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

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



Case Details

This is page 118 out of 172

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VAERS ID: 1338213 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-09
Submitted: 0000-00-00
Entered: 2021-05-21
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: AUPFIZER INC2021559013

Write-up: Adverse event following immunisation with outcome fatal; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 550219. A 79-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on an unspecified date at single doses for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced adverse event following immunization on 09May2021 with outcome of fatal. The Medicine/Onset Time in Days with event ''adverse event following immunization'' reported as 5 days. The patient died in 2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Adverse event following immunisation with outcome fatal


VAERS ID: 1338217 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001176 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Blood creatinine, Blood potassium, Blood sodium, C-reactive protein, Chest X-ray, Death, Glycosylated haemoglobin, Infection, Pollakiuria, Ultrasound kidney, Urine albumin/creatinine ratio, Urogram, White blood cell count
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: 2021-04-08
   Days after onset: 37
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: Albuminuria; Confused; Diabetes (present through a longer period); Fall (Fell mutiple times during hospitalisation); Hypertension; Hyperthyroidism; Renal failure (kidney failure had been present for a longer period)
Preexisting Conditions: Medical History/Concurrent Conditions: Polio
Allergies:
Diagnostic Lab Data: Test Name: Creatinine; Result Unstructured Data: Elevating during hospitalisation from 214 ?mol/L to 337 ?mol/L; Test Name: Potassium; Result Unstructured Data: nothing abnormal; Test Name: Sodium; Result Unstructured Data: Nothing abnormal; Test Date: 20210407; Test Name: Thorax X-ray; Result Unstructured Data: small pleural accumulation, no obvious infiltrates; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: No results were provided.; Test Date: 20210405; Test Name: C-reactive protein; Result Unstructured Data: elevating to 225 mg/L; Test Name: HbA1C; Test Result: Inconclusive ; Result Unstructured Data: No results were provided.; Test Name: Ultrasound kidney; Result Unstructured Data: No drainage obstruction; Test Name: Urine albumin/creatinine ratio; Test Result: Inconclusive ; Result Unstructured Data: No results were provided.; Test Name: CT Urography; Result Unstructured Data: Cholecystolithiasis, normal size kidney; Test Name: Leukocyte count; Test Result: Inconclusive ; Result Unstructured Data: Not convincingly decreasing during hospitalisation
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: Kidney failure Can have been present through a longer period.; Death; Infection during hospitalisation increasing infection parameters; Frequent urination; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), ACUTE KIDNEY INJURY (Kidney failure Can have been present through a longer period.), INFECTION (Infection during hospitalisation increasing infection parameters) and POLLAKIURIA (Frequent urination) in an 83-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001176) for COVID-19 vaccination. The patient''s past medical history included Polio. Concurrent medical conditions included Hyperthyroidism since 30-Mar-2021, Renal failure (kidney failure had been present for a longer period), Hypertension, Albuminuria since 30-Mar-2021, Fall (Fell mutiple times during hospitalisation), Diabetes (present through a longer period) and Confused since 30-Mar-2021. On 18-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In March 2021, the patient experienced POLLAKIURIA (Frequent urination) (seriousness criterion hospitalization). On 01-Apr-2021, the patient experienced INFECTION (Infection during hospitalisation increasing infection parameters) (seriousness criterion hospitalization). On an unknown date, the patient experienced ACUTE KIDNEY INJURY (Kidney failure Can have been present through a longer period.) (seriousness criteria hospitalization and medically significant). The patient died on 08-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ACUTE KIDNEY INJURY (Kidney failure Can have been present through a longer period.), INFECTION (Infection during hospitalisation increasing infection parameters) and POLLAKIURIA (Frequent urination) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, C-reactive protein: 225 (High) elevating to 225 mg/L. On 07-Apr-2021, Chest X-ray: abnormal (abnormal) small pleural accumulation, no obvious infiltrates. On an unknown date, Blood creatinine: 337 (High) Elevating during hospitalisation from 214 ?mol/L to 337 ?mol/L. On an unknown date, Blood potassium: normal (normal) nothing abnormal. On an unknown date, Blood sodium: normal (normal) Nothing abnormal. On an unknown date, C-reactive protein: unknown (Inconclusive) No results were provided.. On an unknown date, Glycosylated haemoglobin: unknown (Inconclusive) No results were provided.. On an unknown date, Ultrasound kidney: normal (normal) No drainage obstruction. On an unknown date, Urine albumin/creatinine ratio: unknown (Inconclusive) No results were provided.. On an unknown date, Urogram: abnormal (abnormal) Cholecystolithiasis, normal size kidney. On an unknown date, White blood cell count: unknown (Inconclusive) Not convincingly decreasing during hospitalisation. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. This is a case of death in a 83-year-old male subject with a medical history of HTN, DM and Hyperthyroidism, who died 21 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 83-year-old male subject with a medical history of HTN, DM and Hyperthyroidism, who died 21 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Death


VAERS ID: 1338219 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-04-05
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000489 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute coronary syndrome, Dyspnoea, Hypokalaemia, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Myocardial infarction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypokalaemia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LOSARSTAD; METOPROLOL; NORVASC; CENTYL MED
Current Illness: Aortic stenosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: acute coronary syndrome; Hypokalaemia; Oedema; Dyspnoea; This regulatory authority case was reported by a physician and describes the occurrence of ACUTE CORONARY SYNDROME (acute coronary syndrome), HYPOKALAEMIA (Hypokalaemia), OEDEMA (Oedema) and DYSPNOEA (Dyspnoea) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000489) for COVID-19 vaccination. Concurrent medical conditions included Aortic stenosis. Concomitant products included LOSARTAN POTASSIUM (LOSARSTAD) from 29-Oct-2009 to an unknown date, METOPROLOL from 08-Nov-2010 to an unknown date, AMLODIPINE BESILATE (NORVASC) from 22-Jun-2018 to an unknown date and BENDROFLUMETHIAZIDE, POTASSIUM CHLORIDE (CENTYL MED) from 09-Sep-2014 to an unknown date for Hypertension. On 27-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ACUTE CORONARY SYNDROME (acute coronary syndrome) (seriousness criteria death, hospitalization, medically significant and life threatening), HYPOKALAEMIA (Hypokalaemia) (seriousness criteria hospitalization and medically significant), OEDEMA (Oedema) (seriousness criterion hospitalization) and DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization). The patient died on 10-Apr-2021. The reported cause of death was Acute coronary syndrome. An autopsy was performed, but no results were provided. At the time of death, HYPOKALAEMIA (Hypokalaemia), OEDEMA (Oedema) and DYSPNOEA (Dyspnoea) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. This is a case of death in a 79-year-old male subject with unknown medical history of HTN, and Aortic stenosis, who died 14 days after receiving the first dose of vaccine. Based on information received, patient''s rage and risk factors for acute coronary syndrome, the events are assessed as unlikely related to mRNA-1273.; Sender''s Comments: This is a case of death in a 79-year-old male subject with unknown medical history of HTN, and Aortic stenosis, who died 14 days after receiving the first dose of vaccine. Based on information received, patient''s rage and risk factors for acute coronary syndrome, the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Acute coronary syndrome


VAERS ID: 1338222 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Acute respiratory distress syndrome, Atrioventricular block, Blood bicarbonate, Blood bilirubin, Blood creatine, Blood creatine phosphokinase, Blood lactic acid, Blood potassium, Blood sodium, Bradycardia, Brain natriuretic peptide, C-reactive protein, Cardiac arrest, Cardio-respiratory arrest, Constipation, Echocardiogram, Electrocardiogram, Fibrin D dimer, Haemoglobin, Hyperkalaemia, Hyperlactacidaemia, Investigation, Lipase, Multiple organ dysfunction syndrome, Myalgia, PCO2, PO2, Platelet count, Psychomotor skills impaired, Troponin, White blood cell count, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VALSARTAN HCT; BISOPROLOL; KARDEGIC; PARIET; ZOCOR; SERETIDE; IKOREL; FLUTICASONE PROPIONATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD (smoker who quit $g 20 years ago); Dyslipidaemia; Hypertension arterial; Infarct myocardial (myocardial infarction, stented in 2002,); Polyposis coli (operated colic polyps); Prostate resection; Varicose vein operation (bilateral varicose stripping,)
Allergies:
Diagnostic Lab Data: Test Name: bicarbonates; Result Unstructured Data: Test Result:7.1 mmol/L; Test Name: Bilirubines; Result Unstructured Data: Test Result:6 mg/l; Test Name: Creatine; Result Unstructured Data: Test Result:20.1 mg/l; Test Name: Creatine phosphokinase; Result Unstructured Data: Test Result:168UI/l; Test Name: Lactic acid; Result Unstructured Data: Test Result:13.34 mmol/L; Test Name: Potassium; Result Unstructured Data: Test Result:7.3 mmol/L; Test Name: Sodium; Result Unstructured Data: Test Result:136 mmol/L; Test Name: Brain natriuretic peptide; Result Unstructured Data: Test Result:2002 pg/mL; Test Name: C-reactive protein; Result Unstructured Data: Test Result:<2.90 mg/l; Test Name: Trans-thoracic echocardiogram; Result Unstructured Data: Test Result:Good left ventricular..; Comments: ..no evidence for a pulmonary embolism, good kinetic, preserved ejection fraction, hypovolaemia; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Bradycardia to wide QRS; Test Name: D-dimers; Result Unstructured Data: Test Result:3.37; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.8 g/dl; Test Name: Chlorine; Result Unstructured Data: Test Result:106 mmol/L; Test Name: glutamate-oxaloacetate-transaminase; Result Unstructured Data: Test Result:327UI/l; Test Name: glutamate-oxaloacetate-transaminase; Result Unstructured Data: Test Result:206 UI/l; Test Name: Lipase; Result Unstructured Data: Test Result:196UI/l; Test Name: partial pressure of carbon dioxide; Result Unstructured Data: Test Result:32.5; Test Name: pH; Result Unstructured Data: Test Result:6.9; Test Name: platelets; Result Unstructured Data: Test Result:235 g/l; Test Name: partial pressure of oxygen; Result Unstructured Data: Test Result:258; Test Name: High-sensitive troponin; Result Unstructured Data: Test Result:81.7 pg/mL; Test Name: Leukocytes; Result Unstructured Data: Test Result:14.2 g/l
CDC Split Type: FRPFIZER INC2021553639

Write-up: acute respiratory distress syndrome; acute renal failure; multi-visceral failure; hyperlactaemia; asystole; Cardio-respiratory arrest; Atrioventricular block; constipation; hyperkalemia; Psychomotor skills impaired/psychomotor slowdown; bradycardia; myalgia; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number FR-AFSSAPS-LL20212868 An 89 years old male patient receive second dose of BNT162B2 (COMIRNATY), intramuscular, lot not specified, on 16Feb2021 for covid-19 immunization. Patient with a Medical History of dyslipidemia, hypertension, myocardial infarction stented in 2002, chronic obstructive pulmonary disease (smoker who quit $g 20 years ago), bilateral varicose stripping, operated colic polyps, transurethral prostate resection. Concomitant drugs included bisoprolol, acetylsalicylate lysine (KARDEGIC), rabeprazole sodium (PARIET, 10mg), simvastatin (ZOCOR, 40mg), fluticasone propionate/salmeterol xinafoate (SERETIDE, 2X2/day), fluticasone propionate, salmeterol xinafoate (IKOREL), hydrochlorothiazide/valsartan (VALSARTAN HCT 160mg/12.5mg). Historical Vaccine was 1st dose of COMIRNATY in Jan2021 for covid-19 immunization. Thereafter, onset of myalgia, constipation, psychomotor slowdown described by his wife. On 19Feb2021, around 12:00, the patient described violent abdominal pain. He reported to Emergency Room. At the Emergency department: a few minutes after he arrived, cardiac arrest with asystole - no flow < 2 minutes, low flow 10 minutes. orotracheal intubation 7.5 / Adrenalin 5mg/2 ampoules of Bicarb 8.4%. Trans-thoracic echocardiogram: Good left ventricular, no evidence for a pulmonary embolism, good kinetic, preserved ejection fraction, hypovolaemia. Atrioventricular block 3 with new cardiocirculatory arrest no flow 0 low flow 4 minutes. Administration of ISUPREL rapidly increased to 8mg/h (v40). Electrolyte check: correction of hyperkalemia (5). Multiple cardiac arrests < 2 minutes with extreme bradycardia. Summary: Adrenalin 15mg. Vascular filling 4l given the +++hypovolemic profile on the trans-thoracic echocardiography. Bicarb molar 500ml given severe metabolic acidosis. Motor reaction to the pain without contact requiring the introduction of hypnovel + Ultiva + curarisation. Transfer to the intensive care unit. 20Feb2021: persistence of hemodynamic instability, continuation of vascular filling and increase in amines, transition towards a syndrome of multi-visceral failure acute respiratory distress syndrome acute renal failure with hyperkalaemia, hyperlactaemia, palliative situation, comfort care, continuation of end-of-life sedation, no renewal of supportive treatments. 21Feb2021: patient died. Outcome of the events were fatal. It was unknown whether autopsy was done. Scanner: Cranium: No bleeding, no parenchymal anomalies; Thorax: No endoluminal defect in the pulmonary arteries No pleural-pericardial effusion. No adenomegaly. Parenchyma: Subject to kinetic artefacts. Presence of some bilateral condensing infiltrates of a non-specific appearance associated with thickening of the interlobe septa predominant at the apex. Abdomen-pelvis: No peritoneal effusion. No pneumoperitoneum. No individualised collection. No dilation of the pyelocaliceal cavities. Good permeability of the mesenteric arteries. No anomalies of the small intestines. SUMMARY: No pulmonary embolism or evidence of mesenteric ischemia. Electrocardiogram: Bradycardia to wide QRS. Blood panel assessment (in cardiac arrest): Leukocytes 14.2g/l, haemoglobin 10.8g/dL, platelets 235g/l. D-dimers 3.37. pH 6.9, partial pressure of carbon dioxide 32.5, partial pressure of oxygen 258, bicarbonates 7.1mmol/l. Creatine 20.1mg/l, Chlorine 106 mmol/l, Sodium 136mmol/l, Potassium 7.3 mmol/l, Lactic acid 13.34mmol/l,Bilirubines6mg/l,C-reactiveprotein<2.90mg/l, glutamate-oxaloacetate-transaminase 327UI/l, glutamate-oxaloacetate-transaminase 206 UI/l, Creatine phosphokinase 168UI/l, Lipase 196UI/l, Brain natriuretic peptide 2002pg/ml, High-sensitive troponin 81.7pg/ml. other aetiologies: Functional acute renal failure with dehydration and betablocker + angiotensin-converting enzyme inhibitor + calcium inhibitor overdose. The patient was also confused, and could not remember whether or not he had taken his medication. Possible accidental overdose associated with a double dose the previous day? Treatment with adrenaline, filling and bicarbonates. In summary, III atrioventricular block and cardiac-respiratory arrest at Day 3 from vaccination Dose 2 in a patient with a cardiovascular medical history. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: asystole; hyperkalemia; bradycardia; multi-visceral failure; Psychomotor skills impaired/psychomotor slowdown; Cardio-respiratory arrest; Atrioventricular block; Acute respiratory distress syndrome; hyperlactaemia; acute renal failure; myalgia; const


VAERS ID: 1338262 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-18
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   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: Bone metastases; Hypertension arterial; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: febrile; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210418; Test Name: Sars-cov-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021553633

Write-up: drug ineffective; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable other hcp downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-RN20211289. A 73-years-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 13Feb2021 (Lot Number: EM0477) as 1st dose, single, second dose intramuscular on 03Apr2021 (Lot Number: EJ6788) as 2nd dose, single, for covid-19 immunisation. Medical history included ongoing Bone metastases, ongoing type 2 diabetes mellitus , ongoing Hypertension arterial , covid-19. The patient''s concomitant medications were not reported. Symptoms included flu syndrome (asthenia and febrile 38C) from 14Apr2021, as well as diarrhoea on 22Apr2021. Patient positive for Covid-19. COVID-19 test on 18Apr2021 was positive. On 04May2021, the patient was dead. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test; drug ineffective


VAERS ID: 1338273 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-10-01
Onset:2021-04-13
   Days after vaccination:194
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiotensin converting enzyme, Blood pressure measurement, Blood test, Coma scale, Computerised tomogram, Heart rate, Scan brain, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ROSUVASTATIN; ACEBUTOLOL; KARDEGIC; PERINDOPRIL; PERMIXON; TARDYFERON; PANTOPRAZOLE; CALCIUM LEVOFOLINATE; FLUOROURACILE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of colon (Hepatic metastatic colonic adenocarcinoma); Arterectomy (TAVI with arterial resection in 2019); Benign prostatic hyperplasia; Cholecystectomy; Drug allergy (Allergies: EFFERALGAN); Extracorporeal shock wave lithotripsy (2 extracorporeal lithotripsy); Gastrectomy total (for MALT lymphoma in 1996); Hepatic cancer metastatic (Hepatic metastatic colonic adenocarcinoma); Hypertension arterial; Ischaemic heart disease; MALT lymphoma; Metastases to lung (Lieberkuhnien adenocarcinoma diagnosed with synchronous hepatic and pulmonary metastases.); Penicillin allergy; Skin carcinoma (Epithelial carcinomas of the scalp); TAVI (TAVI with arterial resection in 2019); Triple vessel bypass graft (Triple coronary artery bypass surgery in 2012); Urinary calculus (Urinary lithiasis (2 extracorporeal lithotripsy))
Allergies:
Diagnostic Lab Data: Test Name: angiotensin-converting enzyme; Result Unstructured Data: Test Result:929; Test Name: angiotensin-converting enzyme; Result Unstructured Data: Test Result:56; Test Date: 20210413; Test Name: Blood pressure; Result Unstructured Data: Test Result:168/77; Comments: Upon arrival of the Emergency medical assistance service; Test Date: 20210413; Test Name: blood bradykinin concentration; Result Unstructured Data: Test Result:unknown results; Comments: Upon arrival of the Emergency medical assistance service; Test Date: 20210413; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:7; Comments: Upon arrival of the Emergency medical assistance service; Test Name: Computed tomography scan; Result Unstructured Data: Test Result:diminution of the hepatic lesions with thoracic st; Comments: diminution of the hepatic lesions with thoracic stability; Test Date: 20210413; Test Name: Computed tomography scan; Result Unstructured Data: Test Result:Emergency cerebral computed tomography: Fisher 4 s; Comments: Emergency cerebral computed tomography: Fisher 4 sub-arachnoid haemorrhage with damage to the left temporal horn and significant intracranial hypertension.; Test Date: 20210413; Test Name: heart rate; Result Unstructured Data: Test Result:98; Comments: Upon arrival of the Emergency medical assistance service; Test Date: 20210413; Test Name: Cerebral scan; Result Unstructured Data: Test Result:Predominantly peri-mesencephalic meningeal haemorr; Comments: Predominantly peri-mesencephalic meningeal haemorrhage, and in the occipital cortical sulci. Tetra-ventricular hematic flooding leading to upstream hydrocephalus with early transependymal resorption disorders. No aneurism seen in the Willis polygon arteries. Mesencephalic oedema.
CDC Split Type: FRPFIZER INC2021553668

Write-up: Subarachnoid hemorrhage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-SE20211054 , Safety Report Unique Identifier FR-AFSSAPS-2021052754.Telephone declaration on 29Apr2021, medically confirmed. An 85-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 22Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation; bevacizumab (ZIRABEV), intravenous (IV) drip from 01Oct2020 (Batch/Lot number was not reported) to 08Apr2021, at 5 mg/kg, frequency as every14 days for adenocarcinoma of colon. The patient''s medical history included hypertension arterial; MALT (mucosa-associated lymphoid tissue) lymphoma; Ischaemic heart disease; Benign prostatic hyperplasia; Urinary lithiasis (2 extracorporeal lithotripsy); Epithelial carcinomas of the scalp; Hepatic metastatic colonic adenocarcinoma. Surgeries history also reported Total gastrectomy for MALT lymphoma in 1996; Cholecystectomy in 2006; Triple coronary artery bypass surgery in 2012; and TAVI with arterial resection in 2019. Patient has allergies to PENICILLIN and "EFFERALGAN ?" (Toxic: 0). COVID-19 HISTORY: patient was at risk of developing a severe form of COVID-19, patient was with no history of COVID-19, it was unknown if patient had been tested for COVID-19. ONCOLOGY HISTORY: in Jul2020, Lieberkuhnien adenocarcinoma diagnosed with synchronous hepatic and pulmonary metastases; On 07Sept2020, Multidisciplinary Oncology Digestive meeting: Indication of first chemotherapy of a bio-chemical type plus biotherapy according to the complete molecular biology, then re-evaluation of the surgical project secondarily; On 18Jan2021, Multidisciplinary Oncology Digestive meeting: Assessment after 6 treatments with FOLFOX AVASTIN, significant hypertension and AVASTIN stopped at treatment 5 despite treatment adjustments. Weight loss with poor state of health despite the adapted dosage. Drop in angiotensin-converting enzyme to 56 compared to 929. Computed tomography scan = diminution of the hepatic lesions with thoracic stability. Proposition of maintenance therapy with 5FU hormone therapy. Discussion of reintroduction of BEVACIZUMAB depending on pressure balance; Last chemotherapy treatment on 08Apr2021: Response after 6 treatments with FOLFOX AVASTIN but poor state of health and improved hypertension after dose was adapted. Currently: maintenance with 5Fu plus Bevacizumab with Treatment 1: 11Feb2021, Treatment 2: 25Feb2021, Treatment 3: 11Mar2021, Treatment 4: 25Mar2021, Treatment 5: 08Apr2021. Cure composed of: ZIRABEV (bevacizumab): 5mg/kg, Calcium Levofolinate: 200mg/m?, and Fluorouracile: 400mg/m? slow intravenous plus 2400 mg/m? via mobile diffuser. The patient''s concomitant medications included rosuvastatin 5mg: 0-0-1; acebutolol 200mg: 0.5-0-0; acetylsalicylate lysine (KARDEGIC) 75mg: 0-1-0; perindopril 8mg: 0-0-1; serenoa repens extract (PERMIXON) 160mg: 1-0-1; ferrous sulfate (TARDYFERON) 1-0-0; pantoprazole 20mg: 1-0-0; calcium levofolinate 200mg/m?; and fluorouracil (FLUOROURACILE) 400mg/m? slow intravenous + 2400 mg/m? via mobile diffuser. The patient experienced subarachnoid hemorrhage on 13Apr2021 which resulted in death. The description of the effect and detailed clinical course was follows: On 13Apr2021, treated by the Emergency medical assistance service for neurological issues in a context of metastatic rectal cancer being treated with chemotherapy. Context of balance issues since the previous day (12Apr2021). Last contact with the patient yesterday at 23:00. Patient found at home in a coma since at least this morning. No evidence of a fall or head injury. Upon arrival of the Emergency medical assistance service: Glasgow Coma Scale 7, left hemiparesis with + blood bradykinin concentration. Blood pressure: 168/77. HR: 98. Emergency cerebral computed tomography: Fisher 4 sub-arachnoid haemorrhage with damage to the left temporal horn and significant intracranial hypertension; Neurosurgeon opinion: no surgical evidence or indication selected. IMAGING: Cerebral scan on 13Apr2021: Predominantly peri-mesencephalic meningeal haemorrhage, and in the occipital cortical sulci. Tetra-ventricular hematic flooding leading to upstream hydrocephalus with early transependymal resorption disorders. No aneurism seen in the Willis polygon arteries. Mesencephalic oedema; Urgent neurosurgeon opinion. PROGRESS: patient transferred to the palliative care unit. Death on 18Apr2021. CONCLUSION: patient presented with a meningeal haemorrhage at Day 23 from Dose 1 of COMIRNATY, in a context of chemotherapy for a metastatic adenocarcinoma with treatment 5 of bevacizumab 10 days earlier. The patient died on 18Apr2021. The cause of death was reported as subarachnoid hemorrhage. It was unknown if an autopsy was performed. The outcome of the other events besides subarachnoid hemorrhage was unknown. No follow-up attempts possible. No further information expected. Batch/lot number cannot be obtained.; Reported Cause(s) of Death: Subarachnoid hemorrhage


VAERS ID: 1338276 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-25
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Cardio-respiratory arrest, Ejection fraction, Electrocardiogram, Electroencephalogram, Polymerase chain reaction, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IMOVAN; BIPRETERAX [INDAPAMIDE;PERINDOPRIL ARGININE]; TADENAN; CARDENSIEL
Current Illness: Arrhythmia; Benign prostatic hyperplasia; Hypertension arterial; Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Angioplasty
Allergies:
Diagnostic Lab Data: Test Date: 20210325; Test Name: left ventricular ejection fraction; Result Unstructured Data: Test Result:at 30 percent %; Test Date: 20210325; Test Name: Electrocardiography; Result Unstructured Data: Test Result:STEMI (ST-Elevation Myocardial Infarction) aspect; Comments: in aVR: angioplasty of the IVA (2 stents) and of the circumflex (one stent); Test Date: 20210325; Test Name: Electrocardiography; Result Unstructured Data: Test Result:a frank regression of the repolarization disorder; Comments: but treatment emergent adverse event brings to light severely-altered left ventricular ejection fraction at 30 percent, major kinetic disorder with septo-apical akinesia, hypokinesia of the lateral wall. No hypertrophy or left ventricular dilation. Non-dilated ascending aorta, type II mitral profile, non-dilated atria, non-dilated right ventricle but kinetic altered, dry pericardium.; Test Date: 20210325; Test Name: electroencephalogram; Result Unstructured Data: Test Result:burst suppression-like line with a poor prognosis; Test Date: 20210327; Test Name: electroencephalogram; Result Unstructured Data: Test Result:artefact line; Test Date: 20210329; Test Name: electroencephalogram; Result Unstructured Data: Test Result:flat line; Test Date: 20210325; Test Name: Polymerase Chain Reaction; Test Result: Negative ; Comments: Negative Severe acute respiratory syndrome COV-2 Polymerase Chain Reaction test result.
CDC Split Type: FRPFIZER INC2021553673

Write-up: Tachycardia ventricular; Non ST segment elevation acute coronary syndrome; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [FR-AFSSAPS-ST20211757], Safety Report Unique Identifier [FR-AFSSAPS-2021047013]. A 73-year-old male patient received bnt162b2 (COMIRNATY) intramuscular, administered in Arm Left on 11Mar2021 (Batch/Lot Number: EP9605) as first dose, 0.3 mL, single for covid-19 immunisation. Medical history included ongoing benign prostatic hyperplasia, ongoing obesity, ongoing Hypertension arterial, ongoing arrhythmia/cardiac rhythm disorder, angioplasty of the left anterior descending artery and the convex (a stent). His father died from myocardial infarction and brother had triple bypass surgery. No History of COVID-19. Concomitant medications included zopiclone (IMOVAN); indapamide, perindopril arginine (BIPRETERAX [INDAPAMIDE;PERINDOPRIL ARGININE]); prunus africana extract (TADENAN); bisoprolol fumarate (CARDENSIEL). The patient experienced tachycardia ventricular, non ST segment elevation acute coronary syndrome and cardio-respiratory arrest, all on 25Mar2021. Clinical course as follows: Patient autonomous at home, lives with his wife. 14 days after Dose 1 of the vaccination (25Mar2021): the patient presented with cardiac respiratory arrest in front of his wife while he was driving his car. He had felt a violent pain in his breast before losing consciousness. When the paramedic firefighters arrived they immediately began cardiac pulmonary resuscitation (NO flow 10 minutes), the automatic defibrillator delivered 2 electric shocks then the patient transitioned to non-shockable rhythm (asystole/dissociation) with 8mg of adrenaline (Low flow of 30 minutes). Electrocardiography: STEMI (ST-Elevation Myocardial Infarction) aspect in aVR: angioplasty of the IVA (2 stents) and of the circumflex (one stent). Very calcified tri-trunk lesion on the coronary network. With no sedation the patient did not present with signs of waking no corneal reflex but presented with spontaneous ventilation as well as several episodes of diarrhoea. Negative Severe acute respiratory syndrome COV-2 Polymerase Chain Reaction test result. Progress: Noradrenalin taken for hypotension; ventricular tachycardia bursts regressed with Cordarone. Electrocardiography on 25Mar2021 showed a frank regression of the repolarization disorder but treatment emergent adverse event brings to light severely-altered left ventricular ejection fraction at 30 percent, major kinetic disorder with septo-apical akinesia, hypokinesia of the lateral wall. No hypertrophy or left ventricular dilation. Non-dilated ascending aorta, type II mitral profile, non-dilated atria, non-dilated right ventricle but kinetic altered, dry pericardium. No sign of waking up: Electroencephalogram on 25Mar2021: burst suppression-like line with a poor prognosis; electroencephalogram of 27Mar2021: artefact line, electroencephalogram of 29Mar2021: flat line. Poor neurological prognosis, decision to stop treatment on 31Mar2021, with extubation, heavy sedation and comfort care. Death on 01Apr2021 at 13:19. file discussed with the patient s general practitioner who specified that the patient presented with numerous risk factors, comorbidities (history of resolved severe cardiac rhythm disorder, obesity, hypertension). Conclusion: cardiorespiratory arrest on ACS-ST+ 14 days after D1 with fatal outcome. The patient died on 01Apr2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cardiopulmonary arrest on SCA ST +


VAERS ID: 1338311 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 2 - / -

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

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: GBPFIZER INC2021555125

Write-up: Death; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-APPCOVID-20210516102301. Safety Report Unique Identifier GB-MHRA-ADR 25304752. A 57-year-old female patient received Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose (Batch/lot numer EW4109) on 14May2021 as single dose for COVID-19 immunisation. Medical history included patient has not had symptoms associated with COVID-19, not had a COVID-19 test, unsure if patient is enrolled in clinical trial. Concomitant medications were not reported. The patient was vaccinated under the normal protocol processes. Was observed for 15 minutes and left the premises. Reporter were informed later on the day by the police that the patient has passed away on 14May2021. Not sure if related to the vaccine but needs to be reported. It was unknown if Autopsy Done. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1338994 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-13
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM4965 / 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: 2021-05-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021548908

Write-up: Death sudden; This is a spontaneous report from a contactable physician from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202105141046542160-ORTAS and Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25297408. A 41-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration in May2021 (Batch/Lot Number: EM4965) as single dose (Age at vaccination: unknown) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included COMIRNATY 1st dose, single for covid-19 immunisation. The patient experienced death sudden on 13May2021. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Unsure if patient was enrolled in clinical trial. It is unknown if autopsy was done. No follow-up attempts possible. No further information expected. Information about batch number has been obtained. ; Reported Cause(s) of Death: Death sudden


VAERS ID: 1339006 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-04-25
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Wrong product administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APIXABAN; ATORVASTATIN; BISOPROLOL; BUMETANIDE; BUTEC; COLECALCIFEROL; FERROUS GLUCONATE; LANSOPRAZOLE; MEBEVERINE; MIRABEGRON; MIRTAZAPINE; NOVOMIX; RAMIPRIL; SERTRALINE; SODIUM BICARBONATE; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic kidney disease stage 3; CVA; Heart failure; Hypertension; Ischaemic heart disease; Recurrent urinary tract infection; Type 2 diabetes mellitus; Vascular dementia; Vitamin D deficiency.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021549110

Write-up: first dose COMIRNATY, second dose COVID-19 vaccine astrazeneca; Death; This is a spontaneous report from a contactable physician from the Regulatory Authority. A male patient of an unspecified age received BNT162B2 (COMIRNATY) via an unspecified route of administration on 08Jan2021 (Batch/Lot Number: EL0141) at first dose, single for COVID-19 immunization; COVID-19 vaccine astrazeneca via an unspecified route of administration from 23Apr2021 (Batch/Lot Number: PW40010) at second dose, single for COVID-19 immunization. Patient was not enrolled in clinical trial. Medical history included atrial fibrillation, type 2 diabetes mellitus, vascular dementia, ischaemic heart disease, chronic kidney disease (CKD stage 3), hypertension, cerebro vascular accident (CVA), vitamin D deficiency, heart failure, and recurrent urinary tract infection. Concomitant medication included apixaban for atrial fibrillation; atorvastatin; bisoprolol; bumetanide; buprenorphine (BUTEC); colecalciferol; ferrous gluconate; lansoprazole; mebeverine; mirabegron (MIRABEGRON); mirtazapine; insulin aspart/ insulin aspart protamine (crystalline) (NOVOMIX); ramipril; sertraline; sodium bicarbonate; and tamsulosin. The patient previously received vitamin D. Patient had not had symptoms associated with COVID-19, and had not tested positive for COVID-19 since having the vaccine. Patient collapsed and died at home on 25Apr2021. COVID-19 vaccine astrazeneca is considered as wrong vaccine administered. It was not reported if an autopsy was performed. The cause of death was not reported. The report doesn''t relate to possible blood clots or low platelet counts. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1339081 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-21
Onset:2020-12-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0724 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021545709

Write-up: Cause of death: Anaphylaxis; This is a spontaneous report from a contactable healthcare professional. A 96-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 96-year-old, via an unspecified route of administration on 21Dec2020 (Lot Number: EJ0724) as 1st dose single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had received his first dose of the vaccine back on the 21st December 2020. He had waited for the 15 minutes post-vaccination after which he exited the centre and started walking down the road, then dropped dead shortly after. Cause of death was reported as anaphylaxis on 21Dec2020 caused by the Pfizer COVID-19 vaccine (as confirmed by pathologist but expert to re-confirm this in due course). The patient died on 21Dec2020. It was not reported if an autopsy was performed.; Sender''s Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of anaphylaxis due to temporal relationship and current known drug safety profile. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Anaphylaxis


VAERS ID: 1339116 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-04-05
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Acute respiratory failure, COVID-19, Cardiac arrest, Death, Drug ineffective, Dyspnoea, Pain, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021561186

Write-up: Death; drug ineffective; COVID-19; General body pain; Dyspnoea; Acute respiratory insufficiency; Cardiac arrest; Acute renal insufficiency; Somnolence; This is a spontaneous report from a contactable consumer or other non hcp downloaded from a regulatory authority-WEB GR-GREOF-20213117 A 78-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced drug ineffective on 05Apr2021, covid-19 on 05Apr2021, death on 25Apr2021, acute respiratory insufficiency on an unspecified date, cardiac arrest on an unspecified date, acute renal insufficiency on an unspecified date, general body pain on 05Apr2021, dyspnoea on 05Apr2021, somnolence on 05Apr2021. The patient was hospitalized on 14Apr2021. On 20Apr2021 he was intubated. The patient died on 25Apr2021. Causes of death were: acute renal insufficiency, acute respiratory insufficiency and cadiac arrest. No cases of COVID-19 in the working environment of 5 persons of the deceased , neither on the friend cycle on the reported dates. It was not reported if an autopsy was performed. Time Interval between Beginning of Drug Administration and Start of Reaction / Events: Covid-19, Somnolence, General body pain, Dyspnoea / 5 days Time Interval between Beginning of Drug Administration and Start of Reaction / Event: death / 25 days Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Acute respiratory insufficiency; Cardiac arrest; Acute renal insufficiency


VAERS ID: 1339117 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-04-01
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cerebral haemorrhage, Cerebral ischaemia, Coma scale, Computerised tomogram, Hydrocephalus, Ischaemic stroke, Neurological examination
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   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: APROVEL; PLAVIX; LOSEC [OMEPRAZOLE]; OMEPRAZOLE; APROVEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Transient ischemic attack (Transient ischemic stroke)
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: GCS; Result Unstructured Data: Test Result:climax: GCS E3V4M6 13/15; Test Date: 202104; Test Name: CT Scan; Result Unstructured Data: Test Result:intracerebral hemorrhage; Test Date: 20210419; Test Name: CT Scan; Result Unstructured Data: Test Result:extensive ischemic lesion of right cerebellum; Comments: extensive ischemic lesion of right cerebellum hemisphere with edema and pressure of brain stem on 4th ventricle; Test Date: 20210420; Test Name: CT Scan; Result Unstructured Data: Test Result:CT Scan due to hydrocephalus; Comments: due to relapse neurologically signs she underwent a new CT Scan due to hydrocephalus and it was decided to underwent neurosurgeon procedure (external ventricular drainage); Test Date: 202104; Test Name: neurological examination; Result Unstructured Data: Test Result:remains the same (serious)
CDC Split Type: GRPFIZER INC2021561195

Write-up: Intracerebral haemorrhage; Refractory hydrocephalus; Ischemic stroke - obstructive/lesion; Cardiorespiratory arrest due to vascular ischemia of the mid brain and vertebral arteries; atrial fibrillation; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number GR-GREOF-20213319. An 85-year-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 05Mar2021 (Lot Number: EP2166) as single dose for covid-19 immunisation. Medical history included hypertension from 2016, ischaemic stroke (transient ischemic stroke) from 2016. Concomitant medications included irbesartan (APROVEL), clopidogrel bisulfate (PLAVIX) from 13May2017 to an unspecified stop date, omeprazole (LOSEC [OMEPRAZOLE]), omeprazole (OMEPRAZOLE), irbesartan (APROVEL). On 19Apr2021 patient experienced intracerebral haemorrhage, refractory hydrocephalus, Ischemic stroke - obstructive/lesion. Patient was admitted on 19Apr2021, admittance cause reported as follows: Ischemic stroke -refractory hydrocephalus - intracerebral haemorrhage. The patient was admitted to clinic on 19Apr2021 due to right hemiparesis (climax: Glasgow Coma Scale (GCS) E3V4M6 13/15). Computerised tomogram (CT) Scan revealed extensive ischemic lesion of right cerebellum hemisphere with edema and pressure of brain stem on 4th ventricle. Medication in her admittage (in the clinic): MANNITOL 150 for 3 intravenous (iv), SALOSPIR 325 MG 1X1 per oral solution (os). It was followed atrial fibrillation and they administered 2 amp ANGORON in 100 D/W 5% in a 2 hours infusion and 6 amp ANGORON in 500 cc D/W %. On 20Apr2021 due to relapse neurologically signs she underwent a new CT Scan due to hydrocephalus and it was decided to underwent neurosurgeon procedure (external ventricular drainage). On unknown date in Apr2021 (reported by the regulatory authority as 24Apr2021) the neurological examination remains the same (serious). New CT Scan was performed which revealed intracerebral hemorrhage. Respiratory problems appeared so she was incubated. Finally, the patient died due to cardiac arrest following ischemia of brain stem - rear circulation. On 23Apr2021 patient died due to cardiorespiratory arrest due to vascular ischemia of the mid brain and vertebral arteries, intracerebral haemorrhage, hydrocephalus, ischemic stroke, it was reported that an autopsy was done, no results provided. Outcome of the other mentioned event was unknown. No follow-up attempts possible. No further information expected. Lot/Batch number already obtained.; Reported Cause(s) of Death: Cardiorespiratory arrest due to vascular ischemia of the mid brain and vertebral arteries; Intracerebral haemorrhage; Hydrocephalus; Ischemic stroke


VAERS ID: 1339133 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-05-09
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection rupture, Autopsy
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Autopsy; Result Unstructured Data: Test Result:RUPTURED AORTIC DISSECTING ANEURYSM
CDC Split Type: HKPFIZER INC2021576740

Write-up: DISSECTING AORTIC ANEURYSM RUPTURED; This is a spontaneous report from a contactable consumer based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS001192), license party for BNT162B2(Pfizer vaccine). A 44-year-old female patient BNT162B2 (Pfizer vaccine) (lot number: unknown) on 21Apr2021 via unknown route at single dose for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. The patient had stayed in the vaccination center for observation after vaccination, but there was no record of discomfort. The patient experienced dissecting aortic aneurysm ruptured on 09May2021, 18 days after vaccination, and was sent to hospital. The patient died on 09May2021; initial autopsy was performed on an unknown date and revealed that the cause of death was a ruptured aortic dissecting aneurysm. There was no clinical evidence that the incident was caused by the vaccine. BioNTech SE remarks: The medical review comments of PV Department on the reports of aortic dissection rupture is as follows: The seriousness of aortic dissection rupture was serious. Aortic dissection rupture is not a adverse event in the package insert of COMIRNATY, so its expectedness is unexpected. There was no clinical evidence that the incident was caused by the vaccine. And based on the existing understanding of the pathomechanism of aortic dissection rupture, it is difficult to attribute it to vaccination. So, the relationship between aortic dissection rupture and COMIRNATY was considered as unlikely related. BioNTech SE Comment: The medical review comments of PV Department on the reports of aortic dissection rupture is as follows: The seriousness of aortic dissection rupture was serious. Aortic dissection rupture is not an adverse event in the package insert of COMIRNATY, so its expectedness is unexpected. There was no clinical evidence that the incident was caused by the vaccine. And based on the existing understanding of the pathomechanism of aortic dissection rupture, it is difficult to attribute it to vaccination. So, the relationship between aortic dissection rupture and COMIRNATY was considered as unlikely related Causality assessment: Per Reporter Unlikely, Per Company Unlikely No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information expected.; Sender''s Comments: Based on the current available information, the event Dissecting aortic aneurysm, ruptured is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. ,Linked Report(s) : HK-PFIZER INC-2021539838 Same reporter, same product, different patients;HK-PFIZER INC-2021563740 Same reporter, same product, different patients; Reported Cause(s) of Death: A RUPTURED AORTIC DISSECTING ANEURYSM; Autopsy-determined Cause(s) of Death: RUPTURED AORTIC DISSECTING ANEURYSM


VAERS ID: 1339136 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Pain, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMORA; NIBEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adiposis (borderline adipose); Arterial hypertension; Blood pressure fluctuation; Gastroesophageal reflux disease; Holter monitoring (Holter RR); Lipids blood increased (Mildly Lipids blood increased); Non-smoker; Tachycardia (occasional Tachycardia); Comments: had arterial hypertension, mildly elevated blood lipids, non-smoker, borderline adipose, GERB In the last month occasional tachycardia, blood pressure fluctuation so his therapy was changed after Holter RR and ECG
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Quick COVID-19 antigen test; Test Result: Negative
CDC Split Type: HRPFIZER INC2021562733

Write-up: Feeling unwell/ wasn''t feeling well; General body pain/ everything hurt; This is a spontaneous report received from a contactable physician via regulatory authority and downloaded from another regulatory authority-WEB, regulatory authority number is HR-HALMED-300047432. A 60-year-old male patient received BNT162B2 (COMIRNATY, lot number EX3599), intramuscular on 29Apr2021 19:00 (reported as on 19.05 19.10 hours) as 1st dose, 0.3 mL single for COVID-19 immunisation. The patient''s medical history included arterial hypertension, tachycardia (occasional tachycardia), adiposis (borderline adipose), lipids blood increased (mildly Lipids blood increased), holter monitoring (holter RR), non-smoker, gastroesophageal reflux disease, blood pressure fluctuation from Apr2021. Concomitant medications included amlodipine besilate/ramipril (AMORA) 5 mg/5 mg, oral from unspecified date at 1 dosage form (DF), once a day (reported as 1,0,0) and nebivolol hydrochloride (NIBEL) 5 mg tablet, oral from unspecified date at 2.5 mg (1/2 tablet), once a day both for arterial hypertension. The patient experienced feeling unwell and general body pain on 30Apr2021, death on 01May2021. As per coroner (nurse reported death of person during the night) (as reported) it was reported that patient was found in bed in the morning. On Thursday 29Apr2021 patient was vaccinated against COVID-19 with Pfizer vaccine lot EX3599 1st dose on 19.05 19.10 hours. According to coroner, he wasn''t feeling well on Friday (30Apr2021), everything hurt, he stated that he could barely come home from work. He went to lie down and in the evening told his neighbor that he was feeling better and that it must be due to vaccination. Coroner performed quick antigen test for COVID 19 which was negative. Vaccination was uneventful, he had no problems during observation period. The events were all reported as serious with death as criteria. The patient died on 01May2021. It was unknown if an autopsy was performed. The patient underwent lab tests and procedures which included quick COVID-19 antigen test (negative) on May2021. The outcome of the events was fatal. Sender''s Comment: Reporter was requested to provide follow-up information, including cause of death, autopsy data (in case it was performed), relevant hospitalization and family history information. So far, no follow-up information has been received. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Feeling unwell/ wasn''t feeling well; General body pain/ everything hurt


VAERS ID: 1339138 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-21
Onset:2021-03-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood test, Bradycardia, C-reactive protein, COVID-19 pneumonia, Chest X-ray, Heart rate increased, Hypotension, Investigation, Oxygen saturation, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 25
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: Glaucoma; Obesity; Varicose veins of lower extremities
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: Blood test; Result Unstructured Data: Test Result:increased inflammatory values, increased liver enz; Comments: increased inflammatory values, increased liver enzyme values and impaired renal function; Test Date: 20210329; Test Name: Chest X-ray; Result Unstructured Data: Test Result:COVID-19 pneumonia; Test Date: 20210410; Test Name: CRP; Result Unstructured Data: Test Result:CRP levels increased; Test Date: 202104; Test Name: inflammatory levels; Result Unstructured Data: Test Result:increased; Test Date: 20210405; Test Name: oxygen saturation; Result Unstructured Data: Test Result:below 80% %; Test Date: 20210329; Test Name: COVID-19 rapid POC test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021560199

Write-up: Blood pressure increased; COVID-19 pneumonia; pulse rate increased; bradycardia; hypotension; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority (RA)-WEB (Regulatory Authority number HU-OGYI-251921). This 75 years old female patient received the first dose of BNT162B2 (COMIRNATY; lot EW4815) on 21Mar2021, at 0.3 ml single, for COVID-19 immunisation. Medical history included obesity, varicose veins of lower extremities and glaucoma, all from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 21Mar2021 the patient experienced blood pressure increased, COVID-19 pneumonia, pulse rate increased and hypotension. Clinical course of the events included the following information. From the same day of vaccination, the patient experienced subfebrile body temperature, fatigue, increased blood pressure and increased pulse rate. The patient was later diagnosed with COVID-19 pneumonia. On 29Mar2021, the patient was sent to the hospital. The COVID-19 POC rapid test was positive. The blood test showed increased inflammatory values, increased liver enzyme values and impaired renal function. Chest X-ray showed COVID-19 pneumonia on 29Mar2021. The patient used unknown medicinal therapy in her home, at the hospital antibiotic therapy was added. On 05Apr2021, the patient''s condition worsened, oxygen saturation was below 80%. The patient was transferred to the intensive care unit and went under oxygen therapy. The patient died on 15Apr2021. It was unknown if an autopsy was performed. These events were reported with a fatal outcome. Blood pressure increased, COVID-19 pneumonia, pulse rate increased were reported as serious also per hospitalization. Sender''s comment: According to the SmPC of Comirnaty, COVID-19 pneumonia, increased blood pressure, increased pulse rate and vaccination failure were not listed and not expected. TTO was 0 days for the symptoms, 8 days for the diagnose. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the events was considered unlikely. The case was considered serious due to hospitalization and fatal outcome. On 10Apr2021, the patient''s CRP levels increased, another antibiotic therapy was initiated. On 13Apr2021, the patient''s condition further worsened, mechanical ventilation was necessary. The patient experienced hypotension and the inflammatory levels increased. The patient received another antibiotic therapy and norepinephrine for the hypotension. On 15Apr2021, the patient experienced bradycardia and died. In the patient''s medical history, there was obesity, varicosity of the lower limb and glaucoma. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Blood pressure increased; COVID-19 pneumonia; pulse rate increased; hypotension; bradycardia


VAERS ID: 1339139 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-22
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW229 / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Hypovolaemic shock, Oesophageal haemorrhage, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow), Gastrointestinal haemorrhage (narrow), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchial carcinoma; Oesophageal cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: covid-19 virus test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021559797

Write-up: oesophageal bleeding; hypovolemic shock; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority. This is a report received from the regulatory authority. The regulatory authority report number HU-OGYI-282421. A 58-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly, administered in Arm Left on 02Apr2021 (Lot Number: EW229) as UNKNOWN, 0.3 ML SINGLE for covid-19 immunisation. Medical history included ongoing Oesophageal cancer and ongoing Bronchial carcinoma. The patient''s concomitant medications were not reported. On 22Apr2021, the patient experienced oesophageal bleeding. The cause of death was hypovolemic shock, the underlying diseases were oesophageal cancer and bronchial carcinoma. In the reporter physician opinion, the patient death is related to his underlying diseases. The patient died on 22Apr2021. An autopsy was not performed. The Covid-19 rapid test was negative on an unknown date. The outcome of events was fatal. Sender comments: According to the Summary of product characteristics of Comirnaty concentrate for dispersion for injection, oesophageal bleeding is not listed and not expected. TTO is 20 days. Dechallenge and rechallenge were not applicable. The causal relationship between the reported death and the vaccine is considered unlikely. The case is serious due to fatal outcome. Please note that it is unknow whether the reporter is also the patient, thus VAERS Primary Reporter Addl Qualification could not be completed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: hypovolemic shock; oesophageal bleeding


VAERS ID: 1339140 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH I035926710000I3 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19, Cough, Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (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: 2021-03-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hyperlipidemia; Hypertension; Vertebrobasilar insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210314; Test Name: COVID-19 rapid POC test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021560095

Write-up: Covid-19 positive/chest pain; cough; dyspnoea; acute respiratory distress syndrome; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number HU-OGYI-285221. This is a report received from another regulatory authority. Regulatory authority report number HU-OGYI-285221. This serious, spontaneous case was reported by a physician on 26Apr2021, concerning the occurrence of positive Covid-19 rapid POC test after the use of Comirnaty concentrate for dispersion for injection (BioNTech Manufacturing). On 09Mar2021, the 65-year-old female patient received the first dose of 0.3 ml Comirnaty concentrate for dispersion for injection (tozinameran; batch number: I035926710000I3, expiry date: not reported, intramuscularly in the left arm) for COVID-19 immunisation. Medical history included ongoing hyperlipidemia, hypertension, and vertebrobasilar insufficiency. The patient''s concomitant medicinal products were not reported. On 14Mar2021, the patient experienced fever, cough, chest pain, and dyspnoea. The Covid-19 POC test was positive, therefore the patient was admitted to the hospital. On 17Mar2021, the patient died. According to the patient''s death certificate, the direct cause of death was acute respiratory distress syndrome, the indirect cause was Covid-19 infection. Events stop date is provided -17APR2021- with outcome fatal. The autopsy was not performed. No further information is expected. Sender''s comment: According to the publication for Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient received the first dose of Comirnaty on 09Mar2021 and got infected with the virus 5 days after, therefore immunity may not have developed yet without the second dose. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse events. The case is considered serious because the outcome was fatal. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: respiratory distress syndrome; Covid-19 infection; cough; dyspnoea


VAERS ID: 1339141 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-04-26
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560094

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number HU-OGYI-285921. A 71-year-old female patient received BNT162B2 (COMIRNATY) intramuscular, administered in arm left on 27Mar2021 (Batch/Lot Number: Unknown) as unknown, 0.3ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Apr2021, the patient died 30 days after COMIRNATY vaccination. The cause of death was unknown. It was unknown if an autopsy was performed. The causal relationship between the reported death and the vaccine is not assessable. The case is serious due to fatal outcome. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: died


VAERS ID: 1339142 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Laboratory test, Oesophageal varices haemorrhage, SARS-CoV-2 test
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (treated); Cholelithiasis (treated); Gastrooesophageal varices (treated); Hepatic cirrhosis (treated)
Allergies:
Diagnostic Lab Data: Test Date: 20210425; Test Name: Laboratory test; Result Unstructured Data: Test Result:Severe metabolic acidosis, high ammonia levels, si; Comments: Severe metabolic acidosis, high ammonia levels, significant anemia; Test Date: 20210425; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Covid-19 infection was not detected based on tests performed in the Emergency Department.
CDC Split Type: HUPFIZER INC2021560201

Write-up: Gastrooesophageal varices haemorrhage; This is a spontaneous report from a contactable physician received from a regulatory authority and downloaded from another regulatory authority-WEB (Regulatory Authority number HU-OGYI-286521). A 45-year-old female patient received the first dose of BNT162B2 (COMIRNATY; lot EW4815) intramuscular, in left arm, on 16Apr2021 at 12:00, at 0.3 ml single, for COVID-19 immunisation. Medical history included hepatic cirrhosis, alcohol abuse, gastrooesophageal varices and cholelithiasis, all from an unknown date to an unknown date and all were treated. Concomitant medications were not reported. No events occurred during the post-vaccination observation period. On 25Apr2021 the patient experienced gastrooesophageal varices haemorrhage. Clinical course included the following details. On 25Apr2021, an ambulance was called as the patient was vomiting fresh blood. Covid-19 infection was not detected based on tests performed in the Emergency Department. Laboratory tests performed on 25Apr2021 showed severe metabolic acidosis, high ammonia levels, significant anemia. The patient received blood transfusion in the intensive care unit; pantoprazole (CONTROLOC), NaHCO3, glucose, and amino acids (GLUTARSIN) were given intravenously. Despite this therapy, the patient died on 26Apr2021 at 6:30 A.M. An autopsy was requested. Results were not yet available. Sender''s comments: The 45-year-old patient died 10 days after Comirnaty vaccination due to gastrooesophageal varices haemorrhage. The causal relationship between the reported event and Comirnaty was considered not related. The case was serious due to fatal outcome. Stop date 26Apr2021 at 06:30 for event: gastrooesophageal varices haemorrhage, provided with outcome fatal. No follow-up attempts possible. No further information expected.; Sender''s Comments: The Company considered there was not a reasonable possibility that the reported event Gastrooesophageal varices haemorrhage (with fatal outcome) was related to the suspect product BNT162B2 (COMIRNATY). The event is more consistent with patient''s underlying condition of hepatic cirrhosis. 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: Gastrooesophageal varices haemorrhage


VAERS ID: 1339143 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-04-15
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Cardiac arrest, Circulatory collapse, Drug ineffective, Dyspnoea, Loss of consciousness, Pulmonary embolism, Respiratory failure, SARS-CoV-2 antibody test, SARS-CoV-2 test, Scan, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lack of efficacy/effect (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), 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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   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? Yes
Previous Vaccinations:
Other Medications: CO-RENITEC; THEOSPIREX [THEOPHYLLINE]; MERCKFORMIN; MILURIT; QUAMATEL; GLICLADA; ASA PROTECT PHARMAVIT; LYRICA; TRAJENTA; ELONTRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; Asthma; Cerebrovascular disorder; Diabetes mellitus; Hypertension; Obesity; Psychiatric decompensation
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: COVID-19 with a rapid test; Test Result: Negative ; Test Date: 20210416; Test Name: PCR tests; Test Result: Positive ; Test Date: 20210423; Test Name: PCR tests; Test Result: Positive ; Test Date: 20210415; Test Name: scan; Result Unstructured Data: Test Result:COVID-19 pneumonia; Comments: confirmed COVID-19 pneumonia and pulmonary embolism
CDC Split Type: HUPFIZER INC2021559800

Write-up: COVID-19 pneumonia; COVID-19 pneumonia; collapse; loss of consciousness; dyspnea; cardiovascular failure; respiratory failure; asystole; pulmonary embolism; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority; regulatory authority number HU-OGYI-286621. A 63-years-old female patient received the first dose of BNT162B2(COMIRNATY, lot number/ batch number ET7205) Intramuscular on 27-MAR-2021 at 0.3 ml single to COVID-19 immunisation. Medical history includes psychiatric decompensation, Asthma, hypertension, obesity, diabetes mellitus, cerebrovascular disorder and arthrosis. Concomitant products are enalapril maleate, hydrochlorothiazide(CO-RENITEC), theophylline(THEOSPIREX, 300 mg), metformin hydrochloride(MERCKFORMIN, 1000 mg), allopurinol(MILURIT, 300 mg), famotidine(QUAMATEL, 40 mg), gliclazide(GLICLADA, 30 mg), acetylsalicylic acid(ASA PROTECT PHARMAVIT), pregabalin(LYRICA, 150 mg) , linagliptin(TRAJENTA, 5mg), bupropion hydrochloride (ELONTRIL, 30 mg). On 15Apr2021 the patient was taken to the hospital due to collapse, loss of consciousness and dyspnea. She was tested negative to COVID-19 with a rapid test but scans confirmed COVID-19 pneumonia and pulmonary embolism. PCR tests on 16Apr2021 and 23Apr2021 also confirmed COVID-19 infection. On 26Apr2021 the patients condition deteriorated, she experienced asystole, cardiovascular and respiratory failure, resuscitation was unsuccessful. The patient died due to asystole, pulmonary, Respiratory failure and cardiovascular failure caused by the infection 30 days after vaccination. The patient was hospitalized due to events COVID-19 pneumonia, collapse, loss of consciousness and dyspnea on 15Apr2021. The events asystole, pulmonary embolism, Respiratory failure and cardiovascular failure were assessed as hospitalization prolonged. The patient died on 26-APR-2021. It''s unknown if an autopsy was performed. The cause of death was asystole, pulmonary, Respiratory failure and cardiovascular failure. The patient underwent lab tests and procedures, which included COVID-19 with a rapid test on 15-APR-2021: Negative; scan on 15-APR-2021: confirmed COVID-19 pneumonia and pulmonary embolism; PCR tests on 16Apr2021 and 23Apr2021: Positive also confirmed COVID-19 infection. The outcome of the events asystole, pulmonary embolism, Respiratory failure , cardiovascular failure, COVID-19 pneumonia, Drug ineffective was Fatal, the others was unknown. Sender Comment: COVID-19 pneumonia was detected 19 days after vaccination with COMIRNATY. Immunity does not develop within 19 days after the first dose. The patient died due to asystole, pulmonary and cardiovascular failure caused by the infection 30 days after vaccination. The causal relationship between the vaccine and the event is unlikely. The case is considered serious due to fatal outcome. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information currently available, there was not a reasonable possibility that the events "COVID-19 pneumonia, pulmonary embolism, cardiovascular failure, respiratory failure, asystole" were related to BNT162B2. The patient only received single dosage BNT162B2 and was not well protected for the occurrence of COVID-19 pneumonia. ; Reported Cause(s) of Death: asystole; Respiratory failure; cardiovascular failure; pulmonary; pulmonary; pulmonary embolism


VAERS ID: 1339144 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 10359267100013 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Computerised tomogram thorax, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Gastroesophageal reflux disease; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Chest CT; Result Unstructured Data: Test Result:Covid-19 pneumonia; Test Date: 20210218; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021560196

Write-up: Covid-19 infection; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority. This is a spontaneous report from a contactable physician. This is a report received from Regulatory Authority. A 77-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 12Feb2021 (Batch/Lot Number: 10359267100013) as 0.3mL single for covid-19 immunisation . Medical history included ongoing gastrooesophageal reflux disease , ongoing hypertension. The patient''s concomitant medications were not reported. The patient experienced covid-19 infection on 18Feb2021 leading to patient death on 12Mar2021. The patient underwent lab tests and procedures which included computerised tomogram thorax: covid-19 pneumonia, Sars-cov-2 test: positive on 18Feb2021. Course of the event. On 18Feb2021, the patient''s Covid-19 PCR test was positive. On 22Feb2021, the patient was admitted to the hospital because of coughing, fever, and loss of consciousness. According to CT, Covid-19 pneumonia was detected. Mechanical ventilation was necessary. On 12Mar2021, the patient died. Medical history included hypertension and gastroesophageal reflux disease. The patient''s concomitant medicinal products were not reported. According to the patient''s death certificate, the direct cause of death was respiratory insufficiency, the indirect cause was pneumonia and Covid-19 infection. The autopsy was not performed. Sender Comment: According to the Summary of Product Characteristics of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient received the first dose of Comirnaty on 12Feb2021 and got infected with the virus 6 days after, therefore immunity may not have developed yet without the second dose. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse events. The case is considered serious because the outcome was fatal. No further information is expected.; Reported Cause(s) of Death: Covid-19 infection; respiratory insufficiency; pneumonia


VAERS ID: 1339145 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Cachexia, Dementia, SARS-CoV-2 test
SMQs:, Dementia (narrow), Noninfectious encephalopathy/delirium (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease; Bipolar affective disorder; Hypertension; Osteoporosis; Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021560195

Write-up: cachexia; Dementia NOS; General atherosclerosis; This is a spontaneous report from a contactable physician downloaded from a regulatory authority WEB HU-OGYI-287021. A 70-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 06Apr2021 (Batch/Lot Number: EW2239) as 2nd dose, 0.3ml single for covid-19 immunisation. Medical history included ongoing Alzheimer''s disease, ongoing osteoporosis, ongoing hypertension, ongoing Parkinson''s disease, ongoing Bipolar affective disorder. Historical vaccine included the first dose of 0.3 ml bnt162b2 (batch number: EJ6790, expiry date unknown, intramuscularly, in left arm) for COVID-19 immunisation. The patient''s concomitant medications were not reported. On 14Apr2021, the patient died. According to the patient s death certificate, the direct cause of death was cachexia (on 14Apr2021), indirect causes were dementia NOS (in Apr2021) and general atherosclerosis (in Apr2021). The autopsy was not performed. Other information the patient was under in-patient care at the time of the vaccinations, the hospitalization started on 21Dec2020 (reported as 21Dec2021). The COVID-19 PCR test was negative. The outcome of events was fatal. In the reporter physician s opinion, the patient s death is related to her underlying diseases. Sender''s comments: The 70 year old patient died 8 days after Comirnaty vaccination. The cause of death was cachexia. The causal relationship between the reported death and the vaccine is considered unlikely. The case is serious due to fatal outcome. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Dementia NOS; General atherosclerosis; cachexia


VAERS ID: 1339146 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-26
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cachexia, SARS-CoV-2 test negative
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia NOS; Hypertension; Pleural mesothelioma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210222; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210309; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021560194

Write-up: cachexia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-287221. This is a report received from the Regulatory Authority. Regulatory authority report number HU-OGYI-287221. An 81-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 02Mar2021 (Batch/Lot Number: EJ6790) as 0.3 mL, single at the age of 81-year-old for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing dementia, ongoing pleural mesothelioma. The patient''s concomitant medications were not reported. The patient was under in-patient care at the time of the vaccination. The hospitalization started on 14Dec2020. The patient experienced cachexia on 26Mar2021. The patient''s hospitalization was prolonged as a result of cachexia. The patient underwent lab tests and procedures which included Sars-cov-2 test: negative on 22Feb2021 and on 09Mar2021. The patient died on 14Apr2021 (also reported as 24 days after Comirnaty vaccination). An autopsy was not performed. According to the patient''s death certificate, the direct cause of death was cachexia, indirect causes were pleural mesothelioma and dementia NOS. The outcome of events was fatal. In the reporter physician''s opinion, the patient''s death was related to his underlying diseases. Reporter Comment: The 81- year-old patient died 24 days after Comirnaty vaccination. The cause of death was cachexia. The causal relationship between the reported death and the vaccine is considered unlikely. The case is serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The 81- year-old patient died 24 days after Comirnaty vaccination. The cause of death was cachexia. The causal relationship between the reported death and the vaccine is considered unlikely. The case is serious due to fatal outcome.; Reported Cause(s) of Death: cachexia


VAERS ID: 1339147 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cachexia, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history/concurrent conditions: aseptic necrosis of head and neck of femur; coxarthrosis; decubitus; dementia; paranoid schizophrenia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 with PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021560091

Write-up: cachexia associated with dementia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. Regulatory authority report number HU-OGYI-287321. A 68-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via intramuscular on 02Mar2021 (Lot Number: EJ6790) as 0.3 ml, single for covid-19 immunization. Medical history included dementia, aseptic necrosis of head and neck of femur, coxarthrosis, paranoid schizophrenia, decubitus. The patient was in the hospital since 22Jan2021 in need of inpatient care. She was tested several times to COVID-19 with PCR test with negative results each time. She experienced no side effects from vaccination. The patient had decubitus. Her condition was deteriorating in general and she died on 21Mar2021. According to the reporter physician the patient died due to cachexia associated with dementia. An autopsy was performed and results was unknown. The outcome of the event was fatal. Sender Comment: The patient died due to cachexia associated with dementia 19 days after with COMIRNATY. The event and the vaccination are not related. The case is considered serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Sender''s Comments: The 68-year-old female patient had medical history included dementia, aseptic necrosis of head and neck of femur, coxarthrosis, paranoid schizophrenia, and decubitus. The fatal event cachexia associated with dementia was not related to BNT162B2 (COMIRNATY), but was due to her pre-existing dementia and underlying diseases.; Reported Cause(s) of Death: cachexia associated with dementia; cachexia associated with dementia


VAERS ID: 1339148 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-15
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cachexia, Hyperventilation, Pneumonia, Pyrexia, Somnolence
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 8
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: COVID-19 (in the hospital since 25Sep2020 initially with COVID-19 infection); Dementia; Dystopic kidney; Gastroesophageal reflux disease; Hypertension; Psoriasis
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560092

Write-up: cachexia associated with pneumonia; cachexia associated with pneumonia; hyperventilation; somnolence; fever; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB. Regulatory authority report number HU-OGYI-287421. An 85-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via intramuscular on 02Mar2021 (Lot Number: EJ6790) as 0.3 ml, single for covid-19 immunization. Medical history included covid-19 (The patient was in the hospital since 25Sep2020 initially with COVID-19 infection. On 10Nov2020 she was transferred to the Nursing Department), dementia, hypertension, psoriasis, dystopic kidney and gastro-esophageal reflux disease. The patient''s concomitant medications were not reported. On 15Mar2021 the patient experienced hyperventilation, somnolence and fever due to pneumonia (hospitalization) not related to COVID-19. On 23Mar2021 the patient died due to cachexia associated with pneumonia. An autopsy was performed and results was unknow. The outcome of the event cachexia associated with pneumonia was fatal. Outcome for other events was unknown. Sender Comment: The patient died due to cachexia associated with pneumonia 21 days after with COMIRNATY. The event and the vaccination are not related. The case is considered serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on information provided, the events of hyperventilation, somnolence and fever due to pneumonia, cachexia associated with pneumonia more likely represent intercurrent illnesses which are unrelated to BNT162B2 (COMIRNATY). The case will be reassessed once more information become available.; Reported Cause(s) of Death: cachexia associated with pneumonia; cachexia associated with pneumonia


VAERS ID: 1339149 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-25
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560191

Write-up: death; This is a spontaneous report from a contactable physician via a regulatory authority, downloaded from another regulatory authority-WEB (Regulatory authority report number HU-OGYI-287821). A 91-year-old female patient received the first dose of BNT162B2 (COMIRNATY) intramuscular on 09Apr2021 (Batch/Lot number was not reported) at 0.3 ml single (30 micrograms of COVID-19 mRNA Vaccine) for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 25Apr2021, 16 days after COMIRNATY vaccination, the patient died. There was no information about the cause of death. Autopsy was requested. The causal relationship between the reported death and COMIRNATY was unassessable. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1339150 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-16
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, COVID-19 pneumonia, Cardiac failure, Chest X-ray, Multiple organ dysfunction syndrome, Respiratory failure, SARS-CoV-2 test, Shock
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Sepsis (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 17
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: ADEXOR; ELIQUIS
Current Illness: Fatty liver; Gastroesophageal reflux; NIDDM; Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Choroid neoplasm; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20210316; Test Name: Chest X-ray; Result Unstructured Data: Test Result:COVID-19 pneumonia; Comments: diagnose of COVID-19 pneumonia; Test Date: 20210316; Test Name: SARS-CoV-2 test positive; Test Result: Positive ; Comments: diagnose of COVID-19; Test Name: Body temperature; Result Unstructured Data: Test Result:fever (unknown value)
CDC Split Type: HUPFIZER INC2021560200

Write-up: respiratory failure; shock; multiple organ failure; heart failure; COVID-19; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-288321. A 72-year-old female patient received first dose of BNT162B2 (COMIRNATY), intramuscular, administered in arm left on 04Mar2021 (Batch/Lot Number: ET1831) as 0.3 mL single dose for COVID-19 immunisation. Medical history included ongoing type 2 diabetes mellitus (NIDDM), pulmonary embolism in 2016, ongoing gastrooesophageal reflux disease, ongoing fatty liver, choroid neoplasm from an unknown date and unknown if ongoing and ongoing obesity. Concomitant medications included trimetazidine hydrochloride (ADEXOR, strength: 80 mg ) at 80 mg once a day and apixaban (ELIQUIS, strength: 2.5 mg) at 2.5 mg twice a day, both taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced fever and dyspnoea. On 11Mar2021, the patient was hospitalized. On 16Mar2021, the patient''s COVID-19 test was positive. On the same day, chest X-ray showed COVID-19 pneumonia. The patient''s condition worsened with time in the hospital. In the hospital, the patient received medicinal therapy as antibiotics, antiviral therapy, steroids, mucolytic medicines, mucus protective medicines, LMWH and oxygen therapy. The course of the disease was critical, the patient had respiratory failure, shock and multiple organ failure. On 02Apr2021, the patient died. According to the patient''s death certificate, the direct cause of death was heart failure. The primary disease that caused the patient''s death was COVID-19, which escalated to COVID-19 pneumonia and respiratory failure. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: heart failure; COVID-19 pneumonia; covid-19; respiratory failure; shock; multiple organ failure


VAERS ID: 1339151 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: 2021-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain; Lung neoplasm malignant; Myocardial infarction; Vasoconstriction peripheral
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021559886

Write-up: suddenly died; This is a spontaneous report from a contactable physician received from the Regulatory Authority. A 76-year-old male patient received the second dose of BNT162B2 (PFIZER concentrate for dispersion for injection, tozinameran; MAH: BioNTech Manufacturing GmbH, batch number: not reported, expiry date: unknown), administration route and site not reported, at 0.3 ml single dose on 20Apr2021 for COVID-19 immunisation. In the patient medical history, there was myocardial infarction, severe lower limb vasoconstriction and lung neoplasm malignant. The patient''s concomitant medications were not reported. On 20Apr2021, the patient suddenly died. It was unknown if an autopsy was performed. According to the patient wife, he experienced stabbing chest pain in the morning, before the vaccination. According to the reporter, there was no causal relationship between sudden death and vaccination. Sender Comment: Sudden death is not expected after the use of Comirnaty concentrate for injection. TTO is less than a day. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the events is considered not assessable per lack of information. The case is considered serious due to fatal outcome. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Sender''s Comments: Based on the available information and known product profile, the causal relationship between the reported fatality and the use of the vaccine is unrelated, in agreement with the reporting physician. This is considering that the patient was reported to have had already experienced stabbing chest pain in the morning, before the vaccination which may indicate an ongoing event prior to vaccination. The possibility that the noted stabbing chest pain is a manifestation of an unknown fatal event is supported a history of myocardial infarction, severe lower limb vasoconstriction and lung neoplasm malignant. The case will be assessed further upon receipt of additional information.; Reported Cause(s) of Death: suddenly died


VAERS ID: 1339152 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, COVID-19, Chills, Clostridium test, Drug ineffective, SARS-CoV-2 test, Urosepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Lack of efficacy/effect (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), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   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: EUCREAS; APO-FAMOTIDIN; ASA PROTECT PHARMAVIT; BISOBLOCK; COVERCARD PLUS; MILURIT; SPIRIVA; VALONGIX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anal fistula; Appendectomy; Atherosclerosis generalised; Diabetes mellitus; Hypertension; Hyperuricaemia; Obesity; Pneumonia; Polyarthritis; Renal insufficiency; Spondylosis; Vertebrobasilar insufficiency
Allergies:
Diagnostic Lab Data: Test Name: Clostridium test positive; Test Result: Positive ; Test Date: 20210319; Test Name: COVID-19 antigen test negative; Test Result: Negative ; Test Date: 20210320; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: HUPFIZER INC2021559798

Write-up: COVID-19 infection; drug ineffective/COVID-19; Acute renal insufficiency; Urosepsis; chills without fever; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-288921. A 77-year-old male patient received the first dose of BNT162B2 (COMIRNATY, concentrate for dispersion for injection tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), lot number: ET1831, expiry date: unknown: BioNTech Manufacturing Pfizer) intramuscularly on 05Mar2021 at 0.3 ml single dose for COVID-19 immunization. Medical history included appendectomy, anal fistula, diabetes mellitus, hypertension, hyperuricemia, obesity, pneumonia, polyarthritis, renal insufficiency, spondylosis, vertebrobasilar insufficiency and generalized atherosclerosis. Concomitant drugs were hydrochloride/vildagliptin (EUCREAS), famotidine (APO-FAMOTIDIN), acetylsalicylic acid (ASA PROTECT PHARMAVIT), bisoprolol fumarate (BISOBLOCK), amlodipine besilate, indapamide/ perindopril arginine (COVERCARD PLUS), allopurinol (MILURIT), tiotropium bromide (SPIRIVA) and amlodipine besilate/atorvastatin calcium/ perindopril arginine (VALONGIX). On 19Mar2021 the patient was admitted in the hospital because of urosepsis, acute renal insufficiency and needed mechanical ventilation. Before hospitalization, the patient was experiencing chills for 2 days without fever. A covid antigen test was done in the ambulance which came back negative on 19Mar2021, but on 20Mar2021 a PCR test confirmed the Covid-19 infection. On 03Apr2021 the patient passed away. It was unknown if autopsy was done. The direct cause of death was COVID-19. The outcome of events urosepsis, acute renal insufficiency, COVID-19 was reported as fatal ( urosepsis, acute renal insufficiency were not reported as cause of death), outcome of chills was unknown. Sender Comment: The causal relationship is unlikely between the suspected drug and the adverse events as the cause of death was determined to be Covid-19. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1339153 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-04-07
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain injury, Cardiopulmonary failure, Computerised tomogram, Congestive hepatopathy, Laboratory test, Oxygen saturation, SARS-CoV-2 test, Status epilepticus, Suspected COVID-19
SMQs:, Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Acute central respiratory depression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NEUROTOP
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Incontinence of urine; Meningioma; Vascular encephalopathy
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: Cranial CT scan; Result Unstructured Data: Test Result:edema and possible white brain matter damage; Comments: abnormalities including edema and possible white brain matter damage; Test Date: 20210407; Test Name: Examinations; Result Unstructured Data: Test Result:congestive hepatopathy and circulatory decompensat; Comments: implied congestive hepatopathy and circulatory decompensation caused by cardiac insufficiency. Examinations not specified.; Test Date: 20210407; Test Name: oxygen saturation; Result Unstructured Data: Test Result:Low; Test Date: 20210408; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210408; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021559799

Write-up: Cardio-respiratory failure; Status epilepticus; congestive hepatopathy; Covid-like symptoms; possible white brain matter damage; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number HU-OGYI-289021. This is a report received from a regulatory authority. A 72-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EP2166, expiry date: unknown), intramuscularly on 18Mar2021 (at the age of 72-year-old) at 0.3 ml, single for active immunization to prevent COVID-19. Medical history included epilepsy, vascular encephalopathy, meningioma and Incontinence of urine, all from an unknown date and unknown if ongoing. Concomitant medication included carbamazepine (NEUROTOP) taken for epilepsy. The patient previously took carbamazepine (TIMONIL). The patient experienced cardio-respiratory failure and status epilepticus on 07Apr2021. This serious, medically confirmed report concerned the occurrence of status epilepticus and cardiorespiratory failure resulting in death after bnt162b2 injection. At the time of this report the patient was under care due to epilepsy. On 07Apr2021 the patient had a grand mal seizure which lasted for 30 minutes. After the seizure the patient was somnolent, had difficulty in breathing and her oxygen saturation was low on 07Apr2021. The patient was transferred to the hospital on 07Apr2021. Cranial CT scan on 07Apr2021 showed abnormalities including edema and possible white brain matter damage. The patient had Covid-like symptoms on 07Apr2021, but both antigen and PCR tests were negative on 08Apr2021. Examinations also implied congestive hepatopathy and circulatory decompensation caused by cardiac insufficiency on 07Apr2021. On 08Apr2021 at 15:15 the patient suddenly passed away due to cardiorespiratory failure. The outcome of events cardio-respiratory failure and status epilepticus was fatal, outcome of the other events was unknown. The patient died on 08Apr2021 at 15:15. It was not reported if an autopsy was performed. Sender Comment: The causal relationship cannot be assessed between the suspected drug and the adverse events because the patient passed away before additional examinations. TTO was 20 days. 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: Cardio-respiratory failure; Status epilepticus


VAERS ID: 1339154 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19, Cardiac arrest, Chest X-ray, Cough, Dyspnoea, Pyrexia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Interstitial lung disease (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), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (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: 2021-04-16
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CO IRABEL; LIPANOR; XETER; ACTRAPID HM [INSULIN HUMAN]; COVERCARD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral vascular lesion; Diabetic vascular disorder; Dyslipidaemia; Hypertension; Type II diabetes mellitus; Vertebrobasilar insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: Chest X-ray; Result Unstructured Data: Test Result:COVID-19 pneumonia; Test Date: 20210401; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021560093

Write-up: SARS-CoV-2 infection/COVID-19 pneumonia/COVID-19 rapid antigen test became positive; dyspnoea; coughing; fever; acute respiratory distress syndrome; Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority also received from the agency, The regulatory authority report number is HU-OGYI-289721. A 70-year-old male patient received BNT162B2 (COMIRNATY, strength: 0.3 ml), dose 1 intramuscular, administered in Arm Left on 31Mar2021 (Batch/Lot Number: ET3620) as 1st dose, 0.3 ml single for COVID-19 immunisation. Medical history included diabetic angiopathy, Type II diabetes mellitus, cerebral vascular lesion from 26Nov2013, vertebrobasilar insufficiency from Nov2013, dyslipidaemia and hypertension, all were not ongoing. Concomitant medications included hydrochlorothiazide, irbesartan hydrochloride (CO IRABEL, strength: 150 mg/12,5 mg); ciprofibrate (LIPANOR); rosuvastatin calcium (XETER); insulin human (ACTRAPID HM); amlodipine besilate, perindopril arginine (COVERCARD, strength: 5 mg/5 mg). Clinical course: On 01Apr2021, COVID-19 rapid antigen test became positive (SARS-CoV-2 infection). The patient was transferred to the emergency department due to fever, dyspnoea, and coughing. On 06Apr2021, chest X-ray confirmed COVID-19 pneumonia. Despite the applied therapy (clarithromycin 500 mg (KLACID); Dexamethasone 4 mg; vitamin D 3000 IU; Vitamin C 1000 mg; acetyl salicylic acid 100 mg; Pantoprazol 40 mg; Frontin (alprazolam) 0,25 mg; O2-supplementation, enoxaparin sodium 0,6 ml (CLEXANE), amoxicillin; clavulanic acid 1,2 g (AKTIL INJECTION); methylprednisolone 40 mg (SOLU MEDROL), acute respiratory distress syndrome developed, the patient died on 16Apr2021. Cause of death was cardiac arrest according to the death certificate. Autopsy was not done. All events reported as serious with seriousness criteria of fatal. All events reported requiring hospitalization except event ''cardiac arrest''. Please note that it was unknow whether the reporter was also the patient, thus VAERS Primary Reporter Addl Qualification could not be completed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest; SARS-CoV-2 infection; Dyspnoea; coughing; fever; acute respiratory distress syndrome


VAERS ID: 1339155 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-04-11
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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: 2021-04-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Ischemic heart disease; Myocardial infarction; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560099

Write-up: circulatory failure; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number HU-OGYI-289821. An 81-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3 ml), dose 1 intramuscular on 19Mar2021 (Batch/Lot Number: Unknown) as 0.3 ml, single dose for covid-19 immunisation. Medical history included myocardial infarction, arteriosclerosis, Parkinson''s disease, and myocardial ischaemia, all from an unknown date to an unknown date. The patient''s concomitant medications were not reported. The patient experienced circulatory failure on 11Apr2021. Additional information: On 11Apr2021 the patient collapsed, an ambulance was called. Reanimation was unsuccessful, the patient died due to circulatory failure. Autopsy was not done. In the reporter physician''s opinion, the event is related to the patient''s underlying diseases. The patient died on 11Apr2021. Sender''s comment: The 81-year-old patient died 23 days after Comirnaty vaccination. Cause of death was circulatory failure. Autopsy was not done. In the reporter physician''s opinion, the event is related to the patient''s underlying diseases. The case is serious due to fatal outcome. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Circulatory failure


VAERS ID: 1339156 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Fatigue, Haematemesis, Pain of skin, Pyrexia, SARS-CoV-2 test, Visual impairment
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: OXYCORT [HYDROCORTISONE;OXYTETRACYCLINE HYDROCHLORIDE]; VITAMIN D3 FRESENIUS; DICLOFENAC; VEROSPIRON; QUAMATEL; FUROSEMIDE; ELENIUM [CHLORDIAZEPOXIDE]; KALDYUM; UREGYT; ALGOPYRIN [METAMIZOLE SODIUM]
Current Illness: Esophageal varices; Hepatic cirrhosis; IHD; Papular rash
Preexisting Conditions: Medical History/Concurrent Conditions: Ovarian cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: Covid-19 test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021560090

Write-up: vomiting blood; vision deterioration; diarrhoea; fever; weakness; fatigability; pain of skin; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number HU-OGYI-290021. A 69-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EW4815; Expiration Date: Jul2021), intramuscular, administered in Arm Left on 16Apr2021 09:10 (at unknown age) as 0.3 ml single for COVID-19 immunisation. Medical history included Ovarian cancer from 2006, ongoing Papular rash, ongoing IHD (Myocardial ischaemia), ongoing Hepatic cirrhosis, Esophageal varices from 2014 and ongoing. Concomitant medications included hydrocortisone, oxytetracycline hydrochloride (OXYCORT); colecalciferol (VITAMIN D3 FRESENIUS); diclofenac; spironolactone (VEROSPIRON); famotidine (QUAMATEL); furosemide; chlordiazepoxide (ELENIUM); potassium chloride (KALDYUM); etacrynic acid (UREGYT); metamizole sodium (ALGOPYRIN). A physician describes the occurrence of adverse events resulting in death after vaccination with COMIRNATY (tozinameran). On 21Apr2021, the patient experienced diarrhoea, fever, weakness, fatigability and pain of skin. From 24Apr2021, she experienced vision deterioration (low visual acuity). On 26Apr2021, the patient had vomiting blood and died after when submitted to hospital. The patient was hospitalized on unknown date. COVID-19 test was negative on 26Apr2021. Autopsy has been done, the results are not available. Based on the patient physician, the patient symptoms and death are not related with the vaccination. The patient died on 26Apr2021. Sender comments: Diarrhoea, fever, weakness, fatigability and skin pain are expected adverse events of COMIRNATY. Vision decreased and haematemesis are not expected adverse events. They might be resulted by the patient chronic diseases. TTO was 5 days for diarrhoea, fever, weakness, fatigability and skin pain; 8 days for low visual acuity and 10 days for haematemesis. Based on the above, relationship between the events and COMIRNATY is unlikely. The case is serious because the patient died. Comirnaty/Weakness, Fever, Pain of skin, Fatigability, Diarrhoea/Time Interval between Beginning of Drug Administration and Start of Reaction 5 days, Comirnaty/ Vision decreased/Time Interval between Beginning of Drug Administration and Start of Reaction 8 days, Comirnaty/Haematemesis/Time Interval between Beginning of Drug Administration and Start of Reaction 10 days. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the information available the events are attributed to intercurrent medical conditions and assessed Unrelated to BNT162B2 (COMIRNATY) vaccine.; Reported Cause(s) of Death: diarrhoea; fever; weakness; fatigability; pain of skin; vision deterioration; vomiting blood


VAERS ID: 1339157 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / UNK LA / 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: 2021-04-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASTRIX; MERAMYL HCT; BISOBLOCK
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560189

Write-up: sudden death cause unknown; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority report. A 68-year-old female patient received BNT162b2 (COMIRNATY), intramuscular, administered in Arm Left on 07Apr2021 (Batch/Lot Number: EW2239) as 0.3ml, single for Covid-19 immunization. Medical history included ongoing hypertension. Concomitant medications included acetylsalicylic acid (ASTRIX); hydrochlorothiazide, ramipril (MERAMYL HCT); bisoprolol fumarate (BISOBLOCK), all taken for an unspecified indication, start and stop date were not reported. The patient experienced sudden death on 10Apr2021. On 07Apr2021, the 68-year-old female patient received BNT162b2. On 10Apr2021, her son found the patient dead at her home. Presumably, she could feel bad, so she took a chair to the open window and was found lying next to her. The patient died on 10Apr2021. The cause of death was unknown. The autopsy was initiated at the time of the report. Results are not available. According to the reporter physician, the relationship between the reported death and the vaccine is unlikely. Sender Comment: The 68-year-old patient died 3 days after Comirnaty vaccination. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the events is considered not assessable per lack of information. The case is considered serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the limited information available, until additional data surrounding the fatal event becomes available, the company, as a cautionary measure and for reporting purposes, cannot completely exclude that the patient''s sudden death, cause unknown, is related to the suspect drug Comirnaty. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: sudden death


VAERS ID: 1339158 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   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: Lymphoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560188

Write-up: sudden death; weakness; inappetence; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, regulatory authority number HU-OGYI-290921. An 89-year-old male patient received bnt162b2 (Pfizer vaccine), dose 2 intramuscular, administered in arm left on 14Apr2021 (Lot Number: EW4815) as 0.3 ml, single dose for covid-19 immunisation. Medical history included ongoing lymphoma. The patient previously received first dose of bnt162b2 (batch number: EP2163) intramuscularly, in the left arm at 0.3 ml on an unspecified date for covid-19 immunisation. The patient''s concomitant medications were not reported. The patient experienced sudden death on 28Apr2021. The patient experienced weakness and inappetence in the period before death. The patient died on 28Apr2021. In the reporter physician opinion, the causal relationship between the reported death and the vaccine is unlikely. The outcome of weakness and inappetence was unknown. The autopsy was initiated at the time of the report. Results are not available. Sender comments: The 89- year-old patient died 14 days after Pfizer vaccination. The cause of death was unknown. Dechallenge and rechallenge were not applicable. The causal relationship between the reported death and the vaccine is not assessable. The case is serious due to fatal outcome. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: sudden death


VAERS ID: 1339159 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-23
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
SMQs:, 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: 7
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: KALIUM-R; ASA PROTECT PHARMAVIT; FURON [FUROSEMIDE]; NOLPAZA; RENITEC COMP; CONCOR; CORDARONE; SYNJARDY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis of arteries of the extremities; Cardiac insufficiency; Cardiomyopathy; COPD; Diabetes mellitus non-insulin-dependent; Hypertension; Measles; Myocardial infarct; Obesity; Respiratory insufficiency; Triple vessel disease; Ventricular tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210323; Test Name: COVID-19 antigen test positive; Test Result: Positive
CDC Split Type: HUPFIZER INC2021559890

Write-up: COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-291121 received via regulatory authority. This spontaneous, serious, medically confirmed case was reported on 28Apr2021 by a physician and concerns the occurrence of Covid-19 infection resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. A 70-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot Number: ET1831), intramuscular in right arm on 17Mar2021 at 0.3 ml single for covid-19 immunisation. The patient was hospitalized on 27Mar2021 because of weakness which has been ongoing for 1 week and difficulty in breathing which occurred the day before. Previously a covid antigen was done on 23Mar2021 because the patient''s daughter got infected with covid, who she lives together with. The test result was positive. Bilateral pneumonia was confirmed in the hospital. The patient received antiviral, steroid, anticoagulant, anti-decompensation therapy and ulcus prophylaxis. Despite the therapy, the patients oxygenation continued to worsen and passed away on 30Mar2021 at 18:02. Medical history included atherosclerosis of arteries of the extremities, cardiac insufficiency, cardiomyophathy, COPD, non-insulin-dependent diabetes mellitus, hypertension, measles, myocardial infarct, obesity, respiratory insufficiency, triple vessel disease and ventricular tachycardia. Drug history included Xigduo (metformin; dapagliflozin), clopidogrel and canakinumab. Concomitant drugs were ASA Protect Pharmavit 100 mg (acetylsalicylic acid), Concor 2.5 mg (bisoprolol fumarate), Cordarone 100 mg (amiodarone), Furon 40 mg (furosemide), Kalim-R 1 g (potassium chloride), Nolpaza 40 mg (pantoprazole), Renitec 2.5 mg (enalapril) and Synjardy (empagliflozin; metformin). Further information is not expected. Sender Comment: According to the information of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient got infected with Covid-19 6 days after the first dose, therefore immunity may have not developed yet. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse event as the patient died due to Covid-19. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the available information the event "infected with Covid-19" is attributed to an intercurrent medical condition that was not related to BNT162B2 (COMIRNATY0 vaccine.; Reported Cause(s) of Death: covid-19


VAERS ID: 1339160 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-09
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 - / OT

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: 2021-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder cancer; Haematuria; Hypertension; Metastatic colon cancer; Psychiatric disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560088

Write-up: cardiovascular failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, number HU-OGYI-291221. This spontaneous, serious case was reported on 27Apr2021 by a physician and concerns the occurrence of cardiovascular failure resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. On 18Feb2021 the 77-year-old male patient received COMIRNATY concentrate for dispersion for injection (one dose 0.3 ml, contains tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), batch number: EL0725, expiry date: unknown, MAH: BioNTech Manufacturing GmbH/Pfizer) intramuscularly to prevent COVID-19. He received the first Comirnaty vaccine (one dose 0.3 ml, contains tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), batch number: EJ6134, expiry date: unknown, MAH: BioNTech Manufacturing GmbH/Pfizer) intramuscularly on 28JAN2021. On 09Mar2021 the patient died from cardiovascular failure caused by the patient''s underlying hematuria, bladder cancer and metastatic colon cancer. Medical history included hematuria, metastatic colon cancer, bladder cancer, hypertension and psychiatric disorder not otherwise specified, all from an unspecified date and unknown if ongoing. Concomitant drugs are not reported. Further information is not expected. It was unknown if autopsy was performed. Sender''s comment: The patient died due to cardiovascular failure 19 days after the second dose of COMIRNATY caused by the patient''s underlying hematuria, bladder cancer and metastatic colon cancer. The events and the vaccination are not related. The case is considered serious due to fatal outcome. No follow up attempts are needed, no further information is expected.; Sender''s Comments: Based on the information currently available, the Company concurs with the reporter that there is not a reasonable possibility of an association between the suspect medication and the event cardiovascular failure, due most likely to underlying medical conditions.; Reported Cause(s) of Death: cardiovascular failure


VAERS ID: 1339161 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-14
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0725 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Hypertension; Ischemic heart disease; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560101

Write-up: died on 14Mar2021 due to cachexia and heart insufficiency; died on 14Mar2021 due to cachexia and heart insufficiency; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB HU-OGYI-291421. This is a report received from the administrative authority (AA). A 83-year-old female patient received second dose BNT162B2 (COMIRNATY, lot/batch number EJ0725), intramuscular on 18-FEB-2021 at 0.3 ml single dose for COVID-19 immunization. Medical history included ischemic heart disease, Parkinson''s disease, hypertension and cerebral infarction. The concomitant medications were not reported.The Historical Vaccine was first dose COMIRNATY on 28JAN-021(batch number: EL6134 ,0.3 ml single) intramuscular for COVID-19 immunization. The patient died on 14Mar2021 due to cachexia and heart insufficiency. According to the reporter physician''s opinion the patient''s death was caused by her underlying diseases. The event and the vaccination were not related. The patient died on 14Mar2021. The autopsy was not performed. The cause of death was cachexia and heart insufficiency. The outcome of the events was fatal. Sender comments: The patient died due to cachexia and heart insufficiency 26 days after vaccination with COMIRNATY. The event and the vaccination are not related. The case is considered serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the clinical information currently provided, the company concurs with the causality assessment expressed by the reporter, considering there is not a reasonable possibility that the reported events are related to the suspect drug Comirnaty.; Reported Cause(s) of Death: cachexia; heart insufficiency


VAERS ID: 1339162 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypertensive encephalopathy, Respiratory failure, SARS-CoV-2 test, Vascular dementia
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (narrow), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (narrow), Hypertension (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcoholism; Arteriosclerosis; Dementia; Enlarged prostate; Hypertension; Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: COVID-19 rapid POC test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021560190

Write-up: respiratory failure; hypertensive encephalopathy; vascular dementia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, Safety Report Unique Identifier HU-OGYI-291521. This is a report received from the regulatory authority. Regulatory authority report number HU-OGYI-291521. An 80-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscularly in the left arm on 28Jan2021 (lot number: EJ6134) at 0.3ml, single dose for COVID-19 immunisation. Medical history included ongoing Parkinson''s disease, ongoing enlarged prostate, ongoing hypertension, ongoing dementia, ongoing arteriosclerosis, and ongoing alcoholism. Concomitant medication was not reported. On 03Feb2021, the patient died. The autopsy was not performed. According to the patient''s death certificate, the direct cause of death was respiratory failure, indirect causes were hypertension, hypertensive encephalopathy, and vascular dementia. Other information: the patient lived in a nursing home at the time of the vaccinations. On 27Jan2021, the Covid-19 rapid POC test was negative. In the physician''s opinion, the patient''s death was related to his underlying diseases. Outcome of events was fatal. Senders comments: The 80- year-old patient died 6 days after BNT162B2 vaccination. The cause of death was respiratory failure. Dechallenge and rechallenge were not applicable. The relationship between the reported death and the vaccine was considered unlikely. The case was serious due to fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Respiratory failure; hypertension; hypertensive encephalopathy; vascular dementia


VAERS ID: 1339163 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-02-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchial neoplasm, Death, Lung neoplasm, Neoplasm progression
SMQs:, Malignancy related conditions (narrow), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchial neoplasm; COPD; Lung neoplasm
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560197

Write-up: Bronchial neoplasm progresion; Bronchial neoplasm progresion; Lung neoplasm progression; Lung neoplasm progression; death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority. A 63-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 20Feb2021 (Batch/Lot Number: EP2163) as 0.3 mL, single for covid-19 immunisation . Medical history included ongoing chronic obstructive pulmonary disease , ongoing lung neoplasm , ongoing bronchial neoplasm. The patient''s concomitant medications were not reported. On 30Jan2021, the patient received the first dose. Comirnaty The patient died on 22Feb2021. According to the patient death certificate, direct cause of death were respiratory and circulatory failure, indirect causes was lung and bronchial neoplasm. According to the physician, the patient death is related to his underlying diseases. The autopsy was not performed. Sender Comment: According to the SmPC of Comirnaty concentrate for dispersion for injection, death is not expected. TTO (to take out) is 2 days. 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 fatal outcome. No further information is expected.; Reported Cause(s) of Death: respiratory and circulatory failure - direct cause according to the patient death certificate; respiratory and circulatory failure - direct cause according to the patient death certificate; lung and bronchial neoplasm - indirect cause according to th


VAERS ID: 1339164 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-12
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-22
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, 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: 2021-04-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BRETARIS GENUAIR; FRONTIN; CLOPIDOGREL; NITROMINT; MONTELUKAST; THEOSPIREX [THEOPHYLLINE]; CAVINTON; PANTOPRAZOLE; FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL FUMARATE]; LETROX; BETALOC [METOPROLOL SUCCINATE]; PAROGEN
Current Illness: Allergic asthma; Arteriosclerosis; Breast cancer; COPD (Her COPD was very severe with regular exacerbation requiring antibiotic treatment.); Hypertension; Smoker; Thyroid disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: COVID-19 test; Test Result: Positive ; Comments: Post-mortem COVID-19 test was positive.
CDC Split Type: HUPFIZER INC2021560098

Write-up: Lack of drug effect; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB HU-OGYI-292121, received from Regulatory Authority. A 70-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 26Mar2021 (Lot Number: ET7205) as 0.3 ml single for Covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (Her COPD was very severe with regular exacerbation requiring antibiotic treatment), ongoing allergic asthma, ongoing thyroid disorder, ongoing arteriosclerosis, ongoing smoker, ongoing breast cancer, ongoing hypertension. Concomitant medications included aclidinium bromide (BRETARIS GENUAIR); alprazolam (FRONTIN); clopidogrel; glyceryl trinitrate (NITROMINT); montelukast; theophylline (THEOSPIREX); vinpocetine (CAVINTON); pantoprazole; beclometasone dipropionate, formoterol fumarate (FOSTER); levothyroxine sodium (LETROX); metoprolol succinate (BETALOC); paroxetine hydrochloride (PAROGEN). On 12Apr2021, the patient died at home. Post-mortem COVID-19 test was positive. The patient died on 12Apr2021. An autopsy performed (also reported as autopsy had not been done) and COVID-19 test was positive. Sender''s comments: The patient was detected to have COVID-19 17 days after receiving the first dose of COMIRNATY. Immunity may have not developed within less than 3 weeks before the first dose of vaccine. The case is serious because the patient died. No further information is expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19; COVID-19; Autopsy-determined Cause(s) of Death: COVID-19 test was positive


VAERS ID: 1339165 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Haematemesis, Oesophageal varices haemorrhage, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VEROSPIRON; QUAMATEL
Current Illness: Alcoholism; Cirrhosis liver; Gallstones; Spleen enlarged
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: COVID-19 rapid POC test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021560245

Write-up: bleeding esophageal varices; bleeding esophageal varices, caused vomiting of blood; asystole; This is a spontaneous report received from a contactable other Healthcare Professional downloaded from the Regulatory Authority report. A 59-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 24Apr2021 (Batch/Lot Number: ET6956) as unknown, 0.3 mL, single for covid-19 immunisation. Medical history included ongoing alcoholism, ongoing spleen enlarged, ongoing cirrhosis liver, ongoing gallstones. Concomitant medications included spironolactone (VEROSPIRON) and famotidine (QUAMATEL). On 26Apr2021, the patient was admitted to the hospital, because the patient experienced bleeding oesophageal varixes, and this caused vomiting of blood, the COVID-19 rapid point-of-care (POC) test was negative. 3 days later, the patient was unable to contact or communicate with the outside world. Mechanical ventilation was necessary. On 28Apr2021, the patient died. An autopsy was not performed. The direct cause of death was asystole. In the physician''s opinion, the patient''s death is related to her underlying diseases. The outcome of events was fatal. Sender Comment: According to the SmPC of Comirnaty concentrate for dispersion for injection, bleeding oesophageal varixes is not expected. TTO is 2 days. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is unlikely. 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: vomiting of blood; bleeding esophageal varices; asystole


VAERS ID: 1339166 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-28
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Type 1 diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   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: Dementia; General physical health deterioration (since the end of 2020); Insulin-dependent diabetes mellitus; Mental deterioration (since the end of 2020)
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560240

Write-up: patient died from her not adjustable insulin-dependent diabetes mellitus; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-293021. This is a report received from the Regulatory Authority. A 87-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 30Jan2021 (Batch/Lot Number: EJ6134) as 0.3 mL, single for covid-19 immunisation. Medical history included dementia and insulin-dependent diabetes mellitus, both from an unknown date and unknown if ongoing. According to her doctor the patient''s condition was deteriorating both physically and mentally since the end of 2020. The patient''s concomitant medications were not reported. The patient died from her not adjustable insulin-dependent diabetes mellitus on 28Feb2021. The patient died on 28Feb2021. It was not reported if an autopsy was performed. Sender''s comment: The patient died 29 days after vaccination with COMIRNATY. The patient died due to her underlying diabetes mellitus. The vaccine and the event are not related. The case is considered serious due to fatal outcome.; Reported Cause(s) of Death: patient died from her not adjustable insulin-dependent diabetes mellitus


VAERS ID: 1339167 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-09
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / 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: 2021-02-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Leg ulcer (leg ulcerdue to vein insufficiency in lower extremities); Venous peripheral insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560241

Write-up: sudden death; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority. A 83-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 30Jan2021 (Lot Number: EJ6134) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunisation. Medical history included leg ulcer due to vein insufficiency in lower extremities, and atrial fibrillation. The patient''s concomitant medications were not reported. On 09Feb2021 the patient suddenly died. Sender Comment: The patient died suddenly 10 days after vaccination with COMIRNATY. The causality between the vaccine and the event is unlikely. The case is considered serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: suddenly died


VAERS ID: 1339168 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-16
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiovascular insufficiency, Drug ineffective, Pulmonary oedema, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Haemodynamic oedema, effusions and fluid overload (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: 2021-02-21
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain infarction; Diabetes mellitus; Hyperlipidemia
Allergies:
Diagnostic Lab Data: Test Date: 20210216; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021560242

Write-up: pulmonary oedema; high fever; cardiovascular insufficiency; COVID-19 PCR positive; COVID-19 PCR positive; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is HU-OGYI-316021. A 82-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 30Jan2021 (Batch/Lot Number: EJ6134) as 0.3ML SINGLE for covid-19 immunisation. Medical history included diabetes mellitus, hyperlipidemia and Brain infarction. The patient''s concomitant medications were not reported. On 16Feb2021 the patient was tested positive with COVID-19 polymerase chain reaction (PCR) test. On 21Feb2021 he experienced high fever and pulmonary oedema and he died due to cardiovascular insufficiency. The outcome of the events was fatal. The patient died on 21Feb2021. An autopsy was not performed. Sender Comment: COVID-19 was detected 16 days after vaccination with COMIRNATY. The patient died due to pulmonary eodema caused by COVID-19 infection. Immunity does not develop within 16 days after the first dose of the vaccine. The causality between the vaccine and the event is unlikely. 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: pulmonary oedema; COVID-19 PCR positive; COVID-19 PCR positive; high fever; cardiovascular insufficiency


VAERS ID: 1339169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-05-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA165994 / 1 LA / 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: Encephalopathy hypertensive; Hypertension; Ischaemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560202

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB HU-OGYI-317721. Regulatory authority report number HU-OGYI-317721. An 83-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot. PAA165994) intramuscularly, in the left arm, at 0.3 ml, single dose, on 14Apr2021, for COVID-19 immunisation. Relevant medical history included ischaemic heart disease from an unspecified date and ongoing, hypertension from an unspecified date and ongoing, encephalopathy hypertensive from an unspecified date and ongoing and type II diabetes mellitus from an unspecified date. The patient''s concomitant medicinal products were not reported. On 01May2021, the patient died. it was unknown if autopsy was done. No further information provided. Sender Comment: Death after vaccination with BNT162B2 (COMIRNATY, concentrate for dispersion for injection) is not expected. TTO is 15 days. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered not assessable per lack of information. The case is considered serious due to fatal outcome.; Reported Cause(s) of Death: Death


VAERS ID: 1339170 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: General physical health deterioration (for the last few months); Mental deterioration (for the last few months)
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Brain infarction; Cardiac insufficiency; COVID-19; Dementia; Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560085

Write-up: COVID-19; COVID-19; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB received from the Regulatory Authority. The regulatory authority report number is HU-OGYI-319721. This spontaneous, serious, medically confirmed case was reported to the Regulatory Authority on 03May2021 by a physician. An 89-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 30Jan2021 (Batch/Lot Number: EJ6134) as UNKNOWN, 0.3 ML SINGLE for active immunization to prevent COVID-19. The patient''s medical history included covid-19; atherosclerosis; brain infarction; dementia; depression; and cardiac insufficiency; all from an unknown date and unknown if ongoing. It was also reported that the patient''s physical and mental health have been deteriorating for the last few months. Concomitant medications were not reported. The physician reported the occurrence of Covid-19 infection resulting in death after bnt162b2 injection. On an unknown date the patient got infected with Covid-19 and passed away on 19Feb2021 at 14:30. According to the reporter, the patient''s physical and mental health have been deteriorating for the last few months and his passing was expected. The patient died on 19Feb2021 at 14:30. An autopsy was not performed. Sender Comment: The causal relationship is unlikely between the suspected drug and the adverse event as the patient had Covid-19 and his state has been deteriorating for a while due to his primary diseases. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: COVID-19; COVID-19


VAERS ID: 1339171 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic 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: 2021-02-15
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; COVID-19 pneumonia; Dementia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210216; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021560087

Write-up: a covid PCR test showed a positive result; Covid positive; fever; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. An 85-year-old female patient received BNT162B2 (COMIRNATY), via intramuscular, administered in Arm Left on 30Jan2021 (Lot Number: EJ6134, expiration date unknown) as 0.3ML, single dose for prevent Covid-19. Medical history included dementia, hypertension, covid-19 and covid-19 pneumonia, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The physician concerned the occurrence of Covid-19 infection resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. On 4-5 days (in Feb2021) after vaccination the patient experienced fever. On 16Feb2021 a covid PCR test showed a positive result and on 25Feb2021 the patient passed away. According to the reporter, the patient''s physical and mental health was heavily deteriorated already and rapidly progressed in the last few months. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Feb2021. The outcome of the event fever was unknown. The patient died on 15Feb2021 due to Covid-19 infection. It was unknown if autopsy was done. Sender Comment: The causal relationship is unlikely between the suspected drug and the adverse event as the patient had Covid-19 and her state was already heavily deteriorated. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: COVID-19; COVID-19


VAERS ID: 1339172 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-05-01
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Bacterial test, Clostridium difficile infection, Death, Pancreatitis acute
SMQs:, Acute pancreatitis (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PORTIRON; DOXAZOSIN HEXAL; VITAMIN D3; CAVINTON; MILURIT; CONCOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Kidney failure chronic; Septicaemia
Allergies:
Diagnostic Lab Data: Test Name: Stool sample test; Result Unstructured Data: Test Result:showed clostridium difficile infection
CDC Split Type: HUPFIZER INC2021560244

Write-up: abdominal cramps; acute pancreatitis (subfebrile, chills, weakness and dizziness); clostridium difficile infection; Death; This is as spontaneous report received from a contactable Other Health Professional downloaded from the Regulatory Authority (RA)-WEB. The regulatory authority report number is HU-OGYI-321321. Source verbatim: This spontaneous, serious, medically confirmed case was reported on 04May2021 by a healthcare professional and concerns the occurrence of death after COMIRNATY injection for active immunization to prevent COVID-19. On 05Mar2021 the 87-years-old female patient received the first dose (batch number: ET1831, right arm) on 05Mar2021and on 09Apr2021 received the booster shot of 0.3 ml COMIRNATY concentrate for dispersion for injection (tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), batch number: EW9127, expiry date: unknown,: BioNTech Manufacturing Pfizer) intramuscularly in the left arm to prevent Covid-19. Medical history included Septicaemia, chronic kidney failure and hypertension. Concomitant drugs were Cavinton (vinpocetin), Concor 5 mg (bisoprolol fumarate), vitamin D3 1000 IU, Doxazosin Hexal, Milurit 100 mg (allopurinol) and Portiron 50 mg (losartan). The patient was hospitalized on 17Apr2021 because of abdominal cramps. Before hospitalization the patient experienced subfebrile, chills, weakness and dizziness. The patient was diagnosed with acute pancreatitis. As the patient received analgesic, anticonvulsant and antibiotic therapy, her condition started to get better. Stool sample test showed clostridium difficile infection for which the patient received vancomycin and diuresis, but despite of it her general condition continuously deteriorated and passed away on 01May2021 at 04:15. It was not stated in the hospital discharge summary whether the patient was tested for Covid-19 infection or not. Further information is not expected. The outcome of events was fatal. Sender''s Comments: As the patient was hospitalized due to acute pancreatitis and later confirmed clostridium difficile infection, the causal relationship is unlikely between the suspected drug and the adverse events. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death; abdominal cramps; acute pancreatitis; clostridium difficile infection


VAERS ID: 1339173 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-03-12
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain infarction; Dementia; Femoral neck fracture; Ischemic heart disease; Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560198

Write-up: patient passed away. The cause of death was cardiac insufficiency; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is HU-OGYI-322521. A 92-year-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 20Feb2021 (Lot Number: EP2163, Expiry date unknown) as 0.3 mL single for COVID-19 immunisation. Medical history included dementia, brain infarction and ischemic heart disease, femoral neck fracture in Dec2020 and since then he was bedridden, pneumonia in Jan2021. Concomitant medications were not reported. Previously the patient received the first dose of COMIRNATY (Lot Number: EJ6134) on 30Jan2021 for COVID-19 immunisation. On 12Mar2021 at 14:00 the patient passed away. The cause of death was cardiac insufficiency. An autopsy was not performed. Sender Comment: The causal relationship is unlikely between the suspected drug and the adverse event as the patients state has been deteriorating for a while and the reporter physician assessed the adverse events as related to his primary diseases. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac insufficiency


VAERS ID: 1339174 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-28
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Chest X-ray, Investigation, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
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: 2021-04-09
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AUGMENTIN DUO; FRONTIN; LACIPIL; FUROSEMIDE; MILURIT; VESICARE; VENORUTON [TROXERUTIN]; PRENESSA; VEROSPIRON; KALIUM-R; ELIQUIS; PROSOLIN [TAMSULOSIN HYDROCHLORIDE]; DEXAMETHASONE; PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Congestive heart failure; COVID-19; COVID-19 pneumonia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: Chest X-ray; Result Unstructured Data: Test Result:bilateral Covid-19 pneumonia; Test Date: 20210401; Test Name: laboratory tests; Result Unstructured Data: Test Result:abnormalities in association with Covid-19; Test Date: 20210401; Test Name: oxygen saturation; Test Result: 70 %; Test Date: 20210401; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021560243

Write-up: Vaccination failure; COVID-19; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. An 89-year-old male patient received bnt162b2 (COMIRNATY), first dose via an unspecified route of administration on 27Feb2021 at single dose, second dose intramuscularly administered in left arm on 20Mar2021 (Batch/Lot Number: EP2166) at 0.3 ml single, for COVID-19 immunisation. Medical history included atrial fibrillation, hypertension, congestive heart failure, COVID-19 pneumonia, COVID-19, all unknown if ongoing. Concomitant drugs included amoxicillin trihydrate, clavulanate potassium (AUGMENTIN DUO); alprazolam (FRONTIN); lacidipine (LACIPIL); furosemide; allopurinol (MILURIT); solifenacin succinate (VESICARE); troxerutin (VENORUTON); perindopril erbumine (PRENESSA); spironolactone (VEROSPIRON); potassium chloride (KALIUM-R); apixaban (ELIQUIS); tamsulosin hydrochloride (PROSOLIN); dexamethasone; pantoprazole. The patient experienced vaccination failure (death, hospitalization) on 28Mar2021, covid-19 (death, hospitalization) on 28Mar2021, covid-19 pneumonia (death, hospitalization) on 28Mar2021. The patient was hospitalized from 01Apr2021. The patient died on 09Apr2021. Clinical course: On 01Apr2021 the patient was hospitalized with a positive Covid-19 antigen test result and dyspnea. His oxygen saturation was 70% and laboratory tests also implied abnormalities in association with Covid-19. Chest X-ray confirmed bilateral Covid-19 pneumonia. The patient received covid treatment but his respiratory insufficiency intensified and passed away on 09Apr2021 at 8:20. An autopsy was not performed. The outcome of the events was fatal. Health Authority Comment: According to the SmPC of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. Vaccination failure can be considered possible as the patient died of Covid-19, 19 days after the second dose. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Vaccination failure; COVID-19; COVID-19 pneumonia


VAERS ID: 1339187 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Asthenia, Autopsy, Cardiac arrest, Fall, Groin pain, Imaging procedure, Respiratory arrest, Seizure like phenomena, Syncope, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; COLGOUT; ULTIBRO BREEZHALER; ALLOPURINOL; FOLIC ACID; ISOSORBIDE MONONITRATE; SILDENAFIL; CLOPIDOGREL; ATORVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm (7cm on bedside point of care ultrasound.); Alcohol use; Artificial cardiac pacemaker user; Atrial fibrillation; Chronic obstructive pulmonary disease (with emphysema); Congestive cardiac failure; Coronary artery bypass graft (associated with IHD); Coronary stent user; Emphysema; Gout; Hypertension; Ischemic heart disease (ischemic heart disease with previous 3 vessel coronary artery bypass graft); Peripheral vascular disease; Smoker; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: post-mortem examination; Result Unstructured Data: Test Result:abdominal aortic aneurysm; Comments: (1) Ruptured 8.5cm diameter infrarenal abdominal aortic aneurysm, which was associated with large abdominal haematoma (at least 2 litres). (2) Status post CABG with stenting. (3) Cardiac pacemaker in situ; Test Date: 2018; Test Name: abdominal aortic aneurysm imaging; Result Unstructured Data: Test Result:6.5cm diameter; Comments: 6.5cm diameter on imaging in 2018; Test Date: 202104; Test Name: ultrasound; Result Unstructured Data: Test Result:was 7cm; Comments: the patient''s abdominal aortic aneurysm was 7cm on bedside point of care ultrasound
CDC Split Type: IEPFIZER INC2021553703

Write-up: ABDOMINAL DISTENSION; WEAK; PAIN IN GROIN; SEEMED TO HAVE A SEIZURE; PRONOUNCED DEAD AN HOUR LATER/ CARDIAC ARREST; collapse; syncope; stopped breathing; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is IE-HPRA-2021-071836. A 77 years old male patient received 2nd dose of BNT162B2 (COMIRNATY, lot number: EW8904) at 0.3 ml single dose on 16Apr2021 09:30 via an unknown route for COVID-19 immunisation. Medical history/concurrent conditions included cardiac assistance device user/ Coronary stent user/ cardiac stenting, peripheral vascular disorder, hypertension, diabetes mellitus type 2, ischaemia /ischemic heart disease with previous 3 vessel coronary artery bypass graft, congestive cardiac failure, atrial fibrillation, gout, chronic obstructive pulmonary disease with emphysema, artificial cardiac pacemaker user, abdominal aortic aneurysm (6.5cm diameter on imaging in 2018). The patient was a lifelong smoker and alcohol drinker. Concomitant medication included clopidogrel, isosorbide mononitrate, acetylsalicylic acid (ASPIRIN), atorvastatin, bisoprolol, colchicine (COLGOUT), folic acid, sildenafil, allopurinol and glycopyrronium bromide, indacaterol maleate (ULTIBRO BREEZHALER). Historical vaccine included 1st dose of BNT162B2 (COMIRNATY) at single dose on 19Mar2021 for COVID-19 immunisation. Patient experienced asthenia, syncope and died following vaccination with Comirnaty for COVID-19 immunisation. On 16Apr2021, following vaccination, the patient was waiting in the observation room, he got weak and collapse. It was noted that the patient experienced groin pain prior to the patient becoming weak and collapsing. Subsequent to a second collapse, abdominal distension was noted. Within 5 minutes post-vaccination, the patient complained of pain in groin and became weak, which he was seemed to have a seizure. It was also reported that when the patient came around he was able to answer questions then stopped breathing with no pulse after a few minutes. The time of vaccination was around 09:30 am and within 15 minutes, the patient collapse and experienced cardiac arrest (pulseless electrical activity). Bystander resuscitation efforts commenced immediately and were ongoing for 60 minutes before ceasing. Cardiopulmonary resuscitation was performed until the ambulance arrived. The patient was administered intravenous adrenaline 8mg during resuscitation attempt. The patient was taken to hospital and pronounced dead an hour later. The time of vaccination was around 09:30 am and within 15 minutes, the patient collapse and experienced cardiac arrest (pulseless electrical activity). Bystander resuscitation efforts commenced immediately and were ongoing for 60 minutes before ceasing. The reported outlined that the patient''s abdominal aortic aneurysm was 7cm on bedside point of care ultrasound. The case was reported to the Coroner''s office at the same day. A report of post-mortem examination was provided. Resuscitation was unsuccessful and patient was pronounced dead at 10:34 on 16Apr2021. Anatomic diagnosis included: (1) Ruptured 8.5cm diameter infrarenal abdominal aortic aneurysm, which was associated with large abdominal haematoma (at least 2 litres). (2) Status post CABG with stenting. (3) Cardiac pacemaker in situ. Covid-19 screen of Sars-CoV-2 RNA was not detected. It was noted that results of toxicology, histology and post mortem tryptase analysis results were pending. Time Interval between Beginning of Drug Administration and Start of Event: cardiac arrest was 1 hour, Abdominal distension was 28 days (as reported), Weakness was 5 minutes, Groin pain was 5 minutes, Seizure like phenomena was 5 minutes, syncope was 15 minutes. Outcome of the events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: ABDOMINAL DISTENSION; WEAK; PAIN IN GROIN; SEEMED TO HAVE A SEIZURE; PRONOUNCED DEAD AN HOUR LATER/ CARDIAC ARREST; collapse; syncope; stopped breathing; Autopsy-determined Cause(s) of Death: ruptured abdominal aortic aneurysm


VAERS ID: 1339262 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-30
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PLAVIX; DROMOS; HUMALOG; ATORVASTATIN CALCIUM; METFORAL; ANTRA [OMEPRAZOLE MAGNESIUM]; NORVASC; KARVEA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CVA ; Diabetes mellitus; Hypertensive heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 13-May-2021. The most recent information was received on 14-May-2021 and was forwarded to Moderna on 14-May-2021. This regulatory authority case was reported by a physician and describes the occurrence of RESPIRATORY FAILURE and DYSPNOEA in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001941) for COVID-19 vaccination. The patient''s past medical history included CVA , Diabetes mellitus and Hypertensive heart disease Previously administered products included for an unreported indication: PREVENAR 13 on 18-Nov-2014 and FLUAD QUAD on 29-Oct-2020. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), LEVOCARNITINE PROPIONATE HYDROCHLORIDE (DROMOS), INSULIN LISPRO (HUMALOG), ATORVASTATIN CALCIUM, METFORMIN HYDROCHLORIDE (METFORAL), OMEPRAZOLE MAGNESIUM (ANTRA [OMEPRAZOLE MAGNESIUM]), AMLODIPINE BESILATE (NORVASC) and IRBESARTAN (KARVEA) for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. On 29-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 ml. On 30-Apr-2021, the patient experienced RESPIRATORY FAILURE; PULMONARY OEDEMA (seriousness criterion death) and DYSPNOEA (seriousness criterion death). The patient died on 01-May-2021. The reported cause of death was Respiration failure, Oedema lung and Dyspnea. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were not reported. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14may2021 includes Patients medical history, Dose 1 start date, Concomitant medications , past drug history. On 18-May-2021: NNI; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. All events conservatively retained as fatal / cause of death as SD Authority assessment shows them all as resulting in death although it is likely that dyspnea was a symptom of pulmonary edema which in turn resulted in respiratory failure.; Reported Cause(s) of Death: Respiration failure; Oedema lung; Dyspnea


VAERS ID: 1339291 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 1 LA / 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: 2021-05-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021553716

Write-up: Patient died overnight after pfizer vaccine for covid-19. Mute anamnesis, no pathology or therapy in progress, no malaise the night before. Family history of sudden cardiac death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-727288. A 71-years-old patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 06May2021 17:48 (Batch/Lot Number: FA5831) as 1st dose single for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. family history of sudden cardiac death of sister 2 years earlier Patient was in excellent health. The patient died 10 hours after taking pfizer vaccine for covid-19 during the night and had fallen asleep in the evening without any disturbances, mute anamnesis, no pathology or therapy in progress, no malaise the night before. The patient died on 07May2021. Sender comment: Additional information regarding this will be provided. It was not reported if an autopsy was performed.


VAERS ID: 1339292 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-16
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC2021553866

Write-up: Initial fever, test positive on 19Apr, treated with azithromycin 500, amoxi + clav 3 times / day and Medrol 32mg day and oxygen therapy at 3-4 L / min. From 22Apr significant dyspnea and subsequent; Initial fever, test positive on 19Apr, treated with azithromycin 500, amoxi + clav 3 times / day and Medrol 32mg day and oxygen therapy at 3-4 L / min. From 22Apr significant dyspnea and subsequent; Initial fever, test positive on 19Apr, treated with azithromycin 500, amoxi + clav 3 times / day and Medrol 32mg day and oxygen therapy at 3-4 L / min. From 22Apr significant dyspnea and subsequent; This is a Non-Interventional Study from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-727345. A 54-year-old male subject received BNT162B2 (COMIRNATY), via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, and via intramuscular, administered in arm left on 07Apr2021 11:53 (Batch/Lot Number: ET7205) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The subject experienced initial fever, test positive on 19apr, treated with azithromycin 500, amoxi + clav 3 times / day and medrol 32mg day and oxygen therapy at 3-4 l / min. from 22apr significant dyspnea and subsequent hospitalization on 16Apr2021. Clinical course reported as follows: DOSE NUMBER (2); Time of administration (11:53) site of administration (left shoulder) Attached is a clinical report from the GP and an extract from the clinical record of the positive patient. The patient underwent lab tests and procedures which included SARS-CoV-2 PCR test: positive on 19Apr2021. Therapeutic measures were taken as a result of the events. The subject died on 26Apr2021. It was not reported if an autopsy was performed. Causes of death was reported initial fever, test positive on 19apr, treated with azithromycin 500, amoxi + clav 3 times / day and medrol 32mg day and oxygen therapy at 3-4 l / min. from 22apr significant dyspnea and subsequent hospitalization on 16Apr2021. The reporter''s assessment of the casual relationship of the events was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Senders comment: The compromised response to the vaccine was reported among the ADRs - based on what is reported in the regulatory authority document dated 27APR21, although close to the week after the second dose. The immunization, on the basis of the reported knowledge, was performed correctly and appropriately as reported in the SmPC of Comirnaty and respecting the three weeks between the two administrations.; Sender''s Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 (COMIRNATY) cannot be completely excluded. Covid-19 infection / Covid-19 PCR test positive were possibly due to LOE of BNT162B2 (COMIRNATY). 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) : IT-PFIZER INC-2021560472 same patient /different drugs; Reported Cause(s) of Death: Initial fever, test positive on 19Apr, treated with azithromycin 500, amoxi + clav 3 times / day and Medrol 32mg day and oxygen therapy at 3-4 L / min. From 22Apr significant dyspnea and subsequent hospitalization; Initial fever, test positive on 19A


VAERS ID: 1339293 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-05-05
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210506; Test Name: oxygen saturation; Result Unstructured Data: Test Result:Reduced; Test Date: 20210505; Test Name: sars-cov-2 test; Test Result: Positive
CDC Split Type: ITPFIZER INC2021553870

Write-up: death from covid-related infection in a patient vaccinated with PFIZER BIONTECH 1st and 2nd dose; death from covid-related infection in a patient vaccinated with PFIZER BIONTECH 1st and 2nd dose; oxygen saturation decreased; hyperpyrexia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-727439. A 92-years-old female patient received second dose of bnt162b2 (COMIRNATY), Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 21Apr2021 as 2nd dose, single and patient received first dose of bnt162b2 (COMIRNATY), Formulation: Solution for injection, (Batch/Lot Number: ET3620; Expiration Date: 30Jun2021), dose 1 intramuscular on 31Mar2021 14:58 as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 05May2021 he carried out a molecular swab (swab code 74380966) with a positive result due to close contact of confirmed case (cohabitants). Since 01May2021 he has been experiencing the following symptoms: hyperpyrexia, nausea and vomiting, headache, low saturation, lack of appetite. On 06May2021 reduced oxygen saturation, 118 alerted, patient. On 06May2021, the patient experienced death from covid-related infection in a patient vaccinated with pfizer biontech 1st and 2nd dose. On 05May2021, the patient underwent lab tests and procedures which included oxygen saturation was reduced, On 05May2021, sars-cov-2 test was positive. The patient died on 06May2021. It was not reported if an autopsy was performed. Batch/Lot# and expiry date not provided and not possible to obtain No follow-up attempts possible. No further information expected.


VAERS ID: 1339297 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chest X-ray, Coma, Computerised tomogram head, Gaze palsy, Magnetic resonance imaging head, Pyrexia, Subarachnoid haemorrhage, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PROVISACOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer of skin (skin ETP); Carcinoma breast (previous breast ETP); Senile dementia, uncomplicated (mild); Venous ulcer NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210417; Test Name: fever; Result Unstructured Data: Test Result:fever; Test Date: 2021; Test Name: chest X-ray; Result Unstructured Data: Test Result:Tenuous thickening; Comments: Tenuous thickening in basal field on the right. Widespread accentuation of bilateral basal peribronchovascular interstitium. Heart shadow at upper limits of normal. Diaphragm in place. Outcome of left rib fractures.; Test Date: 2021; Test Name: Brain CT scan; Result Unstructured Data: Test Result:subarachnoid hemorrhag; Comments: subarachnoid hemorrhage with right peribulbar, pontine anterior and perimesencephalic, of the tentorium at the level of the cerebral falx. Blood component in the fissures, in the III and IV ventricle.; Test Date: 2021; Test Name: cranio-encephalic MRI with contrast; Result Unstructured Data: Test Result:no pathological parenchymal impregnation; Comments: no pathological parenchymal impregnation. Within limits both common carotid artery and internal carotid artery. Calcifications of the carotid siphons. Presence of a saccular aneurysm of 4 mm with a collar of about 25 mm at the level of the apex of the right internal carotid arthery posteriorly between the origin of the middle cerebral artery and the posterior fetal cerebral artery. No obvious alterations in the remaining vessels of the Willis polygon. Present the arteries vertebral and basilar.; Test Date: 2021; Test Name: cranio-encephalic MRI without contrast; Result Unstructured Data: Test Result:Extensive subarachnoid haemorrhage with diffuse; Comments: Extensive subarachnoid haemorrhage with diffuse hyperdensities in right peribulbar, anterior pontine and perimesencephalic cisterns, hyperdensities in Silvian fissures and liquor spaces bilaterally adjacent. Hyperdensity of the tentorium and modest even at the level of the cerebral sickle.Intraventricular blood component in IV, III and bilateral occipital horns. Enlarged supratentorial ventricular cavities, extensive periventricular hypodensities and corona radiata due to chronic vascular leukoencephalopathy.
CDC Split Type: ITPFIZER INC2021560081

Write-up: Diffuse joint pain, fever, vomiting, subarachnoid haemorrhage, gaze deviation, coma; Diffuse joint pain, fever, vomiting, subarachnoid haemorrhage, gaze deviation, coma; Diffuse joint pain, fever, vomiting, subarachnoid haemorrhage, gaze deviation, coma; Diffuse joint pain, fever, vomiting, subarachnoid haemorrhage, gaze deviation, coma; Diffuse joint pain, fever, vomiting, subarachnoid haemorrhage, gaze deviation, coma; Diffuse joint pain, fever, vomiting, subarachnoid haemorrhage, gaze deviation, coma; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB IT-MINISAL02-727922. An 80-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular on 14Apr2021 (Lot Number: EW2246) as single dose for COVID-19 immunisation. Medical history included Cancer of skin from an unknown date and unknown if ongoing (skin ETP), Senile dementia, uncomplicated from an unknown date and unknown if ongoing (mild), Venous ulcer NOS from an unknown date and unknown if ongoing , Carcinoma breast from an unknown date and unknown if ongoing (previous breast ETP). Concomitant medication included rosuvastatin calcium (PROVISACOR) taken for an unspecified indication, start and stop date were not reported. The patient experienced diffuse joint pain, fever, vomiting, subarachnoid haemorrhage, gaze deviation, coma (death) on 17Apr2021. The patient underwent lab tests and procedures which included body temperature: fever on 17Apr2021, chest x-ray: Tenuous thickening in basal field on the right. Widespread accentuation of bilateral basal peribronchovascular interstitium. Heart shadow at upper limits of normal. Diaphragm in place. Outcome of left rib fractures in 2021, computerised tomogram head: subarachnoid hemorrhage with right peribulbar, pontine anterior and perimesencephalic, of the tentorium at the level of the cerebral falx. Blood component in the fissures, in the III and IV ventricle in 2021, magnetic resonance imaging head: no pathological parenchymal impregnation. Within limits both common carotid artery and internal carotid artery. Calcifications of the carotid siphons. Presence of a saccular aneurysm of 4 mm with a collar of about 25 mm at the level of the apex of the right internal carotid arthery posteriorly between the origin of the middle cerebral artery and the posterior fetal cerebral artery. No obvious alterations in the remaining vessels of the Willis polygon. Present the arteries vertebral and basilar in 2021, magnetic resonance imaging head: Extensive subarachnoid haemorrhage with diffuse hyperdensities in right peribulbar, anterior pontine and perimesencephalic cisterns, hyperdensities in Silvian fissures and liquor spaces bilaterally adjacent. Hyperdensity of the tentorium and modest even at the level of the cerebral sickle.Intraventricular blood component in IV, III and bilateral occipital horns. Enlarged supratentorial ventricular cavities, extensive periventricular hypodensities and corona radiata due to chronic vascular leukoencephalopathy in 2021. The patient died on 21Apr2021. An autopsy was not performed. The outcome of events was fatal. The clinical course was reported as follows: Chest radiography in bed. Examination performed in supine position. Tenuous thickening in basal field on the right. Widespread accentuation of bilateral basal peribronchovascular interstitium. Heart shadow at upper limits of normal. Diaphragm in place. Outcome of left rib fractures. CRANIO-ENCEPHALIC COMPUTED TOMOGRAPHY WITHOUT AND WITH CONTRAST MEDIUM Response: Urgent examination in comatose patient with fever, post anticovid vaccination. Examination performed directly and after intravenous medium of contrast (50 cm3 of Iomeron 400). Extensive subarachnoid haemorrhage with diffuse hyperdensities in right peribulbar, anterior pontine and perimesencephalic cisterns, hyperdensities in Silvian fissures and liquor spaces bilaterally adjacent. Hyperdensity of the tentorium and modest even at the level of the cerebral sickle.Intraventricular blood component in IV, III and bilateral occipital horns. Enlarged supratentorial ventricular cavities, extensive periventricular hypodensities and corona radiata due to chronic vascular leukoencephalopathy. After intravenous medium of contrast no pathological parenchymal impregnation. Within limits both common carotid artery and internal carotid artery. Calcifications of the carotid siphons. Presence of a saccular aneurysm of 4 mm with a collar of about 25 mm at the level of the apex of the right internal carotid arthery posteriorly between the origin of the middle cerebral artery and the posterior fetal cerebral artery. No obvious alterations in the remaining vessels of the Willis polygon. Present the arteries vertebral and basilar. At cranial computed tomography, subarachnoid hemorrhage with right peribulbar, pontine anterior and perimesencephalic, of the tentorium at the level of the cerebral falx. Blood component in the fissures, in the III and IV ventricle. Sender''s comment: attached the report from the emergency room to which the patient has accessed, in order to see the instrumental and diagnostic analysis carried out the reporting doctor refers on 12May2021: the autopsy examination was not performed, there is a brain computed tomography at the patient''s entrance to the hospital, which shows, in addition to acute lesions, an advanced cerebral vasculopathy. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Gaze palsy; Coma; Vomiting; Subarachnoid haemorrhage; Pain in joint; Fever


VAERS ID: 1339299 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac failure, Condition aggravated, Dyspnoea, Polyuria
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Tubulointerstitial diseases (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bi-ventricular failure (amyloidotic heart disease with severe heart failure from biventricular dysfunction.); Non ST segment elevation acute coronary syndrome (acute coronary syndromes)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021553854

Write-up: Aggravation of heart failure already present: weakness, dyspnoea, contraction, diuresis; Aggravation of heart failure already present: weakness, dyspnoea, contraction, diuresis; Aggravation of heart failure already present: weakness, dyspnoea, contraction, diuresis; Aggravation of heart failure already present: weakness, dyspnoea, contraction, diuresis; Aggravation of heart failure already present: weakness, dyspnoea, contraction, diuresis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB IT-MINISAL02-728117. A 93-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Deltoid Right on 04May2021 15:30 (Batch/Lot Number: EX7389) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Bi-ventricular failure (amyloidotic heart disease with severe heart failure from biventricular dysfunction) from an unknown date and unknown if ongoing; Non-ST segment elevation acute coronary syndrome from 01Jan2012 and unknown if ongoing. The patient''s concomitant medications were not reported. The patient received first dose of COMIRNATY intramuscular in Deltoid Right on 10Apr2021 10:00 a.m. for covid-19 immunisation and no side effects reported. The patient experienced aggravation of heart failure already present: weakness, dyspnoea, contraction, diuresis on 07May2021 and the patient died due to the events on 10May2021. It was not reported if an autopsy was performed. Reporter comment: Initial information of 12May2021: The reporter indicated other clinically relevant condition as the severity and death as the outcome. I had to change the severity to serious - death as the system would not accept what the reporter had biffed.; Reporter''s Comments: Initial information of 12May2021: The reporter indicated other clinically relevant condition as the severity and death as the outcome. I had to change the severity to serious - death as the system would not accept what the reporter had biffed.; Reported Cause(s) of Death: Aggravation of heart failure already present: weakness, dyspnoea, contraction, diuresis; Aggravation of heart failure already present: weakness, dyspnoea, contraction, diuresis; Aggravation of heart failure already present: weakness, dyspnoea, contra


VAERS ID: 1339302 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA 5831 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood creatinine, Blood gases, Blood lactic acid, Blood pressure measurement, Body temperature, Computerised tomogram head, Electrocardiogram, Hyperpyrexia, Hypotension, Nausea, Oxygen saturation, PCO2, PO2, Sopor, pH body fluid
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   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: DOPAMINE; SYMBICORT; EMAGEL; CARDICOR; PLASIL [METOCLOPRAMIDE]; TRITTICO; LASIX [FUROSEMIDE]; OXYGENE LIQUID AIR LIQUID MEDICAL; CRESTOR; MYCOSTATIN; LANTUS; XARELTO; NOVORAPID; LANSOPRAZOLE; PERFALGAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure (the patient was hospitalized for acute renal failure on chronic dehydration; creatinine 4.1 all); Bradycardia-tachycardia syndrome; Candida of mouth; Chronic obstructive bronchopneumopathy; Decompensation cardiac; Dehydration; Dyslipidaemia; Hospitalization; Hypertensive heart disease; Insomnia; Permanent atrial fibrillation; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: HCO3; Result Unstructured Data: Test Result:25 mmol/L; Test Name: creatinine; Result Unstructured Data: Test Result:4.1; Test Date: 20210510; Test Name: Blood gases; Result Unstructured Data: Test Result:unknown results; Test Name: lactates; Result Unstructured Data: Test Result:7.7; Test Date: 20210509; Test Name: blood pressure; Result Unstructured Data: Test Result:90/50 mmHg; Test Date: 20210509; Test Name: blood pressure; Result Unstructured Data: Test Result:65/45 mmHg; Test Date: 20210509; Test Name: blood pressure; Result Unstructured Data: Test Result:100/60 mmHg; Test Date: 20210510; Test Name: blood pressure; Result Unstructured Data: Test Result:90/50 mmHg; Test Date: 20210510; Test Name: blood pressure; Result Unstructured Data: Test Result:80/40 mmHg; Comments: at 6:40; Test Date: 20210509; Test Name: body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Test Date: 20210509; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Test Date: 20210510; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Test Date: 20210510; Test Name: brain computed tomography; Result Unstructured Data: Test Result:negative for acute events; Test Date: 20210510; Test Name: electrocardiography; Result Unstructured Data: Test Result:unknown results; Test Name: saturation; Test Result: 90 %; Test Name: pCO2; Result Unstructured Data: Test Result:32 mmHg; Test Name: ph; Result Unstructured Data: Test Result:7.47; Test Name: pO2; Result Unstructured Data: Test Result:52 mmHg
CDC Split Type: ITPFIZER INC2021560645

Write-up: Sopor; Hyperpyrexia; Nausea; Hypotension; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-728650. A 90-year-old female patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 08May2021 19:20 (lot number FA 5831) at single dose for COVID-19 immunization. Medical history included Decompensation cardiac, Type 2 diabetes mellitus, the patient was hospitalized for acute renal failure on chronic dehydration; creatinine 4.1 all, Permanent atrial fibrillation, Bradycardia-tachycardia syndrome, Chronic obstructive bronchopneumopathy, Hypertensive heart disease, Insomnia, Dyslipidaemia, Candida of mouth. Concomitant medications included dopamine, budesonide, formoterol fumarate (SYMBICORT) for Chronic obstructive bronchopneumopathy, polygeline (EMAGEL), bisoprolol fumarate (CARDICOR) for Hypertensive heart disease, metoclopramide (PLASIL), trazodone hydrochloride (TRITTICO) from 08May2021 to 09May2021 for Insomnia, furosemide (LASIX), oxygen (OXYGENE LIQUID AIR LIQUID MEDICAL), rosuvastatin calcium (CRESTOR) for Dyslipidaemia, nystatin (MYCOSTATIN) for Candida of mouth, insulin glargine (LANTUS) for Diabetes mellitus non-insulin-dependent, rivaroxaban (XARELTO) from 03May2021 to 09May2021 for Permanent atrial fibrillation, insulin aspart (NOVORAPID) for Diabetes mellitus non-insulin-dependent, lansoprazole, paracetamol (PERFALGAN). Historical Vaccine included first dose of Comirnaty on 16Apr2021 for COVID-19 immunization. The patient experienced Hyperpyrexia with nausea from 18:00 on 09May2021, subsequent hypotension: Temperature 38.7 Centigrade arterial tension 90/50 mmHg; after 1 vial Perfalgan Temperature 37.5 Centigrade arterial tension 65/45 mmHg; after 1 vial iv of Emagel arterial tension 100/60 mmHg; at 00:15 of 10May2021 sopor patient with blood pressure 90/50 mmHg, electrocardiography, blood gas analysis performed and oxygen therapy started; 1:24 hours marbled, not awakened, brain computed tomography performed (negative for acute events), Central venous catheter positioned for infusions, pumped Lasix and Dopamine; 6:40 blood pressure 80/40 mmHg body temperature 37.8 Centigrade, repositioned ice locally. Died at 7:50. It was unknown if autopsy was done. Measures Taken: Prescribed and administered: Perfalgan 1 vial intravenous, Emagel 1 vial intravenous, Plasil 1 vial in saline. 100 ml intravenous, Dopamina 1 vial in saline. 45cc in syringe pump at 1.8cc / hour then increased to 2cc / h, oxygen therapy 35% 8 liters / min, Lasix 250ml in syringe pump at 0.5cc / hour. Blood gas analysis result: pH 7.47; pCO2 32 mmHg; pO2 52 mmHg; HCO3 25 mmol / L; lactates 7.7; sO2 90%. The outcome of the events were fatal.; Reported Cause(s) of Death: Hyperpyrexia; Nausea; Hypotension; Sopor


VAERS ID: 1339303 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: 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: 2021-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVETIRACETAM; PHENOBARBITAL; LANSOPRAZOLE
Current Illness: Paralytic disability
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021560707

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB IT-MINISAL02-728694 A 65-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: FA5831 and expiration date: 31Aug2021), via intramuscular, in arm left, on 10May2021 12:10, at 0.3 mL single dose, for COVID-19 immunization. Medical history included paralytic disability from 14Nov2014 to 11May2021. Concomitant medications included levetiracetam, phenobarbital and lansoprazole. The patient experienced cardio-respiratory arrest (fatal) on 11May2021. The outcome of the event was fatal. Patient died on 11May2021. It was not reported if an autopsy was performed. Reporter comment: From the administration of the drug to the patient''s exit, there is no evidence of specific symptoms (patient in a vegetative state); Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1339304 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-07
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   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: Medical History/Concurrent Conditions: Aortocoronary bypass (chronic ischemic heart disease (two aortocoronary bypasses about 25 years ago)); Arterial hypertension; Atrial fibrillation; Chronic ischemic heart disease, unspecified
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: Sars-cov-2 molecular test; Test Result: Positive
CDC Split Type: ITPFIZER INC2021560678

Write-up: THE PATIENT DIED AT HOME ON 05.07.2021, ASYMPTOMATIC BUT POSITIVE TO COVID-19, MOLECULAR SWAB OF 04.27.2021, VACCINATED WITH PFIZER BIONTECH 2 DOSES; THE PATIENT DIED AT HOME ON 05.07.2021, ASYMPTOMATIC BUT POSITIVE TO COVID-19, MOLECULAR SWAB OF 04.27.2021, VACCINATED WITH PFIZER BIONTECH 2 DOSES; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-728833. A 95-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 18Mar2021 09:46 (Batch/Lot Number: EP9598) as 2ND DOSE, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included chronic ischemic heart disease (two aortocoronary bypasses about 25 years ago), atrial fibrillation, arterial hypertension, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced the patient died at home on 07May2021, asymptomatic but positive to covid-19, molecular swab of 27Apr2021, vaccinated with pfizer biontech 2 doses on 07May2021. The patient underwent lab tests which included sars-cov-2 test positive: positive on 27Apr2021. The patient died on 07May2021. It was not reported if an autopsy was performed. Reporter''s comment: The patient died on 07May2021, tested positive for Covid-19 with a molecular swab on 27APR21. Vaccinated with two administrations of PFIZER COMIRNATY; in anamnesis: chronic ischemic heart disease (two aortocoronary bypasses about 25 years ago), atrial fibrillation, arterial hypertension. No follow up attempts needed, no further information is expected; Reported Cause(s) of Death: THE PATIENT DIED AT HOME ON 05.07.2021, ASYMPTOMATIC BUT POSITIVE TO COVID-19, MOLECULAR SWAB OF 04.27.2021, VACCINATED WITH PFIZER BIONTECH 2 DOSES; THE PATIENT DIED AT HOME ON 05.07.2021, ASYMPTOMATIC BUT POSITIVE TO COVID-19, MOLECULAR SWAB OF 04.


VAERS ID: 1339321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-05-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021566360

Write-up: Unknown cause of death; This is a spontaneous report received from contactable consumer (patient''s brother-in-law). A 59-years-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 09May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history was none (patient was fine, she did not suffer from any pathology, she did not take drugs). There were no concomitant medications. The patient experienced unknown cause of death on 11May2021. The patient had been subjected to the Pfizer vaccine on 09May2021, without having complained of uncomfortable situations. The morning of 11May2021 (at 7), the patient was found died in bed. The alarm to Emergency medical service was immediately gave, but on the arrival of the health workers there was nothing more to be done. A Healthcare worker collaborator told that probably it was a cardiovascular short circuit. An autopsy was requested to clarify the cause (results were not provided) and if there was a connection with vaccination but a declaration of death has been issued with specified that it was an inexplicable cause. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1339519 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Brain herniation, Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatic disease
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021550660

Write-up: Extensive cerebral haemorrhage/Hypertensive cerebral haemorrhage; Brain herniation; Consciousness disturbed; This is a spontaneous report from a contactable pharmacist. This is a report received from the Regulatory Authority (RA). Regulatory authority report number is v21106552. A 95-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration on 10May2021 at 14:30 at a single dose for covid-19 immunisation. Medical history included hepatic disease. The patient''s concomitant medications were not reported. On 12May2021 at 19:00, the patient experienced extensive cerebral haemorrhage/hypertensive cerebral haemorrhage, brain herniation, and consciousness disturbed, which required emergency room visit and hospitalization from 12May2021 to 13May2021. The clinical course was as follows: on 10May2021 around 14:30 (the day of vaccination), the patient received the first dose of BNT162b2. On 12May2021 at 19:00 (2 days after the vaccination), the patient experienced consciousness disturbed. On 12May2021 at 22:00 (2 days after the vaccination), the patient was groaning on the floor in her room and was unresponsive to calls; an ambulance was called and transported the patient to the reporting hospital. On 12May2021 (2 days after the vaccination), the patient was admitted to the hospital. Extensive cerebral haemorrhage mainly manifesting from the left thalamus over the left putamen was noted with a condition of brain herniation. The patient would only be attended on her deathbed as it was difficult to save her. On 13May2021 (3 days after the vaccination), the patient died and was discharged. The patient underwent lab tests and procedures which included body temperature: 36.8 degrees Centigrade on 10May2021 before vaccination. Therapeutic measures were taken as a result of extensive cerebral haemorrhage/hypertensive cerebral haemorrhage, brain herniation, and consciousness disturbed. The clinical outcome of the event was fatal. The patient died on 13May2021 due to extensive cerebral haemorrhage/hypertensive cerebral haemorrhage, brain herniation, and consciousness disturbed. It was not reported if an autopsy was performed. The reporting physician classified the events as serious (hospitalization) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause of the events such as any other diseases was hypertensive cerebral haemorrhage. No follow-up attempts needed. No further information expected, batch number/ lot number cannot be obtained.; Reported Cause(s) of Death: Consciousness disturbed; Brain herniation; Extensive cerebral haemorrhage/Hypertensive cerebral haemorrhage


VAERS ID: 1339521 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax
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: 2021-05-14
   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: Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidaemia; Hypertension; Old cerebral infarction; Pleurisy
Allergies:
Diagnostic Lab Data: Test Date: 20210513; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Name: Abdomen CT; Result Unstructured Data: Test Result:no abnormalities; Test Name: Head CT; Result Unstructured Data: Test Result:no abnormalities; Test Name: Chest CT; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC2021552247

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the regulatory authority and a contactable pharmacist. Regulatory authority report number is v21106665. A 75-year-old patient of unspecified gender received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: ET9096, Expiration date 31Jul2021), via intramuscular route of administration on 13May2021 13:30 (at the age of 75-year-old) as single dose for COVID-19 immunization. Medical history included old cerebral infarction, pleurisy, hypertension, hyperlipidaemia and ongoing living in nursing home. Concomitant medications included treatment drugs for hypertension and hyperlipidaemia within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. No information on family history was provided. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# ET9096, Expiration date 31Jul2021) via Intramuscular route of administration on 21Apr2021 at around 13:30 as a single dose for COVID-19 immunization. On 14May2021 the patient died of cardio-respiratory arrest. The course of the event was described by the physician as follows: On 13May2021 at around 13:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# ET9096, Expiration date 31Jul2021) via an intramuscular route of administration as a single dose for COVID-19 immunization. On 14May2021 at 14:21 (1 day after the vaccination), the patient died of cardio-respiratory arrest. On 14May2021 at 14:20 (1 day after the vaccination), the patient was found lying on the stomach in the room by a staff and the staff called an ambulance. When the emergency team arrived, cardio-respiratory arrest was confirmed. While transporting to the reporter''s hospital, epinephrine (EPIQUICK) 7 ampules was administered and resuscitation was performed, however, the patient''s spontaneous circulation did not return. After arriving the reporter''s hospital, CPR (cardiopulmonary resuscitation) was performed for about 30 minutes, but the patient did not recover. Head CT (computerized tomography), chest CT and abdomen CT showed no abnormalities. The reporting physician classified the event cardio-respiratory arrest 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 commented as follows: The patient had underlying conditions of old cerebral infarction and pleurisy. It was reported that the patient was walking as usual on 14May2021 at around 14:00. The reporting pharmacist reported that the cause of death was provided as acute circulatory failure. Autopsy was not performed.; Reported Cause(s) of Death: Cardio-respiratory arrest; acute circulatory failure


VAERS ID: 1339529 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-02
Onset:2021-05-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Polymerase chain reaction, Pyrexia, Septic shock
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 12
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: PCR; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab
CDC Split Type: JPPFIZER INC2021557661

Write-up: Pyrexia; Septic shock; This is a spontaneous report from a contactable physician. The patient was a 93-years-old (at the vaccination) female patient. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medical history. The patient''s concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. On 02May2021 (the day of vaccination), the patient received?the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: unknown, expiry date: unknown) via an unspecified route of administration for COVID-19 immunization in a hospital. On 03May2021 (one day after vaccination), the patient experienced pyrexia. On 15May2021 (13 days after vaccination), the patient died due to septic shock. An autopsy was not performed. The event pyrexia resulted in hospitalization (Emergency room/department or urgent care), disability and fatal. The duration of hospitalization was 2 days. The treatment received for the adverse event included antibacterial agents, infusions, vasopressors, oxygen administration, etc. On 15May2021, the patient has been tested for COVID-19 by polymerase chain reaction (PCR) test (Nasal Swab) and the test result was negative. An autopsy was not performed. The clinical outcome of septic shock and pyrexia was reported as fatal.; Sender''s Comments: Based on the available information and known product profile, the causal relationship between the reported events pyrexia and septic shock with a fatal outcome and the use of BNT162B2 seems unlikely. There is limited information available in this case to make a more meaningful assessment. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: pyrexia; Septic shock


VAERS ID: 1339530 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Cardiac tamponade, Pyrexia
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: 2021-05-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021557888

Write-up: Aortic dissection; pyrexia; cardiac tamponade; This is a spontaneous report from a contactable pharmacist received via a Company sales representative. The patient''s age and gender were not provided. Body temperature before vaccination was not provided. The patient family history and medical history were not provided.On 17May2021 at (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via intramuscular at a dose of 0.3 mL, single for COVID-19 immunization. On 17May2021 (the day of the vaccination), the patient experienced pyrexia and aortic dissection. On 17May2021 (the day of the vaccination), the outcome of the events was fatal. The course of the events was as follows: On 17May2021 (the day of vaccination), after the patient received BNT162b2 vaccination at the institution where she was admitted to, she experienced an adverse event of pyrexia, and she was emergently transferred to another hospital. While the patient was being treated in the hospital, she experienced an adverse event of aortic dissection and cardiac tamponade occurred. Thereafter, the patient died. Cause of death was reported as cardiac tamponade; aortic dissection, pyrexia also reported as fatal. Unknown whether autopsy was performed or not. The causality between the event and BNT162b2 was not provided. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event pyrexia cannot be excluded. However, the events of Aortic dissection and Cardiac tamponade are most likely related to an intercurrent or underlying condition which is unlikely related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Aortic dissection; pyrexia; cardiac tamponade


VAERS ID: 1339532 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Blood test, Body temperature, Cardiac arrest, Computerised tomogram thorax, Cyanosis, Magnetic resonance imaging head, Oxygen saturation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic dissection; Cerebral infarction; Gastrostomy; Hypertension; Obstruction lung disease; Prostatic hyperplasia
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: Blood test; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210510; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210514; Test Name: Chest CT; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210514; Test Name: Head MRI; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210514; Test Name: SpO2; Result Unstructured Data: Test Result:84-86 %; Comments: decreased
CDC Split Type: JPPFIZER INC2021558977

Write-up: Apnoea; Acute cardiac arrest; Cyanosis; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21106877. The patient was an 89-year and 0-month-old male. Body temperature before vaccination was 36.3 degrees Centigrade. Medical history included hypertension, cerebral infarction, post-acute aortic dissection surgery, obstruction lung disease, post-gastrostomy and prostatic hyperplasia. No information on concomitant medications or family history was provided. On 19Apr2021, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# ER9480, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 10May2021 at 15:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# ER9480, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16May2021 at 04:50 (6 days after the vaccination), the patient died of apnoea. It was not reported if an autopsy was performed.The course of the event was as follows: On 19Apr2021, the patient received the first dose of the vaccination. On 04May2021, as the patient developed rash on the body trunk and four limbs, he visited a nearby hospital. Anti-histamine medication was administered and then the symptoms improved. During the first dose of the vaccination and the second one, neither dermatologic symptoms, cardiovascular symptoms, respiratory symptoms, nor gastrointestinal symptoms other than the above mentioned symptoms were noted, and pyrexia was not recognized either. On 10May2021 at 15:00, the patient received the second dose of the vaccination. On 14May2021, after the patient made a regular visit to a different hospital, he visited the reporter''s hospital. At that time, no abnormalities were noted in particular. At that night, since SpO2 (oxygen saturation percutaneous) decreased (to 84-86%), he visited an emergency hospital where chest CT, head MRI and blood test were performed. The result showed no abnormalities and the symptoms showed improvement. On 15May2021, his condition was good as usual. On 16May2021 at 04:50 (in the morning), the patient developed sudden respiratory arrest, and cyanosis appeared. Therefore, he was transferred to a hospital on emergency. Acute cardiac arrest and geromarasmus were diagnosed, and the patient''s death was confirmed. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162b2. It was not reported if there was other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was considered that there was no causal relationship with BNT162b2.; Sender''s Comments: Based on information provided, the event apnoea was more likely related to underlying disease but unlikely related to BNT162b2 (COMIRNATY). The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Acute cardiac arrest; apnea; cardiac arrest; geromarasmus


VAERS ID: 1339534 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-05-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CILOSTAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210516; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210518; Test Name: CT; Result Unstructured Data: Test Result:suspected myocardial infarction; Comments: (only findings of severe pulmonary congestion)
CDC Split Type: JPPFIZER INC2021563636

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician, medical examiner. This is a report received from the Regulatory Authority (RA). Regulatory authority report number is v21107059. An 89-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EX3617; Expiration Date: 31Aug2021), via an unspecified route of administration on 16May2021 at 09:15 at a single dose for covid-19 immunisation. The medical history included hypertension. Concomitant medication included cilostazol (CILOSTAZOL). On 18May2021 at 01:00, the patient experienced acute myocardial infarction, which was serious for death. On 16May2021 at 09:15 (the day of vaccination), the patient received the first dose of BNT162b2. On 17May2021 (one day after vaccination), until at night, the patient led a normal life. On 18May2021 around 01:00 (2 days after the vaccination), the patient experienced acute myocardial infarction. On 18May2021 at 06:30, the patient was found to collapse to the floor of the bedroom, and she was confirmed to be dead. The patient underwent lab tests and procedures which included body temperature: 36.7 degrees Centigrade on 16May2021 before vaccination, computerised tomogram: strongly suspected myocardial infarction (only findings of severe pulmonary congestion) on 18May2021. The patient died on 18May2021 due to acute myocardial infarction. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was hypertension. REPORTER COMMENT: The causal relationship between the event and BNT162b2 was unknown according to the patient''s age and underlying disease. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1339535 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pneumonia aspiration, Pyrexia
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: 2021-05-15
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:pyrexia; Test Date: 20210511; Test Name: Body temperature; Result Unstructured Data: Test Result:reported as uncertain
CDC Split Type: JPPFIZER INC2021564216

Write-up: Pneumonia aspiration; Pyrexia; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number is v21107080. A 92-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) at 92-years-old as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: pyrexia (non-serious). On 12May2021, the patient experienced: pneumonia aspiration (death, hospitalization, medically significant). The patient was hospitalized for pneumonia aspiration from 12May2021 to an unknown date. The clinical course was reported as follows: The patient was a 92-year and 10-month-old male. Body temperature before vaccination was not provided (reported as uncertain). No information on medical history, concomitant medications, or family history was provided (reported as uncertain). On 11May2021, the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, Lot number and Expiration date was not reported). On an unspecified date, the patient experienced pyrexia. On 12May2021 (1 day after the vaccination), the patient experienced pneumonia aspiration, and was hospitalized. On 15May2021 (4 days after the vaccination), the patient died of pneumonia aspiration (dysphagia), although treatment was provided. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal outcome) and assessed that there was no causal relationship with BNT162b2. Dysphagia was reported as another possible cause of the event. The reporting physician commented as follows: It was considered that there was no causal relationship with BNT162b2. The patient underwent lab tests and procedures which included body temperature: reported as uncertain on 11May2021, body temperature: pyrexia on an unspecified date. Therapeutic measures were taken as a result of pneumonia aspiration. The clinical outcome of the event, pyrexia, was unknown. The clinical outcome of the event, pneumonia aspiration, was fatal. The patient died on 15May2021 due to pneumonia aspiration and dysphagia. It was unknown if an autopsy was performed. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up. ; Reported Cause(s) of Death: pneumonia aspiration; dysphagia


VAERS ID: 1339536 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
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: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021564364

Write-up: Pulmonary artery thromboembolism due to deep vein thrombosis leg; Pulmonary artery thromboembolism due to deep vein thrombosis leg; This is a spontaneous report from a contactable physician received via regulatory authority. A 34-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly on 21Apr2021 at 12:00 (Batch/Lot Number: ER9480; Expiration Date: 31Jul2021) at 34-years-old as a single dose for COVID-19 immunization. The patient''s medical history was reported as none. Concomitant medications were not reported. On an unspecified date, the patient experienced: pulmonary artery thromboembolism due to deep vein thrombosis leg (death, medically significant). The clinical course was reported as follows: The patient was a 34-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient had no other medical history. On 21Apr2021 at 12:00 (the day of vaccination), the patient received?the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ER9480, Expiration date 31Jul2021) intramuscularly for COVID-19 immunization. On an unspecified date, the patient experienced pulmonary artery thromboembolism due to deep vein thrombosis leg. The event resulted in death. The outcome of the events was fatal. No treatment was given. The reported narrative was as follows: On 10May2021 (19 days after the vaccination), the patient was found dead in a car. The estimated date of death according to the police was 05May2021. Forensic autopsy results revealed pulmonary artery thromboembolism due to deep vein thrombosis leg. Date of death was reported as May2021. Cause of death was pulmonary artery thromboembolism. Autopsy remarks included pulmonary artery thromboembolism. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was fatal. The patient died on an unspecified date in May2021 due to pulmonary artery thromboembolism. An autopsy was performed that revealed pulmonary artery thromboembolism due to deep vein thrombosis leg.; 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 pulmonary artery thromboembolism and deep vein thrombosis leg, due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including complete autopsy results, serum toxicology screen and coagulation panel, 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: Pulmonary artery thromboembolism; Autopsy-determined Cause(s) of Death: Pulmonary artery thromboembolism due to deep vein thrombosis leg; Pulmonary artery thromboembolism due to deep vein thrombosis leg


VAERS ID: 1339538 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-05-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: 2021-05-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Myocardial infarction old; Rectal cancer; Surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021570910

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21107238. A 73-year and 7-month-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 16May2021 at 14:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included abdominal aortic aneurysm, non-ongoing myocardial infarction old on an unspecified date, and status post surgery for rectal cancer (non-ongoing surgery on an unspecified date). The patient''s concomitant medications were not reported. The patient experienced cardio-respiratory arrest on 17May2021 at 07:50 (17 hours and 50 minutes after the vaccination), which was reported as fatal. The clinical course was reported as follows: The body temperature before vaccination was not provided. On 16May2021 (the day of vaccination), and on 17May2021, at 05:00 (15 hours after the vaccination), no particular abnormalities were observed. At 07:50 on 17May2021 (17 hours and 50 minutes after vaccination), when a staff member visited the patient''s room the next time, she had been already in cardio-respiratory arrest. The patient died on 17May2021. The cause of death was reported as cardio-respiratory arrest. It was not reported if an autopsy was performed. The reporting physician assessed that the causality between the event and BNT162B2 as unassessable (reported as unknown). Other possible causes of the event, such as any other diseases, was reported as unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1339539 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac arrest, Cardio-respiratory arrest, Physical examination, Respiration abnormal
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: 2021-05-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FRANDOL; BISONO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Activities of daily living impaired; Cardiac failure chronic (hospitalized until Apr2021); Home care; Hospitalization; Oral intake reduced; Total parenteral nutrition (due to poor oral intake since hospitalization)
Allergies:
Diagnostic Lab Data: Test Date: 20210519; Test Name: Blood pressure; Result Unstructured Data: Test Result:157/80 mmHg; Test Date: 20210519; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination; Test Date: 20210519; Test Name: examination; Result Unstructured Data: Test Result:in a state of cardio-respiratory arrest
CDC Split Type: JPPFIZER INC2021572376

Write-up: something was wrong with her respiratory state/her respiratory condition suddenly changed; Cardio-respiratory arrest; Asystole; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority (RA). Regulatory authority report number is v21107471. An 89-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 19May2021 10:15 (Batch/Lot number was not reported) at 89-years-old as a single dose for COVID-19 immunization. Medical history included cardiac failure chronic from an unknown date and unknown if ongoing (hospitalized until Apr2021), hospitalized from an unknown date to 13Apr2021, home care from 13Apr2021 to an unknown date, total parenteral nutrition from an unknown date and unknown if ongoing (due to poor oral intake since hospitalization), inadequate oral intake from an unknown date and unknown if ongoing, ADL (activities of daily living) was full assist from an unknown date and unknown if ongoing. Concomitant medications included isosorbide dinitrate (FRANDOL, Transdermal patch/ tape) taken for an unspecified indication, start and stop date were not reported; bisoprolol (BISONO, Transdermal patch/ tape) taken for an unspecified indication, start and stop date were not reported. On 19May2021 at 11:15, the patient experienced: something was wrong with her respiratory state/her respiratory condition suddenly changed (death). On 19May2021, the patient experienced: cardio-respiratory arrest (death, medically significant), and asystole (death, medically significant). The events required an emergency room visit. The clinical course was reported as follows: The patient was an 89-year and 1-month-old female. Body temperature before vaccination was 36.9 degrees Centigrade. The patient had a medical history of cardiac failure chronic, and she had been hospitalized until Apr2021. On 13Apr2021, she discharged home and started to receive home care. She was continuously receiving total parenteral nutrition because of inadequate oral intake. The patient was using isosorbide dinitrate (FRANDOL tape) and bisoprolol (BISONO tape). The patient had no significant family history. On 19May2021 at 10:15 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not provided) via an unspecified route of administration as a single dose for COVID-19 immunization. On 19May2021 at 11:15 (1 hour after the vaccination), the patient experienced that something was wrong with her respiratory state. On 19May2021 (specific time not reported), she died. It was not reported if an autopsy was performed. The course of the event was as follows: The patient stayed in bed all day. The level of ADL (activities of daily living) was full assist. Oral intake was almost impossible. She had been receiving total parenteral nutrition since hospitalization. On 19May2021, the reporting physician made a home visit. At 10:15 on the same day, the vaccination was administered. The reporting physician observed the patient until around 11:00 and returned to the hospital. On 19May2021 at 11:19, the reporting physician was informed by her family member that something was wrong with her respiratory state, and so he examined the patient emergently. On 19May2021 at 11:25, at the time of examination, she was in a state of cardio-respiratory arrest. Then, he performed tracheal intubation, cardiopulmonary resuscitation and intravenous administration of adrenaline together with the emergency team who arrived at around the same time as him. On 19May2021 at 11:52, the patient was transferred to a nearby emergency medical facility. While transporting to a medical facility, she was in a state of asystole and resuscitation was continuously done. However, she died without return of spontaneous circulation. The reporting physician classified the event as serious (Fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event was reported as follows: The patient was observed for around 45 minutes after the vaccination, but no change was noted in her vital signs. One hour after the vaccination, her respiratory condition suddenly changed. The reporting physician commented as follows: After the vaccination the physician stayed at home and observed her for about 45 minutes. The blood pressure measured at that time was 157/80 mmHg. When he left her house (around 11:00), she waved her hand and greeted him. From the time between leaving home and receiving the phone call (11:19), her respiratory condition suddenly changed. When the physician examined her emergently and resuscitated her with the emergency team, she was in a state of asystole, and she did not respond to adrenaline. The patient underwent lab tests and procedures which included blood pressure: 157/80 mmHg on 19May2021, body temperature: 36.9 Centigrade on 19May2021 (Before vaccination), examination: in a state of cardio-respiratory arrest on 19May2021. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was fatal. The patient died on 19May2021 due to respiration abnormal, cardio-respiratory arrest, and asystole. It was unknown if an autopsy was performed. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up. ; Reported Cause(s) of Death: Respiration abnormal; Cardio-respiratory arrest; Asystole


VAERS ID: 1339906 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Targeted heart / VCI emergency ultrasound; Result Unstructured Data: Test Result:strong suspicion of obstructive shock due to massi; Comments: emergency ultrasound heart / VCI: wide right system, D-shape septum, McCullen sign +, empty left ventricle with moderate LVF, VCI wide, does not collapse. No pericardial fluid. Conclusion: clear signs of legal burden with positive mc cullen sign, strong suspicion of obstructive shock due to massive pulmonary embolism.; Test Name: ECG; Result Unstructured Data: Test Result:80; Comments: SR 80/min
CDC Split Type: NLPFIZER INC2021544894

Write-up: massive pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority NL-LRB-00535901. An 86-year-old female patient received second dose bnt162b2 (COMIRNATY), via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: EP2166) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunisation and experienced no adverse event. The patient experienced massive pulmonary embolism on 14Mar2021. Targeted heart / vci emergency ultrasound (ER): wide right system, D-shape septum, Mc cullen sign +, empty left ventricle with moderate Left ventricular failure (LVF), VCI wide, does not collapse. No pericardial fluid. Conclusion: clear signs of legal tax with positive mc cullen sign, strong suspicion of obstructive shock due to massive pulmonary embolism. Electrocardiogram (ECG): SR 80 / min, normal cardiac axis, normal conductances, minimum segment (ST) depressions in I, V5-V6, no segment (ST) elevations, normal T-waves. After one-time filling (started from ambulance) no improvement, hemodynamics. With clear signs of legal tax on targeted emergency ultrasound with high suspicion of obstructive shock pulmonary embolism now no longer filled (due to worsening of circulatory situation in case of obstruction of the right system). Considering that it is too unstable for Computed tomography (CT) hemodynamically, consult IC about yes / no thrombolysis given deep shock and clear desire not to resuscitate want to become. Decided after assessment by intensivis. The patient did not have previous COVID-19 infection. The patient died on 15Mar2021 due to lung embolism. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: massive pulmonary embolism


VAERS ID: 1339907 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-05-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cerebrovascular accident, SARS-CoV-2 test
SMQs:, Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; RIVAROXABAN; OMEPRAZOL; ALLOPURINOL; NORTRIPTYLINE; SIMVASTATINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Encephalitis herpes
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021544984

Write-up: deceased, suspected CVA; deceased, suspected CVA in AF; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number NL-LRB-00536469. A 84-years-old male patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 07May2021 (Batch/Lot Number: Unknown) as 0.3 ml single for covid-19 immunisation. Patient received the first dose on 02Apr2021. Medical history included covid-19 from 12Apr2021 to an unknown date, meningoencephalitis herpetic from an unknown date and unknown if ongoing. Concomitant medications included furosemide taken for an unspecified indication, start and stop date were not reported; rivaroxaban taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOL) taken for an unspecified indication, start and stop date were not reported; allopurinol taken for an unspecified indication, start and stop date were not reported; nortriptyline taken for an unspecified indication, start and stop date were not reported; simvastatine taken for an unspecified indication, start and stop date were not reported. The patient experienced died suddenly 2 days after vaccination with cerebrovascular accident, fibrillation atrial, in between no manifestations of muscle pain, fever. The patient died on 09May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): yes ADRs: no Date:02Apr2021 Additional information ADR: died suddenly 2 days after vaccination, in between no manifestations of muscle pain, fever. citizen service number available: yes Previous COVID-19 infection: disease symptoms: none diagnostic procedures: no; Reported Cause(s) of Death: AF; suspected stroke in AF in patient with status after herpes encephalitis and recently Covid-19


VAERS ID: 1339908 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-04-29
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021544908

Write-up: Death, heart failure; This is a spontaneous report from a contactable consumerl downloaded from the regulatory authority, regulatory authority number NL-LRB-00536831. An 82-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 25Feb2021 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on 18Jan2021 for COVID-19 Immunization. In the evening of 28Apr2021, the patient went to bed fine, but did not wake up the next morning. Remained in a comatose state until she passed away around 3:00 PM (29Apr2021). Cause: heart failure, but her heart had nothing to do with her, super strong. Unclear reason ... people talked about ''acute'' heart failure. There is no previous COVID-19 infection. The patient died on 29Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death, heart failure


VAERS ID: 1339909 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-28
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021553991

Write-up: Cerebral haemorrhage 7 days after successful surgery resulting in death of date 29Apr2021 No complaints after vaccination.; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority NL-LRB-00536980, received from Regulatory Authority. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 13Apr2021 (Batch/Lot Number: EW9127) as single dose for covid-19 immunisation; clopidogrel (manufacturer unknown, 75 mg), via an unspecified route of administration from 06Apr2021 (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose daily in connection with carotid artery narrowing/surgery in 21Apr2021. The patient''s medical history was not reported. Concomitant medications included non specified blood pressure medication, and non specified cholesterol lowering agent (In connection with surgery under anesthesia, blood pressure reducer/blood thinner/cholestorol reducer were prescribed). The patient experienced cerebral haemorrhage on 28Apr2021, 7 days after successful surgery resulting in death of date 29Apr2021, no complaints after vaccination. The outcome of cerebral haemorrhage was fatal. The action taken in response to the event for clopidogrel was not applicable. It was unknown if an autopsy was performed. Patient had no previous COVID-19 infection. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1339910 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD (COPD gold II); Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident; COVID-19 (Previous COVID-19 infection: disease symptoms: little.)
Allergies:
Diagnostic Lab Data: Test Date: 20201209; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021554011

Write-up: Died unexpectedly 1.5 days after 2nd COVID vaccination.; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00537147. An 84-year-old male patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 08May2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. Medical history included COVID-19 from 09Dec2020, cerebrovascular accident from 2003; ongoing type 2 diabetes mellitus, ongoing COPD gold II. Previous COVID-19 infection: disease symptoms: little. The patient''s concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for covid-19 immunization with no adverse reaction. The patient died unexpectedly (Sudden death) 36 hours (1.5 days) after 2nd COVID vaccination on 10May2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Dec2020. The patient died on 10May2021. It was unknown if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1339911 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-04-30
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   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: Pneumonia recurrent
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: Diagnostic procedures were regarded the specific variant of Covid-19; Result Unstructured Data: Test Result: Specific variant of Covid-19
CDC Split Type: NLPFIZER INC2021553987

Write-up: patient was the second resident in nursing home who died of covid19, despite being vaccinated/ Diagnostic procedures were regarded the specific variant of Covid-19; patient was the second resident in nursing home who died of covid19, despite being vaccinated/ Diagnostic procedures were regarded the specific variant of Covid-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number NL-LRB-00537347. A 76-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), first dose via an unspecified route of administration on 28Jan2021 (batch/lot number unknown) as 0.3ml single dose, second dose via an unspecified route of administration on 25Feb2021 (lot number: EJ6790) as 0.3ml single dose for covid-19 immunization. Medical history included ongoing recurring pneumonia, no previous COVID-19 infection. The patient''s concomitant medications were not reported. The patient died on 10May2021 due to Covid-19 and vaccination failure since 30Apr2021 following administration of covid-19 vaccine Pfizer injection 2 months after start (as reported). Confounding factor was recurring pneumonia. Diagnostic procedures were regarded the British variant of Covid-19 on 30Apr2021. The events were treated with dexamethasone and oxygen therapy. The patient was the second resident in nursing home who died of covid19, despite being vaccinated. The outcome of the events was fatal. It was unknown if an autopsy was performed, cause of death was reported as Covid-19 in known lung disease. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: patient was the second resident in nursing home who died of covid19, despite being vaccinated/ Diagnostic procedures were regarded the British variant of Covid-19; patient was the second resident in nursing home who died of covid19, despite being vac


VAERS ID: 1339912 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ISORDIL; SIMVASTATINE; METOPROLOL; SINTROM; PERINDOPRIL ERBUMINE; PANTOPRAZOL [PANTOPRAZOLE]
Current Illness: Coronary sclerosis
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Triple vessel disease (NON-STEMI, found 3-fold coronary artery disease)
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: corona, confirmed with test; Result Unstructured Data: Test Result:Positive; Test Date: 20210219; Test Name: corona, confirmed with test; Result Unstructured Data: Test Result:Positive
CDC Split Type: NLPFIZER INC2021561310

Write-up: passed away. Familiar with main stem stenosis 90% was on the Coronary Artery Bypass Grafting waiting list.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is [NL-LRB-00538479]. A 72 years old male patient received first dose of BNT162B2 (Comirnaty, solution for injection, lot number/expiration date unknown) on 10May2021 at 13:00 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included ongoing coronary sclerosis, Covid 19 on 24Jan2021, Triple vessel disease on 19Feb2021. Concomitant medications included isosorbide dinitrate (ISORDIL), simvastatine, metoprolol and acenocoumarol (SINTROM). It was informed patient had a positive COVID test on 19Feb2021 for which he was admitted to hospital initially for Non STEMI but this turned out to be triple vessel disease. Patient already had coronary artery stenosis about 90% for which he was on a waiting list to get a Coronary Artery Bypass Grafting. On 11May2021 between 10.30 am and 2 pm passed away probably acute cardiac death / w s acute myocardial infarction (as reported). It was unknown if an autopsy was performed. It was also mentioned: Link between vaccination and acute death not very likely, but the Health Service physician advised, after internal consultation, to report it anyway. Information about lot/batch number cannot be obtained. No further information expected; Reported Cause(s) of Death: acute cardiac death / ws acute myocardial infarction


VAERS ID: 1339914 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-22
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: 2021-05-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021561306

Write-up: Death, died 4 days after vaccination. No complaints reported in advance. sudden death.; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB NL-LRB-00539807. A 71-year-old male patient received the first dose of BNT162b2 (COMIRNATY, Lot number unknown) via an unspecified route of administration on 08May2021 at single dose for COVID-19 immunisation. Relevant medical history included that the patient was a smoker. The patient had no previous COVID-19 infection. Concomitant medications were not reported. On 13May2021 the patient died due to sudden death, presumably cardiac based on the medical history. He had no complaints prior to his death. He had no complaints reported in advance. No autopsy was performed as wished by his family. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: sudden death, presumably cardiac based on the story. no autopsy.


VAERS ID: 1339926 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   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: Overweight
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021554083

Write-up: EMBOLISM PULMONARY; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Umwy3p, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00028831. A 57-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 15Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included overweight. The patient''s concomitant medications were not reported. The patient experienced embolism pulmonary on an unspecified date in Apr2021. Pulmonary embolism with fatal outcome is reported one to two days after vaccination. The patient was significantly overweight. Otherwise, there were no known risk factors for pulmonary embolism. The patient was legally autopsied. The patient died of embolism pulmonary on 17Apr2021. An autopsy was performed and results were not provided. Relatedness of drug to reaction/event: Source of assessment - an unlisted regulatory authority. Result of Assessment was Possible. Sender''s comment: Thank you for reporting a suspected side effect after vaccination. If you should have further information related to the incident, this can be sent in response to this message. The information is processed securely, and this dialog is automatically deleted after 4 months. Processing and storage of personal data takes place in accordance with the Health Register Act. Since the vaccine is new, it is subject to special surveillance in order to detect new safety information as quickly as possible. It is especially important that serious and / or unusual side effects are reported. Your message is therefore important to increase knowledge about side effects that have not been discovered in the studies, and is an important contribution to international cooperation to maintain safe vaccination worldwide. Reports after coronary vaccination in the Adverse Reaction Register are processed by the Norwegian Institute of Public Health in collaboration with a regulatory authority. Causality is assessed in accordance with international criteria. We do not currently have the capacity to send individual adverse reaction reports. For updated information and advice on the use of the vaccines and precautions, refer to the Vaccination Guide. Questions about coronary vaccine that cannot be answered by local experts can be directed to PRIVACY. We request that no special categories of personal information (health information) be sent by e-mail. If it is impossible to ask a question without including such information, we recommend calling the vaccine telephone. No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: embolism pulmonary


VAERS ID: 1339930 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-24
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immobile; Vascular disorder (It is stated in the report that the patient had known vascular disease,without further specification)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021561373

Write-up: EMBOLISM PULMONARY; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [NO-NOMAADVRE-FHI-2021-Urjr93], Safety Report Unique Identifier [NO-NOMAADVRE-E2B_00028837]. A 71-years-old female patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EJ6795) intramuscular on 07Jan2021 12:48 in the arm left at single dose for COVID-19 immunization. Concomitant drugs were not reported. On 24Jan2021, the patient developed pulmonary embolism. The outcome of the event was fatal, the patient died on 12Feb2021. It is stated in the report that it is uncertain whether the vaccine was the cause of the pulmonary embolism. The patient was immobile, had known vascular disease. Also there was a period of 17 days between the vaccination and the pulmonary embolism. The Regional Pharmacist assessed the causal relationship between bnt162b2 (COMIRNATY) and the reported event as Possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1339935 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Coma scale, Confusional state, Depressed level of consciousness, Muscle spasms
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREDNISOLONE; BURINEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Confusion (Occasionally,no change); COPD; Coronary artery bypass; Edema (Pronounced edemas feet, abdomen, truncus.); Heart failure; Immune thrombocytopenia (Recent immune thrombocytopenia, Thrombocyte count 118-106); Liver cirrhosis (idiopathic, advanced); Living in nursing home; Multimorbidity; Renal failure (grade III); Sick sinus syndrome (pacemaker); Tiredness
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:3
CDC Split Type: NOPFIZER INC2021545019

Write-up: Muscle spasms; Consciousness decreased; Confusion; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uwzpw5, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00028161. A 78-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 25Mar2021 11:17 (Lot Number: ER9480) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included, multimorbid, living in a nursing home, and occasionally confusion, there was no change in the patient''s condition before or after vaccination, hepatic cirrhosis (idiopathic, advanced), tiredness/ fatigue, Sick sinus syndrome (pacemaker), renal failure grade III , oedema (Pronounced edemas feet, abdomen, truncus), chronic obstructive pulmonary disease (COPD), Heart failure, coronary artery bypass from 2004, recent immune thrombocytopenia (Thrombocyte count 118-106). Concomitant medication(s) included prednisolone and bumetanide (BURINEX), both taken for an unspecified indication, start and stop date were not reported. The day after vaccination on 26Mar2021, the patient was hospitalized due to decreased consiuousness, ongoing muscle spasms and confusion. Treated with midazolam 5 mg in each nostril, which made the muscle spasms more intermittent. At hospitalization it was not possible to get in touch with the patient, and he remained unreachable. The patient died three days on 28Mar2021 at 05:30 am after vaccination. Patient with competence to give consent for vaccination. The patient underwent lab tests and procedures which included Glasgow coma scale: 3 on 26Mar2021. The outcome was fatal of events after treatment given. It''s was unknown if autopsy have been done. Event assessment: Regional Pharmacist / Comirnaty / All Events / Possible Reporter Comment: There was no change in the patient''s condition before or after vaccination, but the day after vaccination the patient was hospitalized due to decreased consiuousness and ongoing muscle spasms. Died three days after vaccination. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: decreased consiuousness; muscle spasms; confusion


VAERS ID: 1339948 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Drug ineffective
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (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), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PEPFIZER INC2021562761

Write-up: acute respiratory insufficiency / viral pneumonia / unidentified COVID-19 virus; acute respiratory insufficiency / viral pneumonia / unidentified COVID-19 virus; acute respiratory insufficiency / viral pneumonia / unidentified COVID-19 virus; This is a spontaneous report from a contactable pharmacist. A 100-year-old female patient received BNT162B2 (COMIRNATY, batch/lot number was not reported), via an unspecified route of administration on 01May2021 (at 100-year-old) at 1st dose, single for COVID-19 immunisation. The patient did not receive the second dose of the vaccine. The patient medical history and concomitant medications were not reported. The patient died on 17May2021. The cause of death was reported as acute respiratory insufficiency / viral pneumonia / unidentified COVID-19 virus. It was unknown if the autopsy was performed. Information on the lot/batch number has been requested.; 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, acute respiratory insufficiency, viral 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: acute respiratory insufficiency / viral pneumonia / unidentified COVID-19 virus; acute respiratory insufficiency / viral pneumonia / unidentified COVID-19 virus; acute respiratory insufficiency / viral pneumonia / unidentified COVID-19 virus


VAERS ID: 1339957 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Breath sounds abnormal, Hypotonic-hyporesponsive episode, Myocardial infarction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Hypotonic-hyporesponsive episode (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210417; Test Name: Body temperature; Result Unstructured Data: Test Result:39-39.4 degree Celsius Centigrade; Test Date: 20210417; Test Name: Body temperature; Result Unstructured Data: Test Result:increased up to 39 Centigrade; Test Date: 20210417; Test Name: Body temperature; Result Unstructured Data: Test Result:dropped to 36.6 Centigrade
CDC Split Type: PLPFIZER INC2021554031

Write-up: Hypotonic-hyporesponsive episode; Fever/fever 39-39.4 C/dropped to 36.6 degrees C; Breath sounds abnormal; Myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number PL-URPL-3-630-2021. A 72-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 14Apr2021 20:29 (Lot Number: EW9127; Expiration Date: 18Apr2021) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced myocardial infarction and breath sounds abnormal on 17Apr2021, hypotonic-hyporesponsive episode and fever on 17Apr2021 07:00. Additional information: Reaction date 17Apr2021 at 07:00. In the submitted adverse reaction report the following symptoms were listed after the vaccination: fever 39-39.4 C, up to 24 hours; hypotonic-hyporesponsive episode. Description of the reaction: On 17Apr2021, the patient''s body temperature increased up to 39 degrees C. After administration of Paracetamol, the temperature dropped to 36.6 degrees C. The woman fell asleep. It was impossible to wake her up, she was snoring. An ambulance was called. The patient died in the hospital on April 18 at 00:30. Autopsy Cause of Death: Myocardial Infarction. Application at the request of the family. The outcome of events was fatal. The patient died on 18Apr2021. Sender''s comment: Pyrexia is an expected side effect as described in the regulatory authority and may occur following the administration of Comirnaty vaccine. The report includes a hypotonic-hyporesponsive episode, which, according to the definition, occurs among children under 2 years old. The report concerns an adult. The episode was marked by a physician because the undesirable post-vaccination reaction report does not provide a possibility to select the appropriate symptoms for adults. According to the regulatory authority, hypotonic-hyporesponsive episode among adults should not be taken into account in the assessment. In such a case, it is symptoms that should be assessed: syncope or presyncope state. Myocardial infarction is an effect not expected with Comirnaty vaccine. Until May 10, 2021, the regulatory authority database has had 133 cases of myocardial infarction reported, including 59 fatal cases. Snoring is not an expected reaction to the vaccine. Breathing sounds abnormal have been reported in the regulatory authority database. The regulatory authority does not have information about the patient''s medical history, only the cause of death is known, which was determined as a result of an autopsy. There is a time relationship between the administration of the vaccine and the occurrence of side effects. The reporting person qualified undesirable post-vaccination reaction as heavy. The regulatory authority assessed the undesirable post-vaccination reaction as heavy. Relatedness of drug to reaction(s)/event(s):Hypotonic-hyporesponsive episode, Source of assessment - regulatory authority, Method of assessment - regulatory authority, Result of Assessment - Unclassifiable Relatedness of drug to reaction(s)/event(s): Myocardial infarction, Source of assessment, Method of assessment - regulatory authority, Result of Assessment - Possible Relatedness of drug to reaction(s)/event(s): Fever, Source of assessment - Regulatory Authority, Method of assessment - regulatory authority, Result of Assessment - Probable Relatedness of drug to reaction(s)/event(s): Breath sounds abnormal, Source of assessment - Regulatory Authority, Method of assessment - regulatory authority, Result of Assessment - Possible No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Hypotonic-hyporesponsive episode; Fever; Breath sounds abnormal; Autopsy-determined Cause(s) of Death: Myocardial infarction


VAERS ID: 1340051 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / -

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: 2021-01-01
   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: Cardiac failure; Chronic obstructive pulmonary disease; Liver cirrhosis; Type 2 diabetes mellitus; Vascular dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021554110

Write-up: ACUTE CIRCULATION CONDITION (FAILURE); This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is [SE-MPA-2021-037891]. An 85-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on Jan2021 (Lot Number: EJ6134) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease, ongoing type 2 diabetes mellitus, ongoing hepatic cirrhosis, ongoing vascular dementia, ongoing cardiac failure. The patient''s concomitant medications were not reported. The patient experienced acute circulation condition in Jan2021 with fatal outcome. Patient was die in Jan2021. Patient was entirety an elderly, multi-sick man, who received the vaccine the day before death. Unclear causal relationship. But report due to new vaccine. The patient died on Jan2021. It is unknown if autopsy was done. No follow-up attempts are possible. No further information is expected. Information about batch number already obtained. ; Reported Cause(s) of Death: Acute circulatory failure


VAERS ID: 1342118 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FOREIGN / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-18
   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: Warfin Anticoagulant
Current Illness: No
Preexisting Conditions: heart valve operation
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death - after 4 days


VAERS ID: 1342583 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210541498

Write-up: DEATH; This spontaneous report received from a patient via a company representative from news article concerned a patient of unspecified age and sex. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, frequency once total, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient was died. The cause of death was not reported. It was unknown whether the autopsy was done or not. It was reported that first forensic investigations did not revealed obvious connections with the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210541498-covid-19 vaccine ad26.cov2.s -death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: DEATH


VAERS ID: 1342765 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-05
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021562781

Write-up: Cardiac arrest; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 551568. A 90-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient experienced Cardiac arrest on 05May2021 and was died on unknown date. It was unknown if an autopsy was performed No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1342766 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature decreased, Hypotension, Hypoxia, Unresponsive to stimuli, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210507; Test Name: Body temperature; Result Unstructured Data: Test Result:decreased
CDC Split Type: AUPFIZER INC2021562782

Write-up: Body temperature decreased; Hypotension; Hypoxia; Unresponsive to stimuli; Wheezing; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 551850. An 81-year-old female patient received BNT162B2 (COMIRNATY), 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 was not reported. The patient''s concomitant medications were not reported. The patient experienced body temperature decreased, hypotension, hypoxia, unresponsive to stimuli, wheezing, all on 07May2021 and caused death. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Body temperature decreased; Hypotension; Hypoxia; Unresponsive to stimuli; Wheezing


VAERS ID: 1342767 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease progression
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021562783

Write-up: Concomitant disease progression; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 552212. An 83-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced concomitant disease progression on an unspecified date. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Concomitant disease progression


VAERS ID: 1342768 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021562784

Write-up: Adverse event following immunisation; This is a spontaneous report from a contactable other health professional via a regulatory authority. Regulatory authority report number is 551345. A 66-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced adverse event following immunisation on an unspecified date. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Adverse event following immunisation


VAERS ID: 1342769 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-14
Submitted: 0000-00-00
Entered: 2021-05-24
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: AUPFIZER INC2021562786

Write-up: Adverse event following immunisation; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 552974. An 88-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unknown route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient developed and adverse event following immunization on 14May2021 which led patient''s death on unknown date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Adverse event following immunisation


VAERS ID: 1342770 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-26
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease progression, Cyanosis, Pain, Pallor
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021562789

Write-up: Concomitant disease progression; Cyanosis; Pain; Pallor; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 551047. An 88-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration in Apr2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced concomitant disease progression, cyanosis, pain and pallor, all on 26Apr2021. The outcome of the events was fatal. The patient died in 2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Concomitant disease progression; Cyanosis; Pain; Pallor


VAERS ID: 1342771 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Incoherent, Malaise
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021562790

Write-up: Contusion; Incoherent; Malaise; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 553718. An 83-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, lot/batch number not provided), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced Contusion; Incoherent; Malaise and was died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Contusion; Incoherent; Malaise


VAERS ID: 1342802 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   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: Age-related macular degeneration; Glaucoma; Hypercholesteremia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Malaise; This regulatory authority case was reported by a physician and describes the occurrence of DEATH and MALAISE (Malaise) in a 75-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Hypercholesteremia, Age-related macular degeneration and Glaucoma. On 22-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Mar-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced MALAISE (Malaise) (seriousness criterion medically significant). The patient died on 08-Apr-2021. The cause of death was not reported. An autopsy was not performed. At the time of death, MALAISE (Malaise) outcome was unknown. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered MALAISE (Malaise) to be possibly related and DEATH to be unlikely related. No concomitant medications were reported. Treatment details was not provided. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is unclear if the reported malaise was associated with the death of the patient and cause of death is not provided. Two dates of death reported in SD and later one retained; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is unclear if the reported malaise was associated with the death of the patient and cause of death is not provided. Two dates of death reported in SD and later one retained; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1342830 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001651 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   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: Aortic valve stenosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100056376

Write-up: Acute dyspnea; Oxygen saturation decreased; Decompensation cardiac; This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA (Acute dyspnea), OXYGEN SATURATION DECREASED (Oxygen saturation decreased) and CARDIAC FAILURE (Decompensation cardiac) in a 75-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001651) for COVID-19 vaccination. Concurrent medical conditions included Aortic valve stenosis. On 28-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DYSPNOEA (Acute dyspnea) (seriousness criterion death), OXYGEN SATURATION DECREASED (Oxygen saturation decreased) (seriousness criterion death) and CARDIAC FAILURE (Decompensation cardiac) (seriousness criteria death and medically significant). The patient died on 28-Apr-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. Resuscitation was done on 28-apr-2021. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Events conservatively all retained as resulting in death per Authority assessment / reporting in SD although it is unknown if an autopsy was performed and the captured decreased oxygen saturation and dyspnea are likely effects of the also captured heart failure; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Events conservatively all retained as resulting in death per Authority assessment / reporting in SD although it is unknown if an autopsy was performed and the captured decreased oxygen saturation and dyspnea are likely effects of the also captured heart failure; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1342833 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ8723 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021572958

Write-up: Sudden death unexplained; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100069081. An 86-year-old female patient received BNT162B2 (COMIRNATY, strength: 0.3 ml), via an unspecified route of administration on 05Feb2021 (at age of 86 years old) (lot number: EJ8723) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 06Feb2021, the patient experienced sudden death unexplained. This report was serious - death. The event outcome was fatal. 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: Sudden death, cause unknown


VAERS ID: 1342834 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021572960

Write-up: Sudden death unexplained; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100069738. A 46-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection), strength: 0.3ml (as reported), via an unspecified route of administration at age of 46 years old on 12May2021 (Batch/Lot Number: EX8680) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sudden death unexplained on 12May2021, 12 hours after beginning of drug administration. The regulatory authority Regulatory Authority assessed causality between BNT162b2 and event death to be unclassifiable. The patient died on 12May2021. An autopsy was planned (not done yet). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death unexplained


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