony. Tracheal aspirations were inefficient. At 04:01 am, blood pressure was 171/77 mmHg, saturation was 97%, respiratory rate was 43, oxygen 15 L high concentration mask; At 05:53 am, blood pressure was 122/43 mmHg, saturation was 75%, respiratory rate was 13, oxygen 15 L high concentration mask. At 06:55 am patient''s death. The patient underwent lab tests and procedures which included Sars-CoV2 PCR test: Positive on 15May2021. The patient died on 15May2021. Outcome of the events was fatal. Cause of death included respiratory distress. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Vaccination failure; COVID-19; Distress respiratory


VAERS ID: 1389581 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021638970

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-TO20214017. A 68-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 22Apr2021 (Batch/Lot Number: ET6956) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sudden death on 23Apr2021. It was not reported if an autopsy was performed. Additional comment: Sudden death without further information on the declaration, under investigation. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1389603 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Lip and/or oral cavity cancer recurrent, Mental impairment
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Oropharyngeal neoplasms (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   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: ORAMORPH [MORPHINE SULFATE PENTAHYDRATE]; PARACETAMOL; TRANEXAMIC ACID
Current Illness: Mouth cancer
Preexisting Conditions: Medical History/Concurrent Conditions: Chemotherapy (showing signs of good recovery); Radiotherapy (showing signs of good recovery)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649422

Write-up: Death Bleeding; Mental Health Deterioration & Bleeding Return OF Oral Cancer Accelerated.; Mental Health Deterioration & Bleeding Return OF Oral Cancer Accelerated.; Mental Health Deterioration & Bleeding Return OF Oral Cancer Accelerated.; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-EYC 00252016. Safety Report Unique Identifier (GB-MHRA-ADR 25388192). A 75-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 75-years-old, parenteral on 29Jan2021 as single dose for covid-19 immunisation. Medical history included ongoing Lip and/or oral cavity cancer, chemotherapy and radiotherapy showing signs of good recovery prior to administration of the Pfizer vaccine. Concomitant medications included morphine sulfate pentahydrate (ORAMORPH) taken for an unspecified indication, start and stop date were not reported; paracetamol taken for an unspecified indication, start and stop date were not reported; tranexamic acid taken for an unspecified indication, start and stop date were not reported. The patient experienced death bleeding on 13Feb2021, mental health deterioration & bleeding return of oral cancer accelerated on 29Jan2021. The patient died on 13Feb2021. It was not reported if an autopsy was performed. Seriousness assessment from HA was Results in death and Other medically important condition. Clinical course was reported as follows: As soon as vaccine was administered 2 weeks prior to death of my mother she showed a marked decrease in mental health and her physical health deteriorated rapidly including the return of oral cancer at an accelerated rate. She had had chemotherapy and radiotherapy and was showing signs of good recovery prior to administration of the Pfizer vaccine resulting in sudden death. Death bleeding. Mental health deterioration & bleeding return of oral cancer accelerated. No follow-up attempts are possible; Information about Batch/Lot Number cannot be obtained.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1389927 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-29
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 4120Z001 / 2 - / -

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: 2021-03-29
   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: EVACAL D3; MIRTAZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Living in care; Multiple sclerosis; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021621804

Write-up: Cardiac arrest; This is a spontaneous report received from a contactable physician by Pfizer from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25380821. An 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 19Mar2021 (Lot Number: 4120Z001) as 2nd dose, single dose for covid-19 immunisation. Medical history included multiple sclerosis, depression, osteoporosis, care home resident. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications included calcium carbonate, colecalciferol (EVACAL D3) taken for osteoporosis; mirtazapine taken for depression. The patient experienced cardiac arrest (death) on 29Mar2021. Unable to state if related or not to the vaccine but thought it should be reported given that it occurred within 10 days of her 2nd dose. The patient died on 29Mar2021. An autopsy was not performed. The event clinical course was as follows: CPR performed, ambulance called, taken to hospital, sadly passed away despite CPR. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1389929 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2245 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Death, Discomfort, Inappropriate schedule of product administration
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADCAL D3; ALVERINE; FUROSEMIDE; LANSOPRAZOLE; PREDNISOLONE; SENNAE; SODIUM BICARBONATE; TRIMBOW
Current Illness: COPD (Severe); Frailty
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Barrett''s oesophagus; Chronic kidney disease; Mitral regurgitation; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649336

Write-up: Discomfort; first dose administered 23Dec2020 second dose 23May2021; Death; confused; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202105281720369680-PL4ER, Safety Report Unique Identifier GB-MHRA-ADR 25382261. A 91-years-old male patient received second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH) via unspecified route of administration on 24May2021 (lot number EW2245), expiration date not reported, dose 1 via an unspecified route of administration on 23Dec2020 (Lot Number: ej0724-l456) as single dose for covid-19 immunisation. Medical history included ongoing Chronic obstructive pulmonary disease, steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)), chronic kidney disease, mitral valve incompetence, aortic stenosis and barrett''s oesophagus, ongoing Frailty. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Unsure if patient is enrolled in clinical trial. Concomitant medication included calcium carbonate, colecalciferol (ADCAL-D3) from 14Jul2017; alverine from 24Mar2020; furosemide from an unspecified start date to 12Apr2021; lansoprazole from 04Oct2019; prednisolone from 21Sep2017; senna alexandrina (SENNAE) from 15Aug2016 to an unspecified stop date; sodium bicarbonate from 14Jul2017; beclometasone dipropionate, formoterol fumarate and glycopyrronium bromide (TRIMBOW) from 12Apr2021. The patient experienced death on 26May2021 with fatal outcome, confused on 25May2021, discomfort on an unspecified date, first dose administered 23Dec2020 second dose 24May2021 on an unspecified date. The patient died on 26May2021. It was not reported if an autopsy was performed. The patient outcome of events for confused (confusional state), discomfort (discomfort) and first dose administered 23Dec2020 second dose 24May2021 were reported as unknown. The clinical course was reported as follows: He was extremely frail, with severe chronic obstructive pulmonary disease (COPD), but his condition was stable. The day after his second COVID vaccination he became very confused. He said that his body felt like lead. There were no symptoms to suggest any infection. He seemed to be improving the next day. His son left him for an hour, and he was dead when his son returned. Clearly it is not certain that the vaccination caused his death, but I cannot rule it out as a contributory factor. Patient has not tested positive for COVID-19 since having the vaccine. Report did not relate to possible blood clots or low platelet counts and no details of any relevant investigations or tests conducted. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1389951 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

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: 2021-05-21
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: Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649204

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106021221176480-8GKNS. Safety Report Unique Identifier: GB-MHRA-ADR 25404742. A patient of unspecified age and gender received BNT162B2 (BNT162B2), second dose via an unspecified route of administration on an unspecified date (Lot Number: Not Known) as single dose at the age of an unspecified age for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. The patient experienced unexpected cardiac arrest (death) on an unspecified date 9 days after vaccination. The patient died on 21May2021. The outcome of the event was fatal. The patient had not a COVID-19 test. Not yet known if any connection. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1389999 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   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: EXTRASTATIN; THYROHORMONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-smoker; Stent placement (Stent placed in subclavian artery (right))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021664645

Write-up: Acute chest pain; Diarrhea; Vomiting; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number GR-GREOF-20213993. A 69-year-old female patient received bnt162b2 (COMIRNATY), intramuscularly on 04May2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included stent placement from an unknown date and unknown if ongoing (stent placed in subclavian artery (right)), former smoker from an unknown date and unknown if ongoing. Concomitant medications included simvastatin (EXTRASTATIN) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (THYROHORMONE) taken for an unspecified indication, start and stop date were not reported. On 05May2021, the patient experienced acute chest pain (death, medically significant), diarrhea (death, medically significant), and vomiting (death, medically significant). The clinical outcome of the events was fatal. The patient died on 06May2021 due to acute chest pain, diarrhea, and vomiting. It was unknown if an autopsy was performed. Reporter''s Comments: "sent to adverse reaction department as additional information: No reported allergies. Former smoker. Stent placed in subclavian artery (right). Sender Comment: Reaction(s) / Event(s) Assessed for Comirnaty to all events: Time Interval between Last Dose of Drug and Start of Reaction / Event (number): 1 day" No follow-up attempts are possible; information about batch/lot number cannot be obtained. ; Reported Cause(s) of Death: Diarrhea; Acute chest pain; Vomiting


VAERS ID: 1390000 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7083 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Heart rate, Pulse absent, SARS-CoV-2 test
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR [ATORVASTATIN]; EXFORGE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Essential hypertension; Family history of cardiovascular disorder (of father; at the age of 40-45); Heart failure (of father; at the age of 40-45); Pure hypercholesterolemia; Sudden death (of father; at the age of 40-45)
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: pulses; Result Unstructured Data: Test Result:without; Comments: at 10:30; Test Date: 20210528; Test Name: COVID-19 rapid POC test; Test Result: Negative
CDC Split Type: GRPFIZER INC2021662284

Write-up: Death; Pulse absent; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB (GR-GREOF-20214167). A 62-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: FA7083), intramuscularly, on 27May2021 as 0.3 mL, single for COVID-19 immunisation. Medical history included pure hypercholesterolemia and hypertension (idiopathic). Family history included sudden death from heart failure (of his father at the age of 40-45). Concomitant medications included atorvastatin (LIPITOR) for hyperlipidemia and amlodipine besilate, valsartan (EXFORGE) taken for hypertension. The patient experienced death and pulse absent on 28May2021, which were reported as medically significant and fatal. The clinical course was reported as follows: No adverse reactions showed up 15 minutes after the vaccination in the vaccination center. On 28May2021, the patient was admitted in the hospital without pulses (at 10:30) where his death was diagnosed. The patient underwent lab tests and procedures which included COVID-19 rapid point-of-care (POC) test: negative on 28May2021. The patient died on 28May2021. The cause of death was unknown and reported as pulse absent. An autopsy was performed, and results were not provided (pending). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death; Pulse absent


VAERS ID: 1390063 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-21
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal X-ray, Colon neoplasm, Endoscopic retrograde cholangiopancreatography, Explorative laparotomy, Ileus, Jaundice, Large intestine perforation, SARS-CoV-2 test, Sepsis, Ultrasound abdomen
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Ischaemic colitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological tumours of unspecified malignancy (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic bronchitis, unspecified; Diverticulosis; Hypertension; Ischaemic heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210503; Test Name: Abdominal X-ray; Result Unstructured Data: Test Result:Ileus of small intestine; Test Date: 20210503; Test Name: exploratory laparotomy; Result Unstructured Data: Test Result:sigmoid tumour and performated coecum; Test Date: 20210429; Test Name: COVID-19 rapid POC test; Test Result: Negative ; Test Date: 20210503; Test Name: abdominal ultrasound; Result Unstructured Data: Test Result:Ileus; Test Date: 20210502; Test Name: ERCP; Result Unstructured Data: Test Result:Result unknown
CDC Split Type: HUPFIZER INC2021639665

Write-up: icterus; Ileus; sigmoid tumour; performated coecum; septic state; This is a Spontaneous report received from the Local RA downloaded from the Agency Regulatory Authority-WEB HU-OGYI-322021. This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number HU-OGYI-322021. A 77-year-old female patient received the second dose of (COMIRNATY, batch number: EW9127) at 0.3 ml single dose for COVID-19 immunisation on 09Apr2021. Relevant history included hypertension, ischaemic heart failure, chronic bronchitis and diverticulosis. Relevant concomitant drug was unknown. From 21Apr2021 to 27Apr2021, the patient was hospitalized due to icterus, where endoscopic retrograde cholangiopancreatography was initiated. The patient''s COVID-19 rapid POC test was negative on 29Apr2021. The outcome of event icterus was unknown. On 02May2021, after ERCP, the patient developed abdominal bloating and vomiting. Abdominal x-ay and abdominal ultrasound were initiated on 03May2021. Ileus was diagnosed. Due to the ileus, an exploratory laparotomy was performed, sigmoid tumour and performated coecum were found. Colectomy was performed. Due to septic state, the patient''s circulation became unstable, the patient was transferred to the intensive care unit. On 03May2021, the patient died. Sender Comment: Sigma toumor leading to perforation and finally death after vaccination with Comirnaty is not expected. TTO is 24 days until death. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered not related. The case is considered serious due to fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Ileus; performated coecum; sigmoid tumour; septic state


VAERS ID: 1390065 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-05-05
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Emphysema; Myocardial infarction; Pulmonary edema
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: Myocardial Infarction; Death; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial Infarction) and DEATH (Death) in a 79-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001940 and 3001414) for COVID-19 vaccination. The patient''s past medical history included Atherosclerosis, Myocardial infarction, Emphysema and Pulmonary edema. On 06-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 04-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 05-May-2021, the patient experienced MYOCARDIAL INFARCTION (Myocardial Infarction) (seriousness criteria death and medically significant) and DEATH (Death) (seriousness criteria death and medically significant). The patient died on 05-May-2021. The reported cause of death was Myocardial infarction. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered MYOCARDIAL INFARCTION (Myocardial Infarction) and DEATH (Death) to be unlikely related. Treatment and Concomitant medicines were not provided, Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Very limited information regarding this event has been provided at this time. No further information in expected. Patient?s cardiovascular risk factors are co-suspect for the events.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information in expected. Patient?s cardiovascular risk factors are co-suspect for the events.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1390066 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-16
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Death, Disease recurrence, Epilepsy, Hemiplegia, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Generalised convulsive seizures following immunisation (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Epilepsy (On 03Feb2021 the patient was admitted in the hospital because of a seizure); Hypertension; Ischemic heart disease; NIDDM
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021628092

Write-up: Death; a major stroke /stroke complications; left sided hemiplegia; another epileptic seizure; another epileptic seizure; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is HU-OGYI-347921. A 67-year-old male patient received BNT162B2 (COMIRNATY), first dose intramuscularly, administered in arm left on 06Apr2021 (Batch/Lot Number: EW2239; Expiration Date: 30Apr2021) as 0.3 ml, single dose for covid-19 immunisation. Medical history included arteriosclerosis from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, epilepsy from an unknown date and unknown if ongoing (On 03Feb2021 the patient was admitted in the hospital because of a seizure), Non-insulin-dependent diabetes mellitus (NIDDM) from an unknown date and unknown if ongoing, ischemic heart disease from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 16Apr2021 the patient had another epileptic seizure caused by a major stroke and developed left sided hemiplegia. His condition continued to worsen and passed away on 30Apr2021 at 01:00 due to symptoms of stroke complications. The patient''s concurrent disease included epilepsy. Events resulted in hospitalization. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 26Apr2021. The patient died on 30Apr2021. An autopsy was not performed. The outcome of the events left sided hemiplegia, epileptic seizure was unknown. Sender''s Comments: The reporter physician assessed the event as related to the patient''s primary diseases, therefore the causal relationship is unlikely between the suspected drug and the event of death. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death; a major stroke /stroke complications


VAERS ID: 1390067 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-05-03
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bilirubin, Blood bilirubin increased, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Blood urea, Blood urea increased, C-reactive protein increased, COVID-19, Computerised tomogram thorax, Drug ineffective, Fibrin D dimer, Fibrin D dimer increased, Hyponatraemia, Investigation, Leukopenia, SARS-CoV-2 test, Thrombocytopenia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 5
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: FURON [FUROSEMIDE SODIUM]; ROCEPHIN IM.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decompensation cardiac; Hypertension; Myasthenia gravis; NIDDM; Urinary infection
Allergies:
Diagnostic Lab Data: Test Date: 20210503; Test Name: bilirubin; Result Unstructured Data: Test Result:elevated; Test Date: 20210503; Test Name: CK; Result Unstructured Data: Test Result:elevated; Test Date: 20210503; Test Name: urea; Result Unstructured Data: Test Result:elevated; Test Date: 20210503; Test Name: Chest CT; Result Unstructured Data: Test Result:signs of Covid pneumonia; Comments: Chest CT did not confirm pulmonary embolism despite the elevated D dimer level but showed signs of Covid pneumonia; Test Date: 20210503; Test Name: CRP; Result Unstructured Data: Test Result:elevated; Test Date: 20210503; Test Name: D dimer; Result Unstructured Data: Test Result:elevated; Test Date: 20210503; Test Name: hyponatremia; Result Unstructured Data: Test Result:hyponatremia; Test Date: 202105; Test Name: inflammatory parameters; Result Unstructured Data: Test Result:started to get better at first; Test Date: 20210503; Test Name: leucopenia; Result Unstructured Data: Test Result:leucopenia; Test Date: 20210503; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210503; Test Name: thrombocytopenia; Result Unstructured Data: Test Result:thrombocytopenia
CDC Split Type: HUPFIZER INC2021628094

Write-up: COVID-19/COVID-19 pneumonia/ COVID-19 antigen test positive; COVID-19/COVID-19 pneumonia/ COVID-19 antigen test positive; thrombocytopenia; leucopenia; hyponatremia; elevated urea, CRP, CK, bilirubin and D dimer values; elevated urea, CRP, CK, bilirubin and D dimer values; elevated urea, CRP, CK, bilirubin and D dimer values; elevated urea, CRP, CK, bilirubin and D dimer values; elevated urea, CRP, CK, bilirubin and D dimer values; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [HU-OGYI-349721] This spontaneous, serious, medically confirmed case was reported on 13May2021 by a physician and concerns the occurrence of Covid-19 infection and pneumonia resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. On 15Apr2021 the 77-year-old male patient received the first dose of 0.3 ml BNT162B2 (COMIRNATY, Solution for injection, lot number: EW4815, expiry date: unknown, MAH: BioNTech Manufacturing GmbH/Pfizer) intramuscularly in the left arm as 1st dose, 0.3 ml, single dose for COVID-19 immunisation. Medical history hypertension, myasthenia gravis and NIDDM, all from an unspecified and unknown if ongoing, decompensation cardiac, urinary infection. Concomitant medications included furosemide sodium (FURON) from 06May2021 to 08May2021 for decompensation cardiac, ceftriaxone sodium, lidocaine hydrochloride (ROCEPHIN IM.) from 03May2021 to 08May2021 for urinary infection. On 03May2021 the patient was examined in the Outpatient Department because of weakness, fever and decreased appetite ongoing for 3 weeks. Covid-19 antigen test was positive. Laboratory tests showed thrombocytopenia, leucopenia, hyponatremia, elevated urea, CRP, CK, bilirubin and D dimer values. Chest CT did not confirm pulmonary embolism despite the elevated D dimer level but showed signs of Covid pneumonia. The patient received covid therapy and his inflammatory parameters started to get better at first, but later the patient passed away on 08May2021 at 04:45. No autopsy was performed. While hospitalized, the patient received dexamethasone and Clexane (enoxaparin sodium) injection for Covid pneumonia from 03May2021 to 08May2021. The outcome of events COVID-19/COVID-19 pneumonia/ COVID-19 antigen test positive was fatal. Outcome of the other events was unknown. Further information is not expected. Senders Comment: As the patient got infected with Covid-19 after the first dose of Comirnaty, immunity may have not developed yet, therefore the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19/COVID-19 pneumonia/ COVID-19 antigen test positive; COVID-19/COVID-19 pneumonia/ COVID-19 antigen test positive


VAERS ID: 1390068 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-07
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   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: ROXERA; SPERSALLERG; DICETEL; ZYLLT; NEBIVOLOL; ARBARTAN; MEMORIL [PIRACETAM]; MOTIDIN [FAMOTIDINE]; NASOTASONE; OPTALGIN; CITROKALCIUM; LERTAZIN; CAVINTON FORTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain infarction; Cholecystectomy; Hypertension; Kidney failure chronic; NIDDM; Varicotomy
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: Chest X-ray; Test Result: Positive ; Comments: covid pneumonia; Test Date: 20210407; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021639667

Write-up: COVID-19 antigen test positive; COVID-19 pneumonia; COVID-19; This is a Spontaneous report received from the Regulatory Authority downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB HU-OGYI-358021 from a contactable physician. A 71-years-old female patient received the first dose of 0.3 ml BNT162B2 (COMIRNATY) concentrate for dispersion for injection (tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), batch number: ET7205, expiry date: unknown, MAH: BioNTech Manufacturing GmbH/Pfizer) intramuscularly On 30Mar2021 in the left arm for Covid-19 immunization. Medical history included hypertension, NIDDM (Type 2 diabetes mellitus), chronic kidney failure, cholecystectomy, varicectomy and brain infarction. Concomitant drugs were losartan (ARBARTAN, 100 mg), vinpocetin (CAVINTON FORTE), calcium citrate (CITROKALCIUM), pinaverium (DICETEL, 50 mg), levocetirizine (LERTAZIN, 5 mg), piracetam (MEMORIL), famotidine (MOTIDIN, 40 mg), mometason furoate (NASOTSONE), Nebivolol-Teva 5 mg, metamizole sodium monohydrate (OPTALGIN, 500 mg), rosuvastatin calcium (ROXERA, 15 mg), antazoline/tetryzoline (SPERSALLERG) and clopidogrel bisulfate (ZYLLT, 75 mg). The patient was hospitalized on 07Apr2021 where her antigen test was positive and chest X-ray confirmed Covid-19 pneumonia. As the patients condition worsened, she was transferred to the ICU on 13Apr2021 and had to be intubated. Despite the treatment, the patient did not get better and after an unsuccessful reanimation, she passed away on 29Apr2021 at 12:10. Autopsy was not performed. This is a serious, medically confirmed case. Sender Comment: As the patient got infected with Covid-19 after the first dose, immunity may have not developed yet, therefore the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19; COVID-19 pneumonia; COVID-19 antigen test positive


VAERS ID: 1390069 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of colon; Cerebral infarction; Chronic renal failure; Insulin dependent diabetic; STEMI
Allergies:
Diagnostic Lab Data: Test Name: Chest X-ray; Result Unstructured Data: Test Result:bilateral, multi-focal, extensive pneumonia; Test Date: 20210408; Test Name: COVID-19 rapid POC test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021639668

Write-up: COVID-19 rapid test positive; COVID-19 pneumonia; This is a spontaneous report received from the RA via a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-358621. This is a report received from the Regulatory Authority. An 82-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: EW2239), intramuscularly in arm left on 07Apr2021 at single dose (0.3 ML SINGLE), and the first dose (lot number: EJ6790) via an unspecified route of administration on 01Mar2021 at single dose for COVID-19 immunisation. Medical history included STEMI in 2018, cerebral infarction, adenocarcinoma of colon in 2015, insulin dependent diabetes mellitus and chronic renal failure. The patient''s concomitant medications were not reported. The patient experienced COVID-19 rapid test positive, and COVID-19 pneumonia on 08Apr2021. On 08Apr2021 the patient was admitted to the hospital due to dyspnoea and positive COVID-19 rapid test. Chest X-ray showed bilateral, multi-focal, extensive pneumonia on unknown date. The patient received oxygen supplementation, dexamethasone, favipiravir, ceftriaxone, and LMWH. Despite the applied therapy, the patient died on 11Apr2021 at 15:40. Autopsy was not requested. Sender Comment: COVID-19 pneumonia occurred after 1 day, and the patient died 4 days after the second dose of BNT162B2. Autopsy was not done. Immunity may has not developed after the first dose of vaccine. The case was serious due to hospitalization and fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19 rapid test positive


VAERS ID: 1390070 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-27
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure congestive, Chest X-ray, Confusional state, Drug ineffective, General physical health deterioration, Hydrothorax, Pulmonary arterial pressure increased, Pulmonary congestion, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Cardiac failure (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pulmonary hypertension (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic renal failure; Dementia; Ischemic heart disease; Polymyalgia rheumatica
Allergies:
Diagnostic Lab Data: Test Date: 20210327; Test Name: Chest X-ray; Result Unstructured Data: Test Result:unilateral hydrothorax; Comments: increased arterial tension in pulmonary circulation, suspected COVID-19; Test Date: 20210328; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021639666

Write-up: Congestive heart failure; Suspected COVID-19; Suspected COVID-19; confusion; deterioration of her condition; unilateral hydrothorax; increase in arterial tension of pulmonary circulation; congestive pulmonary circulation; This is a spontaneous report received from the local RA downloaded from the Regulatory Authority-WEB HU-OGYI-358821. This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number HU-OGYI-358821. An 82-year-old female patient received the first dose of bnt162b2 (COMIRNATY, concentrate for dispersion for injection, 30 micrograms of COVID-19 mRNA Vaccine), intramuscularly in left arm on 05Mar2021 (lot number: ET 1831) as 0.3 mL single dose for COVID-19 immunisation. The patient medical history included atrial fibrillation, ischemic heart disease, dementia, polymyalgia rheumatic and chronic renal failure. The patient concomitant medications were not reported. The patient experienced congestive heart failure on an unspecified date, suspected COVID-19 on 27Mar2021. On 27Mar2021, the patient was admitted to the hospital due to confusion and deterioration of her condition. Chest X-ray showed unilateral hydrothorax, increase in arterial tension of pulmonary circulation, and suspicion of COVID-19. On 28Mar2021, COVID-19 PCR test became negative, but the patient was referred to the infectious department and received antiviral (favipiravir), antibiotic (ceftriaxon) and oxygen therapy. Despite the applied therapy, the patient condition further deteriorated, and the patient died on 30Mar2021 at 21:10, among the symptoms of cadiorespiratory insufficiency. Autopsy was not requested. The outcome of the events congestive heart failure and suspected COVID-19 was fatal. The outcome of the other events was not provided. Sender Comment: Suspected COVID-19 occurred after 22 days, and the patient died 25 days after Comirnaty vaccination. Shadows seen on chest X-ray were possibly caused by congestive pulmonary circulation, but COVID-19 pneumonia could not be excluded. Autopsy was not done. The case is serious due to hospitalization and fatal outcome. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: cardiorespiratory insufficiency; Suspected COVID-19; Suspected COVID-19


VAERS ID: 1390071 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; REXETIN; TANYDON; RESONIUM; ATORIS; IMOVANE; MIRTAZAPINE; DOXICARD; DETRALEX; LETROX; ADIMET; LERCATON; ADENURIC; NEO FERRO FOLGAMMA; NEUROMULTIVIT-EP
Current Illness: Depression; Hyperlipidaemia; Hypertension; Hypertensive cardiomyopathy; Hyperuricaemia; Hypothyreosis; Knee prosthesis user; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder carcinoma; Cataract operation
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Blood test; Result Unstructured Data: Test Result:impaired renal function; Comments: increased inflammatory parameters, increased fibrin D-dimer; Test Date: 20210415; Test Name: Chest X-ray; Result Unstructured Data: Test Result:COVID-19 pneumonia with small circulatory stagnati; Comments: COVID-19 pneumonia with small circulatory stagnation; Test Date: 20210414; Test Name: COVID-19 rapid POC test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021639669

Write-up: COVID-19 pneumonia; COVID-19 rapid POC test positive/COVID-19 and COVID-19 pneumonia; COVID-19; This is a spontaneous report received from a contactable physician from the Local RA downloaded from the regulatory authority HU-OGYI-363321. This is a report received from the regulatory authority. Regulatory authority report number HU-OGYI-363321. A 77 years old female patient received the first dose of BNT162B2 (COMIRNATY concentrate for dispersion for injection, tozinameran; batch number: EW2239, expiry date: unknown) intramuscularly in the left arm on 01Apr2021 at 0.3 ml single dose for COVID-19 immunisation. In the patient''s medical history, there is ongoing hypertension, hypertensive cardiomyopathy, hyperlipidaemia, Type II diabetes mellitus (since 2000), hyperuricemia, hypothyreosis, depression, cataract operation (in 2013), knee prosthesis (since 2018) and bladder carcinoma from 2015 to 2017. The patient''s concomitant medicinal products were febuxostat (ADENURIC), metformin hydrochloride (ADIMET), atorvastatin calcium (ATORIS), diosmin, hesperidin (DETRALEX), doxazosin mesilate (DOXICARD), furosemide, zopiclone (IMOVANE), lercanidipine hydrochloride (LERCATON), levothyroxine sodium (LETROX), mirtazapine, Folic acid, ferrous sulphate, dried (NEO-FERRO-FOLGAMMA), B vitamins (Neuromultivit-EP), sodium polystyrene sulphonate (RESONIUM), paroxetine hydrochloride (REXETIN) and telmisartan (TANYDON). This serious, spontaneous case was reported by a physician on 19May2021, concerning the occurrence of COVID-19 and COVID-19 pneumonia after the use of Comirnaty concentrate for dispersion for injection (MAH: BioNTech Manufacturing GmbH). It was reported after the vaccination, the patient experienced fever and fatigue. On 14Apr2021, the patient was hospitalized. The patient''s rapid POC test was positive on 14Apr2021 (onset from last dose 13days). Chest x-ray showed COVID-19 pneumonia with small circulatory stagnation on 15Apr2021 (onset from last dose 14days). On 14Apr2021 the blood tests showed impaired renal function, increased inflammatory parameters and increased fibrin D-dimer levels. In the hospital, the patient general condition has steadily deteriorated. On 17Apr2021, the patient died. According to the death certificate, cause of death was COVID-19 pneumonia. The patient''s primary diseases that contributed to the death were TYPE 2 DIABETES MELLITUS (NIDDM) and hypertension. Sender Comment: COVID-19 and COVID-19 pneumonia after vaccination with Comirnaty is not expected. TTO is 13 days calculated from the first dose. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the events is considered unlikely. The case is considered serious due to hospitalization and fatal outcome. The patient''s outcome was fatal for COVID-19 and COVID-19 pneumonia. It is unknown if autopsy was done. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19, COVID-19 pneumonia and suspected LOE. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: COVID-19; COVID-19 pneumonia


VAERS ID: 1390105 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer (NOS) (not specified in report)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021639216

Write-up: Death; Myalgia; High fever; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number IS-IMA-2624. A 65-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing cancer (NOS) (not specified in report). Patient had other underlying conditions, not specified. The patient''s concomitant medications were not reported. The patient experienced myalgia on 17Apr2021, high fever on 17Apr2021, death on 23Apr2021. The patient died on 23Apr2021. It was not reported if an autopsy was performed. Sender Comment: No further information is available at the time of submitting the case. Local investigation is ongoing, follow-up information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Death; Myalgia; Fever


VAERS ID: 1390106 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 2021-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021639300

Write-up: DVT of leg; Pulmonary embolism; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IS-IMA-2731. A 68-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 04May2021 (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 death on 05May2021, DVT of leg on 05May2021, pulmonary embolism on 05May2021. The patient died on 05May2021. Autopsy revealed pulmonary embolism caused by DVT in leg, which caused patient''s death on 05May2021 according to autopsy reports. Sender Comment: ''This case is being investigated locally. Follow-up information will be submitted once available.'' No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism caused by DVT in leg; Pulmonary embolism caused by DVT in leg; Autopsy-determined Cause(s) of Death: Pulmonary embolism caused by DVT in leg; Pulmonary embolism caused by DVT in leg


VAERS ID: 1390134 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-12
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   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:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA in a 77-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 29-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 12-May-2021, the patient experienced PNEUMONIA (seriousness criteria death and medically significant). The patient died on 20-May-2021. The reported cause of death was Bilateral pneumonia. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. Very limited information regarding this event/s has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: The Follow up document was received on 4th June 2021 and had significant data. The patient''s death date and vaccination date was updated. On 07-Jun-2021: The follow up document was received on 7 June 2021 and had No New information.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time.; Reported Cause(s) of Death: Bilateral pneumonia


VAERS ID: 1390140 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-05-14
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperpyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: iperpiressia scarsamente responsiva a terapia antipiretica; This regulatory authority case was reported by a physician and describes the occurrence of HYPERPYREXIA (iperpiressia scarsamente responsiva a terapia antipiretica) in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001943) for COVID-19 vaccination. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter in total. On 14-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced HYPERPYREXIA (iperpiressia scarsamente responsiva a terapia antipiretica) (seriousness criteria death and medically significant). The patient died on 14-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment product information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; 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, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1390145 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Dyspnoea, Haematoma, Hypocapnia, Hypoxia, Loss of consciousness, Petechiae, Tachypnoea, Thrombocytopenic purpura
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Mitral valve replacement
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021627746

Write-up: thrombocytopenic purpura; tachypnea; hypocapnia; hypoxia; loss of consciousness; anemia; petechiae on the trunk; worsening dyspnea; hematomas of the upper limbs; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-735359. A 75-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in arm right (reported as right shoulder) on 17Apr2021 08:25 (Batch/Lot Number: EX0893) as 1st dose, single for covid-19 immunisation. Medical history included mitral valve replacement from 2013 to an unknown date, and diabetes mellitus. The patient''s concomitant medications were not reported. The patient previously took warfarin sodium (COUMADIN), carvedilol (DILADREND), sitagliptin phosphate (JANUVIA), gliclazide (DIAMICRON). On 20Apr2021 there is worsening dyspnea, hematomas of the upper limbs, petechiae on the trunk. On 29Apr2021: loss of consciousness, hypoxia, hypocapnia, tachypnea, anemia. On 30Apr2021 hospitalization in intensive care and diagnosis of thrombocytopenic purpura. Death 01May2021. Death - Actions taken (platelet transfusion, fresh plasma, plasma exchange). The reporting pharmacist assessed the event as serious due to death, and hospitalization. The patient died on 01May2021. It was not reported if an autopsy was performed. Reporter Comment: Previous therapy: warfarin sodium (COUMADIN), carvedilol (DILADREND), sitagliptin phosphate (JANUVIA), gliclazide (DIAMICRON). Predisposing conditions: mitral valve replacement in 2013: Diabetes mellitus.; Reporter''s Comments: Previous therapy: Coumadin, Diladrend, Januvia, Diamicron. Predisposing conditions: mitral valve replacement in 2013: Diabetes mellitus.; Reported Cause(s) of Death: tachypnea; hypocapnia; thrombocytopenic purpura; loss of consciousness; petechiae on the trunk; anemia; worsening dyspnea; hematomas of the upper limbs; hypoxia


VAERS ID: 1390146 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anuria, Arthralgia, Blood uric acid, Cardiac arrest, Cardiovascular disorder, Electrocardiogram, Heart rate, Hyperuricaemia, Myalgia, Physical examination, Pyrexia, Respiratory disorder, Toxic epidermal necrolysis, Urticaria, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tumour lysis syndrome (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: uricemia; Result Unstructured Data: Test Result:rise in uricemia; Test Date: 20210527; Test Name: ECG; Result Unstructured Data: Test Result:absence of ECGgraphic activity; Comments: 11.00 pm; Test Date: 20210527; Test Name: central pulse; Result Unstructured Data: Test Result:absence; Comments: 11.00 pm; Test Date: 20210527; Test Name: bilateral areflexic mydriasis; Result Unstructured Data: Test Result:bilateral areflexic mydriasis; Comments: 11.00 pm
CDC Split Type: ITPFIZER INC2021627888

Write-up: aggravation of cardiovascular and respiratory conditions; aggravation of cardiovascular and respiratory conditions; toxic epidermal necrolysis involving oral conjunctival mucosa and genital lyell syndrome/ evident bullous reaction plantar and palmar and dorsal; Irreversible Cardiocirculatory Arrest; Oligoanuria; urticarial reaction; vomiting; fever; muscle and joint pain, especially in the foot; muscle and joint pain, especially in the foot; rise in uricemia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-735467. A 74-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), dose 2 intramuscular, administered in arm right (also reported as right shoulder) on 06May2021 10:15 (Batch/Lot Number: Unknown) as 0.3 ml single dose for covid-19 immunisation; allopurinol, oral from 09May2021 to 13May2021, at 300mg once a day for hyperuricaemia. The patient medical history and concomitant medications were not reported. The patient experienced toxic epidermal necrolysis involving oral conjunctival mucosa and genital lyell syndrome on 13May2021, suspended allopurinol was hydrated and started cyclosporine 400 mg and immunoglobulin 70 mg. Serious criteria reported as fatal and hospitalization (May2021). On 27May2021 Stable clinical picture in the extreme criticality of multi-organ pathology. Analgosedated intubated and mechanically ventilated. Markedly unstable hemodynamics despite adequate amine dosages. Oligoanuria, ongoing continuous infusion of phenoldopam. Apiretic. Continuous monitoring and and ongoing therapy. 27May2021 at 10.30 pm Cardiocirculatory arrest in asystole Practice Advanced Life Support maneuvers. At 11.00 pm: absence of central pulse and ECG graphic activity, bilateral areflexic mydriasis: it is found that the death occurred due to Irreversible Cardiocirculatory Arrest. The last action taken in response to the events for allopurinol was post-therapy. The patient died on 27May2021 as a result of toxic epidermal necrolysis and genital lyell syndrome and irreversible cardiocirculatory arrest. It was not reported if an autopsy was performed. The outcome of the events toxic epidermal necrolysis and genital lyell syndrome and irreversible cardiocirculatory arrest was fatal, other events was unknown. Reporter''s comments: After vaccination, (in May2021) the patient presented an urticarial reaction, vomiting, fever, muscle and joint pain, especially in the foot, and after a rise in uricemia, she takes allopurinol since 09May2021. On 13May2021 she presented evident bullous reaction plantar and palmar and dorsal with aggravation of cardiovascular and respiratory conditions and she was first admitted to the Hospital of PRIVACY (May2021) and on 23May2021 she was admitted to our hospital. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: After vaccination, the patient presents an urticarial reaction, vomiting, fever, muscle and joint pain, especially in the foot, and after a rise in uricemia, she takes allopurinol since 09May2021. On 13May2021 she presents evident bullous reaction plantar and palmar and dorsal with aggravation of cardiovascular and respiratory conditions and she was first admitted to the Hospital of PRIVACY and on 23May2021 she was admitted to our hospital.; Reported Cause(s) of Death: Irreversible Cardiocirculatory Arrest; toxic epidermal necrolysis and genital lyell syndrome/ evident bullous reaction plantar and palmar and dorsal


VAERS ID: 1390147 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021627907

Write-up: Patient WAS FOUND DEAD THIS MORNING AT 8.30; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-735543. A 66-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 21May2021 10:35 (Lot Number: FA8016) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: X7389) on 30Apr2021 12:27 for covid-19 immunisation. The patient was found dead this morning at 8:30 (sudden death) on 24May2021. The patient died on 24May2021. It was not reported if an autopsy was performed. Sender Comment: FIRST DOSE TAKEN ON 30Apr2021 12:27 LOT EX7389 No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Patient WAS FOUND DEAD THIS MORNING AT 8.30


VAERS ID: 1390149 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-22
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: POTASSIUM CANRENOATE; FUROSEMIDE; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia (previous hospitalization for anemia from digestive bleeding); Asthenia (started in the days preceding the vaccine booster); Dilated cardiomyopathy (cardiac fibrillating dilatative disease in labile compensation); Hemorrhage of digestive tract; Hepatic neoplasia (suspected hepatic neoplasia)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021639168

Write-up: PATIENT DIED IN HIS SLEEP/Sudden death; PATIENT DIED IN HIS SLEEP/Died in sleep; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, Safety Report Unique Identifier IT-MINISAL02-736081. A 91 years old male patient received the second dose of BNT162B2 (COMIRNATY, Pfizer,*195fl 0.45ml) on 18May2021 11:15 in left shoulder at age of 91 years old at single dose for COVID-19 immunisation. Medical history included cardiac fibrillating dilatative disease in labile compensation (dilated cardiomyopathy), suspected hepatic neoplasia, previous hospitalization for anemia from digestive bleeding from 01Jan2019 (hemorrhage of digestive tract), asthenia which had already started in the days preceding the vaccine booster. Concomitant medications included furosemide 150 mg/day, potassium canrenoate (CANRENOATE) 50 mg/day, omeprazole 20 mg/day. Patient previous received the first dose of BNT162B2 (COMIRNATY) on unspecified date for Covid-19 immunisation and no side effects were reported after the first dose. On 22May2021, patient was found dead in bed asleep, no immediate reaction reported to vaccine booster performed on 18May2021, only asthenia which had already started in the days preceding the vaccine booster. Reporters comments: given his age and comorbidities, the death cannot be clearly correlated with the vaccine. no side effects were reported after the first dose and even immediately after the execution of the second one - reaction time: 05:00 - sent by covid19-cardiac fibrillating dilatative disease in labile compensation, suspected hepatic neoplasia, previous hospitalization for anemia from digestive bleeding (2019) therapy: furosemide 150 mg/day, potassium canrenoate (CANRENOATE) 50 mg/day, omeprazole 20 mg/day. The patient''s outcome was fatal for unknown cause of death. It is unknown if autopsy was done. Senders comments: 27/05/2021 contacted reporter updated card, asked for clinical report.; Reporter''s Comments: given his age and comorbidities, the death cannot be clearly correlated with the vaccine. no side effects were reported after the first dose and even immediately after the execution of the second one - reaction time: 05:00 - sent by covid19- cardiac fibrillating dilatative disease in labile compensation, suspected hepatic neoplasia, previous hospitalization for anemia from digestive bleeding (2019) therapy: furosemide 150 mg/day, canrenoate 50 mg/day, omeprazole 20 mg/day; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1390150 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7065 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: ROSUVASTATIN CALCIUM; BISOPROLOL FUMARATE; OMEPRAZOLE; TRIATEC HCT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive impairment; Hypertension; Polyarthritis; Polypoidal choroidal vasculopathy (with syncopal episodes); Vertiginous syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021639293

Write-up: found dead in her bed with no previous apparent manifestations of adverse reactions; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB IT-MINISAL02-736136. A 92-year-old female patient received BNT162B2 (COMIRNATY, Lot number EY7065) at single dose for COVID-19 immunisation on 14Mar2021. Relevant history included chronic vertiginous syndrome, polyvasculopathy with syncopal episodes, polyarthrosis, hypertension, cognitive impairment. Relevant concomitant drug included rosuvastatin calcium, bisoprolol fumarate, omeprazole, hydrochlorothiazide, ramipril (TRIATEC HCT). The patient previously received the first dose of Comirnaty for COVID-19 immunisation. The overheard signaler confirming that no adverse reactions were detected after vaccination, it was sudden death in the night. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden death unexplained


VAERS ID: 1390411 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GASMOTIN; MAGNESIUM OXIDE; PERSANTIN; PANVITAN [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;P
Current Illness: Gastrostomy; Hospitalization NOS
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Dysphagia
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021622953

Write-up: Cardiac failure acute; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution and from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21110339. The patient was a 92-year-old female (pregnancy: unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received mosapride citrate (GASMOTIN), magnesium oxide (MAGNESIUM OXIDE), dipyridamole (PERSANTIN) and ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, folic acid, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate, tocopheryl acetate (PANVITAN [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE]) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included dementia from an unknown date and unknown if ongoing, dysphagia from an unknown date and unknown if ongoing and gastrostomy from an unknown date and unknown if ongoing. On 28May2021 at 10:30 (the day of vaccination), the patient received?the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EY2173; Expiration Date: 31Aug2021) intramuscularly in the arm right for COVID-19 immunization. Body temperature before vaccination was 36.7 degrees centigrade. The patient had no specific family history. The patient was state of gastrostomy and had been hospitalized at the reporter''s hospital. On 28May2021 at 23:12 (12 hours and 42 minutes after the vaccination), the patient experienced cardiac failure acute. (event description was updated from death, and event onset time was updated from 23:15). On 28May2021 (the same day as after the vaccination), the outcome of the event was death. The course of the event was as follows: The patient had been hospitalized at the reporter''s hospital. Although it was confirmed that there was not abnormality at the same day night of the vaccination at 22:30, the patient was found as the status of cardio-respiratory arrest at 23:12. Resuscitation such as cardiac massage was performed, but the patient did not have reaction. The death was confirmed at 23:40. The reporting physician classified the event as serious (death) and assessed the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases were the advanced age, bedridden, and it was also considered the possibility such as airways obstruction due to cerebrovascular disorder or sputum. The reporting physician commented as follows: BNT162b2 and death was considered as unknown. The event resulted in death. The outcome of the event was death with treatment including cardiac massage. The patient''s cause of death was cardiac failure. An autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19.; Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1390412 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anal incontinence, Body temperature, Death, Physical deconditioning, Urinary incontinence, Vomiting
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TAKELDA; MICARDIS; BETANIS; SERMION [NICERGOLINE]; LOTRIGA; EDIROL
Current Illness: Cardiac failure chronic; Hypertension; Late effects of cerebral infarction; Osteoporosis; Overactive bladder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210522; Test Name: Body temperature; Result Unstructured Data: Test Result:not provided
CDC Split Type: JPPFIZER INC2021623433

Write-up: Found dead; Vomit (food residue); urinary and fecal incontinences; urinary and fecal incontinences; Physical deconditioning; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Authority. Regulatory authority report number is v210273. A 94-year-old female patient received the first dose of the bnt162b2 (COMIRNATY), via an unspecified route of administration on 22May2021 at 13:30 (Lot Number: EY2173; Expiration Date: 31Aug2021) at a single dose for covid-19 immunisation. Medical history included ongoing chronic cardiac failure, ongoing hypertension, ongoing hyperactive bladder, ongoing late effects of cerebral infarction, and ongoing osteoporosis. The family history was not reported. Concomitant medications included acetylsalicylic acid/lansoprazole (TAKELDA); telmisartan (MICARDIS); mirabegron (BETANIS); nicergoline (SERMION [NICERGOLINE]); omega-3-acid ethyl ester (LOTRIGA); eldecalcitol (EDIROL); TSUMURA NINJIN-YOEI-TO; TSUMURA MASHI-NIN-GAN. On 27May2021, the patient experienced physical deconditioning. On 28May2021, the patient experienced vomit (food residue) and urinary and fecal incontinences. On 28May2021 at 03:00, the patient experienced found dead, which was serious for death. The course of the event was as follows: On 22May2021 at 13:30 (the day of vaccination), the patient received the first dose of BNT162b2. On 28May2021 at 03:00 (5 days, 13 hours, and 30 minutes after the vaccination), the patient experienced found dead. The events were further described as: on 22May2021 (the day of vaccination), at 13:30, the patient received the first dose of BNT162b2 vaccination. No particular side reactions other than vaccination site pain were observed, and no abnormalities were observed both on the same day and the following day. On 27May2021 (5 days after vaccination), the patient did not have supper because of physical deconditioning, and she went to bed. On 28May2021, at 06:00 (5 days, 16 hours, and 30 minutes after vaccination), the patient was found dead. Vomit (food residue) and urinary and fecal incontinences were observed. Body temperature before vaccination was not provided on 22May2021. The clinical outcome of the events, physical deconditioning, vomit (food residue), and urinary and fecal incontinences, were unknown. The clinical outcome of the event, found dead, was fatal. The patient died on 28May2021 due to unknown cause of death. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were death due to cardiac failure and cardiac sudden death. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Found dead


VAERS ID: 1390414 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-05-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Heart disease, unspecified
Allergies:
Diagnostic Lab Data: Test Date: 20210523; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021624537

Write-up: Death; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21110303. An 89-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot# EY2173, Expiration date 31Aug2021), via an unspecified route of administration on 23May2021 14:25 at single dose at the age of 89 years old for covid-19 immunisation. Medical history included heart disease and dementia. On 24May2021 at 08:46 (1 day after the vaccination), the patient died. Details on an autopsy was unknown. It was uncertain if an autopsy was performed. The cause of death was unknown. The patient underwent lab test included body temperature: 36.1 degrees Centigrade on 23May2021 before vaccination. The outcome of the event was fatal. The course of the event was as follows: On 23May2021, the patient received the vaccination with her daughter at a medical facility (which was temporarily used as an assemblage vaccination site). The patient was living by herself and after she returned home, probably she was at her home alone. On 24May2021 in the morning, the patient was found lying on her face at the entrance of her house by an elderly facility staff when he or she visited the patient. On 24May2021 at 8:46, they made an emergency call. The whole body had entered rigor mortis. The police took over and they were to work on medical examination and death certificate. It was uncertain if an autopsy or an AI (autopsy imaging) was to be performed. The reporting physician classified the event as serious (fatal) and assessed the causality between the event and BNT162b2 as unassessable. Heart disease, extremely advanced age, dementia and living alone were reported other possible causes of the event. The reporting physician commented as follows: The reporter was a chairman of the city medical association as well as an administrator of the assemblage vaccination site. He was reported by the city, but the contents of the death certificate were unknown. According to the prevaccination screening questionnaire, the patient had underlying heart disease and dementia, and she was found on the following day of the vaccination, it was clear that she died after the vaccination, but it was uncertain if the vaccination was the cause. A disease name described in the death certificate should be confirmed, but the reporter did not have right to do that, therefore it was uncertain.; Reported Cause(s) of Death: death


VAERS ID: 1390415 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pyrexia, Severe invasive streptococcal infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021626358

Write-up: Severe invasive streptococcal infection; Pyrexia; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. The patient was a 90-year-old female. Body temperature before vaccination was not reported. Family history, medical history, and concomitant medication were not reported. On an unspecified date (the day of vaccination, at the age of 90-year-old), the patient received?BNT162b2 (COMIRNATY, Solution for injection, Dose number, Lot number, and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. On an unspecified date (after the vaccination), the patient experienced pyrexia. Then, 2 days after pyrexia, severe invasive streptococcal infection developed. The outcome of the event was fatal. The course of the event was as follows: After receiving COMIRNATY intramuscular injection, the patient developed pyrexia. Two days later, the patient developed severe invasive streptococcal infection and died. Details were unknown. Seriousness criteria, causality assessment, and other possible cause of the event such as any other diseases were not provided. The outcome of the event pyrexia was unknown. The outcome of the event severe invasive streptococcal infection was fatal. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information currently available and currently known drug safety profile, the reported event severe invasive streptococcal infection more likely represented intercurrent illness, but not related to BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Severe invasive streptococcal infection


VAERS ID: 1390416 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anti-cyclic citrullinated peptide antibody, Antibody test negative, Antinuclear antibody, Antiphospholipid antibodies, Azotaemia, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Blood pressure measurement, Body temperature, Cardiolipin antibody, Coma scale, Complement factor C3, Complement factor C4, Computerised tomogram head, Double stranded DNA antibody, Haemoglobin, Heart rate, Heparin-induced thrombocytopenia test, Hydrocephalus, Intracranial pressure increased, Investigation, Matrix metalloproteinase-3, Oxygen saturation, Platelet count, Platelet count decreased, Pupillary light reflex tests, Renal impairment, Respiratory rate, Rheumatoid factor, SARS-CoV-2 test, Scan with contrast, Subarachnoid haemorrhage, Total complement activity test, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: THYRADIN; MAGNESIUM OXIDE; SIMPONI; MIRCERA
Current Illness: Bronchiectasis; Chronic kidney disease; Constipation; Hashimoto''s disease; Interstitial pneumonia
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (no treatment or oral medication); Ovarian cancer; Rheumatoid arthritis (stage 4 class 3. As of 12May2021, activity was only pain of the right hand.)
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: Anti-Sm antibody; Test Result: Negative ; Comments: at the time of hospital admission; Test Date: 20210524; Test Name: Anti-CCP antibody; Result Unstructured Data: Test Result:positive (142.0 U/mL); Comments: at the time of hospital admission; Test Date: 20210524; Test Name: Antinuclear antibody; Test Result: Negative ; Comments: at the time of hospital admission; Test Date: 20210524; Test Name: Anti-RNP antibody; Test Result: Negative ; Comments: at the time of hospital admission; Test Date: 20210524; Test Name: Lupus anticoagulant; Test Result: Negative ; Comments: at the time of hospital admission; Test Date: 20210524; Test Name: IgA; Test Result: 693 mg/dl; Comments: at the time of hospital admission; Test Date: 20210524; Test Name: IgG; Test Result: 1547 mg/dl; Comments: at the time of hospital admission; Test Date: 20210524; Test Name: PA-IgG; Result Unstructured Data: Test Result:206.0 ng/10^7 cells; Comments: at the time of hospital admission; Test Date: 20210524; Test Name: IgM; Test Result: 70 mg/dl; Comments: at the time of hospital admission; Test Date: 20210524; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:120/86 mmHg; Comments: on arrival; Test Date: 20210520; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210524; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: on arrival; Test Date: 20210524; Test Name: Anticardiolipin beta-2 GP1 antibody; Test Result: Negative ; Comments: at the time of hospital admission; Test Date: 20210524; Test Name: Anticardiolipin IgG antibodies; Test Result: Negative ; Comments: at the time of hospital admission; Test Date: 20210524; Test Name: Consciousness level; Result Unstructured Data: Test Result:III-100; Comments: on arrival; Test Date: 20210525; Test Name: Consciousness level; Result Unstructured Data: Test Result:improved to 2 digits; Test Date: 20210525; Test Name: Consciousness level; Result Unstructured Data: Test Result:III-200; Test Date: 20210524; Test Name: C3; Test Result: 70 mg/dl; Comments: at the time of hospital admission; Test Date: 20210524; Test Name: C4; Test Result: 18 mg/dl; Comments: at the time of hospital admission; Test Date: 20210524; Test Name: Head CT; Result Unstructured Data: Test Result:revealed manifestation of subarachnoid haemorrhage; Test Date: 20210524; Test Name: Anti-dsDNA antibody; Test Result: Negative ; Comments: at the time of hospital admission; Test Date: 20200610; Test Name: Hb; Result Unstructured Data: Test Result:9.0 g/dl; Test Date: 20200902; Test Name: Hb; Result Unstructured Data: Test Result:9.4 g/dl; Test Date: 20201028; Test Name: Hb; Result Unstructured Data: Test Result:9.2 g/dl; Test Date: 20210120; Test Name: Hb; Result Unstructured Data: Test Result:10.3 g/dl; Test Date: 20210317; Test Name: Hb; Result Unstructured Data: Test Result:9.2 g/dl; Test Date: 20210524; Test Name: Pulse rate; Result Unstructured Data: Test Result:97/minute; Comments: on arrival; Test Date: 20210524; Test Name: HIT antibody; Test Result: Negative ; Comments: at the time of hospital admission; Test Date: 20210524; Test Name: Pupils; Result Unstructured Data: Test Result:4 mm/4 mm; Comments: on arrival; Test Date: 20210524; Test Name: MMP3; Result Unstructured Data: Test Result:111.5 ng/ml; Comments: at the time of hospital admission; Test Date: 20210524; Test Name: SpO2; Test Result: 96 %; Comments: on arrival; room air; Test Date: 20200610; Test Name: Platelet; Result Unstructured Data: Test Result:114000/uL; Test Date: 20200902; Test Name: Platelet; Result Unstructured Data: Test Result:134000/uL; Test Date: 20201028; Test Name: Platelet; Result Unstructured Data: Test Result:126000/uL; Test Date: 20210120; Test Name: Platelet; Result Unstructured Data: Test Result:133000/uL; Test Date: 20210317; Test Name: Platelet; Result Unstructured Data: Test Result:112000/uL; Test Date: 20210524; Test Name: Platelet; Result Unstructured Data: Test Result:8000/uL; Test Date: 20210525; Test Name: Platelet; Result Unstructured Data: Test Result:16000/uL; Test Date: 20210526; Test Name: Platelet; Result Unstructured Data: Test Result:3000/uL; Test Date: 20210527; Test Name: Platelet; Result Unstructured Data: Test Result:4000/uL; Test Date: 20210524; Test Name: Light reflex; Result Unstructured Data: Test Result:+/+; Comments: on arrival; Test Date: 20210524; Test Name: Respiratory rate; Result Unstructured Data: Test Result:16 breaths/minute; Comments: on arrival; Test Date: 20210524; Test Name: RF; Result Unstructured Data: Test Result:positive at high level (871 U/mL); Comments: at the time of hospital admission; Test Date: 20210524; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210524; Test Name: Contrast-enhanced CT; Result Unstructured Data: Test Result:no apparent aneurysm was noted; Test Date: 20210524; Test Name: CH50; Result Unstructured Data: Test Result:55.0 U/mL; Comments: at the time of hospital admission; Test Date: 20200610; Test Name: White blood cell; Result Unstructured Data: Test Result:5900/uL; Test Date: 20200902; Test Name: White blood cell; Result Unstructured Data: Test Result:5900/uL; Test Date: 20201028; Test Name: White blood cell; Result Unstructured Data: Test Result:4400/uL; Test Date: 20210120; Test Name: White blood cell; Result Unstructured Data: Test Result:7100/uL; Test Date: 20210317; Test Name: White blood cell; Result Unstructured Data: Test Result:3200/uL
CDC Split Type: JPPFIZER INC2021627544

Write-up: Subarachnoid haemorrhage; Platelets decreased; Hydrocephalus; Intracranial hypertension; Renal function aggravated; Uraemia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21110328. The patient was an 80-year and 12-month-old female. Body temperature before vaccination was 36.2 degrees centigrade. The patient had no family history. Medical history included rheumatoid arthritis diagnosed in Jul2010 (stage 4 class 3. As of 12May2021, activity was only pain of the right hand. Blood test conducted every 3 months showed CRP of 0.21 mg/dL on 17Mar2021 and remission was maintained. Historical drug included BUCILLAMINE 200 mg/day (from Jul2010 to Feb2011, discontinued by the patient), methotrexate (started in Jul2013. Discontinued in Jan2014 due to myelosuppression both for Rheumatoid arthritis. Used between 4 mg/week to 8 mg/week, adjusting by renal function), and iguratimod 50 mg/day for Rheumatoid arthritis (started in May2014 and discontinued in Mar2016 due to lack of effect), ongoing chronic kidney disease (CKD classification of G5A2 (on 17 March, Cr was 2.96 mg/dL, eGFR was 12.4 mL/min, and proteinuria +1), ongoing Hashimoto''s disease, ongoing constipation, ongoing mild interstitial pneumonia, ongoing mild bronchiectasis, left ovarian cancer in Jan2003 (postoperative chemotherapy was performed. Recurred in Jun2013, for which surgery was conducted. Not recurred without postoperative chemotherapy), and hypertension (no treatment or oral medication). The patient had no allergies or vaccinations within the last one month. There was no point to be considered in terms of growth status. Concomitant medication included thyroid (THYRADIN) 75 ug/day taken orally for Hashimoto''s disease from unknown date and magnesium oxide (MAGNESIUM OXIDE) 990 mg/day taken orally for constipation from unknown date, as well as golimumab (SIMPONI) injection 100 mg received for rheumatoid arthritis from May2014 (dose increased to 100 mg in May2015, dose decreased to 50 mg in Mar2016, and dose increased to 100 mg in Apr2019) and methoxy polyethylene glycol-epoetin beta (MIRCERA) injection 100 ug received for renal failure chronic from 16Aug2017, both of which were received subcutaneously once a month (once every 4 weeks) and last administration was on 12May2021. On 29Apr2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not reported) for COVID-19 immunisation. On 20May2021 at 15:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021), at same age, via an unspecified route of administration as a single dose for COVID-19 immunization. On 24May2021 at 14:00 (3 days 23 hours after the vaccination), the patient experienced subarachnoid haemorrhage and platelets decreased. On 24May2021 (4 days after the vaccination), the patient was admitted to the hospital. On 27May2021 (7 days after the vaccination), the outcome of the events was fatal. The course of the event was as follows: The patient received the first dose on 29Apr2021 and the second dose on 20May2021, which were vaccinated by a physician who made a home visit. Between the first and the second dose, the patient visited the reporting hospital; however, blood collection was not conducted because the condition was stable. Previous blood count conducted on 10Jun2020 showed white blood cell of 5900/uL, haemoglobin of 9.0 g/dL, and platelet of 114000/uL. On 02Sep2020, white blood cell was 5900/uL, haemoglobin was 9.4 g/dL, and platelet was 134000/uL. On 28Oct2020, white blood cell was 4400/uL, haemoglobin was 9.2 g/dL, and platelet was 126000/uL. On 20Jan2021, white blood cell was 7100/uL, haemoglobin was 10.3 g/dL, and platelet was 133000/uL. On 17Mar2021, white blood cell was 3200/uL, haemoglobin was 9.2 g/dL, and platelet was 112000/uL, which were relatively low but retained, and bleeding tendency was not observed. Reportedly, the patient had subjective symptoms of headache and queasy on around 20May2021, and the condition was watched. On 24May2021 in the morning, the patient stayed conscious and was able to talk. Until 13:00, the patient was able to wave hands. However, at 14:00, the patient was noticed to have depressed level of consciousness and dark colour vomiting. The reporting department was contacted and the patient was taken to the reporting hospital by ambulance. On arrival, consciousness level was III-100, pupils were 4 mm/4 mm, light reflex was +/+, body temperature was 37.1 degrees centigrade, blood pressure was 120/86 mmHg, pulse rate was 97/minute, 96% (room air), and respiratory rate was 16 breaths/minute. COVID-19 antigen test was negative. Head CT revealed manifestation of subarachnoid haemorrhage. Although there was a high risk of renal function aggravation, consent was obtained from family member and contrast-enhanced CT was performed; however, no apparent aneurysm was noted. A laboratory technician notified us that reexamination was ongoing due to abnormally low levels of platelet count, which was eventually turned out to be 8000/uL. The patient was admitted to GICU and received administration of 10 units of platelet transfusion. On 25May2021, consciousness level improved to 2 digits and the patient could be aroused easily by being spoken to and was able to say name. However, platelet count remained at low level of 16000/uL and treatment such as puncture for the purpose of decompression was difficult. Subsequently, blood transfusion was repeated but no response was obtained. Consciousness level aggravated again to III-200. Renal function aggravation and manifestation of uraemia were observed. On 26May2021, platelet was 3000/uL. On 27May2021, platelet was 4000/uL, which remained at low level. Symptoms of hydrocephalus and intracranial hypertension appeared. On 27May2021 at 13:46, the patient died. Family member did not wish to conduct autopsy. The reporting physician classified the events as serious (death) and assessed that the event was related to BNT162b2. Other possible causes of the event such as any other diseases were reported in reporter''s comment. The reporting physician commented as follows: Examinations at the time of hospital admission showed that anti-CCP antibody was positive (142.0 U/mL), RF was positive at high level (871 U/mL), and MMP3 was 111.5 ng/mL, which were manifestations that conformed to rheumatoid arthritis. Although positive conversion of antinuclear antibody and anti-dsDNA antibody due to anti-TNF drugs has been reported, all of these were negative. In addition, anti-RNP antibody was negative, anti-Sm antibody was negative, antiphospholipid antibodies (lupus anticoagulant, anticardiolipin IgG antibody, anticardiolipin beta-2 GP1 antibody) were all negative. C3 was 70 mg/dL, C4 was 18 mg/dL, CH50 was 55.0 U/mL, which were almost within normal ranges; thus, platelets decreased due to complication of SLE was unlikely. IgG was 1547 mg/dL, IgA was 693 mg/dL, and IgM was 70 mg/dL. The patient had no history of heparin use and HIT antibody was negative. PA-IgG was 206.0 ng/10^7 cells (reference value: 46 ng/10^7 cells or lower) and multiple IgGs (antiplatelet antibodies) bound to the surface of platelets were noted. Autoantibodies that showed abnormal values before hospital admission expect for ones associated with rheumatoid arthritis were checked; however, there was no measurement record. In this case, PA-IgG was 206.0 ng/10^7 cells and multiple IgGs (antiplatelet antibodies) bound to the surface of platelets were noted. Causes of a sudden onset of platelets decreased in a patient with rheumatoid arthritis, which was stable for long term, was considered as follows. Positive conversion of antiplatelet antibody in rheumatoid arthritis occasionally occurs; however, polyclonal increase in immunoglobulins were not observed. Also, activity of rheumatoid arthritis was not high. Therefore, positive conversion of antiplatelet antibody in vivo due to rheumatoid arthritis itself was considered unlikely. Next, cases of platelets decreased, although frequencies were unknown, were reported with injections of SIMPONI and MIRCERA, which the patient were receiving. The possibility of these medications having induced platelets decreased could not be denied; however, whether or not the mechanism involved platelet antibodies was unknown. Considering these medications were used safely for a long term, the possibility of them causing platelets decreased was low. Continued accumulation of cases is required and immediate assessment is not possible. However, the events occurred at the timing immediately after the second vaccination and it was surmised that causality between the events and the vaccine could not be denied. At the time of this report, it was most likely that the vaccine administered immediately before the onset (4 days and 25 days before) was the responsible agent that induced lethal platelets decreased and resulted in subarachnoid haemorrhage.; Reported Cause(s) of Death: Renal function aggravated; Uraemia; Hydrocephalus; Intracranial hypertension; Subarachnoid haemorrhage; Platelets decreased


VAERS ID: 1390418 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (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), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bruising of chest (occurred a few days before vaccination of COMIRNATY); Decreased activity; Diabetes mellitus; Fall (occurred a few days before vaccination of COMIRNATY); Hypertension; Oedema lower limb; Oedema upper limb; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021631721

Write-up: Acute renal failure; This is an initial spontaneous report from a contactable physician. The patient was a 91-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included diabetes mellitus, hypertension, bruise of the left chest due to fall (occurred a few days before vaccination of COMIRNATY), decreased daily activities due to pain by the bruise, and oedema of the lower limb(s) and upper limb of the lowered one. The clinical course before vaccination was as follows: A few days before vaccination, the patient fell and hit the left chest. Daily activities decreased due to pain. Oedema was noticeable on the lower limb(s) and upper limb hit by the ground. The patient responded to the reporter as usual without complaining of pain. The reporter judged that vaccination was possible. On 28May2021 at 12:00 a.m. (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 left arm for COVID-19 immunization. On 01Jun2021 at 01:30 a.m. (3 days, 13 hours and 30 minutes after the vaccination), the patient experienced acute renal failure. The event resulted in entry to emergency room/department or urgent care. The outcome of the event was fatal with treatment including drip infusion. On 01Jun2021, the patient died of acute renal failure. Autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of acute renal failure due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this elderly patient with medical history of diabetes mellitus and hypertension, along with recent history of fall There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Acute kidney injury


VAERS ID: 1390419 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood test, Body temperature, Cardiac failure, Pyrexia, Urine output decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), 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), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clavicle fracture; Confusion; Dementia with Lewy bodies (for about 25 years); Eating disorder; Fall; Hallucination, visual; Nutritional condition abnormal; Parkinson''s disease (for about 25 years); Scapula fracture; Sleep disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210513; Test Name: Blood collection; Result Unstructured Data: Test Result:revealed renal failure acute on chronic; Test Date: 20210513; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210514; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8 Centigrade
CDC Split Type: JPPFIZER INC2021631809

Write-up: pyrexia of 37.8 degrees centigrade; Renal failure acute on chronic; manifestation of cardiac failure; urine output decreased; This is a spontaneous report from a contactable other health professional received from the Regulatory Authority (RA). Regulatory authority report number is v21110452. The patient was an 89-year-old female. Body temperature before vaccination was 36.2 degrees centigrade on 13May2021. Family history was not reported. Medical history included Parkinson''s disease (for about 25 years), dementia with Lewy bodies (for about 25 years), Hallucination, visual, confusion and fracture of right coracoid process and distal end of clavicle due to fall from bed from 30Jan2021. There were no concomitant drugs. On 13May2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization at the age of 89-year-old. On 13May2021 (on the same day of the vaccination), the patient experienced renal failure acute on chronic. On 17May2021 (4 days after the vaccination), the outcome of the event was fatal. The course of the event and patient''s history was as follows: The patient had Parkinson''s disease and dementia with Lewy bodies for about 25 years. Hallucination, visual and confusion were being controlled by medication. On 30Jan2021, the patient fell from bed and experienced fracture of right coracoid process and distal end of clavicle. These few years, the patient had sleep disorder due to Parkinson''s disease with fluctuation in arousal, and eating meals were sometimes difficult. In Nov2020 and Feb2021, we told family member that the patient was at risk due to aggravation of nutritional condition; however, the patient managed to recover. On 13May2021, the patient recovered and was state of lull, and the patient could eat meals at full volume. On 13May2021, the patient was vaccinated. On 14May2021, the patient developed pyrexia of 37.8 degrees centigrade. Blood collection revealed renal failure acute on chronic on 13May2021. The patient also had urine output decreased and showed manifestation of cardiac failure in May2021. Policy was confirmed that the patient will be cared at home until death when the condition aggravated. On 17May2021, the patient died due to renal failure acute on chronic. It was not reported if an autopsy was performed. Outcome of renal failure acute on chronic was fatal and of other events was unknown. The reporting other heath professional classified the event- renal failure acute on chronic as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was present (detail was not provided). The reporting other health professional commented as follows: The patient was already in aggravated condition. Since the beginning of this year (2021), we have told family member several times that the patient could have sudden death at any time. It was unassessable whether the death was due to the vaccine or due to the above-mentioned condition. There was a reasonable possibility that this could have happened even when the patient did not receive the vaccine.; Reported Cause(s) of Death: Renal failure acute on chronic


VAERS ID: 1390420 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Hyperlipidaemia; Hypertension; Hyperuricaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021632320

Write-up: acute cardiac insufficiency due to advanced cardiac hypertrophy; acute cardiac insufficiency due to advanced cardiac hypertrophy; This is a spontaneous report from a contactable physician (anatomist) received from the Regulatory Authority (RA). Regulatory authority report number is v21110610. An 87-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported) at the age of 87-year-old, dose 1 via an unspecified route of administration on 28May2021 13:00 as single dose for covid-19 immunisation. Medical history obtained at the time of autopsy included hypertension, hyperlipidaemia, hyperuricaemia, and angina pectoris. Family history was unknown. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.0 degrees centigrade. On 28May2021 at around 13:00 (the day of vaccination), the patient received the first dose of bnt162b2. On 28May2021 from around 15:00 to 16:00 (around 2 to 3 hours after the vaccination), the patient experienced sudden death. The outcome of the event was fatal. The course of sudden death was as follows: The patient was found to be dead in a bathroom (washing place) at home. On 28May2021 at around 13:00, the patient received the vaccine. According to electricity usage investigated by the police, it was estimated that the patient died on the same day from around 15:00 to 16:00 while taking a bath. 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 estimated as acute cardiac insufficiency due to advanced cardiac hypertrophy; however, causal relationship between the event and the vaccine was unknown. The reporting physician commented as follows: Since it was unusual death, autopsy was conducted at the reporting hospital on 31May2021. Advanced cardiac hypertrophy was noted and cause of death was estimated as acute cardiac insufficiency due to advanced cardiac hypertrophy. Manifestation suggestive of anaphylaxis such as oedema glottis was absent; thus, it could be denied that the vaccine was the direct cause of the death. However, it could not be stated positively that the vaccination and the cause of death were completely unrelated, considering indirect influences such as influence on cardiovascular system including change in blood pressure associated with the vaccine, physical stress including fatigue, and psychological stress including anxiety. Information on batch/lot number has been requested.; Reported Cause(s) of Death: acute cardiac insufficiency due to advanced cardiac hypertrophy; Autopsy-determined Cause(s) of Death: advanced cardiac hypertrophy


VAERS ID: 1390421 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood glucose, Blood pressure decreased, Blood pressure measurement, Body temperature, Bundle branch block right, Cerebral infarction, Circulatory collapse, Cold sweat, Coma scale, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax, Electrocardiogram, Myocardial infarction, Oxygen saturation, Respiratory arrest, Seizure
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Conduction defects (narrow), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; TELMISARTAN; ALFACALCIDOL; ASPARA-CA; PREDNISOLONE; SYMMETREL; TRADIANCE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Dementia; Diabetes mellitus; Hypertension; Osteoporosis; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: Blood sugar; Test Result: 168 mg/dl; Comments: 14:50; Test Date: 20210511; Test Name: Blood pressure; Result Unstructured Data: Test Result:85/42 mmHg; Comments: normally 110/60; Test Date: 20210511; Test Name: Blood pressure; Result Unstructured Data: Test Result:120/80 mmHg; Comments: 14:50; Test Date: 20210511; Test Name: Blood pressure; Result Unstructured Data: Test Result:90/54 mmHg; Comments: 15:10; Test Date: 20210511; Test Name: Blood pressure; Result Unstructured Data: Test Result:74 to 54 mmHg; Comments: After hospitalization low; Test Date: 20210510; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210511; Test Name: Body temperature; Result Unstructured Data: Test Result:35.5 Centigrade; Comments: After hospitalization body temperature was in the range of 35 degrees Centigrade; Test Date: 20210511; Test Name: CS; Result Unstructured Data: Test Result:II-20; Comments: 14:50; Test Date: 20210511; Test Name: CS; Result Unstructured Data: Test Result:I-2; Comments: 15:10; Test Date: 20210511; Test Name: CS; Result Unstructured Data: Test Result:fluctuated between II-30 and I-2; Comments: After hospitalization; Test Date: 20210511; Test Name: Abdomen CT; Result Unstructured Data: Test Result:no significant change; Test Date: 20210511; Test Name: Head CT; Result Unstructured Data: Test Result:no significant change; Test Date: 20210511; Test Name: Chest CT; Result Unstructured Data: Test Result:no significant change; Test Date: 20210511; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:CRBBB; Comments: CRBBB (complete right bundle branch block) and low voltage; Test Date: 20210511; Test Name: SpO2; Test Result: 94 %; Comments: SpO2 maintained at 95% with 1-2L/min of oxygen
CDC Split Type: JPPFIZER INC2021632363

Write-up: circulatory failure; respiratory arrest; Consciousness disturbed; Convulsion; blood pressure decreased; myocardial infarction; cerebral infarction; CRBBB (complete right bundle branch block) and low voltage; cold sweat; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21110560. A 90-year and 1-month-old female patient received BNT162B2 (COMIRNATY), 1st dose intramuscularly on 10May2021 14:20 (Lot Number: EX3617; Expiration Date: 31Aug2021) at age of 90 years old (as reported) as a single dose for covid-19 immunisation. Body temperature before vaccination was 36.3 degrees Centigrade. Medical history included hypertension, diabetes mellitus, cerebral infarction, dementia, osteoporosis and rheumatoid arthritis (all of histories was reported as underlying disease). Concomitant medications included clopidogrel tablet, telmisartan tablet, alfacalcidol capsule, aspartate calcium (ASPARA-CA) tablet, prednisolone tablet, amantadine hydrochloride (SYMMETREL) tablets, and empagliflozin linagliptin (TRADIANCE) tablet, and the patient had no adverse reactions regarding all concomitant medications. Family history was not provided. On 10May2021 at 14:20 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EX3617, Expiration date 31Aug2021) intramuscularly as a single dose for COVID-19 immunization. The patient experienced consciousness disturbed, convulsion and blood pressure decreased, all on 11May2021 at 14:40 (1 day after the vaccination), circulatory failure and respiratory arrest, both on 12May2021, all with fatal outcome, myocardial infarction and cerebral infarction, both on 11May2021, cold sweat in May2021. On 12May2021 at 02:38 (2 days after the vaccination), the patient died. The outcome of the events myocardial infarction and cerebral infarction, cold sweat, was unknown. It was not reported if an autopsy was perform. Clinical course: On 10May2021 at 14:20, the patient received the vaccination at a congregate living facility. No abnormalities were noted in particular until 11May2021 at 14:35. On 11May2021 at around 14:38, the patient suddenly bent backward and her eyes went out of focus. Disordered breathing was noted. She did not respond when spoken to. They made a emergency call. At that time, blood pressure was 85/42 mmHg (normally 110/60), SpO2 (oxygen saturation percutaneous) was 94%. At 14:50, an emergency service team arrived. Blood pressure was 120/80 mmHg, blood sugar was 168 mg/dL. CS (coma scale) was II-20. At 15:10, an ambulance arrived at a hospital. Blood pressure was 90/54. She responded. CS was I-2. Head CT, chest CT and abdomen CT showed no significant change. Electrocardiogram findings indicated CRBBB (complete right bundle branch block) and low voltage. Symptomatic epilepsy was suspected, therefore, the patient was hospitalized for observation of her progress. The reporter explained to the patient''s family that hospitalization for monitoring her progress would be necessary since she had diabetes mellitus and hypertension and considering the possibility of being signs of myocardial infarction or cerebral infarction. After hospitalization, body temperature was 35.5 degrees Centigrade, no rash was noted but cold sweat was present. CS fluctuated between II-30 and I-2, blood pressure was 74 to 54 mmHg indicating low. On 12May2021, suddenly her blood pressure could not be measured and respiratory arrest developed. On 12May2021 at 02:38, the patient''s death was confirmed. The reporting physician classified the events as serious (fatal outcome) and assessed that the events were not related to BNT162b2. Circulatory failure due to diabetes mellitus or hypertension was considered as a possible cause of the events. The reporting physician commented as follows: On 11May2021, decreased blood pressure and disturbed consciousness due to sudden seizure appeared. Her body temperature was in the range of 35 degrees Centigrade and SpO2 maintained at 95% with 1-2L/min of oxygen. The events were considered to be caused by circulatory failure due to the diabetes mellitus and hypertension that she had suffered for long term period rather than adverse reactions due to BNT162b2.; Sender''s Comments: Based on the available information and known product profile, agree that the causal relationship between the reported events that led to a fatal outcome ( e.g. consciousness disturbed, convulsion, blood pressure decreased, circulatory failure and respiratory arrest) were unrelated to the use the vaccine as reported by the attending physician. Agree with the reporter causality as the patient had several underlying conditions which includes hypertension, diabetes mellitus, cerebral infarction, and advanced age which may be risk factors to the occurrence of the above reported events which have fatal outcomes . The HCP further emphasized circulatory failure due to diabetes mellitus or hypertension was considered as a possible cause of the fatal events.; Reported Cause(s) of Death: Consciousness disturbed; convulsion; blood pressure decreased; circulatory failure; respiratory arrest


VAERS ID: 1390422 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021632387

Write-up: Death; This is a spontaneous report from a contactable other-health professional (chief clerk) received from the Regulatory Authority (RA). Regulatory authority report number is v21110428. The patient was a 98-year-old female. Body temperature before vaccination was 35.8 degrees Centigrade on 24May2021. 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). No information on family history was provided. On 24May2021 at 09:40 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 27May2021 at 10:00 (3 days after the vaccination), the patient died. An autopsy was performed, but details on the patient''s death was not provided. The course of the event was as follows: On 27May2021, the reporting other-health professional was informed by the patient''s family that the patient died. The physician (of a different hospital from the reporter) explained to the patient''s family that based on the results of an autopsy, the death was considered not to be related to BNT162b2. The reporting other-health professional classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as un-assessable. There was no other possible cause of the event such as any other diseases. The reporting other-health professional commented as follows: The reporter gave the patient the vaccination on 24May2021 and was informed of her death by her family on 27May2021. The family was given an explanation by the physician of another hospital that based on the results of an autopsy, the death was considered not to be related to BNT162b2.; Reporter''s Comments: The reporter gave the patient the vaccination on 24May2021 and was informed of her death by her family on 27May2021. The family was given an explanation by the physician of another hospital that based on the results of an autopsy, the death was considered not to be related to BNT162b2.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1390423 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Cyanosis, Pain in extremity, Pyrexia, Respiratory arrest, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Hepatic cancer; Interstitial pneumonia; Microscopic polyangiitis
Allergies:
Diagnostic Lab Data: Test Date: 20210526; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210527; Test Name: Body temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Comments: At 12:29
CDC Split Type: JPPFIZER INC2021632394

Write-up: Respiratory arrest; pyrexia of 38.6 degrees Centigrade; Cyanosis; shivering; pain of the left upper arm; pain of the left upper arm; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21110609. The patient was an 88-year and 7-month-old male. Body temperature before vaccination (on 26May2021) was 36.4 degrees Centigrade. Medical history included hepatic cancer, interstitial pneumonia, microscopic polyangiitis and cardiac failure. No information on concomitant medications or family history was provided. On 26May2021 at 15:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY2173, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 27May2021 at 14:50 (1 day after the vaccination), the patient died of respiratory arrest. It was not reported if an autopsy was performed. The course of the event was as follows: On 26May2021 at 15:30, BNT162b2 was injected into the left upper arm. There were no problems in particular on that day. On 27May2021 at 10:36, shivering and pain of the left upper arm were noted. At 12:29, pyrexia of 38.6 degrees Centigrade was noted. Cyanosis was present, but there was no decreased consciousness level. At 14:05, he developed respiratory arrest. The outcome of event ''respiratory arrest'' was fatal, of rest events was unknown. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the events and BNT162b2 as unassessable. Interstitial pneumonia and cardiac failure were reported as other possible causes of the events. The reporting physician commented as follows: Although the patient had underlying diseases of hepatic cancer, interstitial pneumonia and cardiac failure, at the time of the vaccination, his condition was stable. The causal relationship with BNT162b2 could not be ruled out.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1390424 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Aspartate aminotransferase, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood chloride, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood creatinine, Blood fibrinogen, Blood lactate dehydrogenase, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Brain natriuretic peptide, C-reactive protein, Cardiopulmonary failure, Computerised tomogram thorax, Condition aggravated, Dyspnoea, Echocardiogram, Fibrin D dimer, Fibrin degradation products, Gamma-glutamyltransferase, Haemoglobin, Hepatic enzyme, Hepatic function abnormal, Hypoxia, International normalised ratio, Investigation, Lymphocyte count, Monocyte count, Multiple organ dysfunction syndrome, Myocardial ischaemia, Nausea, Neutrophil count, Platelet count, Pneumoconiosis, Pneumonia, Prothrombin level, Renal failure, Right ventricular failure, SARS-CoV-2 test, Sepsis, Ultrasound scan, Vomiting, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Diabetes mellitus; Pneumoconiosis (on home oxygen therapy)
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: APTT; Result Unstructured Data: Test Result:37.8; Test Date: 20210523; Test Name: ALT; Result Unstructured Data: Test Result:604; Test Date: 20210525; Test Name: ALT; Result Unstructured Data: Test Result:623; Test Date: 20210527; Test Name: ALT; Result Unstructured Data: Test Result:3730; Test Date: 20210523; Test Name: AST; Result Unstructured Data: Test Result:873; Test Date: 20210525; Test Name: AST; Result Unstructured Data: Test Result:436; Test Date: 20210527; Test Name: AST; Result Unstructured Data: Test Result:6260; Test Date: 20210525; Test Name: ALB; Result Unstructured Data: Test Result:2.9; Test Date: 20210527; Test Name: ALB; Result Unstructured Data: Test Result:3.1; Test Date: 20210523; Test Name: ALP; Result Unstructured Data: Test Result:220; Test Date: 20210525; Test Name: ALP; Result Unstructured Data: Test Result:179; Test Date: 20210527; Test Name: ALP; Result Unstructured Data: Test Result:238; Test Date: 20210523; Test Name: TB; Result Unstructured Data: Test Result:1.0; Test Date: 20210525; Test Name: TB; Result Unstructured Data: Test Result:0.8; Test Date: 20210525; Test Name: CI; Result Unstructured Data: Test Result:96; Test Date: 20210523; Test Name: CK; Result Unstructured Data: Test Result:210; Test Date: 20210523; Test Name: CK-MB; Result Unstructured Data: Test Result:19.0; Test Date: 20210523; Test Name: Cr; Result Unstructured Data: Test Result:1.66; Test Date: 20210525; Test Name: Cr; Result Unstructured Data: Test Result:1.18; Test Date: 20210527; Test Name: Cr; Result Unstructured Data: Test Result:2.07; Test Date: 20210525; Test Name: Fibrinogen; Result Unstructured Data: Test Result:360; Test Date: 20210523; Test Name: LDH; Result Unstructured Data: Test Result:1205; Test Date: 20210525; Test Name: K; Result Unstructured Data: Test Result:5.0; Test Date: 20210527; Test Name: K; Result Unstructured Data: Test Result:5.6; Test Date: 20210527; Test Name: blood pressure; Result Unstructured Data: Test Result:a steep drop; Test Date: 20210525; Test Name: Na; Result Unstructured Data: Test Result:135; Test Date: 20210527; Test Name: Na; Result Unstructured Data: Test Result:135; Test Date: 20210523; Test Name: BUN; Result Unstructured Data: Test Result:42.0; Test Date: 20210525; Test Name: BUN; Result Unstructured Data: Test Result:54.2; Test Date: 20210527; Test Name: BUN; Result Unstructured Data: Test Result:88.0; Test Date: 20210523; Test Name: BNP; Result Unstructured Data: Test Result:643; Test Date: 20210525; Test Name: BNP; Result Unstructured Data: Test Result:738.2; Test Date: 20210523; Test Name: Chest computerised tomography (CT); Result Unstructured Data: Test Result:revealed a large volume of bilateral pleural effus; Comments: revealed a large volume of bilateral pleural effusion, atelectasis in the left side, and GGO predominantly in the left lung; Test Date: 20210523; Test Name: CRP; Result Unstructured Data: Test Result:11.02; Test Date: 20210525; Test Name: CRP; Result Unstructured Data: Test Result:9.98; Test Date: 20210527; Test Name: CRP; Result Unstructured Data: Test Result:5.67; Test Date: 20210523; Test Name: Echocardiography; Result Unstructured Data: Test Result:showed EF 20-30%, left ventric; Comments: showed EF 20-30%, LV diffuse severe hypokinesis, akinesis from the anterior wall to the lateral wall, left atrial enlargement, left ventricular enlargement, and marked MR and TR due to valve enlargement; Test Date: 20210527; Test Name: Echocardiography; Result Unstructured Data: Test Result:revealed no findings such as distinct abnormality; Comments: revealed no findings such as distinct abnormality of the wall motion; Test Date: 20210525; Test Name: DD; Result Unstructured Data: Test Result:4.3; Test Date: 20210525; Test Name: FDP; Result Unstructured Data: Test Result:7.8; Test Date: 20210523; Test Name: y-GT; Result Unstructured Data: Test Result:74; Test Date: 20210525; Test Name: y-GTP; Result Unstructured Data: Test Result:59; Test Date: 20210523; Test Name: Hb; Result Unstructured Data: Test Result:12.0; Test Date: 20210525; Test Name: Hb; Result Unstructured Data: Test Result:13.2; Test Date: 20210527; Test Name: Hb; Result Unstructured Data: Test Result:11.8; Test Date: 20210527; Test Name: Hepatic deviation enzyme; Result Unstructured Data: Test Result:a sharp increase in hepatic deviation enzyme was n; Test Date: 20210525; Test Name: INR; Result Unstructured Data: Test Result:1.39; Test Date: 20210527; Test Name: Investigation NOS; Result Unstructured Data: Test Result:Marked inferior vena cava dilatation and hepatic v; Comments: Marked inferior vena cava dilatation and hepatic vein dilatation were noted, and right cardiac failure was suspected; Test Date: 20210523; Test Name: Lymph; Result Unstructured Data: Test Result:7.1; Test Date: 20210523; Test Name: Mono; Result Unstructured Data: Test Result:3.8; Test Date: 20210523; Test Name: Neut; Result Unstructured Data: Test Result:88.9; Test Date: 20210523; Test Name: PLT; Result Unstructured Data: Test Result:21.3; Test Date: 20210525; Test Name: PLT; Result Unstructured Data: Test Result:25.9; Test Date: 20210527; Test Name: PLT; Result Unstructured Data: Test Result:12.4; Test Date: 20210525; Test Name: PT; Test Result: 15.5 %; Test Date: 20210523; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:(-); Test Date: 20210527; Test Name: Ultrasonography of the liver and gall blabber; Result Unstructured Data: Test Result:showed no evident abnormal findings in the hepatic; Comments: showed no evident abnormal findings in the hepatic parenchyma or findings of cholecystitis; Test Date: 20210523; Test Name: WBC; Result Unstructured Data: Test Result:10680; Test Date: 20210525; Test Name: WBC; Result Unstructured Data: Test Result:11980; Test Date: 20210527; Test Name: WBC; Result Unstructured Data: Test Result:18150
CDC Split Type: JPPFIZER INC2021632410

Write-up: Cardiopulmonary insufficiency; Pneumonia; sepsis associated with cardiac failure; multi-organ failure; Right heart failure/right cardiac failure; aggravation of the underlying disease pneumoconiosis; aggravation of the underlying disease pneumoconiosis; myocardial ischaemia; hypoxaemia; hepatic function disorder; renal failure; dyspnoea feeling; queasy; vomiting; This is a spontaneous report from a contactable physician received from the a regulatory authority. Regulatory authority report number is v21110475. An 80-year-old (also reported as 80-year and 2-month-old) male patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration at the age of 80 years old on 20May2021 as single dose for covid-19 immunisation. Medical history included pneumoconiosis (on home oxygen therapy), atrial fibrillation, and diabetes mellitus. Concomitant medications included home oxygen therapy. Body temperature before vaccination and family history were not reported. On 20May2021 at unknown time (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 immunisation. On 22May2021 at unknown time (2 days after the vaccination), the patient experienced cardiopulmonary insufficiency. On 23May2021 (3 days after the vaccination), the patient was admitted to the hospital. On 27May2021 (7 days after the vaccination), the patient died and was discharged from the hospital; the outcome of the event cardiopulmonary insufficiency was fatal. It was unknown whether autopsy was done. The course of the event was as follows: On 20May2021 (Thursday) (the day of vaccination), the patient complained of physical deconditioning after receiving BNT162B2. On 22May2021 (Saturday) (2 days after the vaccination), dyspnoea feeling, queasy, and vomiting developed. On 23May2021 (Sunday) (3 days after the vaccination), an ambulance was called because of the persistent symptoms. Chest computerised tomography (CT) revealed a large volume of bilateral pleural effusion, atelectasis in the left side, and ground-glass opacity (GGO) predominantly in the left lung. Echocardiography showed ejection fraction (EF) 20-30%, left ventricular (LV) diffuse severe hypokinesis, akinesis from the anterior wall to the lateral wall, left atrial enlargement, left ventricular enlargement, and marked mitral regurgitation (MR) and tricuspid regurgitation (TR) due to valve enlargement. Lab data on admission: white blood cell (WBC) 10680, neutrophil (Neut) 88.9, lymphocyte (Lymph) 7.1, monocyte (Mono) 3.8, haemoglobin (Hb) 12.0, platelet (PLT) 21.3, C-reactive protein (CRP) 11.02, aspartate aminotransferase (AST) 873, alanine aminotransferase (ALT) 604, lactate dehydrogenase (LDH) 1205, alkaline phosphatase (ALP) 220, gamma glutamyltransferase (y-GT) 74, total bilirubin (TB) 1.0, blood urea nitrogen (BUN) 42.0, creatinine (Cr) 1.66, creatine kinase (CK) 210, CK-myocardial band (CK-MB) 19.0, brain natriuretic peptide (BNP) 643, COVID-19 polymerase chain reaction (PCR) test negative (-). Based on the above levels, aggravation of the underlying disease pneumoconiosis and concurrent onset of pneumonia were considered. Treatment was started for cardiac failure suggestive of relative myocardial ischaemia due to associated hypoxaemia, hepatic function disorder, renal failure, and other conditions. On 25May2021 (Tuesday) (5 days after the vaccination), the patient was treated with drugs including diuretics, vasopressors, and antibacterial drugs, which led to a temporary improvement of the general condition, ''Labo date'', and others. Test levels: WBC 11980, Hb 13.2, PLT 25.9, CRP 9.98, prothrombin (PT) 15.5%, international normalised ratio (INR) 1.39, activated partial thromboplastin time (APTT) 37.8, fibrinogen 360, D dimer (DD) 4.3, fibrin degradation products (FDP) 7.8, AST 436, ALT 623, ALP 179, gamma glutamyl transpeptidase (y-GTP) 59, TB 0.8, BUN 54.2, Cr 1.18, sodium (Na) 135, potassium (K) 5.0, chloride (CI) 96, albumin (ALB) 2.9, BNP 738.2. On 27May2021 (Thursday) (7 days after the vaccination), the respiratory condition and general condition rapidly worsened. The patient experienced a steep drop in the blood pressure and died. Pneumonia, sepsis associated with cardiac failure, and multi-organ failure were considered as the cause. Test levels: WBC 18150, Hb 11.8, PLT 12.4, CRP 5.67, AST 6260, ALT 3730, ALP 238, ''y-GTP ALB 3.1 120'' (as reported), BUN 88.0, Cr 2.07, Na 135, K 5.6. A sharp increase in hepatic deviation enzyme was noted, but ultrasonography of the liver and gall blabber showed no evident abnormal findings in the hepatic parenchyma or findings of cholecystitis. Echocardiography revealed no findings such as distinct abnormality of the wall motion. Marked inferior vena cava dilatation and hepatic vein dilatation were noted, and right cardiac failure was suspected. Based on these findings, the death was presumed to be due to right cardiac failure caused by the pulmonary circulation-related conditions including pneumoconiosis. The reporting physician classified the event cardiopulmonary insufficiency as serious (hospitalization, death) and assessed that the event was related to BNT162b2. Other possible causes of the event such as any other diseases was pneumoconiosis. The outcome of the events cardiopulmonary insufficiency, pneumonia, sepsis associated with cardiac failure, and multi-organ failure was fatal, of the other events was unknown. The reporting physician commented as follows: The patient had underlying diseases of pneumoconiosis (on home oxygen therapy), atrial fibrillation, and diabetes mellitus, and was regularly seeing a physician. On a routine examination on 17May2021, she had no significant changes compared to her normal condition. On 20May2021, the patient was vaccinated, and 2 days later, she experienced vomiting and dyspnoea with a sudden aggravation of the general condition, due to which she was transported by ambulance and was admitted to the hospital urgently. Regarding the episode this time, it was undeniable that the vaccination may have become a trigger as a result of the aggravated underlying diseases based on the course. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Pneumonia; sepsis associated with cardiac failure; multi-organ failure; Right heart failure; Cardiopulmonary insufficiency


VAERS ID: 1390425 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210522; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021632601

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21110670. The patient was a 91-year and 4-month-old female. Body temperature before vaccination was 36.5 degrees Centigrade. The family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 22May2021 at 11:58 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscularly in left upper arm as the first single dose for COVID-19 immunization. On unknown date in May2021 (unknown days/hours/minutes after the vaccination), the patient experienced cardio-respiratory arrest. The course of the event was as follows: On 22May2021 (the day of vaccination), the patient received BNT162b2 vaccination (left upper arm). On the same day, at 16:27 (4 hours and 29 minutes after vaccination), a staff member confirmed that no abnormalities were observed in the patient''s physical condition by phone. On 23May2021 (one day after vaccination), at night, the sensor of home security showed no body motion. On 24May2021, at 06:30 (1 day, 18 hours, and 32 minutes after vaccination), the staff member of home security visited the patient''s house, and the patient was found to have cardio-respiratory arrest in the bathtub. Thereafter, an autopsy was performed. The outcome of event was fatal. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not reported. The reporting physician commented as follows: The causality between the event and BNT162b2 was unknown.; Reporter''s Comments: The causality between the event and BNT162b2 was unknown; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1390426 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRYPTANOL [AMITRIPTYLINE HYDROCHLORIDE]; MAGMITT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021635213

Write-up: Death; This is a spontaneous report from a contactable physician. The patient was a non-pregnant 93-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received amitriptyline hydrochloride (TRYPTANOL) and magnesium oxide (MAGMITT) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included hypertension. On 31May2021 at 15:00 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. The patient was found dead in the morning on 01Jun2021. On 01Jun2021 (1 day after the vaccination), the patient died. No treatment was provided. Autopsy was not performed. Cause of death was provided as unknown. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available.; Reported Cause(s) of Death: Death


VAERS ID: 1390427 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; FUROSEMIDE; BISOPROLOL; LANSOPRAZOLE
Current Illness: Cardiac failure chronic; Chronic atrial fibrillation (under oral treatment)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021635357

Write-up: Sudden death/ Suspected Cardiac failure chronic aggravated; Sudden death; This is a spontaneous report from a contactable physician. The patient was a non-pregnant 61-year-old female (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received apixaban (ELIQUIS), furosemide, bisoprolol, and lansoprazole 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 ongoing cardiac failure chronic and ongoing chronic atrial fibrillation (the patient was under oral treatment for chronic atrial fibrillation). On 26May2021 at 14:00 (the day of vaccination, age at vaccination was 61-year-old), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. On 02Jun2021 at 07:15 (6 days after the vaccination), the patient experienced sudden death. The outcome of the event was fatal. Cause of death was provided as aggravation of chronic cardiac failure suspected. The patient classified the event, sudden death, as serious (death). An autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of sudden death and suspected aggravation of chronic cardiac failure due to temporal relationship. However, the reported events may possibly be associated with intercurrent medical conditions in this elderly patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: Suspected Cardiac failure chronic aggravated; sudden death


VAERS ID: 1390428 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarction; Shoulder pain (had left shoulder pain from 2 to 3 days before the vaccination)
Allergies:
Diagnostic Lab Data: Test Date: 20210529; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021636047

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the a regulatory authority. Regulatory authority report number is v21110784. The patient was a 76-year and 4-month-old male. Body temperature before vaccination was 36.1 degrees centigrade. Family history was unknown. Medical history included a history of myocardial infarction and left shoulder pain. On 29May2021 at unknown time (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5829, Expiration date 31Aug2021) via an unspecified route of administration at the age of 76-year-old at a single dose for COVID-19 immunization. On 29May2021 at 20:00 (on the same day of the vaccination), the patient experienced cardio-respiratory arrest. On 29May2021 (on the same day of the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 29May2021 (on the same day of the vaccination), the patient had cardio-respiratory arrest and was transferred to the reporting hospital. The patient died without resuscitation. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was a history of myocardial infarction. The outcome of event cardio-respiratory arrest was fatal. The reporting physician commented as follows: The patient reportedly had left shoulder pain from 2 to 3 days before the vaccination; thus, it was highly likely that the patient had cardiac arrest due to myocardial infarction.; Sender''s Comments: Based on current information, in agreement with the physician that the event cardio-respiratory arrest was unrelated to BNT162b2 and highly due to the history of myocardial infarction and left shoulder pain.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1390429 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Brain compression, Cerebral haemorrhage, Computerised tomogram head, Dizziness, Headache, Pyrexia, Snoring
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 3
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: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis
Allergies:
Diagnostic Lab Data: Test Date: 20210529; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: 05:00; Test Date: 20210529; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Comments: 12:00; Test Date: 20210529; Test Name: Head CT; Result Unstructured Data: Test Result:cerebral haemorrhage; Comments: cerebral haemorrhage accompanied by compression of the brainstem
CDC Split Type: JPPFIZER INC2021636194

Write-up: body temperature was 38.1 degrees centigrade; Cerebral haemorrhage; snore while sleeping; pain in his temple; compression of the brainstem; feeling lightheaded; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority (RA). Regulatory authority report number is v21110780. An 88-year-old male patient received bnt162b2 (COMIRNATY), the first dose via an unspecified route of administration on 27May2021 (lot number: FA4597, expiration date: 31Aug2021) as single dose for COVID-19 immunisation. The relevant medical history included arteriosclerosis from an unspecified date. Concomitant medications included acetylsalicylic acid (BAYASPIRIN). Body temperature before vaccination was not reported. Information on other medical history or concomitant medications were unknown. No information on family history was provided. On 29May2021 at 05:00 (2 days after the vaccination), the patient experienced cerebral haemorrhage. On 30May2021, the patient died. It was not reported if an autopsy was performed. The course of the event was as follows: On 27May2021, after the vaccination, the patient complained of feeling lightheaded. On 29May2021 at 02:00, the patient complained that he had pain in his temple. (This was the last conversation with him). On 29May2021 at 05:00, the patient started to snore while sleeping. The body temperature measured at that time was 37.1 degrees centigrade. Therefore, they contacted a city consultation service who instructed them to monitor the patient. At 12:00, as his body temperature was 38.1 degrees centigrade, they called the city consultation service again. Following the instruction of the consultation service, an emergency procedures were requested and then the patient was taken to the reporter''s hospital. After arriving at the hospital, head CT indicated cerebral haemorrhage accompanied by compression of the brainstem. Administration of medications was performed for the purpose of antihypertensive effect and reducing cerebral oedema. His family was to attend him until the end of his life after informed consent was obtained by his family. On 30May2021, the patient died. The reporting pharmacist classified the event as serious (fatal) and assessed the causality between the event and BNT162b2 as unassessable. His advanced age, arteriosclerosis and administration of BAYASPIRIN was reported as other possible causes of the event. The reporting pharmacist commented as follows: There were various factors other than the vaccination. The involvement of BNT162b2 in the event should not be actively suspected but could not be completely ruled out. The outcome of the event Cerebral haemorrhage was fatal, while the other events were unknown.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1390431 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Gastrointestinal haemorrhage, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (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), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Ischaemic colitis (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Chronic respiratory failure; Dementia (hospitalized for long term due to dementia and schizophrenia); Respiratory infection; Schizophrenia (hospitalized for long term due to dementia and schizophrenia)
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021636430

Write-up: Respiratory failure; Haemorrhage of digestive tract; This is a spontaneous report from a contactable physician, and received from the Regulatory Authority (RA). Regulatory authority report number is v21111052. A 72-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 31May2021 13:30 (Lot Number: EY0779; Expiration Date: 31Aug2021) as 1st dose, single at the age of 72-year-old for covid-19 immunisation. Body temperature before vaccination was 36.7 degrees centigrade. Family history was unknown (no family). The patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medical history included schizophrenia, dementia, chronic respiratory failure. The patient was hospitalized for long term due to dementia and schizophrenia. The patient had repeated episodes of respiratory infection and was bedridden. The condition of the patient was stable and it was judged that vaccination was possible (including opinion of primary care physician). On 31May2021, the patient was vaccinated. The patient''s concomitant medications were not reported. On 01Jun2021, the condition was complicated by haemorrhage of digestive tract. On 01Jun2021 (1 day after the vaccination), the patient experienced haemorrhage of digestive tract. The outcome of the event was fatal with treatment including famotidine, fluid replacement, diuretic, and antibiotic. Subsequently, general condition aggravated and on 02Jun2021, the patient died. The patient died on 02Jun2021 due to haemorrhage of digestive tract and respiratory failure. 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. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Assessment of haemorrhage of digestive tract was not thoroughly conducted; thus, in primary physician''s opinion, causality was unknown and detailed assessment was not possible.; Reported Cause(s) of Death: Haemorrhage of digestive tract; Respiratory failure


VAERS ID: 1390433 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-28
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / 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: 2021-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Myocardial infarction old
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021639142

Write-up: Acute cardiac arrest; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was an 89-year-old non-pregnant female. Body temperature before vaccination was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medical history included diabetes mellitus and myocardial infarction old. The patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received acetylsalicylic acid (BAYASPIRIN) within 2 weeks prior to the event onset. On 20May2021 at 13:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscularly as a single dose (0.3 mL) in the left arm for COVID-19 immunization. On around 28May2021 (around 8 days after the vaccination), the patient experienced acute cardiac arrest. On around 28May2021 (around 8 days after the vaccination), the outcome of the event was fatal. The cause of death was reported as acute cardiac arrest. Autopsy was not performed. It was unknown whether the patient received the medical treatment or not. It was unknown whether the patient had not been tested for COVID-19 after the vaccination. The course of the event was as follows: On 31May2021, it was found out by a phone call received from family member to cancel the second vaccination. The phone call was mainly about cancellation rather than reporting death. The physician classified the event acute cardiac arrest as serious (death) and assessed it as possibly related to BNT162b2. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: The reported event acute cardiac arrest is likely due to an intercurrent condition and not related to BNT162b2 (COMIRNATY).; Reported Cause(s) of Death: Acute cardiac arrest


VAERS ID: 1390434 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Body temperature, Cardio-respiratory arrest, Oropharyngeal pain, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   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: 20210528; Test Name: body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Comments: at 08:30
CDC Split Type: JPPFIZER INC2021641842

Write-up: Apnoea; body temperature was 38.7; cardio-respiratory arrest; pharynx pain; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21110942. The patient was an 83-year-old male. Body temperature before vaccination was not provided. The family history and medical history were not provided. On 25May2021 (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number, Expiration date and dose number unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 28May2021 at 08:30 (3 days after the vaccination), the patient experienced apnoea. On 28May2021 (3 days after the vaccination), the patient died. The course of the event was as follows: On 25May2021 (the day of vaccination), the patient received a dose of BNT162b2. On 26May2021, at 06:00 (one day after vaccination), pharynx pain developed. On 28May2021, at 08:30 (3 days after vaccination), the body temperature was 38.7 degrees Celsius. The patient contacted the vaccine consultation center and was instructed to visit his nearby hospital. Thereafter, the patient experienced cardio-respiratory arrest. 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 pneumonia and cardiac failure. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Apnoea; body temperature was 38.7; cardio-respiratory arrest; pharynx pain


VAERS ID: 1390435 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol dependence syndrome; Aortic surgery; Aortic valve replacement; Atrial fibrillation; Cardiac failure chronic; Stent replacement; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210517; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021641846

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician received from the . Regulatory authority report number is v21110907. The patient was an 86-year and 6-month-old male. Body temperature before vaccination was 36.5 degrees Centigrade. The family history was unknown. The patient had medical histories of cardiac failure chronic, atrial fibrillation, after coronary artery stent replacement, after aortic valve replacement, after replacement of ascending aorta, type 2 diabetes mellitus, and alcohol dependence. On 17May2021 at 13:30 (the day of vaccination) (at age of 86-year-old), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 19May2021 at 21:40 (2 days, 8 hours, and 10 minutes after the vaccination), the patient experienced acute myocardial infarction. On 19May2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 17May2021 (the day of vaccination), no abnormalities were observed during follow up for 30 minutes after the vaccination. On 19May2021 (2 days after vaccination), at night, the patient''s wife noticed his abnormality, and an ambulance was called. The patient was transferred to hospital by an ambulance. Although there was no incident according to the situation while the patient was being transferred. However, an autopsy was performed, and the cause of death was diagnosed as acute myocardial infarction. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. The reporting physician commented as follows: It was considered that the event was unrelated to BNT162b2 vaccination.; Reporter''s Comments: It was considered that the event was unrelated to BNT162b2 vaccination.; Sender''s Comments: Fatal event acute myocardial infarction represents an intercurrent medical condition and unrelated to BNT162b2 .; Reported Cause(s) of Death: acute myocardial infarction


VAERS ID: 1390436 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Gastrointestinal disorder, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210527; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021641853

Write-up: Suspected gastrointestinal disease; haemorrhage was confirmed; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21110906. The patient was an 87-year and 3-month-old female. Body temperature before vaccination was 36.7 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient had a relevant family history of heart disease, osteoporosis and pyothorax. On 27May2021 at around 15:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA5715, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 28May2021 at 14:10 (1 day after the vaccination), the patient experienced suspected gastrointestinal disease and died. It was unknown if an autopsy was performed. The course of the event was as follows: The physician in charge gave permission for giving the vaccination to her, therefore, the physician who belonged to the same medical association as the reporter determined that administering the vaccine was possible. Since haemorrhage was confirmed, gastrointestinal disease was suspected. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162b2. Suspected gastrointestinal disease was a possible cause of the event.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the events of gastrointestinal disease and hemorrhage. The reported events likely represent intercurrent medical conditions. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.; Reported Cause(s) of Death: haemorrhage was confirmed; Suspected gastrointestinal disease


VAERS ID: 1390437 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   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: Cardiac failure
Allergies:
Diagnostic Lab Data: Test Date: 20210518; Test Name: Body temperature; Result Unstructured Data: Test Result:35.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021641868

Write-up: cardiac failure; Death, died suddenly; Appetite impaired; Malaise; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21110905. The patient was an 88-year-old male. Body temperature before vaccination was 35.4 degrees centigrade. Family history was not reported. Medical history included cardiac failure. On 18May2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) (age at vaccination reported as 88-year-old) via an unspecified route of administration as a single dose for COVID-19 immunization. On 25May2021 (7 days after the vaccination), the patient experienced death. On 25May2021 (7 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 18May2021, the patient was placed under observation after the vaccination, had no particular problem, and returned home. On 23May2021, no marked change was observed until the morning. On 24May2021 in the afternoon, the patient developed appetite impaired and malaise. On 24May2021, a phone call was received. It was confirmed that the patient had no pyrexia and was able to eat pudding, etc. Since home visit was not possible, it was explained that ambulance should be called if the patient could not move. On 25May2021, a phone call was received from the police to notify that the patient died suddenly. Details were unknown. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was cardiac failure. The reporting physician commented as follows: Considering time course from the vaccination and clinical course, causal relationship was considered unlikely.; Reported Cause(s) of Death: Appetite impaired; Malaise; Death, died suddenly; cardiac failure


VAERS ID: 1390438 (history)  
Form: Version 2.0  
Age: 99.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, Computerised tomogram, Fibrin D dimer, Haemoglobin, Oxygen saturation, Pulmonary alveolar haemorrhage, SARS-CoV-2 test, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 9
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: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Reflux oesophagitis
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210515; Test Name: CT; Result Unstructured Data: Test Result:ground-glass opacities on the both lung fields; Comments: CT showed infiltrative shadows and ground-glass opacities on the both lung fields.; Test Date: 20210515; Test Name: C-reactive protein; Result Unstructured Data: Test Result:0.876; Test Name: DD dimer; Result Unstructured Data: Test Result:gradually decreased; Test Date: 20210515; Test Name: DD dimer; Result Unstructured Data: Test Result:119.1; Test Date: 20210515; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.0; Test Date: 20210515; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased; Test Date: 20210515; Test Name: quantitative antigen test for COVID-19; Test Result: Negative ; Test Date: 20210515; Test Name: white blood cell; Result Unstructured Data: Test Result:14600
CDC Split Type: JPPFIZER INC2021642921

Write-up: Pulmonary alveolar haemorrhage; This is a spontaneous report from a contactable physician received from the ). Regulatory authority report number is v21111275. The patient was a 99-year-old female. Body temperature before vaccination was 36.7 degrees Centigrade. The patient had no family history. The patient had medical history of reflux oesophagitis. The concomitant medication included oral Bayaspirin. On 12May2021 at 15:00 (the day of vaccination), the patient (at age of 99-year-old) received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 15May2021 at 10:00 (2 days, and 19 hours after the vaccination), the patient experienced pulmonary alveolar haemorrhage. On 15May2021 (3 days after the vaccination), the patient was admitted to the hospital. On 24May2021 (12 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 15May2021 (3 days after vaccination), the patient experienced bloody sputum, and the oxygen saturation decreased, and thus, the patient was transferred to the reporting hospital. The blood examination showed white blood cell of 14600, hemoglobin of 8.0, and DD dimer of 119.1, and C-reactive protein of 0.876. CT showed infiltrative shadows and ground-glass opacities on the both lung fields. The quantitative antigen test for COVID-19 was negative. The patient was admitted to the reporting hospital, and administration of antibacterial drugs (tazobactam and piperacillin), an infusion solution (coinjection of tranexamic acid and Kaytwo), and oxygen administration were initiated. DD dimer gradually decreased; however, the bloody sputum did not subside. On 21May2021 (9 days after vaccination), the patient developed CO2 narcosis. On 24May2021 (12 days after vaccination), the patient died. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. Other possible causes of the event such as any other diseases was lung atypical mycobacteriosis. The reporting physician commented as follows: DD dimer significantly increased, and haemorrhagic tendency was observed. The antibacterial drugs were ineffective, and pulmonary alveolar haemorrhage was considered as the cause of death. Since the event occurred 3 days after the vaccination, the causality between the event and BNT162b2 was strongly suspected.; Reported Cause(s) of Death: Pulmonary alveolar haemorrhage


VAERS ID: 1390439 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Body temperature, Vomiting
SMQs:, Acute pancreatitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disuse syndrome; Dysphagia; Twitching of limbs
Allergies:
Diagnostic Lab Data: Test Date: 20210527; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021642934

Write-up: Asphyxia; Vomiting; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21111242. A 94-year and 3-month-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 27May2021 14:00 (Batch/Lot Number: EY0779; Expiration Date: 31Aug2021) (age at vaccination: 94 years old) as single dose for covid-19 immunisation . Body temperature before vaccination was 36.1 degrees Centigrade. The family history was not reported. The disuse originally progressed, and the patient had twitching of limbs and dysphagia. On 01Jun2021 at 14:30 (5 days, and 30 minutes after the vaccination), the patient experienced asphyxia and Vomiting. On 01Jun2021 (5 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 02Jun2021, at 14:30 (6 days and 30 minutes after vaccination), the patient''s family member found that the patient had respiratory arrest on her bed at home. Vomit was attached to the face, and the possibility of vomiting, aspiration, and asphyxia was considerable. Since the disuse originally progressed, and the patient also had dysphagia. Thus, at the time of sudden deterioration, life extension or emergency transfer was not performed, and it was determined that the family members would be by her side when she would die at home. Since vomiting and asphyxia were assumable events, the death was confirmed at her home by the attending physician of home care. 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 originally had dysphagia, and the risk of vomiting and aspiration was high. Thus, there was a possibility that the event was incidental which was unrelated to the vaccine. The reporting physician commented as follows: Since the course was observed without particularly great abnormalities from the vaccination to the date of death. Thus, the causality between the event and BNT162b2 vaccine was unknown. The possibility, that BNT162b2 was the cause of physical deconditioning which led to vomiting, could not be ruled out.; Reported Cause(s) of Death: Vomiting; Asphyxia


VAERS ID: 1390440 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood test, Body temperature, Cardio-respiratory arrest, Chest discomfort, Computerised tomogram, Hypopnoea, Respiration abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (narrow), Hypersensitivity (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: before vaccination; Test Name: CT; Result Unstructured Data: Test Result:unknown results; Test Name: blood collection; Result Unstructured Data: Test Result:unknown results
CDC Split Type: JPPFIZER INC2021643158

Write-up: Cardio-respiratory arrest; Had abnormal expiration; the rhythm was very slow with intervals of 3 to 4 seconds and heavy groans; The patient''s breathing was gradually shallow; The possibility of anaphylaxis was undeniable; A stuck feeling in the chest; This is a spontaneous report from a contactable healthcare professional (HCP, deputy secretary-general) received from the regulatory authority. Regulatory authority report number is v21111253. The patient was a 73-year and 6-month-old female. Body temperature before vaccination was 35.6 degrees centigrade. Medical history included diabetes mellitus. Family history and concomitant medications were not reported. On 28May2021 at 16:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) at the age of 73-year-old, via an unspecified route of administration as 1st dose, single for COVID-19 immunisation. On 28May2021 at 19:00 (2 hours and 30 minutes after the vaccination), the patient experienced a stuck feeling in the chest. On 28May2021 at 19:10 (2 hours and 40 minutes after the vaccination), the patient had abnormal expiration; the rhythm was very slow with intervals of 3 to 4 seconds and heavy groans. The patient''s breathing was gradually shallow. At the same time, she also experienced cardio-respiratory arrest. The possibility of anaphylaxis was undeniable. On an unknown date, the outcome of the event cardio-respiratory arrest was fatal, while for other events was not reported. It was unknown whether autopsy was performed. The course of the events was as follows: On 28May2021 at 19:00 (2 hours and 30 minutes after the vaccination), the patient experienced a stuck feeling in the chest. At 19:10 (2 hours and 40 minutes after the vaccination), the patient had abnormal expiration; the rhythm was very slow with intervals of 3 to 4 seconds and heavy groans. The patient''s breathing was gradually shallow, and cardio-respiratory arrest developed. At 19:20 (2 hours and 50 minutes after the vaccination), a call was made to the reporting hospital. At 20:02 (3 hours and 32 minutes after the vaccination), the patient was transferred to another hospital. CT and blood collection were performed. The reporter classified the case as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. It was not reported whether there was other possible cause of the event such as any other diseases. The reporter commented as follows: The possibility of anaphylaxis was undeniable. The results for tryptase blood test was awaited.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1390441 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Cardio-respiratory arrest, Coma scale, Dizziness, Dyspnoea, Loss of consciousness, Restlessness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: IFENPRODIL; URSO [URSODEOXYCHOLIC ACID]; BETAHISTINE; ZACRAS; AMLODIPINE; BETANIS; LEVOCETIRIZINE; SILODOSIN; FAMOTIDINE; CILOSTAZOL; EPERISONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal (blood pressure related condition); Prostatic hyperplasia; Rash (Several days before the vaccination, not have allergies to food or drug)
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Coma Scale; Result Unstructured Data: Test Result:E2V3M5; Comments: at 19:53; Test Date: 20210602; Test Name: coma scale; Result Unstructured Data: Test Result:20; Comments: at 19:53
CDC Split Type: JPPFIZER INC2021643342

Write-up: cardiac arrest due to arrhythmia/cardio-respiratory arrest; cardiac arrest due to arrhythmia/cardio-respiratory arrest; consciousness clouding/collapsed; Faint; dizziness; breathing difficulty/respiratory distress; unrest; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative, and from a contactable physician (the emergency physician) of the same hospital as the previous reporter, received from a regulatory authority via regulatory authority report number is v21111425. An 82-year and 10-month-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 02Jun2021 at around 15:00 (Batch/Lot Number: EY0779; Expiration Date: 31Aug2021) (age at vaccination: 82 years old) as single dose for covid-19 immunisation. Medical history included blood pressure related condition and prostatic hyperplasia. Several days before the vaccination, the patient developed rash, but he did not have allergies to food or drug. Concomitant medications included ifenprodil tartrate (IFENPRODIL), ursodeoxycholic acid (URSO), betahistine mesilate (BETAHISTINE), azilsartan/amlodipine besilate (ZACRAS) 1, amlodipine besilate (AMLODIPINE), mirabegron (BETANIS), levocetirizine hydrochloride (LEVOCETIRIZINE), silodosin, famotidine (FAMOTIDINE), cilostazol, and eperisone. On 02Jun2021, while observing the patient after the vaccination, no problems were noted, and then he returned home. On 02Jun2021 at around 18:00, the patient took a bath, and when he got out of the bathroom, he collapsed and fainted. Conversation was possible. He complained of dizziness and breathing difficulty. Dizziness, respiratory distress, and unrest were present. At 19:00, ambulance was called. Conversation was possible. On 02Jun2021 at around 19:00, the patient was transferred to the emergency department of the reporter''s hospital as an outpatient. When transferring to a hospital, he was able to have a conversation, but afterwards, he developed consciousness clouding. At 19:53, when the ambulance arrived at the hospital, his consciousness level was (coma scale): 20 and E2V3M5 (other Coma Scale). A few minutes later, he developed respiratory arrest. On 02Jun2021 after 20:00, adrenaline was started to be administered (6 times in total) and procedures including cardiac massage was performed. Even though cardiopulmonary resuscitation was performed, he did not recover. On 02Jun2021 at 21:00, the patient''s death was confirmed. Since the possibility of artery dissection and abdominal aortic rupture was suspected, AI (autopsy imaging) was performed. However, bleeding tendency was not confirmed, therefore, the cause of death was determined to be cardiac arrest due to arrhythmia. The outcome of other events was unknown. On 02Jun2021 at 21:49, this case was reported to the police. On 02Jun2021 at around 22:40, the emergency physician responded to police interrogation. On 03Jun2021 at around 00:30, the patient was transferred to the medical department of a university. Whether or not an autopsy would be performed was under consideration. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. The reporting pharmacist stated that he would cooperate further investigation regarding the subsequent course after transferring to an emergency hospital, but not the patient''s underlying diseases or information on the vaccination because the vaccination was not performed at a different medical facility from the reporter''s.; Reported Cause(s) of Death: cardiac arrest due to arrhythmia


VAERS ID: 1390442 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood creatinine, Blood lactate dehydrogenase, Blood potassium, Blood pressure measurement, Blood test, Blood urea, Body temperature, C-reactive protein, Cerebral haemorrhage, Haemoglobin, Neck pain, Platelet count, Prothrombin time, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Arteriosclerosis obliterans; Atrial fibrillation; Cardiovascular disorder; Emphysema; Neck discomfort (improved in several days with prescription of acetaminophen); Osteoporosis; Renal failure chronic (stage 4)
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: Creatinine; Result Unstructured Data: Test Result:1.62; Test Date: 20210528; Test Name: LDH; Result Unstructured Data: Test Result:228; Test Date: 20210528; Test Name: Potassium; Result Unstructured Data: Test Result:4.1; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:stable at 130s; Comments: in the last few months; Test Date: 20210528; Test Name: blood correction; Result Unstructured Data: Test Result:as usual with no remarkable change; Test Date: 20210528; Test Name: BUN; Result Unstructured Data: Test Result:23; Test Date: 20210525; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210528; Test Name: CRP; Result Unstructured Data: Test Result:0.18; Test Date: 20210528; Test Name: hb; Result Unstructured Data: Test Result:11.8; Test Date: 20210528; Test Name: Platelet; Result Unstructured Data: Test Result:200000; Test Date: 20210416; Test Name: PT; Result Unstructured Data: Test Result:2.1; Comments: most recent value; Test Date: 20210528; Test Name: White blood cell; Result Unstructured Data: Test Result:6900
CDC Split Type: JPPFIZER INC2021643906

Write-up: Cerebral haemorrhage; Pain from shoulder to neck; Pain from shoulder to neck; This is a spontaneous report from a contactable physician received via a regulatory authority. The case was also received from a regulatory authority. Regulatory authority report number is v21111480. The patient was a non-pregnant 86-year-old female. Body temperature before vaccination was 36.3 degrees centigrade (on 25May2021). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included warfarin orally for an unspecified indication, start date was not reported and ongoing. Most recently tested prothrombin time was 2.1 on 16Apr2021. 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 renal failure chronic (stage 4), emphysema, atrial fibrillation, angina pectoris, arteriosclerosis obliterans, cardiovascular disease, osteoporosis could not turn neck and had pain unlike usual stiff neck in Mar2021 (improved in several days with prescription of acetaminophen). On 25May2021 at 10:30 (the day of vaccination), the patient (at age of 86-year-old) received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscular in the arm left for COVID-19 immunization. On 31May2021 (6 days after the vaccination), the patient experienced cerebral haemorrhage. The outcome of the event was fatal. Since the vaccination, the patient has not been tested for COVID-19. The course of the event was as follows: Three days after the vaccination, on 28May2021, the patient developed pain from shoulder to neck. Six days after the vaccination, on 31May2021, the patient experienced cerebral haemorrhage. On 01Jun2021, the patient was found dead at home. The police contacted to the reporting physician and told that diagnosis of cerebral haemorrhage was made as a result of autopsy. The reporting physician 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 taking anticoagulant drug orally and had a history of cardiovascular disease (past history) and renal failure. It was quite likely that there was a change to arteriosclerosis. The patient lived alone and had impaired comprehension appropriate for her age. It was suspected that the patient had a problem in drug compliance. The reporting physician commented as follows: Three days after the vaccination, the patient visited the reporting hospital due to pain of back and from shoulders to neck. The patient had no pyrexia or consciousness disturbed. Blood collection data was as usual with no remarkable change (white blood cell was 6900, haemoglobin was 11.8, platelet was 200000, creatinine was 1.62, BUN was 23, LDH was 228, potassium was 4.1, and CRP was 0.18). On the same day, acetaminophen was prescribed since pain due to the vaccine was suspected. It was considered the patient probably had no adequate water intake due to pain; thus, the patient received replenisher solution of SOLDEM 1 and then returned home. At this time, there were no manifestations suggestive of bleeding tendency such as haemorrhage subcutaneous or purpura. Also, hemostasis at the time of infusion did not require time. In March, the patient visited the reporting hospital and complained that the patient couldn''t turn neck and had pain unlike usual stiff neck. At this time, the symptoms improved in several days with prescription of acetaminophen. Other than the reporting hospital, the patient was undergoing treatment of osteoporosis at another orthopedic surgery hospital. On 25May2021, the patient was vaccinated. On 28May2021, the patient visited the reporting hospital due to pain. The patient was estimated to have died 3 days later. The patient had multiple underlying diseases and multiple oral medications. The possibility of sudden death due to cardiovascular event was already expected, had been explained to the patient. Primary impression of the bleeding this time was considered not strongly associated with the vaccine. However, inspection revealed no particular findings suggestive of traumatic injury such as head bruise, most recent blood test was not different from usual, and blood pressure measured at consultation in the last few months was stable at 130s. Thus, although death due to cerebral haemorrhage was possible enough considering the underlying diseases, influence of the vaccine could not be completely denied considering the time course, and therefore, the case was reported.; Reported Cause(s) of Death: Cerebral haemorrhage; Pain from shoulder to neck; Pain from shoulder to neck; Autopsy-determined Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1390443 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture, Body temperature, Computerised tomogram abdomen, Laboratory test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   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: Abdominal aortic aneurysm
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210527; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 201806; Test Name: abdominal CT scan; Result Unstructured Data: Test Result:unknown results; Test Date: 201811; Test Name: abdominal CT scan; Result Unstructured Data: Test Result:unknown results; Test Date: 201906; Test Name: abdominal CT scan; Result Unstructured Data: Test Result:unknown results; Test Date: 202007; Test Name: abdominal CT scan; Result Unstructured Data: Test Result:revealed aortic aneurysm enlarged by 1 cm; Test Date: 20171218; Test Name: Laboratory test; Result Unstructured Data: Test Result:abdominal aortic aneurysm 48 mm in diameter
CDC Split Type: JPPFIZER INC2021646247

Write-up: abdominal aortic aneurysm rupture; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21111410. The patient was a 93-year and 3-month-old male. Body temperature before vaccination was 36.5 degrees Centigrade. Medical history included hypertension from unknown date, abdominal aortic aneurysm from 18Dec2017. No information on concomitant medications or family history was provided. On 27May2021 at 09:45 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY2173, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 31May2021 in the morning (4 days after the vaccination), the patient experienced abdominal aortic aneurysm rupture. On 02Jun2021 at 00:30, the patient died. It was not reported if an autopsy was performed. The clinical course of the history of abdominal aortic aneurysm (based on the patient''s story) and event abdominal aortic aneurysm rupture was as follows: On 18Dec2017, the patient was diagnosed with abdominal aortic aneurysm and referred to the cardiovascular surgery department of a hospital A (different from reporter''s) where abdominal aortic aneurysm 48 mm in diameter was indicated. The patient had regularly visited the hospital for observation. In Jun2018, Nov2018, Jun2019 and Jul2020, the patient visited hospital A and underwent abdominal CT scan. The exam performed in Jul2020 revealed aortic aneurysm enlarged by 1 cm, but the progress had been followed up. On 31May2021 in the morning, the patient developed abdominal pain and an emergency service was requested. The patient was transferred to a hospital B (different from the reporter''s). The patient was hospitalized to receive the treatment with a diagnosis of abdominal aortic aneurysm rupture. On 02Jun2021 at 00:30, the patient died. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported if there was other possible cause of the event such as any other diseases. The outcome of event was fatal.; Reported Cause(s) of Death: abdominal aortic aneurysm rupture


VAERS ID: 1390444 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Bradycardia, Marasmus
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021646251

Write-up: Geromarasmus; Bradycardia; blood pressure decreased; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111414. The patient was a 91-year-old female. Body temperature before vaccination was 36.1 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient had no relevant family history. On 02Jun2021 at 08:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration as a 1st dose, single dose for COVID-19 immunization. Clinical course was reported as follows: On 03Jun2021 at around 04:00 (1 day after the vaccination), the patient developed bradycardia and blood pressure decreased. On 03Jun2021 at 05:15 (1 day after the vaccination), the patient died. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. The reporting physician commented as follows: geromarasmus was considered to be the cause of death. The outcome of event geromarasmus was fatal; other events was unknown.; Reported Cause(s) of Death: geromarasmus


VAERS ID: 1390445 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-05-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Bradykinesia, Computerised tomogram, Fall, Hypoxic-ischaemic encephalopathy, Loss of consciousness, Near drowning, Respiratory arrest, Skin laceration
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210530; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210531; Test Name: CT scan; Result Unstructured Data: Test Result:hypoxic encephalopathy; Test Date: 20210531; Test Name: Head CT scan; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC2021646293

Write-up: near drowning; Hypoxic encephalopathy; respiratory arrest; his consciousness did not recover; bradykinesia; fell down twice; had laceration on his face; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111386. The patient was a 72-year-old male. On 30May2021 at 10:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Medical history included lung cancer. The patient had no allergies. He had not received any other vaccines in the past one month. The patient had no relevant family history. The patient had no developmental problems. No information on concomitant medications was provided. On 31May2021 at 21:30 (1 day after the vaccination), the patient experienced near drowning. On 01Jun2021, he developed respiratory arrest and died. It was not reported if an autopsy was performed. The course of the event was as follows: Body temperature before vaccination was 36.5 degrees Centigrade on 30May2021. On 31May2021, it took some time for the patient to get up that morning and bradykinesia was noted. Also, he fell down twice, and after the second fall, he could not stand up. As he had laceration on his face, he visited the emergency department for the treatment. Head CT (Computerised tomogram) scan showed no abnormalities. He received sutures and returned home. When he went home, he could walk by himself. The patient was the same as usual, and he took a bath. The patient was found in a state of near drowning. The patient was taken to the reporter''s hospital and hospitalized, but his consciousness did not recover. CT scan findings indicated hypoxic encephalopathy. On 01Jun2021, the patient''s death was confirmed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. It was uncertain if there was other possible cause of the event. The outcome of near drowning, hypoxic encephalopathy, respiratory arrest and his consciousness did not recover was fatal, the outcome of other events was unknown. Reported Cause(s) of Death: near drowning; Hypoxic encephalopathy; respiratory arrest; his consciousness did not recover


VAERS ID: 1390446 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, N-terminal prohormone brain natriuretic peptide, Pyrexia, Respiratory arrest, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Disorder cardiac (NOS); Myocardial infarction; Pyrexia
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210527; Test Name: Body temperature; Result Unstructured Data: Test Result:pyrexia of 38.8 Centigrade; Test Date: 20210528; Test Name: Body temperature; Result Unstructured Data: Test Result:the temperature decreased to 36.4 Centigrade; Test Date: 20210410; Test Name: NT-pro BNP; Result Unstructured Data: Test Result:2188 pg/mL
CDC Split Type: JPPFIZER INC2021647611

Write-up: Death; No spontaneous respiration; The caregiver visited the patient''s room and found her lying down with her head and vomit on the floor; Pyrexia of 38.8 degrees centigrade; This is a spontaneous report from a contactable other healthcare professional (HCP) received from the Health Agency (HA). Regulatory authority report number is v21111438. The patient was a 90-year and 5-month-old female. Body temperature before vaccination was 36.4 degrees centigrade. Family history was not reported. Medical history included heart disease/myocardial infarction and cerebral infarction. Concomitant medications included aspirin (acetylsalicylic acid) (BAYASPIRIN). On 25May2021 at 10:36 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 29May2021 at 16:51 (4 days after vaccination), the patient was confirmed death by physician. As of the reporting date, the outcome of the event was unknown. The course of the event was as follows: The patient had tended to develop pyrexia about once a month or two months since before. As of 27May2021 in the morning (2 days after the vaccination for the new coronavirus), pyrexia of 38.8 degrees centigrade was noted without other symptoms. With a prescription for cooling and acetaminophen, the patient was put on a follow-up care. On the following 28May2021 in the morning (3 days after the vaccination), the temperature decreased to 36.4 degrees centigrade, and the patient spent the rest of the day without having aggravated condition. On 29May2021 at 02:53 (4 days after the vaccination), the patient urinated into the portable toilet with assistance of the caregiver. Later, the patient said that she wanted to watch TV and was allowed to do so while sitting on the bed. On the same day at 04:05, the caregiver visited the patient''s room and found her lying down with her head and vomit on the floor. At this point, the patient had no spontaneous respiration. After moving her onto the bed, the caregiver performed oral suctioning, which only collected a small volume of white saliva. When previously asked about their intention, the patient and her family had not wish to receive cardiopulmonary resuscitation on a sudden change. On the same day at 04:51, the physician confirmed the patient''s death. She had historical condition of cerebral infarction and myocardial infarction. The test performed on 10Apr2021 had revealed N-terminal prohormone brain natriuretic peptide (NT-pro BNP) 2188 pg/ml. The reporting other HCP classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases: details unknown. ; Reported Cause(s) of Death: No spontaneous respiration; Death


VAERS ID: 1390447 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Condition aggravated, Inflammation, Jaundice, Oxygen saturation, Oxygen saturation decreased, Pseudomonas test, Pyrexia, Staphylococcus test
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   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: Bile duct cancer; Cardiac failure; Hepatic dysfunction NOS; Inflammation; Methicillin-resistant Staphylococcus aureus infection; Pseudomonas aeruginosa infection NOS; Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 202103; Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 202104; Test Name: body temperature; Result Unstructured Data: Test Result:fever decreased Centigrade; Comments: In early April; Test Date: 202104; Test Name: body temperature; Result Unstructured Data: Test Result:high fever Centigrade; Comments: in mid-April; Test Date: 202104; Test Name: body temperature; Result Unstructured Data: Test Result:fever decreased Centigrade; Comments: In late April; Test Date: 20210426; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210428; Test Name: body temperature; Result Unstructured Data: Test Result:high fever Centigrade; Test Date: 202103; Test Name: SpO2; Result Unstructured Data: Test Result:normal; Comments: In late March; Test Date: 20210428; Test Name: SpO2; Result Unstructured Data: Test Result:normal; Test Date: 202105; Test Name: SpO2; Result Unstructured Data: Test Result:decreased; Comments: oxygen saturation decreased; Test Name: Pseudomonas aeruginosa; Test Result: Positive ; Test Name: MRSA; Test Result: Positive
CDC Split Type: JPPFIZER INC2021647894

Write-up: Jaundice aggravation; Jaundice aggravation; Blood pressure decreased; Oxygen saturation decreased; High fever; Inflammation was observed; This is an initial spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21111437. The patient was a 79-year-old female. Body temperature before vaccination was 36.7 degrees Centigrade on 26Apr2021. The family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). There were no concomitant drugs. On 26Apr2021 at 14:30 (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 the first single dose for COVID-19 immunization at the age of 79-year-old. On 28Apr2021 (2 days after vaccination), the patient experienced high fever and inflammation was observed. In early May2021 (after vaccination), the patient experienced jaundice aggravation, blood pressure decreased, and oxygen saturation decreased. On 08May2021 (11 days after the vaccination), the patient died due to jaundice aggravation, blood pressure decreased, oxygen saturation decreased and other unknown cause of death. It was unknown whether autopsy was performed or not. Outcome of high fever and inflammation was observed was unknown, of other events was fatal. The course of the events was as follows: On 17Feb2021, the patient was admitted to the hospital for common bile duct cancer, cardiac failure, and renal failure (methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa were positive). In late March, the patient had high fever of 40 degrees Celsius and significant inflammatory findings (the SpO2 was normal), and an intravenous administration of antibacterial drugs was initiated. In early April, the fever decreased; however, in mid-April, the patient experienced high fever, inflammatory findings, and hepatic dysfunction again, and administration of antibacterial drugs was resumed. In late April, since the fever decreased, the patient received the first dose of BNT162b2 vaccination on 26Apr2021 (the day of vaccination). On 28Apr2021 (2 days after vaccination), the patient experienced high fever and significant inflammatory findings (the SpO2 was normal). In early May2021, the jaundice aggravation, blood pressure decreased, and oxygen saturation decreased were noted. On 08May2021 (12 days after vaccination), the patient died. The reporting physician classified the case as serious (death) and assessed that the events were unrelated to BNT162b2. There were other possible causes of the events such as any other diseases. The reporting physician commented as follows: The patient was in the end stage of common bile duct cancer, and she also had cardiac failure and renal failure. Since the patient had terminal symptoms of cancer and infectious symptoms since before the vaccination, it was considered that the events were unrelated to BNT162b2 vaccination.; Reporter''s Comments: The patient was in the end stage of common bile duct cancer, and she also had cardiac failure and renal failure. Since the patient had terminal symptoms of cancer and infectious symptoms since before the vaccination, it was considered that the events were unrelated to BNT162b2 vaccination.; Sender''s Comments: There is not a reasonable possibility that the reported events (jaundice aggravation, blood pressure decreased, and oxygen saturation decreased, high fever, and significant inflammatory findings) are related to BNT162 vaccine, being rather complications of mentioned end stage common bile duct cancer, cardiac failure, and renal failure.; Reported Cause(s) of Death: Unknown cause of death; Jaundice aggravation; Jaundice aggravation; Blood pressure decreased; Oxygen saturation decreased


VAERS ID: 1390448 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021647979

Write-up: Died suddenly; This is a spontaneous report from a contactable physician via Medical information team. An 82-year-old male patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, expiration date was unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced died suddenly about 10 days after vaccination. The cause was unknown. It was not reported if an autopsy was performed. The reporter commented that she did not think it was adverse events due to vaccine. Information on the lot/batch number has been requested.; Sender''s Comments: Lacking precise details on the circumstances and cause of patient''s demise, sudden death is considered as related to BNT162B2 vaccine as a cautionary measure only. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Died suddenly


VAERS ID: 1390449 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: MORPHINE
Current Illness: End stage cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021647999

Write-up: Pneumonia; This is a spontaneous report from a contactable pharmacist via Medical Information Team. A patient of unspecified age and gender received BNT162b2 (COMIRNATY, Batch/Lot number and dose number were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included ongoing end stage cancer. Concomitant medication included morphine. The patient who had end stage cancer and used morphine received vaccination and died from pneumonia on an unspecified date. It was not reported if an autopsy was performed. The outcome of pneumonia was fatal. Causality between the event pneumonia and BNT162b2 was not provided. Information on the lot/batch number has been requested.; Sender''s Comments: Pneumonia, fatal, is considered a complication of the unspecified end stage cancer and is unrelated to BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1390450 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Dementia Alzheimer''s type; Symptomatic epilepsy
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021650880

Write-up: Respiratory arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21111484. The patient was an 88-year and 5-month-old male. Body temperature before vaccination was 36.7 degrees Centigrade. The patient had no particular family history. The patient had medical histories of symptomatic epilepsy, cerebral infarction, and Dementia Alzheimer''s type. On 10May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# ET3674, Expiration date 31Jul2021). On 01Jun2021 at 13:57 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5829, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 02Jun2021 at 06:00 (16 hours, and 3 minutes after the vaccination), the patient experienced respiratory arrest. On 02Jun2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 02Jun2021, at 03:40 (13 hours, and 43 minutes after vaccination), the patient was sleeping. At 06:00 (16 hours, and 3 minutes after vaccination), the patient was confirmed to have respiratory arrest. Response to automated external defibrillator (AED) was not obtained. At 06:30 (16 hours, and 33 minutes after vaccination), the patient arrived in the reporting hospital while a cardiac massage was being performed. Although cardiopulmonary resuscitation was performed, the patient was confirmed to die at 07:00 (17 hours and 3 minutes after vaccination). An autopsy and an administrative autopsy will be performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was the possibility of myocardial infarction. The reporting physician commented as follows: CT which was performed after the death showed no cerebral haemorrhage and aortic dissection. Follow up information has been requested.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1390451 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATELEC; VALSARTAN; PRAVASTATIN; NESINA; METGLUCO; PAROXETINE; MENESIT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage (old bleeding site in the head); Debility marked (considerable debility); Dementia; Diabetes mellitus; Dyslipidaemia; Hyperlipidaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021650913

Write-up: Intra-cerebral haemorrhage due to fall; Intra-cerebral haemorrhage due to fall; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was an 80-year-old female. Body temperature before vaccination was not reported. Medical history included diabetes mellitus, hyperlipidaemi, dyslipidaemia, dementia, hypertension, considerable debility and an old bleeding site in the head. Concomitant medication included cilnidipine (ATELEC) tablet 15 mg/day taken orally for hypertension from Nov2015 to ongoing, valsartan (VALSARTAN) tablet 80 mg/day taken orally for hypertension from Jul2019 to ongoing, pravastatin (PRAVASTATIN) tablet 10 mg/day taken orally for hyperlipidaemia from May2019 to ongoing, alogliptin benzoate (NESINA) tablet 25 mg/day taken orally for type 2 diabetes mellitus from May2019 to ongoing, metformin hydrochloride (METGLUCO) tablet 1000 mg/day taken orally for type 2 diabetes mellitus from Feb2020 to ongoing, paroxetine (PAROXETINE) tablet 10 mg/day taken orally for unspecified indication from Jun2019 to ongoing, and carbidopa, levodopa (MENESIT) tablet 100 mg/day taken for unspecified indication from Apr2021 to ongoing. On 28May2021 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Jun2021 (6 days after the vaccination), the patient experienced intra-cerebral haemorrhage due to fall. On 03Jun2021 (6 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 28May2021, the patient received COMIRNATY. On 03Jun2021 in the morning, it was found out that the patient fell to the ground and was dead. At the time of this report, autopsy was being conducted by the police and details were unknown yet. Information including lot number was unknown. The reporting physician classified the event as serious (death) and assessed that the event was possibly related to BNT162b2. The reporting physician commented as follows: The patient was an elderly female in her 80s and had considerable debility in the last one month. There was an old bleeding site in the head; thus, the cause was considered as intra-cerebral haemorrhage due to fall rather than direct association of COMIRNATY vaccination.; Reported Cause(s) of Death: Intra-cerebral haemorrhage due to fall; Intra-cerebral haemorrhage due to fall


VAERS ID: 1390452 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021651420

Write-up: pyrexia; inappetence; cardiac arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111517. The patient was a 95-year-old male. Body temperature before vaccination was not reported. No information on medical history, concomitant medications or family history was provided. On 28May2021, the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, Lot number and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization, and afterwards the patient experienced pyrexia and inappetence. On 03Jun2021 at 09:30 (6 days after the vaccination), the patient died of cardiac arrest. It was not reported if an autopsy was performed. The course of the event was as follows: After the vaccination, the patient experienced pyrexia and inappetence. On 03Jun2021 at 09:30, the patient was found in a state of cardiac arrest. The reporting physician could not specify any obvious disease which was considered as a cause and considered that the causal relationship between BNT162b2 and cardiac arrest was uncertain. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1390454 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure (under treatment); Diabetes mellitus (under treatment)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Dementia (mother''s family history); Family history of cancer (father''s family history for Large intestine carcinoma, Prostate cancer and Bladder cancer)
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021653914

Write-up: Myocarditis suspected; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21111657. A 72-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EY4834; Expiration Date: 31Aug2021), via an unspecified route of administration, on 31May2021 at 11:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from Jan2021, ongoing cardiac failure (under treatment), ongoing diabetes mellitus (under treatment), family history of cancer (father''s family history for large intestine carcinoma, prostate cancer and bladder cancer), and family history of dementia (mother''s family history). Concomitant medications included unspecified treatment for cardiac failure and diabetes mellitus. The patient experienced myocarditis suspected in Jun2021 (unknown days/hours/minutes after the vaccination), which was reported as fatal. The clinical course was reported as follows: The body temperature before vaccination was 35.9 degrees Centigrade on 31May2021. On 31May2021 (the day of vaccination), at 11:00, the patient received the first dose of BNT162B2 vaccination. On the same day, the patient stayed in the institution overnight. On 01Jun2021 (one day after vaccination), the patient used day care and went home. Until then, the patient had only mild malaise. On 02Jun2021 (2 days after vaccination), in the morning, the nursing helper found the patient dead. After the death certificate was received, the city police contacted the reporting hospital. The patient died on 02Jun2021 (2 days after the vaccination). The cause of death was reported as myocarditis suspected. It was not reported if an autopsy was performed. The reporting physician assessed the causality between the event and BNT162B2 as unassessable. Other possible cause of the event, such as any other diseases, was as follows: Since the patient was being treated for cardiac failure and diabetes mellitus, these underlying diseases might be related to the event. The reporting physician commented as follows: Since the patient lived alone, the details were unknown. Since the date of death was close to the date of BNT162b2 vaccination, the causality between the event and BNT162B2 could not be ruled out.; Reported Cause(s) of Death: Myocarditis suspected


VAERS ID: 1390455 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Body temperature, Chills, Delirium, Depressed level of consciousness, Incontinence, Muscle spasms, Pain, Respiratory distress, Seizure
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 11
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: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210522; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021653975

Write-up: chills; generalized pain; incontinence; breathing difficulty; blood pressure decreased; cramps of right upper extremity/cramps of right and left, upper and lower extremities; lost energy; his consciousness level temporarily decreased; Convulsion; delirium; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number is v21111728. A 100-year-old male patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration on 22May2021 at 12:00 at a single dose for covid-19 immunisation. Medical history included bronchial asthma. Concomitant medication included rivaroxaban (XARELTO). No information on family history was provided. On 22May2021 at 19:30, the patient experienced convulsion, which was serious for death. On 22May2021, the patient experienced chills, generalized pain, incontinence, breathing difficulty, and delirium. On 24May2021, the patient experienced his consciousness level temporarily decreased. On 27May2021, the patient experienced cramps of right upper extremity/cramps of right and left, upper and lower extremities and lost energy. On 31May2021, the patient experienced blood pressure decreased. The patient was hospitalized for chills, generalized pain, incontinence, and breathing difficulty from 22May2021 to an unknown date. The clinical course was as follows: on 22May2021 at around 12:00 (the day of vaccination), the patient received the first dose of BNT162b2. On 22May2021 at 19:30 (about 7 hours and 30 minutes after the vaccination), the patient experienced convulsion. On that day, the patient was hospitalized. The event was further described as: On 22May2021(the day of vaccination), the patient was found lying down in the bathroom. The patient complained of chills and generalized pain. Incontinence was noted. An emergency service was requested. The patient had a medical history of bronchial asthma. During a medical examination, as the patient complaint of breathing difficulty, inhalation was performed. The patient was hospitalized for the purpose of observation. He had delirium but not high fever. On 24May2021 (2 days after the vaccination) in the evening, his consciousness level temporarily decreased. On 27May2021 (5 days after the vaccination), cramps of right upper extremity appeared. The patient gradually lost energy. On 30May2021(8 days after the vaccination), cramps of right and left, upper and lower extremities appeared, and depressed level of consciousness and respiratory state were worsened. Trilogy ventilator device was set up. On 31May2021(9 days after the vaccination), blood pressure decreased and administration of vasopressor drug was started. On 02Jun2021(11 days after the vaccination), cramps of left upper extremity persisted. On 02Jun2021 at 19:36 (11 days, about 7 hours and 36minutes after the vaccination), the patient died. The patient underwent lab tests and procedures which included blood pressure: decreased on 31May2021 and body temperature: 36.2 degrees Centigrade on 22May2021 before vaccination. Therapeutic measures were taken as a result of breathing difficulty, his consciousness level temporarily decreased, and blood pressure decreased. The clinical outcome of the event, convulsion, was fatal. The clinical outcome of the events, chills, generalized pain, incontinence, breathing difficulty, delirium, his consciousness level temporarily decreased, cramps of right upper extremity/cramps of right and left, upper and lower extremities, lost energy, and blood pressure decreased, was unknown. The patient died on 02Jun2021 due to convulsion. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. It was uncertain if there was possible cause of the events. REPORTER COMMENT: The reporter requested to assess the causal relationship between BNT162b2 and the death.; Reported Cause(s) of Death: Convulsion


VAERS ID: 1390457 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 202106; Test Name: CT; Result Unstructured Data: Test Result:did not identify the cause of death; Comments: CT of the whole body did not identify the cause of death.
CDC Split Type: JPPFIZER INC2021658523

Write-up: cardio-respiratory arrest; consciousness disturbed/found in a state of loss of consciousness; This is a spontaneous report from a contactable physician received via a Pfizer sales representative, and another contactable physician (different from the previous reporter) received from the regulatory authority, with regulatory authority report number v21111929. The patient was a 92-year-old female (92-year and 2-month-old). Medical history included Alzheimer''s disease. On 04Jun2021, body temperature before vaccination was 36.2 degrees Centigrade. On 04Jun2021 at 13:00 (the day of vaccination), the patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: FA5765, Expiration date: 30Sep2021), via an unspecified route of administration as first dose, single dose for COVID-19 immunization. On 05Jun2021 (1 day after the vaccination), the patient experienced death. On 05May2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was vaccinated at the primary care physician''s hospital. On the following day, the condition aggravated, and the patient was taken to the reporting hospital by ambulance. Lifesaving measures was conducted; however, the patient died. At the time of this report, autopsy was being conducted and results will be available on 08Jun2021. Updated clinical course was as follows: On 05Jun2021 at 04:18 (1 day after the vaccination), the patient was found in a state of loss of consciousness (also reported as consciousness disturbed). At 05:12, the patient was transferred to the hospital. He was in cardio-respiratory arrest. At 05:27, the patient''s death was pronounced. After the patient died, autopsy imaging was performed. CT of the whole body (Jun2021) did not identify the cause of death. The primary reporting physician classified the event as serious (death) and assessed that the event was possibly related to BNT162B2. The additional reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician''s comment: After an autopsy, forensic dissection was considered to be needed. It was planned to be conducted on 06Jun2021.; Reported Cause(s) of Death: cardio-respiratory arrest; consciousness disturbed/found in a state of loss of consciousness


VAERS ID: 1390458 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021665737

Write-up: Death; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient (demographics unknown) received BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unknown route, on unknown date at 0.3 ml single for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On unspecified date, the patient died after receiving BNT162B2 vaccination. The cause of death was not reported. It was not reported if an autopsy was performed. Information about Batch/Lot number has been requested.; Sender''s Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on current convention, the case of death is assessed as related to BNT162B2 until sufficient information is available to confirm an unrelated cause of death. Additional information including concomitant medications and their indications, concurrent medical conditions, medical history, autopsy report (if done)is needed to better assess this report. 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: 1390459 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living in nursing home
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021665748

Write-up: Cardiac failure; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A female patient in her 80s received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unspecified route of administration, in May2021 at single dose for COVID-19 immunisation. The patient was in her 80s at the time of the vaccination. The patient was a residence of the special elderly nursing home. No additional medical history was provided. No relevant concomitant medications were provided. On an unspecified date, the patient died due to cardiac failure after receiving the first dose of BNT162b2 vaccination. The details such as the date of death and the patient''s background could not be confirmed at the time of the report. It was not reported if an autopsy was performed. Information about Batch/Lot number has been requested.; Sender''s Comments: Based on chronological connection to the vaccine causality between evet "patient died due to cardiac failure after receiving the first dose of BNT162b2 vaccination" and BNT162B2 (COMIRNATY) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : JP-PFIZER INC-2021665738 Same product and reporter, different AE and patient; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1390462 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, COVID-19, Decreased appetite, Delirium, Disorientation, Drug ineffective, Pneumonia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 49
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: body temperature; Result Unstructured Data: Test Result:elevation; Test Date: 2021; Test Name: Covid-19 test; Test Result: Positive ; Comments: Covid-19 found
CDC Split Type: LTPFIZER INC2021627269

Write-up: Delirious; Disorientation; Temperature elevation; Pneumonia; Vomiting; Appetite lost; Drug ineffective; COVID-19 test positive; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority. An 87-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on Apr2021 (Batch/Lot Number: asked but unknown) as 1ST DOSE, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced covid-19 test positive and drug ineffective in 2021, and experienced delirious, disorientation, temperature elevation, pneumonia, vomiting and appetite lost in Apr2021. The case considered serious due to death, hospitalization. During 24 hours after vaccination patient started vomiting, had no appetite, his body temperature elevated. Ambulance was called out for a few times, unspecified medicines were injected. As condition of the patient didn''t get better, he was hospitalized in Covid-19 department for more than 3 weeks. Patient was diagnosed with pneumonia, treatment with oxygen applied, he was delirious, disorientated, didn''t recognize people. Covid-19 test was done at the hospital - positive. Patient died at the hospital on 20May2021. It is unknown if autopsy was done. No follow-up attempts are possible, information on batch number cannot be obtained. ; Reported Cause(s) of Death: pneumonia; covid-19 test positive; drug ineffective; delirious; disorientation; temperature elevation; vomiting; appetite lost


VAERS ID: 1390471 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-14
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back disorder, Death, Decreased appetite, Dysstasia, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MTPFIZER INC2021630029

Write-up: unable stand straight due back issue; unable stand straight due back issue/back paralysed; blood clots; loss appetite; died; This is a spontaneous report from a contactable consumer via the Regulatory Authority. A male patient (father in law of the reporter) of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died on 14May2021 after 2nd covid vaccine day, after 1st vaccine started high blood pressure, previously no blood pressure problems, started loss appetite, eat drink previously always thinking next meal drink, blood pressure continued rising taken hospital, released day after 2nd vaccine could not get out bed, back paralysed, previously no physical movement problems, unable stand straight due back issue taken again hospital, diagnosed blood clots went out hospital. The patient died on 14May2021. It was not reported if an autopsy was performed. The outcome of event died was fatal, of other events was unknown.; Reported Cause(s) of Death: died


VAERS ID: 1390507 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COUMARIN
Current Illness: Acute coronary syndrome; Peripheral arterial disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021628443

Write-up: Found dead, acute circulatory arrest; This is a serious spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00555368. A 74-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 21May2021 (Batch/Lot number was not reported) as 0.3ml single dose for covid-19 immunisation. Medical history included ongoing acute coronary syndrome and Peripheral arterial disease. The patient previously took the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on unspecified date as 0.3ml single dose for covid-19 immunisation. The patient previous not had COVID-19 infection. Concomitant medications included coumarin via anticoagulation clinic taken for an unspecified indication, start and stop date were not reported. The patient died 2 days after covid vaccine on 23May2021. In history known with peripheral arterial vascular disease for which also treatment with coumarin derivative and acute coronary syndrome some years ago. In the week of death no other acute concomitant disease that was a direct cause of death. Found dead at home during weekend shift. Found dead, acute circulatory arrest. It was unknown if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Found dead, acute circulatory arrest


VAERS ID: 1390508 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-11
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, 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: 2021-05-03
   Days after onset: 32
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: Coronary thrombosis (About 4 years ago); Thrombosis leg (About 4 years ago thrombosis in leg)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021627686

Write-up: 2 weeks after 1st vaccination blood clot in brain (stroke) (meanwhile deceased); arteries in both legs closed; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00556053. A 77-years-old male patient received BNT162B2 (Comirnaty; formulation: Solution for injection, Lot number: unknown and expiry date: unknown) dose 1 via an unspecified route of administration on 11Apr2021 (at the age 77 year old) as first dose single dose for COVID-19 immunisation. patient medical history included thrombosis in leg from 2017 to an unknown date About 4 years ago and Coronary thrombosis. The patient''s concomitant medications were not reported. patient had not Previous COVID-19 infection. On an unspecified date in Apr2021 patient arteries in both legs were closed, on 26Apr2021 2 weeks after 1st vaccination blood clot brain (stroke) (meanwhile deceased). patient was died on 03May2021. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained. ; Reported Cause(s) of Death: Blood clot in left hemisphere (stroke) 2 weeks after vaccination! 6 days after vaccination arteries in both legs closed


VAERS ID: 1390509 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASCAL [CARBASALATE CALCIUM]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021627814

Write-up: Cerebrovascular accident; First dose on 22Feb2021, second dose on 12Apr2021; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00556429. A 95-year-old female patient received BNT162B2 (COMIRNATY) second dose on 12Apr2021 (95-year-old) at 0.3 ml single for COVID-19 immunisation. Previous COVID-19 infection was no. Medical history was not reported. Concomitant medications included carbasalate calcium (ASCAL, strength 600 mg). Historical vaccine included first dose of BNT162B2 (COMIRNATY) on 22Feb2021 at 0.3 ml for COVID-19 immunization. Patient experienced cerebrovascular accident on 13May2021. Patient died due to cerebrovascular accident on unspecified date. It was unknown if autopsy was done. Treatment: Cerebrovascular accident is treated with antistolling clopidogrel (was already treated with ascal). No follow-up attempts possible. Batch/LOT number cannot be obtained.; Reported Cause(s) of Death: Cerebrovascular accident


VAERS ID: 1390510 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Epilepsy, Pulmonary embolism
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   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: NLPFIZER INC2021645712

Write-up: Lung embolism; Cerebral haemorrhage; Epileptic seizure; This is a spontaneous report received from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00559335. A 74-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, 0.3ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Past drug therapy BioNTech/Pfizer vaccine (Comirnaty). No Previous COVID-19 infection. The patient experienced lung embolism, cerebral haemorrhage, and epileptic seizure on 07Apr2021 (7 days after start). The patient died on 09Apr2021. It was not reported if an autopsy was performed. Case narrative: This serious spontaneous report from a consumer or other non-health professional concerns a male aged 74 years, with cerebral haemorrhage (death), lung embolism (death), epileptic seizure (death) following administration of covid-19 vaccin pfizer injvlst for covid 19 immunisation. The outcome of cerebral haemorrhage, epileptic seizure and lung embolism is fatal. BSN available: yes. Additional information ADR: My brother passed away as a result. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Lung embolism; cerebral hemorrhage; epileptic seizure


VAERS ID: 1390511 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood test, Cardiac failure, Dyspnoea, Echocardiogram, Electrocardiogram, Lung disorder, Oxygen saturation decreased, Pericardial effusion, Pleural effusion, Pneumonia, Renal failure, Ultrasound chest
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Arthritis (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AIRFLUSAL; METFORMINE [METFORMIN]; SALBUTAMOL; TOLBUTAMIDE; SPIRIVA RESPIMAT; MICARDIS; EZETIMIBE; COLECALCIFEROL; TESAVEL; ACETYLSALICYLZUUR; PANTOPRAZOL [PANTOPRAZOLE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disorder NOS; COPD; Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:significant damage to the heart, pneumonia.; Comments: overall tests showed significant damage to the heart and a pneumonia; Test Name: Ultrasound heart; Result Unstructured Data: Test Result:significant damage to the heart, pneumonia.; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:significant damage to the heart, pneumonia.; Comments: overall tests showed significant damage to the heart and a pneumonia; Test Name: ultrasound lungs; Result Unstructured Data: Test Result:significant damage to the heart, pneumonia.; Comments: overall tests showed significant damage to the heart and a pneumonia
CDC Split Type: NLPFIZER INC2021645747

Write-up: Renal failure; Lung disorder; Pneumonia; Cardiac failure (NOS); Dyspnoea; fluid accumulation around the lungs and heart; fluid accumulation around the lungs and heart; Oxygen saturation low; Shoulder blade pain; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00560615. A 74-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: Unknown) as 0.3 ml single dose for COVID-19 immunisation. Medical history included diabetes mellitus, chronic obstructive pulmonary disease (COPD), cardiovascular disorder NOS (cardiovascular disease). Concomitant medications included fluticasone propionate, salmeterol xinafoate (AIRFLUSAL); metformine; salbutamol; tolbutamide; tiotropium bromide (SPIRIVA RESPIMAT); telmisartan (MICARDIS); ezetimibe; colecalciferol; sitagliptin phosphate (TESAVEL); acetylsalicylzuur; pantoprazol. The patient experienced shoulder blade pain on 03Apr2021 (1 days after start) event reported as non-serious, initially it was thought to be myalgia. Later it turned out to be problem around his heart, and experienced oxygen saturation low, severe dyspnoea which was caused by fluid accumulation around the lungs and heart, pneumonia, cardiac failure (NOS) on 04Apr2021 (2 days after start), renal failure, lung disorder on unknown date, events were reported as death, hospitalization, life threatening. Patient was admitted to the hospital from 05Apr2021 until 12Apr2021 with severe dyspnoea and lowered oxygen saturation. Patient was discharged and was readmitted on 28Apr2021 until he died on 10May2021. It is not yet known why he was readmitted to the hospital. Hospitalization information also reported as severe shortness of breath, low statutory. In hospital from April 5-12, 2021 and from 28Apr to 10May2021. Treatment: Patient was treated with adjusting medication in the hospital. The outcome of event shoulder blade pain was unknown. The outcome of rest events was fatal. The patient died on 10May2021. It was unknown if an autopsy was performed and the reported cause of death was lung failure, kidney failure, heart failure, oxygen saturation low, dyspnoea, pneumonia, lung disorder, bilateral pleural effusion and pericardial effusion.; Reported Cause(s) of Death: lung failure; Kidney failure; Heart failure; oxygen saturation low; dyspnoea; pneumonia; lung disorder; fluid accumulation around the lungs and heart; fluid accumulation around the lungs and heart


VAERS ID: 1390517 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-05-11
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Hypoxia, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (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: 2021-05-16
   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: LEVAXIN; ATORVASTATIN XIROMED; CLOPIDOGREL ARISTO; METOPROLOL; ALENDRONAT SANDOZ; CIRCADIN; CALCIGRAN FORTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Cardiovascular disorder NOS; Hypothyreosis; Living in residential institution; Myocardial infarction; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: B.1.1.7 lineage (VOC 202012/01)
CDC Split Type: NOPFIZER INC2021628485

Write-up: covid-19 infection/vaccination failure and lack of drug effect; covid-19 infection; FEVER; COUGH; Hypoxia, oxygen deficient; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-U9pgj7. An 87-year-old-male patient received 1st dose of bnt162b2 (COMIRNATY) on 04Feb2021 (lot number: EJ6789) and 2nd dose (lot number: EP9605) administered in left arm on 05Mar2021 both via intramuscular at single dose for vaccination. The medical history included living in residential institution, alzheimers disease, cardiovascular disorder NOS, osteoporosis, hypothyreosis, myocardial infarction. Concomitant medication the patient was given included alendronate sodium (ALENDRONAT SANDOZ) for osteoporosis, atorvastatin calcium (ATORVASTATIN XIROMED) for hypercholesterolaemia, calcium carbonate/colecalciferol (CALCIGRAN FORTE) for thrombosis prophylaxis, melatonin (CIRCADIN) for sleep disorder, clopidogrel bisulfate (CLOPIDOGREL ARISTO), levothyroxine sodium (LEVAXIN) for hypothyroidism, metoprolol for hypertension. On 11May2021, the patient developed fever and cough. On 12May2021, the patient took a COVID-test with positive result, thereby confirming COVID-19, vaccination failure and lack of drug effect. The patient developed hypoxia, which demanded oxygen therapy. The patient received palliative care and died peacefully but related to worsening on 16May2021. Cause of death was reported COVID-19. No autopsy was done. Relevant laboratory findings and investigations included in the report SARS-COV-2 PCR TEST on 12May2021 with result positive, B.1.1.7 lineage (VOC 202012/01). The outcome of events was fatal. The Regional Pharmacist assessed the causal relationship between bnt162b2 (COMIRNATY) and Pyrexia, Oxygen therapy, Cough, Hypoxia, COVID-19 events as No relationship. The Regional Pharmacist assessed the causal relationship between bnt162b2 (COMIRNATY) and Vaccination failure, Drug ineffective events as Possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: covid-19; COVID-19


VAERS ID: 1390542 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH A4DEY4834 / EY4 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC2021653040

Write-up: 2 days after vaccination, patient was found dead in his residence.; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300075783. A 58-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 19May2021 (at the age of 58 years old) (Lot Number: A4DEY4834 / EY4834) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that 2 days after vaccination, patient was found dead in his residence on 21May2021 3:00. The patient died on an unspecified date in May2021. It was unknown if an autopsy was performed. Outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: 2 days after vaccination, patient was found dead in his residence.


VAERS ID: 1390543 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram, Vaccination site pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210519; Test Name: ECG; Result Unstructured Data: Test Result:trop-I negative
CDC Split Type: PHPFIZER INC2021653379

Write-up: pain in injection site radiating to chest; pain in injection site radiating to chest; This is a spontaneous report from a contactable other health professional. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300075861 and PH-PHFDA-300078120. A 73-year-old male patient received the BNT162B2 (COMIRNATY, lot number: EY4834 and expiration date not provided), via intramuscular, on 19May2021 (at the age of 73-year-old), at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. At 15:42, patient arrived in Emergency Room (ER) with complaint of pain in injection site radiating to chest (death) on 19May2021. Lab data included Electrocardiogram (ECG) done was trop-I negative on 19May2021. The outcome of the events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: PAIN IN INJECTION SITE RADIATING TO CHEST; PAIN IN INJECTION SITE RADIATING TO CHEST


VAERS ID: 1390544 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Dysarthria, Fall, Hemiparesis, Hypersomnia
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC2021653380

Write-up: Loss of appetite; Slurred speech; left side body weakness; increase in sleeping; fell from his bed; This is a spontaneous report from a contactable other healthcare professional (HCP). This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300078646. A 66-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 17May2021 (Batch/Lot Number: EY4834) at the age of 66-years-old as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. 4 days ''PTC'', noted to have decrease in sensorium characterized as slurring of speech and weakness on the left side of the body, patient was also reported to have increase in sleeping time and decrease in appetite on 18May2021. No medications were taken. No consult done. Patient''s relatives opted to observe the patient at home. Interim showed persistence of symptoms until. On the day of consult (4 am) (unknown date in 2021), patient fell from his bed and was noted to be unresponsive. This prompted consult at the Emergency Room (ER). The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Slurred speech; left side body weakness; Loss of appetite; increase in sleeping; fell from his bed


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