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

Found 14,925 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 88 out of 150

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VAERS ID: 1151774 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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:
Current Illness: Lung cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021317258

Write-up: Respiratory failure; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-PEI2021003607. A 66-year-old male patient received first dose of bnt162b2 (COMIRNATY), via intramuscular on 17Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing palliative situation with lung cancer (CA). The patient''s concomitant medications were not reported. On the same day after vaccination the patient developed respiratory insufficiency, lasting for unknown. The patient died on 17Mar2021. Death cause was reported as respiratory failure. It was not reported if an autopsy was performed. Relatedness of drug to event assessed by PEI as indeterminate. No Follow-Up attempts are possible, information about batch number cannot be obtained.; Reporter''s Comments; Reported Cause(s) of Death: Respiratory failure


VAERS ID: 1151775 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-31
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: 2021-02-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021317243

Write-up: Vaccination adverse reaction; This is a spontaneous report downloaded from the regulatory authority-WEB DE-PEI-PEI2021003616. This is a report received from the Regulatory Authority. A male patient of an unspecified age received BNT162B2 (COMIRNATY, LOT# unknown), via an unspecified route of administration on 18Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25Feb2021, after vaccination, the patient developed vaccination adverse reaction, lasting for unknown, which resulted to death on 25Feb2021. The patient died on 25Feb2021. Unknown if autopsy was performed. Event assessment: Comirnaty: for all events / PEI/ D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination adverse reaction


VAERS ID: 1151776 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure congestive, Metabolic disorder, Pyrexia
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021317251

Write-up: Fieber; Decompensated heart failure; Metabolic imbalance in diabetes; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory Agency-WEB. The regulatory authority report number is DE-PEI-PEI2021003619. A 96-year-old male patient received second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EP9598) via an unspecified route of administration on 08Mar2021 at single dose for covid-19 immunisation. Medical history included diabetes mellitus. Historical Vaccine included first dose of bnt162b2 (COMIRNATY) on 15Feb2021 for covid-19 immunisation, and patient had been tolerated. The patient''s concomitant medications were not reported. The patient experienced fieber, decompensated heart failure, metabolic imbalance in diabetes on 13Mar2021. Events seriousness criteria was death. It was reported that 5 days after vaccination the patient developed Fever and Congestive cardiac failure and Metabolic disorder NOS, lasting for 5 days. The patient died on an unspecified date. It was not reported if an autopsy was performed. Relatedness of drug to all events assessed by PEI as Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Fieber; Decompensated heart failure; Metabolic imbalance in diabetes


VAERS ID: 1151778 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Lymphopenia, Thrombocytopenia
SMQs:, Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021328289

Write-up: Symptomatic Covid-19 Infection; Thrombopenia; Lymphopenia; Symptomatic Covid-19 Infection; This is a spontaneous report received from a non-contactable physician downloaded from the WEB. The regulatory authority report number is DE-PEI-PEI2021003640. An 88-year-old male patient received bnt162b2 (COMIRNATY), first dose via an unspecified route of administration on 01Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 18-Mar-2021 after vaccination the patient developed COVID-19 (reported as Symptomatic Covid-19 Infection) and Lymphopenia and Thrombopenia, lasting for unknown. The patient is dead. Relatedness of drug to all event(s) assessed by PEI as Unclassifiable. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on lot and batch numbers cannot be obtained. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Symptomatic Covid-19 Infection; Lymphopenia; Thrombopenia; Symptomatic Covid-19 Infection


VAERS ID: 1151780 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity
SMQs:, Angioedema (broad), 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: DEPFIZER INC2021328307

Write-up: suspected allergic reaction; This is a spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-PEI2021003648. A 94-year-old male patient received the second dose of BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on 16Mar2021 at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of Comirnaty on 24Feb2021 for COVID-19 immunisation (had been tolerated). The patient experienced suspected allergic reaction on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Relatedness of drug to reactions/events was unclassifiable per Regulatory Authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: suspected allergic reaction


VAERS ID: 1151784 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular disorder, Cerebral haemorrhage, Chills, Fall, Feeling cold, Malaise, Myalgia, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021328786

Write-up: severe cerebral hemorrhage due to fall trauma; severe cerebral hemorrhage due to fall trauma; syncope; chills; fever; felt cold; circulation problems; pain must have been muscle pain due to the vaccination; did not feel well; This is a spontaneous report based on information received by Pfizer from Biontech, manufacturer control number: 25400], license party for Comirnaty. A contactable consumer reported that a 89-year-old female patient received the second dose bnt162b2 (COMIRNATY, lot number and expiry date unknown), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on an unspecified date for COVID-19 immunization and experienced mild vaccination site pain. The reporter stated that the patient was fit and healthy despite of her age. Her death could have been avoided if they had known that the patient should not be left alone after vaccination. The patient saw the reporter on 07Mar2021 and they went on a long walk. The patient had to "wait" 15 minutes after the vaccination on 08Mar2021. In the evening of 08Mar2021, the reporter''s aunt and sister spoke to the patient on the phone and she was well. She was very happy that life would go on as usual and she would be able to go to the gym 3 times weekly. The reporter spoke to the patient on the phone on 09Mar2021 between 9.30 to 10 am. She had no complaints due to the vaccination by then. They thought everything was fine because she had no side-effects after the first vaccination except for mild vaccination site pain. The reporter''s aunt was not able to reach the patient on the evening of 09Mar2021. They both tried reaching the patient on 10Mar2021 until the early evening unsuccessfully. Afterwards the reporter went to check on her. The reporter found her on the kitchen floor. She lay on her back like sleeping. The police and the emergency physician came fast and confirmed her death. The autopsy has been performed on 11Mar2021 according to instruction of the prosecution department. The reporter''s mother died due to severe cerebral hemorrhage caused by trauma. The cause of death was fall. They were able to find out what must have happened before her death. Due to a neighbor''s observations and the fact that the reporter''s aunt was not able to reach her, they suspect that she died between 10 am and before dawn on 09Mar2021. The heating was extremely turned on. They suspect that she had chills or fever and felt cold. Additionally, she was looking for painkillers in her draw despite not taking any medication otherwise. She has taken a painkiller "in prop form" NOS (as reported) from the draw and went towards the kitchen probably in order to get some water. The patient collapsed at the entrance of the kitchen and fell backwards on the floor or against a metal leg of a small table. According to the physicians she was dead at once, a so called "second death". The physicians in their family explained to the reporter the cause of death described in the autopsy. Due to the heat in the apartment, the patient probably experienced circulatory problems, the pain must have been muscle pain due to the vaccination. She usually drank enough, but it is possible that she did not drink enough that day because she did not feel well. The outcome of the events syncope, chills, fever, felt cold, muscle pain, did not feel well and circulation problems was unknown. The patient died on 09Mar2021 due to severe cerebral hemorrhage due to fall trauma. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: severe cerebral hemorrhage due to fall trauma; severe cerebral hemorrhage due to fall trauma


VAERS ID: 1151790 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-13
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Pulmonary embolism, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Embolic and thrombotic events, venous (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: MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; DEXAMETHASONE; DEXAMETHASONE; ONYTEC; FERRO DURETTER
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenal cortical insufficiency (concurrent medical condition); Adrenogenital syndrome (concurrent medical condition); Constipation (concurrent medical condition); Dermatophytosis of nail (concurrent medical condition); Iron deficiency (concurrent medical condition)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021322753

Write-up: Lung embolism; Feeling unwell; Neck swelling; This is a spontaneous report downloaded from the regulatory agency WEB [DK-DKMA-WBS-0054206]. The case was received from a contactable physician via The regulatory Agency, additional safety reference number DK-DKMA-ADR 24940761. An 88-year-old female patient received the first dose of bnt162b2 (COMIRNATY, batch/Lot Number: ER2659; Expiration Date: 30Jun2021), via an unspecified route of administration on 01Mar2021 as SINGLE DOSE for Covid-19 immunisation. The patient''s medical history were Adrenogenital syndrome, Adrenal cortical insufficiency, Constipation and Dermatophytosis of nail, iron deficiency (all concurrent medical conditions). Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) for constipation from 14Feb2018 to 13Mar2021; dexamethasone for adrenal insufficiency from 14Feb2018 to 13Mar2021; dexamethasone for adrenogenital syndrome from 23Jan2020 to 13Mar2021; ciclopirox (ONYTEC) for dermatophytosis of nail from 15May2020 to 13Mar2021; ferrous sulfate (FERRO DURETTER) for iron deficiency from 14Feb2018 to 13Mar2021. The patient experienced feeling unwell, neck swelling and lung embolism on 13Mar2021. No treatment or medical procedure performed for the events reported. The lung embolism was reported as being Fatal. The patient died on 13Mar2021. The outcome of event neck swelling was not recovered; for feeling unwell was unknown. An autopsy was not performed. There was no information regarding test results. Causality: The reporter stated that the patient had the age where embolism / acute myocardial infarction occurs, so it probably had nothing to due with the vaccine. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the available information the event is most likely related to the patient''s predisposition to an inter current or underlying condition due to advanced age hence event assessed as unrelated to the suspect drug.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1151806 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Atrial fibrillation, Auscultation, Cardiac failure, Dyspnoea, Eating disorder, Heart rate, Tachycardia, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Cardiovascular disease, unspecified (Cardiovascular disease (excluding hypertension)); Neuropsychiatric symptoms
Allergies:
Diagnostic Lab Data: Test Name: cardiac auscultation; Result Unstructured Data: Test Result:Tachycardiac arrhythmia; Test Name: heart rate; Result Unstructured Data: Test Result:130
CDC Split Type: ESPFIZER INC2021311631

Write-up: Atrial fibrillation with rapid ventricular response; Tachycardiac arrhythmia. Heart rate: 130; does not eat; dyspnea; abdominal discomfort; Vomiting; Decompensation cardiac; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB and received via Regulatory Authority ES-AEMPS-783800. A 93-year-old female patient received bnt162b2 (COMIRNATY, lot number: EL0725), dose 1 unknown route of administration on 25Feb2021, single dose for covid-19 immunisation. Medical history included Cardiovascular disease (excluding hypertension), Alzheimer''s disease, Neuro-psychiatric disorders. The patient previously took lormetazepam, quetiapine, edoxaban, donepezil, memantine, omeprazole. The patient''s concomitant medications were not reported. Patient was referred from primary care due to Atrial fibrillation with rapid ventricular response. According to reports after a dose of COVID 19 vaccination a week ago, she presents vomiting and abdominal discomfort unspecified. Also associated dyspnea sensation. Cardiac Auscultation: Tachycardiac arrhythmia. Heart rate: 130 She was given concor 2.5: 1/2-0-1/2 and dilutol 1 and 1/2-0-0. She still does not eat practically anything, she has not vomited again. Her daughter finds her dead. Decompensation cardiac also reported with stop date 6-MAR-2021. Vomiting and Decompensation cardiac reported start date was 26Feb2021 (reported also as time Interval between Beginning of Drug Administration and Start of AEs : 2 days). The outcome of the events vomiting and Decompensation cardiac were reported as fatal by the reporter. The outcome of the other events was unknown. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: vomiting; Decompensation cardiac


VAERS ID: 1151812 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-11
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   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: GABAPENTIN; LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; Cholelithiasis (resolved by endoscopic retrograde cholangiopancreatography); Hypertension; Pancreatitis (resolved by endoscopic retrograde cholangiopancreatography)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021311680

Write-up: Sudden death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB ES-AEMPS-790777. An 89-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number: ET1831), intramuscular on 04Mar2021 as a single dose for covid-19 immunisation. Medical history included hypertension, cholelithiasic pancreatitis, resolved by endoscopic retrograde cholangiopancreatography, and cholecystectomy. Concomitant medications included gabapentin taken for an unspecified indication from 02Oct2019; losartan taken for hypertension from 12Sep2012. The patient''s condition when she was vaccinated was stable, without serious pathologies. Then it was reported that the patient had a sudden death on 11Mar2021 (duration of 8 hours as reported). The outcome of the event was fatal. The cause of death was unknown. The patient died on 11Mar2021. It was unknown if an autopsy was performed. Additional information on ADRs: The registered patient was vaccinated on March 4, 2021 with the first dose of the PFIZER covid vaccine. On March 11, her death was reported. The patient''s condition when she was vaccinated was stable, without serious pathologies. 11Mar2021 the daughter comments to me that last night was ok, talked with her and met with her that morning to go to auditory center. "I call the family and at the end the home emergency services have signed the certificate of death of." 11Mar2021 the patient has died, home emergency services at her home did not certify death, because the family has told them that the deceased was phenomenal and they did not know what cause to put. There are no signs of violence. Under these circumstances I am not going to sign the certificate either. No toxic habits. Hypertension. No diabetes mellitus. No dislipemia. Cholelithiasic pancreatitis, resolved by endoscopic retrograde cholangiopancreatography. No other pathological history. Background surgery: Cholecystectomy No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1151825 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 35
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: APIXABAN; DIFFU K; FUROSEMIDE; ALLOPURINOL; HYDROCORTISONE; MIANSERIN; OXYCODONE; PANTOPRAZOLE; PHLOROGLUCINOL; ZOPICLONE; SYMBICORT
Current Illness: Angina attack; Asthma; Atrial fibrillation; Generalised arthritis; Heart failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210308; Test Name: SARS-COV-2 PCR; Test Result: Positive ; Comments: COVID-19 variant
CDC Split Type: FRPFIZER INC2021333550

Write-up: Acute respirtory distress syndrome; asthenia; fever; vaccination failure; COVID-19 pneumonia aggravated; This is a spontaneous report received from a contactable physician downloaded from the WEB. The regulatory authority report number is FR-AFSSAPS-BS20210414. A 92-year-old female patient received first dose of BNT162B2 (COMIRNATY) intramuscularlyon 14Jan2021 at single dose (lot EM0477) and second dose of BNT162B2 (COMIRNATY)i ntramuscularly on 04Feb2021 at single dose (lot EJ6788) for Covid-19 immunisation. Medical History included continuous atrial fibrillation, Heart failure, angina, asthma, arthritis. Concomitant medications included apixaban, potassium chloride (DIFFU K), furosemide, allopurinol, hydrocortisone, mianserin, oxycodone, pantoprazole, phloroglucinol, zopiclone, budesonide, formoterol fumarate (SYMBICORT). It was reported variant covid-19 infection on day 25 (07Feb2021) after a complete, well-conducted vaccination schedule. No conservation condition problem reported. On day 29 (05Mar2021), the patient experienced 1st symptoms, with fever and asthenia. On day 32 (08Mar2021), positive PCR variant, sequencing in progress. On day 33 (09Mar2021), Hospitalization for dyspnea on covid-19 infection, rapidly oxygen-retaining. On day 38 (14Mar2021): death. On 08Mar2021, SARS-COV-2 PCR resulted positive . The outcome of asthenia and fever was unknown. The patient died on 14Mar2021 due to COVID-19 pneumonia aggravated, Drug ineffective and Acute respiratory distress syndrome. No autopsy was performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021333507 same reporter, same drug, different patient and events; Reported Cause(s) of Death: COVID-19 pneumonia aggravated; drug ineffective; Acute respiratory distress syndrome


VAERS ID: 1151834 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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: Cardiovascular disease, unspecified; Diabetes; Diarrhea; Weight loss
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021333521

Write-up: Hemorrhage of gastrointestinal tract, unspecified; This is a spontaneous report received from a contactable consumer or other non-HCP downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-LM20210562. Verbatim: Not medically confirmed. Patient notification Lot no EP2166, 1st dose 03Mar2021, left arm. Medical History, current diseases, context : COVID-19 disease history: NO, diabetes and cardiovascular disease. Description of Adverse Effect: Death of digestive hemorrhage on D3 of vaccination. The patient who lost weight due to diarrhea for a few weeks before vaccination. Brief observation, no further information available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hemorrhage of gastrointestinal tract, unspecified


VAERS ID: 1151858 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Asthenia, Blood pressure measurement, Blood test, Body temperature, Brain natriuretic peptide, C-reactive protein, Cardiac failure, Dyspnoea, Echocardiogram, Electrocardiogram, Heart rate, Malaise, Oxygen saturation, Pulmonary embolism, Tachycardia, Troponin
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: THYROZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperthyroidism (controlled)
Allergies:
Diagnostic Lab Data: Test Date: 20210301; Test Name: BP; Result Unstructured Data: Test Result:9/6; Test Date: 20210302; Test Name: BP; Result Unstructured Data: Test Result:13/8; Test Date: 201911; Test Name: blood test; Result Unstructured Data: Test Result:normal; Test Date: 20210301; Test Name: Body temperature; Result Unstructured Data: Test Result:no temperature; Test Date: 20210302; Test Name: Body temperature; Result Unstructured Data: Test Result:no temperature; Test Date: 20210301; Test Name: BNP; Result Unstructured Data: Test Result:17920; Test Date: 20210301; Test Name: CRP; Result Unstructured Data: Test Result:55; Test Date: 20210302; Test Name: echocardiography; Result Unstructured Data: Test Result:possible signs of pulmonary embolism; Test Date: 20210301; Test Name: ECG; Result Unstructured Data: Test Result:normal; Test Date: 20210301; Test Name: pulse; Result Unstructured Data: Test Result:90; Test Date: 20210301; Test Name: SaO2; Result Unstructured Data: Test Result:87-88 %; Test Date: 20210302; Test Name: SaO2; Result Unstructured Data: Test Result:93-94 %; Test Date: 20210302; Test Name: SaO2; Result Unstructured Data: Test Result:86-87 %; Test Date: 20210302; Test Name: tachycardia; Result Unstructured Data: Test Result:115; Test Date: 20210301; Test Name: Troponin; Result Unstructured Data: Test Result:79
CDC Split Type: FRPFIZER INC2021312118

Write-up: Arrhythmia NOS; Feeling sick; possible signs of pulmonary embolism; flare-up of heart failure; Dyspnoea; Asthenia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-TO20211456. An 86-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot Number: unknown) dose 2 intramuscular on 24Feb2021 as single dose for covid-19 immunisation. Medical history included controlled hyperthyroidism, independent patient living at home. Concomitant medication included thiamazole (THYROZOL) 5 mg for a well-controlled hyperthyroidism. Following the COVID-19 vaccination (24Feb2021), the patient presented with severe asthenia on 25Feb2021. On 28Feb2021, asthenia persisted with the presence of shortness of breath (Dyspnoea) on exertion (walking, climbing stairs). On 01Mar2021, clinical examination showed drowsiness, no particular pain, Sa02 87-88%, BP 9/6, pulse at 90, no temperature, no sign of DVT of the lower limbs. The blood assessment showed BNP 17920, Troponin 79, CRP 55 (previous blood test carried out in Nov2019 strictly normal). Apparently normal ECG. Suspicion of flare-up of heart failure. Furosemide 20 mg IV administration seemed to be getting better. On 02Mar2021, fairly good general condition, BP 13/8, Sa02 93-94%, get up and have a little lunch Lasilix injection and prescription for further oral treatment. At noon seemed to be doing better, eat a little without finishing his meal, however. At the end of the afternoon, no alarming sign but at 7 p.m., the situation will degenerate as not feeling well (sick), dyspnea plus, SaO2 86-87%, tachycardia 115, no temperature, no pain would lengthen. At 8:20 pm, arrival of the firefighters with discomfort with rhythm disturbances (arrhythmia) in the ambulance. Hospitalization, unsuccessful resuscitation attempt; The resuscitator found on echocardiography possible signs of pulmonary embolism. The patient was hospitalized due to above events. The outcome of events flare-up of heart failure and pulmonary embolism was unknown and other events was fatal. The patient was died on 02Mar2021. It was unknown if an autopsy was performed. Cause of death was reported as arrhythmia, feeling sick, asthenia and dyspnoea. No follow-up attempts are needed; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Arrhythmia; Feeling sick; Asthenia; Dyspnoea


VAERS ID: 1151860 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-06
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, COVID-19 pneumonia, Haemoglobin, Platelet count, Vaccination failure, Ventilation/perfusion scan, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Atrial fibrillation; Cardiac failure; COVID-19; Hepatic damage; Hypothyroidism; Ischemic stroke; Living in nursing home; Neutropenia; Thrombocytopenia
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:233; Test Name: Hb; Result Unstructured Data: Test Result:12; Test Name: platelets; Result Unstructured Data: Test Result:82000; Comments: thrombocytopenia; Test Name: lung scanner; Result Unstructured Data: Test Result:large areas of frosted glass scattered; Comments: large areas of frosted glass scattered around the 2 typical COVID19 lung fields. More than 50% attack; Test Name: leukocytes; Result Unstructured Data: Test Result:0.53; Comments: leucopenia
CDC Split Type: FRPFIZER INC2021333512

Write-up: COVID-19 pneumonia; Vaccination failure; This is a spontaneous report from a contactable physician from the regulatory authority-WEB FR-AFSSAPS-TO20211864. A 92 years old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ6789) on 11Feb2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included Hepatic damage, Neutropenia, COVID-19, Anxiodepressive syndrome, Atrial fibrillation, Ischemic stroke, Thrombocytopenia, Hypothyroidism, Cardiac failure and living in nursing home. Concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date at single dose. On 06Mar2021 the was diagnosed with COVID-19 Pneumonia. Possible vaccination failure occurred. Covid 19 was evolving into severe form. Patient had an Emergency hospitalization on 11Mar2021 with respiratory distress. He was put under O2 15 liters. Performed lab test included CRP at 233, Hb at 12, leukopenia 0.53, thrombocytopenia 82 000. On the scanner: large areas of frosted glass scattered around the 2 typical COVID19 lung fields. More than 50% attack. The patient died on 13Ma2021 due to COVID-19 pneumonia and suspected vaccination failure. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia; vaccination failure


VAERS ID: 1152831 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-19
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Clot retraction, Confusional state, Constipation, Dehydration, Infection, Investigation, Limb discomfort, Peripheral swelling, SARS-CoV-2 test, Urinary tract infection
SMQs:, Cardiac failure (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure; Dementia
Allergies:
Diagnostic Lab Data: Test Name: Lab tests; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021306665

Write-up: Poorly dehydrated; Constipated; Urine infection; Became more confused; left leg became very swollen and heavy; left leg became very swollen and heavy; infection; Clot retraction; This is a spontaneous report from a contactable consumer (patient child). This is a report received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202103190919451600, Safety Report Unique Identifier is GB-MHRA-ADR 24975124. An 84-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number: Unknown), via an unspecified route of administration on 31Dec2020 as a single dose for COVID-19 immunization. Medical history included dementia and blood pressure. Patient has not had symptoms associated with COVID-19 and is not enrolled in clinical trial. The patient''s concomitant medications were not reported. On an unspecified date the patient was poorly dehydrated, constipated, urine infection, became more confused, left leg became very swollen and heavy and infection. On 19Jan2021, the patient experienced clot retraction (until 20Jan2021, as reported). The patient was taken to A&E of a hospital where the tests were performed (Unknown results). The clinical course was reported as follows: The patient had the vaccine and after that became very poorly dehydrated, constipated and more serious a urine infection she became more confused as she had been suffering from dementia then suddenly left leg became very swollen and heavy. Ambulance was called and patient was diagnosed as having a blood clot and infection and she was dehydrated. On an unspecified date, the patient had COVID-19 virus test and the result was No - Negative COVID-19 test. The case is serious, events causing hospitalization; event clot retraction is fatal. Patient has not tested positive for COVID-19 since having the vaccine. The cause of death was clot retraction. The outcome for events poorly dehydrated, constipated, urine infection, became more confused, left leg became very swollen and heavy and infection was unknown; clot retraction was fatal. An autopsy was not 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: Clot retraction


VAERS ID: 1152835 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-21
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4243 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arterial thrombosis, Malaise, SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), COVID-19 (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021306489

Write-up: Felt unwell; a large blood clot was discovered in the artery to the bowel; Death sudden; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority (RA). Regulatory authority report number: GB-MHRA-WEBCOVID-202103201901276170, Safety Report Unique Identifier: GB-MHRA-ADR 24986407. A 90-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4243, expiration date: unknown), via an unspecified route of administration on 21Jan2021 (at the age of 90 years old) at a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medication included simvastatin. The patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. It was reported that the patient felt unwell on unspecified date immediately after the COVID vaccine. The patient continued to feel unwell and a large blood clot was discovered in the artery to the bowel and was admitted to hospital on Thursday, 04Feb2021. It was further reported that the patient deteriorated and died (sudden death) on 21Feb2021 (also reported as 10Feb2021). The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 05Feb2021. Since the vaccination, the patient had not tested positive for COVID-19. Outcome of the events felt unwell and a large blood clot was discovered in the artery to the bowel was unknown. The patient died on 21Feb2021. It was unknown whether an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1152839 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 47
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021327233

Write-up: Stroke; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The Regulatory authority report number is (GB-MHRA-WEBCOVID-202103222059565510) and the Safety Report Unique Identifier is (GB-MHRA-ADR 25002071). A patient of unspecified age and gender received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK1768), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced stroke on 15Jan2021 and then died on 03Mar2021. 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: Stroke


VAERS ID: 1152860 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021328892

Write-up: Cardiac arrest; The initial case was missing the following minimum criteria: first-hand knowledge of the event. Upon receipt of follow-up information on 28Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer, with follow-up from a nurse (colleague of the patient). A 53-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscularly in Feb2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. It was unknown if the patient had been tested for COVID-19 since the vaccination. It was unknown if the patient received any other vaccine within four weeks of the suspect vaccine. It was unknown if the patient was diagnosed with COVID prior to vaccination. The patient''s medical history included hypertension from an unknown date and unknown if ongoing. It was unknown if the patient had allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (COMIRNATY) for COVID-19 immunization on an unknown date in Jan2021 (intramuscularly; (Batch/Lot Number: Unknown).On 08Feb2021, the patient experienced cardiac arrest, which was assessed as medically significant and resulted in death. It was unknown if treatment was received for the cardiac arrest. It was initially reported that the reporter mentioned that she was talking to someone casually. That person said to the reporter that she knew someone, who was a nurse, in the age group 50-60, and was vaccinated with the second dose of the Pfizer COVID vaccine, and some days later died. The patient died on an unspecified date in 2021 due to cardiac arrest. An autopsy was not performed. Follow-up attempts have been completed and no further information is expected.; Sender''s Comments: Limited information precludes a medically meaningful assessment of the case. Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Cardiac arrest cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1152869 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4241 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congestive heart failure (CHF); Diabetes mellitus (DM); Hyperlipidemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330143

Write-up: Circumstances of death: was hospitalized on the background of DKA (Diabetic ketoacidosis); This is a spontaneous report from a contactable healthcare professional via the regulatory Authority. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EK4241) as a single dose for COVID-19 immunization. Medical history included hypertension, hyperlipidemia, diabetes mellitus, and CHF. The patient''s concomitant medications were not reported. Circumstances of death: was hospitalized on the background of DKA (Diabetic ketoacidosis). 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.; Sender''s Comments: Based on the current available information, the event Diabetic ketoacidosis is most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: DKA (Diabetic ketoacidosis)


VAERS ID: 1152870 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Seizure, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330151

Write-up: collapsed in the ER convolution and VF (Ventricular fibrillation); collapsed in the ER convolution and VF (Ventricular fibrillation); This is a spontaneous report from a contactable healthcare professional received via regulatory authority. A 51 years old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK4238) on an unknown date, for COVID-19 immunisation. Medical history included diabetes. Concomitant medications were not reported. On an unspecified date the patient collapsed in the ER convolution and VF (ventricular fibrillation), as reported. The events required hospitalization and were reported with a fatal outcome. The patient died on an unknown date. It was unknown if an autopsy was performed. No follow-up attempts possible. No information expected.; Sender''s Comments: Limited information does not allow a medically meaningful assessment for the events "collapsed in the ER convolution and VF (Ventricular fibrillation)". Details regarding the drug-event temporal association, complete medical history, concomitant medication, hospitalization summary and autopsy results are not provided. The case will be re-evaluated if more 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: convolution and VF (Ventricular fibrillation); convolution and VF (Ventricular fibrillation)


VAERS ID: 1152871 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension; Ischemic heart disease; Rheumatoid factor
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330247

Write-up: was found dead in her home; This is a spontaneous report received from a contactable other HCP via regulatory authority. A 77-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK4238) via an unspecified route of administration on an unspecified date (at the age of 77-year-old), at single dose for COVID-19 immunisation. Relevant medical history included ischemic heart disease, rheumatoid factor (as reported), hypertension and diabetes. Concomitant medications were not reported. The patient was found dead in her home on the day of the vaccine. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The reported event is likely due to underlying disease, however, unless further information regarding specific cause of death is provided, at present, the reported event death, cause unknown, is assessed as possibly related to BNT162B2, as a cautionary measure and for reporting purposes. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: was found dead in her home


VAERS ID: 1152872 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4240 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dyspnoea, Heart rate, Investigation, Loss of consciousness, Pulmonary embolism, Pulseless electrical activity, Pupil fixed, Respiratory arrest, Right ventricular enlargement, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (narrow), Guillain-Barre syndrome (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), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Exposure to COVID-19; Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Name: pulse; Result Unstructured Data: Test Result:without pulse; Test Name: investigation nos; Result Unstructured Data: Test Result:she was without a pulse and independent breathing; Comments: the pupils were dilated did not react to light; Test Name: ultrasound; Result Unstructured Data: Test Result:right ventricle enlarged
CDC Split Type: ILPFIZER INC2021330256

Write-up: loss consciousness at home later a week of breathing difficulty.; loss consciousness at home later a week of breathing difficulty.; she was without a pulse and independent breathing; Asystola/PEA/she was without a pulse; Asystola/PEA; lung embolism; the pupils were dilated did not react to light; Right ventricle enlarged; This is a spontaneous report from a contactable other health professional reporting for a patient received from the regulatory Authority. Regulatory Authority number was not provided. A 42-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Jan2021 (Batch/Lot Number: EK4240) as SNIGLE DOSE for covid-19 immunisation, age of vaccination was unknown. Medical history included penicillin allergy and exposure to a confirmed ill person (COVID-19) from an unknown date. The patient''s concomitant medications were not reported. The patient was generally healthy and was allergic to penicillin. She was in quarantine because of exposure to a confirmed ill person. She was brought to a hospital while being resuscitated after she collapsed in her home. About a week ago (unspecified date) she started to suffer from difficulty breathing that became worse in the morning. After she collapsed, her partner started heart massage and alerted the emergency services staff. The ambulance team found the patient unconscious and continued with resuscitation activities (including airways and heart massage). When she was admitted to the hospital, she was without a pulse and independent breathing and the pupils were dilated did not react to light. The hospital staff continued with resuscitation activities. In a bedside ultrasound right ventricle enlarged was noted. Due to the possibility that this was a lung embolism she was treated with TPA. In the course of the long resuscitation peaks of Asystola/PEA appeared that were dealt with accordingly and also an attempt at external pace-making did not succeed. After about an hour and a half of resuscitation activity, her death was certified, and a message was sent to the partner who did not agree to conduct an autopsy after the death. She was given the first dose of the vaccine for COVID-19 it seems on 19Jan2021. Therapeutic measures were taken as a result of loss consciousness at home later a week of breathing difficulty, she was without a pulse and independent breathing, asystola/pea/she was without a pulse, asystola/pea, and lung embolism. Outcome of the events loss consciousness at home later a week of breathing difficulty, she was without a pulse and independent breathing, asystola/pea/she was without a pulse, asystola/pea was fatal. Outcome of other events was unknown. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts possible. No further information expected. Information on lot number has been obtained.; Sender''s Comments: Linked Report(s) : IL-PFIZER INC-2020517122; Reported Cause(s) of Death: she was without a pulse and independent breathing; asystola/PEA/She was without a pulse; Asystola/PEA; loss consciousness at home later a week of breathing difficulty; loss consciousness at home later a week of breathing difficulty


VAERS ID: 1152873 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4237 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Prostatic hyperplasia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330262

Write-up: Under inquiry(Unknown cause of death); This is a spontaneous report from a contactable healthcare professional. A 73-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4237), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included prostatic hyperplasia. The patient''s concomitant medications were not reported. The patient''s circumstance of death was under inquiry on an unspecified date. The patient died on an unspecified date. The cause of death was unknown. It was not reported if an autopsy was done. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information available in this report is limited, and does not allow a medically meaningful assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. The case will be re-assessed when relevant information, particularly the cause of death, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Under inquiry(Unknown cause of death)


VAERS ID: 1152874 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330296

Write-up: was found dead in his home; This is a spontaneous report received from Health Care Professional via Agency Regulatory Authority. A 74-years-old male patient received the second dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EK4238) at single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient was found dead in his home on an unspecified date. the cause of patient''s death was unknown at the reporting time. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow up attempts are possible, no further information is expected.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1152875 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Ejection fraction
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congestive heart failure (CHF EF 35%,); Hypertension; Paroxysmal supraventricular tachycardia
Allergies:
Diagnostic Lab Data: Test Name: EF; Test Result: 35 %
CDC Split Type: ILPFIZER INC2021330325

Write-up: was found lifeless at her home; This is a spontaneous report from a contactable other hcp received via regulatory authority. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK4238) on an unknown date at single dose for COVID-19 immunization. medical history included congestive hear failure (CHF) EF 35%, hypertension, ventricular tachicardia paroxysmal. Concomitant drugs were unknown. The patient was found dead in her home 4 days after vaccination. No follow-up attempts possible. No information expected.; Sender''s Comments: Based on the information currently available, the patient''s underlying diseases might have contributed to patient''s demise. However, unless further information regarding specific cause of death provided, at present, the reported event death, cause unknown, is assessed as possibly related to suspect drug, as a cautionary measure and for reporting purposes. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2020517122 same source, diffrent patient; Reported Cause(s) of Death: was found lifeless at her home


VAERS ID: 1152876 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4242 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Cardiac arrest, Chronic obstructive pulmonary disease, Haematemesis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (~~~); Atrial fibrillation; Chronic heart failure; COPD (~~~); Diabetes; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:drop
CDC Split Type: ILPFIZER INC2021330454

Write-up: Brought to the emergency room due to worsening of COPD; black vomit; asystole in the monitor; drop in blood pressure; This is a spontaneous report from a contactable other health care professional. An 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EK4242) as single dose for covid-19 immunisation. Medical history included Atrial fibrillation, diabetes, hypertension, chronic heart failure, COPD, Alzheimer''s. The patient''s concomitant medications were not reported. One day after receiving the vaccine, breathing problems and a drop in blood pressure, after a few days breathing problems worsened and was transferred to [PRIVACY] emergency room due to worsening of COPD, in the emergency room one black vomit and then asystole in the monitor, resuscitation was performed for 50 min, the patient died. The events black vomit and asystole was assessed as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: drop. The patient died due to the event Brought to the emergency room due to worsening of COPD on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events black vomit, asystole in the monitor, and drop in blood pressure was unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the temporal association, a causal relationship between the events worsening of COPD, black vomit, asystole and blood pressure decreased and BNT162B2 cannot be completely excluded. Other risk factors to be considered may include the patient''s underlying atrial fibrillation, diabetes, hypertension, chronic heart failure, and COPD. The case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern 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: Brought to the emergency room due to worsening of COPD


VAERS ID: 1152877 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4242 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Cardiac death, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypertension (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: Congestive heart failure; COPD; Diabetes; Smoker
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:one-time rise in blood pressure
CDC Split Type: ILPFIZER INC2021330475

Write-up: She was found dead in the nursing home in her room; cardiac event; A one-time rise in blood pressure; This is a spontaneous report from a contactable other HCP received via the regulatory authority. A 79 -year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK4242) on an unknown date at single dose for COVID-19 immunization. The first dose of vaccine was done on an unknown date. medical history included congestive heart failure, COPD, diabetes, smoking. Concomitant drugs were unknown. She was found dead in the nursing home in her room 5 days from the vaccine administration, coronary event. On the day of her death, a one-time rise in blood pressure. No follow-up attempts possible. No further information expected. Batch/lot number already provided.; Sender''s Comments: The event death is unexpected with this 79 year old female living in a nursing home. Her significant medical history of congestive heart failure, COPD, diabetes and smoking are confounding factors to her demise. This case will be updated when new information becomes available including which concomitant medications were used for her medical illnesses and if autopsy report is available.,Linked Report(s) : IL-PFIZER INC-2020517122 same source, different patient; Reported Cause(s) of Death: cardiac event; Found dead in her room


VAERS ID: 1152878 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension; Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330486

Write-up: died in the institution he was hospitalized in; This is a spontaneous report from a contactable Healthcare Professional received via the regulatory authority. The report was received in the epidemiology department division by medical staff for patient. A 58-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration on an unspecified date (Batch/Lot Number: EK4238) at single dose for COVID-19 immunization. Medical history included schizophrenia, hypertension and diabetes mellitus, all from an unknown date. The patient''s concomitant medications were not reported. On an unspecified date the patient died in the institution he was hospitalized in for an unknown reason. The cause of death was unknown and it was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : IL-PFIZER INC-2020517122 master case-patient 1; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1152879 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4240 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: ALS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330530

Write-up: died at home; This is a spontaneous report from a contactable other hcp. A 67-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/Lot Number: EK4240), via an unspecified route of administration as single dose on an unspecified date (at 67-year-old) for COVID-19 immunisation. Medical history included ongoing amyotrophic lateral sclerosis (ALS). There was no information on heart disease. The patient''s concomitant medications were not reported. The patient experienced died at home on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2020517122 master case; Reported Cause(s) of Death: Unknown Cause of Death


VAERS ID: 1152881 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-06
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, 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: 2021-03-10
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021328274

Write-up: Died; Unconscious; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB IS-IMA-2072. An 89-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 02Mar2021 (batch/lot number: unknown) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient did not have any complaints immediately following the vaccination. She stated that she did not have any soreness after the needle. In the evening of 06Mar2021, the patient was found found unconscious. She never regained consciousness and died on the eve of Wednesday, 10Mar2021. The outcome of the event was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: died


VAERS ID: 1152908 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aneurysm ruptured, Gastrointestinal haemorrhage, Haematemesis, Haemoperitoneum
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALPRAZOLAM; BISOPROLOL FUMARATE; SERTRALINE; STILNOX; TALOFEN; LIXIANA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial aneurysm; Depression; Hypertensive heart disease; Insomnia; Sedative therapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021322987

Write-up: Hematemesis and haemoperitoneum from ruptured gastroduodenal artery aneurysm. From clinical report: diagnosis of digestive haemorrhage.; Hematemesis and haemoperitoneum from ruptured gastroduodenal artery aneurysm. From clinical report: diagnosis of digestive haemorrhage.; Hematemesis and haemoperitoneum from ruptured gastroduodenal artery aneurysm. From clinical report: diagnosis of digestive haemorrhage.; Hematemesis and haemoperitoneum from ruptured gastroduodenal artery aneurysm. From clinical report: diagnosis of digestive haemorrhage.; This is a spontaneous report downloaded from the Agency Agency-WEB, IT-MINISAL02-697430. This report was received from a contactable physician via the Regulatory Authority. A 90-year-old female patient received the first dose of BNT162B2 (COMIRNATY; batch/lot number: EJ6790 and expiry date unknown), intramuscular on 18Feb2021 as a SINGLE DOSE for COVID-19 immunisation; and edoxaban tosilate (LIXIANA; batch/lot number was not reported), oral from an unspecified date to an unspecified date, at 1 DF, 1x/day for AFib (atrial fibrillation). The patient''s medical history included arterial aneurysm, sedative therapy/ sedation, hypertensive heart disease, depression, and insomnia, all from an unknown date and unknown if ongoing. Concomitant medications included alprazolam for sedative therapy; bisoprolol fumarate for hypertensive heart disease; sertraline for depression; zolpidem tartrate (STILNOX) for insomnia; and promazine hydrochloride (TALOFEN for sedation; therapy dates for all were not reported. On 19Feb2021, the patient experienced hematemesis and haemoperitoneum from ruptured gastroduodenal artery aneurysm. From clinical report, diagnosis of digestive haemorrhage. The patient died on 23Feb2021. The cause of death was not reported. It was not reported if an autopsy was performed. Reporter comment: There is a temporal link, I don''t think about the causal link of the bleeding with vaccination. I don''t know the type of vaccine. Lixiana contributed. The aneurysm was not known. Sender comment: 12Mar2021 Local agency center: request for follow-up information from the reporter regarding clinical report. Waiting. 18Mar2021 Local agency center: the form is updated with the additional information provided by the reporter and the clinical report is attached. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number of Comirnaty was already obtained.; Reporter''s Comments: There is a temporal link, I don''t think about the causal link of the bleeding with vaccination. I don''t know the type of vaccine. Lixiana contributed. The aneurysm was not known.; Reported Cause(s) of Death: The patient died


VAERS ID: 1152909 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Disorientation, Epilepsy, Hallucination
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   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: LEVOPRAID [LEVOSULPIRIDE]; TORVAST; DIBASE; LUVION [CANRENONE]; PANTORC; LANTUS; SEROQUEL; KCL-RETARD; METFORAL; APIDRA; COUMADIN; THEO-DUR; ZYLORIC; LORTAAN; LASIX [FUROSEMIDE]; DULOXETINE HYDROCHLORIDE; RANEXA; CONGESCOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Diabetic metabolic decompensation; Fractured femur (excl neck); Gross obesity; Respiration failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021302772

Write-up: Allucinazioni, disorientamento, crisi comiziale; Hallucinations, disorientation, seizure; Hallucinations, disorientation, seizure; Hallucinations, disorientation, seizure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-697877. A 75-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Deltoid Right on 01Mar2021 13:00 (Batch/Lot Number: EP9598; Expiration Date: Jun2021) as single dose for COVID-19 immunisation. The patient received dose 1 on 08Feb2021 (1st dose, lot EL0725 exp. Mar2021). Medical history included respiratory failure, diabetic metabolic decompensation, atrial fibrillation, Fractured femur (excl neck), Gross obesity. Concomitant medications included levosulpiride (LEVOPRAID); atorvastatin calcium (TORVAST); colecalciferol (DIBASE); canrenone (LUVION; pantoprazole sodium sesquihydrate (PANTORC); insulin glargine (LANTUS); quetiapine fumarate (SEROQUEL); potassium chloride (KCL-RETARD); metformin hydrochloride (METFORAL); insulin glulisine (APIDRA); warfarin sodium (COUMADIN); theophylline (THEO-DUR); allopurinol (ZYLORIC); losartan potassium (LORTAAN); furosemide (LASIX); duloxetine hydrochloride; ranolazine (RANEXA); bisoprolol fumarate (CONGESCOR), all were taken for an unspecified indication, start and stop date were not reported. On 02March2021 the patient experienced Disorientation, Hallucinations, Disorder aggravation, and Epileptic fit. The event caused hospitalization. The events were assessed as fatal. The patient died on 03Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Patient institutionalized for femur fracture, the lady presented with glycometabolic decompensation, severe obesity, chronic respiratory insufficiency for bpco requiring 02 3l / min, hyperlipidemia, high frequency AF, hyperuricemia. From 15Feb2021 she had persistent nausea with episodes of vomiting after the ingestion of food, with improvement after taking levopraid before the meal.; Reported Cause(s) of Death: Disorientation; Hallucinations; Disorder aggravation; Epileptic fit


VAERS ID: 1152911 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK - / OT

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: 2021-03-14
   Days after onset: 8
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: DONEPEZIL; CARDICOR; ACETYLSALICYLIC ACID; EUTIROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive deterioration; Ischaemic heart disease; Thyroidectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021322984

Write-up: bridging ischaemic stroke; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-701388. An 82-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, batch/lot number: EP2166), intramuscular on 05Mar2021 at 11:41 at 0.3 mL, single for SARS-CoV-2 vaccination. The patient''s medical history included thyroidectomy, ischaemic heart disease, and cognitive deterioration; all from an unknown date and unknown if ongoing. Concomitant medications included donepezil, bisoprolol fumarate (CARDICOR), acetylsalicylic acid, and levothyroxine sodium (EUTIROX); all taken for an unspecified indication, start and stop date were not reported. The patient experienced bridging ischaemic stroke on 06Mar2021, reported as the patient arrived at the emergency department on 06Mar2021 in a sleepy state. She was admitted to the emergency medicine ward on 11Mar2021 for coma in acute cerebral ischaemia. Her family reported that the patient had undergone the Pfizer vaccine on 05Mar2021. The patient died on 14Mar2021 due to the bridging ischaemic stroke. It was not reported if an autopsy was performed. Sender''s comment: Comirnaty vaccine batch EP2166 carried out on 05Mar2021 at 11.41. The report of the referring physician and the vaccination card always sent by the referring physician are attached. Requested additional data on previous pathologies or drugs taken by the patient and awaiting a reply. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: bridging ischaemic stroke


VAERS ID: 1152956 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-09
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTPFIZER INC2021328359

Write-up: Lung edema; Death; This is a spontaneous report from a contactable consumer (patient) downloaded from the Agency Regulatory Authority-WEB LT-SMCA-1551. This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number LT-SMCA-1551. A 69-years-old male patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), suspension for injection, intramuscular on an unknown date in 2021 (Batch/Lot Number: EN6200) at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 09Mar2021 lungs edemas was observed. The outcome was fatal. It was also reported that the date of death and cause of death were not submitted. The patient died in Mar2021. 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: Lung edemas


VAERS ID: 1152971 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Hypophagia, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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: FOSINOPRIL; METFORMINE [METFORMIN]; NITROFURANTOINE; COMBIGAN; OXAZEPAM; CLOPIDOGREL; NORTRIPTYLINE; CALCIUM CARBONATE; AMLODIPINE; PARACETAMOL; HYDROXOCOBALAMINE; CLOBETASOL
Current Illness: Alzheimer''s disease; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident; Multiple myeloma; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: corona sneltest; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: A Regulatory Authority report was received from a pharmacist for a 78 year old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and who experienced fatigue, nausea, vomiting, and decreased oral intake (hypophagia). The patient''s medical history included cerebrovascular accident, type 2 diabetes mellitus, urinary tract infection, alzheimer''s dementia, and plasma cell myeloma. The concomitant medications included clopidogrel, nortriptyline, calcium carbonate, amlodipine, paracetamol, hydroxocobalamine, clobetasol, fosinopril, metformine [metformin], nitrofurantoine, brimonidine tartrate timolol maleate and oxazepam. On 11-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 30042721) intramuscularly for prophylaxis of COVID-19 infection. On 12-Feb-2021, one day after receiving the vaccine, the patient experienced fatigue, nausea and vomiting. A SARS-CoV-2 test was performed which was negative. On a date not reported, the patient experienced decreased oral intake. The patient died on 18 Feb 2021. The cause of death was reported as nausea and decreased oral intake. No autopsy was performed. Treatment information was not applicable. Action taken with mRNA-1273 was not applicable. The outcome of the events nausea, vomiting, and decreased oral intake was fatal and the outcome for the event of fatigue was unknown. On 11Mar2021, follow up information was received which provided cause of death as decreased oral intake with no autopsy performed. A SARS-CoV-2 test was performed on 12Feb2021 which was negative.; Reporter''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient''s comorbidities may confound causality assessment. This case concerns a 78-year-old female who experienced serious unexpected events of fatigue, nausea, vomiting. The events occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes fatal. As above, a causal relationship cannot be excluded.


VAERS ID: 1152975 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Death, Malaise, Oxygen saturation, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (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: 2021-03-07
   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: CLOPIDOGREL; FUROSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: Oxygen saturation; Result Unstructured Data: Decreased; Test Date: 20210305; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Covid PCR test; Test Date: 20210304; Test Name: COVID-19 rapid POC test; Test Result: Negative ; Result Unstructured Data: Covid test
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Death; oxygen saturation decreased; A regulatory authority report was received from a physician, concerning an 81 year-old male patient, who was administered Moderna''s COVID-19 vaccine (mRNA-1273), and experienced oxygen saturation decreased, malaise (malaise), asthenia, and pyrexia and subsequently died (Death). The patient''s medical history was not reported. Concomitant medications reported included clopidogrel, and furosemide. On 25 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 300042722), intramuscularly for the prophylaxis of COVID-19 infection. On 04 Mar 2021, the patient experienced oxygen saturation decreased, malaise, asthenia and pyrexia. On the same day, the patient underwent COVID-19 rapid point-of care (POC) test which was negative. On 05 Mar 2021, the patient underwent COVID-19 polymerase chain reaction (PCR) test which was negative. On 07 Mar 2021, the patient died. Cause of death was not reported. Plans for an autopsy were unknown. No treatment information was reported. Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcomes of the events, oxygen saturation decreased, malaise, asthenia and pyrexia, were unknown.; Reporter''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (oxygen saturation decreased, malaise, asthenia and pyrexia), a causal relationship cannot be excluded. Very limited information regarding this patient''s death has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1152976 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Death, Headache, Hyperpyrexia, Malaise, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   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: INSULINE ASPARTATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No adverse event history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Death; A regulatory authority report was received from a consumer concerning a 87-year-old, male patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced generalized joint pain, malaise, hyperpyrexia, pain, chills, headache and died. The patient''s medical history was not provided. Concomitant products known to have been used by patient, within two weeks prior to the event, included Insulin Aspartate. On 12-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 12-FEB-2021, after receiving mRNA-1273, the patient began experiencing generalized joint pain, malaise, hyperpyrexia, pain, chills and headache and finally resulted in death of patient. The patient died on 12FEB2021. The cause of death is unknown. Treatments of these events were not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, generalized joint pain, malaise, hyperpyrexia, pain, chills and headache were not provided.; Reporter''s Comments: This is a case of death in a 87-year-old male subject with unknown medical history, who died same day 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: unknown cause of death


VAERS ID: 1152977 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Cardiac murmur, Chest pain, Dyspnoea, Oxygen saturation, Troponin
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Dementia; Diabetes mellitus; Heart failure; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: Souffle grade 3; Result Unstructured Data: Test Result:souffle grade 3; Test Name: CRP; Result Unstructured Data: Test Result:50; Test Name: saturatie; Test Result: 95 %; Test Name: troponine; Result Unstructured Data: Test Result:366
CDC Split Type: NLPFIZER INC2021311622

Write-up: Dyspnoea; Chest pain; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00474154. A 90-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 23Feb2021 as a single dose (at the age of 90-years-old) for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), dementia, heart failure, diabetes mellitus, and hypertension; all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 27Feb2021, the patient experienced chest pain and dyspnoea. The patient was admitted to the hospital for his dyspnoea and they could not find the cause of his dyspnoea. No diagnosis was made. The patient underwent lab tests and procedures which included cardiac murmur: souffle grade 3, c-reactive protein: 50, oxygen saturation: 95 %, and troponin: 366; all on an unspecified date. The outcome of the events was fatal. The cause of death was chest pain and dyspnoea. The patient died on 28Feb2021. It was unknown if an autopsy was performed. Case Summary and Reporter''s Comments Text: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no Additional information ADR: the patient became increasingly dyspnoeic. Demented gentleman, copd, smoker, tendency to the cordis. Admission: PRIVACY 27Feb21. work diagnosis; copd, / dec cordis / pneumonia / acs ?? no exact diagnosis has been established. 28fb died No follow-up attempts are possible, information about lot number cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no Additional information ADR: the patient became increasingly dyspnoeic. Demented gentleman, copd, smoker, tendency to the cordis. Admission: PRIVACY 27Feb21. work diagnosis; copd, / dec cordis / pneumonia / acs ?? no exact diagnosis has been established. 28fb died; Reported Cause(s) of Death: Chest pain; Dyspnoea


VAERS ID: 1152978 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-12-08
Onset:2021-02-17
   Days after vaccination:437
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chills, Drug ineffective, Hernia pain, Malaise, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUROGESIC; HYDROCHLOORTHIAZIDE; DEXAMETHASON [DEXAMETHASONE]; REMDESIVIR; CODEINE; DIAZEPAM; CLINDAMYCINE [CLINDAMYCIN]; ENZALUTAMIDE; AMLODIPINE; COLECALCIFEROL; ZOLADEX [GOSERELIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Prostatic cancer metastatic
Allergies:
Diagnostic Lab Data: Test Date: 20210301; Test Name: pyrexia; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Test Date: 20210301; Test Name: Covid culture; Result Unstructured Data: Test Result:positive
CDC Split Type: NLPFIZER INC2021323064

Write-up: COVID-19 infection; COVID-19 infection; Fever: 38 to 40.5 degrees Celsius; Hernia pain/back pain due to hernia; Cold shivers; Not feeling well; Muscle strain/Myalgia; Nausea; Reaction at or around the injection site: pain; This is a spontaneous report from a contactable physician downloaded from the Agency Agency-WEB, regulatory authority number NL-LRB-00480709. An 87-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Feb2021 (Batch/Lot Number: EJ6789) as single dose for COVID-19 vaccination; and goserelin (ZOLADEX), via an unspecified route of administration from 08Dec2019 to an unspecified date, at 10.8 mg, every 3 months for prostate cancer metastatic. Medical history included prostate cancer metastatic from an unknown date. Concomitant medications included fentanyl (DUROGESIC); hydrochloorthiazide (HYDROCHLOORTHIAZIDE); dexamethasone (DEXAMETHASON); remdesivir; codeine; diazepam; clindamycin (CLINDAMYCINE); enzalutamide; amlodipine; and colecalciferol. The patient was reported to have hernia pain/ back pain due to hernia on 23Feb2021, cold shivers on 23Feb2021 reported as cause of death, not feeling well on 23Feb2021 reported as cause of death, Muscle strain/myalgia on 23Feb2021 reported as cause of death, nausea on 23Feb2021 reported as cause of death, reaction at or around the injection site: pain on 17Feb2021, fever: 38 to 40.5 degrees Celsius on 01Mar2021 reported as cause of death, and COVID-19 infection on 01Mar2021 reported as cause of death following administration of Pfizer COVID-19 vaccine for COVID -19 immunization and gosereline implant for prostatic cancer metastatic. Chills was treated with dexamethasone, remdesivir and O2; and injection site pain, malaise, pyrexia and COVID-19 were treated with dexamethasone and remdesivir. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of the events hernia pain and reaction at or around the injection site: pain was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 infection; Cold shivers; muscle strain; Not feeling well; Nausea; Fever: 38 to 40.5 degrees Celsius


VAERS ID: 1152979 (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: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Cardiac failure, Erysipelas, Erythema, Fluid retention, Peripheral swelling, Pyrexia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Arthritis (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210315; Test Name: fever; Result Unstructured Data: Test Result:38 to 40.5 Centigrade
CDC Split Type: NLPFIZER INC2021328267

Write-up: Fluid retention; Renal failure/kidney failure; Erysipelas; Generalized joint pain; very thick inflamed legs; Fever: 38 to 40.5 degrees Celsius; Cardiac failure/heart failure; erythema; This is a spontaneous report from a contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00481336. An 89-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number and expiry date unknown), via an unspecified route of administration, on 14Mar2021, at a single dose, for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had no previous covid-19 infection. The patient experienced the following adverse events on 15Mar2021: fluid retention, renal failure/kidney failure, erysipelas, generalized joint pain, very thick inflamed legs, fever: 38 to 40.5 degrees Celsius, cardiac failure/heart failure, and erythema. The outcome of the events was fatal. The patient died on an unspecified date in Mar2021. It was unknown if an autopsy was performed. Reporter''s comments: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): No. Kidney failure. Additional information ADR: Fluid retention, very thick legs, inflamed legs, erythema, heart failure. BSN available: Yes. COVID-19. Previous COVID-19 infection: No. Other: diagnostic procedures: No was no more. No follow-up attempts are possible; information on the lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): No. Kidney failure. Additional information ADR: Fluid retention, very thick legs, inflamed legs, erythema, heart failure. BSN available: Yes. COVID-19. Previous COVID-19 infection: No. Other: diagnostic procedures: No was no more.; Reported Cause(s) of Death: fluid retention; renal failure/kidney failure; erysipelas; generalized joint pain; very thick inflamed legs; fever: 38 to 40.5 degrees Celsius; cardiac failure/heart failure; erythema


VAERS ID: 1152980 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-03-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: positive after 9 days; Test Result: Positive
CDC Split Type: NLPFIZER INC2021333751

Write-up: vaccination failure/COVID-19 confirmed by positive COVID-19 test 9 days after start; COVID-19 confirmed by positive COVID-19 test 9 days after start; This is a spontaneous report from a contactable physician downloaded from the Agency Agency-WEB, regulatory authority number NL-LRB-00482557. An 87-year-old female patient received the first dose of bnt162b2 (COMIRNATY), on 26Jan2021 and then received the second dose on 23Feb2021 both via an unspecified route of administration as a single dose for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. On 04Mar2021, the patient experienced vaccination failure/covid-19 confirmed by positive covid-19 test 9 days after start. The outcome of the events was fatal. Cause of death was vaccination failure/covid-19 confirmed by positive covid-19 test 9 days after start. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test 9 days after start; vaccination failure/COVID-19 confirmed by positive COVID-19 test 9 days after start


VAERS ID: 1152983 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-02-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram abdomen, Diarrhoea, Disease recurrence, Fall, Gastrointestinal necrosis, Gastrointestinal surgery, General physical health deterioration, Intestinal ischaemia, Mesenteric artery embolism, Sepsis
SMQs:, Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Noninfectious diarrhoea (narrow), Sepsis (narrow), Opportunistic infections (broad)

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mesenteric ischemia
Allergies:
Diagnostic Lab Data: Test Date: 20210301; Test Name: abdominal CT; Result Unstructured Data: Test Result:Acute on chronic mesenteric ischemia; Comments: acute on chronic mesenteric ischemia with necrosis of the small intestine; Test Date: 202103; Test Name: Gastrointestinal surgery; Result Unstructured Data: Test Result:only 40 cm of viable intestines were found; Comments: and this was not compatible with life
CDC Split Type: NOPFIZER INC2021328319

Write-up: SEPSIS; EMBOLISM MESENTERIC; MESENTERIC ISCHEMIA/acute on chronic mesenteric ischemia with necrosis of the small intestine; MESENTERIC ISCHEMIA/acute on chronic mesenteric ischemia with necrosis of the small intestine; acute on chronic mesenteric ischemia with necrosis of the small intestine; DIARRHEA; REDUCED GENERAL CONDITION; FALLING DOWN; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory authority report number NO-NOMAADVRE-FHI-2021-Uj3g9z, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00022624. An 86-years-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number: EP2166), via unspecified route of administration on 26Feb2021 at a single dose for COVID-19 immunization. Medical history included Chronic Mesenteric Ischemia. The patient''s concomitant medications were not reported. On 27Feb2021, the patient experienced diarrhea, reduced general condition, and ''falling down''. On 01Mar2021, the patient developed sepsis, embolism mesenteric, mesenteric ischemia. On the same day, abdominal CT confirmed acute on chronic mesenteric ischemia with necrosis of the small intestine. The patient was admitted to hospital from 01Mar2021 to an unspecified date due to sepsis, embolism mesenteric, mesenteric ischemia/acute on chronic mesenteric ischemia with necrosis of the small intestine. On an unspecified date in Mar2021, gastrointestinal surgery was performed and only 40 cm of viable intestines were found and this was not compatible with life. The patient died in Mar2021 due to sepsis, embolism mesenteric, and mesenteric ischemia/acute on chronic mesenteric ischemia with necrosis of the small intestine. The outcome of the other events was unknown. It was not reported if an autopsy was performed. Sender Comment: The report applies to a patient who got diarrhea, reduced general condition and fell at home the day after the second dose of COMIRNATY. On 01Mar2021, the patient was hospitalized due to sepsis, embolism mesenteric, mesenteric ischemia/acute on chronic mesenteric ischemia with necrosis of the small intestine. Abdominal CT showed acute on chronic mesenteric ischemia with necrosis of the small intestine. The reported reactions are not among the known side effects of this vaccine. As of today, we know a lot about side effects that occur in the days and weeks after vaccination, but we cannot rule out rare side effects or whether there should be side effects that only appear long after the vaccination. In each case, it is difficult to know whether the symptoms are due to the vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition and thus is disposed of in the relevant case. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed 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. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sepsis; Embolism mesenteric; mesenteric ischemia/acute on chronic mesenteric ischemia with necrosis of the small intestine; mesenteric ischemia/acute on chronic mesenteric ischemia with necrosis of the small intestine; mesenteric ischemia/acute on ch


VAERS ID: 1152992 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-07
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / 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:
Current Illness: Arterial hypertension (hypertonia arterialis); Epidural hematoma (Chronic epidural hematoma); Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021323083

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Agency Agency-WEB PL-URPL-3-367-2021. An 81-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EP9598; Expiration Date: 30Jun2021), intramuscular, administered in left arm on 18Feb2021 11:45 at a single dose for COVID-19 immunisation. Medical history included ongoing chronic extradural haematoma, ongoing arterial hypertension (hypertonia arterialis), and ongoing Type 2 diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced death on 07Mar2021 07:30, 3 weeks after vaccination of Comirnaty. The cause of death was unknown. It was unknown if an autopsy was performed. The reporter commented that death was not related to vaccination. Sender comments: In the submitted report, no post-vaccination symptoms preceding the patient death were described. Agency has only knowledge about comorbidities in the patient, i.e. arterial hypertension, non-insulin-dependent diabetes mellitus, chronic epidural hematoma. There is a time relationship between vaccine administration and death. Due to the above information, Agency assessed the reported death as occurring in a temporary coincidence with vaccination. The reporting doctor, in the description of the reaction, also did not link the death with the administration of the Comirnaty vaccine. The person reporting vaccine adverse event qualified it as severe. Due to the health result - death, Agency assessed the vaccine adverse event as severe. Death /WHO scale, Agency/ Unlikely. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Death not related to vaccination; Sender''s Comments: Event unknown cause of death is assessed as Related by the company until sufficient information is available to confirm an unrelated cause of death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1152993 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Oxygen saturation decreased
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), Infective pneumonia (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021328338

Write-up: Cardiac arrest; Oxygen saturation decreased; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority number is PL-URPL-DML-MLP.4401.1.180.2021. An 89-year-old male patient received his second dose of BNT162B2 (COMIRNATY, lot number: EP9598), via an unspecified route of administration on 19Feb2021 at 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received his first dose of BNT162B2 (COMIRNATY, lot number and expiration date were not reported) at the age of 89-years-old, via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunisation without side effects. On 25Feb2021 at 18:30, the patient experienced a decrease in saturation and on 26Feb2021, the patient experienced cardiac arrest. The patient died on 26Feb2021. The causes of death were cardiac arrest and oxygen saturation decreased. An autopsy was not performed. The physician reported that the second dose was fatal and assessed the side effect as severe (death). The reporting physician assessed the side effect as severe (death). URPL classified the application as serious. 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. Causality assessment for the events and the suspect drug was reported as unlikely. Sender''s Comment: The fall in saturation (which resulted in cardiac arrest) is an unexpected adverse reaction, not included in section 4.8 of Comirnaty''s Summary of Product Characteristics. There is a time relationship between the administration of the drug and the occurrence of the side effect. Due to the lack of detailed information (autopsy results, health history, comorbidities, medications taken, etc.), it cannot be ruled out that a factor other than the administered vaccine may have contributed to the death. The reporting physician assessed the side effect as severe (death). URPL classified the application as serious. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: ICD-10 I46 Cardiac arrest; Oxygen saturation decreased


VAERS ID: 1153022 (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: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypotension, Infection, Pneumonia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOXALOLE; EBIXA; CYKLOKAPRON; PARACETAMOL NET; RISPERIDON ACTAVIS; OXASCAND; MIRTAZAPIN ACTAVIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Dementia; Depressed mood; Pain; Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: blood pressure; Result Unstructured Data: Test Result:95/47 mmHg; Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: SEPFIZER INC2021282922

Write-up: Fainted; Blood pressure 95/47; Suspected infection/pneumonia; Suspected infection/pneumonia; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority report number: SE-MPA-2021-007688). A 95-year-old male patient received BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) in Jan2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included pain, dementia, anxiety, depressed mood and renal failure; all unknown if ongoing. Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOXALOLE) from 19Nov2020 to an unspecified date; memantine hydrochloride (EBIXA) from Jan2021 to an unspecified date; tranexamic acid (CYKLOKAPRON) from 19Nov2020 to an unspecified date; paracetamol (PARACETAMOL NET) from 19Nov2020 to an unspecified date; risperidone (RISPERIDON ACTAVIS) from 19Nov2020 to an unspecified date; oxazepam (OXASCAND) from 05Nov2020 to an unspecified date; and mirtazapine (MIRTAZAPIN ACTAVIS) from 19Nov2020 to an unspecified date. In Jan2021, 22 days after the vaccination, the patient had fainted while sitting on a chair; and blood pressure was at 95/47 mmHg. The events were reported to be serious (medically significant). The patient''s COVID-19 virus test in Jan2021 came back negative. A few days later, on an unspecified date in 2021, the patient had died, and the cause of death was suspected infection/pneumonia according to the death certificate. No autopsy was performed. The outcome of the events, ''fainted'' and ''blood pressure was at 95/47 mmHg'', was unknown. 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: Suspected infection/pneumonia; Suspected infection/pneumonia


VAERS ID: 1153028 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, General physical health deterioration, Pyrexia, Respiratory arrest, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic surgery; Aortic valve stenosis; Atrial fibrillation; Cardiovascular disorder; Chronic obstructive pulmonary disease; Diabetes mellitus; Hypertension; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: SEPFIZER INC2021311839

Write-up: cardiac arrest; respiratory arrest; Fever; Reduced general condition; This is a spontaneous report from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-012281 and SE-MPA-1614936640058. A contactable physician reported that an 85-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: EJ6795), via an unspecified route of administration on Jan2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included atrial fibrillation, cardiovascular disorder, aortic surgery chronic obstructive pulmonary disease, diabetes mellitus and hypertension, previous aortic valve stenosis surgery and stroke. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number: EJ6795) on Dec2020 at 0.3 ml, single for COVID-19 immunisation and approximately 2 weeks after the first dose, the woman developed a fever and had a CRP of $g160, treatment with DOXYFERM was initiated due to infection with unclear focus. The woman recovered. In late January, 9 days after the vaccination with dose 2, the woman developed reduced general health and a fever. There was a previous decision to initiate palliative care in case of deterioration. There was no CRP taken, COVID-test was negative (Jan2021). The woman died 15 days after the second dose (Jan2021). No autopsy has been performed. The reporter had never met the patient and on her death certificate he has submitted cardiac arrest and respiratory arrest as causes of death, alongside previous illnesses as contributing factors. However, he clearly states that he cannot know for certain what the cause of death was without an autopsy. He submitted what he thought was most likely. The outcome of the events was reported as fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Fever; Reduced general condition; cardiac arrest; respiratory arrest


VAERS ID: 1153587 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-03-06
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 626761A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, Myocardial infarction
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (narrow), Haemorrhagic central nervous system vascular conditions (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Autoimmune hepatitis; Cachexia; Calcinosis; Cirrhosis of liver; CREST syndrome; Enteroparesis; Gastroparesis; Hydrops fetalis; Large intestine angiodysplasia; Malnutrition; Peripheral artery occlusion; Portal hypertension; Sigmoid diverticulosis; Sjoegren''s syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Finger amputation; Gastrooesophageal varices ; Oesophageal variceal ligation; Pleural cavity drainage; Procedural pneumothorax; Upper gastrointestinal bleeding; Upper gastrointestinal bleeding; Comments:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20210

Write-up: A regulatory authority report was received from a physician concerning, a 60-year-old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced myocardial infarction and cerebral hemorrhage. The patient''s medical history included finger amputation, large intestine angiodysplasia, cachexia, autoimmune hepatitis, portal hypertension, peripheral artery occlusion, upper gastrointestinal bleeding, esophageal variceal ligation, cirrhosis of liver, enteroparesis, pleural cavity drainage, sigmoid diverticulosis, procedural pneumothorax, gastroesophageal varices, malnutrition, CREST syndrome, gastroparesis, sjogren''s syndrome, hydrops fetalis, calcinosis and drug intolerance to ilomedin and rivotril . No concomitant medications were reported. On 12 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 626761A) for prophylaxis of COVID-19 infection. On 6 Mar 2021, the patient experienced myocardial infarction and cerebral hemorrhage and subsequently died. No treatment information were provided. Cause of death was unknown. Plans for an autopsy were unknown. Action taken with mRNA-1273 in response to the events was not applicable.; Reporter''s Comments: Very limited information regarding circumstances leading to fatal myocardial infarction and fatal cerebral hemorrhage has been provided at this time.


VAERS ID: 1153614 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bronchiolitis, Decreased appetite, Depressed level of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-27
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Rarely was conscious; Could not eat and drink; Bronchiolitis; A regulatory authority report was received concerning a 100-year-old, female patient who experienced bronchiolitis, could not eat and drink/decreased appetite and rarely was conscious/ depressed level of consciousness. The patient''s medical history included COVID-19 in Oct 2021. Concomitant product use was not provided by the reporter. On 15 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient experienced reduced level of consciousness with difficulty in eating and drinking by mouth. On an unknown date,the patient was hospitalized. On 27 Feb 2021, the patient died with a diagnosis of bronchiolitis, with no accompanying fever. Treatment for the event included oxygen, buscopan as needed and morphine for pain and discomfort as well as temesta for sedation. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, could not eat and drink/decreased appetite and rarely was conscious/ depressed level of consciousness was unknown. The Patient died on 27 Feb 2021. Cause of death was reported as bronchiolitis. Plans for autopsy was not reported.; Reporter''s Comments: This case concerns a 100-year-old, female patient who experienced fatal event of bronchiolitis, decreased appetite and depressed level of consciousness. Very limited information regarding this event has been provided at this time. The patient''s advanced age and previous COVID-19 infection remains a risk factor. Cause of death was reported as bronchiolitis. Plans for autopsy was not reported.; Reported Cause(s) of Death: Bronchiolitis


VAERS ID: 1153633 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Lymphocytic infiltration, Pulmonary artery thrombosis, Pulmonary vasculitis
SMQs:, Interstitial lung disease (narrow), Embolic and thrombotic events, arterial (narrow), Eosinophilic pneumonia (narrow), Vasculitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021328303

Write-up: ; This is as spontaneous report received from a non-contactable physician downloaded from there regulatory authority. The regulatory authority report number is DE-PEI-PEI2021003643. A 75-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscular on 19Feb2021 first/ second or other dose (Batch/Lot Number: EL8723) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 20Feb2021 after vaccination the patient developed Thrombosis pulmonary artery and Lymphocytic infiltration and Pulmonary vasculitis, lasting for unknown. The patient was dead. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts possible. No further information expected. Information on lot/batch number already obtained.; Reporter''s Comments: Autopsy follows; Reported Cause(s) of Death: Fulminant thrombosis of the pulmonary arteries bds; Lymphocytic infiltration of the right ventricular myocardium; Microvascular inflammatory reaction of the pulmonary end-stream pathway


VAERS ID: 1153647 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal heart rate abnormal, Maternal exposure during pregnancy
SMQs:, 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: 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: ESPFIZER INC2021348584

Write-up: lack of fetal heartbeat; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable other healthcare professional reporting mother and fetus cases. This is second of two reports. The first report was downloaded from regulatory authority, The regulatory authority report number ES-AEMPS-784906. A 38-year-old female (mother) received BNT162B2 (COMIRNATY, Solution for injection, lot number: EJ6796), via an unspecified route of administration, 08Jan2021 at a single dose for COVID-19 immunization. Date of LMP (last menstrual period) was 16Dec2021. Gestation Period at Exposure was at 3 weeks. Concomitant medications was not reported. The patient with fertility problems was vaccinated with BNT162B2 on 08Jan2021 without knowing she was pregnant. The fetus patient experienced Maternal exposure during pregnancy first trimester on 08Jan2021 and lack of fetal heartbeat (foetal heart rate abnormal) (death) on an unspecified date. Outcome is fatal as the mother suffered an induced abortion due to lack of fetal heartbeat on 24Feb2021, at 10 weeks of gestation. No follow-up attempts are possible, no information is expected.; Sender''s Comments: Linked Report(s) : ES-PFIZER INC-2021283153 mother and fetus cases; Reported Cause(s) of Death: Fetal heartbeat absent


VAERS ID: 1153649 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Hypopnoea, Increased upper airway secretion
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   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: PRIMASPAN; AVODART; PANADOL FORTE [PARACETAMOL]; MEMANTIN ORION; GALVUS; TAMSULOSINE HCL SANDOZ; ANORO ELLIPTA; GABAPENTIN RATIOPHARM; DONEPEZIL ORION; SPESICOR DOS; CARDACE [RAMIPRIL]; KALCIPOS-D; MULTIVITAMINS [VITAMINS NOS]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021328220

Write-up: Death; Shallow breathing; Increased upper airway secretion; This is a spontaneous report from a contactable consumer via Regulatory Authority, downloaded from the regulatory authority A male patient of an unspecified age received BNT162B2 (COMIRNATY) via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history was not reported. Concomitant medications included acetylsalicylic acid (PRIMASPAN) at 100 mg daily, dutasteride (AVODART) at 0.5 mg daily, paracetamol (PANADOL FORTE), memantine hydrochloride (MEMANTIN ORION) at 10 mg daily, vildagliptin (GALVUS) at 50 mg daily, tamsulosin hydrochloride (TAMSULOSINE HCL SANDOZ) at 0.4 mg daily, umeclidinium bromide/vilanterol trifenatate (ANORO ELLIPTA) at 1 DF daily, gabapentin (GABAPENTIN RATIOPHARM) at 900 mg daily, donepezil hydrochloride (DONEPEZIL ORION) at 10 mg daily, metoprolol succinate (SPESICOR DOS), ramipril (CARDACE) at 5 mg daily, calcium carbonate/colecalciferol (KALCIPOS-D) at 2 DF daily and multivitamins (MULTIVITAMINS [VITAMINS NOS]), 1x1, all taken for unspecified indications, start and stop dates were not reported. On 26Feb2021, the patient experienced increased upper airway secretion and shallow breathing and he died on 26Feb2021 (cause of death was unknown). On 26Feb2021, the patient became very mucous and his breathing was superficial. On 26Feb2021 he passed away. It was unknown if an autopsy was performed. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1153652 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ9795 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia supraventricular; Cognitive disturbance; Hypertension arterial; Ischaemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021311540

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authorian. This is a report received from the Regulatory Authority. An 87-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscular on 27Jan2021 (lot number: EJ9795) as single dose for COVID-19 vaccination. The patient''s medical history included ischaemic heart disease, arrhythmia supraventricular, cognitive disturbance, and hypertension arterial. The patient''s concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (COMIRNATY) on 06Jan2021 for COVID-19 immunisation. The patient died due to cardio-respiratory arrest on 31Jan2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1153657 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Ischaemic stroke, SARS-CoV-2 test
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (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: Cancer of prostate (Hormonal therapy); Ketosis-prone diabetes mellitus (insulin-dependent diabetes)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201022; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021333492

Write-up: Ischemic stroke; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. An 83-year-old male patient received the second dose of bnt162b2 (COMIRNATY, lot number: EP9598), intramuscular administered in left arm on 01Mar2021 as SINGLE DOSE for COVID-19 immunisation. Medical history included ongoing ketosis-prone diabetes mellitus (insulin-dependent diabetes), COVID-19 history (positive test date 22Oct2020, form presented not provided) from 22Oct2020, and ongoing cancer of prostate (on hormonal therapy). The patient''s concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (COMIRNATY) on an unspecified date for COVID-19 immunisation. On 01Mar2021, the patient experienced ischemic stroke leading to the death of the patient on the same day. The patient died on 01Mar2021. 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: Ischemic stroke


VAERS ID: 1153707 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-02-23
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4243 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Brain injury, Cardiac arrest, Computerised tomogram head, Congestive cardiomyopathy, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   Days after onset: 7
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: H hernia
Allergies:
Diagnostic Lab Data: Test Name: Coronary Angiogram; Result Unstructured Data: Test Result:Clear; Test Name: CT Head; Result Unstructured Data: Test Result:Normal; Test Date: 20210227; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021319627

Write-up: Hypoxic Brain Injury; Dilated cardiomyopathy; Cardiac arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. Safety Report Unique Identifier GB-MHRA-ADR 25000301. A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4243, expiration date was not reported), via an unspecified route of administration on 13Feb2021 at single dose for covid-19 immunization. Medical history included H hernia. It was reported that patient has no major medical issues other than H hernia. Patient has not had symptoms associated with COVID-19, and was not enrolled in clinical trial. Concomitant medication included lansoprazole for hiatus hernia. The patient experienced cardiac arrest on 23Feb2021 (also reported as 23Mar2021). The clinical course was reported as follows: patient was taken to A&E (accident and emergency) with an out of hospital cardiac arrest on 23Feb2021 (also reported as 23Mar2021) 10 days after vaccination, patient was admitted to ITU (Intensive Therapy Unit). Coronary angiogram was clear, CT head normal. Death reported as due to hypoxic brain injury, cardiac arrest, and dilated cardiomyopathy. Patient had no prior cardiac history. This may of course be unrelated to the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (no - negative covid-19 test) on 27Feb2021. The patient died on 02Mar2021. It was not reported if an autopsy was performed. Patient had not tested positive for COVID-19 since having the vaccine. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: In concurrence with the reporting investigator, the Company deems the reported cardiac arrest occurred 10 days after the administration of COVID19 vaccine, BNT162N2, unlikely related to the suspect. Similarly, hypoxic brain injury and dilated cardiomyopathy are unrelated to the suspect.; Reported Cause(s) of Death: Hypoxic Brain Injury; Dilated Cardiomyopathy; Cardiac arrest


VAERS ID: 1153708 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-02-01
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia (advanced)
Preexisting Conditions: Comments: Unsure if patient has had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: Chest X-ray; Result Unstructured Data: Test Result:unremarkable; Test Date: 20210201; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021327159

Write-up: SARS-CoV-2 infection/ Vaccine breakthrough infection; This is a spontaneous report from a contactable healthcare professional. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202103231343284950, Safety Report Unique Identifier GB-MHRA-ADR 25005895. An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunisation. Medical history included ongoing dementia (advanced). Unsure if patient has had symptoms associated with COVID-19. She was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced SARS-CoV-2 infection and vaccine breakthrough infection on 01Feb2021. The events were assessed as serious by HA (fatal and medically significant). Case narrative: The patient received COVID vaccination 19Jan2021, confirmed COVID positive 01Feb2021. Treated with antibiotics. Chest x-ray unremarkable. Died 13Feb2021. Cause of death 1) advanced dementia and 2) COVID-19. An autopsy was not performed. The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive COVID-19 test on 01Feb2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Dementia; SARS-CoV-2 infection/ Vaccine breakthrough infection


VAERS ID: 1153718 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NORVASC; RAMIPRIL; METFORMIN; JARDIANCE; ZOCOR
Current Illness: Cardiovascular disorder; COVID-19 immunization; Diabetes mellitus; Hyperlipidemia; Hypertension; Smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC2021339609

Write-up: FEELING DIZZINESS; FAINT OUT DURING DRIVING; This is a spontaneous report from a non-contactable other healthcare professional and contactable consumer via Regulatory authority- (regulatory authority number: not reported), based on information received by Pfizer from BioNtech SE (manufacturer control number: 2021FOS000452), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from the department of health. The regulatory authority report number is unknown. A non-contactable HCP reported events for a 66-year-old male patient. Patient started to receive COVID-19 VACCINE (COMIRNATY) injection on 16-Mar-2021 at unspecified dosing frequency for COVID-19 immunization. Medical history included hypertension, diabetes mellitus, hyperlipidemia, cardiovascular disease and smoking history. Concomitant medication(s) included Norvasc(AMLODIPINE BESILATE), Ramipril(RAMIPRIL), Metformin(METFORMIN), Jardiance(EMPAGLIFLOZIN) and Zocor(SIMVASTATIN). Past drug not reported. The patient experienced FEELING DIZZINESS, FAINT OUT DURING DRIVING 19-Mar-2021. Clinical course as follow: patient had no discomfort during vaccination observation. On 19-Mar-2021, patient was feeling dizziness in the morning walking around in the park, then he was faint out in the car during driving, he was admitted to hospital immediately, but passed away eventually. No lab test was provided. Expert Committee on Clinical Event Evaluation of COVID-19 Vaccine claimed that the patient has chronic diseases, "three highs" and other problems, as well as smoking habits, possibly related to cardiovascular diseases. It is preliminarily considered that it has little direct relationship with the vaccine. A government expert consultant and professor of respiratory lecture said that the patient had a number of cardiovascular problems, all of which were high risk factors. It was not excluded that natural death was caused by acute myocardial infarction, and the cause of death may not be directly related to the vaccine. Many countries have received a total of more than 100 million doses of nucleic acid vaccine, and there is no report shows it will increase the risk of cardiovascular disease. The action taken for COVID-19 VACCINE (COMIRNATY) was not applicable. The patient died on 19-Mar-2021. It is unknown if an autopsy was performed. Follow-up (20-Mar-2021, 21-Mar-2021, 22-Mar-2021, 23-Mar-2021 and 25-Mar-2021): New information reported from a non-contactable consumer includes: medical history, new reporter, patient status during vaccination observation. Follow-up closed, no further information is possible. Causality Assessment: The reporter and manufacturer considered the causality of events dizziness and faint out during driving with the vaccine as possible.; Reported Cause(s) of Death: FEELING DIZZINESS; FAINT OUT DURING DRIVING


VAERS ID: 1153725 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dialysis; Renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330123

Write-up: collapsed at home; This is a spontaneous report from a contactable other healthcare professional via Agency Regulatory Authority. A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4238), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included ongoing dialysis patient and ongoing renal insufficiency both from an unknown date. It was unknown if the patient was pregnant at the time of vaccination. The patient''s concomitant medications were not reported. It was reported that the patient collapsed at home on an unspecified date. Emergency medical services performed, resuscitation. The outcome of collapsed at home was fatal. The patient died on an unspecified date. Cause of death was unknown. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. 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) : IL-PFIZER INC-2020517122 same correspondence reporter, same product, other patient, other events (master case); Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1153726 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiac arrest, Coronavirus test, Drug ineffective, Dyspnoea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure congestive; Cardiac pacemaker insertion; Lipids NOS
Allergies:
Diagnostic Lab Data: Test Name: Coronavirus test; Result Unstructured Data: Test Result:found positive for Corona
CDC Split Type: ILPFIZER INC2021330257

Write-up: Cardiac arrest and breathing; Cardiac arrest and breathing; Was found positive for Corona the day prior death; Was found positive for Corona the day prior death; This is a spontaneous report received from a contactable other HCP. A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route on unknown date for COVID-19 immunization. Medical history included Cardiac failure congestive, Cardiac pacemaker insertion and Lipid disorder. Concomitant medications were not reported. On unknown date the patient experienced Cardiac arrest and breathing and he was found positive for Corona the day prior death. No follow-up attempts are possible, information about batch /lot number cannot be obtained; 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. Cardiac arrest and Breathing difficult are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. 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: breathing difficult; Cardiac arrest and breathing


VAERS ID: 1153727 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4175 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high (Medically treated)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330263

Write-up: Was found lifeless in her home; This is a spontaneous report received from a non-contactable other health care professional via regulatory authorities. A 68-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EK4175), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included high blood pressure, medically treated. Concomitant medications were not reported. The patient was found lifeless in her home on an unspecified date. Time range between the vaccination and adverse event was 10 days. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: The limited information in this report precludes a full assessment of the case. However, "death cause unknown" is processed as "related" until sufficient information becomes available to exclude a reasonable possibility of relatedness to BNT162B2. 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: found lifeless in her home


VAERS ID: 1153728 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4175 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330274

Write-up: was found dead at home; This is a spontonues report received from Health Care Professional via regulatory authority. A 64 -year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK4175), on an unknown date at single dose for COVID-19 immunization. The patient had a lot of background diseases (not reported). Concomitant drugs were unknown. The patient was found dead in his home 60 hours after vaccination. No follow up attempts are possible , no further information is expected.; Sender''s Comments: Based on the information currently available, the underlying diseases might have contributed to patient''s demise. However, unless further information regarding specific cause of death is provided, at present, the reported event death of unknown cause is assessed as possibly related to suspect drug, as a cautionary measure and for reporting purposes. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2020517122 Same source,similar event,diffrent paitent; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1153729 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4242 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330310

Write-up: was found dead in his car; This is a spontaneous report received from other healthcare professional. A 41-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: EK4242) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) for COVID-19 immunization at unspecified date. It was reported that the patient was found dead in his car (reported as Time range: 3 days). The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2020517122 master; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1153730 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4240 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Myocarditis, 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), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypercholesterolemia; Hypertension; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330432

Write-up: Brought to the emergency room due to myocarditis; cough; difficulty breathing mainly when lying down; fever for three days; This is a spontaneous report from a contactable other healthcare professional via Agency Regulatory Authority. A 47-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EK4240) as SINGLE DOSE for COVID-19 immunisation. Medical history included Hypertension, hypercholesterolemia, hypothyroidism, diabetes with target organ damage. The patient received first dose of vaccine on unspecified date. The patient''s concomitant medications were not reported. The patient was brought to emergency room due to myocarditis, fever for three days, cough and difficulty breathing mainly when lying down. He was anesthetized and resuscitated due to his rapidly deteriorating condition. The patient died due to myocarditis. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Batch/lot number already provided.; Sender''s Comments: Linked Report(s) : IL-PFIZER INC-2020517122 same reporter/vaccine, reporting similar events in different patients; Reported Cause(s) of Death: myocarditis


VAERS ID: 1153731 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4242 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial disorder (heart diseases and arteries including heart failure); Diabetes; Disorder lung; Heart disorder (heart diseases and arteries including heart failure); Heart failure; Hypertension; Kidney disorder; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330457

Write-up: was found dead in his home; This is a spontaneous report from a non-contactable other healthcare professional (HCP) via regulatory authority. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (batch/lot number: EK4242) as a single dose for COVID-19 immunisation. Medical history included hypertension, heart diseases and arteries including heart failure, lung diseases, kidney diseases, diabetes, obesity. The patient''s concomitant medications were not reported. The patient was found dead in his home on an unspecified date. Time range reported as 3 days. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. Medical history of hypertension, heart diseases and arteries including heart failure, lung diseases, kidney diseases, diabetes, obesity may provide plausible explanations for the event. 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) : IL-PFIZER INC-2020517122 same drug and event, different patient; Reported Cause(s) of Death: was found dead in his home


VAERS ID: 1153732 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4242 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Pyrexia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Anemia; Diabetes; Hepatitis C; Hypertension; Hypoalbuminemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330464

Write-up: Died in the emergency room; Fever raised; Wheezing in lungs; This is a spontaneous report from a contactable healthcare professional. A 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4242; Expiration date was not reported) as a single dose, with route of administration and therapy date unspecified for COVID-19 immunization. Medical history included hepatitis C, Alzheimer''s, hypertension, diabetes, hypoalbuminemia and anemia. The patient''s concomitant medications were not reported. On an unspecified date, days after the vaccination, the patient had fever raised and wheezing in the lungs. The events resulted into an emergency room visit, and the patient was treated with antibiotics. On an unspecified date, the patient had died in the emergency room. The outcome of the events, ''fever'' and ''wheezing in the lungs'', was unknown. It was unknown if an autopsy was performed, and the cause of death was not reported. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on current convention, the case of death is assessed as related to BNT162B2 until sufficient information is available to confirm an unrelated cause of death. The patient had multiple comorbidities that may have contributed to patient''s demise. Additional information is needed to better assess this report. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: died in the emergency room


VAERS ID: 1153733 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4242 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm aortic; Hypertension; Stenosis aortic valve
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330520

Write-up: death; This is a spontaneous report from a contactable other healthcare professional (hcp) received from Agency Regulatory Authority. Regulatory report number was not reported. A 61-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EK4242, expiry date not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included aortic valve aneurysm, hypertension, and valve stenosis, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced death on an unspecified date. The cause of death was unknown. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1153736 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-10
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Dyspnoea, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   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: Medical History/Concurrent Conditions: Dementia; Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021328271

Write-up: Sudden death 11 days after injection; Shortness of breath; aphasia; This is a spontaneous report from a contactable consumer and physician downloaded from the regulatory authority. The case was received via regulatory authority. An 80-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Dec2020 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included diabetes and dementia. The patient''s concomitant medications were not reported. According to the HCPs at the nursing home, she did not experience any adverse events directly after the vaccination or changes to her condition. According to the reporting relative, she experienced aphasia after the vaccination when he spoke to her on the phone. In the morning of 10Jan2021, it was reported that the patient felt breathlessness when she walked to the toilet. She was found dead in her bed about 30 minutes later. The doctor on duty confirmed the death. Went through the medical records and there was no indication of a reaction to the vaccination, both during review of the medical records and in conversations with staff. Sudden death 11 days after injection. The patient died on 10Jan2021. Autopsy was performed on 12Jan2021 and the conclusion was as follows: Acute closure of the right coronary artery is considered to fully explain unexpected cardiac death. The connection between this event and the vaccination 11 days earlier would be judged to be non-existent or unlikely. Sender Comment: This case was received via the e-reporting system from a relative. Follow-up information was received from the treating physician. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Sudden death; Autopsy-determined Cause(s) of Death: Acute closure of the right coronary artery is considered to fully explain unexpected cardiac death


VAERS ID: 1153762 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood albumin, Blood bilirubin, Blood creatinine, Bradykinesia, C-reactive protein, Computerised tomogram, Decreased appetite, Dyspnoea, Echocardiogram, Fall, Haemoglobin, Haemoglobin decreased, Hypotension, Jaundice, Lumbar puncture, Lung disorder, Lymphadenopathy, Metabolic acidosis, Procalcitonin, Renal impairment, Respiratory failure, Serratia test positive, Stenotrophomonas test positive, Thrombocytopenia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 14
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: LASIX [FUROSEMIDE]; ZYLORIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure; Diabetes mellitus; Hypertension arterial; Hyperuricemia; MGUS; Prostatic hypertrophy (benign) (declared "prostatic hypertrophy")
Allergies:
Diagnostic Lab Data: Test Name: albuminemia; Test Result: 2.1 [iU]; Comments: 2.1 INTERNATIONAL UNIT(S)-(UNDER 100); Test Name: Bilirubin; Test Result: 10.38 [iU]; Comments: 10,38 INTERNATIONAL UNIT(S)-(UNDER 1000); Test Name: creatininemia; Test Result: 6 [iU]; Comments: 6 INTERNATIONAL UNIT(S)-(UNDER 100); Test Name: Whole body CAT; Result Unstructured Data: Test Result:multiple polydistrict lymphadenopathies; Comments: multiple polydistrict lymphadenopathies, right supleural lung lesion of 2 cm ndd, right renal expansion; Test Name: C-reactive protein; Test Result: 150 [iU]; Comments: 150 INTERNATIONAL UNIT(S)-(UNDER 1000); Test Name: Transesophageal echocardiogram; Result Unstructured Data: Test Result:negative; Test Name: Haemoglobin; Test Result: 8.4 [iU]; Comments: 8.4 INTERNATIONAL UNIT(S)-(UNDER 100); Test Name: Spinal tap; Result Unstructured Data: Test Result:Negative; Test Name: Procalcitonin; Test Result: 4.88 [iU]; Comments: 4.88 INTERNATIONAL UNIT(S)-(UNDER 100); Test Name: Serratia test positive; Result Unstructured Data: Test Result:positive; Test Name: Stenotrophomonas test positive; Result Unstructured Data: Test Result:positive; Test Name: Thrombopenia; Test Result: 19000 k[iU]
CDC Split Type: ITPFIZER INC2021323049

Write-up: stenotrophomonas test positive; serratia test positive; haemoglobin: 8.4 IU; thrombocytopenia: 19000 kiu; multiple polydistrict lymphadenopathies; right supleural lung lesion; ideomotor slowdown; Dyspnea; loss of appetite appears; worsening jaundice; metabolic acidosis; fell to the ground; worsening of renal function; arterial hypotension; severe respiratory insufficiency; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-701777. A 82-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EP9598, Expiry date: Unknown) via intramuscularly on 02Mar2021 as single dose for covid-19 immunisation. Medical history included hypertension, hyperuricaemia, diabetes mellitus, benign prostatic hyperplasia declared (prostatic hypertrophy), chronic kidney disease, hypergammaglobulinaemia benign monoclonal. Concomitant medications included Furosemide (LASIX) and Allopurinol (ZYLORIC) taken for an unspecified indication. On 02Mar2021, the patient experienced ideomotor slowdown, dyspnea, loss of appetite appears, worsening jaundice, metabolic acidosis, fell to the ground, worsening of renal function, arterial hypotension and severe respiratory insufficiency. The patient arrived in the Emergency Room in on 07Mar2021 and was hospitalized in the Emergency Room from which he was transferred to the Hospital on 09Mar due to lack of beds. The patient underwent lab tests and procedures which included blood albumin: 2.1 IU (international units) (under 100) , blood bilirubin: 10.38 IU (under 1000), blood creatinine: 6 IU (under 100), computerised tomogram: multiple polydistrict lymphadenopathies, right supleural lung lesion of 2 cm ndd, right renal expansion, c-reactive protein: 150 IU (under 1000), echocardiogram: negative, haemoglobin: 8.4 IU (under 100), lumbar puncture: negative, procalcitonin: 4.88 IU (under 100), serratia test positive: positive, stenotrophomonas test positive: positive, thrombocytopenia: 19000 kiu. Therapeutic measures were taken with tracheal intubation and mechanical intubation, antibiotic therapy, vasopressors, CVVH (renal replacement therapy). The patient died on 17Mar2021. It was not reported if an autopsy was performed. The outcome of the event was fatal.; Reporter''s Comments: Initial information dated 18Mar2021: - concomitant use of other products: ''no'';; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1153782 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Body temperature, Brain compression, Brain neoplasm, Cardio-respiratory arrest, Cerebral haemorrhage, Subarachnoid haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210323; Test Name: AI (Autopsy imaging); Result Unstructured Data: Test Result:cerebral hemorrhage (cerebellum); Test Date: 20210319; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021326145

Write-up: Cerebral haemorrhage; brain stem compression; subarachnoid hemorrhage; cardiopulmonary arrest; Brain tumor; This is a spontaneous report from received from the regulatory authority. The regulatory authority report number is v20101958. A contactable physician reported that a 26-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EP9605; Expiration Date: 30Jun2021), via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that On 23Mar2021 (4 days after the vaccination), she did not show up for the night shift, and her family visited her home and found her in cardiopulmonary arrest, around 11.00 Autopsy imaging (AI) showed findings including cerebral hemorrhage (cerebellum), brain stem compression and subarachnoid hemorrhage. Suspicion of brain tumor was also suggested. The patient underwent lab tests and procedures which included body temperature: 36.0 centigrade on 19Mar2021 before vaccination, imaging procedure: cerebral hemorrhage on 23Mar2021, findings included: cerebral hemorrhage, brain stem compression and subarachnoid hemorrhage. Suspicion of brain tumor was also suggested. The patient underwent lab tests and procedures which included body temperature: 36.0 centigrade on 19Mar2021 before vaccination, imaging procedure: cerebral hemorrhage (Cerebellum) on 23Mar2021. Findings included: cerebral hemorrhage, brain stem compression and subarachnoid hemorrhage. Suspicion of brain tumor was also suggested. The outcome of events cardiopulmonary arrest, brain tumor was unknown. The patient died on 23Mar2021. Autopsy was performed. The reporting physician classified the event as serious (Death) and assessed that the causality between the event and BNT162B2 as un-assessable. Other possible causes of the event such as any other diseases were cerebral hemorrhage (cerebellum) and subarachnoid hemorrhage. No further follow-up is possible. No information is required. Health authority comment: The AI showed the above findings and they were determined to be the direct causes of death. The causal relationship between the vaccination and the death could not be evaluated.; Reported Cause(s) of Death: brain stem compression; subarachnoid hemorrhage; Cerebral haemorrhage


VAERS ID: 1153788 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: MTPFIZER INC2021338126

Write-up: covid-19; covid-19; This is a spontaneous report from a contactable physician through a sales representative. This is the 1st report out of 6 from the same reporter reporting similar events for 6 different patients. An over 80 years old elderly patient of an unspecified gender received first and second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were not reported) as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had died from COVID-19 (despite being fully vaccinated) within 14 days of taking the second dose. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Drug causality cannot be excluded for suspect medication BNT162B2 in onset of the reported events. It was noted that patient had died from COVID-19 (despite being fully vaccinated) within 14 days of taking the second dose. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.; Reported Cause(s) of Death: Drug ineffective; COVID-19


VAERS ID: 1153790 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Myocardial infarction, Seizure, Vaccination site pain
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioplasty; Heart attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYPFIZER INC2021315230

Write-up: cause of death was due to a heart attack/complained of chest pain and had difficulty breathing/ became unconscious.; seizure; feeling ache of hand at the vaccination site; dizziness; This is a spontaneous report from press release by regulatory authority from a non-contactable healthcare professional which identified by a sales representative. A 42-year-old male patient received first dose of bnt162b2 (COMIRNATY) on 02Mar2021 morning at single dose for COVID-19 immunisation. Medical history included heart attack from unspecified date and undergone an angioplasty procedure in 2013. Concomitant medications were not reported. The patient showed no contraindications and did not have any side effects when he was observed at the Vaccine Centre. A day after vaccination (on 03Mar2021), he had only complained of feeling ache of hand at the vaccination site and symptoms of dizziness but was able to continue working as usual. On the second day of vaccination, there were no problems and he had carried on with his daily duties as usual until 19Mar2021. Early morning on 21Mar2021, the patient''s wife who is a specialist doctor said he had complained of chest pain and had difficulty breathing, then suffered a seizure and became unconscious. The patient''s wife made an emergency call and performed cardiopulmonary resuscitation (CPR) at home. He was rushed to a hospital''s emergency and trauma department where an active resuscitation was done but failed to be rescued. Based on the symptoms, clinical signs and case presentation, the emergency specialist confirmed that the cause of death was due to a heart attack and there was no link to the Covid-19 vaccination. Outcome of other events was unknown. The patient died on 21Mar2021. It was unknown if autopsy was performed. No follow up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: The events heart attack and seizure were considered as intercurrent conditions and unrelated to the use of bnt162b2. Seizure could be secondary to heart attack. 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: cause of death was due to a heart attack/complained of chest pain and had difficulty breathing/ became unconscious.


VAERS ID: 1153800 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000042722 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210104; Test Name: corona, bevestigd met test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Sudden death; A Agency Regulatory Authority report was received by a healthcare professional, concerning a female patient of 81 years of age, who received Moderna''s COVID-19 vaccine on 02 Mar 2021 and later suddenly died on 04 Mar 2021. The patient''s medical history included Covid-19. Concomitant product use was not provided by the reporter. On 02 Mar 2021, prior to the onset of events, the patient received a dose of mRNA-1273 (lot number - 3000042722) via an unknown route for COVID-19 infection prophylaxis. On 04 Mar 2021, after dose of vaccine, the patient suddenly died. Treatment medication was not reported by the reporter . Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event, Sudden death was considered to be fatal at the time of this report.; Reporter''s Comments: This is a case of sudden death in a 81-year-old female subject with unknown medical history except recent history of Covid infection, who died 2 days after receiving Moderna''s COVID-19 vaccine. Very limited information has been provided at this time. Further information has been requested. No follow up is possible.; Reported Cause(s) of Death: morbus subitum


VAERS ID: 1153802 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Herpes zoster, Malaise, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
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: Drowsiness/waardoor suf worden en uiteindelijk overlijden; Decreased appetite/verminderde intake; Malaise/algehele malaise zonder koorts; Herpes zoster; A regulatory report was received from a physician concerning a 101-year-old, female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced drowsiness/waardoor suf worden en uiteindelijk overlijden, decreased appetite/verminderde intake, malaise/algehele malaise zonder koorts and herpes zoster. The patient''s medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. On 1 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 300042722) intramuscularly for prophylaxis of COVID-19 infection. On 1 Mar 2021, the patient experienced drowsiness, decreased appetite, malaise and herpes zoster. As per the report, drowsiness, decreased appetite, malaise and herpes zoster resulted in patient death. The patient died on 10 Mar 2021. Autopsy information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome for the events, drowsiness, decreased appetite, malaise and herpes zoster, were considered fatal.; Reporter''s Comments: This fatal case concerns a 101 Y/O F with serious unexpected events of somnolence, malaise, decreased appetite, and herpes zoster. Event onset 4 days after first dose mRNA-1273. Event outcome death. Autopsy information not provided. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: algehele malaise zonder koorts; waardoor suf worden; verminderde intake; herpes zoster


VAERS ID: 1157293 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-02-22
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Condrosulf; COVERAM; INVOKANA [CANAGLIFLOZIN]; JANUMET; PLAVIX
Current Illness: Arterial hypertension; Lumbo-sacral pain; Obesity; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial stent insertion (mesenteric artery and celiac trunk); Mesenteric ischemia; Percutaneous coronary intervention (mesenteric artery and celiac trunk)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; A regulatory report, was received from a physician concerning a 76-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced death. The patient''s medical history included type 2 diabetes mellitus, arterial hypertension, obesity, mesenteric ischemia, lumbovertebral syndrome, and PTCA and stenting of the mesenteric artery and celiac trunk. Concomitant medications included chondroitin sulfate sodium, amlodipine besilate/perindopril arginine, canagliflozin, metformin hydrochloride/sitagliptin phosphate, and clopidogrel bisulfate. On 23 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Batch: 300042460) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 20 FEB 2021, the patient received their second of two planned doses of mRNA-1273 (Batch: 300042723) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 22 FEB 2021, the patient died. Cause of death was unknown. Plans for an autopsy was not provided. The action taken with mRNA-1273 in response to the event was not applicable. The reporter considered the death unlikely related to mRNA-1273.; Reporter''s Comments: This case concerns a 76-year-old, male, with multiple comorbidities, who experienced a serious (fatal) unexpected event of death (unknown cause). Death occurred 2 days after receiving 2nd dose of mRNA-1273 (Lot# 300042723). Based on the current available information, the event was considered unrelated to the study medication in agreement with the reporter''s assessment. The advance age and multiple co-morbidities may remain as risk factors. No further information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1157379 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Malaise, Nausea, Pneumonia, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), 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: Atrial fibrillation; Dementia
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: A regulatory authority report was received from a physician concerning a 90- year old-female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced pneumonia, malaise, dyspnea,f atigue, vomiting, nausea, fever and died. The patient''s medical history included Covid-19, dementia and atrial fibrillation. No relevant concomitant medications were reported. On 23-Feb-2021, prior to the onset of the events, the patient received their first of two doses of mRNA-1273 (lot/batch unknown) intramuscularly for prophylaxis of COVID-19 infection. On 24-Feb-2021, the patient experienced fatigue. On 26 Feb 2021,t he patient experienced pneumonia, malaise, dyspnea, vomiting, nausea and fever. Treatment information was not provided. The date and the cause of the death was not provided. Autopsy details were not provided. Action taken with mRNA-1273 in response to the events was not applicable. On an unknown date,t he outcome of the events, pneumonia, malaise, dyspnea, fatigue, vomiting, nausea and fever were considered fatal.; Reporter''s Comments: A case of death of a 90- year old-female (date and cause unknown). Patient experienced fatigued 1-day post mRNA-1273, pneumonia, malaise, dyspnea, vomiting, nausea and fever 2-day post mRNA-1273. With pneumonia being of an infective origin and the patient''s advanced age. The other events are assessed as symptoms of pneumonia, Hence, the reported events with fatal outcome is assessed as unlikely related to mRNA-1273; Reported Cause(s) of Death: unknown


VAERS ID: 1157383 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-03-04
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Plasma cell myeloma
SMQs:, Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Multiple myeloma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Multiple myeloma progression; death; A regulatory authority report was received from a physician concerning a female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and died. The patient''s medical history included multiple myeloma. Concomitant product use was not provided by the reporter. On 26-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. On 23-FEB-2021 the patient received the second dose of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. On 04 March 2021, the patient died. No other details were reported. Treatment information was unknown. Action taken with the drug in response to the event was unknown. The patient died on 04 March 2021. The cause of death was multiple myeloma progression. Plans for an autopsy were unknown.; Reporter''s Comments: This is a case of death in a female subject of unknown age with a medical history of multiple myeloma, who died 9 days after receiving second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death:


VAERS ID: 1158404 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Heart rate
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history reported.)
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: Blood pressure; Result Unstructured Data: normal; Test Date: 20210127; Test Name: pulse; Result Unstructured Data: normal
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death NOS; A regulatory authority report was received from a health care professional concerning a 75-year-old male patient who after the administration of Moderna''s COVID-19 vaccine (mRNA-1273) died (Death). The patient''s medical history was not provided. Concomitant product use was not provided. On 27 Jan 2021, the patient received first dose of two planned doses of mRNA-1273 (Batch number: 300042460) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, approximately 15 minutes after receiving the vaccination, the patient''s pulse (73/ min) and pressure (117/80 mmHg) were taken. Results were normal. On 29 Jan 2021, the patient was found dead by his relatives in his apartment. The patient died on 29 Jan 2021. The cause of death was not reported. Plans for autopsy was not provided. Action taken with the mRNA-1273 was not applicable.; Reporter''s Comments: Very limited information regarding this elderly patient''s death has been provided at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1158406 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Fatigue, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   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: BRIVIACT; LAMICTAL; TEVETEN COMP; ZOLPIDEM; PANTOZOL CONTROL
Current Illness: Epilepsy
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Compression fracture; Vitamin D deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death NOS; Myalgia; Fatigue; A regulatory authority report was received from a pharmacist concerning 80year old, female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced myalgia, fatigue and Death. The patient''s medical history included epilepsy, arterial hypertension and compression fracture with vitamin D deficiency. Products known to have been used by the patient, included brivaracetam, lamotrigine, eprosartan mesylate, zolpidem tartrate and pantoprazole sodium sesquihydrate. On 17 Feb 2021, approximately 1 day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021 the patient had myalgia and fatigue. On 19 Feb 2021, the patient died. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The patient died on 19 Feb 2021. The cause of death was not provided. An autopsy was not done.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (myalgia and fatigue), a causal relationship cannot be excluded. Very limited information regarding this elderly patient''s death has been provided at this time.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1161250 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THROMBO ASA
Current Illness: Breast carcinoma; Peripheral arterial occlusive disease; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke (status after stroke)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021333393

Write-up: Death; Ischaemic event is suspected a few hours after vaccination; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-18836. A 79-year-old male patient received the bnt162b2 (COMIRNATY, Solution for injection, lot number: ET1831), intramuscular, on 19Mar2021 at a single dose for COVID-19 immunisation. The patient''s medical history included peripheral arterial occlusive disease (continuing), Type 2 diabetes mellitus (continuing), Stroke (not continuing), Breast carcinoma (continuing). The patient''s weight and height were not reported. Concomitant medications included acetylsalicylic acid (THROMBO ASA). On 19Mar2021, the patient experienced ischaemia. On 22Mar2021, the patient experienced death. Ischemic event is suspected a few hours after vaccination, patient probably spent 3 days sitting in his armchair. Evidence of death around 11 a.m on 22Mar2021. Outcome of the event ischaemia was unknown. Outcome of the event death was fatal. The patient died on 22Mar2021. It was not reported if an autopsy was performed. Reporter comment: Ischemic event is suspected a few hours after the vaccination, the patient probably spent 3 days sitting in his armchair. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Ischemic event is suspected a few hours after the vaccination, the patient probably spent 3 days sitting in his armchair.; Reported Cause(s) of Death: death


VAERS ID: 1161254 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Computerised tomogram head, Haemorrhage intracranial, Urinary incontinence
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RIVAROXABAN; FRUSEMIDE [FUROSEMIDE]; PANTOPRAZOLE; PERINDOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic obstructive pulmonary disease; Congestive heart failure; Hypertension; Prostate cancer (unclear ifcurrent or previous medial history); Pulmonary hypertension; Tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210324; Test Name: CT of the head; Result Unstructured Data: Test Result:intercranial bleed
CDC Split Type: AUPFIZER INC2021338324

Write-up: incontinent of urine; intercranial bleed; symptoms indicative of stroke; This is a spontaneous report from a contactable other health care professional. An 86-year-old male patient received bnt162b2 (COMIRNATY, lot number and expiration date not provided), via an unspecified route of administration on 23Mar2021 at single dose for Covid-19 immunization. The patient''s medical history included atrial fibrillation, prostate cancer (unclear if current or previous medial history), tachycardia, hypertension, congestive heart failure, Chronic obstructive pulmonary disease, and pulmonary hypertension. The patient''s concomitant medications included rivaroxaban for atrial fibrillation, frusemide [furosemide], pantoprazole, and perindopril. The patient received the vaccine on Tuesday 23Mar2021 between 1 and 4 PM. The injection was given at the aged care facility and it was noted that the patient was well at the time of vaccination. On 24Mar2021 between 14 and 17 hours following the injection, symptoms indicative of stroke were noted to have developed. At 5.30am Wednesday 24Mar2021, the patient was noted to be incontinent of urine which was not usual for the patient. The patient was assessed at 7AM 24Mar2021 and was noted to have right sided weakness, slurred speech and right sided facial weakness. It was suspected that the patient had experienced an intercranial bleed and was sent by ambulance to the local emergency department and subsequently admitted to hospital. During Emergency Department evaluation a CT of the head demonstrated an intercranial bleed. The patient had a NFR (Not for resuscitation) order in place and thus the patient was palliated and not resuscitated should this be required. The patient was admitted overnight for observation and discharged to the nursing home the following day 25Mar2021. The patient passed away in the evening of 25Mar2021. The family have been informed of the death and are no concerned or believe that there are causal links with the vaccine and the patient''s stroke/passing. Representation was on the call and noted given the multiple co-morbidities and progression of events that this was unlikely related to the vaccine and the patient was high risk for a cerebrovascular event. The outcome of the event Urinary incontinence was unknown. The patient died on 25Mar2021. 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.; Sender''s Comments: Information provided was so limited to prevent a meaningful medical assessment. Other than a temporal association, there was no evidence or argument suggesting a causal relationship of BNT162B2 with fatal hemorrhage intracranial, cerebrovascular accident and serious urinary incontinence. Multiple co-morbidities increased cerebrovascular risk, in this old subject who plausibly died of his current medical conditions progression and unlikely to the vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: intercranial bleed; symptoms indicative of stroke


VAERS ID: 1161272 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

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: ASPIRIN [ACETYLSALICYLIC ACID]; LOVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coagulation disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: CRPFIZER INC2021354196

Write-up: Stroke; This is a spontaneous report from a contactable consumer (granddaughter). This consumer reporter similar events for three patients. This is the first of three reports. An elderly female 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 SINGLE DOSE for covid-19 immunisation. Medical history included Coagulation problem (also reported as coagulation) from an unknown date and unknown if ongoing. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and lovastatin (LOVASTATIN); both taken for coagulation, start and stop date were not reported. The reporter stated that: "My grandma passed away, it was unexpected. I''m telling you, we already know two cases similar to my grandmother, she got the vaccine on a Tuesday (unspecified date) and on Sunday (unspecified date) she had a stroke, doctors said that she got worse and could not get better or wake up from the stroke, because she had a coagulation affectation, she had treatment for coagulation, aspirinite and lovastatin". The patient died on an unspecified date. It was not reported if an autopsy was performed. Information about lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : CR-PFIZER INC-2021354341 same reporter, product, events / different patients;CR-PFIZER INC-2021354340 Same product and events, different patient; Reported Cause(s) of Death: Stroke


VAERS ID: 1161273 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

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: CRPFIZER INC2021354341

Write-up: Stroke; This is a spontaneous report from a contactable consumer. This consumer reporter similar events for three patients. This is the 2nd of three reports. An elderly 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 single dose for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that the patient got the vaccine on a Thursday (unspecified date), he had a stroke on Tuesday (unspecified date) and died on Wednesday (unspecified date) because he couldn''t take it anymore. The patient died on an unspecified date. It was unknown if an autopsy was performed. Information about lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : CR-PFIZER INC-2021354196 same reporter, product, and events, different patient;CR-PFIZER INC-2021354340 same reporter, product, and events, different patient; Reported Cause(s) of Death: Stroke


VAERS ID: 1161286 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (assumes that he became infected with COVID-19)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021310332

Write-up: later diagnosed with COVID-19/but vaccine could have worsened his condition significantly; Deterioration of the condition/but vaccine could have worsened his condition significantly; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority- CZ-CZSUKL-21002669. An adult male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included COVID-19, assumes that he became infected with COVID-19 just before the vaccination. The patient''s concomitant medications were not reported. The patient experienced the first symptoms of infection after the vaccination. In the first days of the infection, the patient attributed his condition to adverse reactions after the vaccination. He was later diagnosed with COVID-19 on an unspecified date. The reporter has impression that was a coincidence of two events, but vaccine could have worsened the condition/ deterioration of the condition of the patient significantly. The patient died 1 week after the vaccination with COMIRNATY on an unspecified date due to the events. It was not reported if an autopsy was performed. Information on the batch/lot number has been requested.; Reported Cause(s) of Death: later diagnosed with COVID-19/but vaccine could have worsened his condition significantly; Deterioration of the condition/but vaccine could have worsened his condition significantly


VAERS ID: 1161290 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction
SMQs:, Ischaemic central nervous system vascular conditions (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: Multimorbidity
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021333597

Write-up: malignant middle infarction; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-DCGMA-21188559. An 81-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: unknown), via an unspecified route of administration on 02Feb2021 (at the age of 81years) as single dose for Covid-19 immunization. Medical history included multimorbidity from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was reported that 1 day after vaccination (03Feb2021), the patient developed middle cerebral artery infarct, lasting for unknown, and died on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: malignant middle infarction


VAERS ID: 1161291 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-27
Onset:2021-03-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphthous ulcer, C-reactive protein, General physical health deterioration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   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: PANTOPRAZOL [PANTOPRAZOLE]; LEFLUNOMID; ASS; METHOTREXAT [METHOTREXATE]; PREDNISOLON [PREDNISOLONE]; BICANORM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis rheumatoid (Treatment with MTX, leflunomide and cortisone; Multimorbid patient with autoimmune diseases and RA); Bladder carcinoma; Coronary artery disease; Impaired renal function; Intermittent fever; Pelvic pouch procedure; Vigilance decreased
Allergies:
Diagnostic Lab Data: Test Name: C-reactive protein; Result Unstructured Data: Test Result:50 mg/ml
CDC Split Type: DEPFIZER INC2021333600

Write-up: Aphthous stomatitis; Deterioration in general condition; Fever; This is a spontaneous report a non-contactable physician downloaded from the regulatory authority [company number DE-DCGMA-21188565]. This report was forwarded via regulatory authority, however no RA number was provided. An 85-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 27Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included Vigilance decreased, Coronary artery disease, Bladder carcinoma, Impaired renal function, Pelvic pouch procedure, Intermittent fever, Multimorbid patient with autoimmune diseases and rheumatoid arthritis (Treatment with MTX, leflunomide and cortisone); all from an unknown date and unknown if ongoing. Concomitant medication included: bicanorm, pantoprazol, ass (reported as ass 100), prednisolone for unspecified indication and leflunomid, methotrexate for rheumatoid arthritis; all start and stop date were not reported. It was reported that 7 days after vaccination (06Mar2021) the patient developed Aphthous stomatitis and Condition aggravated (reported as Deterioration in general condition) and Pyrexia (reported as fever), lasting for unknown. The patient is dead. Diagnosis was confirmed by C-reactive protein (result: 50, unit: mg/ml). The patient died on 12Mar2021. An autopsy was not performed. It was reported that the time Interval between Beginning of Drug Administration and Start of Reaction / Event (number): 7 days. Per regulatory authority the result of assessment is indeterminate. Reporters comment: Measures: No hospital admission / extensive diagnostics and therapy in the event of further deterioration on the patient''s clear request on 11Mar2021. Police informed that for polymorbid patient investigations are not started, death was not unexpected, even without vaccination, but at least the patient had been driven to the vaccination and had expressly requested it. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: Measures: No hospital admission / extensive diagnostics and therapy in the event of further deterioration on the patient''s clear request on 11Mar2021. Police informed that for polymorbid patients investigations are not started, death was not unexpected, even without vaccination, but at least the patient had been driven to the vaccination and had expressly requested it.; Reported Cause(s) of Death: Aphthous stomatitis; Deterioration in general condition; fever


VAERS ID: 1161302 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-27
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, SARS-CoV-2 test
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021311571

Write-up: Covid-19 Pneumonia; Covid-19 Infection; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB with regulatory authority number DE-PEI-PEI2021003484. An 87-year-old male patient received his first dose of bnt162b2 (COMIRNATY; unknown lot number and expiration date) at vaccination age of 87-year-old intramuscular on 15Feb2021 as a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was reported that 13 days (27Feb2021) after vaccination the patient developed COVID-19 and COVID-19 pneumonia, lasting for 3 days. The patient is dead. The events was reported as serious with criterion of death. The patient underwent lab tests and procedures which included COVID-19 PCR test was positive on an unspecified date. It was reported that the cause of death was COVID-19 pneumonia. The outcome of the events was fatal. The patient died on 01Mar2021. It was unknown if an autopsy was performed. No follow-up attempts possible, batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1161303 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021311585

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB. An 83-year-old female patient received second dose of (COMIRNATY), via an unspecified route of administration on 15Mar2021 (Lot Number: EJ6789 and ER2659 as reported) as SINGLE DOSE for COVID-19 immunisation. The patient previously had first dose of COMIRNATY on 22Feb2021 for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Unknown after vaccination, the patient developed death on an unspecified date lasting for unknown (as reported). 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: Death


VAERS ID: 1161304 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Organ failure, Pyrexia
SMQs:, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   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: Dementia; Dysphagia; Osteoporosis; Respiratory tract infection; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:40 Centigrade
CDC Split Type: DEPFIZER INC2021311620

Write-up: Organ failure; Fever 40C; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB. A 93-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: EL8723) as single dose, for COVID-19 immunization. Medical history included urinary tract infection, respiratory tract infection, dementia, dysphagia, and osteoporosis from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY) dose 1, on 27Dec2020 for COVID-19 immunization. One day after vaccination, on 05Feb2021, the patient developed fever and organ failure, lasting for 2 days. The patient is dead and was not hospitalized and condition was life threatening. Cause of death was reported as organ failure. The patient died on 07Feb2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Organ failure


VAERS ID: 1161307 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspiration, Brain injury, Brain oedema, Cardiac arrest, Circulatory collapse, Computerised tomogram head
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Dialysis; Hypertension; Pleural effusion; Renal insufficiency (Requires dialysis)
Allergies:
Diagnostic Lab Data: Test Name: Brain computerised tomography; Result Unstructured Data: Test Result:Brain edema bilateral NA
CDC Split Type: DEPFIZER INC2021311658

Write-up: Oedema cerebral; Failure circulatory; Asystole; Aspiration; Post-resuscitation hypoxic brain damage; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB. A 67-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot Number: EP9598), via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. Medical history included hypertension, pleural effusion, renal failure(requires dialysis), dialysis, and diabetes mellitus all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 07Mar2021, the patient experienced failure circulatory, asystolia, aspiration, and post-resuscitation hypoxic brain damage. On 09Mar2021 the patient died of oedema cerebral, failure circulatory, asystolia, aspiration, and post-resuscitation hypoxic brain damage. The patient underwent lab tests and procedures which included computerised tomogram head: brain edema bilateral NA on an unspecified date. The patient died on 09Mar2021. An autopsy was not performed. The reporter considered all the events as fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Oedema cerebral; Failure circulatory; Asystole; Aspiration; Post-resuscitation hypoxic brain damage


VAERS ID: 1161309 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Diabetic retinopathy; Disorder thyroid; Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021311647

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB. An 83-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. Medical history included: Diabetic retinopathy, Diabetes mellitus, Renal insufficiency, Disorder thyroid, from unknown dates. The patient''s concomitant medications were not reported. After vaccination, the patient developed Death (Exitus letalis), lasting for unknown. The patient is dead on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information about batch number is not available. No further information expected; Reported Cause(s) of Death: Exitus letalis


VAERS ID: 1161311 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-02-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Cardiovascular disorder, Circulatory collapse, Dyspnoea, Respiratory tract infection, Respiratory tract inflammation, Stress
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder carcinoma (Removal of the bladder and application of a conduit); Chronic lung disease; Coronary artery sclerosis; Ileal conduit; Urinary bladder excision
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021333611

Write-up: Cardiogenic shock; Shortness of breath; Collapse; massive airway infection; acute circulatory disorder; stress; inflammation of the airways; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-PEI2021003681. An 84-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 26Feb2021 at 17:32 (5:32 p.m.) (Batch/Lot number was not reported) at the age of 84-years-old as single dose for COVID-19 immunisation. The patient''s medical history included chronic lung disease, coronary artery sclerosis, and bladder carcinoma (removal of the bladder and application of a conduit); all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was reported that on the same day after vaccination the patient developed shortness of breath, collapse and death. The patient was dead. Death cause was reported as Cardiogenic shock. Reporter comment: Natural cause of death presumably cariogenic shock with massive inflammation of the airways and coronary sclerosis. No evidence of an allergic or anaphylactic reaction. Sender Comment: A man who was 84 years old and who was vaccinated on 26Feb2021 at 5:32 p.m. in a vaccination center in PRIVACY. There he was inconspicuous after the vaccination (Biontech / Pfizer). At home he collapsed, the emergency doctor was notified at 6.30 p.m., and after unsuccessful resuscitation, the death was certified at 7:08 p.m. We did not find any evidence of an anaphylactic reaction at the autopsy. The patient suffered from a massive airway infection, which was presumably also treated with antibiotics (Azithromycin Aristo 250 mg) and very likely not given at the time of vaccination. We assume that the cause of death is an acute circulatory disorder of the heart muscles with airway infection and stress. In addition, there were massive previous illnesses (status after bladder carcinoma). The patient died on 26Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Natural cause of death presumably cariogenic shock with massive inflammation of the airways and coronary sclerosis. No evidence of an allergic or anaphylactic reaction; Reported Cause(s) of Death: Cardiogenic shock; inflammation of the airways; coronary sclerosis; Shortness of breath; collapse; Autopsy-determined Cause(s) of Death: stress; massive airway infection; acute circulatory disorder


VAERS ID: 1161342 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; COPD; Glaucoma
Allergies:
Diagnostic Lab Data: Test Date: 20210319; Test Name: ECG; Result Unstructured Data: Test Result:asystole
CDC Split Type: ESPFIZER INC2021333412

Write-up: Death sudden/cardiorespiratory arrest; Death sudden/cardiorespiratory arrest; Asystole; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-799295. An 87-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 18Mar2021 (Batch/Lot Number: ET3620) as SINGLE DOSE for covid-19 immunisation. The patient received first dose of COMIRNATY on 25Feb2021 (lot number: EP2163) for COVID-19 vaccination. Medical history included glaucoma, COPD, Arterial hypertension. The patient''s concomitant medications were not reported. On 19Mar2021, the patient experienced death sudden due cardiorespiratory arrest. The report described that: "We were notified for possible cardiorespiratory arrest. Despite the fact that the son (nurse) began basic CPR maneuvers for 10-15 min until our arrival, the absence of vital signs persisted and the ECG revealed asystole." The patient underwent lab tests and procedures which included ECG: asystole on 19Mar2021. The patient died on 19Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiorespiratory arrest; Sudden death; Asystole


VAERS ID: 1161350 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

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:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021333471

Write-up: Cardiopulmonary arrest/cardiorespiratory arrest; Feeling sick/malaise; Loss of consciousness/consciousness disorder; Dyspnoea; Chest pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. The regulatory authority report number is FR-AFSSAPS-AN20210936. An 81-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number and expiry date unknown), intramuscular, on 09Mar2021, at a single dose, for covid-19 immunization. Medical history included dyslipidaemia and hypertension arterial. The patient''s concomitant medications were not reported. The patient was at risk of developing a severe form of Covid-19 disease. It was unknown if the patient previously had Covid-19. It was also unknown if the patient had a Covid-19 PCR or serology test. On 11Mar2021 17:30 the patient experienced feeling sick/malaise with loss of consciousness/consciousness disorder associated with dyspnoea and chest pain. At 17:55 the same day, the patient had a cardiopulmonary arrest/cardiorespiratory arrest (cause of death) and the patient received resuscitative care by the Emergency team of the Emergency Service. The adverse events resulted in the rapid death of the patient. Conclusion reported as: The patient presented a malaise with consciousness disorder and thoracic pain then died rapidly 2 days after a first dose of Comirnaty vaccine. Summary reported as: Man, who has malaise with consciousness disorder, thoracic pain then death 2 days after first administration of Comirnaty. The patient died on 11Mar2021. No autopsy was performed. Nota Bene: Imputation made without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. Official bulletin of the Department, published in Specific Abstract. No follow-up attempts are possible, information on the lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiopulmonary arrest


VAERS ID: 1161353 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Culture urine, SARS-CoV-2 test, Urinary tract infection, 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: 2021-03-12
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer (Discovered at the end of 2018, initially treated with concomitant radiochemotherapy); Palliative care (Due to cancer of the lower rectum)
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm; Aortic aneurysm repair (Thoracic aortic aneurysm operated by custom thoracic endoprosthesis); Arrhythmia (Complete arrhythmia due to atrial fibrillation); Atrial fibrillation (Complete arrhythmia due to atrial fibrillation); Benign prostatic hyperplasia; Colocolostomy (Discharge colostomy); Herniated disc; Osteoarthritis; Pleurisy; Thoracic aortic aneurysm (Thoracic aortic aneurysm operated by custom thoracic endoprosthesis)
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Urine culture; Result Unstructured Data: Test Result:Positive for Citrobacter freundii; Test Date: 202103; Test Name: PCR Covid test; Result Unstructured Data: Test Result:Pos: variant (S gene N501Y, A570D mut); Comments: Positive for the variant (presence of the N501Y and A570D mutations of the S gene)
CDC Split Type: FRPFIZER INC2021311532

Write-up: Vaccination failure; Vaccination failure; Urinary tract infection; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB (regulatory authority number: FR-AFSSAPS-CN20210903). An 89-year-old male patient received the first single dose of BNT162b2 (COMIRNATY), via an unspecified route of administration, on 11Jan2021 (Lot Number: EM0477), and the second dose, intramuscular, on 01Feb2021 (Lot Number: EK9788), for COVID-19 immunisation. The patient was vaccinated with a 25G 25 mm needle. The patient''s medical history included cancer of lower rectum discovered at the end of 2018, initially treated with concomitant radiochemotherapy, then discharge colostomy was performed in Dec2019, and finally palliative care from Jul2020, due to which the patient was in a nursing home. Additional medical history included complete arrhythmia due to atrial fibrillation, herniated disc, osteoarthritis, purulent pleurisy, benign prostatic hyperplasis, thoracic aortic aneurysm operated by custom thoracic endoprosthesis, and popliteal aneurysm. The patient had no previous history of COVID-19. On 04Mar2021 the patient was hospitalized following fever and pharyngeal pain. The patient was put in isolation and a PCR Covid test returned positive for the variant (presence of the N501Y and A570D mutations of the S gene). There was a progressive worsening with associated urinary tract infection (ECBU positive for Citrobacter freundii), patient objecting to treatment. The patient eventually died on 12Mar2021 at 7:05 p.m. It was unknown if an autopsy was performed. The reported event was ''vaccination failure'' with fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19; Vaccination failure


VAERS ID: 1161356 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-02-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood lactic acid, Blood pressure measurement, Body temperature, C-reactive protein, Coma scale, Glomerular filtration rate, Heart rate, Hypercalcaemia, Hyperglycaemia, Hyperproteinaemia, Hypochloraemia, Hypokalaemia, Ileus, Intestinal obstruction, Oxygen saturation, Pneumonia aspiration
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Gastrointestinal obstruction (narrow), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ADENURIC; ZANEXTRA; DOLIPRANE; LANTUS; OROCAL VITAMINE D3 [CALCIUM CARBONATE;COLECALCIFEROL]; TANAKAN [GINKGO BILOBA EXTRACT]; PRAVASTATIN SODIUM; CHONDROSULF; LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Arterial hypertension; Chronic renal insufficiency (GFR equal to 35mL/min); Diabetes mellitus insulin-dependent; Dyslipidemia; Hyperuricaemia; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210224; Test Name: Blood glucose; Result Unstructured Data: Test Result:4.2 g/l; Test Date: 20210224; Test Name: lactic acid; Result Unstructured Data: Test Result:9.6 mmol/L; Comments: normal range <2.2; Test Date: 20210224; Test Name: blood pressure; Result Unstructured Data: Test Result:101/45 mmHg; Test Date: 20210224; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Test Date: 20210224; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:15; Test Date: 20210224; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:13; Comments: GCS 13 (drowsy); Test Date: 20210224; Test Name: CRP; Result Unstructured Data: Test Result:153 mg/l; Test Date: 20210224; Test Name: GFR; Result Unstructured Data: Test Result:12.9 mL/min/1.73m?; Comments: (CKD); Test Date: 20210224; Test Name: heart rate; Result Unstructured Data: Test Result:75; Comments: 75 BPM; Test Date: 20210224; Test Name: hypercalcaemia; Result Unstructured Data: Test Result:2.7 mmol/L; Test Date: 20210224; Test Name: hyperglycaemia; Result Unstructured Data: Test Result:4.65 g/l; Test Date: 20210224; Test Name: hyperproteinemia; Result Unstructured Data: Test Result:91 g/l; Test Date: 20210224; Test Name: hypochloremia; Result Unstructured Data: Test Result:93 mmol/L; Test Date: 20210224; Test Name: Hypokalaemia; Result Unstructured Data: Test Result:3.4 mmol/L; Test Date: 20210224; Test Name: saturation; Test Result: 85 %; Comments: in ambient air
CDC Split Type: FRPFIZER INC2021333544

Write-up: Bowel obstruction; occlusive syndrome complicated by probable inhalation pneumonitis; occlusive syndrome complicated by probable inhalation pneumonitis; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority FR-AFSSAPS-LY20211765. An 89-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 22Feb2021 (Batch/Lot Number: EJ6795) as a single dose for COVID-19 immunization. Medical history included chronic renal insufficiency (GFR equal to 35mL/min), osteoporosis, arterial hypertension, diabetes mellitus insulin-dependent, anaemia, hyperuricemia, and dyslipidemia. No alcohol or tobacco intoxication. Concomitant medications included febuxostat (ADENURIC) for hyperuricemia from 22Jul2019; enalapril maleate, lercanidipine hydrochloride (ZANEXTRA) for hypertension arterial from 22Jul2019; paracetamol (DOLIPRANE); insulin glargine (LANTUS) for diabetes mellitus insulin-dependent from 22Jul2019; calcium carbonate, colecalciferol (OROCAL VITAMINE D3) for osteoporosis from 22Jul2019; ginkgo biloba extract (TANAKAN); pravastatin sodium for dyslipidaemia from 22Jul2019; chondroitin sulfate sodium (CHONDROSULF); and lansoprazole from 22Jul2019. Lifestyle: at home with her husband, daily nurse and household help. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19. Patient received the first dose of bnt162b2 (COMIRNATY) on 22Jan2021, batch number: EJ6795, in the left arm, intramuscular. The patient experienced bowel obstruction (death) on 22Feb2021. Adverse events reported as follows: Patient received the second dose on 22Feb2021. After returning home and having a normal lunch with her son, the first vomiting occurred within 2 hours. The patient felt pains during the night. On 23Feb2021, patient experienced persistent vomiting, initially of food and liquids. On 24Feb2021, during the night of 23Feb2021 to 24Feb2021, the vomiting appeared bile-like then fecal-like and was noticed by a home care nurse. Blood glucose was 4.2g/L; the patient received 10 IU of LANTUS to correct at 06:15 am. The patient was referred to the emergency room at 6:53 a.m. after a call from the EMS. Clinical examination: BP 101/45 mmHg; 75 BPM; saturation 85% in ambient air; temperature 36.1 C degrees; GCS 15, bronchial congestion, polypnea, retractions and soft abdomen. In view of a suspected occlusive syndrome with fecal vomiting and probable inhalation pneumopathy with respiratory distress syndrome (crackles from both lung fields to the apex). Treatment with AMOXCICILLIN + METRONIDAZOLE with vascular filling and respiratory physiotherapy was initiated. Blood test on 24Feb2021: Hypokalaemia at 3.4 mmol/L, hypochloremia at 93 mmol/L, hyperproteinemia at 91g/L, GFR at 12.9 mL/min/1.73m? (CKD), hyperglycaemia at 4.65g/L, hypercalcaemia at 2.7 mmol/L, CRP at 153 mg/L, lactic acid at 9.6 mmol/L [normal range <2.2]. Development: 24Feb2021: subsequently, the patient''s condition continued to deteriorate with very unstable haemodynamic function (mottling), GCS 13 (drowsy) and ARDS. The patient died on 24Feb2021 at 8:40 am. It was not reported if an autopsy was performed. No resuscitation. Conclusion: Death due to occlusive syndrome complicated by probable inhalation pneumonitis.; Reported Cause(s) of Death: Bowel obstruction; occlusive syndrome complicated by probable inhalation pneumonitis; occlusive syndrome complicated by probable inhalation pneumonitis


VAERS ID: 1161357 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral atrophy, Computerised tomogram, Computerised tomogram head, Ischaemic stroke, Mini mental status examination, SARS-CoV-2 test, Scan brain
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 24
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: Arterial hypertension; Biventricular pacemaker insertion; Cognitive disorder (Moderate cognitive impairment); Leukoencephalopathy; Malaise
Preexisting Conditions: Medical History/Concurrent Conditions: Antipyresis; Discomfort; Normochromic normocytic anaemia
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: CT; Result Unstructured Data: Test Result:abnormal; Comments: vascular leukoencephalopathy; Test Date: 202102; Test Name: brain ct; Result Unstructured Data: Test Result:vascular leukoencephalopathy; Comments: eliminates a haemorrhagic complication but confirms an intermediate stage vascular leukoencephalopathy and cortico-subcortical atrophy predominantly at the skull base with hippocampal atrophy.; Test Name: MMS; Result Unstructured Data: Test Result:24/30; Test Date: 20210212; Test Name: SARS-COV-2 TEST; Test Result: Negative ; Test Name: Brain scan; Result Unstructured Data: Test Result:occlusion; Comments: recent occlusion of the left sylvian artery and ischemic sequelae of the left posterior cerebral artery and no significant ASD stenosis.
CDC Split Type: FRPFIZER INC2021333540

Write-up: Ischemic stroke; cortico-subcortical atrophy; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-LY20211855. A 96-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 03Feb2021 (Lot Number: EJ6788) as single dose for COVID-19 immunization. Medical history included ongoing Arterial hypertension, ongoing cognitive disorder (Moderate cognitive impairment), ongoing malaise, leukoencephalopathy from 2019 and ongoing, normochromic normocytic anaemia from 2019 to an unknown date (unknown if ongoing), ongoing Biventricular pacemaker insertion, Repeated discomfort, and antipyretic treatment. The patient''s concomitant medications were not reported. On 03Feb2021, vaccination with a first dose of COMIRNATY vaccine (lot no. EJ6788) IM in the right arm. Then on 12Feb2021, 9 days after the vaccination, the patient presents episodes of brutal confusion since the morning and, a few hours later, the appearance of a left hemiparesis requires her hospitalization. On 15Feb2021, the patient is taken to the emergency department for a left brachiocephalic ischemic stroke with left hemiplegia, phasic and swallowing disorders. Brain and ASD scan shows recent occlusion of the left sylvian artery and ischemic sequelae of the left posterior cerebral artery and no significant ASD stenosis. No indication for thrombectomy but introduction of LMWH and ASPEGIC 250 mg injectable. On 17Feb2021, Transient improvement of swallowing disorders. On 23Feb2021, Clinical worsening leading to suspicion of haemorrhagic transformation. The follow-up CT scan eliminates a haemorrhagic complication but confirms an intermediate stage vascular leukoencephalopathy and cortico-subcortical atrophy predominantly at the skull base with hippocampal atrophy on an unspecified date in Feb2021. On 25Feb2021, in view of the patient s condition worsening with disturbances of vigilance, presence of mottling on the knees and feet as well as polypnoea, palliative treatment was instituted with a subcutaneous syringe of morphine. Progress as of 25Feb2021: the patient died. Severity criterion: Death. No other information available. The patient underwent lab tests and procedures which included computerised tomogram: abnormal (vascular leukoencephalopathy) on 2019, computerised tomogram head: vascular leukoencephalopathy (eliminates a haemorrhagic complication but confirms an intermediate stage vascular leukoencephalopathy and cortico-subcortical atrophy predominantly at the skull base with hippocampal atrophy) on Feb2021, mini mental status examination: 24/30 on an unspecified date, SARS-CoV-2 test: negative on 12Feb2021, scan brain: occlusion (recent occlusion of the left sylvian artery and ischemic sequelae of the left posterior cerebral artery and no significant ASD stenosis) on an unspecified date. Therapeutic measures were taken as a result of ischemic stroke. The outcome of the event ischemic stroke was fatal while for other event was unknown. The patient died on 25Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: ischemic stroke


VAERS ID: 1161358 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   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: VERAPAMIL; XARELTO; PANTOPRAZOLE; ATORVASTATIN; FUROSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia (fibrillation close to 120 bpm at ETT (transthoracic echocardiography).); Atrial fibrillation; Carotid artery stenosis; COPD; Dysarthria; Essential hypertension; Ex-smoker; Hemiparesis; Hip surgery (Placement of a gamma nail, following a fall with a per-trochanteric fracture of the left hip.); Hypercholesterolemia; Ischemic stroke; Myocardial infarction (10 years ago. Normal scintigraphy in 2015 and normal LVEF in 2016.); Prostatic adenoma; Tuberculosis (20 years ago)
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: Blood pressure; Result Unstructured Data: Test Result:between 180 and 230 mmHg; Comments: during hospitalization after hip surgery; Test Date: 20210212; Test Name: Blood pressure; Result Unstructured Data: Test Result:165/75 mmHg; Test Date: 20210215; Test Name: Blood pressure; Result Unstructured Data: Test Result:178/77 mmHg; Test Date: 20210217; Test Name: Blood pressure; Result Unstructured Data: Test Result:119/92 mmHg; Test Date: 20210218; Test Name: Blood pressure; Result Unstructured Data: Test Result:161/70 mmHg; Test Date: 20210212; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5; Test Date: 20210217; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6; Test Date: 20210218; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6; Test Date: 20210107; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:Fast atrial fibrillation close to 120 bpm; Test Date: 20210212; Test Name: pulse/heart rate; Result Unstructured Data: Test Result:80bpm; Test Date: 20210215; Test Name: pulse/heart rate; Result Unstructured Data: Test Result:83bpm; Test Date: 20210217; Test Name: pulse/heart rate; Result Unstructured Data: Test Result:87bpm; Test Date: 20210218; Test Name: pulse/heart rate; Result Unstructured Data: Test Result:72bpm; Test Date: 20210212; Test Name: Saturation; Test Result: 99 %; Test Date: 20210215; Test Name: Saturation; Test Result: 96 %; Test Date: 20210217; Test Name: Saturation; Test Result: 97 %; Test Date: 20210218; Test Name: Saturation; Test Result: 97 %
CDC Split Type: FRPFIZER INC2021333560

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority, Regulatory Authority Report Number FR-AFSSAPS-LY20211939. A 93-year-old male patient received second dose of BNT162B2 (COMIRNATY), intramuscular on 12Feb2021 (Lot Number: EJ9788, unknown expiration) as single dose for COVID-19 immunisation. Medical history included ischemic stroke in carotid stenosis in 2017 leading to dysarthria and hemiparesis in 2017 since then; hypercholesterolemia; essential hypertension; prostatic adenoma; chronic obstructive pulmonary disease (COPD); myocardial infarction in 2011 (10 years ago. Normal scintigraphy in 2015 and normal LVEF in 2016); tuberculosis in 2001 (20 years ago); hip surgery from 11Dec2010 (Placement of a gamma nail, following a fall with a per-trochanteric fracture of the left hip. Continuation of the management in geriatrics department for rehabilitation in walking. During hospitalization in Dec2020, high blood pressure: systolic blood pressure between 180 and 230 mmHg); Smoking weaned for 20 years; complete arrhythmia due to atrial fibrillation on 07Jan2021 [fast atrial fibrillation close to 120 bpm at ETT (transthoracic echocardiography). Introduction of Hemigoxine and Perindopril (blood pressure levels always high in the morning)]. Concomitant medications included verapamil; rivaroxaban (XARELTO); pantoprazole; atorvastatin; and furosemide. The patient also received first dose of COMIRNATY vaccine on 22Jan2021 (lot number: EJ6795) as prophylactic vaccination which was well tolerated by the patient; however, on 04Feb2021, the patient was drowsy/drowsiness with difficulty waking up with blood pressure 190/100, apyretic, heart rate 70, saturation 96%. On 12Feb2021, the patient had vaccination with a second dose of COMIRNATY vaccine. Blood pressure was 165/75 mmHg, pulse was 80 bpm, saturation was 99%, and temperature was 36.5. On 15Feb2021, the patient had blood pressure 178/77 mmHg, heart rate 83 bpm, saturation 96%. Verticalization and resumption of walking. On 16Feb2021, the patient is stable. On 17Feb2021, the patient had blood pressure 119/92 mmHg, heart rate 87 bpm, temperature 36.6, saturation 97%. Amlor not administered before patient''s blood pressure. Stable patient. On 18Feb2021, the patient had blood pressure 161/70 mmHg, saturation 97%, heart rate 72 bpm, temperature 36.6, stable patient. On 19Feb2021 at 11:00 am, the patient is found in cardio-respiratory arrest for an unknown duration. Resuscitation performed without effect. Death was declared on 19Feb2021 at 11:20am. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about batch number was already obtained.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1161359 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PRADAXA; BISOPROLOL BGR; ALDACTONE [SPIRONOLACTONE]; FUROSEMIDE ARROW; ENTRESTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021333575

Write-up: Cardiac arrest; This is a spontaneous report from a contactable consumer from the Regulatory Authority FR-AFSSAPS-LY20212004. A 74-year-old male patient received bnt162b2 (COMIRNATY; Batch/Lot Number: EP9605), intramuscular on 12Mar2021 at 74-year-old as single dose for covid-19 immunisation; sacubitril valsartan sodium hydrate (ENTRESTO), via an unspecified route of administration from an unspecified date at 49 mg/51 mg for an unspecified indication; furosemide (FUROSEMIDE ARROW), oral from an unspecified date at unknown dose for an unspecified indication. Medical history included heart failure from an unknown date and unknown if ongoing. No past history Covid, no test carried out. Concomitant medication included dabigatran etexilate mesilate (PRADAXA), bisoprolol fumarate (BISOPROLOL BGR); spironolactone (ALDACTONE). On 12Mar2021 6 hours later, patient had sudden death following cardiac arrest. 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 expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1161360 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Auricular fibrillation; Bedridden; Haemorrhagic stroke; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021333485

Write-up: Death unexplained; This is a spontaneous report from a contactable physician from the Regulatory authority-WEB FR-AFSSAPS-MA20210973. An 85-year-old male patient received first dose of bnt162b2 (COMIRNATY; Lot Number: ET3620) intramuscular, administered in Arm Left, at the age of 85-year-old, on 17Mar2021, as single dose for covid-19 immunisation. Medical history included haemorrhagic stroke, parkinson''s disease, bedridden, and atrial fibrillation all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced death unexplained on 18Mar2021 (24hours after first bnt162b2). The patient died on 18Mar2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death unexplained


VAERS ID: 1161361 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-19
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Choking, Drug ineffective, Pneumonia aspiration, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   Days after onset: 23
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: Asthma; Bedridden; Dementia; Hypertension; Lung lobectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021333476

Write-up: Pneumonia aspiration; Choked on food; Asthenia; Covid-19 PCR test performed: yes (19Feb2021, positive); Covid-19 PCR test performed: yes (19Feb2021, positive); This is a spontaneous report from a contactable physician from the Agency Regulatory Authority-WEB FR-AFSSAPS-MA20210975. A 94-year-old female patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on an unspecified date at a single dose and second dose, intramuscular administered in right arm on 09Feb2021 (Lot Number: EJ6788) as a single dose for COVID-19 immunisation. Medical history included asthma, hypertension, lung lobectomy, bedridden, and dementia. Serious risk factors for COVID-19 includes age, dementia, hypertension, asthma, lobectomy, bedridden. Concomitant medication included unspecified anticoagulant. On 19Feb2021, COVID-19 PCR test was performed and was positive. The patient presented on Day 10 of the second dose of Comirnaty, on 19Feb2021, with significant asthenia in a context of undernutrition and pneumonia aspiration on false route (choked on food) with involvement of the vital prognosis and death on 15Mar2021. The patient died on 15Mar2021. It was not reported if an autopsy was performed. The outcome of the events "Covid-19 PCR test performed: yes (19Feb2021, positive)" was unknown while the rest of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pneumonia aspiration; Choked on food; Asthenia


VAERS ID: 1161362 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Decreased appetite, Fall, Fatigue, General physical health deterioration
SMQs:, Accidents and injuries (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021333569

Write-up: Fall; alteration of the general condition; complete anorexia; fatigue; hip pain; This is a spontaneous report from a contactable physician from the regulatory authority (regulatory authority report number: FR-AFSSAPS-MP20210668). An 89-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EJ6788), intramuscular in the left arm, on 21Jan2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. She had no history of COVID-19 and was not tested for COVID-19. The patient was at risk of developing a severe form of COVID-19 disease and was vaccinated as part of the COVID-19 vaccination campaign. On 22Jan2021, the patient experienced alteration of the general condition, fatigue, complete anorexia, fall. An assessment was made in hospital. The patient was then returned to nursing home on 23Jan2021 with analgesics for hip pain (started on an unspecified date). Outcome of the events fatigue and hip pain was unknown. Outcome of the events alteration of the general condition, complete anorexia, fall was fatal. The patient died on 31Jan2021. It was unknown if an autopsy was performed. NB: Accountability made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fall; alteration of the general condition; complete anorexia


VAERS ID: 1161364 (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: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Asthenia, Blood lactate dehydrogenase, Blood pressure measurement, Body temperature, Bradycardia, C-reactive protein increased, Diarrhoea, Heart rate, Hypotension, Investigation, N-terminal prohormone brain natriuretic peptide, Platelet count, Respiratory rate, SARS-CoV-2 test, Tachycardia, White blood cell count
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Noninfectious diarrhoea (narrow), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; LEVOTHYROXINE; DUROGESIC; RISPERDAL; PANTOPRAZOLE; NOCTAMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure (patient on oxygen); Delirious; Diaphragmatic hernia; Fracture; Heart failure (Heart failure with RTA (Renal tubular acidosis) 1 year ago); Hypothyroidism; Persistent atrial fibrillation; Renal tubular acidosis (Heart failure with RTA (Renal tubular acidosis) 1 year ago); Trauma; Volvulus of bowel
Allergies:
Diagnostic Lab Data: Test Date: 20210223; Test Name: lactate dehydrogenaze; Result Unstructured Data: Test Result:362; Test Date: 20210220; Test Name: Blood pressure; Result Unstructured Data: Test Result:7/6 mmHg; Test Date: 20210222; Test Name: Blood pressure; Result Unstructured Data: Test Result:110/60 mmHg; Test Name: body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Test Date: 20210223; Test Name: CRP; Result Unstructured Data: Test Result:427 mg/l; Test Date: 20210220; Test Name: Heart rate; Result Unstructured Data: Test Result:up to 40 bpm; Test Date: 20210220; Test Name: Heart rate; Result Unstructured Data: Test Result:up to 160 bpm; Test Date: 20210222; Test Name: Heart rate; Result Unstructured Data: Test Result:95 bpm; Test Name: glucose infusion rate (GIR); Result Unstructured Data: Test Result:2; Test Date: 20210223; Test Name: proBNP; Result Unstructured Data: Test Result:34800; Test Date: 20210223; Test Name: platelets; Result Unstructured Data: Test Result:72 000; Test Date: 20210220; Test Name: respiratory rate; Result Unstructured Data: Test Result:28/min; Test Date: 20210222; Test Name: respiratory rate; Result Unstructured Data: Test Result:24/min; Test Date: 20210223; Test Name: COVID-19 PCR; Result Unstructured Data: Test Result:unknown; Test Date: 20210223; Test Name: leukocytes; Result Unstructured Data: Test Result:15400 with 14600 PN
CDC Split Type: FRPFIZER INC2021311847

Write-up: hypotension of 7/6; tachycardia (up to 160 bpm); Arrhythmia; bradycardia (up to 40 bpm); asthenic/significant asthenia; diarrhoea; This is a spontaneous report downloaded from the regulatory authority and received via Regulatory Authority FR-AFSSAPS-NC20210836. A contactable physician reported that a 80-year-old female patient received the second dose of bnt162b2 (COMIRNATY, lot number: EJ6788), intramuscular, administered in the right arm on 19Feb2021 as a single dose for COVID-19 immunization. Medical history included persistent atrial fibrillation, chronic respiratory failure (patient on oxygen), hypothyroidism, left diaphragmatic hernia, heart failure with renal tubular acidosis (RTA) (reported as a year ago), several traumas/fractures, intestinal volvulus and delirious flushes all from an unknown date and unknown if ongoing. Concomitant medications included apixaban (ELIQUIS); levothyroxine (manufacturer unknown); fentanyl (DUROGESIC); risperidone (manufacturer unknown); pantoprazole (manufacturer unknown); lormetazepam (NOCTAMIDE) all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of Comirnaty for COVID-immunization with very good tolerance. The patient is in an assisted living residence and had a glucose infusion rate (GIR) of 2. The elderly patient was considered fragile, having cardiac and respiratory failure and is on oxygen therapy. Before the vaccination, the patient had a notion of fever of 38.2. The vaccination was given with very good immediate tolerance and the rest of the day was clear. On 20Feb2021, it the morning, the patient was asthenic and had diarrhoea. It was reported that the patient experienced rhythm disorders; arrhythmia, alternating bradycardia (up to 40 bpm) and tachycardia (up to 160 bpm). The patient''s rhythm is usually around 70. The patient also had hypotension of 7/6, diarrhoea and a respiratory rate of respiratory rate of 28/min was present. Respiratory distress was noted but the patient had no fever. On 21Feb2021, it was advised that the patient start paracetamol on suspicion of post-vaccination reactogenicity. On 22Feb2021, clinical examination showed tachycardia at 95 and respiratory rate of 24/min, significant asthenia and a blood pressure of 11/6 the patient still had no fever. Laboratory tests were then required. On 23Feb2021 lab results showed leukocytes: 15400 with 14600 PN, platelets: 72 000, LDH (Lactate dehydrogenase): 362, CRP (C-reactive protein): 427mg/l, proBNP (N-terminal pro b-type natriuretic peptide) = 34800. The patient had a COVID-19 PCR (Polymerase chain reaction) test on 23Feb2021 with unknown results. The patient was given provision of comfort care and morphine for hypnovel sedation in the evening. On the evening of 24Feb2021, the patient died. It was reported that the death in a patient with post-vaccination symptomatology was possibly attributable to the vaccine that may have contributed to death. The outcome of the events asthenia and diarrhoea was unknown while the events hypotension, tachycardia, arrhythmia and bradycardia were fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Arrhythmia; tachycardia (up to 160 bpm); bradycardia (up to 40 bpm); bradycardia (up to 40 bpm); hypotension of 7/6


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