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From the 9/10/2021 release of VAERS data:

Found 14,925 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

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VAERS ID: 1165514 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Sopor
SMQs:, Dementia (broad), Hypoglycaemia (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; FENTANYL; HUMALOG; SIMVASTATIN; PANTOPRAZOLE; MAG 2 [MAGNESIUM CARBONATE]; DIGOXIN; APIXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Cognitive deterioration; COVID-19; Hypertensive heart disease; Hypoglycaemia aggravated; Ischemic stroke; SARS-CoV-2 infection; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021342288

Write-up: first pfizer vaccine dose performed on 12Feb2021 patient who had contracted the virus. Patient died on 21Feb2021 after having manifested a sleep state after 7 days; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-704634. A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EK9788, expiry date not reported), intramuscular on 12Feb2021 at 0.3 mL, single dose for covid-19 immunisation. Medical history included hypoglycaemia aggravated on 09Jan2021, AFib (atrial fibrillation) unknown if ongoing at the time of the reported event, type 2 diabetes mellitus, hypertensive heart disease, cognitive deterioration, COVID-19 from 13Nov2020 to 11Dec2020, ischemic stroke from 09Jan2021 to 11Jan2021, and another reported sars-cov-2 from an unknown date to an unknown date. Concomitant medications included oral furosemide (25 mg tablet) at 25 mg; transdermal fentanyl (transdermal patch 12.5 ug) at 12.5 ug; insulin lispro (HUMALOG, 100 IU/ml) taken for type 2 diabetes mellitus, subcutaneously at 2 iU; oral simvastatin (coated tablet 20 mg), at 20 mg; oral pantoprazole (20 mg gastro-resistant tablet) at 20 mg; oral magnesium carbonate (MAG 2); oral digoxin (0.06 mg tablet) at 0.06 mg; and oral apixaban (2.5 mg film-coated tablet) at 2.5 mg; all with start and stop date not reported. It was reported that the "first Pfizer vaccine dose performed on 12Feb2021, host who had contracted the virus. Patient died on 21Feb2021 after having manifested a sleep state after 7 days" (sopor) on 19Feb2021 (as provided). The patient died on 21Feb2021. The cause of death was "manifested a sleep state after 7 days". No autopsy was performed. Sender Comment: The pathologies and concomitant medications have been entered after contacting the Reporter. No further information is available. Reporter comment: performed first dose on 12Feb2021, guest who had contracted the virus. The lady died on 21Feb2021 after showing a worsening sleep state after 7 days until her death. No follow-up attempts possible. No further information expected.; Reporter''s Comments: performed first dose on 12Feb2021, guest who had contracted the virus. The lady died on 21Feb2021 after showing a worsening sleep state after 7 days until her death.; Reported Cause(s) of Death: manifested a sleep state after 7 days


VAERS ID: 1165515 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-23
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Drooling, Foaming at mouth, Loss of consciousness, SARS-CoV-2 test, Urinary tract infection bacterial
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; ENALAPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholelithiasis; Hypertension arterial; Osteopenia; Vascular encephalopathy
Allergies:
Diagnostic Lab Data: Test Date: 20210209; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: ITPFIZER INC2021342305

Write-up: first dose performed on 13Jan2021, the lady had never been infected with the virus. She was hospitalized on 09Feb2021 with loss of consciousness, she drooled in the mouth and died on 10Feb2021.; first dose performed on 13Jan2021, the lady had never been infected with the virus. She was hospitalized on 09Feb2021 with loss of consciousness, she drooled in the mouth and died on 10Feb2021.; first dose performed on 13Jan2021, the lady had never been infected with the virus. She was hospitalized on 09Feb2021 with loss of consciousness, she drooled in the mouth and died on 10Feb2021.; Acute pulmonary edema; Urinary tract infection bacterial; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (RA). The regulatory authority report number is IT-MINISAL02-704636. An 88-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular at the age of 88-years-old on 13Jan2021 (Lot Number: EL1484) as 0.3 mL, single for COVID-19 immunization. Medical history included Hypertension arterial, vascular encephalopathy, osteopenia, and cholelithiasis, all from an unknown date and unknown if ongoing. Concomitant medication included furosemide (FUROSEMIDE) and enalapril (ENALAPRIL); both taken for an unspecified indication, start and stop date were not reported. Clinical report request containing information relevant to the specific case, date and cause of death, which will be attached in the Regulatory Authority Center as soon as available. - Actions taken (reporting) - Covid 19 Commirnaty Vaccine (Pfizer): Booster dose number (1). Negative. The patient experienced, "first dose performed on 13Jan2021, the lady had never been infected with the virus. she was hospitalized on 09Feb2021 with loss of consciousness, she drooled in the mouth and died on 10Feb2021." The patient also experienced acute pulmonary edema and urinary tract infection bacterial both on 23Jan2021 with outcome of recovered on 04Feb2021. The patient was hospitalized for frothing at the mouth, loss of consciousness, drooling. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 09Feb2021. The patient died on 10Feb2021. An autopsy was not performed. Reporter''s comments: Privacy, born on Privacy, first dose performed on 13Jan2021, the lady had never been infected with the virus. She was hospitalized on 09Feb2021 with loss of consciousness, she drooled in the mouth and died on 10Feb2021. Sender''s comments: The concomitant pathologies and drugs were entered after contacting the Reporter. No further information is available. Adjustment 23Mar2021: the report sent by the Reporter is attached. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Privacy, born on Privacy, first dose performed on 13Jan2021, the lady had never been infected with the virus. She was hospitalized on 09Feb2021 with loss of consciousness, she drooled in the mouth and died on 10Feb2021.; Reported Cause(s) of Death: Privacy., born on Privacy, first dose performed on 13Jan2021, the lady had never been infected with the virus. She was hospitalized on 09Feb2021 with loss of consciousness, she drooled in the mouth and died on 10Feb2021.; Privacy., born on Privacy, f


VAERS ID: 1165517 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Oxygen saturation, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test
SMQs:, 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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 4
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: ALLOPURINOL; PANTOPRAZOLE; BISOPROLOL FUMARATE; GOLTOR; SERTRALINE; AMLODIPINE; LASIX [FUROSEMIDE]; TRAJENTA; GLYCERYL TRINITRATE; LANTUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioplasty; Chronic renal failure; Decompensation cardiac; Hypertension arterial; IHD; Infarct myocardial; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: Oxygen saturation; Result Unstructured Data: Test Result:low; Test Date: 20210312; Test Name: COVID-19 swab; Test Result: Negative
CDC Split Type: ITPFIZER INC2021342310

Write-up: At night after the vaccination with Cominraty, the patient presented a peak of fever and desaturation, following which the emergency 118 was contacted and transported the patient to the hospital.; At night after the vaccination with Cominraty, the patient presented a peak of fever and desaturation, following which the emergency 118 was contacted and transported the patient to the hospital.; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-705463. An 88-year-old male patient received the first dose of BNT162B2 (COMIRNATY; lot number: ET1831) intramuscular, administered on the left arm on 11Mar2021 (Batch/Lot Number: ET1831) as 0.3 mL, single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, Infarct myocardial, Chronic renal failure, Decompensation cardiac, IHD, Angioplasty and hypertension arterial. Concomitant medications included allopurinol, pantoprazole, bisoprolol fumarate, ezetimibe, simvastatin (GOLTOR), sertraline, amlodipine, furosemide (LASIX [FUROSEMIDE]), linagliptin (TRAJENTA), glyceryl trinitrate (GLYCERYL TRINITRATE) and insulin glargine (LANTUS). At night after the vaccination with Cominraty, the patient presented a peak of fever and desaturation, following which the emergency 118 was contacted and transported the patient to the hospital. Despite the basic clinical conditions, however serious, the patient in the last days was in good clinical compensation (he could breathe well, short walks, small daily actions independently, etc.). They knew from relatives that he had carried out a swab on entry, therefore on the day 12Mar2021, negative result. The patient died on 16Mar2021. 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: Oxygen saturation low; fever


VAERS ID: 1165518 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Blood fibrinogen, Blood fibrinogen increased, Computerised tomogram, Confusional state, Fibrin D dimer, Fibrin D dimer increased, Hypotension, Intestinal ischaemia, Pneumatosis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   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: ZYLORIC; FINASTERIDE; ELIQUIS; PANTORC; CONGESCOR; TRIATEC COMP; LASIX [FUROSEMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210321; Test Name: Blood fibrinogen; Test Result: 832 mg; Test Date: 20210321; Test Name: CT scan; Result Unstructured Data: Test Result:Overdistension of the gastro-duodenal lumen; Comments: Overdistension of the gastro-duodenal lumen with predominantly gaseous stasis and relief of ischemic-necrotic signs in particular affecting the duodenal walls, which appear poorly delimitable, with partial absence of enhancement and with widespread pneumatosis in the lumen of the relative venous vessels mesenteric-portal, also at the level of the intrahepatic branches.; Test Date: 20210321; Test Name: Fibrin D dimer; Test Result: 528 ng
CDC Split Type: ITPFIZER INC2021342345

Write-up: Bowel ischemia; Confusion state; Overdistension of the gastro-duodenal lumen with predominantly gaseous stasis; pneumatosis in the lumen of the relative venous vessels mesenteric-portal, also at the level of the intrahepatic branches/similar finding can be appreciated in the gastric walls at the bottom level; hypotension; blood fibrinogen was checked as 832mg; Fibrin D dimer was 528 ng; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-705601. A 77-years-old male patient received second dose of bnt162b2 (COMIRNATY, Lot Number: ET3620), intramuscular on 19Mar2021 as 0.3 mL, single dose for covid-19 immunisation. Medical history included hypertension, atrial fibrillation, all from an unknown date. The patient received the first dose of bnt162b2 (COMIRNATY) on 26Feb2021. Concomitant medication(s) included allopurinol (ZYLORIC); finasteride; apixaban (ELIQUIS); pantoprazole sodium sesquihydrate (PANTORC); bisoprolol fumarate (CONGESCOR); hydrochlorothiazide, ramipril (TRIATEC COMP); furosemide (LASIX). The patient arrived in the emergency room on 21Mar2021 from a Nursing Home Care where he was a resident in a confused state. The CT scan showed: Overdistension of the gastro-duodenal lumen with predominantly gaseous stasis and relief of ischemic-necrotic signs in particular affecting the duodenal walls, which appear poorly delimited, with partial absence of enhancement and with widespread pneumatosis in the lumen of the relative venous vessels mesenteric-portal, also at the level of the intrahepatic branches. It is associated with periduodenal fluid suffusion. A similar finding can be appreciated in the gastric walls at the bottom level. The Patient underwent emergency surgery where exploratory laparotomy with open abdomen was performed. After the surgery, the conditions immediately appeared very serious with marked hypotension. The death occurred on 22Mar2021. Overdistension of the gastro-duodenal lumen with predominantly gaseous stasis and relief of ischemic-necrotic signs in particular affecting the duodenal walls, which appear poorly delimited, with partial absence of enhancement and with diffuse pneumatosis in the lumen of the relative mesenteric-portal venous vessels, also at the level of the intrahepatic branches. It is associated with periduodenal fluid suffusion. A similar finding can be appreciated in the gastric walls at the bottom level. Altered representation of the remaining intestinal loops, some of which with thin walls with extended lumen, others in a contracted attitude with slightly thickened walls and with uneven post-contrast impregnation in relation to signs of diffuse ischemic-reperfusive vascular suffering. Absence of free air flaps in the peritoneal cavity Absence of peritoneal effusion. Aorto-iliac calcific parietal atheromasia. The patient experienced bowel ischemia and Confusion state, both on 21Mar2021. On 21Mar2021, blood fibrinogen was checked as 832mg, Fibrin D dimer was 528 ng. The outcome of the events bowel ischemia and Confusion state were fatal, other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Lot/Batch number already obtained.; Reported Cause(s) of Death: Bowel ischemia; Confusion state


VAERS ID: 1165540 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-26
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   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: JPPFIZER INC2021353252

Write-up: Cerebral haemorrhage; This is a spontaneous report from a contactable physician received via a regulatory authority. A 69-year-old female (non-pregnant) patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EP9605, Expiration date: 30Jun2021), intramuscular in the left arm on 17Mar2021 at 14:00 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 26Mar2021 at 6:00 am (the 9th days after the vaccination), the patient experienced cerebral hemorrhage. Clinical course was reported as on 26Mar2021, the patient did not come to work, and her family visited her. The family found the patient died. Autopsy showed that the cause of the death was cerebral hemorrhage. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was fatal without treatment.; Sender''s Comments: Based on current information available, the event cerebral hemorrhage mostly represented intercurrent condition in this patient with advanced age, unrelated to Bnt162b2. Relevant medical history and concurrent disease are missing for a medically meaningful assessment.; Reported Cause(s) of Death: Cerebral haemorrhage; Autopsy-determined Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1165545 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-03-12
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Gastric haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

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: Factor V Leiden mutation
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021342669

Write-up: died of likely stomach bleeding; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00482618. An 86-year-old male patient received the first dose of BNT162B2 (COMIRNATY; lot number: EJ6136), via unspecified route of administration on 05Feb2021 at a single dose for COVID-19 immunization. Medical history included Factor V Leiden mutation. The patient''s concomitant medications were not reported. On 12Mar2021 (also reported as one week after vaccination), the patient died of likely stomach bleeding. The patient died on 12Mar2021. It was not reported if an autopsy was performed. Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. Died 1 week after vaccination (also reported as stomach hemorrhage: 1 month after start). Confounding factors: Factor V Leiden.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. Died 1 week after vaccination (also reported as stomach hemorrhage: 1 month after start). Confounding factors: Factor V Leiden.; Reported Cause(s) of Death: died of likely stomach bleeding


VAERS ID: 1165546 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Diarrhoea, Malaise, Pyrexia, SARS-CoV-2 test negative, Sudden death, Urine analysis
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: 2021-03-22
   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: Chest pain (Mild complaints in recent weeks); Confusional state (Prior to second vaccination); Dyspnoea on effort (Prior to second vaccination); Fatigue (Prior to second vaccination); Urine discoloration (Prior to second vaccination)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210321; Test Name: corona test; Test Result: Negative ; Test Date: 20210321; Test Name: urine test for urinary tract infection; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021342685

Write-up: just before death contact with the patient''s daughter, patient was more confused; unexpected death/sudden death in case of mild preexistent complaint before vaccination; 2 days after the vaccination, a doctor of the General practice center visited and a picture was seen of general malaise; Diarrhoea; Fever; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00482851. An 83-year-old female patient received the second dose of BNT162B2 (COMIRNATY), via unspecified route of administration on 19Mar2021 at a single dose for COVID-19 immunization. Medical history included ongoing chest pain (mild complaints in recent weeks); urine discoloration, fatigue, dyspnoea on effort and confusional state, all ongoing prior to second vaccination. The patient''s concomitant medications were not reported. The patient previously took the first dose of COMIRNATY on 19Feb2021 for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 21Mar2021, two days after the vaccination, a doctor of the general practice center visited and a picture was seen of general malaise, diarrhoea and fever. On 22Mar2021, just before death contact with the patient''s daughter, patient was more confused. An unexpected death/sudden death in case of mild preexistent complaint before vaccination was reported on 22Mar2021. The patient underwent lab tests and procedures which included negative Corona test and urine test for urinary tract infection with unknown results, both on 21Mar2021. The patient died on 22Mar2021. It was not reported if an autopsy was performed. The events ''just before death contact with the patient''s daughter, patient was more confused and unexpected death/sudden death in case of mild preexistent complaint before vaccination'' led to fatal outcome; while unknown for the other events. Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): Yes (Date: 19Feb2021). Unexpected death in case of mild preexistent complaint before vaccination. All in all, as a GP, I do not think that the death was a direct result of the corona vaccination. But given that it has been put right in advance, I would like to report it. Patient was already not well before the second vaccination. Experienced fatigue, dyspnoea on effort and changed urine color. After the vaccination there was also a mild fever and diarrhea; shortness of breath has not increased. Three days after the vaccination, patient died suddenly. Just before death there was still contact with daughter because she found her mother more confused. Two days after the vaccination, a doctor of the general practice center visited and a picture was seen of general malaise, mild fever and diarrhea, dedicated to side effects in Covid vaccination, urine test for urinary tract infection was carried out. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Summary of Reporter''s Comment: Unexpected death in case of mild preexistent complaint before vaccination. All in all, as a GP, I do not think that the death was a direct result of the corona vaccination. But given that it has been put right in advance, I would like to report it. Patient was already not well before the second vaccination.; Reported Cause(s) of Death: just before death contact with the patient''s daughter, patient was more confused; unexpected death/sudden death in case of mild preexistent complaint before vaccination


VAERS ID: 1165547 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Transient ischaemic attack
SMQs:, 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain damage; Cerebrovascular accident; Dementia; Elderly
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021342696

Write-up: Transient ischemic attack/ neurological deterioration after TIA; Cerebrovascular accident with disarthria, loss of strength and loss of consciousness; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00483125. A 82-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot Number: EM0477) as single dose for covid-19 immunisation. Medical history included elderly, dementia, cerebrovascular accident, pre-existent brain damage. The patient''s concomitant medications were not reported. The patient experienced transient ischemic attack/ neurological deterioration after (death) on 30Jan2021, cerebrovascular accident with disarthria, loss of strength and loss of consciousness (death) on 30Jan2021. This serious spontaneous report from a physician concerns a male aged 82 years, with transient ischemic attack (death), cerebrovascular accident (death) following administration of covid-19 vaccin pfizer injectable solution (action taken: not applicable) for covid 19 immunisation. The outcome of cerebrovascular accident (CVA) is fatal and the outcome of transient ischemic attack (TIA) is fatal. No previous COVID-19 infection. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: CVA; tia


VAERS ID: 1165548 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROXYZINE; FOLIC ACID; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident (Family History: false)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021342690

Write-up: (suspicion) ischemic cerebrovascular accident; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00483194. A 93-year-old male patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 26Feb2021 (lot number: EP9598) as single dose for COVID-19 vaccination. Medical history included cerebrovascular accident: family history: false. Concomitant medications included hydroxyzine; folic acid; and clopidogrel; all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of COMIRNATY on 02Feb2021 for COVID-19 immunisation. On 03Mar2021, the patient experienced (suspicion) ischemic cerebrovascular accident and described as "probably had an ischemic cerebrovascular accident (iCVA)". Confounding factors included previous CVA. The patient had no previous COVID-19 infection and no other diagnostic procedures were done. The patient died in Mar2021. It was unknown if an autopsy was done. Reporter comment: BioNTech / Pfizer Vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes ADRs: no Date: 02Feb2021 (suspicion) iCVA: Additional information ADR: probably had a ischemic cerebrovascular accident (iCVA) on 03Mar2021 confounding factors: confounding factors: previous CVA, COVID-19: Previous COVID-19 infection: No. Other diagnostic procedures: no No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech / Pfizer Vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes ADRs: no Date: 02Feb2021 (suspicion) iCVA: Additional information ADR: probably had a ischemic cerebrovascular accident (iCVA) on 03Mar2021 confounding factors: confounding factors: previous CVA, COVID-19: Previous COVID-19 infection: No. Other diagnostic procedures: no; Reported Cause(s) of Death: (suspicion) ischemic cerebrovascular accident


VAERS ID: 1165549 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-02-18
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SIMVASTATIN; DARIFENACIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:unknown result; Test Name: lab; Result Unstructured Data: Test Result:unknown result
CDC Split Type: NLPFIZER INC2021342698

Write-up: Myocardial infarct; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00483517. An 89-year-old female patient received first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 13Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Patient had no COVID-19 infection previously. The patient has no past drug. Concomitant medications included simvastatin (10mg film-coated tablet); darifenacin (7.5mg modified-release tablet). The patient experienced myocardial infarct 5 days after BNT162B2 administration on 18Feb2021. The patient underwent lab tests and procedures which included examination at the cardiology department with electrocardiogram (ECG), lab (test), etc., with unknown results (undated). The patient died on an unspecified date. It was not reported if an autopsy was performed. The reported cause of death is Myocardial infarct. The outcome of myocardial infarct is fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Myocardial infarct


VAERS ID: 1165550 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021342705

Write-up: Fatigue; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB [NL-LRB-00483991]. An 83-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration at an unspecified age on 12Feb2021 (lot number: EJ6788, expiration date unknown) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient did not have previous COVID-19 infection. The patient experienced fatigue on 13Feb2021. Therapeutic measures were taken as a result of fatigue included OPTIFLOW. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter Comment: BioNTech / Pfizer vaccine (Comirnaty), Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no; COVID19, Previous COVID-19 infection: No. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no COVID19 Previous COVID-19 infection: No.; Reported Cause(s) of Death: fatigue


VAERS ID: 1165556 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-10
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021342630

Write-up: death; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is PT-INFARMED-T202103-936. A 91-year-old male patient received the first dose of BNT162B2 (COMIRNATY), intramuscular on 01Mar2021 (lot number: EP2166) at 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died on 10Mar2021 (9 days after the vaccine administration). The event was reported to have lasted about 1 minute, but the circumstance of death was not known. No drug-drug interaction or medication error was suspected. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s): Death: Source of assessment: Notifier, Method of assessment: Unknown, Result of Assessment: Unlikely. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1165558 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-02-20
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Polymerase chain reaction, SARS-CoV-2 antibody 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: 2021-03-01
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atheromatosis (Aortic and other large vessels); Calculous cholecystitis; Chronic renal failure (stage 3); COPD; Hepatic steatosis; Hypertension; Hypertensive nephropathy; Ischemic heart disease; Nitrogen retention; Obesity; Prostate adenoma; Stable angina pectoris; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Clear cell renal cell carcinoma (Operated (right nephrectomy)); Nephrectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210225; Test Name: RT-PCR test; Result Unstructured Data: Test Result:Positive; Test Date: 20210301; Test Name: SARS-CoV-2 neutralizing IgG antibodies (anti-spike); Result Unstructured Data: Test Result:554 AU/mL; Comments: Biological reference range: positive over 13 AU/mL
CDC Split Type: ROPFIZER INC2021343141

Write-up: Pneumonia associated with SARS-CoV-2 infection/SARS-CoV-2 infection positive; Pneumonia associated with SARS-CoV-2 infection/SARS-CoV-2 infection positive; This is a spontaneous report from a contactable Physician downloaded from the regulatory authority RO-NMA-2021-SPCOV1021 A 74-year-old male patient received bnt162b2 (COMIRNATY), first dose via an unspecified route of administration on 23Jan2021 (Batch/Lot number was not reported), second dose intramuscular on 13Feb2021 (Batch/Lot Number: Unknown) both as single dose for COVID-19 immunisation. Medical history included the patient is known with: operated clear cell renal cell carcinoma (right nephrectomy), ongoing chronic renal failure stage 3, ongoing chronic obstructive pulmonary disease (COPD), ongoing hypertension, ongoing hypertensive nephropathy and fixed nitrogen retention, ongoing obesity, ongoing type 2 diabetes, ongoing systemic atheromatosis (aortic and other large vessels), ongoing ischemic heart disease, ongoing stable angina pectoris, ongoing prostate adenoma, ongoing hepatic steatosis and ongoing lithiasic cholecystitis. The patient''s concomitant medications were not reported. On 13Feb2021, the patient received the 2nd intramuscular dose of Comirnaty for active immunisation. On 20Feb2021, the patient developed pneumonia associated with SARS-CoV-2 infection. As a corrective therapy the patient received Anakinra (400 mg/day subcutaneous, SC) starting with 25Feb2021 up to 01Mar2021, Anakinra (200 mg/day SC) starting with 02Mar2021up to 07Mar2021, Clexane 0.8 ml (2/day SC) starting with 25Feb2021 up to 08Mar2021, dexamethasone 8 mg intravenous (IV) (2 x 8 mg/day) starting with 25Feb2021 up to 08Mar2021, Controloc 40 mg IV (2 x 40 mg/day) starting with 25Feb2021 up to 02Mar2021, Quamatel 20 mg IV (2 x 20 mg/day) starting with 03Mar2021 up to 08Mar2021, levofloxacine 500 IV (1 vial/day) starting with 28Feb2021 up to 08Mar2021, furosemide IV (40 mg/day) starting with 02Mar2021 up to 08Mar2021, hyperimmune plasma 200 ml IV starting with 28Feb2021 up to 02Mar2021, amikacin IV ( 1000 mg/day) 02Mar2021 up to 08Mar2021, piperacilline/tazobactam 4.5 g every 8 hours IV starting with 02Mar2021 up to 08Mar2021, tocilizumab and parenteral hydro-electrolytic rebalancing. At a date not specified in Mar2021 by the rapporteur the patient died. The patient has been tested for SARS-CoV-2 infection (RT-PCR test) on 25Feb2021 and the result was positive. On 01Mar2021, SARS-CoV-2 neutralizing IgG antibodies (anti-spike) were dosed and result was 554 AU/mL. On 23Jan2021, the patient received his 1st dose of Comirnaty, without further specification. The patient died on an unspecified date in Mar2021. It was unknown if an autopsy was performed. The adverse reaction was assessed as "results in death" by the primary reporter. In the reporter''s opinion pneumonia associated with SARS-CoV-2 infection were related to Comirnaty. Sender Comment: The medical assessor of the Authority requested the investigation of the case at agency to no result yet. No follow-up attempts are possible. The information about lot number and expiration date cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Updating the listedness of the events.; Reported Cause(s) of Death: Pneumonia associated with SARS-CoV-2 infection/SARS-CoV-2 infection positive


VAERS ID: 1165559 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Arrhythmia, Echocardiogram, Fatigue, Feeling abnormal, General physical health deterioration, Loss of consciousness, Magnetic resonance imaging, N-terminal prohormone brain natriuretic peptide, Troponin
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data: Test Name: angiogram; Result Unstructured Data: Test Result:age insults/infarcts; Test Name: Echocardiography; Result Unstructured Data: Test Result:hypokinesia; Comments: possibly increased hypokinesia septally; Test Name: MRI; Result Unstructured Data: Test Result:age insults/infarcts; Test Name: NTproBNP; Result Unstructured Data: Test Result:doubled release; Test Name: Troponin; Result Unstructured Data: Test Result:doubled release
CDC Split Type: SEPFIZER INC2021342619

Write-up: possible cause of possible arrhythmia; possible cause of deteriorating general condition; she collapsed; felt a little bad; felt tired; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-1615363791551. An 84-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on Mar2021 (Batch/Lot Number: EP2166) as SINGLE DOSE for covid-19 immunisation. Medical history included cardiac failure. The patient''s concomitant medications were not reported. In Mar2021, Possible cause of deteriorating general condition and possible arrhythmia was reported. After the vaccination, the patient felt a little bad and felt tired. The next day at 15:00, she collapsed. RLS 8 CPR started, narrow QRS complexes and ROSC (return of spontaneous circulation) are detected after 6min. DT (Diffusion tensor imagining) brain and angio as well as MRI only show age insults/infarcts. Shows a general slowdown. Neurological status improved, at best RLS 4. Echocardiography shows similar picture as before, possibly increased hypokinesia septally. Doubled NTproBNP and Troponin release. Extubated but hypercapne, inability to keep airways clear. The woman passing away about a week after arrival at hospital. It does not appear from the report whether the woman had any other contemporary medicines. The patient underwent lab tests and procedures which included angiogram: age insults/infarcts, echocardiogram: hypokinesia, possibly increased hypokinesia septally, magnetic resonance imaging: age insults/infarcts, n-terminal prohormone brain natriuretic peptide: doubled release, troponin: doubled release. It was not reported if an autopsy was performed. The patient died on an unspecified date. The outcome of the events felt a little bad, felt tired, and collapsed was not unknown. The events possible cause of possible arrhythmia, and possible cause of deteriorating general condition were fatal. No follow-up attempts possible. No further information expected. Information on lot and batch numbers already obtained.; Reported Cause(s) of Death: possible cause of deteriorating general condition; possible cause of possible arrhythmia


VAERS ID: 1165561 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pulmonary embolism, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VISCOTEARS; SERTRONE; ALVEDON; EXELON [RIVASTIGMINE]; BISOPROLOL SANDOZ; DIGOXIN BIOPHAUSIA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic thrombus; Aortic arteriosclerosis; Cerebral atrophy (medial atrophy in temporal lobe and hippocampus); Cerebral embolism; Cerebral small vessel ischaemic disease; Chronic atrial fibrillation; Coronary artery disease; Embolus leg (Previous old cerebral embolism, and old cerebral embolous leg); Enlargement heart; Infarction; Left ventricular hypertrophy; Lipoma (old unchanged lipoma on the forehead); Palliative care; Parkinsonism; Progressive supranuclear palsy; Right ventricular dilatation
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade
CDC Split Type: SEPFIZER INC2021342510

Write-up: massive bilateral pulmonary embolisms; Fever; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is SE-MPA-2021-012877. A 71-year-old male patient received bnt162b2 (COMIRNATY), second dose via an unspecified route of administration on Feb2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. Medical history included aortic arteriosclerosis, abdominal aortic thrombus, enlargement heart, coronary artery disease from unspecified dates, cerebral small vessel ischaemic disease from Jan2020, chronic atrial fibrillation from an unspecified date, progressive supranuclear palsy, cerebral atrophy (medial atrophy in temporal lobe and hippocampus) from Jan2020, embolus leg (Previous old cerebral embolism, and old cerebral embolous leg) from 2010, right ventricular dilatation, lipoma (old unchanged lipoma on the forehead), left ventricular hypertrophy from an unknown date, palliative care on 28Jan2021, cerebral embolism on an unspecified date, Parkinsonism and infarction on an unspecified date; all unknown if ongoing.. Concomitant medications included carbomer (VISCOTEARS) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRONE) taken for an unspecified indication from 28Jan2021 to an unspecified stop date; paracetamol (ALVEDON) taken for an unspecified indication, start and stop date were not reported; rivastigmine (EXELON) taken for an unspecified indication, start and stop date were not reported; bisoprolol fumarate (BISOPROLOL SANDOZ) taken for an unspecified indication from 28Jan2021 to an unspecified stop date; digoxin (DIGOXIN BIOPHAUSIA) taken for an unspecified indication from 04Feb2021 to an unspecified stop date. The patient received the first dose of bnt162b2 (COMIRNATY) on an unspecified date for covid-19 immunisation. The patient was vaccinated in the morning with Comirnaty, at midnight developed fever 39 degrees, without focal infection or other symptoms. Became fever-free with Alvedon. The next morning, one day after the vaccination, the man was in his habitual state, but suddenly collapses and dies, a previous decision was made to refrain from CPR (cardiopulmonary resuscitation). An autopsy was performed and the cause of death was established as massive bilateral pulmonary embolisms. Clinical suspicion that the rise in temperature may have been a vaccine side effect, but not the pulmonary embolism. Contributing factors from the autopsy protocol according to the rapporteur are cardiomegaly with left ventricular hypertrophy and right ventricular dilatation, coronary artery disease and older infarction. Sometimes severe aortic atherosclerosis and in the abdominal partial aortic thrombus 8 x 2 cm. The outcome of the events was fatal. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: massive bilateral pulmonary embolisms


VAERS ID: 1165562 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; OMEPRAZOLE; RISPERIDONE; CILAXORAL; LEVAXIN; TRIMBOW; SPIRIVA; WARAN; LITAREX [LEVOFLOXACIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bipolar disorder; Chronic obstructive pulmonary disease; Diaphragmatic hernia; Ischemic heart disease; Renal failure; Respiratory insufficiency (due to infections)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021342531

Write-up: Respiratory insufficiency; Fever; vomiting; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-014634, Other Case Identifier number SE-MPA-1615373668028. A 69-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on Feb2021 (Batch/Lot Number: EL0725) as SINGLE DOSE for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease, Respiratory insufficiency (respiratory failure due to infections), diaphragmatic hernia, bipolar disorder, Ischemic heart disease, renal failure. The patient previously took pregabalin and experienced angioedema. Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) taken for an unspecified indication from 17Jun2020 to Feb2021; omeprazole taken for an unspecified indication from 15Jun2020 to Feb2021; risperidone taken for an unspecified indication from 30Jan2020 to Feb2021; sodium picosulfate (CILAXORAL) taken for an unspecified indication from 14Jun2020 to Feb2021; levothyroxine sodium (LEVAXIN) taken for an unspecified indication from 16Dec2008 to Feb2021; beclometasone dipropionate, formoterol fumarate, glycopyrronium bromide (TRIMBOW) taken for an unspecified indication from 27Feb2020 to Feb2021; tiotropium bromide (SPIRIVA) taken for an unspecified indication from 30Jan2020 to Feb2021; warfarin sodium (WARAN) taken for an unspecified indication from 30Jan2020 to Feb2021; levofloxacin (LITAREX) taken for an unspecified indication from 20Nov2017 to Feb2021. After receiving dose 1, the same day at night, the woman developed fever and vomiting. The next day image as in respiratory insufficiency, according to the reporter. Went to the emergency room, was assessed due to multiple illness. The woman died two days after vaccination. The event respiratory insufficiency was assessed as fatal; other events were unknown. Autopsy performed without the cause of immediate death being determined by macroscopic examination. However, there''s heart enlargement and fluid including pus-like ones in the lungs. Awaiting response to microscopic analyzes. The patient died on an unspecified date. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: respiratory insufficiency; Autopsy-determined Cause(s) of Death: heart enlargement; fluid including pus-like ones in the lungs


VAERS ID: 1165563 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021342551

Write-up: two cerebral hemorrhages; fell unconscious; This is a spontaneous report received from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority report number is SE-MPA-2021-022425. A 75-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot Number: EP2166) as single dose for COVID-19 immunisation. Medical history included dementia alzheimer''s type and atrial fibrillation. The patient''s concomitant medications was anticoagulant, unspecified which. The patient previously took BNT162B2 (COMIRNATY, solution for injection, lot number: EJ6134), dose 1 in Jan2021 for COVID-19 immunisation. The patient experienced two cerebral heamorrhages one day after dose 2 which conflicts with submitted onset date of four days before dose 2. The man was found outside his home and transported to hospital, upon arrival he was conscious and able to state his date of birth/social security number but then fell unconscious. He remained unconscious until his death a few days later. The reporter writes that the man was in good health and walked every day. The patient died on an unspecified date in 2021. 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: two cerebral hemorrhages; fell unconscious


VAERS ID: 1165565 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-17
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Computerised tomogram head, International normalised ratio, Unresponsive to stimuli
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MAREVAN; DAROB MITE; LESCOL XL
Current Illness: Chronic kidney disease; Dermatosis bullous; Urinary retention
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Spinal cord ischemia
Allergies:
Diagnostic Lab Data: Test Date: 20210317; Test Name: Head CT scan; Result Unstructured Data: Test Result:extensive bleeding; Comments: extensive bleeding in the right basal ganglion area spreading to the right thalamus and mesencephalon to the right, blood penetration into the ventricles, cerebral herniation transterritorially and through the foramen magnum; Test Date: 20210317; Test Name: INR; Result Unstructured Data: Test Result:2.79
CDC Split Type: SIPFIZER INC2021341652

Write-up: massive cerebral hemorrhage; unresponsive; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [SI-JAZMP-NCPHV-2021SI0341_0341]. A 78-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: EP9598; Expiration Date: 30Jun2021), intramuscular first dose on 25Feb2021 at single dose for Covid-19 immunization. The patient''s medical history included ongoing Urinary retention, Cerebral infarction (condition after CVI years ago (cerebral infarction left)), ongoing Dermatosis bullous, ongoing Chronic kidney disease, and Spinal cord ischemia (condition after ischemic lesion in the cervical spinal cord). The patient''s concomitant medications includes warfarin sodium (MAREVAN) from 05Jun2007 to 18Mar2021 at 3 mg, sotalol hydrochloride (DAROB MITE) from 10May2007 to 18Mar2021 at 80 mg, and fluvastatin sodium (LESCOL XL) from 15Apr2008 to 18Mar2021 at 80 mg. On 17Mar2021, the patient was found unresponsive on the bathroom floor and experienced massive cerebral hemorrhage. The patient was hospitalized on 17Mar2021. A head CT scan of the head was performed, which showed: extensive bleeding in the right basal ganglion area spreading to the right thalamus and mesencephalon to the right, blood penetration into the ventricles, cerebral herniation transterritorially and through the foramen magnum. The patient was receiving anticoagulant therapy, international normalized ratio was 2.79. The patient died on an unspecified date. It was not reported if an autopsy was performed. Senders comment: Follow up data and assessment of the case are expected in due course. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: massive cerebral hemorrhage; unresponsive


VAERS ID: 1168808 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   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: Aortic stenosis (no report available yet from a physician); Prediabetes; Smoker (20 cigarettes a day)
Preexisting Conditions: Medical History/Concurrent Conditions: Altered state of consciousness (patient examined for neurology - cause not identified, epilepsy not ruled out); Comments: Medical history: - no allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20210

Write-up: Cardiac arrest; A Regulatory Authority report was received from a physician concerning 57-years-male patient, received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced cardiac arrest The patient''s medical history provided by the reporter included prediabetes, smoker, altered state of consciousness and aortic stenosis. No relevant Concomitant medications were reported. On 8 mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 3000493 ) via unknown route for prophylaxis of COVID-19 infection. On 9 mar 2021, the patient experience fatal event of cardiac arrest. Treatment information was not provided Action taken with mRNA-1273 in response to the event was not applicable The patient died on 9 Mar 2021. The cause of the death was reported as cardiac arrest. It was unknown If autopsy was performed. Outcome of the event, cardiac arrest was fatal. The reporter assessed the causality of the event cardiac arrest as not related to mRNA-1273.; Sender''s Comments: Very limited information regarding this event has been provided at this time and additional information is not expected. A causal relationship cannot be excluded; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1168836 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-03-06
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-06
   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: VITAMINE B COMPLEXE; ALLOPURINOL; CLOPIDOGREL +PHARM; PERINDOPRIL ARGININE; ROSUVASTATINE [ROSUVASTATIN]; METOPROLOL [METOPROLOL TARTRATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Sudden cardiac death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Mar-2021 and was forwarded to Moderna on 23-Mar-2021. This regulatory authority case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SUDDEN CARDIAC DEATH (Sudden cardiac death) in a 58-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042722) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history). Concomitant products included NICOTINAMIDE, PANTOTHENATE SODIUM, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, VITAMIN B1 NOS (VITAMINE B COMPLEXE), ALLOPURINOL, CLOPIDOGREL BESYLATE (CLOPIDOGREL +PHARM), PERINDOPRIL ARGININE, ROSUVASTATINE [ROSUVASTATIN] and METOPROLOL TARTRATE (METOPROLOL [METOPROLOL TARTRATE]). On 29-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. The patient died on 06-Mar-2021. The reported cause of death was. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was unknown. Very limited information regarding this event has been provided at this time and additional information is not expected. A causal relationship cannot be excluded Reporter did not allow further contact; Sender''s Comments: Very limited information regarding this event has been provided at this time and additional information is not expected. A causal relationship cannot be excluded; Reported Cause(s) of Death:


VAERS ID: 1168843 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000489 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Loss of consciousness, Mydriasis, Seizure, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROMODERNATX, INC.MOD20210

Write-up: Fixed mydriasis; Convulsive crisis; Unconsciousness; Bilious vomiting; Cardiac arrest; This case was received via an unknown source (no reference has been entered for a health authority) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIAC ARREST (Cardiac arrest) in a 55-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000489) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history). On 08-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 11-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criterion death). The patient was hospitalized on sometime in March 2021 due to LOSS OF CONSCIOUSNESS, MYDRIASIS, SEIZURE and VOMITING. The patient died on 11-Mar-2021. The reported cause of death was acute cardio-respiratory failure. An autopsy was performed, but no results were provided. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 55-year-old female patient with unknown medical history, who died 3 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: Acute cardio-respiratory failure


VAERS ID: 1170615 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-02-19
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BRIVARACETAM; LAMOTRIGINE
Current Illness: Epilepsy grand mal
Preexisting Conditions: Medical History/Concurrent Conditions: Craniocerebral injury (Traumatic brain injury 4 years ago with subdural hematoma); Operation NOS; Subdural haematoma (traumatic)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in an 80-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Subdural haematoma (traumatic), Craniocerebral injury (Traumatic brain injury 4 years ago with subdural hematoma) in 2017 and Operation NOS. Concurrent medical conditions included Epilepsy grand mal. Concomitant products included BRIVARACETAM and LAMOTRIGINE for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 19-Feb-2021 The patient died on 19-Feb-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 considered DEATH (Death) to be unlikely related. Reporter did not allow further contact.; Sender''s Comments: Based on reporter''s causality of unlikely and considering patient''s underlying epilepsy with possible epileptic seizure the night before with possible tongue bite, the event of death is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1170617 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000455 / 1 - / OT

Administered by: Unknown       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: Bundle branch block left; Cardiac insufficiency; Coronary artery disease; Hypertension arterial; Renal insufficiency; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Effusion pleural
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Exitus letalis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3000455) for COVID-19 vaccination. The patient''s past medical history included Effusion pleural. Concurrent medical conditions included Bundle branch block left, Coronary artery disease, Hypertension arterial, Cardiac insufficiency, Renal insufficiency and Type II diabetes mellitus. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding this event has been provided at this time Reporter did not allow further contact; Sender''s Comments: Very limited information regarding this event has been provided at this time; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1170711 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-28
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 1 - / OT

Administered by: Unknown       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: 2021-02-28
   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: LERCATON; ASPIRIN
Current Illness: Hypercholesteraemia; Hypertension; Osteoporosis
Preexisting Conditions: Medical History/Concurrent Conditions: Gonarthrosis; Myocardial ischaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20210

Write-up: Death; A Agency Regulatory Authority report was received from a Physician, concerning, a 88-year old female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and died/ Sudden death. The patient''s medical history included myocardial ischaemia, gonarthrosis, osteoporosis, hypercholesteraemia and hypertension. Concomitant medication included lercanidipine hydrochloride and acetylsalicylic acid On 04-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number G26761A) intramuscularly for COVID-19 infection prophylaxis. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 28-Feb-2021.The cause of the death was unknown. Plans for an autopsy was unknown. The reporter had assessed the causality between the event and mRNA-1273 as unlikely.; Sender''s Comments: Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1170712 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-16
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVEREX-AS KOMB; CARDURA XL
Current Illness: Aortic stenosis; Generalised arteriosclerosis; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20210

Write-up: chest pain; This case was received via an unknown source (no reference has been entered for a health authority) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN (chest pain) in an 89-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Generalised arteriosclerosis and Aortic stenosis. Concomitant products included indapamide, perindopril arginine (COVEREX-AS KOMB) and DOXAZOSIN MESILATE (CARDURA XL) for Hypertension. On 04-Feb-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 16-Feb-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CHEST PAIN (chest pain) (seriousness criterion death). The patient died on 16-Feb-2021. The reported cause of death was Chest pain. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered CHEST PAIN (chest pain) to be not related. No treatment information provided; Sender''s Comments: This is a case of death in a 89-year-old male subject with a medical history of hypertension, generalized arteriosclerosis and aortic stenosis, who died 12 days after receiving a dose (unknown whether it is first vs second dose) of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Chest pain


VAERS ID: 1171929 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-03-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Breath sounds abnormal, Cardiac arrest, Cardiopulmonary failure, Dyspnoea, Fatigue, Hyperventilation, Investigation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   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: QUETIALAN; KREON; SEDOGELAT; PANTOLOC [PANTOPRAZOLE]; VENOSIN [AESCULUS HIPPOCASTANUM EXTRACT]; OLEOVIT-D3; THROMBO ASS; EUCREAS; ATORVALAN; LEGALON
Current Illness: Dementia; Depression; Faecal incontinence; Hypertension arterial; Type II diabetes mellitus; Urinary incontinence
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatitis A; Hepatitis B; Hip injury; Pancreatitis; Posterior cerebral artery infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210315; Test Name: Temp.; Result Unstructured Data: Test Result:normal; Test Date: 20210316; Test Name: NACA score; Result Unstructured Data: Test Result:7; Comments: NACA score: 7
CDC Split Type: ATPFIZER INC2021342437

Write-up: Cardiorespiratory decompensation; asystole; Difficulty breathing/labored breathing; breathing heavily; rattle; Tiredness, spent all day in bed; vomited; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-17609. An 87-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 14Mar2021 (Lot Number: EP2163) as SINGLE DOSE for COVID-19 immunisation. The patient previously had first dose of Comirnaty on 21Feb2021 for COVID-19 immunization and was tolerated very well the first time, no side effects. Medical history included ongoing dementia, Posterior infarction in Nov2020, hypertension arterial, ongoing type II diabetes mellitus, hepatitis A and B, pancreatitis, stool and urinary incontinence; hip joint shattering right in 1958 and depression. Concomitant medications included quetiapine fumarate (QUETIALAN), pancreatin (KREON), officinalis extract, passiflora incarnata extract, valeriana officinalis extract (SEDOGELAT), pantoprazole (PANTOLOC) , aesculus hippocastanum extract (VENOSIN), colecalciferol (OLEOVIT-D3), acetylsalicylic acid (THROMBO ASS), metformin hydrochloride, vildagliptin (EUCREAS), atorvastatin calcium (ATORVALAN) and silybum marianum (LEGALON); all taken for an unspecified indication, start and stop date were not reported. The patient vomited once on 15Mar2021 Monday evening. On 16Mar2021, had difficulty breathing in the morning (according to the 24 hour nurse ''breathed heavily'') on 16Mar2021 and tiredness, spent the whole day in bed, started to rattle in the afternoon. Emergency doctor was called but patient had asystole already upon arrival. The patient had relatives no infection, temperature was measured several times, was always normal. Before that, she had not had COVID-19. On 16Mar2021, the patient experienced labored breathing death, tiredness, breath sounds abnormal, cardio-respiratory failure. The patient score was 7 on 16Mar2021. The outcome of the event vomited was recovered on unspecified date. The patient died on 16Mar2021 due to cardiovascular failure, tiredness, spent all day in bed , rattle, difficulty breathing/labored breathing, cardiorespiratory decompensation, breathing heavily and asystole. An autopsy was performed that revealed dilated cardiomyopathy, high-grade basal artery sclerosis and brain atrophy. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiorespiratory decompensation; breathing heavily; Difficulty breathing/labored breathing; Tiredness, spent all day in bed; rattle; asystole; cardiovascular failure; Autopsy-determined Cause(s) of Death: dilated cardiomyopathy; high-grade basal artery sclerosis; brain atrophy


VAERS ID: 1171931 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-25
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021347773

Write-up: central pulmonary embolism after Covid vaccination; This is a spontaneous report a contactable physician downloaded from the Agency Regulatory Authority-WEB [regulatory authority AT-BASGAGES-2021-19479]. A 87-year-old male patient received second dose of BNT162B2 (COMIRNATY) Lot number ET3620, on 24Feb2021 at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY) on unknown date for Covid-19 immunisation. On 25Mar2021 07:15 the patient experienced central pulmonary embolism after Covid vaccination. The patient died due to Pulmonary embolism. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: central pulmonary embolism after Covid vaccination


VAERS ID: 1171938 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Depressed level of consciousness, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021350948

Write-up: Depressed level of consciousness; Pyrexia; Rash; This is a spontaneous report received from a contactable other Health Professional via the Regulatory Authority (RA). Regulatory authority report number is 526002. A 77-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died on an unspecified date due to depressed level of consciousness, pyrexia and rash. It was not reported if an autopsy was performed. No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Depressed level of consciousness; Pyrexia; Rash


VAERS ID: 1171939 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-22
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021351576

Write-up: Dyspnoea; Pneumonia aspiration; This is a spontaneous report received from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 527228. A 94-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced dyspnoea and pneumonia aspiration, both on 22Mar2021. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: The events dyspnea and aspiration pneumonia are likely due to an intecurrent condition and not related to BNT162B2.; Reported Cause(s) of Death: Pneumonia aspiration; Dyspnoea


VAERS ID: 1171941 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021351579

Write-up: General physical health deterioration; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 527894. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced general physical health deterioration on an unspecified date with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1171955 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-25
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Cardiac failure, Nausea, Poor quality sleep
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RAMIPRIL; DENOSUMAB
Current Illness: Arterial hypertension; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Cardiac failure; Abdominal pain; Poor sleep; Nausea; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Cardiac failure) in an 80-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arterial hypertension and Osteoporosis. Concomitant products included RAMIPRIL for Arterial hypertension, DENOSUMAB for Osteoporosis. On 27-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain), POOR QUALITY SLEEP (Poor sleep) and NAUSEA (Nausea). On 26-Feb-2021, the patient experienced CARDIAC FAILURE (Cardiac failure) (seriousness criterion death). The patient died on 26-Feb-2021. The reported cause of death was Cardiac failure. An autopsy was not performed. At the time of death, ABDOMINAL PAIN (Abdominal pain), POOR QUALITY SLEEP (Poor sleep) and NAUSEA (Nausea) outcome was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIAC FAILURE (Cardiac failure), ABDOMINAL PAIN (Abdominal pain), POOR QUALITY SLEEP (Poor sleep) and NAUSEA (Nausea) to be unlikely related. Very limited information regarding these events has been provided at this time and additional information is not expected. A causal relationship cannot be excluded Reporter did not allow further contact; Sender''s Comments: Very limited information regarding these events has been provided at this time and additional information is not expected. A causal relationship cannot be excluded; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1171957 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-02-04
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Aspiration pneumonia; Cardiac insufficiency; Cardiomyopathy (hypertensive, valvular and arrhythmogenic cardiopathy); Chronic renal insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Haemorrhage subarachnoid (status post traumatic subarachnoid haemorrhage); Syncope (recurrent syncope)
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: Body temperature; Result Unstructured Data: 38?C
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; Acute dyspnea; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 18-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death), DYSPNOEA (Acute dyspnea) and PYREXIA (Fever) in a 90-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Syncope (recurrent syncope), Haemorrhage subarachnoid (status post traumatic subarachnoid haemorrhage) in 2019 and Aortic valve replacement. Concurrent medical conditions included Cardiac insufficiency, Cardiomyopathy (hypertensive, valvular and arrhythmogenic cardiopathy), Arterial hypertension, Aspiration pneumonia and Chronic renal insufficiency. On 12-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced DYSPNOEA (Acute dyspnea) (seriousness criterion death) and PYREXIA (Fever) (seriousness criterion death). The patient died on 06-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 38 ?C (High) 38?C. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered PYREXIA (Fever) to be possibly related and DEATH (Death) and DYSPNOEA (Acute dyspnea) to be unlikely related. Reporter did not allow further contact; Sender''s Comments: Based on reporter''s causality and patient''s advanced age along with multisystem underlying conditions, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1172004 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / UNK - / OT

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

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: Atrial fibrillation; AV block third degree; Carotid artery repair; Hyperlipidemia; Hypertension arterial; Nephrectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Exitus letalis; An Agency Regulatory authority report was received from a physician concerning an 82-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and died. The patient''s medical history was hypertension arterial, hyperlipidemia, carotid artery repair, nephrectomy, atrial fibrillation, AV block third degree. Concomitant product use was not provided by the reporter. On 08 Mar 2021, prior to onset of the event, the patient received the dose of mRNA-1273 (lot/batch number: 3000495) via unknown route for prophylaxis of COVID-19 infection. On 09 Mar 2021, the patient died. Treatment information was unknown. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 09 Mar 2021. The cause of death was unknown. Plans for an autopsy were unknown.; Sender''s Comments: This is a case of death in an 82-year-old male subject with a medical history of hypertension arterial, hyperlipidemia, carotid artery repair, nephrectomy, atrial fibrillation, AV block third degree, who died one day after receiving one dose (unknown whether it is first vs second) of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1172013 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cardiac failure, Circulatory collapse, Diarrhoea
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021347738

Write-up: Circulatory failure; Cardiac arrest; Diarrhea; Cardiac decompensation; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-PEI2021003772. A 97-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cardiac arrest on 19Mar2021, diarrhea on 17Mar2021, circulatory failure on an unspecified date, cardiac decompensation on 17Mar2021. Reported 6 days after vaccination the patient developed Diarrhea and Decompensation cardiac and Circulatory failure, lasting for 3 days. The patient died on 19Mar2021. An autopsy was not performed. Death cause was reported as Cardiac arrest. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1172014 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-21
Onset:2021-02-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Acute myocardial infarction, Hypoxia
SMQs:, Asthma/bronchospasm (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   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: DEPFIZER INC2021347741

Write-up: Hypoxia; STEMI (ST elevation myocardial infarction); ACS (Acute Coronary Syndrome); This is as spontaneous report received from a non-contactable physician downloaded from the regulatory authority-WEB. An 85-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 21Feb2021 (Lot Number: EJ6789) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On the same day after vaccination (21Feb2021), the patient developed hypoxia, STEMI (ST elevation myocardial infarction) and ACS (acute coronary syndrome), lasting for unknown. The patient was dead on 21Feb2021 due to hypoxia, STEMI and ACS. An autopsy was not performed. Outcome of events was fatal. Regulatory authority reported the causality between the events (hypoxia, STEMI) and bnt162b2 as unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hypoxia; ACS (Acute Coronary Syndrome); STEMI (ST elevation myocardial infarction)


VAERS ID: 1172016 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis; Ill-defined disorder NOS (various pre- and concomitant diseases)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021347735

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB. This is a report received from the Regulatory Authority. A 95-year-old female patient was vaccinated with the second dose of bnt162b2 (COMIRNATY (batch/lot number: ER7812) at age of 95-year-old for COVID-19 immunization, route of administration was not reported on 16Mar2021. Medical history included anaphylaxis from 2012. Patient suffered from various pre- and concomitant diseases. Concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 22Feb2021 for COVID-19 immunization and had been tolerated. On 18Mar2021 after vaccination the patient developed death, lasting for unknown. The patient was dead. It was unknown if an autopsy was performed. The event assessment of bnt162b2 for death per Regulatory Authority was unclassifiable. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Exitus letalis


VAERS ID: 1172018 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-11
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-06
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: 2021-03-11
   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: Diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Deep vein thrombosis; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021347749

Write-up: developed death; This is as spontaneous report received from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-PEI2021003790. An 81-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Feb2021(age at vaccination 81 years old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included dementia from an unknown date and unknown if ongoing, atrial fibrillation from an unknown date and unknown if ongoing, deep vein thrombosis from 1990 to an unknown date, ongoing diabetes mellitus. The patient''s concomitant medications were not reported. The patient developed death on 11Mar2021,13 days after vaccination. It was unknown if an autopsy was performed.The Relatedness of drug to Death was provided as Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: developed death


VAERS ID: 1172035 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-03-13
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Death, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE; METOPROLOL; MELPERONE
Current Illness: Behavioural disorder; Mental retardation
Preexisting Conditions: Medical History/Concurrent Conditions: Stomach upset
Allergies:
Diagnostic Lab Data:
CDC Split Type: EEPFIZER INC2021348021

Write-up: Pulmonary oedema; Acute myocardial infarction; Death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB EE-SAM-259121031722. A 45-years-old male patient received the second dose of bnt162b2 (COMIRNATY), intramuscular on 22Feb2021 (Batch/Lot Number: EJ6790) as 0.3 mL, single for covid-19 immunisation. Patient received the first dose on 01Feb2021. Medical history included ongoing severe mental retardation and behavioural disorders, so he was under the supervision of a psychiatrist and social worker. The family doctor had seen the man twice, most recently in 2018. The patient''s main problems were psychiatric, the family doctor could not say why metoprolol was prescribed. She prescribed omeprazole because of a patient''s stomach upset. Concomitant medications included melperone, omeprazole for stomach upset, metoprolol. Patient experienced acute myocardial infarction, pulmonary oedema and death. He died on 13Mar2021. Data on pathoanatomical necropsy and cause of death: left ventricular failure, acute pulmonary oedema, acute myocardial infarction. The family doctor did not vaccinate the patient and does not know of any possible side effects after vaccination. An autopsy was performed and results were not provided. Sender Comment: Serious side effect, but the causal link is considered doubtful. The patient was also taking melperone, following which sudden deaths have also been reported. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute myocardial infarction; Acute pulmonary oedema; Left ventricular failure


VAERS ID: 1172036 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure congestive, Glycosylated haemoglobin, Heart rate, Hypertensive heart disease, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VILDAGLIPTIN; METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus NOS (treatment has been irregular); Gonarthrosis; Joint pain (previously active person); Obesity (BMI 36)
Allergies:
Diagnostic Lab Data: Test Date: 2017; Test Name: HbA1c; Test Result: 8.9 %; Test Date: 2018; Test Name: HbA1c; Test Result: 10.2 %; Test Date: 2019; Test Name: HbA1c; Test Result: 6.9 %; Test Date: 2020; Test Name: HbA1c; Test Result: 7.1 %; Test Date: 20210314; Test Name: heart rhythm/heart rate; Result Unstructured Data: Test Result:asystole
CDC Split Type: EEPFIZER INC2021348253

Write-up: congestive heart failure; hypertensive heart disease; Sudden death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB EE-SAM-262121031752. Case narrative including clinical course, therapeutic measures, outcome and additional relevant information. This spontaneous case report from general practioner (GP) concerns a 69-year-old male patient who experienced sudden death after vaccination with COVID-19 mRNA vaccine. The patient was vaccinated with the first dose of bnt162b2 (COMIRNATY, Batch/lot number ER2659) vaccine intramuscularly on 11Mar2021 at 0.3 ml, single for COVID-19 immunization. Ambulance call on 14Mar2021 at 18:45. The primary heart rhythm was asystole, pupils broad, unresponsive to light. Adrenaline administered every 3-5 minutes. After 20 minutes of resuscitation, the heart rate was still asystole. Time of termination of resuscitation at 19.11. Diagnosis: death without witnesses. Other information: the patient had a diabetes, concomitant medications: metformin, vildagliptin. On 18Mar2021, follow-up information: the patient had diagnosed diabetes mellitus in 2015. He also had gonarthrosis and obesity (BMI 36). No other chronic diseases have been diagnosed. For diabetes, treatment has been irregular, but the patient has been taking medication prescribed in the last 2 years. HbA1c 2017 8,9%, 2018 10,2%, 2019 6,9%, 2020 7,1%. The patient has not contacted the family doctor about side effects after vaccination. According to his wife, he had mild joint pain. The patient was a previously active person. An ambulance had been called by an passer-by who had found a patient lying on the street. The patient was referred for autopsy. On 23Mar2021 additional information: the previous cause of death of the patient is congestive heart failure and the root cause of death is hypertensive heart disease with congestive heart failure. Sudden death stop date 14Mar2021. Reporter''s comments: According to the GP, the sudden death was not due to a side effect of the vaccine. Sender''s comments: Sudden death that cannot be linked to the vaccine. The causal link is considered doubtful. No follow-up attempts possible. No further information expected.; Reporter''s Comments: According to the GP, the sudden death was not due to a side effect of the vaccine.; Sender''s Comments: Based from limited information, the sudden death of the patient is assessed as unrelated to BNT 162b2. Patients current co-morbid condition could be contributory to the event. Case will be reassessed if new information is submitted in relation to this case.; Reported Cause(s) of Death: Congestive heart failure; hypertensive heart disease


VAERS ID: 1172057 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-03-05
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Bacterial test, Bilirubin urine, Blood pressure measurement, Body temperature, COVID-19 pneumonia, Chest X-ray, Glucose urine, Haemoglobin urine, Heart rate, Influenza virus test, Nitrite urine, Oedema peripheral, Oxygen saturation, Physical examination, Protein urine, Red blood cells urine, Respiratory syncytial virus test, SARS-CoV-2 antibody test, SARS-CoV-2 test, Specific gravity urine, Urinary tract infection, Urine ketone body, Urobilinogen urine, Vaccination failure, White blood cells urine, pH urine
SMQs:, Cardiac failure (broad), Angioedema (broad), Lack of efficacy/effect (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Proteinuria (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   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: OMEPRAZOLE; EUTHYROX; FUROSEMIDE; TRAZODONE; QUETIAPINE; PARACETAMOL; LEVOFLOXACIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Age-related macular degeneration; Cellulitis of legs (pretibial hematoma after fall, admission in Geriatrics); Chronic kidney disease (3a); Cognitive impairment (moderate-severe); Dermatitis atopic; Fall; Hearing loss bilateral; Herpes zoster; Hip fracture (Right hip pertrochanteric-basicervical fracture); Hip surgery; Hospitalisation (in Geriatrics due to cellulite in lower limbs); Hypertension (HTA); Hypothyroidism; Leg ulcer; Malnutrition protein-calorie; Myelodysplastic syndrome; Obesity (obesity (BMI$g=30)); Urinary incontinence
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: cardiac auscultation; Result Unstructured Data: Test Result:Rhythmic, no puffs; Test Date: 202103; Test Name: pulmonary auscultation; Result Unstructured Data: Test Result:Rhonchi and bilateral basal crackles; Comments: Conserved vesicular murmur, rhonchi and crackles at bases of both lungs.; Test Date: 202103; Test Name: bacterial test urine; Result Unstructured Data: Test Result:low; Test Date: 202103; Test Name: urine bilirubin; Test Result: Negative ; Test Date: 202103; Test Name: blood pressure; Result Unstructured Data: Test Result:100/74; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Comments: fever temperature of 38; Test Date: 20210311; Test Name: body temperature; Result Unstructured Data: Test Result:37.7-37.8 Centigrade; Test Date: 202103; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210312; Test Name: Chest X-ray; Result Unstructured Data: Test Result:bilateral pneumonia; Comments: bone frames with degenerative changes. Free costophrenic angles. Aorta elongated. No infiltrates or consolidations; Test Date: 202103; Test Name: Urine glucose; Test Result: Negative ; Test Date: 202103; Test Name: urine hemoglobin; Result Unstructured Data: Test Result:10 in uL (+); Test Date: 202103; Test Name: heart rate; Result Unstructured Data: Test Result:68 bpm; Test Date: 20210302; Test Name: Influenza virus test; Test Result: Negative ; Test Date: 202103; Test Name: urine nitrites; Test Result: Negative ; Test Date: 20210311; Test Name: oxygen saturation; Test Result: 90 %; Test Date: 202103; Test Name: oxygen saturation; Test Result: 76 %; Comments: baseline; Test Date: 202103; Test Name: oxygen saturation; Test Result: 96 %; Comments: with 1.5 lpm; Test Date: 202103; Test Name: urine pH; Result Unstructured Data: Test Result:6.0; Test Date: 202103; Test Name: abdominal examination; Result Unstructured Data: Test Result:Soft, depressible, no masses or megalies.; Comments: Soft, depressible, no masses or megalies. No pain on superficial/deep palpation; Test Date: 202103; Test Name: urine proteins; Test Result: Negative ; Test Date: 202103; Test Name: urine red blood cells; Result Unstructured Data: Test Result:10-20/Field; Test Date: 20210302; Test Name: RSV test; Test Result: Negative ; Test Date: 20210308; Test Name: COVID-19 serology test; Test Result: Negative ; Comments: IgG; Test Date: 20210301; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210302; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210312; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: variant; Test Date: 202103; Test Name: urine density; Result Unstructured Data: Test Result:1.005; Test Date: 202103; Test Name: urine ketone bodies; Test Result: Negative ; Test Date: 202103; Test Name: urine urobilinogen; Test Result: Negative ; Test Date: 202103; Test Name: urine leukocytes; Result Unstructured Data: Test Result:40-70/Field; Test Date: 202103; Test Name: urine leukocytes; Result Unstructured Data: Test Result:76-250 in uL (++)
CDC Split Type: ESPFIZER INC2021347754

Write-up: edema of lower limbs; SARS-CoV-2 positive bilateral pneumonia; SARS-CoV-2 positive bilateral pneumonia; Urinary tract infection; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB ES-AEMPS-801332. A 93-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 07Jan2021 (Batch/Lot Number: EJ6796) as single dose; dose 2 intramuscular, administered in arm left on 28Jan2021 (Batch/Lot Number: EK9788) as single dose for covid-19 immunisation. Medical history included obesity (BMI$g=30), chronic kidney disease 3a, hypertension/ arterial hypertension, pretibial hematoma after fall with cellulite in lower limbs (2018), admission in Oct2019 in Geriatrics due to cellulite in lower limbs, hypothyroidism, dermatitis atopic, urinary incontinence, age-related macular degeneration (AMD), protein malnutrition, moderate-severe cognitive impairment, right hip pertrochanteric-basicervical fracture, surgery intervention 2018, thoracoabdominal herpes zoster (2018), bilateral hearing loss, myelodysplastic syndrome, ulcer in lateral calf region lower left limb. The patient had no known allergies. Concomitant medications included omeprazole; levothyroxine sodium (EUTHYROX); furosemide; trazodone; quetiapine; paracetamol; levofloxacin from 05Mar2021. The institution patient, Pfizer/BionTech double dose vaccination completed on 28Jan2021; with negative serology on 08Mar2021; It starts on 11Mar2021 with a sudden drop in general condition, with fever (37.7-37.8C) and marked desaturation despite prolonged oxygen therapy at 1.5 lpm 24 hours. Conserved vesicular murmur, rhonchi and crackles at bases of both lungs. Contact with a positive COVID patient the night of 26-27Feb (roommate who is currently admitted for SARS Cov2 pneumonia). The patient was referred to the Emergency Department for worsening of the general condition, with fever temperature of 38, and desaturation despite home oxygen therapy 24h at 1.5bpm with sat02 90%. She was currently under antibiotic treatment for respiratory infection and urinary tract infection since last Friday, 05Mar2021 with levofloxacin 500 1 tablet/24h. The son who refers that the patient had presented, in addition to fever measured with thermometer, expectoration and hyporexia in the last days. Difficult anamnesis due to the baseline situation of the patient. On Monday 01Mar2021 negative antigen test, she underwent a rapid test for Ag covid was negative result and on 02Mar2021 negative PCR SARS Cov2, influenza and RSV (Respiratory syncytial virus). She was left in preventive isolation: until 09Mar2021, being treated for urinary tract infection. On 11Mar2021, she was referred to the hospital with confirmation of negative IgG serology and positive PCR on 12Mar2021 for variant. Confirmation with radiology presence of bilateral pneumonia. She died on 21Mar2021. The reason for admission were desaturation, edema of lower limbs. The patient underwent lab tests which included urine analysis was appearance of urine normal appearing urine, urinary sediment, red blood cells was 10-20/field, leukocytes was 40-70/field, bacteruria low, glucose negative g/l, negative proteins, negative bilirubin, negative urobilinogen, pH 6.0, density = 1.005, hemoglobin 10 eri/uL (+), negative ketone bodies, negative nitrites, leukocytes 76-250 leu/ul (++), image included thorax X-ray was bone frames with degenerative changes, free costophrenic angles, aorta elongated, no infiltrates or consolidations. Physical exploration included constatns 100/74. Heart rate 68bpm. Sat02 baseline 76% with nasal cannula 1.5 lpm 96%. T 36.5; cardiac auscultation, rhythmic, no puffs; pulmonary auscultation: rhonchi and bilateral basal crackles; abdomen: soft, depressible, no masses or megalies. no pain on superficial/deep palpation; lower limbs: significant edema to the roots of the limbs, no signs of deep vein thrombosis; neurological: conscious, alert; spontaneous eye openin; obeys orders, fluent language, coherent, not paraphasias; external ocular motor nerves without restrictions; non-focal cranial nerves; no alteration in strength and sensitivity; no signs of meningeal irritation; no neurological focus; flexor plantar reflex. Evolution and comments included principal diagnostic was SARS-CoV-2 positive bilateral pneumonia. Severe respiratory failure secondary to the pneumonia. The SARS-CoV-2 positive bilateral pneumonia outcome was fatal, the other events were unknown. It was not reported if autopsy done. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: SARS-CoV-2 positive bilateral pneumonia; SARS-CoV-2 positive bilateral pneumonia


VAERS ID: 1172058 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Malaise
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021342327

Write-up: Malaise; Diarrhea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA), regulatory authority number ES-AEMPS-803210. An 84-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 23Feb2021, the patient experienced malaise and diarrhea. The patient died on 24Feb2021. Causes of death were malaise and diarrhea. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on lot/batch number cannot be obtained.; Reported Cause(s) of Death: malaise; diarrhea


VAERS ID: 1172067 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Anuria, Cardiac flutter, Computerised tomogram, Computerised tomogram abdomen, Dyspnoea, Gastrointestinal necrosis, Hyperlactacidaemia, Intestinal ischaemia, Mesenteric artery thrombosis, Pulmonary embolism, Right ventricular failure, Thrombotic cerebral infarction
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), 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: 2021-03-19
   Days after onset: 4
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: ZOLT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: CT scan; Result Unstructured Data: Test Result:extensive pulmonary embolism, cardiac failure righ; Comments: CT: extensive pulmonary embolism, cardiac failure right. Nothing atypical in the abdomen.; Test Date: 20210319; Test Name: CT of abdomen; Result Unstructured Data: Test Result:mesenteric artery thrombosis, intestinal ischaemia; Comments: mesenteric artery thrombosis, intestinal ischaemia, flutter rhythm, thrombotic mass in auricle of the atrium
CDC Split Type: FIPFIZER INC2021347721

Write-up: acute severe abdominal pain; Pulmonary embolism; Cardiac failure right; Anuria; Hyperlactacidaemia; Mesenteric artery thrombosis; Intestinal ischaemia; flutter rhythm; thrombotic mass in auricle of the atrium; Gastrointestinal necrosis; dyspnoea; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FI-FIMEA-20211502. A 77-year-old female patient received bnt162b2 (COMIRNATY) (Lot Number: UNKNOWN), intramuscular on 12Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included lansoprazole (ZOLT) taken for an unspecified indication from 26May2020 to an unspecified stop date. The patient experienced dyspnoea on 15Mar2021, acute severe abdominal pain (death, hospitalization) on 17Mar2021, pulmonary embolism (death, hospitalization) on 17Mar2021, cardiac failure right (death, hospitalization) on 17Mar2021, anuria (death, hospitalization) on 17Mar2021, hyperlactacidaemia (death, hospitalization) on 17Mar2021, mesenteric artery thrombosis (death, hospitalization) on 17Mar2021, intestinal ischaemia (death, hospitalization) on 17Mar2021, flutter rhythm (death, hospitalization) on 17Mar2021, thrombotic mass in auricle of the atrium (death, hospitalization) on 17Mar2021, gastrointestinal necrosis (death, hospitalization) on 17Mar2021. The patient underwent lab tests and procedures which included computerised tomogram (CT): extensive pulmonary embolism, cardiac failure right. Nothing atypical in the abdomen in Mar2021, computerised tomogram abdomen: mesenteric artery thrombosis, intestinal ischaemia, flutter rhythm, thrombotic mass in auricle of the atrium on 19Mar2021. According to what daughter has said, on 15Mar2021, patient started dyspnoea which was aggravated on 17Mar2021. In addition on 17Mar2021, acute severe abdominal pain. Patient was hospitalized on the same day. CT: extensive pulmonary embolism, cardiac failure right. Nothing atypical in the abdomen. Condition worsened, pressure support, anuria and lactatemia, patient in intensive care. New CT of abdomen on 19Mar2021: mesenteric artery thrombosis, intestinal ischaemia, flutter rhythm, thrombotic mass in auricle of the atrium. 19Mar laparotomy: a hopeless situation: gastrointestinal necrosis, no treatment possibilities. Passed away after pressure support was stopped. Patient died on 19Mar2021. It''s unknown if patient has done autopsy. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: thrombotic mass in auricle of the atrium; dyspnoea; acute severe abdominal pain; Pulmonary embolism; Cardiac failure right; Anuria; Hyperlactacidaemia; Mesenteric artery thrombosis; Intestinal ischaemia; flutter rhythm; Gastrointestinal necrosis


VAERS ID: 1172092 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Anxiety, Asthenia, Body temperature, C-reactive protein, Computerised tomogram head, Confusional state, Muscle spasms, Neurological examination, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   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: LOVENOX [LEVOFLOXACIN]; DOLIPRANE; IZALGI; ACTISKENAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Amoebic liver abscess; Angioplasty (Several peripheral angioplasties (iliac, popliteal, renal, femoral)); Atrial fibrillation; COVID-19; Hernia inguinal; Hip replacement; Hypertension arterial; Peripheral arteritis; Prostatectomy; Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210213; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Test Date: 20210213; Test Name: tomography; Result Unstructured Data: Test Result:cerebellar ischaemic sequelae; Comments: revealed old cerebellar ischaemic sequelae on the right side, but no other abnormalities were detected to explain the confusional picture. No evidence indicative of a subdiaphragmatic infection.; Test Date: 20210213; Test Name: C-reactive protein; Result Unstructured Data: Test Result:333; Test Date: 20210213; Test Name: Neurological examination; Result Unstructured Data: Test Result:Glasgow score of 13.1; Comments: confusional syndrome, temporospatial disorientation. No motor deficit. Normal cranial nerves.
CDC Split Type: FRPFIZER INC2021311736

Write-up: Cramp legs/cramps in the lower limbs; anxiety; severe pain; Asthenia; confusional state; presented motor agitation; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-DJ20210491. A 99-year-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 12Feb2021 (Batch/Lot Number: EJ6788) as single dose for COVID-19 immunization. Medical history included COVID-19 from 13Oct2020, severe arteritis of the lower limbs, total right hip replacement in the 80s and 90s, hernia inguinal, hypertension arterial, atrial fibrillation, amoebic liver abscess, prostatectomy, several peripheral angioplasties (iliac, popliteal, renal, femoral) and surgery. Concomitant medication included levofloxacin (LOVENOX [LEVOFLOXACIN]); paracetamol (DOLIPRANE); papaver somniferum, paracetamol (IZALGI); morphine sulfate (ACTISKENAN) from 02Feb2021, all for unspecified indication. The patient was hospitalized from 20Jan2021 to 29Jan2021 for management of a periprosthetic fracture of the right femur following a mechanical fall. Managed with strapping. The surgery was not associated with any particular complication. Redon drains were removed on day 3. The scar was clean and non-inflammatory. Full support resumed immediately. The patient was referred to the hospital on 13Feb2021 because of severe pain, increased asthenia and confusional state, he was uncommunicative, screamed and presented motor agitation. At the time of admission, the patient was apyretic with good haemodynamic parameters, without signs of hypoperfusion. No sign of thrombosis. Good haematosis in ambient air. No stercolith. Intermittent catheterisation enabled collecting 300 ml of urine. Neurological examination revealed Glasgow score of 13.1, confusional syndrome, temporospatial disorientation. No motor deficit. Normal cranial nerves. At the time of admission, the patient, who could still speak, described cramps in both lower limbs. C reactive protein was 333, which led to the initiation of Augmentin, although there was no evidence of infection. Computed tomography of the head was performed and revealed old cerebellar ischaemic sequelae on the right side, but no other abnormalities were detected to explain the confusional picture. No evidence indicative of a subdiaphragmatic infection. On admission, temperature was 37.5C. On 14Feb2021, the patient felt severe pain, mainly in the pelvis, heels and hypogastrium. Cramps in the lower limbs were no longer mentioned but the patient felt pain on mobilization. On 15Feb2021, the patient still presented good haemodynamic parameters, was apyretic but still very confused and seemed hallucinating. No sign of infection at the surgical site. Thereafter, the patient''s condition did not improve with speech that was no longer understandable with moaning that prompted the introduction of analgesic treatment using morphine administered in an electric syringe pump. The patient calmed down but still presented phases of agitation with anxiety which led to the administration of midazolam boluses and initiation of palliative care. The patient died on 25Feb2021. It was unknown if autopsy was performed. The case was discussed with the doctor in charge of the patient during the hospitalization. He did not link the death to the vaccine. He wondered about the role of the vaccine in the pain in the lower limbs, which resolved during hospitalization, and about the possible worsening of the deterioration of the general health condition (asthenia) in the patient who had, however, deteriorated since the surgery in January. Furthermore, this patient probably should not have been vaccinated given fever the day before with an inflammatory syndrome and an altered general condition. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Reduced general condition


VAERS ID: 1172093 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood creatinine increased, Blood potassium, Blood pressure measurement, C-reactive protein, C-reactive protein increased, Death, Decreased appetite, Dehydration, Haemoglobin, Hyperleukocytosis, Hypotension, Intestinal ischaemia, Lymphocyte count, Monocyte count, Neutrophil count, Oxygen saturation, Platelet count, Vomiting, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   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: MODOPAR; TADENAN; PANTOPRAZOLE; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Behaviour abnormal; Dementia with Lewy bodies; Hypertension arterial; Living in nursing home
Allergies:
Diagnostic Lab Data: Test Name: serum creatinine; Result Unstructured Data: Test Result:182 umol/l; Test Date: 20191121; Test Name: serum creatinine; Result Unstructured Data: Test Result:91 umol/l; Test Name: serum potassium; Result Unstructured Data: Test Result:4.1; Test Date: 20210209; Test Name: blood pressure; Result Unstructured Data: Test Result:low 9/6; Test Name: CRP; Result Unstructured Data: Test Result:92 mg/l; Test Date: 20160410; Test Name: CRP; Result Unstructured Data: Test Result:1; Comments: prior to the balance sheet; Test Name: Hb; Result Unstructured Data: Test Result:17.5 g/dl; Test Name: lymphocytes; Result Unstructured Data: Test Result:1.11 10*6/L; Test Name: monocytes; Result Unstructured Data: Test Result:1.53 10*6/L; Test Name: Neutrophils; Result Unstructured Data: Test Result:10.76 10*6/L; Test Date: 20210207; Test Name: Oxygen saturation; Test Result: 95 %; Test Name: platelets; Result Unstructured Data: Test Result:334 10*6/L; Test Name: leukocytes; Result Unstructured Data: Test Result:13.5 10*6/L
CDC Split Type: FRPFIZER INC2021342418

Write-up: Cause of death mentioned but not proven was mesenteric ischemia; slight dehydration and hyperleukocytosis; no appetite; slight dehydration; serum creatinine 182 umol / L (versus 91 on 21Nov2019); CRP at 92 m10*6/L (prior to the balance sheet = 1 on 10Apr2016); Patient was found dead; Low blood pressure at 9/6; Vomiting; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA), regulatory authority number FR-AFSSAPS-DJ20210653. An 88-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in in the left arm, on 04Feb2021 (Batch/Lot Number: EJ6788) as single dose for covid-19 immunization. Patient''s medical history included dementia with lewy bodies, Hypertension arterial and Living in nursing home. Patient previously received the first dose of COMIRNATY on 14Jan2021 for COVID-19 immunization without problem. Concomitant medications included benserazide hydrochloride, levodopa (MODOPAR), prunus africana extract (TADENAN), pantoprazole and paracetamol, all taken from unspecified dates, for unspecified indications. Two days later after vaccination, in the morning of 06Feb2021, patient experienced two episodes of vomiting of food-like nature. No fever. Then also experienced vomiting from the evening meal. Administration of Vogalene and Dafalgan as a result of the vomiting. The next morning, 07Feb2021, at 9 am, patient experienced vomiting before breakfast; oxygen was 95% saturation, Bilious vomiting and Supple abdomen. Patient experienced another episode of vomiting in the afternoon. Antiemetics was then administered. At 19:00 on the same day (07Feb2021) patient had no fever. In the morning of 08Feb2021, patient had no appetite. No new episode of vomiting during the day. On 09Feb2021 in the morning, patient was seen by a doctor (different from the declaring doctor) the clinical examination found a hard abdomen. The patient grimaces (he is insane and therefore cannot take priority over sex). No defense. Low blood pressure at 9/6 on 09Feb2021. No respiratory or cardiac call point. no other call point (especially respiratory or cardiac). Blood assessment taken on an unspecified date showing a slight dehydration and hyperleukocytosis (Hb = 17.5 g / dl, leukocytes at 13.5 10*6/L, neutrophils 10.76 10*6/L, lymphocytes at 1.11 10*6/L, monocytes at 1.53 10*6/L, platelets 334 10*6/L. Normal liver test, blood serum at 146, serum potassium at 4.1, serum creatinine 182 umol / L (versus 91 on 21Nov2019), CRP at 92 m10*6/L (prior to the balance sheet = 1 on 10Apr2016). Patient was found dead in bed at 2 p.m. on 09Feb2021. The doctor who noted the death and the same one who saw the patient in the morning (different from the doctor declaring that we recontacted). Caused of death raised the hypothesis of a mesenteric ischemia but without any evidence apart from the examination clinical. An autopsy was not performed. The outcome of all other events was unknown. Follow-up attempts are completed. The information on the batch/lot number has already been obtained.; Reported Cause(s) of Death: died; Cause of death mentioned but not proven was mesenteric ischemia


VAERS ID: 1172111 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-28
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood lactic acid, Brain natriuretic peptide, Cardio-respiratory arrest, Electrocardiogram, Haemoglobin, Left ventricular dysfunction, Neutrophil count, PCO2, PO2, Troponin, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (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? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XATRAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hypertrophy
Allergies:
Diagnostic Lab Data: Test Date: 20210302; Test Name: creatinine; Result Unstructured Data: Test Result:139 umol/l; Test Date: 20210302; Test Name: lactic acid; Result Unstructured Data: Test Result:3.0 mmol/L; Test Date: 20210302; Test Name: BNP; Result Unstructured Data: Test Result:1228 ng/L; Test Date: 20210302; Test Name: ECG; Result Unstructured Data: Test Result:regular sinus rhythm, fine QRS, lateral sub-ST; Test Date: 20210302; Test Name: Hemoglobin; Result Unstructured Data: Test Result:131 g/l; Test Date: 20210303; Test Name: Hemoglobin; Result Unstructured Data: Test Result:107 g/l; Test Date: 20210302; Test Name: Polynuclear neutrophils; Result Unstructured Data: Test Result:13.3 g/l; Test Date: 20210303; Test Name: Polynuclear neutrophils; Result Unstructured Data: Test Result:6.6 g/l; Test Date: 20210302; Test Name: pCO2; Result Unstructured Data: Test Result:48.8 mmHg; Test Date: 20210302; Test Name: pO2; Result Unstructured Data: Test Result:92 mmHg; Test Date: 20210302; Test Name: troponin; Result Unstructured Data: Test Result:21000 ng/L; Test Date: 20210303; Test Name: troponin; Result Unstructured Data: Test Result:102504 ng/L; Test Date: 20210302; Test Name: Leukocytes; Result Unstructured Data: Test Result:17 g/l; Test Date: 20210303; Test Name: Leukocytes; Result Unstructured Data: Test Result:9 g/l
CDC Split Type: FRPFIZER INC2021342457

Write-up: Cardiopulmonary arrest; Left ventricular dysfunction; This is a spontaneous report downloaded from the regulatory authority (Regulatory Authority report number: FR-AFSSAPS-LY20212242). A contactable pharmacist (contactable through Regulatory Authority only) reported that an 86-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot number: EP2163; Expiration date was not reported), intramuscular on 17Feb2021 as a single dose for COVID-19 immunization. Medical history included benign prostatic hypertrophy (unknown if ongoing). Concomitant medication included alfuzosin hydrochloride (XATRAL). The patient had previously received the first dose of BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On 28Feb2021, the patient had left ventricular dysfunction. The patient was then initiated with amoxicillin/clavulanic acid (AUGMENTIN). On 08Mar2021, the patient had cardiopulmonary arrest. The event, cardiopulmonary arrest, was reported to be life-threatening. The patient had required a 20-minute resuscitation (3 mg of adrenaline, 2 ampoules of IV Cordarone and 5 external electric shocks in total). The patient underwent laboratory tests and procedures which included creatinine of 139 umol/l on 02Mar2021; lactic acid of 3.0 mmol/l on 02Mar2021; brain natriuretic peptide (BNP) of 1228 ng/l on 02Mar2021; electrocardiogram (ECG) showed regular sinus rhythm, fine QRS and lateral sub-ST on 02Mar2021; hemoglobin of 131 g/l on 02Mar2021 and 107 g/l on 03Mar2021; polynuclear neutrophils of 13.3 g/l on 02Mar2021 and 6.6 g/l on 03Mar2021; pCO2 of 48.8 mmHg on 02Mar2021; pO2 of 92 mmHg on 02Mar2021; troponin of 21000 ng/l on 02Mar2021 and 102504 ng/l on 03Mar2021; leukocytes of 17 g/l on 02Mar2021 and 9 g/l on 03Mar2021. On 08Mar2021, the patient had died due to the events, ''left ventricular dysfunction'' and ''cardiopulmonary arrest''. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiopulmonary arrest; Left ventricular dysfunction


VAERS ID: 1172143 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-28
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood glucose, Blood sodium, Diabetic hyperosmolar coma, Interstitial lung disease, Lower respiratory tract congestion, Renal failure, Respiratory distress, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Interstitial lung disease (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Ischaemic heart disease; Malnutrition; Starvation
Allergies:
Diagnostic Lab Data: Test Name: creatinine; Result Unstructured Data: Test Result:213 umol/l; Test Name: Blood sugar; Result Unstructured Data: Test Result:49 mmol/L; Comments: hyperglycemia; Test Name: Blood sodium; Result Unstructured Data: Test Result:153 mmol/L; Comments: hypernatremia; Test Date: 20210228; Test Name: Covid-19 virus test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021342445

Write-up: Respiratory distress; Hyperosmolar (non-ketotic) coma; Kidney failure; Bronchial congestion; Interstitial syndrome of the 2 bases; This is a spontaneous report downloaded from the Regulatory Authority-WEB (Regulatory Authority report number: (FR-AFSSAPS-PC20210599). A contactable physician (contactable through Regulatory Authority only) reported that an 88-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot number: EJ6789; Expiration date was not reported), intramuscular on 11Feb2021 as a single dose, for COVID-19 immunization. Medical history included starvation, breast cancer, ischaemic heart disease and undernutritrion; all unknown if ongoing. The patient''s concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (COMIRNATY, Lot number: EJ6795; Expiration date was not reported) on 21Jan2021 for COVID-19 immunization. The patient was considered to be at risk of developing a severe form of COVID-19; and has not had COVID-19. On 28Feb2021, the patient had respiratory distress; hyperosmolar coma (hyperglycemia 49 mmol/L; hypernatremia 153 mmol/L); kidney failure (creatinine 213 uM); bronchial congestion; and insterstitial syndrome of the two bases. The patient was hospitalized from 28Feb2021 to 04Mar2021 due to the reported events. The patient had tested negative for COVID-19 virus test on 28Feb2021. On 04Mar2021, the patient had died to the events, respiratory distress, hyperosmolar coma, kidney failure, bronchial congestion and insterstitial syndrome of the two bases. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Respiratory distress; Hyperosmolar (non-ketotic) coma; Kidney failure; Bronchial congestion; Interstitial syndrome of the 2 bases


VAERS ID: 1172191 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Purpura, Rash macular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021347530

Write-up: she died 5 days after occurrence of the spots; purpura-like spots on the face; purpura-like spots on the face; This is a spontaneous report from a contactable other health professional received a pfizer sponsored program. An elderly female patient (age not specified but patient in a retirement home) received BNT162B2 (COMIRNATY, Solution for injection, unknown lot number and expiration date), via an unspecified route of administration at an unspecified age on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications were not reported but included unspecified oral anti diabetic drug. The patient experienced purpura-like spots on the face on an unspecified date and she died 5 days after occurrence of the spots. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. Information on the batch/lot number has been requested.; Sender''s Comments: Based on the available information, a possible contributory role of the subject vaccine cannot be excluded. However, there was no information provided regarding autopsy results, specific cause of death, complete medical history, co-morbid conditions, and concomitant medications, which does not allow a full assessment of the case. 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: purpura-like spots on the face; death; purpura-like spots on the face


VAERS ID: 1173177 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-02-01
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4243 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Confusional state, Cough, Diarrhoea, Dyspnoea, General physical health deterioration, Hypoxia, Oxygen saturation, SARS-CoV-2 test, Vaccine breakthrough infection
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Oxygen saturation; Result Unstructured Data: Test Result:Okay; Test Date: 20210201; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021349517

Write-up: confused; cough; diarrhoea; short of breath; Hypoxia; SARS-CoV-2 infection/ COVID positive; Vaccine breakthrough infection; General physical health deterioration/ gradual deterioration/ off legs; This is a spontaneous report from a contactable pharmacist received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202103281032444760. Safety Report Unique Identifier GB-MHRA-ADR 25039712. A 91-years-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 (Lot Number: EK4243) as single dose for covid-19 immunisation. The patient medical history was not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Unsure if patient was enrolled in clinical trial. Concomitant medication included influenza vaccine reported as a/guangdong-maonan/swl1536/2019 (h1n1)pdm09-like strain (a/victoria/2454/2019 ivr-207), a/hong kong/2671/2019 (h3n2)-like strain (a/hong kong/2671/2019 ivr-208), b/washington/02/2019-like strain (b/victoria/705/2018 bvr-11), influenza virus strains inactivated, virus influenza a/california/7/2009 (h1n1) derived strain used nymc x-181, virus influenza a/perth/16/2009 (h3n2)-like strain used nymc x-187 derived from a/victoria/210/2009, virus influenza b/brisbane/60/2008 like strain (SEQIRUS VACCINES INFLUENZA) taken for influenza immunisation on 08Oct2020. The patient experienced sars-cov-2 infection, confused, cough, diarrhoea, short of breath on an unspecified date; vaccine breakthrough infection, general physical health deterioration on 01Feb2021; hypoxia on an unspecified date. The case was reported as serious with seriousness criteria death, medically significant and hospitalization. It also reported as the patient experienced COVID positive on 01Feb2021. Since then, had had gradual deterioration. 2 called ambulances prior to admission, not brought into hospital due to saturating okay. General practitioner (GP) gave oral antibiotics. On date of admission - confused, off legs and hypoxic. Cough and feeling short of breath were the main issues, and diarrhoea. Received azithromycin, ceftriaxone and dexamethasone as per hospital policy. Palliative management started 08Feb2021 and patient passed away 09Feb2021. The patient died on 09Feb2021 with COVID-19 listed as cause of death. The outcome of event COVID-19 was fatal, of the other events was not recovered. It was not reported if an autopsy was performed. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1173181 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-07
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Lower respiratory tract infection, Pneumonia, SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   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: Chest infection; Dementia; Pneumonia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:no-negative
CDC Split Type: GBPFIZER INC2021350114

Write-up: pneumonia; chest infection; lost strength and mobility; Sudden death; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202103291436232640, Safety Report Unique Identifier GB-MHRA-ADR 25045189. An 82-year-old male patient received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH) unspecified route of administration on 01Feb2021 (batch/lot number not reported, expiration date not reported) at single dose for COVID-19 immunisation. Medical history included dementia, chest infection, pneumonia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient was physically strong and well. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced sudden death on 07Feb2021, pneumonia and chest infection on an unspecified date. The clinical course was reported as follows: Within days (redacted) lost strength and mobility. GP diagnosis of chest infection. Further GP visit diagnosed pneumonia. Died 6 days after vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative on unspecified date. Outcome of events pneumonia, chest infection and lost strength and mobility was unknown. The patient died on 07Feb2021. Cause of death was not reported. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1173183 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-03-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1749 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Communication disorder, Death, Fatigue, Inappropriate schedule of product administration, Malaise, Off label use, SARS-CoV-2 test
SMQs:, Medication errors (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   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: VANCOMYCIN
Current Illness: End stage renal failure (On haemodialysis three times a week.); Haemodialysis (Three times a week.); Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Preexisting Conditions: Medical History/Concurrent Conditions: C-reactive protein increased; Infection (Unknown infection.)
Allergies:
Diagnostic Lab Data: Test Date: 20200420; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021354854

Write-up: Malaise/ unwell; Communication disorder/he was not making much sense; Died in sleep; Rigors/shivering; Fatigue; first dose on 31Jan2021; second dose on 28Mar2021; first dose on 31Jan2021; second dose on 28Mar2021; This is a spontaneous report from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202103291741008180; Safety Report Unique Identifier: GB-MHRA-ADR 25046156. A contactable other healthcare professional reported that a 66-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 28Mar2021 (Lot Number: ER1749; expiry date: unknown) at a single dose, for COVID-19 immunisation. Medical history included ongoing end stage renal disease (on haemodialysis three times a week), he had ongoing immunodeficiency and had an illness or condition, not listed above, which reduces the immune response (e.g. immunodef, infection from an unknown date and unknown if ongoing, unknown infection, and C-reactive protein increased. Patient has not had symptoms associated with COVID-19 and is not enrolled in clinical trial. Concomitant medication included vancomycin taken for C-reactive protein increased from 17Dec2020 to 29Jan2021. The patient previously received first dose of bnt162b2 on 31Jan2021 for COVID-19 immunisation. The patient showed a positive COVID-19 virus test on 20Apr2020. Patient has not tested positive for COVID-19 since having the vaccine. On 28Mar2021, patient had rigors and shivering in the afternoon post vaccine which was given in the morning at 10:54. Patient managed to have their dinner in the evening but felt fatigue, slept downstairs in the day bed. Wife went down at 03:00 as could see her husband downstairs, noted that he looked unwell and he was not making much sense (also reported as communication disorder) and possible infection. Wife went to call an ambulance after getting him a drink and getting dressed to find that he had died in sleep. Cardiopulmonary resuscitation (CPR) was performed by paramedic crew. Outcome of the events rigors/shivering was not recovered, for events fatigue, malaise/ unwell, "Communication disorder/he was not making much sense" was unknown. The patient died on 29Mar2021. Cause of death was unknown. It was not reported if an autopsy was performed. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: died in sleep


VAERS ID: 1173185 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BNT162B2 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Leukaemia (Leukaemia- reviewed Feb 2021 and doing well)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021354639

Write-up: breathless; shivers; diarrhoea; Dyspnoea; This is a spontaneous report from a contactable physician. This report is received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202103301324231650. A 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 (lot number: BNT162b2, as per report, unable to confirm) as single dose for covid-19 immunisation. Medical history included leukaemia, reviewed last Feb2021 and doing well. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced dyspnoea on 25Mar2021, breathless, shivers, diarrhoea on an unspecified date. Outcome of the events, breathless, shivers, & diarrhoea was unknown. The patient had a fatal outcome from the event dyspnoea. The patient died on 26Mar2021 it is 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: Dyspnoea


VAERS ID: 1173187 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Echocardiogram, Fall, Left ventricular dysfunction, Myocardial infarction, SARS-CoV-2 test, Troponin
SMQs:, Cardiac failure (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   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: ALLOPURINOL; AMLODIPINE; APIXABAN; CLENIL A; DIGOXIN; FUROSEMIDE; HYDROCORTISONE; LEVOTHYROXINE; LOSARTAN; METFORMIN; PRAVASTATIN
Current Illness:
Preexisting Conditions: Medical history/concurrent conditions: asthma; atrial fibrillation; carotid endarterectomy; chronic kidney disease stage 3; coronary artery disease (long standing ST-T changes); dementia; hypertension; left ventricular dysfunction; pituitary adenoma; radiotherapy; surgery; transient ischemic attack; type 2 diabetes mellitus (on oral therapy)
Allergies:
Diagnostic Lab Data: Test Date: 20201104; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Non-dilated LV with severely impaired LV systolic; Comments: Non-dilated LV with severely impaired LV systolic function, EF 33% Akinesia of the apex, mid inferior, inferoseptal and anteroseptal wall Mild MR and TR; Test Date: 20210327; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: Troponin; Result Unstructured Data: Test Result:trop 800 -$g 10,000
CDC Split Type: GBPFIZER INC2021354961

Write-up: 2x falls in days following vaccination; left ventricular dysfunction; Myocardial infarction; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202103301704196130, Safety Report Unique Identifier: GB-MHRA-ADR 25051986. An 85-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH, COVID-19 MRNA VACCINE, Batch/Lot Number and exp date not reported), via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunisation. Medical history included severe left ventricular dysfunction, asthma, atrial fibrillation, suspected underlying coronary artery disease (long standing ST-T changes), hypertension, Type 2 diabetes (on oral therapy), previous transient ischaemic attack (TIA), bilateral carotid endarterectomy, pituitary adenoma, transphenoidal surgery and radiotherapy in 1990; probable dementia and chronic kidney disease (CKD) stage 3, all from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. It was not sure if patient is enrolled in clinical trial. On 04Nov2020, Echocardiogram showed Non-dilated LV with severely impaired LV systolic function, EF 33%, Akinesia of the apex, mid inferior, inferoseptal and anteroseptal wall, Mild MR and TR. Concomitant medications included allopurinol, amlodipine, apixaban taken for atrial fibrillation, beclometasone dipropionate CLENIL A modulate inhaler, digoxin, furosemide, hydrocortisone, levothyroxine, losartan taken for an unspecified indication, start and stop date were not reported; metformin, pravastatin, and long term steroids (not specified). On an unspecified date, the patient had 2x falls in days following vaccination and attended hospital both times. The patient experienced left ventricular dysfunction on an unspecified date, and experienced myocardial infarction on 28Mar2021, following which the patient died on 29Mar2021. The event of left ventricular dysfunction is non-serious. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 27Mar2021, and troponin: trop 800 -$g 10,000 on an unspecified date. The patient died on 29Mar2021 likely due to myocardial infarction. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1173197 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Scan; Result Unstructured Data: Test Result:at six weeks gestation showed foetal heartbeat
CDC Split Type: GBPFIZER INC2021349643

Write-up: Exposure during pregnancy; foetal heartbeat; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202103221921316910, Safety Report Unique Identifier GB-MHRA-ADR 25001051. The physician reported for both mother and the fetus. This is the fetal case. A fetus of an unspecified gender received bnt162b2 (COMIRNATY) via transplacental route on 07Feb2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included folic acid taken for folic acid supplementation. The fetus experienced fetal exposure during pregnancy and fetal heartbeat (Fetal malformation) on unspecified dates. The mother had private scan at six weeks of gestation which showed foetal heartbeat. The fetus was miscarried on 04Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Fetal malformation


VAERS ID: 1173209 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G 26761A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pericardial haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CHINOTAL; TALLITON; INDAPAMIDE; CAVINTON FORTE; ELIQUIS; TENAXUM; FURON [FUROSEMIDE SODIUM]; POTASSIUM CHLORIDE; BETASERC
Current Illness: Atrial fibrillation; Dizziness; Generalized arteriosclerosis; Hypertension; Myocardial ischaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20210

Write-up: Haemopericardium; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PERICARDIAL HAEMORRHAGE (Haemopericardium) in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G 26761A) for COVID-19 vaccination. Concurrent medical conditions included Generalized arteriosclerosis, Myocardial ischaemia, Atrial fibrillation, Hypertension and Dizziness. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, VINPOCETINE (CAVINTON FORTE) and BETAHISTINE HYDROCHLORIDE (BETASERC) for Dizziness, PENTOXIFYLLINE (CHINOTAL) for Generalised arteriosclerosis, INDAPAMIDE and RILMENIDINE PHOSPHATE (TENAXUM) for Hypertension, CARVEDILOL (TALLITON) and POTASSIUM CHLORIDE for Myocardial ischaemia, FUROSEMIDE SODIUM (FURON [FUROSEMIDE SODIUM]) for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PERICARDIAL HAEMORRHAGE (Haemopericardium) (seriousness criterion death). The patient died on 05-Mar-2021. The reported cause of death was Haemopericardium. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered PERICARDIAL HAEMORRHAGE (Haemopericardium) to be unlikely related. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Haemopericardium


VAERS ID: 1173211 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-18
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / 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: 2021-03-20
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chemotherapy
Allergies:
Diagnostic Lab Data: Test Date: 20210318; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021358707

Write-up: COVID-19 test positive; COVID-19 test positive; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB [HU-OGYI-176021] received via Regulatory Authority. A 78-years-old male patient received bnt162b2 (COMIRNATY, concentrate for dispersion injection; active substance: tozinameran), dose 1 intramuscular on 04Mar2021 (batch number: ET1831) as 0.3 mL (30 micrograms), single for covid-19 immunisation. Medical history included chemotherapy unknown if ongoing. The patient''s concomitant medications were not reported. On 18Mar2021, the patient''s COVID-19 test was positive. He had a severe COVID requiring hospital treatment. The patient was died on 20Mar2021. It was not reported if an autopsy was performed. Sender Comment: COVID-19 was detected 14 days after first dose of COMIRNATY. Immunity may have not developed within two weeks after the first dose of vaccine was given.; Reported Cause(s) of Death: COVID-19 test positive; COVID-19 test positive


VAERS ID: 1173214 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

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

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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified; Cerebral amyloid angiopathy; Diverticular disease; Frailty; Gastrooesophageal reflux disease; Hypothyroidism; Sjogren''s syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021347680

Write-up: This is a spontaneous report from a contactable physician downloaded from the regulatory authority. This is a report received from the Regulatory authority number IE-HPRA-2021-068977. An 84 years old female patient received her first dose of BNT162B2 (COMIRNATY, lot/Batch number: ER7812) via an unspecified route of administration on 13Mar 2021 at 0.3 ml single dose for COVID-19 immunisation. Medical history included cardiovascular disorder, sjogren''s syndrome, diverticulum, hypothyroidism, cerebral amyloid angiopathy, asthenia, and gastrooesophageal reflux disease. It was noted that the patient was more frail in the last year but was living with support. Concomitant medication included paracetamol, administered post vaccination to avoid myalgia and fever, taken for prophylaxis from 13Mar2021 to 14Mar2021. On 14Mar2021, at 9.00 am, the patient was found dead and cold. The patient experienced found dead and cold on 14Mar2021 09:00. The patient died on 14Mar2021. It was not reported if an autopsy was performed. It was reported that the patient had been well, alert and ate normally the previous day. There was no disturbance during the night. It was reported that the patient was found slumped over a chair and may have been on her way to the toilet. The reporter did not feel the fatal outcome was related to the vaccine but outlined that a post-mortem was awaited. Follow-up information was received by the regulatory authority from the reporting healthcare professional on 24Mar2021, it was reported that the patient may have had advanced cardiovascular disease. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Death with an unknown cause is assessed as related to COMIRNATY and documented as such in the global safety database until sufficient information is available to allow an unrelated causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Found dead


VAERS ID: 1173215 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, Malaise
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   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: ZOCOR; AZOPT; ACTOS; ZOPICLONE; EZETROL; FORTISIP; PANTOPRAZOLE; XALATAN; ALLOPURINOL; PARACETAMOL; AMLODIPINE; LISINOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure increased (BP was markedly raised. It was reported that the patient suffered white coat hypertension and when the patient checked her BP at home it was fine so she was not referred for further investigations); Chronic renal failure; Hypertension; Malaise; Type 2 diabetes mellitus; White coat hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021347679

Write-up: FOUND DEAD; WASNT FEELING WELL; DIARRHOEA; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IE-HPRA-2021-069722. A 78-years-old female patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: ER7812) as single dose for covid-19 immunisation. Medical history included chronic kidney disease from 2015, white coat hypertension from an unknown date, hypertension from an unknown date, type 2 diabetes mellitus from an unknown date, malaise from an unknown date, BP was markedly raised from 09Mar2021. It was reported that the patient suffered white coat hypertension and when the patient checked her BP at home it was fine so she was not referred for further investigations. Concomitant medications included simvastatin (ZOCOR), brinzolamide (AZOPT), pioglitazone hydrochloride (ACTOS), zopiclone, ezetimibe (EZETROL 10 mg tablet), carbohydrates nos, fats nos, minerals nos, protein, vitamins nos (FORTISIP), pantoprazole, latanoprost (XALATAN), allopurinol, paracetamol, amlodipine and lisinopril, all taken for an unspecified indications, and start and stop dates were not reported. On 17Mar2021, the patient rang her relative outlining she wasn''t feeling well and had some diarrhoea. At approximately 5 pm, the patient was found dead by her relative. The reporter outlined that the patient was a very ill lady. The reporter did not think that the patient''s death was related to vaccination, however, due to close proximity, thought it should be reported. The case was referred for a post-mortem examination. The outcome of wasn''t feeling well and had diarrhoea was unknown. The events wasn''t feeling well and had diarrhoea were considered as serious of medically significant. No follow-up attempts possible. No further information expected.; Sender''s Comments: Event unknown cause of death is assessed as related until sufficient information is available to confirm an unrelated cause of death or if there is sufficient information to allow an unrelated causality assessment. Case will be reassessed when follow-up information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death of unknown cause


VAERS ID: 1173234 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, Sopor
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL FUMARATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis chronic; COVID-19 (Contracted the virus); Senile dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021342301

Write-up: contracted the virus, on 12Feb2021 vaccinated against COVID, from 19Feb2021 a sleeping patient in O2 therapy, she is not even responsive to auditory and pain stimuli. Liquid dysphagia; contracted the virus, on 12Feb2021 vaccinated against COVID, from 19Feb2021 a sleeping patient in O2 therapy, she is not even responsive to auditory and pain stimuli. Liquid dysphagia; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is IT-MINISAL02-704632. A 99-year-old female patient received bnt162b2 (COMIRNATY), first dose intramuscular on 12Feb2021 (Batch/Lot Number: EK9788) as SINGLE DOSE (reported as 0.3 mL, single) for covid-19 immunisation. Medical history included covid-19 from 13Nov2020 to 14Dec2020 (Contracted the virus); then from an unknown date and unknown if ongoing both senile dementia and bronchitis chronic. Concomitant medication included bisoprolol fumarate (BISOPROLOL FUMARATE) taken for an unspecified indication, start and stop date were not reported. Contracted the virus, on 12Feb2021 vaccinated against COVID, from 19Feb2021 a sleeping patient in O2 therapy, not even responsive to auditory and pain stimuli Liquid dysphagia. Supportive therapy with glucose and physiological. The patient died on 08Mar2021. An autopsy was not performed. Sender comment: The concomitant pathologies and drugs were entered after contacting the Reporter. No further information is available. Adj. 23Mar2021: the report sent by the Reporter is attached. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Contracted the virus, on 12Feb2021 vaccinated against COVID, from 19Feb2021 a sleeping patient in O2 therapy, not even responsive to auditory and pain stimuli Liquid dysphagia. Supportive therapy with glucose and physiological. Died on 08Mar2021; Reported Cause(s) of Death: from 19Feb2021 a sleeping patient in O2 therapy, she is not even responsive to auditory and pain stimuli. Liquid dysphagia; from 19Feb2021 a sleeping patient in O2 therapy, she is not even responsive to auditory and pain stimuli. Liquid dysphag


VAERS ID: 1173235 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-25
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APIXABAN; BISOPROLOL FUMARATE; PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; COVID-19; Decompensation cardiac; Dyslipidaemia; Hypertension arterial; Osteoporosis; Respiratory tract infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021342291

Write-up: Loss of consciousness; This is a spontaneous report downloaded from the Regulatory Authority (Regulatory Authority report number: IT-MINISAL02-704635). A contactable physician (contactable through Regulatory Authority only) reported that an 87-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot number: EL0725; Expiration date was not reported), intramuscular on 12Feb2021 as a single dose for COVID-19 immunization. Medical history included decompensation cardiac from 04Jan2021 to 08Jan2021; osteoporosis (unknown if ongoing); hypertension arterial (unknown if ongoing); atrial fibrillation (AFib) (unknown if ongoing); respiratory tract infection from 04Jan2021 to 08Jan2021; COVID-19 from 13Nov2020 to 11Dec2020; and dyslipidaemia (unknown if ongoing). Concomitant medications included apixaban, bisoprolol fumarate and propranolol. On 25Feb2021, the patient had loss of consciousness and miosis (reported as "myosis"). The patient was put on O2 therapy 3l/min as treatment for the reported events, and support therapy with glucose and physiological saline. The patient had died on 03Mar2021 due to loss of consciousness and miosis, and no autopsy was performed.; Reporter''s Comments: Patient who had contracted the virus. Vaccination done on 12Feb2021 and suddenly lapsed on 3Mar2021 with loss of consciousness after 12 days from the first dose, fixed myosis treated with O2 therapy 3l/min, no longer responsive to auditory and painful stimuli. Support therapy with glucose and physiological saline.; Reported Cause(s) of Death: Loss of consciousness


VAERS ID: 1173290 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021355190

Write-up: Got the 2 doses and died afterwards of COVID; Got the 2 doses and died afterwards of COVID; This is a spontaneous report from a contactable physician. This physician reported same events for two patients. This is the first of two reports. A male patient of an unspecified age received 2 doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose and second dose both via an unknown route of administration on an unspecified date (Lot Number: Unknown) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient vaccinated twice with Pfizer and died after Covid. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on lot 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 and suspected LOE. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including autopsy results, counteractive treatment measures and concomitant medications. 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.,Linked Report(s) : MX-PFIZER INC-2021355191 Same reporter, same drug, same event, different patient.; Reported Cause(s) of Death: died afterwards of COVID


VAERS ID: 1173296 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / 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: 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: MXPFIZER INC2021355191

Write-up: Got the 2 doses and died afterwards of COVID; Got the 2 doses and died afterwards of COVID; This is a spontaneous report received from a contactable physician. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 and dose 2 (lot# not reported) both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the 2 doses and died afterwards of covid on an unspecified date. It was not reported if an autopsy was performed. The outcome was fatal. Information on lot number has been requested. No QA investigation requested as no lot number provided for now; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : MX-PFIZER INC-2021355190 Same reporter, same drug, same event, different patient.; Reported Cause(s) of Death: Got the 2 doses and died afterwards of COVID; Got the 2 doses and died afterwards of COVID


VAERS ID: 1173438 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LISINOPRIL; SIMVASTATINE; METOPROLOL SUCCINATE; ACENOCOUMAROL; PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CVA
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021342679

Write-up: acute cardiac asthma; Death 2 days after 2nd corona vaccination,: 2 days after vaccination the patient became very short of breath out of nowhere and died about half an hour later; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB manufacturer report number NL-LRB-00482739, NL-LRB-00483993. A 90-year-old male patient received the second dose of BNT162B2 (COMIRNATY; lot number: EP9605) via an unspecified route of administration on 16Mar2021 at a single dose for COVID-19 immunisation. Medical history included CVA from 2012. Concomitant medications included lisinopril, simvastatine, metoprolol succinate, acenocoumarol and pantoprazole. The patient previously received first dose of Comirnaty on 16Feb2021 for COVID-19 immunisation (0.3ml). Death 2 days after 2nd corona vaccination, 2 days after vaccination the patient became very short of breath out of nowhere and died about half an hour later. On an unspecified date, the patient experienced acute cardiac asthma. The patient had no previous COVID-19 infection and no other diagnostic procedures. Man was examined by a doctor from the General practice center, there they thought of acute cardiac asthma as the cause of death. He had a CVA in 2012. He still lived independently with his wife. No home care was provided to the couple. He''s condition was unchanged. His children did notice that he was walking a bit more slowly (but they have known this due to his advanced age). He was not familiar with heart or lung problems. The thrombosis service has drawn up a schedule for him on how to deal with the acenocoumarol around the vaccinations. He has adhered to this neatly. He has had no complaints of fever / muscle pain etc. after the first and second vaccination. I don''t know if the vaccine affected his death. The patient died on 18Mar2021 due to dyspnoea and acute cardiac asthma. An autopsy has been performed. Reporter''s comment: 2 days after vaccination the patient became very short of breath out of nowhere and died about half an hour later. Man was examined by a doctor from the General practice center, there they thought of acute cardiac asthma as the cause of death. He had a CVA in 2012. He still lived independently with his wife. No home care was provided to the couple. He''s condition was unchanged. His children did notice that he was walking a bit more slowly (but they have known this due to his advanced age). He was not familiar with heart or lung problems. The thrombosis service has drawn up a schedule for him on how to deal with the acenocoumarol around the vaccinations. He has adhered to this neatly. He has had no complaints of fever / muscle pain etc. after the first and second vaccination. I don''t know if the vaccine affected his death. An autopsy has been performed. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Man was examined by a doctor, there they thought of acute cardiac asthma as the cause of death. Notice that he was walking a bit more slowly (but they have known this due to his advanced age). Not familiar with heart or lung problems. The thrombosis service has drawn up a schedule for him on how to deal with the acenocoumarol around the vaccinations. He has had no complaints of fever/muscle pain etc. after the 1st and 2nd vaccination. I don''t know if the vaccine affected his death; Reported Cause(s) of Death: cardiac asthma acute; Dyspnoea


VAERS ID: 1173440 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Basophil count, Basophil count decreased, Blood fibrinogen, Cerebral haemorrhage, Chest X-ray, Coma scale, Computerised tomogram head, Eosinophil count, Eosinophil count decreased, Fibrin D dimer increased, Fibrin degradation products, Haematocrit, Haematocrit decreased, Haemoglobin, Haemoglobin decreased, Lymphocyte count, Lymphocyte count decreased, Magnetic resonance imaging, Mean cell haemoglobin, Mean cell volume, Monocyte count, Neutrophil count, Neutrophil count increased, Platelet count, Platelet count decreased, Prothrombin time, Prothrombin time ratio increased, Red blood cell count decreased, Red blood cell scan, Red cell distribution width, White blood cell count, White blood cell count decreased
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   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: XTANDI
Current Illness: Carcinoma of the prostate metastatic (lymphogenically metastatic castration resistant prostate carcinoma); Prostate cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210322; Test Name: basophil granulocytes absolute; Result Unstructured Data: Test Result:0.01; Comments: from 0.01 L; Test Date: 20210322; Test Name: basophils granulocyte; Result Unstructured Data: Test Result:0.3; Test Date: 20210322; Test Name: fibrinogen; Result Unstructured Data: Test Result:3.7; Test Date: 20210322; Test Name: X-thorax; Result Unstructured Data: Test Result:no evidence of infiltrates; Test Date: 20210322; Test Name: EMV (Eye Motor Verbal); Result Unstructured Data: Test Result:1-1-1 =bad; Test Date: 20210322; Test Name: CT Cerebrum; Result Unstructured Data: Test Result:Large lobar intraparenchymal haemorrhage right fro; Comments: Large lobar intraparenchymal haemorrhage right frontoparietal, considering mass action as well as aspect of white matter edema formation on both sides DD (differential diagnosis) tumor related, additional hemorrhagic components pons and mesencephalon, DD (differential diagnosis) also tumor related DD (differential diagnosis) Duret haemorrhage in the context of central herniation.; Test Date: 20210322; Test Name: eosinophil granulocyte; Result Unstructured Data: Test Result:0.0; Comments: 0.0 L; Test Date: 20210322; Test Name: eosinophil total; Result Unstructured Data: Test Result:0.00; Comments: 0.01 L; Test Date: 20210322; Test Name: D-dimer (FDP); Result Unstructured Data: Test Result:1221; Comments: 1221 H; Test Date: 20210322; Test Name: hematocrit; Result Unstructured Data: Test Result:0.30; Comments: 0.30 L; Test Date: 20210322; Test Name: hemoglobin; Result Unstructured Data: Test Result:6.2; Comments: 6.2 L; Test Date: 20210322; Test Name: lymphocyte; Result Unstructured Data: Test Result:6.1; Comments: 6.1 L; Test Date: 20210322; Test Name: lymphocyte absolute; Result Unstructured Data: Test Result:0.23; Comments: 0.23 L; Test Name: MRI scan; Result Unstructured Data: Test Result:unknown; Test Date: 20210322; Test Name: MCH; Result Unstructured Data: Test Result:20.8; Test Date: 20210322; Test Name: MCH; Result Unstructured Data: Test Result:1.88; Test Date: 20210322; Test Name: mvc; Result Unstructured Data: Test Result:90; Test Date: 20210322; Test Name: monocyte; Result Unstructured Data: Test Result:6.6; Test Date: 20210322; Test Name: monocyte absolute; Result Unstructured Data: Test Result:0.25; Test Date: 20210322; Test Name: Neutrophil gran. absolute; Result Unstructured Data: Test Result:3.30; Test Date: 20210322; Test Name: neutrophil granulocyte; Result Unstructured Data: Test Result:87.0; Test Date: 20210322; Test Name: thrombocyte; Result Unstructured Data: Test Result:100; Comments: 100 L; Test Date: 20210322; Test Name: PT; Test Result: 11.7 s; Comments: 11.7 H; Test Date: 20210322; Test Name: PT INR; Result Unstructured Data: Test Result:1.1; Test Date: 20210322; Test Name: ERYTROCYTES; Result Unstructured Data: Test Result:3.30; Comments: 3.30 L; Test Date: 20210322; Test Name: Red cell distribution width; Result Unstructured Data: Test Result:12.3; Test Date: 20210322; Test Name: leucocyte; Result Unstructured Data: Test Result:3.8; Comments: 3.8 L
CDC Split Type: NLPFIZER INC2021342692

Write-up: death due to major intraparenchymal intracerebral bleeding; Hemoglobin 6.2 L; Hematocrit 0.30 L; Erythrocytes 3.30 L; Leucocytes 3.8 L; Platelets 100 L; Lymphocytes abs 0.23 L; Basophil granulocytes from 0.01 L; Eosinophils total 0.00 L/Eosinophil granulocytes 0.0 L; Neutrophil granulocytes 87.0 H; Lymphocytes 6.1 L; PT (sec) 11.7 H; D-Dimer (FDP) 1221 H; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB NL-LRB-00483312. An 87-year-old male patient received BNT162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing prostate cancer lymphogenically metastatic castration resistant prostate carcinoma from 03Nov2020 and ongoing prostate cancer from 19Jul2013 as confounding factor. The patient was still living completely independently without assistance. Concomitant medication included enzalutamide (XTANDI) capsule 40mg taken from unspecified dates for an unspecified indication. On 22Mar2021, patient experienced intracerebral hemorrhage 5 days after start of vaccination. The patient underwent lab tests and procedures which included As per hematology result on 22Mar2021, patient had the following: Hemoglobin 6.2 L, Hematocrit 0.30 L, Erythrocytes 3.30 L, MCV 90, MCH 1.88, MCHC 20.8, RDW 12.3, Leucocytes 3.8 L, and Platelets 100 L, Differentiation screening Autom: Neutrophil gran. absolute 3.30, Lymphocytes abs 0.23 L, Monocytes abs 0.25. On 22Mar2021, patient also had X-thorax with no evidence of infiltrates, EMV (Eye Motor Verbal) of 1-1-1 =bad, CT Cerebrum with result Large lobar intraparenchymal haemorrhage right frontoparietal, considering mass action as well as aspect of white matter edema formation on both sides DD (differential diagnosis) tumor related, additional hemorrhagic components pons and mesencephalon, DD (differential diagnosis) also tumor related DD (differential diagnosis) Duret haemorrhage in the context of central herniation, patient also had Basophil granulocytes from 0.01 L, Eosinophils total 0.00 L, Neutrophil granulocytes 87.0 H, Lymphocytes 6.1 L, Monocytes 6.6, Basophil granulocytes 0.3, Eosinophil granulocytes 0.0 L, PT INR 1.1, PT (sec) 11.7 H, Fibrinogen 3.7, D-Dimer (FDP) 1221 H. On an unspecified date, MRI (Magnetic resonance imaging) was unknown. The outcome of intracerebral hemorrhage is fatal. The patient died on 22Mar2021. An autopsy was not performed. Case was reported as serious. Reporter''s comment: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no passing away Additional information ADR (adverse drug reaction): due to large intraparenchymal intracerebral bleeing BSN available: yes confounding factors confounding factors: prostate cancer Other diagnostic procedures: MRI (Magnetic resonance imaging) The patient was still living completely independently without assistance. No follow-up attempts are possible.Information on lot and batch numbers cannot be obtained. No further information is expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no passing away Additional information ADR (adverse drug reaction): due to large intraparenchymal intracerebral bleeing BSN available: yes confounding factors confounding factors: prostate cancer Other diagnostic procedures: MRI (Magnetic resonance imaging) The patient was still living completely independently without assistance.; Reported Cause(s) of Death: death due to major intraparenchymal intracerebral bleeding


VAERS ID: 1173441 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-28
Onset:2021-03-20
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Auscultation, Barre test, Blood albumin, Blood calcium, Blood creatinine, Blood phosphorus, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Blood uric acid, Cardiac asthma, Cardiac death, Central venous pressure, Echocardiogram, Electrocardiogram, Glomerular filtration rate, Haematocrit, Haemoglobin, Heart rate, Investigation, Magnetic resonance imaging, Mean cell volume, NYHA classification, Neurological examination, Platelet count, Reflex test, Ventilation/perfusion scan, Visual field tests, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   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: CYRESS; SIMVASTATIN; PHENPROCOUMON; TRAMADOL; PERINDOPRIL; PANTOPRAZOL PENSA; IVABRADIN; METOPROLOL; NITROGLYCERIN LINGUAL; FUROSEMIDE; ALLOPURINOL; OXAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute coronary syndrome; Angina pectoris; Aortic valve stenosis; Appendectomy; Cholecystectomy; Essential hypertension (Hypertension. 1990 and 2009); Heart failure NYHA class III; Hospital acquired pneumonia; Orthostatic hypotension; Renal function disorder; Tendon disorder
Allergies:
Diagnostic Lab Data: Test Date: 2010; Test Name: coronary angiography; Result Unstructured Data: Test Result:Coronary angiography; Comments: Coronary angiography shows a subtotal lesion in the ramus descendens anterior. Known occlusion of LAD proximal (also in 2010).; Test Date: 2020; Test Name: coronary angiography; Result Unstructured Data: Test Result:Known occlusion of LAD proximal (also in 2010).; Comments: Known occlusion of LAD proximal (also in 2010).; Test Name: chest auscultation; Result Unstructured Data: Test Result:Lungs: clean breath murmurs. Cor: S1S2, no murmur; Test Name: heart auscultation; Result Unstructured Data: Test Result:Cor S1 S2 grade II aortic valve stenosis souffle,; Test Name: lungs auscultation; Result Unstructured Data: Test Result:Lungs both sides. VAG (vesicular breath murmur),; Test Name: Barre; Result Unstructured Data: Test Result:-/-; Test Date: 20200914; Test Name: albumin; Result Unstructured Data: Test Result:38 g/l; Test Date: 20200914; Test Name: calcium; Result Unstructured Data: Test Result:2.33 mmol/L; Test Name: creatinine; Result Unstructured Data: Test Result:170 umol/l; Test Date: 20200914; Test Name: creatinine; Result Unstructured Data: Test Result:162 umol/l; Test Date: 20200914; Test Name: phosphate; Result Unstructured Data: Test Result:0.90 mmol/L; Test Date: 20200914; Test Name: potassium; Result Unstructured Data: Test Result:4.1 mmol/L; Test Name: blood pressure; Result Unstructured Data: Test Result:142/60 mmHg; Test Name: blood pressure; Result Unstructured Data: Test Result:148/64 mmHg; Comments: after 1 minute; Test Name: blood pressure; Result Unstructured Data: Test Result:146/66 mmHg; Comments: after 3 minutes; Test Name: blood pressure; Result Unstructured Data: Test Result:154/64 mmHg; Comments: after 5 minutes; Test Name: blood pressure; Result Unstructured Data: Test Result:168/54 mmHg; Test Name: blood pressure; Result Unstructured Data: Test Result:160/75 mmHg; Test Date: 20200914; Test Name: sodium; Result Unstructured Data: Test Result:142 mmol/L; Test Date: 20200914; Test Name: urea; Result Unstructured Data: Test Result:15.1 mmol/L; Test Date: 20200914; Test Name: uric acid; Result Unstructured Data: Test Result:0.36 mmol/L; Test Name: central venous pressure; Result Unstructured Data: Test Result:not increased; Test Name: Echocardiography; Result Unstructured Data: Test Result:Globally slightly to moderately reduced Lv (left v; Test Name: ECG; Result Unstructured Data: Test Result:Sinus rhythm 59 / min. QRS normal axis and LBBB, d; Test Name: ECG; Result Unstructured Data: Test Result:Sinus rhythm with premature atrial complexes with; Test Name: estimated glomerular filtration rate; Result Unstructured Data: Test Result:24.37 ml/min; Test Date: 20200914; Test Name: estimated glomerular filtration rate; Result Unstructured Data: Test Result:24.37 ml/min; Test Date: 20200914; Test Name: hematocrit; Result Unstructured Data: Test Result:0.43 L/L; Test Date: 20200914; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.4 mmol/L; Test Name: heart rate; Result Unstructured Data: Test Result:53/ min; Test Name: pulse; Result Unstructured Data: Test Result:49; Test Name: pulse; Result Unstructured Data: Test Result:54; Comments: after 1 minute; Test Name: pulse; Result Unstructured Data: Test Result:52; Comments: after 3 minutes; Test Name: pulse; Result Unstructured Data: Test Result:53; Comments: after 5 minutes; Test Name: cranial nerves PR; Result Unstructured Data: Test Result:2 + / 2 + both direct and indirect; Test Name: EMC; Result Unstructured Data: Test Result:maximum, orientation in triad, normal speech and l; Comments: maximum, orientation in triad, normal speech and language; Test Name: OBM; Result Unstructured Data: Test Result:nyscompletely without tagmus or diplopia; Test Name: MRI; Result Unstructured Data: Test Result:The MRI (magnetic resonance imaging) shows a trans; Test Date: 20200914; Test Name: MVC; Result Unstructured Data: Test Result:95 fL; Test Name: biceps strength test; Result Unstructured Data: Test Result:5/5; Test Name: coordination exam; Result Unstructured Data: Test Result:TNP (top nose test), VTNP (fingertip nose test) an; Test Name: Dix-Hallpike / Supine roll tilt tests; Result Unstructured Data: Test Result:negative on both sides; Test Name: finger extenders strength test; Result Unstructured Data: Test Result:5/5; Test Name: finger spreader; Result Unstructured Data: Test Result:5/5; Test Name: gastrocnemius strength test; Result Unstructured Data: Test Result:5/5; Test Name: harmstring strength test; Result Unstructured Data: Test Result:5/5; Test Name: Iliopsoas stength test; Result Unstructured Data: Test Result:4/4; Test Name: Mingazzini; Result Unstructured Data: Test Result:not able to test; Test Name: neurological examination; Result Unstructured Data: Test Result:sensibility and motor function globally symmetrica; Test Name: neurological examination; Result Unstructured Data: Test Result:Light-headedness when verticalizing; Test Name: quadriceps strength test; Result Unstructured Data: Test Result:5/5; Test Name: sensitivity exam; Result Unstructured Data: Test Result:Sensitivity globally symmetrical and intact; Test Name: skill: foram rolling test; Result Unstructured Data: Test Result:intact; Test Name: sqeeze force; Result Unstructured Data: Test Result:5/5; Test Name: tibial anterior strength test; Result Unstructured Data: Test Result:5/5; Test Name: trapezius strength test; Result Unstructured Data: Test Result:5/5 here pain in the neck, pain can be aroused by; Test Name: triceps strength test; Result Unstructured Data: Test Result:5/5; Test Name: NYHA; Result Unstructured Data: Test Result:III (class 3); Test Date: 20200914; Test Name: thrombocyte; Result Unstructured Data: Test Result:163 10e9/L; Test Name: APR; Result Unstructured Data: Test Result:Achilles tendeon reflex: -1 / -1; Test Name: BPR; Result Unstructured Data: Test Result:biceps reflex: -1 / -1; Test Name: KPR; Result Unstructured Data: Test Result:Knee/patellar reflex: 0/0; Test Name: RPR; Result Unstructured Data: Test Result:radius periosteum reflex: -1 / -1; Test Name: TRP; Result Unstructured Data: Test Result:triceps reflex: -1 / -1; Test Name: vzr; Result Unstructured Data: Test Result:foot pad reflex: plantar / plantar; Test Name: V-scan; Result Unstructured Data: Test Result:Reasonable left chamber function, VCI slim.; Test Name: GVO; Result Unstructured Data: Test Result:intact; Test Date: 20200914; Test Name: leucocyte; Result Unstructured Data: Test Result:6.6 10e9/L
CDC Split Type: NLPFIZER INC2021342694

Write-up: Cardiac Asthma; Heart complaints probably died from it/Cardiac death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The Regulatory Authority report number is NL-LRB-00483379] and Safety Report Unique Identifier NL-LRB-00484304. An 87-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 28Feb2021 (Lot Number: EP9598) as a single dose for COVID-19 immunisation. Medical history included acute coronary syndrome in 2010, essential hypertension in 2020, heart failure HA class III in 2019, renal function disorder in 2020, aortic valve stenosis in 2019, BPPD in 2012, chronic tendomyogenic neck complaints, persistent angina pectoris with mainly back pain, hospital-acquired pneumonia, cholecystectomy and appendectomy. Concomitant medications included barnidipine hydrochloride (CYRESS), simvastatin, phenprocoumon, tramadol, perindopril, pantoprazole sodium sesquihydrate (PANTOPRAZOL PENSA), ivabradine hydrochloride (IVABRADIN), metoprolol, furosemide, allopurinol, oxazepam; all taken for an unspecified indication and glyceryl trinitrate (NITROGLYCERIN LINGUAL) taken for chest pain; all start and stop date were not reported. The MD was familiar with cardiac complaints and also with patient''s heart failure. This is probably her cause of death. The MD asked if is it possible that the vaccination accelerated this. The patient''s death had co-founding factors, heart failure, renal dysfunction, aortic valve prosthesis, ACS (acute coronary syndrome) and COVID19 but patient had no previous COVID infection. Suspect cardiac asthma was listed as cause of death. The patient was a woman living independently with little home care. Her health had been moderate to fair for quite some time. She was familiar with aortic stenosis requiring a TAVI in the PRIVACY in Mar2020. HA (heart association functional classification) III, though ADL (activities daily life) independent. According to the cardiologist''s last letter (27Jan), there was no heart failure. As far as it is known, there has been no adjustment in her coagulation medication. The physician was not aware of any side effects. On 16Mar2021, at the Neurology outpatient clinic the patient was seen. The reason for referral was BPPD (Benign Paroxysmal Position Dizziness) suspicion. Consideration / differential diagnosis, Initial orthostatic hypotension to explain the dizziness, etiologically in: a) old age, b) low per oral fluid intake, of which half a caffeine-containing drink, c) polypharmacy (especially combination use of metoprolol, ivabradine, perindopril and barnidipine with oxazepam), 2) Chronic tendomyogenic neck complaints, dated. primarily tendomyogenic or in the context of a coat hanger syndrome (acidification of the neck muscles in the context of chronic orthostatic hypotension). The following was conducted, 1) Detailed explanation of the etiology, prognosis and treatment options, 2) ad. 1. advice to drink at least 1.5 liters of fluids per day and to avoid alcohol / caffeine-containing drinks, 3) ad. 2. same advice ad. 1. and for additional physiotherapy, 4) Neurological consultation was closed, 5) Advice to the general practitioner / cardiologist: to further remediate the polypharmacy in case of persistent complaints. There was no allergies. The patient has been referred by the cardiologist with dizziness. In addition, comes with neck pain. Since a few months the patient have been suffering from dizziness. The vertigo attacks occur when standing up, but sometimes also occur when sitting, and usually last half an hour. Not every day, but alternating a number of days and then not. Hereby blurred for the eyes. Sits after a dizziness attack, and then it slowly fades away. Nausea, no vomiting. Stopped furosemide 2 weeks ago because of low tension and advice to drink more. This did not diminished the dizziness. Does not arise after turning the head. No headaches. No tingling around the mouth. Not seeing black spots. No deafness or ringing in the ears. No palpitations. No decreased feeling or strength in the arms or legs, no swallowing difficulties. In addition, she has been suffering from annoying neck pain for a year, for which she uses tramadol. This prevents the neck from turning properly. This is pain that propagates to the head. Has tried physiotherapy for this, but it is sufficient. No dispersion to the arms, no sensor motor failure complaints in the arms. Has been running with a walker for a few years now. Per oral fluid intake is about 1 liter of fluid per day (of which about 500ml is coffee). General: EMC maximum, orientation in triad, normal speech and language Cranial nerves: PR (reflex examination): 2 + / 2 + both direct and indirect, GVO (visual field examination) intact, OBM completely without nystagmus or diplopia, sensibility and motor function globally symmetrical and intact, tongue protrusion median, Motor skills: Barre: - / -, Biceps strength: 5/5, triceps: 5/5, finger extenders: 5/5, squeeze force: 5/5, finger spreaders 5/5. Mingazzinni not able to test, Iliopsoas 4/4, quadriceps: 5/5, hamstring: 5/5, tibialis anterior 5/5, gastrocnemius 5/5, trapezius 5/5 here pain in the neck, pain can be aroused by pressing in the neck Sensitivity: Sensitivity globally symmetrical and intact Coordination: TNP (top nose test), VTNP (fingertip nose test) and KHP (knee-heel test) undisturbed, walking pattern shaky during pre-existent walking with walker, heels and toe run undisturbed, Skill: forearm rolling test intact, Reflexes: BPR (biceps reflex): -1 / -1, TPR (triceps reflex): -1 / -1, RPR (radius periosteum reflex): -1 / -1, KPR (Knee/patellar reflex): 0/0, APR (Achilles tendeon reflex): -1 / -1, VZR (foot pad reflex): plantar / plantar. Light-headedness when verticalizing. Dix-Hallpike / Supine roll tilt tests negative on both sides. Additional investigation: orthostasis measurement: Lying down: BP (blood pressure) 142/60, pulse 49, After 1 minute: BP 148/64, pulse 54, After 3 minutes: BP 146/66, pulse 52, After 5 minutes: BP 154/64, pulse 53. The patient was seen on 23Feb2021 at the Polyclinic cardiology with no syncopes. Well orthostatism. Good appetite. No more nitro needs lately, blood pressure 168/54 mmHg, heart rate 53 / min. Lungs: clean breath murmurs. Cor: S1S2, no murmur nor malleolar edema. ECG (electrocardiogram), Sinus rhythm 59 / min. QRS normal axis and LBBB, duration 156 msec. Lab: creatinine 170 umol/L, Echocardiogram: Globally slightly to moderately reduced Lv (left ventricle) function. Akinesia apex. Status after Lotus 23 TAVI, mean gradient 9 mmHg, vmax 2.1 m / sec, mildcentral AI (aortic insufficiency). Light MI (myocardial infarction). VCI (inferior vena cava)j falls flat. Discussion and decision: the patient comes for a check-up 1 year after TAVI. Kidney function deteriorates. Clinically no decompensation signs. Good ultrasound function of the TAVI valve and underfill marks. I propose to stop furosemide temporarily and possibly also to stop perindopril in the second time. The patient''s condition deteriorates, more effort dyspnoea. Dizziness is more like BPPD (Benign Paroxysmal Position Vertigo) and not orthostasis. No cordis decompensation. Effort dyspnoe presumably with deconditioning. The following were conducted, ICC (intercollegial consultant) neurologist (PRIVACY). Lung function with call consultation: None obvious deviations. FT for fitness training. Medication right on. Control 6 months. Thyroid function today with medical history entered as hypertension. 1990 and 2009: Cardiology analysis for chest and back pain, with no evidence of ischemia. 2010: Persistent pain on the left under the shoulder blade, suspected of angina pectoris. There appears to have been an ambulatory anterior wall infarction. There is poor left chamber residual function. The MRI (magnetic resonance imaging) shows a transmural anterior wall infarction. Ejection fraction 34%. Coronary angiography shows a subtotal lesion in the ramus descendens anterior. 2012: Orthostatic hypotension, 2013: Persistent angina pectoris with mainly back pain. TENS (transcutaneous electrical neurostimulation) no effect. 2020: Severe aortic valve stenosis. Coronary angiography: Known occlusion of LAD proximal (also in 2010). 2020 (3): TAVI. Fever after TAVI dd (differential diagnosis) hospital-acquired pneumonia for which 5 days of ceftriaxone dd resorption fever in hematomas. New 1st degree AV (atrioventricular) block and left bundle branch block after TAVI for which metoprolol decreased. Other history: Cholecystectomy, appendectomy. Chronic renal failure. On physical examination, the patient was not sick, blood pressure 160/75 mmHg, CVD (central venous pressure) not increased, Cor S1 S2 grade II aortic valve stenosis souffle, irregular, lungs both sides. VAG (vesicular breath murmur), no crepitations, extremities well circulated and slight edema ankle. Per course information, the patient had spinning dizzy so the doctor lowered the metoprolol to 25 mg because of the low negative pressure, pain in the neck, chest pain again a little back, with considerable effort and effort dyspnoe stable. ECG: Sinus rhythm with premature atrial complexes with left bundle branch block conforming, V-scan (ventilation perfusion scan): Reasonable left chamber function, VCI slim. Laboratory investigation: on 14Sep2020, 10:47 Hemoglobin 8.4 mmol/L, hematocrit 0.43 L/L, MCV 95 fL, Thrombocytes 163 10e9/L, Leucocytes 6.6 10e9/L, creatinine 162 umol/L, eGFR (estimated glomerular filtration rate) (CKD-EPI) (chronic kidney disease epidemiology collaboration) 24.37 mL/min, Urea 15.1 mmol / L, Uric acid 0.36 mmol / L, Sodium 142 mmol / L, Potassium 4.1 mmol / L, Calcium 2.33 mmol / L, Phosphate 0.90 mmol / L, Albumin 38 g / L. The patient died on 20Mar2021 20 days after vaccination due to suspect cardiac asthma and "heart complaints probably died from it/Cardiac death". An autopsy was not performed. Reporter''s comments: BioNTech/Pfizer vaccin (Comirnaty) Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no Patient died on 20Mar2021 The MD was familiar with cardiac complaints and also with patient''s heart failure. This is probably her cause of death. The MD asked if is it possible that the vaccination accelerated this? BSN available: yes confounding factors heart failure, renal dysfunction, aortic valve prosthesis, ACS (acute coronary syndrome) COVID19 Previous COVID-19 infection: No Follow-up 24Mar2021 Follow - up received: - is listed as cause of death; suspect cardiac asthma. it was a woman living independently with little home care. Health had been moderate to fair for quite some time. She was familiar with aortic stenosis requiring a TAVI in the PRIVACY in Mar2020. HA (heart association functional classification) III, though ADL (activities daily life) independent. According to the cardiologist''s last letter (27Jan), there was no heart failure. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained. Follow-up (12Apr2021): New information reported from the same contactable physician downloaded from the regulatory authority-WEB, NL-LRB-00483379 and Safety Report Unique Identifier, NL-LRB-00484304 includes: suspect drug details (lot number updated). No follow-up attempts are possible. No further information is expected. Reporter''s Comments: MD was familiar with cardiac complaints and also with patient''s heart failure. This is probably her cause of death. The MD asked if is it possible that the vaccination accelerated this? BSN available: yes confounding factors heart failure, renal dysfunction, aortic valve prosthesis, ACS (acute coronary syndrome) COVID19 Previous COVID-19 infection: No Follow-up 24Mar2021 Follow - up received: - is listed as cause of death; suspect cardiac asthma.


VAERS ID: 1173442 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Fatigue, Malaise, Productive cough, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210301; Test Name: corona test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021347662

Write-up: Sputum; Malaise; Fatigue; covid-19; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) NL-LRB-00485125 and received via Regulatory Authority (RB). An 86-year-old male patient received bnt162b2 (vaccine), via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing COPD. The patient''s concomitant medications were not reported. The patient experienced covid-19, sputum, malaise, fatigue all on 01Mar2021 with fatal outcome. The patient underwent lab tests and procedures which included corona test: positive on 01Mar2021. The patient died on an unspecified date in Mar2021. It was not reported if an autopsy was performed. Reporter''s comment: No past drug therapy BioNTech/Pfizer vaccine). BSN available: yes. Confounding factors was COPD. No previous COVID-19 infection: disease symptoms. No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained.; Reporter''s Comments: No past drug therapy BioNTech/Pfizer vaccine. BSN available: yes. Confounding factors was COPD. No previous COVID-19 infection: disease symptoms.; Reported Cause(s) of Death: covid-19; Fatigue; Malaise; Sputum


VAERS ID: 1173447 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Diarrhoea, Dyspnoea, Haematology test, Heart rate, Hypotension, Physical examination, Renal function test
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANDESARTAN; PRADAXA; PARACET [PARACETAMOL]; SEREVENT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Aortic stenosis; Cerebral infarction (Right sided); Cerebral infarction; COPD; Demented spouse; Elbow bursitis (Aseptic. Due to fall.); Fall (Wounded his elbow.); Hemiparesis (left) (Sequelae of cerebral infarction); Home care; Paroxysmal atrial fibrillation
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: Blood pressure; Result Unstructured Data: Test Result:136/69 mmHg; Test Date: 202001; Test Name: Haematology test; Result Unstructured Data: Test Result:Normal; Comments: Normal; Test Date: 20210204; Test Name: Pulse rate; Result Unstructured Data: Test Result:94; Comments: Units:beats/min; Test Date: 20210204; Test Name: Physical examination; Result Unstructured Data: Test Result:Slim ankles.; Comments: Slim ankles.; Test Date: 202001; Test Name: Renal function test; Result Unstructured Data: Test Result:Normal; Comments: Normal
CDC Split Type: NOPFIZER INC2021347595

Write-up: Dyspnoea and loose stomach. Hypotension. Outcome death; Dyspnoea and loose stomach. Hypotension. Outcome death; Dyspnoea and loose stomach. Hypotension. Outcome death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Database-WEB manufacturer report number NO-NOMAADVRE-FHI-2021-U2mzz4. Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00024723. 26Mar2021: Additional information received from reporter by phone: Updated: Patient$gDisease (added demented spouse, COPD (Chronic obstructive pulmonary disease), paroxysmal atrial fibrillation, cerebral infarction, hemiparesis, aortic stenosis, home care, fall, elbow bursitis), Product (added dabigatran, salmeterol xinafoate, paracetamol), Event: Date of onset updated, Lab (Results from yearly check-up in 2020 and in 2021 added), Event description (further details added).A 92 Years old Male patient received first dose of bnt162b2 (vaccine, lot number: ER2659) intramuscularly on 09Mar2021 for COVID-19 vaccination. The patient had some sniffles on the day of the vaccination, but according to his daughter, this was due to allergic rhinitis. The medical history included COPD, paroxysmal atrial fibrillation, cerebral infarction (2019) with hemiparesis (left) (2019), aortic stenosis, cerebral infarction (2015). The patient lived at home with his demented spouse, and received home care. At a check-up on 04Mar2021, a physician had noted that the patient had a fall (Feb2021), where he hurt his elbow; the fall resulted in elbow bursitis. The reporting physician had advised against the vaccination, due to the frail condition of the patient, but the patient wished to receive the vaccine. As concomitant medication the patient was given candesartan till 12Mar2021, dabigatran (PRADAXA) for paroxysmal atrial fibrillation, salmeterol xinafoate (SEREVENT) for COPD, paracetamol (PARACET). On 10Mar2021, the patient developed dyspnoea, hypotension and loose bowels. The reporting physician had checked up on the patient on 12Mar2021, and then the patient was recovering. Due to the loose stools and persistent hypotension it was decided to discontinue candesartan. Around 18Mar2021 the patient had recovered from the initial symptoms, but then developed dyspnoea again the next day (19Mar2021). The patient died on 20Mar2021. Relevant laboratory findings and investigations included in the report ( renal function test, Jan/2020, normal )( haematology test, Jan2020, normal )( blood pressure, 04Feb2021, 136/69 mmHg )( pulse rate, 04Feb2021, 94 bpm )( physical examination, 04Feb2021, slim ankles ). The patient''s outcome was fatal, at the time of the report. The case was considered to be serious. This case was received from a physician. Sender Comment: Thank you for reporting a suspected side effect after vaccination. The information is registered in the national adverse reaction register (the Norwegian Medicines Agency), and then forwarded to international adverse reaction databases. In this way, your message becomes part of an important international collaboration that is continuously ongoing in order to monitor and maintain safe vaccination worldwide. The report concerns a patient in his 90s, who in the days after the first dose of the Covid-19 vaccine vaccine developed hypotension, diarrhea and dyspnea. The patient recovered within a week, but then experienced dyspnea again and died the next day, 11 days after vaccination. The patient had several serious underlying diseases and was frail. The reporter states that vaccination was initially not recommended for the patient, but that the patient himself wanted this. When vaccinating patients with frailty who are ill with many underlying diseases, some serious incidents, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. In Norway, we have received and processed more than 100 reports of deaths after vaccination of elderly people in need of care, most of whom were nursing home patients. For several of the deaths, reporters have stated that they do not suspect a connection with vaccination and that the incident is due to a serious underlying disease in the patient. The Norwegian Medicines Agency has established an expert group that will review the deaths of frail elderly people after vaccination. The expert group will, among other things, assess whether the patients had any common features, which may have contributed to a fatal outcome (1).In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or something else random, coincidental cause that has nothing to do with the vaccination. Based on the information in the report and in accordance with international criteria, we assess the causal link between the vaccination and the death as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals (2). Since the patient''s death, the message is also classified as serious, although a causal relationship with vaccination has not been surely established. References: 1. The Medicines Agency. The expert group will assess deaths reported after coronary vaccination. (Published: March 2, 2021). 2.. Adverse reactions: definitions, diagnosis and management. 2000; 356: 1255-9. Relatedness of drug to reactions/events of vaccine for all events source of assessment Regional Pharmacovigilance Center was result possible.; Reported Cause(s) of Death: DYSPNOEA


VAERS ID: 1173450 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Confusional state, Delirium, Pain, Rash pruritic, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACET [PARACETAMOL]; FURIX [FUROSEMIDE]; MOVENTIG; PREDNISOLON [PREDNISOLONE]; CALCIGRAN FORTE; FENTANYL SANDOZ; NEURONTIN; TOILAX; FOLSYRE ORIFARM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cauda equina syndrome; Leg pain; Post procedural hematoma; Prolapsed lumbar disc (He had persistent pain after surgery for prolapsed lumbar disc, that was followed by post-operative hematoma and cauda equina syndrome.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021347573

Write-up: DELIRIUM; Itchy rash, confusion, tremors, severe pain.; SEVERE PAIN THAT WAS DIFFICULT TO RELIEVE/severe body pain; Itchy rash, confusion, tremors, severe pain; Itchy rash, confusion, tremors, severe pain; ITCHY RASH ALL OVER, ESPECIALLY ON THE ABDOMEN AND BACK; This is a spontaneous report from a contactable nurse downloaded from the Regulatory Authority NO-NOMAADVRE-FHI-2021-U5y85d. A 90-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 27Jan2021 (Batch/Lot Number: EM0477) as SINGLE DOSE for covid-19 immunisation. It was stated that the patient was not bedridden before the second dose of Comirnaty), He had a history of pain in his legs and feet (persistent pain), after surgery for prolapsed lumbar disc, that was followed by post-operative hematoma and cauda equina syndrome (date for surgery not stated).The first dose of Comirnaty was administrated 06Jan2021 (batch no EJ6795). Concomitant medications included paracetamol (PARACET ) taken for pain; furosemide (FURIX) taken for oedema; naloxegol oxalate (MOVENTIG) taken for constipation; prednisolone (PREDNISOLON) taken for myalgia; calcium carbonate, colecalciferol (CALCIGRAN FORTE) taken for vitamin d deficiency, calcium deficiency, hypovitaminosis; fentanyl (FENTANYL SANDOZ) taken for pain in extremity, start and stop date were not reported; gabapentin (NEURONTIN) taken for back pain, pain in extremity; bisacodyl (TOILAX) taken for constipation; folic acid (FOLSYRE ORIFARM) taken for folate deficiency. The patient experienced itchy rash all over, especially on the abdomen and back on 31Jan2021, delirium on Feb2021, itchy rash, confusion, tremors, severe pain on Feb2021, severe pain that was difficult to relieve/severe body pain on Feb2021. The patient, a 90-year-old man in relatively good condition (not bedridden). After three days, he developed an itchy red rash all over his body, especially on the abdomen and back. The patient complained of severe body pain that was difficult to treat/relieve, and he developed delirium. He was hospitalized for further examination 08Feb2021, but was discharged 10Feb2021, without any clarification for this acute worsening. He died 14Feb2021 (18 days after vaccination). The reactions were Serious and Fatal. The causality assessment was Possible. The patient was hospitalized for events from 08Feb2021 to 10Feb2021. The patient died on 14Feb2021. It was not reported if an autopsy was performed. When vaccinating frail patients who are ill with underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. Rare side effects are generally difficult to detect. Even with large studies, one will never be able to completely insure oneself against rare side effects. There should therefore be a low threshold for reporting unexpected reactions that occur after vaccination. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or another random, concurrent cause that has nothing to do with the vaccination in question. Causality assessment: On the basis of the information in the report and in accordance with international criteria, the causal relationship with vaccination is assessed as possible. Possible causal connection is considered as a reaction, including pathological laboratory tests, which occurs in temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Response to discontinuation may be absent or unclear. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. Time Interval between Beginning of Drug Administration and Start of Reaction Rash pruritic was 3 days. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: ITCHY RASH ALL OVER, ESPECIALLY ON THE ABDOMEN AND BACK; DELIRIUM; SHIVERING; SEVERE PAIN THAT WAS DIFFICULT TO RELIEVE; confusion; tremors


VAERS ID: 1173457 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2010-07-09
Onset:2021-03-22
   Days after vaccination:3909
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Haematemesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral hemorrhage; Corpus uteri carcinoma (stage I); Gout attack; Hypertension; Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021347592

Write-up: HEMATEMESIS/ the face in bloody vomit /pure blood; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Database-WEB [NO-NOMAADVRE-FHI-2021-Uxzm8n]. An 86-years-old female patient received bnt162b2 (vaccine), dose 1 intramuscular on 18Mar2021 (Batch/Lot Number: ER2659) as single dose for covid-19 immunisation; candesartan cilexetil (ATACAND), oral from 09Jul2010 at 16 mg daily for hypertension; amlodipine besilate (AMLODIPIN SANDOZ [AMLODIPINE BESILATE]), oral from 19Jun2018 at 5 mg daily for hypertension. Medical history included cerebral haemorrhage from 2010, renal insufficiency from 2010, gout attack from 2010, corpus uteri carcinoma stage I from 1985, hypertension. The patient''s concomitant medications were not reported. The patient experienced hematemesis on 22Mar2021. Five days later she was found dead in her home with the face in bloody vomit /pure blood. She had been in good shape at 7 p.m. the evening before. The death seemed to have occurred suddenly. The action taken in response to the event for candesartan cilexetil and amlodipine besilate was unknown. The patient died on 22Mar2021. It was not reported if an autopsy was performed. Reporters comment: 26-Mar-2021 NIPH: discussed relevant blood samples with reporting physician in case of autopsy (including antibody against platlet factor 4). 26-Mar-2021 RELIS: requested autopsy report. If new medical information is received, report will be updated. Senders comment: Thank you for reporting a suspected side effect after vaccination. The information is registered in the adverse reaction register (the Medicines Agency), and then forwarded to adverse reaction databases. In this way, your message becomes part of an important collaboration that is continuously ongoing to monitor and maintain safe vaccination worldwide. Comment: In the case in question, it is difficult to know whether the incident is due to the vaccine or another, random simultaneous cause that has nothing to do with the vaccine. Unexpected and serious incidents after vaccination are monitored and assessed, both continuously and collectively, as further experience is gained from completed vaccinations. Your message is important to increase knowledge about side effects that may not have been discovered in the studies. On the basis of the information in the report and in accordance with international criteria, the causal connection with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals (1). It is stated that the woman used amlodipine and Atacand (candesartan), and reports have listed these as suspected drugs as well. Hematemesis and GI haemorrhage are not known adverse reactions of amlodipine and candesartan (2). The woman had been using the drugs for several years. We have considered the causal relationship with amlodipine and candesartan to be unlikely. An unlikely causal relationship is defined as a reaction, including pathological laboratory tests, that occurs in such a temporal relationship to the use of a drug that a causal relationship is unlikely (but not impossible), and where underlying disease, other drugs or chemicals may explain the reaction (1) . If the patient is autopsied, we would like to have sent the autopsy report. Information can be sent safely in this dialog and deleted automatically after 4 months. If additional information is received that changes our assessment, we will send an updated feedback. Reference 1. Adverse reactions: definitions, diagnosis and management. 2000; 356: 1255-1259. 2. Clinical Pharmacology database. Hematemesis, GI bleeding. (Posted: 26Mar2021).; Reporter''s Comments: 26-Mar-2021 NIPH: discussed relevant blood samples with reporting physician in case of autopsy (including antibody against platlet factor 4). 26-Mar-2021 RELIS: requested autopsy report. If new medical information is received, report will be updated.; Reported Cause(s) of Death: HEMATEMESIS


VAERS ID: 1173461 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-17
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood sodium, Diabetes mellitus management, Metabolic acidosis, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   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: Toe amputation (left foot); Type 1 diabetes mellitus (Insulin-dependent diabetes mellitus (with ketoacidosis))
Preexisting Conditions: Medical History/Concurrent Conditions: Debridement (fresh debridement of the ulcer in the distal metatarsal area of the left foot); Diabetic foot infection (infected diabetic foot); Gastrooesophageal reflux disease (Gastroesophageal reflux with esophagitis); Hospitalization (The reporting person provided the information card on the hospital treatment)
Allergies:
Diagnostic Lab Data: Test Name: Sodium; Result Unstructured Data: Test Result:hyponatremia; Test Name: glycemia; Result Unstructured Data: Test Result:hyperglycemia; Test Name: metabolic acidosis; Result Unstructured Data: Test Result:metabolic acidosis
CDC Split Type: PLPFIZER INC2021347563

Write-up: Sudden cardiac death; This is a spontaneous report from a contactable consumer from the Medicines Agency (MA) Database-WEB, regulatory authority number PL-URPL-DML-MLP.4401.2.159.2021. Application PL-URPL-DML-MLP.4401.2.159.2021 was sent to URPL on 07Mar2021 by the patient partner. The application concerns a 42-year-old man, body weight 80 kg and height 188 cm. Patient on 13Jan2021 at 12:00 he received the first dose of BNT162B2 (vaccine) for COVID-19 immunization. On 04Feb2021 at 12:00 he received the second dose of BNT162B2 (vaccine) via Intramuscular. On 17Feb2021, there was a sudden cardiac death while the patient was at work. Rescue team resuscitation ineffective. It was unknown if autopsy was performed. The patient never had any heart problems. The reporting person provided the information card on the hospital treatment of the patient more than 2 years ago (24Dec2018 to 04Jan2019). The most important information from it: Basic diagnosis: E10.1 Type 1 diabetes mellitus (Insulin-dependent diabetes mellitus (with ketoacidosis)); Concomitant diagnosis: K21.0 (Gastroesophageal reflux with esophagitis)); infected diabetic foot (after amputation of the toe of the left foot and fresh debridement of the ulcer in the distal metatarsal area of the left foot). The performed tests showed hyperglycemia with hyponatremia, metabolic acidosis. After treatment, metabolic control. Despite the use of an antibiotic, the infection of the left foot did not improve. Discharge from hospital at the patient request. Several attempts were made to contact the reporting person by phone for additional information, but to no avail. Result: death. The reporting person did not classify the severity of the adverse reactions. URPL classified the notification as severe (death). The data contained in the electronic report is all at the disposal of URPL - in the case of obtaining additional information, another version will be sent. Reporter comments: The reporting person provided the information card on the hospital treatment of the patient more than 2 years ago (24Dec2018-04Jan2019). The most important information from it: Basic diagnosis: E10.1 (Insulin-dependent diabetes mellitus (with ketoacidosis)); Concomitant diagnosis: K21.0 (Gastroesophageal reflux with esophagitis)); infected diabetic foot (after amputation of the toe of the left foot and fresh debridement of the ulcer in the distal metatarsal area of the left foot). The performed tests showed hyperglycemia with hyponatremia, metabolic acidosis. After treatment, metabolic control. Despite the use of an antibiotic, the infection of the left foot did not improve. Discharge from hospital at the patient request. Several attempts were made to contact the reporting person by phone for additional information, but to no avail. Death is an unexpected adverse reaction not listed in section 4.8 of vaccine Summary of Product Characteristics. There is a time relationship between the administration of the drug and the occurrence of the side effect. An adverse reaction has occurred, but additional data is needed for proper evaluation. The reporting person did not classify the severity of the adverse reactions. URPL classified the notification as severe (death) Sender comments: Muscle pain, weakness and dizziness are expected side effects for the vaccine. Feeling hot is a symptom not listed in the vaccine SmPC. Symptoms appeared 11 days after vaccination, death occurred 13 days after vaccination, the obtained death certificate shows that the patient suffered from COVID 19 after vaccination and therefore died. Despite the temporal relationship, it seems unlikely that vaccination would be the cause of side effects, although it cannot be completely ruled out. Most likely the patient was infected while the vaccine had not yet developed immunity. Due to the health result, URPL assessed the application as severe. Sudden cardiac death/ NCA, WHO-UMC/ Unclassified. No follow-up attempts possible. No further information expected. Batch/lot number cannot be obtained.; Reporter''s Comments: Reporter comment: Death is an unexpected adverse reaction not listed in section 4.8 of vaccine Summary of Product Characteristics. There is a time relationship between the administration of the drug and the occurrence of the side effect. An adverse reaction has occurred, but additional data is needed for proper evaluation. The reporting person did not classify the severity of the adverse reactions. URPL classified the notification as severe (death); Reported Cause(s) of Death: sudden cardiac death


VAERS ID: 1173476 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Decreased appetite, Electrocardiogram, Malaise, Myalgia, Myocardial infarction, Troponin, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN; TROMBYL; FELODIPIN; LEVAXIN
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Redness (Redness from unknown substance.)
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: electrocardiogram; Result Unstructured Data: Test Result:abnormal; Test Date: 202103; Test Name: troponin; Result Unstructured Data: Test Result:leakage compatible with myocardial injury, though; Comments: leakage compatible with myocardial injury, though no chest pain
CDC Split Type: SEPFIZER INC2021347509

Write-up: Vomiting; MYOCARD INJURY / HEART ATTACK; Myalgia; abdominal pain; general malaise; No appetite; This is a spontaneous report a contactable physician downloaded from the regulatory authority [regulatory authority SE-MPA-1616663293125], Safety Report Unique Identifier [SE-MPA-2021-023235]. A 96-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular in Mar2021 (Age at Vaccination 96 years old) (Lot Number: ER7812) as 30 ug, single for covid-19 immunisation. Medical history included redness from an unknown date and unknown if ongoing (redness from unknown substance), ongoing hypertension. Concomitant medications included losartan taken for an unspecified indication from 09Feb2018 to an unspecified stop date; acetylsalicylic acid (TROMBYL) taken for an unspecified indication from Mar2021 to an unspecified stop date; felodipine (FELODIPIN) taken for an unspecified indication from 09Feb2018 to an unspecified stop date; levothyroxine sodium (LEVAXIN) taken for an unspecified indication from 26Feb2018 to an unspecified stop date. The patient experienced vomiting, myocard injury/heart attack, myalgia in Mar2021 with fatal outcome. Reported suspect adverse events were myalgia, myocardial infarction and vomiting which resulting in death. It was reported that the patient experienced general malaise after Vaccination in Mar2021. Myalgia debuted the day after the vaccination, and vomiting 7 days after. 9 days after the vaccination, the woman went to emergency care due to abdominal pain and vomiting for the past 2-3 days. No appetite. She had abnormal electrocardiogram and troponin-leakage compatible with myocardial injury, though no chest pain. According to the onset date, this occurred 10 days after the vaccination and the woman died peacefully the same day in Mar2021. It was unknown if an autopsy was performed. The outcome of abdominal pain, general malaise and No appetite was unknown. According to the report, the woman had started treatment with Trombyl the previous day (i.e. the same day she went to the emergency room), there was no information on why treatment with Trombyl was started. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vomiting; Myalgia; MYOCARD INJURY / HEART ATTACK


VAERS ID: 1173479 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SEARCHED / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac failure, Cough, General physical health deterioration, Pyrexia, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALVEDON; FINASTERIDE; ENALAPRIL; NIFEREX [FERROGLYCINE SULFATE COMPLEX]; ALFUZOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure (heart failure); Renal failure (kidney failure)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021342614

Write-up: ATTENTION FLASH (NEWLY DEBUTED); worsening of his heart failure; impaired general condition; fever; brown cough; vomiting; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-014588. Other Case identifier number: SE-MPA-1615362188538. A 94-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 05Mar2021 (Batch/Lot Number: searched) as SINGLE DOSE for covid-19 immunisation. Medical history included heart failure and kidney failure from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (ALVEDON), finasteride, enalapril, ferroglycine sulfate complex (NIFEREX [FERROGLYCINE SULFATE COMPLEX]) and alfuzosin (ALFUZOSIN); all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient was vaccinated and the next day the man shows impaired general condition, fever, brown cough, vomiting and a new onset atrial fibrillation (also reported as attention flash (newly debuted)). The man dies after a few days in hospital due to worsening of his heart failure (reported also as Cardiac failure aggravated) / newly debuted atrial fibrillation. The patient was treated initially given Eliquis, furosemide, bisoprolol related to the newly debuted atrial fibrillation. The patient died on an unspecified date. An autopsy was not performed (also reported and will not be performed). The case assessed as serious (criteria death and hospitalization). No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Atrial fibrillation; Cardiac failure aggravated


VAERS ID: 1173482 (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: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, General physical health deterioration, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Prostate cancer; Renal failure; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021347528

Write-up: Reduced general condition/ decreased general health; Nausea; decreased appetite; This is as spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) Database-WEB. The regulatory authority report number is SE-MPA-2021-018243. A 87-years-old male patient received bnt162b2 (vaccine), intramuscular in Jan2021 as single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus, prostate cancer, cardiac failure, renal failure, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Reported suspect adverse events were decreased general health/ reduced general condition and nausea. The patient suffered from side effects after vaccination, in Jan2021, in the form of severe nausea and decreased appetite. The man never recovered and died five days after vaccination. The events outcome was fatal. Report assessed as serious, death. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. ; Reported Cause(s) of Death: Reduced general condition/ decreased general health; nausea; decreased appetite


VAERS ID: 1173486 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK - / -

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: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Diabetes; Hypertension; Prostate cancer metastatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021347500

Write-up: Pulmonary embolism; This is a spontaneous report from two contactable physicians downloaded from the regulatory authority-WEB, regulatory authority numberSE-MPA-2021-019669. Other Case identifier number: SE-MPA-1615871445349. An 82-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on Mar2021 (Batch/Lot Number: EP2166) as single dose for covid-19 immunisation. Medical history included widespread prostate cancer, heart failure, hypertension, diabetes. The patient''s concomitant medications were not reported. It can be deduced from the reports that the man was vaccinated 4-5 days before the diagnosis of pulmonary embolism. The man dies shortly after the pulmonary embolism is discovered. Cause of death is not specified in the report. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1173487 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CARBAMAZEPINE; FOLACIN [FOLIC ACID]; BEHEPAN [CYANOCOBALAMIN]; MEMANTINE; FURIX [FUROSEMIDE]; METOPROLOL; ARANESP; AMLODIPINE; TROMBYL; CILAXORAL; MELATONIN; ATORVASTATIN; CITALOPRAM; ETALPHA; ALVEDON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Beta-lactam antibiotic resistance; Cardiac failure; Chronic renal failure; Epilepsy; Fractured sternum; IgA nephropathy; Ischemic heart disease; Mixed dementia; Pancreatic cancer metastatic; Rib fracture; Spinal cord compression
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021342547

Write-up: Rapid deterioration of underlying disease; This is a spontaneous report downloaded from the Regulatory Authority-WEB (Regulatory Authority report number: SE-MPA-2021-021649). A contactable physician (contactable through Regulatory Authority only) reported that an 86-year old female patient received the second dose of BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) on 10Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included beta-lactam antibiotic resistance, spinal cord compression, mixed dementia, rib fracture, chronic renal failure, cardiac failure, pancreatic cancer metastatic from 25Jan2021, IgA nephropathy, fractured sternum, ischemic heart disease, anemia and epilepsy; all were unknown if ongoing. Concomitant medication included carbamazepine; folacin (folic acid); cyanocobalamin (BEHEPAN); memantine; furosemide (FURIX); metoprolol; darbepoetin alfa (ARANESP); amlodipine from Oct2020 to an unspecified stop date; acetylsalicylic acid (TROMBYL); sodium picosulfate (CILAXORAL); melatonin from Oct2020 to an unspecified stop date; atorvastatin; citalopram; alfacalcidol (ETALPHA); and paracetamol (ALVEDON). The patient had previously received the first dose of BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) on 19Jan2021 for COVID-19 immunization, and had transient ischemic attack (TIA). In Feb2021, shortly after the second dose of vaccination, the patient had rapid deterioration of underlying disease/aggravation of existing disorder. The patient was hospitalized in Feb2021 due to the reported event. The patient passed away a few days later (on an unspecified date in 2021). Medical judgment by the reporter was that the death was caused by the patient''s underlying diseases. However, the reporter could not rule out that the vaccination contributed in some way to the deterioration since the patient felt quite well before the vaccination. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Rapid deterioration of underlying disease


VAERS ID: 1173490 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021347498

Write-up: SUDDEN DEATH; This is a spontaneous report from a contactable physician downloaded from the regulatory authority [SE-MPA-2021-022684]. Other case identifier number: SE-MPA-1616421809204. A 94-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on an unspecified date in Mar2021 as SINGLE DOSE for covid-19 immunisation. Medical history included heart disease, unspecified from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced sudden death on an unspecified date in Mar2021. The patient died in Mar2021. It was not reported if an autopsy was performed. The reporter stated that the patient died 8 days after vaccination. Furthermore, the reporter stated that the patient was expected to die due to old age of natural cause. No follow-up attempts are possible, batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: SUDDEN DEATH


VAERS ID: 1173491 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PENTACARINAT; ZOLEDRONIC ACID; PRADAXA; BRICANYL; KALCIPOS-D; LIXIANA; IMBRUVICA; ACICLOVIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker user; Atrial fibrillation; AV block; Chronic lymphocytic leukaemia
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: coma scale; Result Unstructured Data: Test Result:RLS 7-8*; Comments: RLS 7-8* (reaction level scale), wide light-stiff pupils *RLS 7 Unconscious. Stereotype stretching movement in pain, RLS 8, Unconscious, No reaction to pain stimulation; Test Date: 202103; Test Name: Brain CT; Result Unstructured Data: Test Result:intracranial haemorrhage; Comments: Brain CT shows fresh intracranial haemorrhage with midline displacement and incipient transstentorial herniation
CDC Split Type: SEPFIZER INC2021347525

Write-up: Intracerebral haemorrhage; transstentorial herniation; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is SE-MPA-2021-023033, Safety report unique identifier SE-MPA-1616598643286. An 81-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration in Mar2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. Medical history included chronic lymphocytic leukaemia from an unknown date and unknown if ongoing, Artificial cardiac pacemaker user from an unknown date and unknown if ongoing due to atrioventricular block, atrial fibrillation from an unknown date and unknown if ongoing. Previous drug reactions, drug rash of trimetoprim-sulfa and rash of lamisil. Concomitant medications included pentamidine isethionate (PENTACARINAT) taken for an unspecified indication from 20Jan2021 to an unspecified stop date; zoledronic acid taken for an unspecified indication from 15Jan2020 to an unspecified stop date; dabigatran etexilate mesilate (PRADAXA) taken for an unspecified indication, start and stop date were not reported; terbutaline sulfate (BRICANYL) taken for an unspecified indication from 20Jan2021 to an unspecified stop date; calcium carbonate, colecalciferol (KALCIPOS-D) taken for an unspecified indication, start and stop date were not reported; edoxaban tosilate (LIXIANA) taken for an unspecified indication from 23Dec2020 to an unspecified stop date; ibrutinib (IMBRUVICA) taken for an unspecified indication from 18Feb2021 to an unspecified stop date; aciclovir taken for an unspecified indication from 20Jan2021 to an unspecified stop date. The patient experienced intracerebral haemorrhage in Mar2021. Described by the reporter, the patient was vaccinated at 10 am. Found unconscious in the home at 10 p.m. When the patient arrived at the emergency room, RLS 7-8* (reaction level scale), wide light-stiff pupils (RLS 7 Unconscious. Stereotype stretching movement in pain, RLS 8, Unconscious, No reaction to pain stimulation.). Brain CT showed fresh intracranial haemorrhage with midline displacement and incipient transstentorial herniation. The patient died during the night in Mar2021.Outcome: Fatal. Report assessed as serious, death. It was unknown if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Intracerebral haemorrhage; transstentorial herniation


VAERS ID: 1173492 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ischemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Coronary angiogram; Result Unstructured Data: Test Result:myocardial infarction; Comments: showed previous coronary artery disease with multiple significant stenosis and reduced function in the left ventricle as well as a new coronary artery occlusion/myocardial infarction
CDC Split Type: SEPFIZER INC2021342615

Write-up: Myocardial infarction; coronary artery occlusion; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Database-WEB. Regulatory Authority report number is SE-MPA-2021-023200. An 83-year-old male patient received bnt162b2 (vaccine), via an unspecified route of administration on Mar2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. Medical history included myocardial ischaemia. The patient''s concomitant medications were not reported. The patient experienced myocardial infarction in Mar2021 and two days later, patient was admitted to hospital with acute myocardial infarction. Coronary angiogram showed previous coronary artery disease with multiple significant stenosis and reduced function in the left ventricle as well as a new coronary artery occlusion/myocardial infarction, which caused the patient''s death. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: coronary artery occlusion/myocardial infarction; coronary artery occlusion


VAERS ID: 1173493 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis; Cardiomyopathy; Chronic kidney disease stage 3; Hereditary neuropathic amyloidosis; Ischemic heart disease; Old myocardial infarction
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: vital parameters; Result Unstructured Data: Test Result:without remark; Comments: no fever, no new symptoms
CDC Split Type: SEPFIZER INC2021347515

Write-up: cardiac death; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is SE-MPA-2021-023230, other report unique identifier is SE-MPA-1616659409924. An 89-year-old male patient received bnt162b2 (COMIRNATY), intramuscular in Mar2021 (Lot Number: ER7812) as 0.3 mL, single for covid-19 immunisation. Medical history included old myocardial infarction from an unknown date and unknown if ongoing, hereditary neuropathic amyloidosis from an unknown date and unknown if ongoing, cardiomyopathy from an unknown date and unknown if ongoing, Ischemic heart disease from an unknown date and unknown if ongoing, aortic valve stenosis from an unknown date and unknown if ongoing, Chronic kidney disease stage 3 from an unknown date and unknown if ongoing. Previous drug reactions: no previously knowns serious reactions. The patient''s concomitant medications were not reported. In the morning before the vaccination, the man had felt unwell, had cried and asked that an ambulance was called. Ambulance came, vital parameters were without remark, no fever, no new symptoms. Unclear why the man felt unwell but according to the ambulance paramedics he was not in need of urgent care. Later that day, the man vas vaccinated (in Mar2021). The next day, the man died. No noticeable symptoms preceding the death, no signs of infection. The reporter described that the man was very ill and had severe cardiac illnesses, the reporter had a very low suspicion of the man''s death being correlated to the vaccination, reports only due to the time correlation (after discussion with colleagues). The cause of death on the death certificate was cardiac death, but when asked, the reporter did not want to report that as an event because she didn''t suspect the vaccination to be the cause of that. No autopsy will be performed. Report assessed as serious, death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac death


VAERS ID: 1173496 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC2021341669

Write-up: sudden cardiac death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Database-WEB, regulatory authority number SI-JAZMP-NCPHV-2021SI0342_0342. A 76-year-old male patient received bnt162b2 (vaccine), dose 1 intramuscular on 19Mar2021 (Batch/Lot Number: ET3620; Expiration Date: 30Jun2021) as single dose for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. After vaccination, the patient felt well. On 22Mar2021, the patient was found unresponsive, resuscitation was unsuccessful, sudden cardiac death was reported. The patient died on 22Mar2021. It was unknown if an autopsy was performed. Sender''s comment: Follow up data and assessment of the case are expected in due course. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac death


VAERS ID: 1174412 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure, Fall, General physical health deterioration, Infection, Pyrexia, Rib fracture, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Osteoporosis/osteopenia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   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: PANTOLOC [PANTOPRAZOLE]; TORASEMID; PREGABALIN; CENIPRES; QUETIALAN; DONEPEZIL; CEREBOKAN
Current Illness: Hypertension arterial (Art.HT); Peripheral arterial occlusive disease (PAVK); Renal insufficiency (NINS)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: body temperature; Result Unstructured Data: Test Result:38,5 Centigrade; Test Date: 20210316; Test Name: Antigen test; Result Unstructured Data: Test Result:negativ
CDC Split Type: ATPFIZER INC2021358199

Write-up: Cardiac failure; Feverish infection without focus; Feverish infection without focus; Stage post fall with rib fracture; Stage post fall with rib fracture; General condition deterioration in the days after vaccination; Fever 38,5?C; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number AT-BASGAGES-2021-19696. A 97-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 04Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation . Medical history included ongoing peripheral arterial occlusive disease, ongoing renal failure, ongoing hypertension. Concomitant medications included pantoprazole (PANTOLOC [PANTOPRAZOLE]) 40 mg once daily taken for an unspecified indication, start and stop date were not reported; torasemide (TORASEMID) 5 mg once daily taken for an unspecified indication, start and stop date were not reported; pregabalin (PREGABALIN) 75 mg twice daily, taken for an unspecified indication, start and stop date were not reported; enalapril maleate, nitrendipine (CENIPRES)10mg+20mg once daily taken for an unspecified indication, start and stop date were not reported; quetiapine fumarate (QUETIALAN) 50 mg once daily taken for an unspecified indication, start and stop date were not reported; donepezil (DONEPEZIL) 10 mg one daily taken for an unspecified indication, start and stop date were not reported; ginkgo biloba extract (CEREBOKAN) 2 DF once daily taken for an unspecified indication, start and stop date were not reported. The patient experienced feverish infection without focus on 12Mar2021 , general condition deterioration in the days after vaccination on Mar2021 , stage post fall with rib fracture on 12Mar2021, cardiac failure on 18Mar2021 , fever 38,5?c (pyrexia) on Mar2021 with outcome of recovered. The patient underwent lab tests and procedures which included body temperature: 38,5 centigrade on Mar2021, sars-cov-2 test: negative on 16Mar2021. The patient died on 18Mar2021. An autopsy was not performed. Course of the event The patient received the following suspect medication: Comirnaty, 1st dosage form on 04Mar2021 for the indication(s) COVID-19 immunisation. On Mar2021 the patient experienced Fever, General physical condition decreased. On 12Mar2021 the patient experienced Fall death, Rib fracture, Infection, Fever. On 18Mar2021 the patient experienced Cardiac failure death. The patient''s outcome was: recovered/resolved for Fever, fatal for General physical condition decreased, fatal for Fall, fatal for Rib fracture, fatal for Infection, fatal for Fever, fatal for Cardiac failure. Sender Comment: comment: Follow-up information has been requested. Relatedness of drug to reaction (all events with outcome: fatal): Source of assessment: Primary Source Reporter Result of Assessment: Possible No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Heart faillure; Pyrexia; General physical condition decreased; Infection; Fall; Rib fracture


VAERS ID: 1174413 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Asthenia, Cachexia, Cardiac arrest, Hypopnoea, Language disorder, Nausea, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TEBOFORTAN; ATORVALAN; NOVALGIN [CAFFEINE;PARACETAMOL;PROPYPHENAZONE]; LASIX [FUROSEMIDE]; FRAGMIN; DILATREND; LANSOBENE; SPIROBENE; CANDESARTAN; UNASYN [AMPICILLIN SODIUM;SULBACTAM SODIUM]
Current Illness: Analgesic medication NOS supportive therapy (Broken rib, treatment with pain infusions, hematoma on the lower leg, therefore antibiotic.); Antibiotic therapy (Hematoma on the lower leg, hence an antibiotic.); Geromarasmus (Old age); Haematoma (Hematoma on the lower leg)
Preexisting Conditions: Medical History/Concurrent Conditions: Rib fracture (Broken rib, treatment with pain infusions, hematoma on the lower leg, therefore antibiotic.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021358174

Write-up: Cardiac arrest; Apnea; Shallow breathing; Wasting; Drowsiness; Weakness; Language disorder; Nausea; This is a spontaneous report from a contactable consumer or non hcp downloaded from the regulatory authority AT-BASGAGES-2021-19991. A 96-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 24Mar2021 (Batch/Lot Number: ET1831) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Geromarasmus (Old age), ongoing Analgesic medication NOS supportive therapy (Broken rib, treatment with pain infusions, hematoma on the lower leg, therefore antibiotic), ongoing antibiotic therapy, rib fracture not ongoing, ongoing haematoma,. Concomitant medication(s) included ginkgo biloba extract (TEBOFORTAN); atorvastatin calcium (ATORVALAN); caffeine, paracetamol, propyphenazone (NOVALGIN); furosemide (LASIX); dalteparin sodium (FRAGMIN); carvedilol (DILATREND); lansoprazole (LANSOBENE); spironolactone (SPIROBENE); candesartan; ampicillin sodium, sulbactam sodium (UNASYN). On 25Mar2021, the patient experienced Nausea, Language disorder, Drowsiness, Weakness, Wasting. On 26Mar2021, the patient experienced shallow breathing, pauses in breathing, left ventricle stagnation, other, apnea, cardiac arrest, all reported with medically significant. Cardiac arrest was fatal. Other events were not recovered. The patient died on 26Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1174414 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-27
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation (AF); Chronic venous insufficiency; Hypertension arterial (HT)
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement (aortic valve implantation)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021358181

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Database-WEB AT-BASGAGES-2021-20019. A 59-year-old male patient received BNT162B2 (vaccine), second dose intramuscular on 11Mar2021 (batch/lot number: EP2163) as a single dose for COVID-19 immunisation. Medical history included aortic valve replacement (aortic valve implantation), ongoing hypertension arterial (HT), ongoing atrial fibrillation (AF), and ongoing chronic venous insufficiency. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 first dose on an unspecified date for COVID-19 vaccination. The patient experienced death on 27Mar2021. The patient was found dead in bed. According to the patient''s son, the patient has been symptom-free immediately after the vaccination and on the days before. Cause of death was unknown. As an emergency doctor, the physician cannot arrange the autopsy. Death certificate had not yet been issued at the time of death. According to his son, the patient was symptom-free, no signs of infection at the time of vaccination. Exact home-taken medication list must be obtained from the treating general practitioner. The patient died on 27Mar2021. It was not reported if an autopsy was performed. Sender Comment: The report is for a male patient. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1174431 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021351577

Write-up: Pneumonia; This is a spontaneous report from a contactable other health professional via the regulatory authority. The regulatory authority report number is 527357. A 90-year-old male patient received bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1174434 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rheumatism
Preexisting Conditions: Medical History/Concurrent Conditions: Hemorrhage brain (18 years ago without persisting injury)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021358155

Write-up: Two days after the vaccination she did not feel well and a week later she died due to a brain hemorrhage; Two days after the vaccination she did not feel well and a week later she died due to a brain hemorrhage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number BE-FAMHP-DHH-N2021-84196. An elderly female patient received bnt162b2 (COMIRNATY, lot number and expiration date not provided), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient''s medical history included ongoing rheuma (coded to Rheumatism), Hemorrhage brain from 2003 to 2003 (18 years ago without persisting injury). The patient''s concomitant medications include antidepressants, blood thinners, and sleeping pills. On 20Jan2021, the patient experienced two days after vaccination that she did not feel well and a week later on 27Jan2021, the patient died due to a brain haemorrhage on 20Jan2021. No treatment was given for the events. The patient died on 27Jan2021. It was not reported if an autopsy was performed. The agency considered the causality of the events with Comirnaty as unclassifiable. The reporter (son of the patient) considered It related to the vaccine, but the physician and nursing staff did not have a standpoint. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Two days after the vaccination she did not feel well and a week later she died due to a brain hemorrhage; Two days after the vaccination she did not feel well and a week later she died due to a brain hemorrhage


VAERS ID: 1174442 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-06
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in a 77-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included No adverse event. On 01-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. Death occurred on 06-Mar-2021 The patient died on 06-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter considered DEATH (Death) to be unlikely related. Concomitant product use was not provided by the reporter. No treatment information was provided. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unkown cause of death


VAERS ID: 1174449 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRESIBA; NOVORAPID; METFIN; TORASEMIDE SODIUM; COVERAM; CARVEDILOLUM; PRAVASTATINUM NATRICUM; ACIDUM FOLICUM; DAFALGAN; LAITEA; ANTIDRY WASH; ANTIDRY CALM; VOLTAREN [DICLOFENAC SODIUM]; PEVARYL [ECONAZOLE]
Current Illness: Arterial hypertension; Chronic venous insufficiency; Elephantiasis (without resting arterial insufficiency, permeable deep venous system.); Gonarthrosis; Hepatic steatosis; Insulin-requiring type 2 diabetes mellitus; MGUS; Obesity (at 131 kg); Peripheral obliterative arteriopathy
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract; Cholecystectomy; Hepatic steatosis
Allergies:
Diagnostic Lab Data: Test Name: creatinine; Result Unstructured Data: Test Result:92 mmol/L
CDC Split Type: CHPFIZER INC2021357941

Write-up: The Vigilyze database reports 1537 deaths out of 167203 reports under the "Comirnaty" monograph. In light of the literature data, despite the interesting temporal correlation, we consider as "unlikely" the correlation between the administration of Comirnaty and the death of this elderly and polymorbid patient in the absence of objective elements that allow us to exclude other causes. However, this judgment of causality does not completely exclude a role of the vaccine.; Reporter''s Comments: Subsequent death of an old male patient on 24Mar2021, just over 24 hours after the second dose of Comirnaty. No pre-decease symptoms are reported other than the patient was a little more "encumbered". We have no further information on the case, no autopsy or laboratory analysis or additional data on the development of objective symptoms .; Reported Cause(s) of Death: massive pulmonary embolism; died suddenly/suddenly passed away


VAERS ID: 1174452 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-10
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CRPFIZER INC2021359751

Write-up: Patient died on 10Mar2021; This is a spontaneous report from a non-contactable consumer by regulatory authority. An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 18Feb2021 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 10Mar2021, the patient died. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected, it is not possible to obtain information about lot/batch number.; Reported Cause(s) of Death: Patient died


VAERS ID: 1174463 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021358463

Write-up: Exitus letalis; First dose: 06Jan2021, Second dose: 11 Mar2021; First dose: 06Jan2021, Second dose: 11 Mar2021; This is a spontaneous report from a non-contactable physician from the regulatory authority-WEB DE-AZ08-003-20210325. This report was forwarded via regulatory authority. An 83-year-old male patient received the second dose of bnt162b2 (COMIRNATY, lot number: unknown) at the age of 83-year-old, via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunisation. The patient was previously vaccinated with the first dose of bnt162b2 (lot/batch unknown) on 06Jan2021 at the age of 83-year-old for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 12Mar2021, one day after the second vaccination the patient developed (death), lasting for unknown. It was not unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Batch/lot number cannot be obtained.; Reported Cause(s) of Death:


VAERS ID: 1174467 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Loss of consciousness, Muscle twitching, Petechiae, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dyskinesia (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: 2021-03-23
   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: Atrial fibrillation; Cardiac failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021358267

Write-up: Unknown cause of death; Loss of consciousness; Petechial haemorrhages; Somnolence, twitching; Somnolence, twitching; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021037846. An 81-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number and expiration date not reported), intramuscular on 19Mar2021 at 0.3 mL, single dose for COVID-19 vaccination. Medical history included ongoing atrial fibrillation and ongoing cardiac failure. The patient''s concomitant medications were not reported. On 20Mar2021, the patient experienced loss of consciousness, petechial haemorrhages, somnolence and muscle twitching. On 23Mar2021, the patient had an unknown cause of death. The outcome of the events loss of consciousness, petechial haemorrhages, and somnolence and muscle twitching was unknown. The patient died on 23Mar2021. An autopsy was not performed. Event assessment: The reporter assessed the relatedness of drug to reactions/events: Petechiae, Unknown cause of death, Consciousness loss, and Muscle twitch as unclassifiable. Sender comment: Information on risk factors or previous illnesses severe heart failure, atrial fibrillation / patient suffers from severe heart failure; after vaccination Clouding of consciousness, twitching, petechial haemorrhages, died after 3 days. No follow-up attempts are possible. Information on lot and batch numbers cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1174468 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021358270

Write-up: Death with unexplained cause of death; This is as spontaneous report received from a non-contactable consumer downloaded from the regulatory authority. The regulatory authority report number is DE-PEI-CADR2021039713. Safety report unique identifier DE-PEI-202100027344. An 80-year-old male patient received the first dose of bnt162b2 (COMIRNATY) lot number: ER7812, intramuscular on 24Mar2021 as single dose for Covid-19 immunisation. Medical history included ongoing cardiac disorder. Concomitant medications were not reported. The patient experienced death with unexplained cause of death. The patient died on 27Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1174470 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   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: Dialysis
Preexisting Conditions: Medical History/Concurrent Conditions: Acidosis renal tubular; Artificial cardiac pacemaker user; Atrial fibrillation; Diabetes mellitus; Erysipelas (Recurrent sepsis with recurrent erysipela); Hypercholesterolaemia; Hypertension; Hyperuricemia; Renal anemia; Renal insufficiency; Sepsis (Recurrent sepsis with recurrent erysipelas); Ulcus cruris
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021358273

Write-up: Exitus letalis; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory Authority. The regulatory authority report number is DE-PEI-PEI2021003805. A 76-year-old male patient received BNT162B2 (COMIRNATY), first dose intramuscular on 24Mar2021 (batch/lot number: ER7812) as a single dose for COVID-19 immunisation. Medical history included hypertension, diabetes mellitus, renal insufficiency, dialysis from Jun2020 and ongoing, hypercholesterolaemia, hyperuricemia, renal anemia, acidosis renal tubular, artificial cardiac pacemaker user, atrial fibrillation, sepsis (recurrent sepsis with recurrent erysipelas), ulcus cruris. The patient''s concomitant medications were not reported. The patient experienced exitus letalis (death) on 25Mar2021, 1 day after vaccination. The patient died on 25Mar2021. 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: Death


VAERS ID: 1174471 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary heart disease
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: Test Result:Haemorrhage intracerebral
CDC Split Type: DEPFIZER INC2021358256

Write-up: Intracerebral haemorrhage; Basal ganglia haemorrhage; This is a spontaneous report from a non-contactable physician downloaded from regulatory authority. Regulatory authority number DE-PEI-PEI2021003812. A 72-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 22Mar2021 (at the age of 72-years-old) (Batch/Lot Number: ER7812) as single dose for covid-19 immunisation. Medical history included Coronary heart disease. Concomitant medication(s) included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. On 23Mar2021, 8 hour(s) after vaccination the patient developed Intracerebral haemorrhage and Basal ganglia haemorrhage, lasting for unknown. The patient is dead. Diagnosis was confirmed by CT. Death cause was reported as Haemorrhage intracerebral, and Basal ganglia haemorrhage. The patient underwent lab tests and procedures which included computerised tomogram: haemorrhage intracerebral. The patient died on 24Mar2021. It was not reported if an autopsy was performed. No follow-up attempts. No information is expected.; Reported Cause(s) of Death: Haemorrhage intracerebral; Basal ganglia haemorrhage


VAERS ID: 1174477 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   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: PAMOL; PANTOPRAZOL KRKA; BRICANYL TURBUHALER; DURAPHAT; SPIOLTO RESPIMAT; KALEORID; ELTROXIN; ARTIFICIAL TEARS [PARAFFIN, LIQUID;WHITE SOFT PARAFFIN]; FURIX [FUROSEMIDE]; RAMIPRIL HEXAL
Current Illness: Osteoporosis; Salivary gland cancer
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive airways disease exacerbated; Dental caries; Dry eyes; Esophageal acid reflux; Hypertension; Hypometabolism; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021357691

Write-up: found dead 05:00 PM the day after vaccination. Asystolic and declared dead. Was seen alive 2-3 hours before; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. regulatory authority number DK-DKMA-WBS-0053203. A 78-year-old male patient received bnt162b2 (COMIRNATY), via intramuscular on 06Mar2021 (Batch/Lot Number: ER2659; Expiration Date: 30Jun2021) as single dose for COVID-19 immunization. Medical history included Chronic obstructive airways disease exacerbated, salivary gland cancer from 28Dec2014 and ongoing, ongoing osteoporosis, hypometabolism, pain, gastrooesophageal reflux disease, hypertension, dry eye and dental caries. Concomitant medication included paracetamol (PAMOL) taken for pain from 16Aug2019; pantoprazole sodium sesquihydrate (PANTOPRAZOL KRKA) taken for gastrooesophageal reflux disease from 10Dec2019; terbutaline sulfate (BRICANYL TURBUHALER) taken for chronic obstructive pulmonary disease from 14Oct2015; sodium fluoride (DURAPHAT) taken for dental caries from 25Jun2019; olodaterol hydrochloride, tiotropium bromide monohydrate (SPIOLTO RESPIMAT) taken for chronic obstructive pulmonary disease from 15Jan2018; potassium chloride (KALEORID) taken for mineral supplementation from 19Aug2019; levothyroxine sodium (ELTROXIN) taken for hypometabolism from 27Oct2015; paraffin, liquid, white soft paraffin (ARTIFICIAL TEARS [PARAFFIN, LIQUID;WHITE SOFT PARAFFIN]) taken for dry eye from 10Mar2015; furosemide (FURIX [FUROSEMIDE]) taken for an unspecified indication from 19Aug2019; ramipril (RAMIPRIL HEXAL) taken for hypertension from 18Jun2019. The patient had radiotherapy and chemotherapy for salivary gland cancer. On 07Mar2021 at 17:00, the patient was found dead the day after vaccination. Asystolic and declared dead. The patient was seen alive 2-3 hours before. The ADR were by the reporter reported as fatal. No treatment or medical procedures due to the ADR was reported. Reported cause of death: Found dead. Only usual/normal confirmation of death was performed post mortem. Normal confirmation of death findings: Asystolia. There was no information regarding test results. Causality: The physician has reported the ADR due to the seriousness and correlation in time between vaccine and ADR. The patient has not reacted to vaccines before. The patient died on 07Mar2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Found dead


VAERS ID: 1174485 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdomen scan, Activated partial thromboplastin time, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood sodium, Blood urea, C-reactive protein, Chest scan, Diarrhoea, Electrocardiogram, Gastrointestinal haemorrhage, Haematocrit, Haemoglobin, Mean cell volume, Platelet count, Thrombocytopenia, Vomiting, White blood cell count
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Lung disease; Type 2 diabetes mellitus; Uncomplicated hypertension (Chronic kidney disease)
Allergies:
Diagnostic Lab Data: Test Name: Rx of Abdomen; Result Unstructured Data: Test Result:discrete dilation of small intestine loops.; Test Name: aPTT; Result Unstructured Data: Test Result:32 seconds; Test Name: Creatinine; Result Unstructured Data: Test Result:2.07; Test Name: Fibrinogen; Result Unstructured Data: Test Result:283; Test Name: Glucose; Result Unstructured Data: Test Result:60; Test Name: LDH; Result Unstructured Data: Test Result:353; Test Name: K; Result Unstructured Data: Test Result:3.7; Test Name: Na; Result Unstructured Data: Test Result:137; Test Name: Urea; Result Unstructured Data: Test Result:109; Test Name: Thorax Rx; Result Unstructured Data: Test Result:uninspired. Doubtful infiltrate in the upper lobe.; Test Name: C-reactive Protein; Result Unstructured Data: Test Result:79.7; Test Name: ECG; Result Unstructured Data: Test Result:75 bpm; Test Name: Hto; Result Unstructured Data: Test Result:32.5; Test Name: Hb; Result Unstructured Data: Test Result:10.4; Test Name: Medium corpuscular volume; Result Unstructured Data: Test Result:91.8; Test Name: Platelets; Result Unstructured Data: Test Result:22000; Test Name: Leukocytes; Result Unstructured Data: Test Result:7770
CDC Split Type: ESPFIZER INC2021358011

Write-up: Thrombopenia; Vomited; Diarrhea; gastrointestinal bleeding; This is a spontaneous report received from a contactable physician, downloaded from the regulatory authority ES-AEMPS-803438. A 95-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EL0725), via an unspecified route of administration on 19Feb2021 as a single dose for COVID-19 immunisation. Medical history included lung disease, uncomplicated hypertension, chronic kidney disease and type 2 diabetes mellitus, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The day after the administration of the vaccine (20Feb2021), vomiting and diarrhea began, which turned into gastrointestinal bleeding, for which it was assessed by professionals in the Hospital Emergency Department where intense thrombopenia was observed (22,000 platelets) on 21Feb2021 and great deterioration of the general state. She remained hospitalized until 23Feb2021, when she was discharged home due to poor evolution, where she died that same day. Awake, disoriented, she does not cooperate. Dehydrated Skin paleness. Head and neck: No jugular engorgement. Cardiac auscultation: regulate at 80bpm. Lung auscultation: preserved vesicular murmur. Abdomen: soft, depressible, complains on palpation without clearly focusing the pain. Noises present. Extremities: numerous bruises in different phases. Do not have edema. Summary of Analytical and Complementary Tests: Hemogram: Leukocytes 7,770 (NEUT 89.4%), Hb 10.4, Hto 32.5, Mean cell volume 91.8, Platelets 22,000; Coagulation: Protect Act 71.7%, APTT 32sec, Fibrinogen 283; Biochemistry: Glucose 60, Urea 109, Creatinine 2.07, Na 137, K 3.7, LDH 353, C-reactive Protein 79.7; ECG: sinus rhythm at 75bpm. QRS at 0 o. No acute repolarization disturbances. Thorax Rx: uninspired. Doubtful infiltrate in the upper lobe. Rx of Abdomen: discrete dilation of small intestine loops. The outcome of the events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: vomiting; diarrhea; gastrointestinal bleeding; thrombopenia


VAERS ID: 1174488 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Cerebral infarction, General physical health deterioration, Hemiplegia, Transient ischaemic attack
SMQs:, Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   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: Alzheimer''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021358058

Write-up: General physical health deterioration; Transient ischaemic attack; Flaccid hemiplegia/limp on the left side; Cerebral infarction; Burning sensation in face/burning on the left side of the face towards the ear; This is a spontaneous report from a contactable nurse downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20211544. An 87-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EJ6795), intramuscular on 20Jan2021 as 0.3 mL, single for COVID-19 immunisation. Medical history included Alzheimer''s from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced general physical health deterioration, transient ischaemic attack, flaccid hemiplegia, cerebral infarction and burning sensation in face on 21Jan2021. Clinical course was as follows: Alzheimer patient living in sheltered housing, hospice treatment line. The patient received the COVID 19 vaccine COMIRNATY first dose on 20Jan2021. The next day after the vaccination, the staff noticed that the patient was limp on the left side. The patient said she felt burning on the left side of the face towards the ear. The patient''s speech was unchanged. A physician was consulted. TIA or a cerebral infraction. The patient was not sent to the hospital due to the treatment line. The patient''s general condition worsened after that and the patient died on 04Feb2021. The outcome of the events was fatal. It was not reported if an autopsy was performed. Follow-up attempts are not possible. No further information is expected.; Reported Cause(s) of Death: transient ischaemic attack; flaccid hemiplegia; cerebral infarction; burning sensation in face; General physical health deterioration


VAERS ID: 1174504 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-28
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Intestinal ischaemia, Peripheral ischaemia
SMQs:, Ischaemic colitis (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dialysis
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Aortic bi-femoral bypass; Carcinoma skin; Cardiac ventricular thrombosis; Ex-tobacco user; Hernia inguinal; Hypertension arterial; Liposarcoma; Peripheral obliterative arteriopathy; Prostatic hyperplasia (prostatic specific antigen (PSA) $g4); Renal failure chronic (treated with dialysis (3 sessions per week, last session on 26Feb2021)); Spinal fractures
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021358072

Write-up: Lower limb ischaemia; Mesenteric ischemia; This is a spontaneous report downloaded from the regulatory authority-WEB [Regulatory authority number FR-AFSSAPS-BX20212424]. A contactable physician reported a 77-year-old male patient received the first dose of bnt162b2 (COMIRNATY), intramuscular administered on arm right on 23Feb2021 (Batch/Lot Number: EP9598) as SINGLE DOSE for COVID-19 immunization. Medical history included chronic renal failure treated with dialysis (3 sessions per week, last session on 26Feb2021), arterial hypertension, abdominal aortic aneurysm treated with multiple aortic bi-femoral bypass, parietal thrombus, skin carcinoma, peripheral obliterative arteriopathy and prostatic hyperplasia (prostatic specific antigen (PSA) $g4). The patient also had liposarcoma, spinal fracture, inguinal hernia and was an ex-tobacco user. Concomitant medications were not reported. The patient had no SARS-CoV-2 infection and was not tested. The patient had received COMIRNATY on 23Feb2021. On day 5 (28Feb2021), patient was admitted to emergency room for epigastralgia, abdominal pain, vomiting, arterial hypotension and asthenia occurring during the night. The diagnosis were mesenteric ischemia and acute ischemia of the lower limb. The patient was transferred for surgery and died during transfer on 28Feb2021 due to mesenteric ischemia and acute ischemia of the lower limb. 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: Mesenteric ischemia; Lower limb ischaemia


VAERS ID: 1174513 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Hypothyroidism; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021358137

Write-up: PARENCHYMATOUS HEMATOMA/parenchymal hematoma with ventricular and arachnoid flooding; This is a spontaneous report downloaded from the [Regulatory authority number FR-AFSSAPS-LL20211394]. A contactable physician reported a 71-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 13Mar2021 (Batch/Lot Number: ET3620) as SINGLE DOSE for COVID-19 immunization. Medical history included type 2 diabetes, arterial hypertension, hypothyroidism and ongoing obesity (also reported as overweight). Concomitant medications were not reported. On 15Mar2021, appearance of a left internal temporal parenchymal hematoma with ventricular and arachnoid flooding was noted with the patient. The patient was brought to the emergency room and was hospitalized in Mar2021 (also reported as in the emergency room during her hospitalization). The patient died in Mar2021 due to temporal parenchymal hematoma with ventricular and arachnoid flooding. 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: temporal parenchymal hematoma with ventricular and arachnoid flooding


VAERS ID: 1174522 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-03-04
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Cardiac failure acute, Ejection fraction, Electrocardiogram, Imaging procedure, Troponin
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-06
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cervical myelopathy (Osteoarthritis cervical myelopathy); Cognitive disorders; COVID-19; Dyslipidaemia; Ex-tobacco user (former tobacco user); Hypertension arterial; Insulin-requiring type 2 diabetes mellitus; Osteoarthritis of cervical spine (Osteoarthritis cervical myelopathy); Transient ischemic attack
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: Coronary angiography; Result Unstructured Data: Test Result:Tritronascular network; Comments: stented on the right ostial coronary artery; Test Date: 20210304; Test Name: LVEF; Result Unstructured Data: Test Result:30-35 %; Test Date: 20210304; Test Name: ECG; Result Unstructured Data: Test Result:Anterior Q waves, left ventricular dysfunction; Comments: anterior necrosis; Test Date: 20210304; Test Name: image; Result Unstructured Data: Test Result:normotensive sub-OAP (subpulmonary edema); Test Date: 20210304; Test Name: Troponin; Result Unstructured Data: Test Result:Gradually increasing
CDC Split Type: FRPFIZER INC2021363004

Write-up: Cardiac failure acute; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority FR-AFSSAPS-LY20212436. A 82-year-old male patient received the first dose of bnt162b2 (COMIRNATY; lot EJ6789) intramuscular on 11Feb2021 as single dose for covid-19 immunisation. Medical history included cognitive disorders, osteoarthritis cervical myelopathy, transient ischemic attack from 2015, dyslipidaemia, arterial hypertension, former tobacco user (Ex-tobacco user) and insulin-dependent type 2 diabetes mellitus all unknown if ongoing and history of COVID. The patient''s concomitant medications were not reported. The patient experienced cardiac failure acute on 04Mar2021, serious as fatal. The event was described as follows: on 04Mar2021 the patient was hospitalized for a normotensive sub-OAP (subpulmonary edema) image. Hemodynamics were still preserved.Anterior Q waves were observed on the ECG, and left ventricular dysfunction (LVEF 30-35%) was discovered on antero-septo-apical kinetic disturbances, at limiting flow. Image of anterior necrosis. Troponin gradually increasing. A coronary angiography showed a tritronascular network stented on the right ostial coronary artery. On 06Mar2021 the general condition of the patient was altered and rapidly evolved into cardiogenic shock. Because of his age, and the comorbidities, it was decided not to proceed with invasive resuscitation.The death was declared. The patient died on 06Mar2021. 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: Cardiogenic shock; Cardiac failure acute


VAERS ID: 1174530 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Disease recurrence, Hypertension, Oxygen saturation, Sense of oppression
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; COVID-19; Diabetes
Allergies:
Diagnostic Lab Data: Test Name: Oxygen saturation; Result Unstructured Data: Test Result:correct
CDC Split Type: FRPFIZER INC2021358154

Write-up: Sense of oppression; weakness; Death NOS; Hypertension arterial; Hypertension arterial; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-MA20211046. A 77-year-old female patient received BNT162B2 (COMIRNATY; lot number: ET3620), via intramuscular route of administration on 18Mar2021 (at the age of 77 years) at a single dose for COVID-19 immunization. Medical history included COVID-19, diabetes, and arterial hypertension. The patient''s concomitant medications were not reported. The patient experienced hypertension arterial on 21Mar2021; sense of oppression and weakness on 22Mar2021; and death NOS on 22Mar2021. The patient underwent lab test which included correct oxygen saturation on an unspecified date. The patient died on 22Mar2021 due to the events. 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: weakness; Death NOS; Hypertension arterial; Hypertension arterial; Sense of oppression


VAERS ID: 1174531 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-03-21
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood potassium, 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: 2021-03-21
   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: APROVEL; ATORVASTATIN; BISOPROLOL; EUPRESSYL [URAPIDIL]; KAYEXALATE; LEVEMIR; LOXEN [NICARDIPINE HYDROCHLORIDE]; PLAVIX; VENOFER
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Blindness; Coronary artery disease; Diabetes; Dialysis (last dialysis on 19Mar2021); Leg amputation; Peripheral obliterative arteriopathy; Retinopathy
Allergies:
Diagnostic Lab Data: Test Name: K; Result Unstructured Data: Test Result:6
CDC Split Type: FRPFIZER INC2021358142

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-MA20211056. A 66-year-old male patient received bnt162b2 (COMIRNATY), first dose via intramuscular on 17Feb2021 (Batch/Lot Number: EP9598) as single dose, then second dose via intramuscular on 17Mar2021 (Batch/Lot Number: ET3620) as single dose for COVID-19 immunization. Medical history included diabetes, coronary artery disease, Arteriopathy obliterans of the lower limbs with amputation of both legs, retinopathy with blindness in one eye, dialysis (last dialysis on 19Mar2021), and arterial hypertension. Concomitant medication included irbesartan (APROVEL); atorvastatin; bisoprolol; urapidil (EUPRESSYL [URAPIDIL]); sodium polystyrene sulfonate (KAYEXALATE); insulin detemir (LEVEMIR); nicardipine hydrochloride (LOXEN [NICARDIPINE HYDROCHLORIDE]); clopidogrel bisulfate (PLAVIX); and saccharated iron oxide (VENOFER), all for unspecified indication. The patient had sudden death following the second vaccination of bnt162b2. The patient underwent lab tests and procedures which included blood potassium: 6 on an unspecified date. The patient died on 21Mar2021. 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


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