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

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



Case Details

This is page 102 out of 172

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VAERS ID: 1174766 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: 2021-03-25
   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: HKPFIZER INC2021368130

Write-up: UNCONSCIOUS; This is a spontaneous report from a non-contactable consumer via Regulatory Authority (Regulatory report number: not provided), based on information received by Pfizer from BioNTech SE (manufacturer control number: 2021FOS000570), license party for bnt162b2 (COMIRNATY). A 59-year-old male patient received bnt162b2 (COMIRNATY), via unknown route of administration on 18Mar2021 (Batch/Lot number was not reported) as an unspecified dose for COVID-19 immunisation. The patient''s medical history and concomitant medications was not reported. According to the information provided by the Hospital Authority (HA). There was no record that the patient complained of feeling unwell during observation at the Vaccination Centre. The patient experienced unconscious on 25-Mar-2021. Clinical course as follow: On 25Mar2021, patient was found unconscious by hikers and was sent to hospital. He did not respond to resuscitation and passed away. No lab test was provided. The department of health has immediately contacted the upon the notification to obtain further information on the incident for conducting investigation and assessment. According to the established mechanism, the DH will provide the case to the Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation for conducting causality assessment. The patient died on 25Mar2021. It is unknown if an autopsy was performed. Information on lot/batch number has been requested. ; Reported Cause(s) of Death: UNCONSCIOUS


VAERS ID: 1174773 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-03-01
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6790 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Melaena, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Exposure to COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Hemodialysis (Dialysis patient; Chronic renal failure - hemodialysis patient); Kidney failure chronic (Dialysis patient; Chronic renal failure - hemodialysis patient)
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: subfebrile; Result Unstructured Data: Test Result:subfebrile; Comments: subfebrile; Test Name: COVID PCR; Result Unstructured Data: Test Result:test results not available
CDC Split Type: HRPFIZER INC2021358551

Write-up: melena; Vaccination failure; Vaccination failure; Subfebrile; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB regulatory authority HR-HALMED-300045644. An 83-years-old female patient received bnt162b2 (COMIRNATY, solution for injection), dose 1 intramuscular on 20Jan2021 (Lot Number: EJ 6134, lot number not reported) as 30 ug, single; and dose 2 intramuscular on 17Feb2021 (Lot Number: EJ 6790, lot number not reported) as 30 ug, single; for covid-19 immunisation. Medical history included patient was a hemodialysis (also reported as dialysis) patient with kidney failure chronic (also reported as chronic renal failure) from an unknown date to an unknown date; and patient was in contact with a positive person (ongoing at the time of the events reported). The patient''s concomitant medications were not reported. It was reported that patient had vaccination failure on 13Mar2021. This dialyzed patient was admitted to the hospital about 14 days ago for melena (Mar2021), and was in contact with a positive person in the same room, had died on 13Mar2021, and was subfebrile 2-3 days ago (Mar2021). It was reported that COVID PCR test results on an unknown date were not available. The events vaccination failure and subfebrile were reported as medically significant. The outcome of the event melena was unknown. The patient died on 13Mar2021. The causes of death were vaccination failure and subfebrile. It was unknown if an autopsy was performed. Sender Comment: Information on Covid 19 PCR test is not available. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: subfebrile; vaccination failure; vaccination failure


VAERS ID: 1174791 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 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: 2021-03-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BLOPRESS; METFORAL; ATORVASTATINA EG; PAROXETINA ACTAVIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker wearer; Diabetes (treated with oral therapy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021315809

Write-up: cardiovascular arrest; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-700913. An 81-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 15Mar2021 (at the age of 81-years-old) (Batch/Lot Number: ET1831) as SINGLE DOSE for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing treated with oral therapy, and wearer of a pacemaker from an unknown date and unknown if ongoing. Concomitant medications included candesartan cilexetil (BLOPRESS) taken for an unspecified indication, start and stop date were not reported; metformin hydrochloride (METFORAL) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (ATORVASTATINA EG) taken for an unspecified indication, start and stop date were not reported; paroxetine hydrochloride (PAROXETINA ACTAVIS) taken for an unspecified indication, start and stop date were not reported. About 12 hours after the administration of the vaccine on 15Mar2021, the patient experienced cardio-circulatory arrest. Cardiopulmonary resuscitation was carried out in place. The patient died on 15Mar2021 from the cardio-circulatory arrest. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: cardio-circulatory arrest


VAERS ID: 1174826 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: Body temperature; Result Unstructured Data: Test Result:36,4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021368293

Write-up: Death; This is a spontaneous report from a contactable physician. This is a report received from the Agency. The regulatory authority report number is v21100370. A 62 and 11 month old year-old male patient received BNT162B2 (COMIRNATY; Lot Number: ER2659; Expiration Date: 30Jun2021), dose 2 via an unspecified route of administration on 01Apr2021, at 14:30 as single dose for covid-19 immunization. The patient''s medical history was not reported. The patient reported that he took unspecified oral antithrombotic drug. The patient had no family history. On 11Mar2021, the patient had received the 1st dose of BNT162B2 (Lot number EP2163, Expiration date 31May2021), and had no adverse reaction. The patient experienced death on 02Apr2021. The patient underwent lab tests and procedures which included body temperature: 36,4 Centigrade on 01Apr2021 before vaccination. Details were as follows: On 02Apr2021, in the morning (1 days after the vaccination), the patient died. The outcome of the event was fatal. On 01Apr2021, the day of the vaccination, the patient went home as no abnormality was noted. In the early morning of 02Apr2021, within 24 hours from the vaccination, his death was confirmed at home. The reporting physician classified the death as serious and assessed that the causality between the event and BNT162B2 as unassessable. The reporting physician considered the oral antithrombotic drug the patient reported as other possible causative factor for the event. The patient died on 02Apr2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Death


VAERS ID: 1174833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, C-reactive protein, Death, Glomerular filtration rate, Heart rate, White blood cell count
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; METFORMIN; ENALAPRIL; EPOETINE BETA; PARACETAMOL; BUMETANIDE; FUSIDINEZUUR CREME; ATORVASTATINE; FLUTICASON-PROPIONAAT NEUSSPRAY; OXYCODON; TACROLIMUS; FERROFUMARAAT; CALCIUMCARB/COLECALC KAUWTB; MAGNESIUMGLUCONAAT; LANETTECREME
Current Illness: Decompensation cardiac; Polycystic kidney
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney transplant
Allergies:
Diagnostic Lab Data: Test Date: 20210301; Test Name: Blood pressure; Test Result: Inconclusive ; Result Unstructured Data: 146/68; Test Date: 20210301; Test Name: T; Result Unstructured Data: 36.6 degree Celsius; Test Name: CRP; Test Result: Inconclusive ; Result Unstructured Data: 190 milligram per litre; Test Date: 20210302; Test Name: CRP; Test Result: Inconclusive ; Result Unstructured Data: 291; Test Date: 20210302; Test Name: eGFR; Test Result: Inconclusive ; Result Unstructured Data: 26; Test Date: 20210301; Test Name: P; Test Result: Inconclusive ; Result Unstructured Data: 68 per minute; Test Name: leucocyten; Test Result: Inconclusive ; Result Unstructured Data: 16.6x10^9/L; Test Date: 20210302; Test Name: leucocyten; Test Result: Inconclusive ; Result Unstructured Data: 24x10^9/L
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Mar-2021 and was forwarded to Moderna on 23-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH in an elderly female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042721) for COVID-19 immunization. The patient''s past medical history included Kidney transplant in 2012. Concurrent medical conditions included Polycystic kidney and Decompensation cardiac since 2019. Concomitant products included AMLODIPINE, METFORMIN, ENALAPRIL, EPOETINE BETA, PARACETAMOL, BUMETANIDE from 02-Mar-2021 to 05-Mar-2021, FUSIDINEZUUR CREME, ATORVASTATINE, FLUTICASON-PROPIONAAT NEUSSPRAY, OXYCODON from 02-Mar-2021 to 05-Mar-2021, TACROLIMUS, TACROLIMUS, FERROFUMARAAT, CALCIUMCARB/COLECALC KAUWTB, MAGNESIUMGLUCONAAT, LANETTECREME MET VASELINE, ESOMEPRAZOL, METOPROLOL, PREDNISONE (PREDNISON), MYCOFENOLAAT MOFETIL, METOCLOPRAMIDE ZETPIL from 02-Mar-2021 to 05-Mar-2021, MACROGOL POEDER V DRANK 1G/G and POVIDON OOGDRUPPELS. On 01-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 04-Mar-2021 The patient died on 04-Mar-2021. The cause of death was not reported. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Blood pressure measurement: 146/68 millimetre of mercury 146/68. On 01-Mar-2021, Body temperature: 36.6 degree Celsius 36.6. On 01-Mar-2021, Heart rate: 68 per minute 68. On 02-Mar-2021, C-reactive protein: 291 milligram per litre 291. On 02-Mar-2021, Glomerular filtration rate: 26ml/min millilitre per minute 26ml/min. On 02-Mar-2021, White blood cell count: 24x10^9/l 10^9/L 24x10^9/L. On an unknown date, C-reactive protein: 190 190. On an unknown date, White blood cell count: 16.6x10^9/l 10^9/L 16.6x10^9/L. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding this event has been provided at this time and additional information is not expected. A causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1174841 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021358055

Write-up: Heavy brain haemorrhage to brain stem, brain dead and died within 13 hours; Heavy brain haemorrhage to brain stem, brain dead and died within 13 hours; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00485782. An 82-year-old female patient received bnt162b2 (COMIRNATY; Lot number was not reported), via an unspecified route of administration on 01Mar2021 at a SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 05Mar2021, the patient experienced heavy brain haemorrhage to brain stem, brain dead and died within 13 hours. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no Heavy brain haemorrhage to brain stem, brain dead and died within 13 hours. Died in XX Additional information ADR: We think there have already been several bleeds within these 4 days before her death! BSN available: yes COVID-19 Previous COVID-19 infection: No.; Reported Cause(s) of Death: Brain death; cerebral haemorrhage


VAERS ID: 1174842 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE; NAPROXEN; COLECALCIFEROL; PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Procedural pain; Shoulder operation
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021358048

Write-up: Nausea; Not feeling well; Generalized joint pain; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00485901. An 84-year-old female patient received bnt162b2 (COMIRNATY; Lot Number: ER7812) via an unspecified route of administration, on 24Mar2021, as SINGLE DOSE for covid-19 immunisation. Medical history included open lateral clavicle resection (left) on 03Mar2021 and procedural pain. Concomitant medications included levothyroxine, naproxen from 04Mar2021 taken for procedural pain, colecalciferol, and pantoprazole. On 25Mar2021, the patient contacted her physician at 6:00 with complaints of nausea, malaise, and generalized joint pain. Physician gave her advice for managing her nausea. On 8:00 home care saw the patient. And on 20:00 home care found patient deceased in her bed. Outcome of the events was fatal. Causes of death were reported as generalized joint pain, nausea, and malaise. It was unknown if an autopsy was performed. Sender Comment: Since it is obvious from the case report that the reported drug naproxen was incorrectly reported as suspect drug, the drug characterization has been changed from suspect to concomitant drug by the agency. Reporter''s comments: BioNTech / Pfizer vaccine (Comirnaty), Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): unknown, Previous COVID-19 infection: No. Diagnostic procedures: Patient has received 24Mar2021 vaccine. Report 25Mar2021 at 6:00 that she is nauseous and unwell. Had advice regarding nausea. Seen around 8 am by home care. Found dead in bed by home care at 8 PM. 3Mar2021 underwent left open lateral clavicle resection. For this use NSAID and PPI. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: nausea; malaise; generalized joint pain


VAERS ID: 1174852 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Condition aggravated, Diarrhoea, Dyspnoea, Lymph node pain, Lymphadenopathy, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breathing difficult
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: Body temperature; Result Unstructured Data: Test Result:39.0-39.4 Centigrade
CDC Split Type: PLPFIZER INC2021357977

Write-up: Fever; Weakness generalised; Muscle pain; Diarrhoea; Painfulness and enlargement of the regional lymph nodes; Painfulness and enlargement of the regional lymph nodes; Breathing problems; Breathing problems; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number PL-URPL-3-301-2021. An 82-years-old patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 09Feb2021 12:31 (Batch/Lot Number: EL8723; Expiration Date: 31May2021) as 0.3 mL, single for covid-19 immunisation. The patient medical history included breathing problems. The patient''s concomitant medications were not reported. The patient experienced fever, weakness generalised, painfulness and enlargement of the regional lymph nodes, breathing problems, muscle pain, diarrhoea on 11Feb2021. Translation of narraive verbatim was provided as Date of the reaction 11Feb2021 at no data. Symptoms are listed in the report of an adverse reaction following vaccination: soreness and enlargement of regional lymph nodes; fever 39-39.4 '' for more than 72 h; diarrhea. Description of the reaction: the patient reported on 16Feb2021 for an appointment with a primary care physician, reporting the following symptoms: high temperature, muscle pain, general weakness. Patient has been prescribed Paracetamol. He also reported breathing problems to his son, of which he had complained before vaccination. On 19Feb2021, the patient was found dead in his own home by the family. The patient underwent lab tests and procedures which included body temperature: 39.0-39.4 centigrade on 11Feb2021. The patient died on 19Feb2021. The event outcome was fatal. It was not reported if an autopsy was performed. Sender''s comments: Name of the vaccine Comirnaty- COVID-19 vaccine (mRNA) Soreness and enlargement of the regional lymph nodes; fever 39-39.4 ''C, muscle pain, general weakness (fatigue) are the adverse reactions expected and described following the administration of Comirnaty. Diarrhea and breathing problems are unexpected reactions for a vaccine. Regulatory authority does not have any other information about the existence of any underlying diseases that could affect the occurrence of adverse reactions. By 25Feb2021, 302 deaths were reported in the database, including 59 cases of dyspnoea. Diarrhea has been reported in the database. The temporal relationship speaks for a cause-and-effect relationship. The person reporting post vaccination adverse reaction qualified its as serious. Regulatory authority assessed as serious. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Breathing problems; Fever; Weakness generalised; Painfulness and enlargement of the regional lymph nodes; Breathing problems; Muscle pain; Diarrhoea; Painfulness and enlargement of the regional lymph nodes


VAERS ID: 1174915 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Decreased appetite, Dizziness, Fall, Fatigue, Heart rate increased, Oxygen saturation, Oxygen saturation decreased, Pain, Rib fracture, Scapula fracture
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Osteoporosis/osteopenia (broad), Respiratory failure (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: Atrial fibrillation; Cardiac failure; Dementia; Diabetes; Hypertension; Renal failure
Preexisting Conditions: Medical History/Concurrent Conditions: Old myocardial infarction
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: SEPFIZER INC2021357986

Write-up: fell; fracture of the ribs and scapula; fracture of the ribs and scapula; decreased saturation; aggravated Cardiac failure; pain in body; Dizzy; Pulse increased, irregular (Pulse increased); Decreased appetite; Tiredness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-018240. A 94-year-old female patient received the first dose of BNT162B2 (COMIRNATY; lot number: EJ6134), via intramuscular route of administration on an unspecified date in Jan2021 (at the age of 94 years) at a single dose for COVID-19 immunization. Medical history included ongoing hypertension, ongoing dementia, ongoing atrial fibrillation, old myocardial infarction (not ongoing), ongoing cardiac failure, ongoing diabetes, and ongoing renal failure. The patient''s concomitant medications were not reported. On an unspecified date in Jan2021, the patient fell and suffered a fracture of the ribs and scapula, had decreased saturation. In Jan2021, the patient also had aggravated cardiac failure, pain in body, was dizzy, pulse increased, irregular (pulse increased), decreased appetite, and tiredness. The patient died on an unspecified date due to multimorbidity specifically fell, fracture of the ribs and scapula, decreased saturation, aggravated cardiac failure, pain in body, dizzy, pulse increased, irregular (pulse increased), decreased appetite, and tiredness. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fell; fracture of the ribs and scapula; fracture of the ribs and scapula; decreased saturation; pain in body; Dizzy; Pulse increased, irregular (Pulse increased); Decreased appetite; Tiredness; aggravated Cardiac failure


VAERS ID: 1174916 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Dysphagia, Pyrexia, Speech disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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: OMEPRAZOLE; CALCICHEW D3 CITRON [CALCIUM CARBONATE;COLECALCIFEROL]; LEVAXIN; FENTANYL
Current Illness: Breast cancer metastatic (metastases in the brain, skeleton, liver and lungs); Neurologic symptoms (due to brain metastases)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Body temperature; Result Unstructured Data: Test Result:40.3 Centigrade; Test Date: 202103; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: SEPFIZER INC2021358242

Write-up: Fever; Cardiac arrest; Poor swallowing ability; difficulty speaking; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number SE-MPA-2021-019642. A 69-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number: EP2163) intramuscular on Mar2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included ongoing breast cancer metastatic (metastases in the brain, skeleton, liver and lungs) and ongoing neurologic symptoms (due to brain metastases). Concomitant medications included omeprazole from 2018, colecalciferol (CALCICHEW D3 CITRON [CALCIUM CARBONATE;COLECALCIFEROL]) from 2015, levothyroxine sodium (LEVAXIN) from 15Feb2021 and fentanyl from 13May2020. The patient previously received first dose of Comirnaty in Feb2021 for COVID-19 immunisation (Lot number: EP2163, intramuscular). The woman received the second dose of Comirnaty and suffered from a high fever of 40.3 degrees during the evening / night and also worsened neurologically, which she used to do when having fever. Poor swallowing ability (but could drink) and difficulty speaking. After the woman has received Alvedon, the fever dropped to 38 degrees in the morning, the day after the vaccination. In the afternoon, the woman suffered from a sudden cardiac arrest and relatives began CPR. The woman was pronounced dead after about 1 hour. Outcome of the events poor swallowing ability and difficulty speaking was unknown. The patient died on Mar2021. 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; Fever


VAERS ID: 1174917 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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: METOPROLOL; BEHEPAN [CYANOCOBALAMIN]; SPIRONOLACTONE; FUROSEMIDE; FELODIPINE; CITALOPRAM; KALEORID; TOLTERODINE; PARACETAMOL; LOSARTAN
Current Illness: Aortic valve stenosis; Cardiac failure; Cerebral atherosclerosis; Essential hypertension; Rash; Schizophrenia
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Name: respiratory rate; Result Unstructured Data: Test Result:increased
CDC Split Type: SEPFIZER INC2021358017

Write-up: Dyspnoea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-020865. An 85-year-old female patient received second dose of bnt162b2 (COMIRNATY), via intramuscular on Mar2021 (Batch/Lot Number: ER7812) as single dose for COVID-19 immunization. Medical history included ongoing schizophrenia, ongoing essential hypertension, ongoing aortic valve stenosis, ongoing cardiac failure, COVID-19 from Dec2020, ongoing rash, ongoing cerebral arteriosclerosis. Concomitant medication included metoprolol; cyanocobalamin (BEHEPAN [CYANOCOBALAMIN]); spironolactone; furosemide; felodipine; citalopram; potassium chloride (KALEORID); tolterodine; paracetamol; losartan; all from unspecified date for unspecified indication. The patient previously took first dose of bnt162b2 (COMIRNATY) on an unspecified date for COVID-19 immunization. In Mar2021, the experienced dyspnoea. According to the reporter, the patient felt good before vaccination. One hour later began dyspnoea, the patient was treated with furix 40 mg subcutaneous. About three hours later, the patient were found dead. The physician was at the nursing home to examine a rash that the woman had for a long time. When the physician examined the woman, she discovered that respiratory rate were increased and prescribe Furix, no swelling, difficult to auscultated lungs but more muffled breathing sounds. 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: Dyspnoea


VAERS ID: 1174919 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: Neoplasm of unspecified nature of brain; Palliative care (with palliative drug prescriptions and plan, though not end of life care)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021358237

Write-up: wheezing breathing; This is a spontaneous report from a contactable nurse downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-023498. An 81-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on Mar2021 (lot number: ET3620) as single dose for covid-19 immunisation. Medical history included ongoing neoplasm of unspecified nature of brain, and ongoing palliative care with palliative drug prescriptions and plan, though not end of life care. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on Mar2021 for COVID-19 immunisation (lot number: ET3620). Previous drug reactions: none known. Reported suspected adverse event was wheezing breathing on Mar2021. The patient had requested vaccination with dose 2. Developed decreased general health condition with labored and wheezing breathing during the night and died in the morning after the vaccination. The patient died on Mar2021. Cause of death was wheezing breathing. 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: wheezing breathing


VAERS ID: 1176377 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-03-16
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNK / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VASCORD HCT
Current Illness: Apnea (Moderate combined sleep apnea); Arterial hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: GI bleed (History of intestinal bleeding with Diclofenac use); Glaucoma; Rotator cuff tear (Transmural lesion of the infraspinatus tendon right); Rotator cuff tear (Right rotator cuff lesion); Tendon dislocation (Medially displaced right long biceps tendon); Tendon rupture (Rupture of right supraspinatus tendon); Tendon rupture (At least partial rupture of the right subscapularis tendon)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in an 80-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. UNK and UNK) for COVID-19 vaccination. The patient''s past medical history included GI bleed (History of intestinal bleeding with Diclofenac use), Rotator cuff tear (Right rotator cuff lesion), Tendon rupture (Rupture of right supraspinatus tendon), Rotator cuff tear (Transmural lesion of the infraspinatus tendon right), Tendon rupture (At least partial rupture of the right subscapularis tendon) and Tendon dislocation (Medially displaced right long biceps tendon). Concurrent medical conditions included Arterial hypertension, Apnea (Moderate combined sleep apnea) and Glaucoma. Concomitant products included AMLODIPINE BESILATE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (VASCORD HCT) from an unknown date to 16-Mar-2021 for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 16-Mar-2021 The patient died on 16-Mar-2021. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Death) to be unlikely related. No treatment information was provided. Reporters comment: First vaccination date is unclear (28 days before apparently), second was on Mar 11, 2021 The only medication he was taking was Vascord HCT Case narrative: Patient with no known allergies. On Dicloflenac history of intestinal bleeding Smoker: no Alcohol: no Kidney disease: no Liver disease: no Known for arterial hypertension, moderate combined sleep apnoea, right rotator cuff lesion, rupture of right supraspinatus tendon transmural lesion of right infraspinatus tendon at least partial rupture of right subscapularis tendon medially displaced right long biceps tendon. Glaucoma The only medication he was taking was Vascord HCT. The patient was vaccinated with Moderna for the second time on Mar 11, 2021 (first dose 28 days before), and on Mar 16, 2021 he was suddenly found dead in his flat. No relevant previous illnesses which could explain the death. Cause of death unclear, a forensic autopsy is not scheduled. Reporter did not allow further contact; Reporter''s Comments: Death in temporal correlation with the Moderna vaccine (after 5 days) in an elderly patient with high blood pressure and sleep apnoea. Age as well as high blood pressure and sleep apnoea, in the first instance, suggest an acute cerebrovascular event. At the moment, there are no known data in the literature correlating sudden deaths with the Moderna Vaccine and, for this reason, even given an initial hypothesis of an acute cerebrovascular event, we consider the causal link to be unlikely, which does not completely rule out a possible involvement in the absence of data that can shed more light (e.g., autopsy).; Sender''s Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities. Further information is required.; Reported Cause(s) of Death: Cause of death


VAERS ID: 1176425 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000489 / UNK - / OT

Administered by: Unknown       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: 2021-03-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history reported.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROMODERNATX, INC.MOD20210

Write-up: Cardio-respiratory arrest; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) in a 77-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000489) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No medical history reported.). On 04-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form(s). On 05-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criterion death). The patient died on 05-Mar-2021. The reported cause of death was Cardio-respiratory arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded Reporter did not allow further contact; Sender''s Comments: Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1179063 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-14
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood test, Brain natriuretic peptide, Cardiac failure, Cardiogenic shock, Cardiomegaly, Computerised tomogram head, Computerised tomogram thorax, Electrocardiogram, Lactic acidosis, Prohormone brain natriuretic peptide increased, Pulmonary oedema, Respiratory acidosis, Troponin T, Troponin T increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VEINOFYTOL; UNI DIAMICRON; XARELTO; ISOTEN; INDAPAMIDE; GLUCOPHAGE [METFORMIN]; RIVASTIGMINE; SEDINAL; ATROVENT; CIRCADIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxious depression; Arterial hypertension (Treated by Xarelto); Artificial cardiac pacemaker user; Bilateral cataracts; Bilateral inguinal hernia; Central sleep apnea syndrome; Cerebral atrophy; Cholecystectomy; Chronic atrial fibrillation (institutionalized anticoagulated chronic atrial fibrillation); CPAP; Dementia with Lewy bodies; Movements involuntary of limbs; Sleep apnea syndrome; Type 2 diabetes mellitus (type 2 diabetes)
Allergies:
Diagnostic Lab Data: Test Name: blood gas analysis; Result Unstructured Data: Test Result:mixed decompensated acidosis, both respiratory and; Comments: lactic; Test Name: blood test; Result Unstructured Data: Test Result:mild inflammatory syndrome, acute renal failure; Comments: (anuria), increased proBNP, troponin T slightly above the norm.; Test Name: proBNP; Result Unstructured Data: Test Result:increased; Test Name: Cerebral CT; Result Unstructured Data: Test Result:normal; Test Name: Thoracic CT; Result Unstructured Data: Test Result:major cardiomegaly, bibasal bronchial mucoid; Comments: impactions; Test Name: ECG; Result Unstructured Data: Test Result:slow atrial fibrillation with chronically known T; Comments: wave inversion, transition to accelerated idio-ventricular rhythm over half of the trace (polymorphic right Bundle branch block-type ventricular complexes without visible triggering of the pacemaker); Test Name: troponin-t; Result Unstructured Data: Test Result:slightly above normal
CDC Split Type: BEPFIZER INC2021363045

Write-up: Acute renal failure; Very rapid development of cardiogenic shock resulting in death the next day; major cardiomegaly on probable alteration of left contractility; Sudden left cardiac decompensation with no sign of associated ischemia or sepsis; Gasometry demonstrating decompensated mixed acidosis, both respiratory and lactic; Prohormone brain natriuretic peptide increased; Admitted in carbonarcosis on pulmonary edema on 16Mar2021; Troponin T sligthly above normal range; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-85054. This report originated from the Agency. A 78-year-old male patient received his second dose of BNT162B2 (COMIRNATY), via intramuscular route on Feb2021 (end of February) (Batch/Lot Number: Unknown) as an unspecified dose for covid-19 vaccination. Medical history included dementia with lewy bodies, institutionalized anticoagulated chronic atrial fibrillation, arterial hypertension (treated by Xarelto), anxiodepression, type 2 diabetes mellitus, cortico-subcortical atrophy, severe sleep apnea syndrome with numerous central apneas. CPAP failure, Numerous periodic movements of the lower limbs: Pramipexole failure, cholecystectomy, Bilateral inguinal hernia cure, bilateral cataract cure, and a pacemaker; all from an unknown date and unknown if ongoing. Concomitant medications included aesculus hippocastanum extract (VEINOFYTOL); gliclazide (UNI DIAMICRON); rivaroxaban (XARELTO); bisoprolol fumarate (ISOTEN); indapamide; metformin (GLUCOPHAGE); rivastigmine; ballota nigra extract, crataegus laevigata extract, passiflora incarnata extract (SEDINAL); ipratropium bromide (ATROVENT); melatonin (CIRCADIN); all taken for an unspecified indication, start and stop date were not reported. The patient previously took xarelto, pramipexole for dyskinesia and experienced drug ineffective. He received his first dose of BNT162B2 (COMIRNATY) on an unspecified date. The patient experienced sudden left cardiac decompensation with no sign of associated ischemia or sepsis on 14Mar2021, admitted in carbonarcosis on pulmonary edema on 16Mar2021, prohormone brain natriuretic peptide increased on 14Mar2021, major cardiomegaly on probable alteration of left contractility on 14Mar2021 , troponin t sligthly above normal range on 14Mar2021 , acute renal failure on 14Mar2021, gasometry demonstrating decompensated mixed acidosis, both respiratory and lactic on 14Mar2021, very rapid development of cardiogenic shock resulting in death the next day. The patient underwent lab tests and procedures on unspecified dates which included CT thoracic: major cardiomegaly, bibasal bronchial mucoid impactions; CT cerebral: normal. ECG: slow atrial fibrillation with chronically known T wave inversion, transition to accelerated idio-ventricular rhythm over half of the trace (polymorphic right Bundle branch block-type ventricular complexes without visible triggering of the pacemaker). At the blood level, mild inflammatory syndrome, acute renal failure (anuria), increased proBNP, troponin T slightly above the norm. Gasometry showing mixed decompensated acidosis, both respiratory and lactic. Therapeutic measures were taken as a result of the events: non-invasive ventilation, intravenous diuretica, comfort cure after discussion with family. The patient died on 17Mar2021 due to the events. It was unknown if an autopsy was performed. The Agency considered the relatedness as unclassifiable. Reporter''s comment (concomitant drugs, ADR treatment and tests) integrated in narrative. No follow-up attempts are possible; information about batch number cannot be obtained.


VAERS ID: 1179064 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-23
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Coagulopathy, Computerised tomogram, Mini mental status examination
SMQs:, Haemorrhage laboratory terms (broad), 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: MICROLAX [SODIUM CITRATE;SODIUM LAURYL SULFOACETATE]; MOTILIUM [DOMPERIDONE]; DIPIPERON; OMEPRAZOL AB; BISOPROLOL EG; DUROGESIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Cholecystectomy; Depressed mood; Ischemic cardiomyopathy; Lung neoplasm; Non STEMI; Paroxysmal atrial fibrillation; Pulmonary embolism; Surgery; Total hysterectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210223; Test Name: CT; Result Unstructured Data: Test Result:established CVA in the right ACM; Comments: showed an established CVA in the right Arterial Cerebral Media area, right frontal reaching from the vertex to the insula; Test Date: 201910; Test Name: MMSE; Result Unstructured Data: Test Result:8/30
CDC Split Type: BEPFIZER INC2021363033

Write-up: Coagulation disorder; CT showed an established CVA in the right ACM area extending right frontally from the vertex to the insula; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB received from a regulatory authority. The regulatory authority number is BE-FAMHP-DHH-N2021-85082. This consumer reported similar events for two patients. This is the first of two reports. A 94-year-old female patient received the second dose of BNT162B2 (COMIRNATY Solution for injection, lot number: EK9788, expiry date: unknown), via an unspecified route of administration, on 02Feb2021 as single dose, for COVID-19 immunisation. Medical history included tumor at lung middle lobe in the 1980s for which successful lobectomy was done on an unspecified date, cholecystectomy on an unspecified date, hysterectomia totalis radicalis on an unspecified date, pulmonary embolisms in 2006, paroxysmal atrial fibrillation in 2007 which started unspecified anticoagulants (reported as "antico/anticoagulators"), depressed mood picture (as reported) on an unspecified date, Alzheimer''s disease on an unspecified date, NSTEMI with ischemic CMP in 2015. Concomitant medications included sodium citrate, sodium lauryl sulfoacetate (MICROLAX); domperidone (MOTILIUM); pipamperone hydrochloride (DIPIPERON); omeprazole (OMEPRAZOL AB 20 mg); bisoprolol fumarate (BISOPROLOL EG); and fentanyl (DUROGESIC); all taken for unspecified indications, start and stop dates were not reported. The patient previously took unspecified anticoagulants (reported as "antico/anticoagulators") for paroxysmal atrial fibrillation and was stopped because of diffuse hematomas. The patient experienced coagulation disorder on 23Feb2021. CT showed an established CVA in the right Arterial Cerebral Media (ACM) area, right frontal reaching from the vertex to the insula on 23Feb2021. Therapeutic measures were taken as a result of coagulation disorder (coagulopathy) and CVA (cerebrovascular accident) which included "thrombolyse" (as reported). The patient underwent lab tests and procedures which included mini mental status examination of 8/30 in Oct2019. The outcome of the events was fatal. The patient died on an unspecified date and it was unknown if an autopsy was performed. The assessed the relatedness for both events as unclassifiable. Reporter''s comment: Treatment - Yes thrombolyse. Evolution of the ADR - Death; ADR description - CT showed a set CVA in right ACM area right frontal reaching from the vertex to the insula. No intracranial bleeding. As cause of CVA, we keep the auricular fibrillation. Anticoagulators were stopped in the past because of diffuse hematomas. After phone call with stroke specialist, we felt necessary to report this given that we had two similar cases with a CVA with fatal outcome. This can, of course, be based on an accidental confluence of vaccination and CVA and is not based on an adverse reaction. No follow-up attempts are possible. No further information is requested.; Sender''s Comments: Linked Report(s) : BE-PFIZER INC-2021363038 Same reporter/product/event, different patient; Reported Cause(s) of Death: Coagulation disorder; CT showed an established CVA in the right ACM area extending right frontally from the vertex to the insula


VAERS ID: 1179065 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anorexia; Depression (probable depression)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021363030

Write-up: patient found deceased on 21Mar2021 with no cause of death found; This is a spontaneous report from the regulatory authority. Regulatory authority number BE-FAMHP-DHH-N2021-85516. A 65-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included anorexia and probable depression both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient found deceased on 21Mar2021 with no cause of death found. It was not reported if an autopsy was performed. Treatment - No. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: patient found deceased on 21Mar2021 with no cause of death found


VAERS ID: 1179080 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Cardiac failure, Circulatory collapse, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Retroperitoneal fibrosis (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), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021363051

Write-up: Cardiac failure; Cardiac failure aggravated; Renal failure; Acute edema of lung, unspecified; rapid escalation of cardio-circulatory decompensation/cardio-circulatory and renal failure resulting in death.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-805813. A 94-year-old male patient received the first dose of bnt162b2 (COMIRNATY; Lot Number: EP2163), via an unspecified route of administration on 06Mar2021 at a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was very fragile with multiple pathologies who, days after the first dose of Comirnaty, began a rapid escalation of cardio-circulatory decompensation and according to the family, with cardio-circulatory and renal failure resulting in death. The patient experienced cardiac failure on 11Mar2021, cardiac failure aggravated on 11Mar2021, acute edema of lung, unspecified on 11Mar2021 and renal failure on 11Mar2021. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Renal failure; Cardiac failure


VAERS ID: 1179083 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-08
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: 2021-03-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contusion of hip (On 11Mar2021 he suffered a fall with a contusion of his right hip.); Diabetic polyneuropathy; Fall; Hip fracture; Hypercholesterolaemia; Hypertension arterial; Ischaemic heart disease; Ischaemic stroke; Limb ischaemia; Obesity; Prostatic hypertrophy (benign); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021363058

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-809511. An 86-year-old male patient received first dose of bnt162b2 (COMIRNATY), via intramuscular route on 12Mar2021 (Batch/Lot Number: ET1831) as 0.3 mL, single for COVID-19 immunization. Medical history included ischaemic stroke from 2015, hypertension arterial, type 2 diabetes mellitus, diabetic polyneuropathy, prostatic hypertrophy (benign), ischaemic heart disease, limb ischaemia, obesity, hypercholesterolaemia. On 11Mar2021, he suffered a fall with a contusion of his right hip. Hip fracture is ruled out on X-ray. The patient''s concomitant medications were not reported. On 13Mar2021, they wake him up for breakfast, finding him in his basal state. While waking him up for food, they find him unreactive. Medical services were notified, they confirmed death. The patient died on 13Mar2021. No autopsy is performed. Case Summary and Reporter Comments Text: 86-year-old multi-pathological and polymedicated male, dependent. On 11Mar2021 he suffered a fall with a contusion of his right hip. Hip fracture is ruled out on X-ray. On 12Mar2021 he receives the 1st dose of the Comirnaty vaccine. On 13Mar2021 they wake him up for breakfast, finding him in his basal state. While waking him up for food they find him unreactive. Medical services are notified, they confirm death. No autopsy is performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1179084 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; CVA; Diabetes mellitus insulin-dependent; Endarterectomy; Peripheral arterial occlusive disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021363017

Write-up: Aspiration; This is a spontaneous report received from a contactable physician downloaded from hysterectomia-WEB; the Regulatory Authority report number is FR-AFSSAPS-BR20211002. An 86-year-old male patient received BNT162B2 (COMIRNATY; dose 2) intramuscular, administered in the right arm on 24Mar2021 (batch/lot number: ER9470, expiry date unknown) at 86 years old at a SINGLE DOSE for COVID-19 immunization. The patient''s medical history included Diabetes mellitus insulin-dependent, endarterectomy, atrial fibrillation, CVA (cerebrovascular accident), and peripheral arterial occlusive disease, all from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 24Mar2021, the patient experienced aspiration and died. It was reported that 3 hours later, the patient suffered an inhalation during his nap, which was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information on batch/lot number was already obtained.; Reported Cause(s) of Death: patient suffered an inhalation during his nap, which was fatal


VAERS ID: 1179102 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-03-08
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood glucose, Blood pressure measurement, Body temperature, C-reactive protein, C-reactive protein increased, Creatinine renal clearance, Cyanosis, Dehydration, Dependent rubor, General physical health deterioration, Glomerular filtration rate, Glomerular filtration rate decreased, Heart rate, Heart rate increased, Hyperglycaemia, Increased bronchial secretion, Leukocytosis, Livedo reticularis, Lower respiratory tract congestion, Monocyte count, Monocytosis, Multiple organ dysfunction syndrome, Oxygen saturation, Productive cough, Prothrombin time, Prothrombin time shortened, Purpura, Pyrexia, Rales, Restlessness, Rhinorrhoea, Somnolence, Wheezing, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   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: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210308; Test Name: creatinine; Result Unstructured Data: Test Result:15.1; Test Date: 20210317; Test Name: glucose; Result Unstructured Data: Test Result:hyperglycaemia; Test Date: 20210308; Test Name: blood pressure; Result Unstructured Data: Test Result:13/7; Test Date: 20210308; Test Name: body temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Test Date: 20210308; Test Name: C-reactive protein; Result Unstructured Data: Test Result:242.8; Test Date: 20210308; Test Name: creatinine clearance; Result Unstructured Data: Test Result:25; Test Date: 20210308; Test Name: GFR; Result Unstructured Data: Test Result:31; Test Date: 20210308; Test Name: heart rate; Result Unstructured Data: Test Result:115; Comments: bpm; Test Date: 20210308; Test Name: monocytes; Result Unstructured Data: Test Result:slight leucocytosis; Test Date: 20210308; Test Name: oxygen saturation; Test Result: 94 %; Comments: in ambient air; Test Date: 20210308; Test Name: prothrombin time; Test Result: 37 %; Test Date: 20210308; Test Name: PNN; Result Unstructured Data: Test Result:slight leucocytosis
CDC Split Type: FRPFIZER INC2021363028

Write-up: Multiorgan failure; sudden deterioration of the general condition; cyanosis of the extremities; mottling of the knees; drowsiness; dehydration with skin folds; hyperglycemia; cracklings in left lung base; growing restlessness; tracheobronchial congestion; declining purpura of the lower limbs: posterior surfaces of the calves and thighs; wet cough with bilateral bronchial wheeze; pulse: 115/minute; leukocytosis; monocytosis; CRP = 242.8 mg/l; prothrombin time = 37%; GFR = 31; Excessive bronchial secretion; Rhinorrhea; Pyrexia/fever at 38.8C; Cough/wet cough; Dependent rubor; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-TO20212104. An 86-year-old female patient received the second dose of bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 17Feb2021 (Batch/Lot Number: EJ6788) as single dose for covid-19 immunisation. Medical history included dementia. The patient had no Covid-19. The patient''s concomitant medications were not reported. The patient experienced excessive bronchial secretion, rhinorrhea, pyrexia, cough, and dependent rubor on 08Mar2021. The patient also experienced multiorgan failure on an unspecified date. Beginning in the early morning of 08Mar2021, the patient had fever at 38.8C with declining purpura of the lower limbs: posterior surfaces of the calves and thighs, rhinorrhea and wet cough with bilateral bronchial wheeze, blood pressure 13/7, pulse: 115/minute, and O2 saturation: 94% in ambient air, discrete PNN (polymorphonuclear neutrocytes) leukocytosis and monocytosis, CRP = 242.8 mg/l, prothrombin time = 37%, creatinine = 15.1, GFR = 31, and Cockcroft (creatinine clearance) = 25 were also noted. On 09Mar2021, increase in tracheobronchial congestion was noted; patient was placed on Ceftriaxone 500mg IM per day. The patient also experienced growing restlessness. On 11Mar2021, numerous cracklings in left lung base was noted. On 17Mar2021 at 3 A.M, the patient had sudden deterioration of the general condition, breathing draft, cyanosis of the extremities, mottling of the knees, disappearance of purpura, drowsiness, dehydration with skin folds and hyperglycemia. The patient was put under O2 at 4 liters per minute. The patient underwent lab tests and procedures which included creatinine: 15.1 on 08Mar2021, glucose: hyperglycaemia on 17Mar2021, blood pressure: 13/7 on 08Mar2021, body temperature: 38.8 centigrade on 08Mar2021, c-reactive protein: 242.8 on 08Mar2021, creatinine clearance: 25 on 08Mar2021, GFR: 31 on 08Mar2021, heart rate: 115 bpm on 08Mar2021, monocytes: slight leucocytosis on 08Mar2021, oxygen saturation: 94 % in ambient air on 08Mar2021, prothrombin time: 37 % on 08Mar2021, and PNN: slight leucocytosis on 08Mar2021. Therapeutic measures were taken as a result of excessive bronchial secretion. The patient died on 17Mar2021 at 11:30 AM due to excessive bronchial secretion, rhinorrhea, pyrexia, cough, dependent rubor and multiorgan failure. Covid test was not done. An autopsy was not performed. The outcome of the other events was unknown. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Excessive bronchial secretion; rhinorrhea; pyrexia; cough; dependent rubor; Multiorgan failure


VAERS ID: 1179119 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-05
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, COVID-19, Drug ineffective, Dyspnoea, Pyrexia, SARS-CoV-2 antibody test positive, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), 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), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210301; Test Name: Blood test; Result Unstructured Data: Test Result:non immunological response in terms of creation of; Comments: non immunological response in terms of creation of special antibodies against epitope S, zero number of antibodies; Test Date: 20210305; Test Name: COVID-19 antibody test positive; Result Unstructured Data: Test Result:POSITIVE RT - PCR; Test Date: 20210305; Test Name: Covid-19 rapid antigen test; Result Unstructured Data: Test Result:positive; Test Date: 20210305; Test Name: Covid-19 RT-PCR test; Result Unstructured Data: Test Result:positive; Test Date: 20210305; Test Name: COVID-19 PCR test positive; Result Unstructured Data: Test Result:POSITIVE
CDC Split Type: GRPFIZER INC2021358077

Write-up: covid-19; covid-19; Fever; Dyspnea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority number is GR-GREOF-20211741. An 87-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: Unknown), dose 2 intramuscular on 24Feb2021 as single dose and the first dose on an unspecified date for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 05Mar2021, the patient experienced fever and dyspnea and covid-19 on 08Mar2021. The events were serious as they lead to death. The patient underwent lab tests and procedures which included blood test on 01Mar2021, showed non immunological response in terms of creation of special antibodies against epitope S, zero number of antibodies, COVID-19 antibody test was positive (reported as positive RT-PCR) on 05Mar2021, Covid-19 rapid antigen test: positive on 05Mar2021, Covid-19 RT-PCR test: positive on 05Mar2021, COVID-19 PCR test positive: positive on 05Mar2021. Details were as follows: The patient completed the vaccination on 24Feb2021. He was in contact with a positive case and showed symptoms of fever and dyspnea. Positive RT-PCR and rapid antigen on 05Mar2021. He stayed at home and died suddenly in his sleep on 08Mar2021. From blood taken before the illness from Covid-19 ( March 1) IgG and IgM antibodies were measured (clia detects IgG antibodies against S protein, including the epitope of the S1 - receptor binding (RBD) region. Antibodies and vaccines against this epitope, were neutralized and zero. Patient with polypharmacy (per os every medication), for unspecified chronic diseases. The cause of death was from Covid-19. No biopsy was performed. Finally, the blood tests performed on 01Mar2021, showed zero number of antibodies as the doctor explained. The relatedness of drug to reactions fever and dyspnea per source of assessment, regulatory authority 14/03/2021: Method of assessment: WHO GLOBAL INTROSPECTION METHOD was reported as unlikely. The patient died on 08Mar2021. An autopsy was not performed. Sender Comment: Initial report with follow up information. No Follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Covid-19


VAERS ID: 1179157 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-16
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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: NLPFIZER INC2021358046

Write-up: cardiac arrhythmias; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00486449. A 96-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 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced cardiac arrhythmias on 16Mar2021. The patient died on an unspecified date due to the event. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: cardiac arrhythmias


VAERS ID: 1180908 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-03-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, 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: 2021-03-31
   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: Depression; Dyspepsia; Parkinson''s disease (slow type for several years)
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:perfect
CDC Split Type: CAPFIZER INC2021361855

Write-up: cerebrovascular accident; This is a spontaneous report received from a contactable consumer (patient''s daughter). An 89-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Mar2021 at 16:30 (at the age of 89 years) at a single dose in the left arm for COVID-19 immunization. Medical history included Parkinson''s disease (slow type for several years), dyspepsia, and depression. Patient had no allergies to medications, food, or other products. Patient had no serious heart condition or other conditions. His last blood test was perfect. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 31Mar2021, the patient had cerebrovascular accident. The patient did not receive any treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient died on 31Mar2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: cerebrovascular accident


VAERS ID: 1180930 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia absoluta; Artificial cardiac pacemaker user; Cardiac insufficiency; Hypertension arterial; Penis carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021358264

Write-up: Exitus letalis with unexplained cause of death; This is a spontaneous report from a non-contactable physician from the Agency Regulatory Authority-WEB DE-PEI-PEI2021003797. An 81-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 22Mar2021 (at the age of 81-years-old) as a single dose for COVID-19 immunisation. Medical history included penis carcinoma, cardiac insufficiency, arrhythmia absoluta, hypertension arterial and artificial cardiac pacemaker user from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced exitus letalis with unexplained cause of death/sudden death, cause unknown on 25Mar2021. Clinical course was as follows: Three day(s) after vaccination the patient developed sudden death, cause unknown, lasting for unknown. The patient died on 25Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: sudden death, cause unknown


VAERS ID: 1180931 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-07
Onset:2021-03-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Chest X-ray, Effusion, Pneumonia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data: Test Name: Chest x-ray; Result Unstructured Data: Test Result:Results NOS
CDC Split Type: DEPFIZER INC2021358243

Write-up: Renal failure; Pneumonia; Effusion; Acute respiratory insufficiency; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-PEI2021003800. A 90-year-old male patient received the second dose of bnt162b2 (COMIRNATY; Lot Number: ER2659), intramuscular on 07Mar2021 at a single dose for covid-19 immunisation. Medical history included dementia from an unknown date and unknown if ongoing. The patient received first dose of COVID vaccine COMIRNATY on 14Jan2021 at single dose for COVID-19 immunization and experienced reduced general condition. The patient''s concomitant medications were not reported. The patient experienced pneumonia on 11Mar2021, renal failure on 25Mar2021, effusion on 09Mar2021 and acute respiratory insufficiency on 08Mar2021. The patient underwent lab tests and procedures which included chest x-ray: results nos on an unspecified date. The patient was hospitalized and died on 25Mar2021. It was reported that death was caused by renal failure. It was not reported if an autopsy was performed. No follow-up attempts are possible.; Reporter''s Comments: Chest x-ray, laboratory performed; Reported Cause(s) of Death: Renal failure


VAERS ID: 1180953 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021362973

Write-up: Haemorrhage cerebral; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number ES-AEMPS-807582. An elderly male patient received bnt162b2 (COMIRNATY) solution for injection, dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: ET3620) as a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died of haemorrhage cerebral on 25Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Haemorrhage cerebral


VAERS ID: 1180959 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-22
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   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: KARDEGIC; SPECIAFOLDINE; TARDYFERON; LACTULOSE; LOPRESSOR; PERINDOPRIL; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial insufficiency coronary; Cognitive disorder; Hypertension arterial; Varicose veins; Venous insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210222; Test Name: oxygen saturation; Test Result: 60 %; Test Date: 20210222; Test Name: SARS-CoV-2; Test Result: Positive
CDC Split Type: FRPFIZER INC2021358093

Write-up: COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-AN20211060. A 96-year-old female patient received first dose of bnt162b2 (COMIRNATY; Batch/Lot Number: EJ6789), intramuscular on 16Feb2021 on the left arm as single dose for COVID-19 immunization. Medical history included varicose veins, cognitive disorder, hypertension arterial, venous insufficiency, and arterial insufficiency coronary; from an unknown date and unknown if ongoing. In Jan2021, the patient was admitted to the hospital for general health deterioration. Following discharge, the patient returned weak to the nursing home. No previous Coronavirus disease 2019 (COVID-19) infection (prior to the episode described below). The patient was at risk of developing a severe form of COVID-19 and she did not know if she had allergies/ hypersensitivity. The patient''s concomitant medications included acetylsalicylate lysine (KARDEGIC 75 mg), folic acid (SPECIAFOLDINE), ferrous sulfate (TARDYFERON),lactulose (unspecified trade name), metoprolol tartrate (LOPRESSOR), perindopril (unspecified trade name), paracetamol ( unspecified trade name). On 22Feb2021, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR) test was performed in the context of a cluster in the nursing room. The PCR returned positive on the same day. On 26Feb2021 the patient presented with COVID symptoms with saturation of peripheral oxygen (oxygen saturation) at 60% (22Feb2021) in ambient air. The patient was not hospitalized due to the pre-existing general health condition deterioration. On 28Feb2021, at 6:00 a.m., the patient ate as usual. Death was noticed at the beginning of the afternoon. Severe COVID-19 was diagnosed in a patient 6 days following vaccination with the first dose of COVID-19 mRNA Vaccine (nucleoside modified), in the context of a cluster in the nursing room. The patient became symptomatic "10 days following vaccination" and died 12 days after vaccination. The patient experienced covid-19 (death) on 22Feb2021. The patient died on 28Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1180960 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-03-01
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-04-08
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, Cough, Pyrexia, Respiratory disorder, SARS-CoV-2 test, Vaccination failure, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KARDEGIC; ADENURIC; FUROSEMIDE; NEBIVOLOL; CETRIZINE
Current Illness: Arteriopathic disease; Carotid artery stenosis; Failure respiratory; Heart failure; Morbid obesity; Osteoarthritis; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210309; Test Name: SARS-CoV-2 PCR; Test Result: Positive ; Comments: variant
CDC Split Type: FRPFIZER INC2021333507

Write-up: Acute respiratory distress syndrome; cough; vomiting; asthenia; vaccination failure; PCR positive, variant covid-19 infection; fever; respiratory discomfort; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number: FR-AFSSAPS-BS20210413. This physician reported similar event for two patients. This is the first of two reports. An 88-year-old female patient received BNT162B2 (COMIRNATY) first dose (Lot Number: EM0477) on 14Jan2021 and second dose (Lot Number EJ6788) on 04Feb2021; both given intramuscular at single dose for COVID-19 immunisation. Medical history included arteriopathic disease, morbid obesity, carotid artery stenosis , osteoarthritis , failure respiratory, type 2 diabetes mellitus, and heart failure; all ongoing. Concomitant medications included acetylsalicylate lysine (KARDEGIC); febuxostat (ADENURIC); furosemide, nebivolol and cetirizine hydrochloride (CETRIZINE). On 01Mar2021 the patient experienced fever and respiratory discomfort. On 09Mar2021 the SARS-CoV-2 PCR was positive for COVID-19, variant, sequencing in progress. On 10Mar2021the patient experienced fever, cough, vomiting and asthenia. On 15Mar2021 she was hospitalized for acute respiratory distress syndrome (ARDS), prognosis live threatening on 18Mar2021. In total, variant covid-19 infection on 01Mar2021 after a complete well-conducted vaccination schedule. No conservation condition problem. The patient died on 21Mar2021. Cause of death was COVID-19 pneumonia, vaccination failure, fever, cough, vomiting, and Acute respiratory distress syndrome. Autopsy was not performed. No follow-up attempts possible. No further information expected. Follow-up (02Apr2021): New information downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-BS20210413 includes updated outcome of events (fatal). No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021333550 same reporter, different patient;AFSSAPS-BS20210414; Reported Cause(s) of Death: vaccination failure; fever; cough; vomiting; Acute respiratory distress syndrome; COVID-19 pneumonia


VAERS ID: 1181203 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000494 / 1 - / OT

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

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: CARDICOR; URBASON [METHYLPREDNISOLONE ACETATE]; GLAZIDIM; LASIX [FUROSEMIDE]; SEVELAMER
Current Illness: Dialysis NOS; Lung neoplasm
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death from natural causes; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death from natural causes) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000494) for COVID-19 vaccination. Concurrent medical conditions included Dialysis NOS and Lung neoplasm Concomitant products included BISOPROLOL FUMARATE (CARDICOR), METHYLPREDNISOLONE ACETATE (URBASON [METHYLPREDNISOLONE ACETATE]), CEFTAZIDIME (GLAZIDIM), FUROSEMIDE (LASIX [FUROSEMIDE]) and SEVELAMER for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage form in total. Death occurred on 04-Mar-2021 The patient died on 04-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. This is a case of sudden death in a 80-year-old male patient with a history of Dialysis NOS and Lung neoplasm, who died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time. Reporter did not allow further contact; Sender''s Comments: This is a case of sudden death in a 80-year-old male patient with a history of Dialysis NOS and Lung neoplasm, who died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: death from natural causes


VAERS ID: 1181240 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-15
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemoglobin, Pancytopenia, Platelet count, Subdural haematoma, White blood cell count
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (broad), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALCIGRAN FORTE; NORMORIX; SIMVASTATIN; BEHEPAN [CYANOCOBALAMIN]; SELO-ZOK; SOMAC; AMLODIPINE; ZYLORIC; PROLIA; ALBYL-E
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Atrial fibrillation; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210315; Test Name: Hemoglobin; Result Unstructured Data: 7.0; Test Date: 20210315; Test Name: Thrombocyte count; Result Unstructured Data: <5 Not measurable; Test Date: 20210315; Test Name: Leukocyte count; Result Unstructured Data: 1.1
CDC Split Type: NOMODERNATX, INC.MOD20210

Write-up: Pancytopenia; Subdural hematoma; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PANCYTOPENIA (Pancytopenia) and SUBDURAL HAEMATOMA (Subdural hematoma) in an 89-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation, Hypertension and Aortic stenosis. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (CALCIGRAN FORTE) from an unknown date to 16-Mar-2021, AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE (NORMORIX) from an unknown date to 16-Mar-2021, SIMVASTATIN from an unknown date to 16-Mar-2021, CYANOCOBALAMIN (BEHEPAN [CYANOCOBALAMIN]) from an unknown date to 16-Mar-2021, METOPROLOL SUCCINATE (SELO-ZOK) from an unknown date to 16-Mar-2021, PANTOPRAZOLE SODIUM SESQUIHYDRATE (SOMAC) from an unknown date to 16-Mar-2021, AMLODIPINE, ALLOPURINOL (ZYLORIC) from an unknown date to 16-Mar-2021, DENOSUMAB (PROLIA) from an unknown date to 16-Mar-2021 and ACETYLSALICYLIC ACID, MAGNESIUM OXIDE (ALBYL-E) from an unknown date to 16-Mar-2021 for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced SUBDURAL HAEMATOMA (Subdural hematoma) (seriousness criterion death). On an unknown date, the patient experienced PANCYTOPENIA (Pancytopenia) (seriousness criterion death). The patient died on 16-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Haemoglobin: 7.0 7.0. On 15-Mar-2021, Platelet count: <5 not measurable <5 Not measurable. On 15-Mar-2021, White blood cell count: 1.1 1.1. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered PANCYTOPENIA (Pancytopenia) and SUBDURAL HAEMATOMA (Subdural hematoma) to be possibly related. This is a case of sudden death in a 89-year-old female patient with a history of Atrial fibrillation, Hypertension and Aortic stenosis, who died after receiving first dose of vaccine (date unknown). Very limited information has been provided at this time. Reporter did not allow further contact; Sender''s Comments: This is a case of sudden death in a 89-year-old female patient with a history of Atrial fibrillation, Hypertension and Aortic stenosis, who died after receiving first dose of vaccine (date unknown). Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1183627 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-03-19
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   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: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Arrhythmia (NOS); Arterial hypertension; Atrial fibrillation; Chronic renal failure; Cognitive disturbance; Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Myocardial infarction; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) in an 89-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Chronic renal failure, Arterial hypertension, Arrhythmia (NOS), Aortic stenosis, Diabetes mellitus, Cognitive disturbance and Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criterion death). The patient died on 19-Mar-2021. The reported cause of death was suspected myocardial infarction as a cause of death. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered MYOCARDIAL INFARCTION (Myocardial infarction) to be unlikely related. No treatment included Reporter did not allow further contact; Sender''s Comments: This is a case of sudden death in a 89-year-old male patient with a history of Chronic renal failure, Arterial hypertension, Arrhythmia (NOS), Aortic stenosis, Diabetes mellitus, Cognitive disturbance and Atrial fibrillation, who died of Myocardial infarction 1 day after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Suspected myocardial infarction as a cause of death


VAERS ID: 1183630 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aneurysm, Angiogram, Aortic stenosis, Blood pressure measurement, Cardiac arrest, Cardiac failure, Circulatory collapse, Coma scale, Computerised tomogram head, Haemorrhage intracranial, Heart rate, Hypokalaemia, Paraesthesia
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Peripheral neuropathy (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), 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), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypokalaemia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TRIPLIXAM; EUTHYROX; ASPIRIN PROTECT; KALNORMIN; XANAX; SORVASTA; HELICID [OMEPRAZOLE SODIUM]; ZOLPIDEM
Current Illness: Arterial hypertension (on therapy, compensated); Atrial fibrillation (found out in Jun2020, unclear age, therapy with low molecular weight heparin was started, patient does not use it); Autoimmune thyroiditis (in care of specialist); Cardiac valve disease (acquired valve disease according to the patient); Chronic diarrhoea (after treatment of rectal cancer she suffered from persistent diarrhoea. there was a regular replenishing minerals by infusion); Gonarthrosis; Oesophagitis (grade II, on therapy - proton pump inhibitors)
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Anorectal cancer (gastroenterology care provided, there is no relapse of tumour according to CT scan and colonoscopy); Colitis (most likely due to Crohn?s disease); Crohn''s disease; Dilatation biliary tract; Diverticulitis (inflammatory changes around the diverticles); Ileal stenosis; Ileus of intestine (small intestine loops); Large intestine erosion (flat cecal lesion, there is no relapse of tumour according to CT scan and colonoscopy); Non-smoker; Pancreatic duct dilatation (without obstructive liver enzymes elevation or inflammatory markers elevation); Recto-sigmoidectomy (due to carcinoma, actinotherapy); Stenosis of colon (Colon transversum and descendens); Comments: no allergies, non-smoker, alcohol occasionally
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: blood pressure; Result Unstructured Data: Test Result:110/40 mmHg; Test Date: 20210219; Test Name: Blood pressure; Result Unstructured Data: Test Result:110/40 mmHg; Test Date: 20210219; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:3; Comments: for the whole time; Test Date: 20210220; Test Name: Brain CT; Result Unstructured Data: Test Result:Massive intracranial hemorrhage; Comments: caused by an aneurysm in the area of vertebral arteries confluence and formation of a basilar artery, basal cisterns filled up with blood, the blood is also present in both Sylvian fissures, along cerebral sulci on the brain convexity, also intrahemispherically and along the cerebellar tentorium (much more on the right side, where the aneurysm is). In all brain ventricles, there is a slightly major amount of blood. There is edema of the brain stem with almost complete compression of the fourth ventricle. Ectasia of middle cerebral artery bilaterally (medially).; Test Date: 20210219; Test Name: Heart rate; Result Unstructured Data: Test Result:97; Comments: Units:/min; Test Date: 20210220; Test Name: angiography; Result Unstructured Data: Test Result:Massive intracranial hemorrhage; Comments: caused by an aneurysm in the area of vertebral arteries confluence and formation of a basilar artery, basal cisterns filled up with blood, the blood is also present in both Sylvian fissures, along cerebral sulci on the brain convexity, also intrahemispherically and along the cerebellar tentorium (much more on the right side, where the aneurysm is). In all brain ventricles, there is a slightly major amount of blood. There is edema of the brain stem with almost complete compression of the fourth ventricle. Ectasia of middle cerebral artery bilaterally (medially).
CDC Split Type: CZPFIZER INC2021363152

Write-up: hypokalemia; aortal stenosis; intracranial hemorrhage; aneurysm; Heart arrest; Circulatory collapse; Heart failure; arm and leg tingling; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority with regulatory authority number: CZ-CZSUKL-21002747. An 81-year-old female patient received second dose of BNT162B2 (COMIRNATY, lot number: EP2163, exp date not reported), intramuscular on 17Feb2021 as single dose for COVID-19 immunisation. Medical history included Recto-sigmoidectomy on 2016 due to carcinoma, actinotherapy; Dilatation biliary tract, ongoing Cardiac valve disease (acquired valve disease according to the patient), ongoing Arterial hypertension wherein patient was on therapy, compensated; Ileus of intestine (small intestine loops) from Jun2020 to an unspecified date; ongoing Atrial fibrillation found out in Jun2020, unclear age, therapy with low molecular weight heparin was started, patient does not use it; Colitis most likely due to Crohn''s disease (in differential diagnosis there is radiation colitis associated with diverticulitis); ongoing after treatment of rectal cancer she suffered from persistent chronic diarrhoea and for this there was a regular replenishing minerals by infusion by a general practitioner (not specified); Pancreatic duct dilatation without obstructive liver enzymes elevation or inflammatory markers elevation, Ileal stenosis, inflammatory changes around the diverticles (diverticulitis), ongoing Oesophagitis grade II, on therapy with proton pump inhibitors, Stenosis of colon transversum and descendens; ongoing Gonarthrosis, Anorectal cancer from an unspecified date to an unspecified date gastroenterology care provided, there is no relapse of tumour according to CT scan and colonoscopy; Large intestine erosion/flat cecal lesion, there is no relapse of tumour according to CT scan and colonoscopy; ongoing Autoimmune thyroiditis in care of specialist. The patient had no known allergies, was a non-smoker and took alcohol occasionally. Concomitant medication included amlodipine besilate, indapamide, perindopril arginine (TRIPLIXAM), levothyroxine sodium (EUTHYROX), acetylsalicylic acid (ASPIRIN PROTECT), potassium chloride (KALNORMIN), rosuvastatin calcium (SORVASTA), omeprazole sodium (HELICID); all given orally, alprazolam (XANAX) and zolpidem. The patient previously took first dose of BNT162B2 (COMIRNATY, Lot number: EJ6797) via intramuscular route on 27Jan2021 for COVID-19 immunisation and did not notice any reaction. On 17Feb2021, after the second dose, the patient complained of arm and leg tingling - but because paresthesia was reported as a possible ADR, they did not pay attention. Shortly after midnight on 19Feb2021, the patient''s husband was awakened by a rattle, an ambulance was called to the patient for heart arrest (called by her husband) and cardiopulmonary resuscitation was initiated by laymen. The physicians continued the resuscitation and revived the patient by defibrillation and heart massage. Return of spontaneous circulation after 35 minutes in total, the first rhythm was asystole, epinephrine administered 3 times. For the whole time, Glasgow coma scale was 3. After successful revival, the patient was transferred to an Anesthesiology, resuscitation, and intensive care department. At the admission the circulation was effective, blood pressure 110/40 mmHg, and heart rate 97/min. Treatment of cardiac arrest: complex resuscitation care, KCl 7,45 %, Norepinephrine, Sufenta, Propofol, Kardegic, Trittico, Amoksiklav, Letrox, Controloc, Ondansetron, Degan, and Novalgin. After the admission patient was subdued and relaxed from the ambulance. On 19Feb2021 in the morning patient woke up able to make a contact, circulation stable. At 8:00 a.m. she was extubated. According to the attending physician, the most likely etiology of cardiac arrest is atrial tachyfibrillation with hypokalemia and aortal stenosis (onset date not reported). During the night from 19Feb2021 to 20Feb2021 there was a sudden episode of unconsciousness, with tongue swallowing and apnea and need of intubation. Check-up brain CT-scan with angiography showed a massive intracranial hemorrhage caused by an aneurysm in the area of vertebral arteries confluence and formation of a basilar artery. Conclusion of brain CT scan + angiography from 20Feb2021: massive intracranial hemorrhage caused by an aneurysm in the area of vertebral arteries confluence and formation of a basilar artery, basal cisterns filled up with blood, the blood is also present in both Sylvian fissures, along cerebral sulci on the brain convexity, also intrahemispherically and along the cerebellar tentorium (much more on the right side, where the aneurysm is). In all brain ventricles, there is a slightly major amount of blood. There is edema of the brain stem with almost complete compression of the fourth ventricle. Ectasia of middle cerebral artery bilaterally (medially). On 21Feb2021 there was an episode of hypertension and bradycardia, followed by a cardiac and circulatory arrest. On 21Feb2021 at 13:15 the patient died due to cardiac and circulatory arrest. Autopsy was not performed. The patient recovered from heart arrest on 19Feb2021 while the outcome of other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cardiac and circulatory arrest; cardiac and circulatory arrest


VAERS ID: 1183631 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Death, Electrocardiogram, Electroencephalogram, Malaise, Neurological examination, Presyncope, Scan brain, Seizure
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PERINDOPRIL; BISOPROLOL; ELIQUIS; EZETIMIBA; FUROSEMIDE; SPIRONOLACTONE; ATORVASTATIN; LEVOTHYROX; MIANSERIN; BROMAZEPAM; ALENDRONIC ACID; CHOLECALCIFEROL; DIFFU-K
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral ischaemia; Coronary angioplasty; Hypoacusis; Hypothyroidism; Sigmoid polyp (Resected)
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Normal; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Normal; Test Name: Electroencephalogram; Result Unstructured Data: Test Result:Normal; Test Name: Neurological examination; Result Unstructured Data: Test Result:Normal; Test Name: Brain Scan; Result Unstructured Data: Test Result:Normal
CDC Split Type: FRPFIZER INC2021363021

Write-up: Death unexplained; Vasovagal reaction/lipothymia; Convulsion; Felt unwell; This is as spontaneous report received from a contactable Physician downloaded from a regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-BR20210969. An 87-year-old female patient received the first dose of BNT162b2 (COMIRNATY), via intramuscular route on 18Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included hypoacusis, hypothyroidism, coronary angioplasty, cerebral ischaemia from 2020, sigmoid polyp (resected). Concomitant medications included perindopril; bisoprolol; apixaban (ELIQUIS); ezetimiba; furosemide; spironolactone; atorvastatin; levothyroxine sodium (LEVOTHYROX); mianserin; bromazepam; alendronic acid; cholecalciferol; potassium chloride (DIFFU-K), all from an unspecified date for unspecified indication. On the way back home after first dose of Comirnaty, in the car with her daughter, the patient felt unwell. At the history, she described prodromal symptoms followed by lipothymia then convulsions. In the emergency room, the patient presented a normal neurological examination, without confusional syndrome, without focal signs. A brain scan, a blood test, an Electroencephalogram (EEG) and an Electrocardiogram (ECG) were carried out: they were all normal, not allowing to identify a particular somatic cause for the malaise. The patient was kept under surveillance in the Short Stay Unit (SSU). The day after her admission, there was no recurrence of the malaise or convulsive seizure. On reviewing the events, it appears that the patient had not eaten breakfast in the morning and that a priori, she would have presented prodromal symptoms before the seizure, and given her more or less forced sitting position in the vehicle, which prevented her from decubitus during the seizure, the convulsions are probably related to a drop in blood pressure of the vagal malaise type. Conclusion: very likely vagal malaise. On 20Mar2021, the patient returns home. On 20Mar2021 at 17:00, the nurse finds the patient dead on the floor (as if she had tipped over from her chair). The outcome of the event felt unwell was unknown. The patient died on 20Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1183633 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-05
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Arterial hypertension; Cardiac insufficiency; Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021363114

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from a regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-NT20210837. A 71-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EJ6795), intramuscular, administered in arm left on 21Jan2021 as a single dose for COVID-19 immunisation. Medical history included Parkinson''s disease, cardiac insufficiency, atrial fibrillation (AFib) and arterial hypertension, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 05Feb2021, the patient was found dead in his room/sudden death. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on an unspecified date. The patient died on 05Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1183635 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-02-20
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Creatinine renal clearance, Death, Drug ineffective, Platelet 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: 2021-02-25
   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: GABAPENTIN; COLECALCIFEROL; ATORVASTATIN; NEBIVOLOL; VENLAFAXINE ABBOTT; AMIODARONE HYDROCHLORIDE; PARACETAMOL; SALBUTAMOL; ZOPICLONE; FERROUS SULPHATE [FERROUS SULFATE]; OMEPRAZOLE; SODIUM BICARBONATE; FLUTICASONE + SALMETEROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain; Pyrexia; Wheeze
Allergies:
Diagnostic Lab Data: Test Name: Creatinine clearance; Result Unstructured Data: Test Result:19 ml/min; Test Name: platelets; Result Unstructured Data: Test Result:65
CDC Split Type: GBPFIZER INC2021365508

Write-up: Deceased; Drug ineffective; covid-19 pneumonitis; This is a spontaneous report from a contactable pharmacist received from the regulatory authority report number is GB-MHRA-MIDB-1ee53a59-86bf-4bf9-b6d3-9685c447661d, Safety Report Unique Identifier is GB-MHRA-ADR 25055199. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK1768), intramuscular on 15Jan2021 as single dose for COVID-19 immunisation. The patient medical history included pain, pyrexia, wheezing, all from an unknown date and unknown if ongoing. Concomitant medications included gabapentin (strength:100 mg, formulation: capsule) oral at 100 mg once a day (every night); colecalciferol (strength: 20 ug, formulation: tablet ) oral at 1600 iU once a day; atorvastatin (strength: 20 mg, formulation: tablet) oral at 20 mg once a day (every night); nebivolol (strength: 5 mg, formulation: tablet) at 2.5 mg once a day at 8am; venlafaxine hydrochloride (VENLAFAXINE ABBOTT, strength: 37.5 mg, formulation: tablet) oral at 37.5 mg twice a day at 8am and 6pm; amiodarone hydrochloride (strength: 100 mg, formulation: tablet) oral at 100 mg once a day every morning; paracetamol (strength: 500 mg, formulation: tablet) at 1000 mg as needed (when required 4 times a day) was taken for pain, pyrexia; salbutamol (strength: 100 ug) nasal at 200 ug as needed (when required) was taken for wheezing; zopiclone (strength 3.75 mg, formulation: tablet) oral at 3.75 mg once a day at night; ferrous sulphate (strength: 200 mg, formulation: tablet) oral at 200 mg three times a day (8am,12,10pm); omeprazole (strength: 20 mg, formulation: capsule) at 40 mg twice a day (8am and 6pm); sodium bicarbonate (strength: 500 mg, formulation: capsule) oral at 1000 mg three times a day 8am,12,18pm); fluticasone propionate, salmeterol xinafoate (FLUTICASONE + SALMETEROL, strength: 25 ug + 250 ug) twice a day at 8am, for all start and stop date were not reported. The patient was hospitalized due to COVID-19 pneumonitis, confirmed COVID-19 on 20Feb2021. The patient underwent lab tests and procedures which included creatinine renal clearance: 19 ml/min and platelet count: 65 on an unspecified date. Therapeutic measures were taken as a result of COVID-19 and included treatment with ceftazidime, azithromycin and dexamethasone. Randomized to recovery trial and had baricitinib 2 mg OD alternate days and monoclonal antibodies. The patient died on 25Feb2021.It was not reported if an autopsy was performed cause of death was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Deceased


VAERS ID: 1183654 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-15
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MEMANTINE; FERROUS FUMARATE 324; MIRTAZAPINE; PARACETAMOL; ESOMEPRAZOLE; LEXAPRO; CARBIMAZOLE DCI; ZOLPIDEM; AMLODIPINE BESILATE; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Anaemia; Anxiety; Asthma; Depression; Gastrooesophageal reflux disease; Hypertension; Pain; Sleep disorder; Thyroid disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021363232

Write-up: triple A; This is a spontaneous report from a contactable other health professional downloaded from a regulatory authority-WEB, regulatory authority number IE-HPRA-2021-069723. An 88-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: ER2659) at 88-years-old as a single dose for COVID-19 immunization. Medical history included sleep disorder, anaemia, gastrooesophageal reflux disease (GERD), hypertension, depression, pain, thyroid disorder, Alzheimer''s disease, asthma, anxiety; all from an unknown date and unknown if ongoing. Concomitant medications included memantine (MANUFACTURER UNKNOWN) taken for Alzheimer''s disease; ferrous fumarate (MANUFACTURER UNKNOWN 324) taken for anaemia; mirtazapine (MANUFACTURER UNKNOWN) taken for anxiety; paracetamol (MANUFACTURER UNKNOWN) taken for pain; esomeprazole (MANUFACTURER UNKNOWN) taken for GERD; escitalopram oxalate (LEXAPRO) taken for depression; carbimazole (MANUFACTURER UNKNOWN DCI) taken for thyroid disorder; zolpidem (MANUFACTURER UNKNOWN) taken for sleep disorder; amlodipine besilate (MANUFACTURER UNKNOWN) taken for hypertension; salbutamol (MANUFACTURER UNKNOWN) taken for asthma; all from an unspecified start date to 15Mar2021. On 15Mar2021, the patient experienced: triple A (Abdominal aortic aneurysm), which caused death. The patient died on 15Mar2021 due to triple A. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: triple A


VAERS ID: 1183680 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   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: No adverse event
Allergies:
Diagnostic Lab Data: Test Date: 20210318; Test Name: Body temperature; Result Unstructured Data: 39.4 degree Celsius
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Pyrexia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021. This regulatory authority case was reported by a physician and describes the occurrence of PYREXIA (Pyrexia) in a 98-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included No adverse event. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PYREXIA (Pyrexia) (seriousness criterion death). The patient died on 18-Mar-2021. The reported cause of death was Pyrexia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 39.4 degree Celsius (High) 39.4. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were provided. Treatment medication was not provided. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding the fatal event of pyrexia has been provided at this time. No further information has been requested.; Reported Cause(s) of Death: Pyrexia


VAERS ID: 1185571 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Atrial fibrillation, C-reactive protein, Cardiac failure, Nausea, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Supraventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Cardiac insufficiency; CLL; Immune thrombocytopenia
Preexisting Conditions: Medical History/Concurrent Conditions: Chemotherapy; Pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 20210217; Test Name: C-reactive protein; Result Unstructured Data: Test Result:NEGATIVE; Test Date: 20210126; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:NEGATIVE
CDC Split Type: ATPFIZER INC2021363327

Write-up: Heart failure; Anemia; Atrial fibrillation; Nausea; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority report number is AT-BASGAGES-2021-20433. An 86-year-old male patient received the first dose of BNT162B2 (COMIRNATY; lot number: ET1831), intramuscular on 13Mar2021 at single dose for COVID-19 immunisation. The patient''s medical history included chemotherapy on Nov2020, ongoing chronic lymphocytic leukaemia (CLL), pneumonia on Nov2020, ongoing atrial fibrillation, ongoing cardiac insufficiency, ongoing immune thrombocytopenia (ITTP). The patient''s concomitant medications were not reported. The patient experienced nausea on 15Mar2021. The patient died due to heart failure, anemia, and atrial fibrillation on 15Mar2021. The patient underwent lab tests and procedures which included C-reactive protein: negative on 17Feb2021, and COVID-19 PCR test: negative on 26Jan2021. The outcome of the event nausea was not recovered and the outcome of the other events was fatal. It was not reported if an autopsy was performed. Relatedness of drug to reactions/events: Source of assessment: Primary Source Reporter; Result of Assessment: Unassessable/Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: heart failure; atrial fibrillation; anemia


VAERS ID: 1185575 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral ischaemia, Cerebrovascular accident, Coagulopathy
SMQs:, Haemorrhage laboratory terms (broad), 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: 2021-02-24
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEANXIT; TRAZODONE; LORAZEPAM; EMCORETIC; ATORVASTATIN; CLOPIDOGREL; LORAZEPAM; DULCOLAX [BISACODYL]; LAXIDO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal insufficiency; Allergy (Allergy (was bad of the sedation with general narcosis)); Aphasia (CVA with fatic disturbances and confusion, hyperventilation, hypotension); Cataract (4 times eye surgery due to cataract); Cataract operation (4 times eye surgery due to cataract); Confusion (CVA with fatic disturbances and confusion, hyperventilation, hypotension); CVA (CVA with fatic disturbances and confusion, hyperventilation, hypotension); CVA; Epithelioma (focal supperficial infiltrative basocellular epithelioma); Fall; Hyperventilation (CVA with fatic disturbances and confusion, hyperventilation, hypotension); Hypotension (CVA with fatic disturbances and confusion, hyperventilation, hypotension); Hysterectomy; Ilium fracture; Ischiopubic fracture; Osteoporosis; Paresthesia hand; Peripheral oedema; Rhabdomyolysis; Urinary incontinence
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021363038

Write-up: Coagulation disorder; Ischemia in the cerebri media area left; CVA with fatal outcome; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority number BE-FAMHP-DHH-N2021-85080. This consumer reported similar events for two patients. This is the second of two reports. A 94-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 08Feb2021 (Batch/Lot Number: EL8723) as second dose administrated for covid-19 immunisation. Medical history included 4 times eye surgery due to cataract, hysterectomy, hypersensitivity (Allergy (was bad of the sedation with general narcosis)), focal supperficial infiltrative basocellular epithelioma in 2003, CVA from 2012, CVA with fatic disturbances and confusion, hyperventilation, hypotension; all from Jun2018 to an unknown date. Admission to geriatric department in Nov2019 due to fall with ilio and ischiopubic branch fracture right, rhabdomyolysis with acute renal insufficiency, osteoporosis, peripheral venous oedema, urinary incontinence and paresthesia of the right hand. Concomitant medications included flupentixol dihydrochloride, melitracen hydrochloride (DEANXIT); trazodone; lorazepam; bisoprolol fumarate, hydrochlorothiazide (EMCORETIC); atorvastatin; clopidogrel; lorazepam; bisacodyl (DULCOLAX [BISACODYL]); macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXIDO; all taken for an unspecified indication, start and stop date were not reported. The patient experienced coagulation disorder, ischemia in the cerebri media area left, cva with fatal outcome; all on 14Feb2021. The patient died on 24Feb2021. It was unknown if an autopsy was performed. The FAMHP considered the causality of the events with Comirnaty as unclassifiable. Case narrative: [BE-FAMHP-DHH-N2021-85080]. Spontaneous COVID-19 report received by the Belgian authorities on 18Mar2021. This female patient was vaccinated on 08/02/2021 with Comirnaty (second dose administered). Concomitant drug(s): Atorvastatin, Clopidogrel, Deanxit, Emcoretic, Lorazepam, Trazodon, Laxido, Dulcolax. Reported ADR''s: Coagulation disorder, Cerebral ischaemia, CVA. Reporter''s comment: Treatment -. Evolution of the ADR - Died. ADR description: Insular ribon sign on the left, expiration of the gray-white differentiation at the basal ganglia and hyperdens artery sign at the left cerebri media: image consistent with a recent ischemia in the cerebri media area on the left. After telephone consultation with a stroke specialist, we found it necessary to report this given that we had two similar cases with a fatal stroke (see cross-linked case). This can of course be due to a coincidence of vaccination and stroke and not be due to an adverse reaction. Follow-up attempts are not needed. No further information is expected.; Sender''s Comments: Linked Report(s) : BE-PFIZER INC-2021363033 Same reporter/product/event, different patient; Reported Cause(s) of Death: Coagulation disorder; Ischemia in the cerebri media area left; CVA with fatal outcome


VAERS ID: 1185587 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1742 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Myocardial infarction, Nausea, Physical examination, Vomiting
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Exercise adequate
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Health check-up; Result Unstructured Data: Test Result:In perfect condition
CDC Split Type: CAPFIZER INC2021375885

Write-up: Heart attack; Nauseous; Explosive diarrhea; Generalized weakness; Vomiting; This is a spontaneous report from a contactable consumer (patient''s son). An 85-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER1742), intramuscular in left deltoid, on 19Mar2021 at 15:05 PM, at a single dose, for COVID-19 immunization. The patient''s medical history included practicing yoga and weighing cement bags every week for muscular fitness. There were no concomitant medications. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient''s son was just calling to find out about the side effects with the COVID-19 vaccine. The patient got vaccinated and then 3 weeks later (20Mar2021), he was nauseous and had explosive diarrhea and generalized weakness. The patient had nausea and vomiting on 20Mar2021 for which the patient had ginger to chew as therapeutic measures. The patient died of a heart attack on 30Mar2021 (passed away). The patient was found dead in his residence on 30Mar2021. According to the patient''s son, patient had his last health check-up 2 months ago (Jan2021) and was in perfect condition, had no health issues, was practicing yoga and weighing cement bags every week for muscular fitness. The patient''s son and his family are shocked and wanted answers. The outcome of heart attack was fatal. The outcome of the remaining events was unknown. The patient died on 30Mar2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1185588 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-03-08
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Coma scale, Haemorrhagic stroke
SMQs:, Haemorrhage terms (excl laboratory terms) (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: 2021-03-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No relevant medical history provided)
Allergies:
Diagnostic Lab Data: Test Date: 20210308; Test Name: glasgow score; Result Unstructured Data: Glasgow score 6
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Hemorrhagic stroke; A regulatory authority report was received from a health care professional concerning a 78-year-old, female patient who received Moderna''s Covid-19 vaccine (mRNA-1273) and experienced Hemorrhagic stroke. The patient''s medical history was not provided. No relevant concomitant medications were reported. On 28 Jan 2021, the patient received their first dose of two planned doses of mRNA-1273 (Lot number: Unkown) intramuscularly in the arm for prophylaxis of COVID-19 infection.. On 25 Feb 2021 the patient received their second dose of two planned doses of mRNA-1273 (Lot number: Unkown) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 8 Mar 2021, the patient had a glasgow score of 6, which then rose to 3/15. She presented with several episodes of biliary vomiting and bronchial aspiration. After intubation on site, she was transferred to the emergency room and then to intensive care. In the emergency room, the brain CT scan showed a right hemispherical cerebral hemorrhage with signs of herniation that appeared hypertensive at initial hypothesis. On 09 Mar 2021, the patient died. The cause of death was hemorrhagic stroke. Plans for an autopsy were unknown. Treatment information was not provided.; Reporter''s Comments: Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: Hemorrhagic stroke


VAERS ID: 1185607 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / UNK - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure ((left ventricular ejection fraction 38%, after CRT-D implantation)); Chronic obstructive lung disease; Diabetes (insulin therapy); Ischemic heart disease; Multimorbidity; Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021363086

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB with regulatory authority number CZ-CZSUKL-21003282. A 69-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: ET3620), intramuscular on 20Mar2021 as 0.3 mL, single for COVID-19 immunisation. Medical history included multimorbidity, diabetes (insulin therapy), obesity, chronic obstructive lung disease, Ischemic heart disease and cardiac failure (left ventricular ejection fraction 38%, after CRT-D implantation); all ongoing. The patient''s concomitant medications were not reported. The patient experienced pulmonary embolism/lung embolism on 24Mar2021. Therapeutic measures were taken as a result of pulmonary embolism. The patient died on 24Mar2021. An autopsy was not performed. The events were assessed as serious, medically significant, life threatening and resulting to death by the regulatory authority. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1185612 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-07
Onset:2021-03-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Laryngeal obstruction
SMQs:, Angioedema (broad), Hypersensitivity (broad)

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: METOHEXAL [METOPROLOL TARTRATE]; ALLOPURINOL; MARCUMAR; CAPTOPRIL; LERCANIDIPINE [LERCANIDIPINE HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Prostatic hyperplasia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021363122

Write-up: found dead. Differential diagnosis of bolus death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority. The Regulatory Authority report number is DE-DCGMA-21188655. A 91-year-old male patient received BNT162B2 (COMIRNATY, lot number and expiration date was not reported), intramuscular on 07Mar2021 as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation and Prostatic hyperplasia. Concomitant medications included metoprolol tartrate (METOHEXAL); allopurinol; phenprocoumon (MARCUMAR) for atrial fibrillation; captopril and lercanidipine hydrochloride (LERCANIDIPINE). The patient was found dead on 07Mar2021 with differential diagnosis of bolus death. It was reported that after vaccination, the patient died on 07Mar2021. The diagnosis was confirmed by vomit around the patient, rigor mortis, death spots and cold. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: found dead. Differential diagnosis of bolus death


VAERS ID: 1185613 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021363127

Write-up: Cerebral parenchymal hemorrhage; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-DCGMA-21188687. A 69-year-old male patient received the first dose of BNT162B2 (COMIRNATY), via unspecified route of administration on 05Feb2021 (at the age of 69 years) at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 06Feb2021, the patient had cerebral parenchymal hemorrhage. The patient was hospitalized due to the event. The event was considered life threatening. The patient died on 11Feb2021 due to the event. An autopsy was performed and results were not provided. Reporter''s comments: Autopsy as part of funeral law request - macroscopic and histological confirmation. Relatedness of drug to reaction(s)/event(s): Source of assessment: Paul-Ehrlich-Institut (PEI); Result of Assessment: Unclassifiable. No follow-up attempts are possible. Information on lot and batch numbers cannot be obtained. No further information is expected.; Reporter''s Comments: Autopsy as part of funeral law request - macroscopic and histological confirmation. Relatedness of drug to reaction(s)/event(s): Source of assessment: Paul-Ehrlich-Institut (PEI); Result of Assessment: Unclassifiable; Reported Cause(s) of Death: Cerebral parenchymal hemorrhage


VAERS ID: 1185620 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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:
Current Illness: Rheumatics
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021363233

Write-up: Cause of death unknown; impaired general condition; Nausea; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100027922. An 85-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing rheumatics. The patient''s concomitant medications were not reported. On 06Mar2021, the patient experienced nausea and impaired general condition. On 12Mar2021, the patient experienced cause of death unknown. The patient has not recovered from nausea and impaired general condition. The patient died on 12Mar2021. Cause of death was unknown. An autopsy was not performed. Event assessment by PEI for Comirnaty was reported as unclassifiable for all events. No follow-up attempts are possible; information on the lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1185621 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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 INC2021370552

Write-up: Unknown cause of death; This is as spontaneous report from a non-contactable pharmacist downloaded from the Medicine Agency (MA) Database-WEB. The regulatory authority report number is DE-PEI-202100029363. Safety report unique identifier DE-AMK-18.003. A 88-year-old female patient received bnt162b2 (vaccine, Batch/Lot Number: Unknown), via an unspecified route of administration on 29Jan2021 as 0.3 mL, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 30Jan2021. The patient died on 30Jan2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1185622 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-25
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021370554

Write-up: cardiac arrest/insufficiency; This is as spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100029371. A female patient of an unspecified age received second dose of bnt162b2 (COMIRNATY) (Batch/Lot Number: ER2659), via an unspecified route of administration on 04Mar2021 at 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on 11Feb2021 for prophylactic vaccination. On 25Mar2021, the patient experienced cardiac arrest/insufficiency. The patient died on 25Mar2021 due to cardiac arrest/insufficiency. An autopsy was not performed. This report is serious - death. Relatedness of drug to reaction/event: Source of assessment: PEI, Result of Assessment: D. Unclassifiable No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac arrest/insufficiency


VAERS ID: 1185625 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous thrombosis, Computerised tomogram head, Delirium, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   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: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210324; Test Name: CCT; Result Unstructured Data: Test Result:Cerebral vein thrombosis; Comments: Cerebral vein thrombosis with subsequent subarachnoid hemorrhage
CDC Split Type: DEPFIZER INC2021363109

Write-up: Acute delirium; Cerebral vein thrombosis with consecutive subarachn. Bleeding.; Cerebral vein thrombosis with consecutive subarachn. Bleeding.; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021040021. Safety Report Unique Identifier DE-PEI-202100027662. An 89-year-old female patient received BNT162B2 (COMIRNATY), first dose intramuscular on 23Mar2021 (batch/lot number: ER7812) as a single dose for COVID-19 immunisation. Medical history included ongoing arterial hypertension. The patient''s concomitant medications were not reported. The patient experienced cerebral vein thrombosis with consecutive subarachnoid bleeding and acute delirium on 24Mar2021. The patient underwent lab tests and procedures which included cranial computed tomography (CCT): cerebral vein thrombosis with subsequent subarachnoid hemorrhage on 24Mar2021. Therapeutic measures were taken as a result of cerebral vein thrombosis and subarachnoid bleeding. The outcome was fatal for cerebral vein thrombosis and subarachnoid bleeding; and not recovered for acute delirium. The patient died on 26Mar2021. It was not reported if an autopsy was performed. The event assessment for all events as per PEI was unclassifiable. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no. Information on risk factors or previous illnesses easy kind. Hypertension / The patient developed delirium the day after a Comirnaty vaccination. The patient admission to acute neurology. One showed up in the CCT Cerebral vein thrombosis with subsequent subarachnoid hemorrhage. Despite therapy of the monitoring station with guideline-based therapy, she died on March 26, 2021 as a result of cerebral vein thrombosis. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cerebral vein thrombosis with consecutive subarachn. Bleeding.; Cerebral vein thrombosis with consecutive subarachn. Bleeding.


VAERS ID: 1185626 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Chest X-ray, Cough, Death, General physical condition abnormal, Oxygen saturation, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Hypercholesteremia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Test Date: 20210322; Test Name: ro-thorax; Result Unstructured Data: Test Result:infiltrates on both sides; Test Name: Oxygen saturation; Test Result: 70 %
CDC Split Type: DEPFIZER INC2021370519

Write-up: cough; powerless; fever up to 38.7 C; Unknown cause of death; General physical condition abnormal; This is a spontaneous report from a non-contactable Consumer or other non HCP downloaded from the regulatory authority-WEB DE-PEI-CADR2021040697 Safety Report Unique Identifier DE-PEI-202100028418 . This is a report received from the Regulatory Authority. An 81 years old female patient received BNT162B2 (Comirnaty, solution for injection) on 17Mar2021 at 0.3 mL single dose intramuscular for COVID-19 immunization. Relevant medical history included ongoing arterial hypertension and ongoing hypercholesterolemia. Concomitant medications were not reported. On 17Mar2021 the patient experienced general condition abnormal for which was hospitalized. Cough, powerless, fever up to 38.7 C appeared. Ro-Thorax on 22Mar2021 showed with infiltrates on both sides. Oxygen saturation was 70 percent. Further deterioration, occurred and intensive supportive therapy and antibiotic therapy was administered. The patient died for unknown cause on 26Mar2021. An autopsy was not performed. The patient had not yet recovered from the events at time of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1185630 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-23
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021363112

Write-up: Cardiovascular arrest; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-PEI2021003831. An 89-year-old female patient (age at vaccination: 89-year-old) received BNT162b2 (COMIRNATY, lot/batch number and expiry date were not reported), via an unspecified route of administration on 04Mar2021 as single dose for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cardiovascular arrest on 23Mar2021 with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s): Source of assessment: Regulatory Authority Result of Assessment: Unclassifiable No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1185639 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   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:
Current Illness: Heart insufficiency; Oedema; Reduced general condition (incompensatio symptoms at the time of vaccination)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: Blood test; Result Unstructured Data: Test Result:Infection count increasing during hospitalisation; Comments: Infection count increasing during hospitalization unit not specified; Test Date: 202102; Test Name: Lab test; Result Unstructured Data: Test Result:Various lab test performed during hospitalization; Comments: Various lab test performed during hospitalization unit not specified
CDC Split Type: DKPFIZER INC2021363826

Write-up: Pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA), regulatory authority number DK-DKMA-WBS-0053598, other safety reference number DK-DKMA-ADR 24946949. An 86-year-old male patient (age at vaccination: 86-year-old) received the first dose of bnt162b2 (COMIRNATY, lot EJ6790, Expiration Date: 31May2021), intramuscular on 15Feb2021 as SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing reduced general condition (incompensation symptoms at the time of vaccination), ongoing oedema , ongoing heart insufficiency. The patient''s concomitant medications were not reported. The patient experienced pneumonia on 15Feb2021. The event was reported as being fatal and life threatening. No treatment or medical procedure was reported. Reported cause of death was Pneumonia. The patient died on 20Feb2021. Test results: Feb2021: Blood test: Infection count increasing during hospitalization. Lab test: Various lab test performed during hospitalization. It was not reported if an autopsy was performed. Follow-up is not possible, no further information expected.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1185640 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-03-13
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210313; Test Name: ECG; Result Unstructured Data: Test Result:STEMI
CDC Split Type: DKPFIZER INC2021363830

Write-up: Hospitalised with STEMI (died 15Mar2021); This is a spontaneous report downloaded from the regulatory authority, regulatory authority number DK-DKMA-WBS-0053925. A contactable physician reported that a 91-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Lot Number:EK9788; Expiration Date: 31May2021), via an unspecified route of administration on 31Jan2021 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 (lot number: EM0477, expiry date: 30Apr2021) on 07Jan2021 at a single dose for COVID-19 immunization. On 13Mar2021 the patient was hospitalized with STEMI which resulted in the hospitalization of the patient also on 13Mar2021. The patient had an ECG with a result of STEMI. The patient was discharged on 14Mar2021 for palliative care. The patient died on 15Mar2021. An autopsy was not performed. No follow-up attempts are not possible. No further information is expected.; Reported Cause(s) of Death: STEMI


VAERS ID: 1185642 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Discomfort, Haematemesis, Haematochezia, Haemodynamic instability, Melaena, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: XARELTO
Current Illness: Atrial fibrillation; Dementia; Diabetes mellitus; Hypercholesteraemia; Hypertension arterial; Recurrent urinary tract infection; Renal insufficiency; Wheelchair user
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy (Cerebral); Apoplexy (Cerebral); Apoplexy (Cerebral); Back surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210311; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021370056

Write-up: Vomiting blood; Bloody stool; Generelized discomfort since vaccination; Melena; Haemodynamic instability; Coffee ground colored vomiting; positive COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory authority number DK-DKMA-WBS-0055221. A 82-years-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 02Mar2021 (Lot Number: ER2659; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included apoplexy cerebral on 2010, ongoing hypercholesterolaemia, apoplexy cerebral on 2009, ongoing hypertension, ongoing atrial fibrillation, ongoing urinary tract infection, ongoing renal failure, apoplexy cerebral on 2008, back surgery, ongoing diabetes mellitus, ongoing dementia, ongoing wheelchair user. There is no information regarding past medication. Concomitant medications included rivaroxaban (XARELTO) taken for atrial fibrillation from 2018. The patient experienced vomiting blood on 02Mar2021, bloody stool on 02Mar2021, generelized discomfort since vaccination on 02Mar2021, melena on 02Mar2021, haemodynamic instability on 02Mar2021, coffee ground colored vomiting on 02Mar2021. The ADRs were reported by the physician as causing acute hospitalisation on 11Mar2021, as being fatal (all besides from general discomfort) on 11Mar2021 and being life threatening. No treatment or medical procedure due to the ADRs were reported. General discomfort was not recovered. Bloody stool, coffee ground vomiting, haemodynamic instability, melena and vomiting blood were all fatal. Patient died on 11Mar2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Mar2021 (outcome unknown). No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Melena; Bloody stool; Coffee ground vomiting; Vomiting blood; Haemodynamic instability


VAERS ID: 1185643 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood gases, Blood lactate dehydrogenase, Blood sodium, C-reactive protein, Electrocardiogram, Haemoglobin, International normalised ratio, Monocyte count, Neutrophil count, Respiratory arrest, White blood cell count
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? Yes
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KALEORID; MOMETASONE FUROATO SANDOZ; MIRTAZAPINE; LYSANTIN; DULCOLAXO; CISORDINOL [ZUCLOPENTHIXOL HYDROCHLORIDE]; PAMOL; OLANZAPIN ACTAVIS; FURIX [FUROSEMIDE]
Current Illness: Abdominal distension (Admitted with large and bloated abdomen.); Moderate mental retardation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:61; Comments: Unit not specfied; Test Date: 202103; Test Name: Blood albumin; Result Unstructured Data: Test Result:34; Comments: Unit not specfied; Test Date: 202103; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:119; Comments: Unit not specfied; Test Date: 202103; Test Name: Bilirubin; Result Unstructured Data: Test Result:Normal; Test Date: 202103; Test Name: Blood calcium; Result Unstructured Data: Test Result:2.16; Comments: Unit not specfied; Test Date: 202103; Test Name: Arterial blood gases; Result Unstructured Data: Test Result:Severe lactate acidose; Test Date: 202103; Test Name: Arterial blood gases; Result Unstructured Data: Test Result:CO2 acidose; Test Date: 202103; Test Name: LDH; Result Unstructured Data: Test Result:390; Comments: Unit not specfied; Test Date: 202103; Test Name: Blood sodium; Result Unstructured Data: Test Result:116 (Severe hyponatriaemia); Comments: Unit not specified; Test Date: 202103; Test Name: C-reactive protein; Result Unstructured Data: Test Result:14; Comments: unit not specified; Test Date: 20210317; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Pulseless electrical activity; Comments: Pulseless electrical activity; Test Date: 20210317; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Asystole when arriving to hospital; Comments: Asystole when arriving to hospital; Test Date: 20210317; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Asystole when arriving to hospital; Comments: Asystole when arriving to hospital; Test Date: 202103; Test Name: Haemoglobin; Result Unstructured Data: Test Result:6.4; Comments: Unit not specfied; Test Date: 202103; Test Name: INR; Result Unstructured Data: Test Result:1.3; Comments: Unit not specfied; Test Date: 202103; Test Name: Monocyte count; Result Unstructured Data: Test Result:0.74; Comments: Unit not specfied; Test Date: 202103; Test Name: Neutrophil count; Result Unstructured Data: Test Result:7.99; Comments: Unit not specfied; Test Date: 202103; Test Name: Leukocyte count; Result Unstructured Data: Test Result:10.3; Comments: Unit not specified
CDC Split Type: DKPFIZER INC2021369846

Write-up: Respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number DK-DKMA-WBS-0057409 and safety report unique identifier DK-DKMA-ADR 24971838. A 60-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EP9605; Expiration Date: 31May2021) via intramuscular on 10Mar2021 as single dose for covid-19 immunisation. Medical history included moderate abdominal distension admitted with large and bloated abdomen, intellectual disability. Past drug included Movicol (POTASSIUM CHLORIDE, Macrogol 3350 and sodium chloride) for constipation. Concomitant medication(s) included potassium chloride (KALEORID); mometasone furoate monohydrate (MOMETASONE FUROATO SANDOZ) for seasonal allergy from 30Nov2017, mirtazapine (MIRTAZAPINE) for sedative therapy from 30Nov2017, orphenadrine hydrochloride (LYSANTIN) for adverse drug reaction from 19Feb2019; bisacodyl (DULCOLAXO) for constipation from 04Jan2019; zuclopenthixol hydrochloride (CISORDINOL [ZUCLOPENTHIXOL HYDROCHLORIDE]) for sedative therapy from 30Nov2017; paracetamol (PAMOL) for pain from 08Feb2018; olanzapine (OLANZAPIN ACTAVIS) for sedative therapy from 30Nov2017; furosemide (FURIX). On 14Feb2021 the patient received the first dose of Comirnaty (batch number: EJ6789), for COVID-19 immunisation. It was reported that on 17Mar2021 the patient developed respiratory arrest. Laboratory details as follows: alanine aminotransferase: 61, blood albumin: 34, blood alkaline phosphatase:, blood bilirubin: normal, blood calcium: 2.16, blood gases: severe lactate acidose, blood gases (Co2 acidose), blood lactate dehydrogenase: 390, blood sodium: 116 (severe hyponatriaemia), c-reactive protein: 14, electrocardiogram: pulseless electrical activity , Pulseless electrical activity , electrocardiogram: asystole when arriving to hospital , Asystole when arriving to hospital , electrocardiogram showed asystole when arriving to hospital, on 17Mar2021 Asystole when arriving to hospital , haemoglobin: 6.4, international normalised ratio: 1. The treatment of the patient was found hopeless after ongoing cardiopulmonary resuscitation more than 90 minutes without signs of life. The case classified as serious as reported as being Fatal on 17Mar202, being life threatening and resulting in hospitalisation on 17Mar2021. The patient died on 17Mar2021. It was not reported if an autopsy was performed. Causality: The reporter is in doubt whether there is a causality between COVID 19 Pfizer vaccine and death, as 1 week passed from vaccine to death which reporter believes is a long time and since the patient came in with other symptoms that may be the cause of death. However, at a department conference, they have agreed to report the adverse drug reaction and a possible causality with the vaccine. The reporter informs that the police have been with them and seen the body and a police report has been made. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1185644 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-17
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood lactic acid, Blood pressure systolic, Cardiac arrest, Depressed level of consciousness, Dyspnoea, Electrocardiogram, Hyperhidrosis, Livedo reticularis, Pain, Pain in extremity, Peripheral swelling, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUORESP SPIROMAX; BUVENTOL EASYHALER
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (concurrent condition); Bronchospasm (concurrent condition); Heart transplant (uncomplicated, satisfactory result, has been active and asymptomatic after)
Allergies:
Diagnostic Lab Data: Test Date: 20210318; Test Name: Lactate; Result Unstructured Data: Test Result:19; Comments: 19 Not specified; Test Date: 20210318; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:70 mmHg; Test Date: 20210318; Test Name: EKG; Result Unstructured Data: Test Result:thrombus mass in right atrium, large right system.; Comments: thrombus mass in right atrium, large right system; Test Date: 20210318; Test Name: EKG; Result Unstructured Data: Test Result:Small left system and D-config of left ventricle; Comments: Small left system and D-configuration of left ventricle - fully compatible with severe pulmonary embolism
CDC Split Type: DKPFIZER INC2021369869

Write-up: Cardiac arrest 8:30; Uncontactable for 7 minutes 07:00; Blue marbled skin; Pulmonary embolism; left leg clearly swollen; Dyspnoea; pain throughout the body; clammy sweating; pain in left leg since the day before; This is a spontaneous report downloaded from a regulatory authority-WEB DK-DKMA-WBS-0057505. The case was received from a contactable PHARMACIST via a regulatory authority. This is a spontaneous case, received on 19Mar2021 from a pharmacist, which describes the occurrence of Consciousness decreased (Uncontactable for 7 minutes, 07:00), Dyspnoea (dyspnoea), Unilateral leg pain (pain in left leg since the day before), Unilateral leg swelling (left leg clearly swollen), General body pain (pain throughout the body), Marbled skin (Blue marbled skin), Sweating (clammy sweating), Pulmonary embolism (pulmonary embolism) and Cardiac arrest (cardiac arrest 08:30), in a 67 year old male patient, vaccinated with Comirnaty (Tozinameran) Patient concomitant medication included DUORESP SPIROMAX (BUDESONIDE and FORMOTEROL FUMARATE DIHYDRATE) for asthma via Resp Inhalation at 4 DF 1x/day and BUVENTOL EASYHALER (SALBUTAMOL SULFATE) STRENGHT: 200 microgram/dose for bronchospasm via Resp Inhalation, both taken from 20Nov2019 There is no information regarding past medication. Patient medical history included Heart transplantation in 2019 (uncomplicated, satisfactory result, has been active and asymptomatic after).Patient concurrent condition included brochospams and asthma On 26Feb2021 the patient was vaccinated with the first dose of BNT162B2 (COMIRNATY) (Batch number: EP9598) via IM for COVID-19 immunisation On 17Mar2021 the patient developed unilateral leg pain On 18Mar2021 the patient falls due to Consciousness decreased for 7 minutes. The patient have afterwards dyspnoea and general body pain. 45 minutes later the wife calls for an ambulance. The patient have developed marbled skin, clearly unilateral leg swelling and the patient is sweating. The patient is diagnosed with pulmonary embolism and treated with 5000 IE heparin. The patient was intubated and thrombolysed. The patient developes clinical cardiac arrest at 8:30 and dies at the hospital. Reported cause(es) of death: Pulmonary embolism and Cardiac arrest.Consciousness decreased stop date 18Mar2021.The outcome of the other event was unknown. The death has been reported to the police, but the police have not been interested in inquest, however, a hospital autopsy has been ordered Test results 18Mar2021: EKG: thrombus mass in right atrium, large right system. Small left system and D-configuration of left ventricle - fully compatible with severe pulmonary embolism;Lactate: 19;Systolic blood pressure: 70 Causality: The death has been reported to the police, but the police have not been interested in forensic autopsies, however, a hospital autopsy has been ordered.; Reported Cause(s) of Death: Cardiac arrest; Pulmonary embolism


VAERS ID: 1185667 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-07-08
Onset:2021-03-17
   Days after vaccination:618
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haematoma, Computerised tomogram, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   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: CARVEDILOL; FUROSEMIDE; ATOZET; EUTHYROX; OMEPRAZOLE; INSPRA; ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bradycardia-tachycardia syndrome; Cardiovascular disease, unspecified; Chronic venous insufficiency; Diffuse cystic mastopathy; Drug allergy; Gonarthrosis; Hypertension (Hypertension (HTA)); Osteoporosis; Percutaneous transluminal coronary angioplasty; Pleomorphic adenoma (Pleomorphic adenoma of Parotida right.)
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:Large acute intraparenchymal hematoma; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: ESPFIZER INC2021363046

Write-up: Acute intraparenchymal hematoma in the right cerebellar hemisphere; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, regulatory authority number ES-AEMPS-807109. An 81-year-old female patient received bnt162b2 (COMIRNATY, lot ET1831), intramuscular on 11Mar2021 at SINGLE DOSE for Covid-19 immunisation; apixaban (ELIQUIS), oral from 08Jul2019 (Batch/Lot Number: Unknown) to 17Mar2021, at 5mg 2x/day for atrial fibrillation. Medical history included hypertension, cardiovascular disease (excluding hypertension), allergic to beta-lactams (Except cefuroxime and cefixime) and Intolerance to Amiodarone and Dronedarone, coronary angiography on Feb2008, tachycardia-bradycardia syndrome on Feb2014, gonarthrosis, osteoporosis, chronic venous insufficiency, diffuse fibrocystic mastopathy, pleomorphic adenoma (Pleomorphic adenoma of Parotida right). Concomitant medications included carvedilol, furosemide, atorvastatin calcium, ezetimibe (ATOZET), levothyroxine sodium (EUTHYROX), omeprazole, eplerenone (INSPRA). The patient experienced acute intraparenchymal hematoma in the right cerebellar hemisphere (principal diagnostic: Acute intraparenchymal hematoma in the right cerebellar hemisphere on 17Mar2021 and was hospitalized. It was reported that she was brought by her husband that last night she started a headache which occasionally had, this morning the headache persisted and took paracetamol and went to sleep, at approximately 12 hours she got up with generalized weakness, "no she stood "with nausea without vomiting, apparently without chest pain, without other symptoms. Previous days without infectious symptoms or other symptoms. Conclusion: Acute intraparenchymal hematoma in the right cerebellar hemisphere, with significant associated edema, complete collapse of the fourth ventricle, ascending transtentorial herniation and slight cerebellar herniation through the foramen magnum. Evolution and comments: Patient admitted with neurological focus in relation to right cerebellar intraparenchymal hemorrhage with progressive neurological deterioration. An assessment is requested by the neurosurgery service, who considers it NOT to be a subsidiary of surgical treatment, so it is decided to enter the ward with conservative treatment and prioritizing patient comfort measures. The patient died on 18Mar2021. Laboratory tests and procedures reported: Physical exploration: Physical examination in emergencies. without anisocoria, without neck stiffness, with marked bradypsychia and bradlilaalai in the context of clouding, but with preserved spontaneous motility of the 4 Extremities (Glasgow Coma Scale (GCS) O3V4M6) although it progressively deteriorated. Summary of complementary tests: Antigen test against SARS-CoV-2: Negative cranial CT without urgent contrast: Acquisition is performed from the foramen magnum to the cranial vertex without administration of intravenous contrast. Large acute intraparenchymal hematoma in the right cerebellar hemisphere, with maximum diameters of 5.7 x 3.4 x 3.8 cm, associated with hypodensity in relation to edema, extending to the right cerebellar peduncle, vermix and pons, with significant Mass effect on the fourth ventricle, which is seen to be completely collapsed and deviated from the midline, with obliteration of the right basal cistern, showing ascending transtentorial herniation and slight cerebellar herniation through the foramen magnum. Supratentorially, there is a slight increase in the size of the ventricular system, consistent with the degree of atrophy and a good differentiation between gray matter and white matter is appreciated. Slight hypodensities of periventricular white matter, compatible with normal aging given the age of the patient. Focal or occupational lesions or signs of supratentorial bleeding are not seen. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot number obtained.; Reported Cause(s) of Death: Acute intraparenchymal hematoma in the right cerebellar hemisphere


VAERS ID: 1185668 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDA [FUROSEMIDE]; ORFIDAL; ADIRO; CARVEDILOL; BROMAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified (excluding Hypertension); Chronic kidney disease; Hypertension; Comments: cardiovascular (HTA) renal HTA
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021363179

Write-up: Distress respiratory; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA), regulatory authority number ES-AEMPS-808111. A 93-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 23Mar2021 (Batch/Lot Number: ET3620) as single dose for covid-19 immunisation. Medical history included hypertension, Cardiovascular disease, unspecified excluding Hypertension, chronic kidney disease. Concomitant medications included furosemida [furosemide] (FUROSEMIDA [FUROSEMIDE]) taken for cardiac failure from 21Jul2020 to an unspecified stop date; lorazepam (ORFIDAL) taken for an unspecified indication from 21Jul2020 to an unspecified stop date; acetylsalicylic acid (ADIRO) taken for an unspecified indication from 21Jul2020 to an unspecified stop date; carvedilol (CARVEDILOL) taken for cardiac failure from 21Jul2020 to an unspecified stop date; bromazepam (BROMAZEPAM) taken for an unspecified indication from 18Feb2015 to an unspecified stop date. The patient received first dose of COMIRNATY (batch/lot number: EP2166) on 26Feb2021. On 24Mar2021, death sudden, and distress respiratory. Additional information on the ADRs: I report the death of the patient, a 93-year-old woman, as reported by her daughter in a telephone conversation, occurred about 12 hours after the administration of the second dose of vaccine (COVID-19 mRNA Pfizer, lot ET3620). The patient died on 24Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No information expected.; Reported Cause(s) of Death: Distress respiratory


VAERS ID: 1185669 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein increased, Cephalhaematoma, Computerised tomogram, Craniocerebral injury, Delirium, Fall, Neutrophilia, Renal impairment, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Neonatal disorders (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Cerebrovascular disorder; Chronic kidney disease; COVID-19 pneumonia (bilateral); Dementia (psycho-behavioral disorders; worsening of her neurocognitive disorder); Diabetes mellitus; Hypertensive heart disease
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: Test Result:without intracranial hemorrhagic complications; Test Name: CRP; Result Unstructured Data: Test Result:7; Test Name: x-ray; Result Unstructured Data: Test Result:Unremarkable; Comments: Unremarkable chest x-ray and knee x-ray
CDC Split Type: ESPFIZER INC2021370606

Write-up: mild neutrophilia; deterioration of normal kidney function; Falling; Cranioencephalic trauma (TBI); bulky cephalohematoma in the perietofrontal region; Delirium, behavioral deterioration, nighttime restlessness, disorientation; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB manufacturer report number ES-AEMPS-810569. A 97-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 16Mar2021 as SINGLE DOSE (Lot number: ET1831) for COVID-19 immunisation. Medical history included dementia with a vascular profile with psycho-behavioral disorders, diabetes mellitus, chronic kidney disease, hypertensive heart disease, and cerebrovascular disease. In Sep2020, she presented with bilateral Covid-19 pneumonia with subsequent functional impairment and worsening of her neurocognitive disorder. Concomitant medications were not reported. The patient experienced Cranioencephalic trauma (TBI) on 21Mar2021, falling on 21Mar2021, Delirium on 17Mar2021. Coinciding with the COVID vaccination (first dose of BNT162B2), the patient presented behavioral deterioration with greater nighttime restlessness and disorientation. She also associated two falls with frontal TBI, so she was evaluated on 21Mar2021 in the emergency room, being diagnosed with: bulky cephalohematoma in the perietofrontal region and (without intracranial hemorrhagic complications observable on CT) and incised wound that was sutured. The analysis showed CRP 7 and mild neutrophilia, with deterioration of normal kidney function. Unremarkable chest x-ray and knee x-ray. The patient was sudden death (death date was reported as 16Mar2021, pending clarification). Outcome of the events Cranioencephalic trauma (TBI), falling, Delirium was fatal, of the other events was unknown. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cranioencephalic trauma (TBI); falling; Delirium, behavioral deterioration, nighttime restlessness, disorientation


VAERS ID: 1185676 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysarthria, Fatigue, Feeling drunk, Investigation, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   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: Medical History/Concurrent Conditions: Alzheimer''s disease; Blood pressure high
Allergies:
Diagnostic Lab Data: Test Date: 20210220; Test Name: basic tests; Result Unstructured Data: Test Result:no acute danger
CDC Split Type: FIPFIZER INC2021363095

Write-up: Feeling drunk; Fatigue aggravated; Lower extremities weakness of; Slurred speech; This is a spontaneous from a contactable other HCP report downloaded from the regulatory authority number FI-FIMEA-20211538. An 89-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 12Feb2021 (Batch/Lot Number: UNKNOWN) as a single dose for COVID-19 immunization. Medical history included Alzheimer and high blood pressure. Concomitant medications were unspecified memory and blood pressure drugs. The patient experienced feeling drunk/felt drunk, fatigue aggravated/more tired than usual, lower extremities weakness of/feet did not carry [her] anymore, and slurred speech/speech slurred a little on 19Feb2021. On 19Feb2021, home care noticed the patient''s worsened condition for the first time. Asked if ambulance is required. Not called. On 20Feb2021, home care called ambulance. Ambulance crew did basic tests and there was no acute danger. The patient was sent via taxi to on-call, where she stayed until she slept away. The patient died on 04Mar2021. It was not reported if an autopsy was performed. The events were reported as serious with seriousness criteria: death. No follow-up attempts are possible; batch/lot number cannot be obtained. No further information is possible.; Reported Cause(s) of Death: feeling drunk; fatigue aggravated; lower extremities weakness of; slurred speech


VAERS ID: 1185677 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Pneumonia aspiration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonia aspiration (Recurrent)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021370688

Write-up: Pneumonia aspiration; Pneumonia aspiration; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-BR20211022. A 58-year-old female patient started to receive the second dose of BNT162b2 (COMIRNATY, Lot # ET3620) intramuscularly in right arm on 18Mar2021 at single dose for COVID-19 immunisation. Relevant medical history included recurrent aspiration pneumonia. Concomitant medications were not reported. The patient presented an unfavorable inhalation pneumonitis with death. It was unknown whether an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pneumonia aspiration; Pneumonia aspiration


VAERS ID: 1185680 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-03-16
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood gases, Blood potassium, Blood pressure measurement, Blood sodium, Body temperature, COVID-19, Glomerular filtration rate, Haemoglobin, Heart rate, Magnetic resonance imaging, Oxygen saturation, Platelet count, Respiratory rate, SARS-CoV-2 test, Vaccination failure, White blood cell count
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: 2021-03-27
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIFFU K; HYDROCORTISONE; LASIX [FUROSEMIDE]; LORAZEPAM; NEBIVOLOL; NORSET; OMEPRAZOLE; PARACETAMOL; MACROGOL; ELIQUIS; SYMBICORT TURBOHALER
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Amputation; COPD; Decompensation cardiac; Fibrillation atrial (AF with cardiac decompensation); Hypertension arterial; Inguinal hernia; Living in nursing home; Peripheral arterial occlusive disease; Rhizomelic pseudopolyarthritis; Squamous cell carcinoma of skin (squamous cell carcinoma of left cheek with ipsilateral orbital extension diagnosed in 2015.); Surgery (left patella surgery.); Transmetatarsal amputation (trans metatarsal amputation of the left foot in 2015); Typhoid fever
Allergies:
Diagnostic Lab Data: Test Name: Creatinine; Result Unstructured Data: Test Result:278 umol/l; Test Name: BGA; Result Unstructured Data: Test Result:under MHC: pH 7.31, hypocapnia, normoxia; Comments: under MHC: pH 7.31, hypocapnia, normoxia; Test Name: Potassium; Result Unstructured Data: Test Result:3.7 mmol/L; Test Name: arterial pressure; Result Unstructured Data: Test Result:97/44 mmHg; Test Name: sodium; Result Unstructured Data: Test Result:170 mmol/L; Test Name: body temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Test Name: glomerular filtration rate; Result Unstructured Data: Test Result:16 mL / min / 1.73 m2; Test Name: hemoglobin; Result Unstructured Data: Test Result:14.5 g/dl; Comments: macrocytic; Test Name: cardiac frequency; Result Unstructured Data: Test Result:75/ min; Test Date: 20180814; Test Name: MRI; Result Unstructured Data: Test Result:no values; Comments: existence of a suspicious left eyelid tissue infiltration extending into the temporal and preseptal region, 64mm long in axis, associated with suspicious left intraparotid lymphadenopathy (11x19mm).; Test Name: Oxygen saturation; Test Result: 93 %; Comments: nasal cannula; Test Name: platelet; Result Unstructured Data: Test Result:216 10*6/L; Test Name: respiratory rate; Result Unstructured Data: Test Result:40/min; Test Name: anti-gene test COVID; Test Result: Positive ; Test Name: PCR SARS CoV2; Test Result: Positive ; Test Name: Leukocytes; Result Unstructured Data: Test Result:15.4 10*6/L; Comments: hyperleukocytosis
CDC Split Type: FRPFIZER INC2021369763

Write-up: Vaccination failure; PCR-SARS Cov 2:positive; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number FR-AFSSAPS-NT20210851. A contactable pharmacist reported that a 97-years-old male patient received first dose of BNT162B2 (COMIRNATY, Formula-tion: Solution for injection, lot number: EJ6795 and Expiry date not reported), via intramuscular route of administration on 21Jan2021, as single dose and second dose of BNT162B2 (CO-MIRNATY, Formulation: Solution for injection, lot number: EJ6789 and Expiry date not reported), via intramuscular route of administration on 11Feb2021, as single dose both for COVID-19 immunization. Medical history included Recurrence of inoperable squamous cell carcinoma of the left cheek with ipsilateral orbital extension initially diagnosed in 2015, Current functional signs: Complete eyelid occlusion, Extension assessment: MRI on 14Aug2018: existence of a suspicious left eye-lid tissue infiltration extending into the temporal and preseptal region, 64mm long in axis, associated with suspicious left intraparotid lymphadenopathy (11x19mm), Treatments received: Excision performed in June 2017: incomplete, Peripheral artery disease, trans metatarsal amputation of the left foot in 2015, Hypertension, AF with cardiac decompensation, Rhizomelic pseudopolyarthritis, Typhoid fever, Malformation of the pelvis, Right foot toe amputation, Inguinal hernia, left patella surgery. Concomitant medication(s) included: potassium chloride (DIFFU K); hydrocortisone (HY-DROCORTISONE); furosemide (LASIX [FUROSEMIDE]); lorazepam (LORAZEPAM); nebivolol (NEBIV-OLOL); mirtazapine (NORSET); omeprazole (OMEPRAZOLE); paracetamol (PARACETAMOL); macrogol (MACROGOL); apixaban (ELIQUIS); budesonide, formoterol fumarate (SYMBICORT TURBO-HALER) all taken for an unspecified indication, start and stop date were not reported.It was re-ported that very fragile patient having presented numerous decompensations of COPD with secondary infections. Greasy cough with increasing dyspnea since 16Mar2021, with crackling right base: put under AUGMENTIN with hydrocortisone increase. 2 episode of hematuria described on 16Mar2021. In emergencies: Clinical picture of multi-visceral failure predominant on the respiratory side in a 97-year-old GIR 3 patient in nursing home with a history of rhythmic heart disease and locally infiltrating squamous cell carcinoma. Major respiratory distress without argument for a quickly curable cause in particular no argument for a pulmonary edema. Background of anti-gene test COVID- positive the day before In view of the age of the history of autonomy and the severity of the current clinical picture, after discussion with the family and the medical and paramedical team, decision of comfort care alone. The patient underwent lab tests and procedures which included blood creatinine: 278 umol/l on, blood gases: under mhc: ph 7.31, hypocapnia, normoxia on under MHC: pH 7.31, hypocapnia, normoxia , blood potassium: 3.7 mmol/l on, blood pressure measurement: 97/44 mmhg on, blood sodium: 170 mmol/l on, body temperature: 37.4 centigrade on, glomerular filtration rate: 16 ml / min / 1.73 m2 on, haemoglobin: 14.5 g/dl on macrocytic , heart rate: 75/ min on, magnetic res-onance imaging: no values on 14Aug2018 existence of a suspicious left eyelid tissue infiltration ex-tending into the temporal and preseptal region, 64mm long in axis, associated with suspicious left intraparotid lymphadenopathy (11x19mm) , oxygen saturation: 93 % on nasal cannula , platelet count: 216 10*6/l on, respiratory rate: 40/min on, sars-cov-2 test: positive on, sars-cov-2 test: positive on. Physical examinations: Glasgow 3, hypotension, with mottling of the knees, cold ex-tremities Sign of respiratory distress, polypnea, unencumbered Implementation of comfort care. The outcome of the events was fatal. The patient died on 27Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.


VAERS ID: 1185683 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-02-08
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bipolar disorder; Deglutition disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210208; Test Name: pyrexia; Result Unstructured Data: Test Result:fever; Test Date: 20210212; Test Name: covid-19 test; Result Unstructured Data: Test Result:unknown result
CDC Split Type: FRPFIZER INC2021363168

Write-up: Pneumonia aspiration; Fever; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-PC20210617. An 87-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number EJ6795), via intramuscular, on 20Jan2021 at a single dose for COVID-19 immunisation. Relevant medical history included bipolar disorder and deglutition disorder, both from an unknown date and unknown if ongoing. No relevant concomitant medications were provided. On 08Feb2021, the patient had fever and inflammatory syndrome. Diagnosis of the EHPAD doctor: inhalation pneumonia. Aggravation of inflammatory syndrome and clinical worsening after transient improvement. The patient was hospitalized on 12Feb2021. On 12Feb2021, a COVID-19 test was done but results were not provided. Diagnosis of pneumonia, probably by inhalation, was confirmed. Patient''s condition worsened despite change of antibiotic therapy and Optiflow. The patient died on 15Feb2021. The reported SAEs are ''fever'' and ''pneumonia aspiration'', both with fatal outcome. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pneumonia aspiration; Fever


VAERS ID: 1186600 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-04
Onset:2021-04-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 AR / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Abdominal tenderness, Acidosis, Acute myocardial infarction, Agitation, Angiogram pulmonary normal, Anxiety, Arteriogram coronary abnormal, Aspartate aminotransferase increased, Asthenia, Blood bicarbonate decreased, Blood calcium decreased, Blood creatine phosphokinase increased, Blood lactic acid, Blood pH decreased, Blood sodium decreased, Blood urea increased, Body temperature normal, Cachexia, Carbon dioxide decreased, Cardiac arrest, Cardiac failure congestive, Cardiac murmur, Cardio-respiratory arrest, Cardiogenic shock, Catheterisation cardiac abnormal, Computerised tomogram abdomen, Confusional state, Coronary artery disease, Cyanosis, Decreased appetite, Dry skin, Dyspnoea, Ecchymosis, Echocardiogram, Echocardiogram abnormal, Electrocardiogram abnormal, Emotional distress, Endotracheal intubation, Essential thrombocythaemia, Fatigue, General physical condition abnormal, Haematocrit increased, Haemoglobin increased, Hypokinesia, Hypotension, Intensive care, International normalised ratio normal, Intra-aortic balloon placement, Jugular vein distension, Liver function test normal, Lymphocyte count increased, Malaise, Multiple organ dysfunction syndrome, Nausea, Pain, Pallor, Pericardial effusion, Platelet count increased, Pneumonia, Pulmonary mass, SARS-CoV-2 test negative, Sepsis, Septic shock, Sinus tachycardia, Speech disorder developmental, Tachycardia, Thoracic operation, Troponin increased, Unresponsive to stimuli, Vomiting, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Blood premalignant disorders (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown. Recent travel history
Preexisting Conditions: HPI: hx of melanoma s/p immunotherapy 2 years ago, chronic thrombocytosis with 7-8 year history on agrelid, followed by Dr.
Allergies: No known allergies
Diagnostic Lab Data: 4/8/21: CTA in all lung fields, no hypoxia or tachypnea on room air. Non tender in all quadrants, no peritoneal signs. No pedal edema or tenderness bilaterally. CTA was negative for PE, revealed multiple pulmonary nodules largest measuring 1 cm in the left upper lobe and additional nodules 0.9 cm in the lateral right middle lobe and 0.9 cm in the inferior lingula. 0.9 nodule in the inferior linear surrounding tree in bud opacity suggestive of atypical infectious process. EKG 4/8/21 at 0113 Rate: 121, Rhythm: sinus tachycardia, no ST elevation. QTC 462, QRS 72. Repeat EKG read at 0341 Rate: 124, Rhythm: sinus tachycardia, no ST elevation, unchagned from prior. Labs at 0120 - Hgb (18.5), Hct (56.9), Plt (940), Immgrans (1.7), Lympohcytes (4.4); Na (132), CO2 (20), BUN (32.0), Createnine GFR (1.12), EGFR (49), Calcium (8.6). LFTs normal except AST (59). INR 1.1, CPK (1,109), Troponin (4.7) Blood work with elevated troponin (4.7 at 0120, 6.272 at 0755), no STEMI criteria, never with CP or SOB evaluated by cardiology , started on DAPT and heparin , CTPA obtained due to high risk factors for PE with melanoma in the past, recent travel and possible adverse reaction/cogulopathy with vaccine, no PE possible infectious/malignant features in lungs. Blood work also with elevated WBC (22.88 at 0532) and lactic acid (7.8 at 0604; 8.5 at 0755), negative beta hydroxy but with a very low ph, tox screen positive for opiates / tylenol/aspirin levels unremarkable. CPK 1,781 at 0830. SARS coronavirus-2 RNA (COVID-19) test negative at 0212. Labs at 0830 - WBC (30.30), Hgb (17.5), Hct (54.4), Plt (884), Na (136), CO2 (14.3), BUN (33.4), Createnine GFR (1.05), Calcium (7.7), CPK (1,781), Troponin (3.973, 4.031) Echo at 0846 - depress EF between 30-40%, with pericardial fluids, possible pericardial tamponade. At 0900 - ordered CTA chest/abd/pelvis for aortic dissection, the risk of CIN was considered but the benefit outweigh the complication. 4/8/21 at 1040 - Perioperative anesthesia eval: 1) Emergent insertion of peripheral percutaneous venous and arterial ECMO cannulae 2) Emergent initiation of veno-arterial extracorporeal membrane oxygenation support 3) Emergent insertion of distal perfusion cannula 4) Ultrasound guided vascular access 5) Lower extremity angiograms 6) Transthoracic and/or transesophageal echocardiogram(s) 7) Left heart catheterization with coronary angiography LHC showed Non obstructive CAD, LVEDP 37 mmHg (Elevated left sided filling pressures) and RHC showed PA pressure 36/30 mmHg, mean 33mmHg; Sat mixed venous 79%, Ao 98%; CO Fick 5.1, CI 3.26. Pertinent Lab Prior to or at Onset of Code: pH 7.12/31/133/10.1/95%
CDC Split Type:

Write-up: ED note: 62 year old patient presented to Main ED on 4/8/21 at 0120. Patient arrived by ambulance and her chief complaint was left sided abdominal pain associated with generalized weakness, malaise, and fatigue x 3 days. HPI: hx of melanoma s/p immunotherapy 2 years ago, chronic thrombocytosis with 7-8 year history on agrelid, followed by Dr. Patient travelled recently. She received her Johnson and Johnson Covid vaccine Sunday afternoon (4/4). The next day she started to feel unwell with malaise, generalized weakness and body aches. with subjective fevers on Monday (4/5), nausea and 1 episode of non bilious vomiting. She refers severe pain that did not improved with ibuprofen, as well as increased fatigue, anorexia and has been unable to drink or eat any food for the past couple of days. As per her husband she also developed SOB with exertion yesterday. No fever, chills, constipation, diarrhea, blurred vision, numbness or paresthesias. Travel 4 days prior and receiving johnson and johnson covid vaccine. No modifying factors. No urinary sx, cough, no sick contacts. Pt denies measured fevers, chills, diarrhea, chest pain, SOB, blood in stool, headache, vision changes, numbness/tingling, focal weakness. No prior hx of MI / PE, no history of similar pain , no abdominal surgeries. PMHx: melanoma, thrombocytosis ; PSHx: none ; Social Hx: (-) tobacco, (-) EtOH, (-) illicit drug use ; Allergies: none ; PCP: in another country NKDA. Family history: Mother CKD. Social history: she is married, originally from another country; has been living in another location for the last 3 months. She is an architect Denies any sick contacts. Her husband has been vaccinated for COVID-19.Travel screening done in the ED: no/unsure if in the last month she may have been in contact with someone who was confirmed or suspected to have COVID-19. Yes (negative result) to "have you had a COVID-19 viral test in the last 14 days. No to "do you have any of the following new or worsening symptoms?" and no to have you traveled internationally in the last month? No documented travel since 03/08/21. No to all high risk personnel screen questions. Physical Exam on 4/8/21 at 0128am: BP 110/58 | Pulse 120 | Temp 97 ?F (36.1 ?C) | Resp (!) 34 | Ht 5'' 2.99" (1.6 m) | Wt 125 lb 10.6 oz (57 kg) | SpO2 97% | BMI 22.27 kg/m? Normal PE in ED: Constitutional: She is oriented to person, place, and time. She appears well , well-developed, well-nourished and appears stated age. Non-toxc appearing, no nystagmus or gaze deviation, no meningismus or rigidity, 2+ equal pulses in all extremities, tachycardic, regular. Code sepsis called at 0250. At 0951 - Dr.at bedside will take patient to the OR for possibly VA ECMO for ischemic cardiomyoptahy. Medications: ASA, brilinta and heparin drip. Started on cefepime, vancomycin and azithromycin (D1) for suspected multifocal pneumonia Patient became hypotensive in the course of the morning and was transferred to the cath lab for urgent cardiac catheterization that showed non-obstructive CAD, elevated filling pressures, normal CO (on levophed). Echo showed LVEF 29%, biventricular failure, global hypokinesis. No valve disease 4/8/21 at 1012 - Cardiothoracic Surgery: Physical Exam positive for: Constitutional: She appears well-developed and well-nourished. She appears toxic. She has a sickly appearance. She appears ill. She appears distressed. Nasal cannula in place. Neck: Normal range of motion. Neck supple. JVD present. Cardiovascular: Regular rhythm. Tachycardia present. Murmur heard. Systolic murmur is present with a grade of 2/6. Pulmonary/Chest: Effort normal. No respiratory distress. She has rales. Abdominal: Soft. She exhibits no distension. There is abdominal tenderness. There is no rebound and no guarding. Neurological: She is alert. She has normal strength. A sensory deficit is present. Skin: Skin is dry and intact. Ecchymosis noted. She is not diaphoretic. There is cyanosis. There is pallor. Psychiatric: Judgment and thought content normal. Her mood appears anxious. Her speech is delayed. She is agitated. Cognition and memory are normal. Assessment: 1) Cardiogenic shock -discussed extensively with patient and husband high likelihood for need for V-A ECMO support 2) NSTEMI -f/u LHC to eval for CAD 3) Essential thrombocytosis - rec heme consult as plts significantly elevated and high risk of thrombus/embolism development 4) Pericardial effusion - rpt echo in AM but no indication for intervention at this time as no evidence of tamponade physiology by echo 4/8/21 at 1230 - Cardiothoracic surgery note: Patient evaluated at bedside with cardiology at time of cardiac cath with decision for no ECMO support as per cardiology recs secondary to shock not thought to be cardiogenic primary in nature with further management as per MICU. 4/8/21 at 1254 - Coronary Care Unit note: CTA abdomen and pelvis showed no acute aortic disease, no ischemic bowel, small linear filling defect in proximal celiac trunk may represent nonocclusive thrombus, stable small mildly hyperdense pericardial effusion. She was taken to the OR for cath and possible ECMO. Found to be agitated and confused. She was intubated in the OR and pressors were started (Levophed and epinephrine). IABP placed during cath, but removed due to good cardiac function. No coronary artery disease on cath. RIJ Swan Ganz placed. During the course of hours WBC increased to 30 and then to 45. Her pressors requirements increased and the acid base status woresened, with depleted bicarb and low pH. Currently on broad spectrum ATB (cefepime, Vancomycin and azithromycin) with infusion of flis and albumin, bicarb pushes (2) and gtt, on Levophed and vasopressin. Currently on broad spectrum ATB (cefepime, Vancomycin and azithromycin) with infusion of IVF and albumin, bicarb pushes (2) and gtt, on Levophed and vasopressin. 4/8/21 at 2127 - Surgery note: We are consulted due to concern for bowel ischemia. The patient is on max dose of Levo, Vaso, Epi with refractory hypotension and acidosis. Her CT shows all mesenteric vessels are patent and no bowel thickening, stranding, or free fluid to suggest bowel ischemia. The abdomen is soft non tender and non distended. In the setting of multiorgan failure and low flow state, non occlusive mesenteric ischemia would be expected but would be diffuse in nature rather than focal. There is no role for surgical resection for diffuse bowel ischemia if it develops--the mainstay of treatment being to improve her overall perfusion to vital organs. She may benefit from ionotropic support in addition to vasopressors. Code Blue called 4/9/2021 at 0045 ? patient found unresponsive, asystole. History: 62 y.o female history of ET, melanoma s/p surgical removal and immunotherapy, presented with septic shock with metabolic acidosis, intubated, sedated on pressors, levophed, epinephrine and vasopressin drip. Pertinent Lab Prior to or at Onset of Code: pH 7.12/31/133/10.1/95%


VAERS ID: 1187212 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral artery embolism, Coronary artery disease, SARS-CoV-2 test
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? Yes
Died? Yes
   Date died: 2021-03-10
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CRINONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021365790

Write-up: Cerebral embolism; Major coronary complications; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202104010837211460, Safety Report Unique Identifier GB-MHRA-ADR 25060241. A male patient of an unspecified age received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH; batch/lot number unknown and expiration date not provided) via unspecified route of administration, on 08Mar2021 as single dose for COVID-19 immunisation. Medical history included steroid therapy [reported as ''Taking regular steroid treatment (e.g. orally or rectally)] from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included progesterone (CRINONE) from an unspecified date and unknown if ongoing. The patient experienced cerebral embolism on 10Mar2021 (death, hospitalization, disability, medically significant, life threatening, congenital anomaly) and ''Major coronary complications'' (hospitalization, disability, medically significant, life threatening, congenital anomaly) on an unspecified date in 2021. Patient''s clinical course is as follows: Major coronary complications occurred after 09Mar2021. The patient underwent lab tests and procedures which included COVID-19 virus test with result of ''no - negative covid-19 test'' on unspecified date. The patient died on 10Mar2021. Cause of death was ''cerebral embolism''. It was not reported if an autopsy was performed. Outcome of the event ''cerebral embolism'' was fatal; outcome of the event ''Major coronary complication'' was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cerebral embolism


VAERS ID: 1187220 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-03-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)); Radiotherapy (6 years ago tumours almost non existent)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021367208

Write-up: Cardiac arrest; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202104022218598930, Safety Report Unique Identifier GB-MHRA-ADR 25074311. A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number not reported) via unspecified route of administration at single dose on 28Mar2021 at 67 years old for COVID-19 immunisation. Medical history included radiotherapy (6 years ago tumours almost non existent), neoplasm (recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)). The patient''s concomitant medications were not reported. The patient experienced cardiac arrest on 29Mar2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. The clinical course was reported as follows: Within 24 hours of 2nd Pfizer vaccine, cardiac arrest, CPR given on bedroom floor, called 999, air ambulance to hospital Resus. On oxygen for 24 hrs, consultant asked for DNR.. Responsive 24 hrs later eyes opening for seconds and trying to speak. 24 hrs later able to speak slightly. 24 hrs later patient was pronounced dead. Patient had not tested positive for COVID-19 since having the vaccine. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1187224 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-24
Onset:2021-01-05
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: High cholesterol (for maybe 30 years)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021367183

Write-up: micro thrombi; massive heart attack; feeling a bit ill; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104031853465280, and Sender''s Safety Report Unique Identifier GB-MHRA-ADR 25077034. An 81-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Dec2020 (Batch/Lot Number: Not known) as single dose for covid-19 immunisation. Patient medical history included ongoing high cholesterol for maybe 30 years. The patient was shielding and had no COVID symptoms. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Patient experienced feeling a bit ill on 05Jan2021 with outcome of unknown, and micro thrombi, massive heart attack on unspecified date with fatal outcome. Clinical course: patient was healthy active (had a dog) and with no health issues except for high cholesterol which had for maybe 30 years, wasn''t fat at all. Patient complained by phone of feeling a bit ill and was going to bed on 05Jan2021. Patient was found dead the next day (06Jan2021). It took 7 weeks to get an autopsy which confirmed micro thrombi gave him a massive heart attack. Reported cause of death was micro thrombi and massive heart attack. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: micro thrombi; massive heart attack; Autopsy-determined Cause(s) of Death: micro thrombi; massive heart attack


VAERS ID: 1187236 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-02
Submitted: 0000-00-00
Entered: 2021-04-09
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: 2021-03-17
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021371697

Write-up: stroke; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number not reported), via an unspecified route of administration on an unspecified date (in late January, early February this year, as reported) at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient had stroke on 02Mar2021. It was mentioned that they were going to transfer him to another hospital to remove the clot but he was too ill and subsequently passed away on 17Mar2021. It as unknown whether an autopsy was performed.; Reported Cause(s) of Death: Stroke


VAERS ID: 1187238 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: GBPFIZER INC2021372971

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; The first report is a report downloaded from the Regulatory Authority GB-MHRA-WEBCOVID-202101261748200590, Safety Report Unique Identifier GB-MHRA-ADR 24651574. This is the second of eight reports. A contactable physician reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection on an unspecified date. The clinical course was reported as follows: This lady''s cause of death was Covid-19. This lady was one of 8 patients in the nursing home who died of Covid-19 within a month of receiving the same vaccine. I did not complete a yellow card for all of them. The events were assessed as results in death and medically significant. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1187239 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: GBPFIZER INC2021372972

Write-up: COVID-19; COVID-19; The report is downloaded from the Regulatory Authority GB-MHRA-WEBCOVID-202101261748200590, Safety Report Unique Identifier GB-MHRA-ADR 24651574. This is the third of eight reports. A contactable physician reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on an unknown date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection on an unspecified date. The physician reported 8 patients in the nursing home who died of Covid-19 within a month of receiving the same vaccine. The physician did not complete a yellow card for all of them. The event was assessed as results in death and medically significant. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021096190 same reporter and event, different patient; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1187240 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: GBPFIZER INC2021372973

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; The first report is a report downloaded from the Regulatory Authority GB-MHRA-WEBCOVID-202101261748200590, Safety Report Unique Identifier GB-MHRA-ADR 24651574. This is the fourth of eight reports. A contactable physician reported a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sars-cov-2 infection on an unspecified date. The clinical course was reported as follows: This lady''s cause of death was Covid-19. This lady was one of 8 patients in the nursing home who died of Covid-19 within a month of receiving the same vaccine. I did not complete a yellow card for all of them. The events were assessed as results in death and medically significant. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1187241 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: GBPFIZER INC2021372974

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; The first report downloaded from the Regulatory Authority GB-MHRA-WEBCOVID-202101261748200590, Safety Report Unique Identifier GB-MHRA-ADR 24651574. This is the fifth of eight reports. A contactable physician reported for a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection on an unspecified date. The clinical course was reported as follows: This lady''s cause of death was Covid-19. This lady was one of 8 patients in the nursing home who died of Covid-19 within a month of receiving the same vaccine. I did not complete a yellow card for all of them. The events were assessed as results in death and medically significant. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1187242 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: GBPFIZER INC2021372975

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; The first report downloaded from the Regulatory Authority GB-MHRA-WEBCOVID-202101261748200590, Safety Report Unique Identifier GB-MHRA-ADR 24651574. This is the sixth of eight reports. A contactable physician reported for a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection on an unspecified date. The clinical course was reported as follows: This lady''s cause of death was Covid-19. This lady was one of 8 patients in the nursing home who died of Covid-19 within a month of receiving the same vaccine. I did not complete a yellow card for all of them. The events were assessed as results in death and medically significant. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1187243 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: Test Name: sars-cov-2 test; Result Unstructured Data: Test Result:positive
CDC Split Type: GBPFIZER INC2021372977

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is the eighth of eight reports. The first report is a report downloaded from the Regulatory Authority GB-MHRA-WEBCOVID-202101261748200590, Safety Report Unique Identifier GB-MHRA-ADR 24651574. This case is 8th of eight reports. A contactable physician reported a female patient of unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, lot no: unknown), via an unspecified route of administration on an unspecified date for covid-19 immunisation. The patient medical history was not reported. The patients concomitant medications were not reported. The patient experienced sars-cov-2 infection on an unspecified date. This patient was one of 8 patients in the nursing home who died of Covid-19 within a month of receiving the same vaccine. I did not complete a yellow card for all of them.The events were assessed as results in death and medically significant. It was not reported if an autopsy was performed. The patient was died on unspecifed date. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1187565 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Death, Intraventricular haemorrhage, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nephrectomy
Allergies:
Diagnostic Lab Data: Test Name: cerebral CT; Result Unstructured Data: Test Result:acute tetraventricular hemorrhage
CDC Split Type: ITPFIZER INC2021323031

Write-up: unknown cause of death; Intraventricular haemorrhage; Vertiginous disorder; Vomiting; This is a spontaneous report from a contactable Physician downloaded from the regulatory authority-WEB IT-MINISAL02-701252 This is a report received from the Regulatory Authority. This 83-year-old male patient received BNT162B2 (COMIRNATY, lot number: EP2166, lot expiry (31May2021)), single dose, dose 1 via intramuscular route of administration in the right arm on 06Jan2021 at 10:00 AM at the age of 83 years-old) for COVID-19 vaccination. Medical history included nephrectomy. Concomitant medications were not reported. On 12Mar2021, the patient experienced vertigo, vertiginous disorder and vomiting occurring within minutes after administration of COVID-19 vaccine. On 12Mar2021, acute tetraventricular haemorrhage is documented following cerebral computerized tomography (without DCS). The patient was hospitalized for vertigo, vertiginous disorder, intraventricular haemorrhage and vomiting. The outcome of vertigo, vertiginous disorder, intraventricular haemorrhage and vomiting was reported as fatal. The patient died of an unknown cause on 16Mar2021. The stop date of vertigo, vertiginous disorder, intraventricular haemorrhage, unknown cause of death and vomiting It was unknown if an autopsy was performed. Reporter''s comments: Reported episode of malaise with mild dizziness and alimentary vomiting occurring a few minutes after the administration of vaccine for COVID-19 (PFIZER-BIONTECH). Acute tetraventricular haemorrhage is documented. Sender''s comments: Asked for follow-up from the referring doctor, he reports that the patient on 16Mar2021 was still hospitalized in intensive care in a pharmacological coma. Reporter''s comment: Died on 16Mar2021. Autopsy reports not yet available. Sender''s comment: Following a new request for follow-up, the reporter, together with reporting the patient''s death on 16Mar2021, provides clinical documentation, which is attached. No follow-up attempts possible. No further information expected. Follow-up (29Mar2021): This is a follow-up report received from a contactable physician downloaded from the regulatory authority-WEB IT-MINISAL02-701252 This is a report received from the Regulatory Authority. New information included: autopsy information(unknown), the new outcome of the all events: fatal with newseriousness criterium: death. Follow-up (01Apr2021): This is a follow-up report received from contactable physician downloaded from the regulatory authority-WEB IT-MINISAL02-701252. This is a report received from the Regulatory Authority. New information includes: The day of death (16Mar2021) and the stop date for all events (16Mar201).; Reporter''s Comments: Reported episode of malaise with mild dizziness and alimentary vomiting occurring a few minutes after the administration of vaccine for covid-19 (pfizer-biontech). Acute tetraventricular haemorrhage is documented. Died on 16Mar2021. Autopsy reports not yet available.; Reported Cause(s) of Death: Intraventricular haemorrhage; Vertiginous disorder; Vomiting; unknown cause of death


VAERS ID: 1187604 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Hypotension, Loss of consciousness, Oxygen saturation, Oxygen saturation decreased, Tremor
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), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENAZEPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Burkitt''s lymphoma
Allergies:
Diagnostic Lab Data: Test Date: 20210323; Test Name: O2 saturation; Result Unstructured Data: Test Result:low; Comments: low saturation of O2 on the pulse oximeter
CDC Split Type: ITPFIZER INC2021370181

Write-up: few hours after vaccination, Patient began to report shaking tremors, breathlessness, loss of consciousness. The emergency 113 intervened and hospitalized the patient for hypotension; few hours after vaccination, Patient began to report shaking tremors, breathlessness, loss of consciousness. The emergency 113 intervened and hospitalized the patient for hypotension; few hours after vaccination, Patient began to report shaking tremors, breathlessness, loss of consciousness. The emergency 113 intervened and hospitalized the patient for hypotension; few hours after vaccination, Patient began to report shaking tremors, breathlessness, loss of consciousness. The emergency 113 intervened and hospitalized the patient for hypotension; few hours after vaccination, Patient began to report shaking tremors, breathlessness, loss of consciousness. The emergency 113 intervened and hospitalized the patient for hypotension; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-706210. An 86-year-old patient received BNT162B2 (COMIRNATY) on 23Mar2021 at single dose for Covid-19 immunisation at the age of 86-year-old. Lot number: ET3620. Medical history included Burkitts type B lymphoma. Concomitant medications included benazepril. A few hours after vaccination with suspect vaccine on 23Mar2021, the patient began to report shaking tremors, breathlessness, loss of consciousness. The emergency 113 intervened and hospitalized the patient for hypotension, low saturation of O2 on the pulse oximeter. The patient was admitted to the medical ward where died the following night; actions taken was hospitalization in the medical ward. On 23Mar2021, low saturation of O2 on the pulse oximeter. On 24Mar2021, the patient died due to shaking tremors, breathlessness, loss of consciousness, hypotension, low saturation of O2. It was unknown if an autopsy was performed. Sender Comment: On 25Mar2021, information was requested on the number of doses administered and clinical report.; Reported Cause(s) of Death: Loss of consciousness; Shakiness; dyspnea; Oxygen saturation low; hypotension


VAERS ID: 1187605 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARDIOASPIRIN; BISOPROLOL FUMARATE; ZOLOFT; ENAPREN; LUVION [CANRENOIC ACID]; DIURESIX [TORASEMIDE SODIUM]; PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm aortic; Carotid artery stenosis; Heart failure; Mitral valve insufficiency; Osteoarthritis; Takotsubo syndrome (acute coronary takotsubo syndrome)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021370137

Write-up: The patient, the day after the administration of the vaccine, was found dead by the family without previous major symptoms (sudden death of unknown cause).; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-706387. A 93-years-old female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 24Mar2021 15:00 (Lot Number: ET3620; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. The first dose of COMIRNATY (lot number: EP2166) was administered on 03Mar2021, 15:00. Medical history included Takotsubo syndrome from 2018 (acute coronary takotsubo syndrome), mitral valve insufficiency, bilateral carotid stenosis, polydistrict osteoarthritis, extrasystolic supraventricular ascending aortic aneurysm, heart failure. Concomitant medications included acetylsalicylic acid (CARDIOASPIRIN); bisoprolol fumarate; sertraline hydrochloride (ZOLOFT); enalapril maleate (ENAPREN); canrenoic acid (LUVION); torasemide sodium (DIURESIX); pantoprazole. The patient, the day after the administration of the vaccine on 25Mar2021, was found dead by the family without previous major symptoms. The reporter reports the following: ''The patient did not have a history of covid, probably, given the dynamics of death and the pathologies of the patient, in particular the severe aneurysm of the ascending aorta that could not be operated, the death is not attributable to the vaccine, but I decided to report it anyway. The family did not give consent to the execution of the autopsy''. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1187606 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TENORMIN; METFORMIN; OLPRESS; CARDIOASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021370968

Write-up: DEATH; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-707492. A 61-year-old female patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, lot# ER9470) via intramuscular route of administration on 24Mar2021 at 16:00 of 0.3 ml on left shoulder as single dose for COVID-19 immunisation. The patient''s medical history included hypertension and diabetes mellitus. Concomitant medications included atenolol (TENORMIN), metformin at 1000 mg, olmesartan medoxomil (OLPRESS) and acetylsalicylic acid (CARDIOASPIRIN). On 25Mar2021, the patient experienced death. The outcome of the event was fatal. No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Reported Cause(s) of Death: DEATH


VAERS ID: 1187607 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cerebrovascular accident, Confusional state, Decreased appetite, Overdose, Suspected COVID-19
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Medication errors (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021370068

Write-up: stroke; bilateral covid pneumonia; received BNT162B2 as 0.5 mL, single; patient performed the sars cov2 et1831 vaccine on 13Mar2021. after the vaccine, anorexia, intense asthenia, mental confusion. Emergency room: bilateral covid pneumonia + Mar 21 death. negative daughter; patient performed the sars cov2 et1831 vaccine on 13Mar2021. after the vaccine, anorexia, intense asthenia, mental confusion. Emergency room: bilateral covid pneumonia + Mar 21 death. negative daughter; patient performed the sars cov2 et1831 vaccine on 13Mar2021. after the vaccine, anorexia, intense asthenia, mental confusion. Emergency room: bilateral covid pneumonia + Mar 21 death. negative daughter; This is a spontaneous report from a contactable physician, regulatory authority report number IT-MINISAL02-707574. A 94-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 13Mar2021 (Batch/Lot Number: ET1831; Expiration Date: 30Jun2021) as 0.5 mL, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient performed the SARS CoV2 ET1831 vaccine on 13Mar2021. After the vaccine, developed anorexia, intense asthenia, mental confusion on 13Mar2021. In emergency room: bilateral covid pneumonia and on 21Mar2021 death. Negative daughter. Actions taken (considering of a stroke, the physician sent the patient to Emergency Room and being at her daughters, she was transported to PRIVACY. Positive sister and brother-in-law (recently vaccinated). The patient died on 21Mar2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. Reporter comments: upon reporting and request from relatives it seems correct to report in doubt of a correlation with the vaccine; Reporter''s Comments: upon reporting and request from relatives it seems correct to report in doubt of a correlation with the vaccine; Reported Cause(s) of Death: mental confusion; anorexia; intense asthenia


VAERS ID: 1187611 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Coronary artery disease, Hypertensive heart disease
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE SODIUM; LASIX [FUROSEMIDE]; LIXIANA; NORVASC; NEBILOX; BIFRIL [ZOFENOPRIL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Percutaneous transluminal coronary angioplasty
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021370964

Write-up: Epigastralgia from cardiac cause in trivasal coronary artery disease, hypertensive heart disease, previous PTCA (2007); Epigastralgia from cardiac cause in trivasal coronary artery disease, hypertensive heart disease, previous PTCA (2007); Epigastralgia from cardiac cause in trivasal coronary artery disease, hypertensive heart disease, previous PTCA (2007); This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-708279. A 93-years-old female patient received the second dose of bnt162b2 (COMIRNATY), intramuscular, administered in deltoid right on 26Mar2021 11:49 (Lot Number: ET3620) as 0.3 mL, single for covid-19 immunisation. No other vaccine was received in four weeks, except for the first dose which was administered 21 days before on 05Mar2021. Medical history included percutaneous transluminal coronary angioplasty from 2007. Concomitant medications included pantoprazole sodium, furosemide (LASIX), edoxaban tosilate (LIXIANA), amlodipine besilate (NORVASC), nebivolol hydrochloride (NEBILOX), zofenopril (BIFRIL). The patient experienced epigastralgia from cardiac cause in trivasal coronary artery disease, hypertensive heart disease previous PTCA (2007) on 27Mar2021. The events resulted in death. The patient died on 27Mar2021 at 02:00. An autopsy was not requested but a detailed clinical report of the event will be prepared by the Doctor of general medicine. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Epigastralgia; Hypertensive heart disease; Multiple vessel coronary artery disease


VAERS ID: 1187612 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-03-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Oxygen saturation, Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   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: Asthma chronic; Haemodialysed
Allergies:
Diagnostic Lab Data: Test Date: 20210330; Test Name: Arterial blood gases; Result Unstructured Data: Test Result:unknown; Test Date: 20210330; Test Name: oxygen saturation; Test Result: 96.6 %
CDC Split Type: ITPFIZER INC2021370981

Write-up: Death in a hemodialysis patient with respiratory diseases.; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-708659. A 84-years-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 30Mar2021 10:20 (Lot Number: Er9470) as 0.3 mL, single for covid-19 immunisation. Medical history included haemodialysis from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was reported death in a hemodialysis patient with respiratory diseases on 30Mar2021. Urgent resuscitation procedures started and urgently contacted Reanimator and Cardiologist. The patient underwent lab tests and procedures which included blood gases: unknown on 30Mar2021, oxygen saturation: 96.6 % on 30Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected; Reported Cause(s) of Death: Respiratory disorder


VAERS ID: 1187666 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Condition aggravated, Embolism, General physical health deterioration, Hyperhidrosis, Malaise
SMQs:, Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RIVAROXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis (Severe aortic stenosis has an unstable balance between underfilling and overfilling.); General physical health deterioration
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021363335

Write-up: thromboembolic event; sweating in the middle of the night; deterioration on 28Mar2021. After which the patient died; deterioration on 28Mar2021. After which the patient died; Chest pain with left arm radiation (also injection arm) on 27Mar. Death on 28Mar; Malaise; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is NL-LRB-00488695. An 89-year-old female patient received the second dose of BNT162B2 (COMIRNATY Solution for injection, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 27Mar2021 15:30, as single dose, for COVID-19 immunisation. Medical history included severe aortic valve stenosis (severe aortic stenosis has an unstable balance between underfilling and overfilling), and general physical health deterioration (reported as "health was declining prior to vaccination/already deteriorated prior to vaccination"). Concomitant medication included rivaroxaban taken for an unspecified indication, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (COMIRNATY Solution for injection, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose for COVID-19 immunisation in which the patient experienced injection site pain. On 27Mar2021 at 19:00, the patient experienced malaise. On 27Mar2021 at 21:00, the patient experienced chest pain with left arm radiation (also injection arm). The pain was radiating to the inside of the left arm and not at the injection site. Then on 28Mar2021, the patient was sweating in the middle of the night (as reported). Temperature was not measured at that time. Deterioration on 28Mar2021 was reported. After which the patient died. It was reported that the patient was known to have severe aortic valve stenosis (severe aortic stenosis has an unstable balance between underfilling and overfilling), the immune response to the second vaccination may have disrupted this balance. It was reported that a thromboembolic event (due to chest pain) cannot be ruled out either. However, no further diagnostic procedures were done for the patient due to the already moderate physical situation with the aortic valve stenosis without treatment desire. Since the patient''s death followed the vaccination so shortly, this raised the question of whether the COVID-19 vaccination played a role in the death of the patient. It was reported that the patient had already deteriorated prior to the vaccination. The outcome of the events "chest pain with left arm radiation (also injection arm)" and "deterioration on 28Mar2021. After which the patient died" was fatal; and the outcome of the remaining events was unknown. The patient died on 28Mar2021. It was unknown if an autopsy was performed. No follow-up attempts possible, unable to obtain information about lot/batch number. No further information expected.; Reported Cause(s) of Death: Chest pain with left arm radiation (also injection arm) on 27Mar. Death on 28Mar; deterioration on 28Mar2021. After which the patient died; deterioration on 28Mar2021. After which the patient died


VAERS ID: 1187667 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Muscular weakness, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021370931

Write-up: The day after the vaccination she collapsed through her legs/muscular weakness on her legs; was in pain with every touch; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00490592. A 100-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had no previous COVID-19 infection. On 04Mar2021, the patient experienced the day after the vaccination she collapsed through her legs/muscular weakness on her legs and was in pain with every touch. Patient got bedridden and passed away three weeks after vaccination. The patient died on 24Mar2021. It was not reported if an autopsy was performed. Additional information ADR: The patient was well, was still walking around and was having a great time. The day after the vaccination she sagged through her legs, was in pain with every touch and kept saying, What do I have. She became bedridden and died exactly 3 weeks after the vaccination. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: was in pain with every touch; The day after the vaccination she collapsed through her legs/muscular weakness on her legs


VAERS ID: 1187671 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-10
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Cerebral infarction, Cerebrovascular accident, Dizziness, Pneumonia aspiration
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EXFORGE HCT; Eliquis
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021363336

Write-up: patient died on the 27Mar2021 due to aspiration pneumonia caused by the stroke.; STROKE WITH THROMBUS IN RIGHT ARTERIA CEREBRI MEDIA M2 SEGMENT; BRAIN In addition, subacute relatively large infarction also on the left side that fits with the event from 10Mar; aphasia/problems with dizziness and that letters and words he read did not make sense; dizziness /problems with dizziness and that letters and words he read did not make sense; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is NO-NOMAADVRE-FHI-2021-U2mrz3, Safety report unique identifier NO-NOMAADVRE-E2B_00025217. A 91-year-old male patient received his second dose of bnt162b2 (COMIRNATY), intramuscular on 25Feb2021 (Batch/Lot number was not reported) as single dose, intramuscular on 25Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation and apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to 24Mar2021, at an unspecified dose for atrial fibrillation. Medical history included atrial fibrillation. Concomitant medications included amlodipine besilate, hydrochlorothiazide, valsartan (EXFORGE HCT) from an unspecified start date to 24Mar2021. On 10Mar2021, the patient experienced developed dizziness and aphasia. He problems with dizziness and that letters and words he read did not make sense and brain in addition, subacute relatively large infarction also on the left side that fits with the event from 10mar. The patient also had stroke with thrombus in right arteria cerebri media m2 segment on 24Mar2021. The patient died on the 27Mar2021 due to aspiration pneumonia caused by the stroke. The reporting physician states that the report is sent since the events happened even though the patient was on anticoagulation with apixaban, therefore lack of drug effect is also suspected. The action taken in response to the events for for apixaban was unknown. The patient died on 27Mar2021. Outcome of the events was fatal. It was not reported if an autopsy was performed. Relatedness of Comirnaty to reactions/events: Aphasia, Dizziness, Stroke, Lack of drug effect, Brain infarction Source of assessment: Regional Pharmacovigilance Center Result of Assessment: Possible No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: aphasia/problems with dizziness and that letters and words he read did not make sense; STROKE WITH THROMBUS IN RIGHT ARTERIA CEREBRI MEDIA M2 SEGMENT; BRAIN In addition, subacute relatively large infarction also on the left side that fits with the ev


VAERS ID: 1187672 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, C-reactive protein, C-reactive protein increased, Fatigue, General physical health deterioration, Hypophagia, Muscle spasticity, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: body temperature; Result Unstructured Data: Test Result:increased; Test Date: 20210115; Test Name: CRP; Result Unstructured Data: Test Result:increased
CDC Split Type: NOPFIZER INC2021363319

Write-up: reduced general condition; increased body temperature; increased CRP; tired/Fatigue; spastic/spasticity; eating little/Markedly reduced food intake; somnolence/Increasing drowsiness; This is a spontaneous report from a contactable nurse downloaded from a regulatory authority-WEB with regulatory authority number NO-NOMAADVRE-FHI-2021-U4nrra and Sender''s (Case) Safety Report Unique Identifier is NO-NOMAADVRE-E2B_00025235. An 85-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly in the right arm on 12Jan2021 18:30 (Lot Number: EJ6795) as a single dose for covid-19 immunisation. Medical history included living in residential institution. The patient''s concomitant medications were not reported. The patient was administered the first dose of Comirnaty on 12Jan2021 and the day after (13Jan2021), the patient developed fatigue (tired), somnolence (increasing drowsiness), reduced food intake (markedly reduced food intake) and spastic (spasticity). Three days after the vaccination (15Jan2021), he got an increased CRP values and increased body temperature. Antibiotic treatment was started but the patient''s condition did not improve, he was still somnolent and eating very poorly. He died about one month after the vaccination (12Feb2021). It was reported that the duration of fatigue, spasticity, markedly reduced food intake and somnolence were 31 days while the duration of body temperature increased and CRP increased were reported as 29 days. The patient died on 12Feb2021. The cause of death was reported as reduced general condition on 12Feb2021. The outcome of the events was fatal. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s) Comirnaty/all events Source of assessment, Result Possible Sender Comment: Standard local Health Authority''s reply. Non-case relevant Reporter comment: Reporter''s qualification: Nurse. No follow-up attempts possible. No further information expected; Reporter''s Comments: Reporter''s qualification: Nurse.; Reported Cause(s) of Death: REDUCED GENERAL CONDITION


VAERS ID: 1187673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, Confusional state, Dyspnoea, Fatigue, General physical health deterioration, Pain, Restlessness, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 31
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: 20210125; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Increased
CDC Split Type: NOPFIZER INC2021363314

Write-up: restlessness; general body pain; tired; slept abnormally; worsening confusion; dyspnea; increased c-reactive protein; reduced general condition; This is a spontaneous report from a contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority report number: NO-NOMAADVRE-FHI-2021-U8exgp, Sender''s (Case) Safety Report Unique Identifier: NO-NOMAADVRE-E2B_00025251. A 96-year-old male patient received the first dose of bnt162b2 (COMIRNATY), lot/batch number unknown, via intramuscular administered in right arm on 05Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced worsening confusion, restlessness, general body pain, tired, slept abnormally. In Jan2021, patient experienced reduced general condition. On 25Jan2021, patient experienced dyspnea and increased c-reactive protein. The outcome of all the events was fatal. Therapeutic measures were taken as a result of dyspnea and increased c-reactive protein which included initiation of antibiotic therapy. The patient died on 01Feb2021 a few days later and did not receive the second vaccine dose. It was not reported if an autopsy was performed. Relatedness of drug to reactions/events to Comirnaty: Source of assessment Regulatory Authority Result of Assessment- Possible. Sender Comment: Since the vaccine is new, it is subject to special surveillance in order to detect new safety information as quickly as possible. It is especially important that serious and / or unusual side effects are reported. Your message is therefore important to increase knowledge about side effects that were not discovered in the studies and is an important contribution to international cooperation to maintain safe vaccination worldwide. Reports after coronary vaccination in the Adverse Reaction Register are processed by the Agency Regulatory Authority collaboration with the Regulatory Authority. The Agency Regulatory Authority publishes weekly summaries of reports of suspected side effects after vaccination. Information about lot/batch number has been requested.; Reported Cause(s) of Death: worsening confusion; reduced general condition; restlessness; general body pain; tired; slept abnormally; dyspnea; increased c-reactive protein


VAERS ID: 1187674 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-15
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood fibrinogen, Blood smear test, Blood test, Cerebral haemorrhage, Fall, Fibrin D dimer, Haemoglobin, Microscopy, Monocyte count, Neutrophil count, Pancytopenia, Petechiae, Platelet count, Red blood cell count, Subdural haematoma, Subdural haemorrhage, White blood cell count
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SOMAC; AMLODIPINE; BEHEPAN [CYANOCOBALAMIN]; NORMORIX; ALBYL-E; PROLIA; ZYLORIC; SIMVASTATIN; SELO-ZOK; CALCIGRAN FORTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Atrial fibrillation; Hypertension; TIA
Allergies:
Diagnostic Lab Data: Test Date: 20210315; Test Name: Fibrinogen; Result Unstructured Data: Test Result:5.5; Test Date: 20210315; Test Name: Blood smear test; Result Unstructured Data: Test Result:performed; Comments: did not provide evidence of leukemia.; Test Date: 202011; Test Name: blood tests; Result Unstructured Data: Test Result:normal; Test Date: 20210315; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:D-dimer 16.6; Comments: FEU < 0.80; Test Date: 20210315; Test Name: Hemoglobin; Result Unstructured Data: Test Result:7.0; Test Date: 20210315; Test Name: Microscopy; Result Unstructured Data: Test Result:Thrombocyte particle consentration (TPK); Comments: controlled in microscope.; Test Date: 20210315; Test Name: Monocyte count; Result Unstructured Data: Test Result:0.03; Test Date: 20210315; Test Name: Neutrophil count; Result Unstructured Data: Test Result:0.1; Test Date: 20210315; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:<5 (not measurable); Test Date: 20210315; Test Name: Red blood cell count; Result Unstructured Data: Test Result:2.0; Test Date: 20210315; Test Name: Leukocyte count; Result Unstructured Data: Test Result:1.1
CDC Split Type: NOPFIZER INC2021363316

Write-up: subdural hemorrhage; fall; Petechiae; Pancytopenia (anemia, leukopenia, trombocytopenia; Cerebral hemorrhage; SUBDURAL HEMATOMA; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB NO-NOMAADVRE-FHI-2021-Uapp8g. An 89-year-old female patient received the second dose of bnt162b2 (COMIRNATY), intramuscular on 18Feb2021 (Batch/Lot Number: EP9598) as single dose for covid-19 immunisation. Medical history included aortic stenosis, TIA, atrial fibrillation and hypertension. Concomitant medications included pantoprazole sodium sesquihydrate (SOMAC), amlodipine, cyanocobalamin (BEHEPAN [CYANOCOBALAMIN]), amiloride hydrochloride, hydrochlorothiazide (NORMORIX), acetylsalicylic acid, magnesium oxide (ALBYL-E), denosumab (PROLIA), allopurinol (ZYLORIC), simvastatin, metoprolol succinate (SELO-ZOK), and calcium carbonate, colecalciferol (CALCIGRAN FORTE). The patient previously had the first dose of bnt162b2 (COMIRNATY) on 28Jan2021 for COVID-19 vaccination. The patient experienced subdural hematoma on 15Mar2021 and pancytopenia (anemia, leukopenia, thrombocytopenia) on an unspecified date. The patient was admitted to hospital in a comatose state due to a subdural hemorrhage. She had received the second dose of Comirnaty 3-4 weeks before. The patient probably had a fall in her home the previous night. Petechiae were seen on her body. She was diagnosed with pancytopenia. Relevant laboratory findings and investigations included in the report: Hb 7.0, platelet number <5 (not measurable) and white blood count 1.1. Normal blood tests in Nov2020. The cause may be acute leukemia, but blood smears did not provide evidence for this. The patient died the day after she was hospitalized. Cerebral hemorrhage is stated as cause of death. According to the discharge summary thrombocytopenia was probably a contributing factor, and the incident could have been triggered by a fall in her home. The patient underwent lab tests and procedures which included fibrinogen: 5.5, blood smear test: performed, did not provide evidence of leukemia, fibrin D dimer: d-dimer 16.6 FEU < 0.80, hemoglobin: 7.0, microscopy: thrombocyte particle concentration (tpk) controlled in microscope, monocyte count: 0.03, neutrophil count: 0.1, thrombocyte count: <5 (not measurable), red blood cell count: 2.0 and leukocyte count: 1.1; all on 15Mar2021. The patient died on 16Mar2021 due to cerebral hemorrhage, subdural hematoma and pancytopenia (anemia, leukopenia, thrombocytopenia). An autopsy was not performed. The outcome of the events subdural hemorrhage, fall, and petechiae were unknown. Reporter comment: IPH: Additional information on previous illnesses and medications is obtained from primary reporter by telephone. Posted under "Person" and "Disease", and "Product". 27-mar-2021 IPH: Follow-up received as duplicate report. All information kept in NO-NOMAADVRE-FHI-2021-Uapp8g (this report). Report NO-NOMAADVRE-FHI-2021-Uxz44m has been nullified. 30-mar-2021 RELIS: Report updated. Vaccine changed from Moderna to Comirnaty. Product notes of Comirnaty: J07BX. Sender Comment: We have received a duplicate message about the same incident from other health personnel and have gathered all the information in one message with reference number Uapp8g. The message with reference number Uxz44m has been deleted. Since the vaccine is new, it is subject to special surveillance in order to detect new safety information as quickly as possible. It is especially important that serious and / or unusual side effects are reported. Your message is therefore important to increase knowledge about side effects that have not been discovered in the studies, and is an important contribution to international cooperation to maintain safe vaccination worldwide. Reports after coronary vaccination in the Adverse Reaction Register are processed by the Institute of Public Health in collaboration with the Information Centers. The Agency publishes weekly summaries of reports of suspected side effects after vaccination. Any additional information can be sent in response to this message. The information is processed securely and deleted automatically after 4 months. Processing and storage of personal data takes place in accordance with the Act. Causality is assessed according to international criteria (1). We do not currently have the capacity to send individual adverse reaction reports. For updated information and advice on the use of the vaccines and precautions, refer to the Vaccination Guide (2). Questions about coronary vaccine that cannot be answered by local specialists can be directed to email. We request that no special categories of personal information (health information) be sent by e-mail. If it is impossible to ask a question without including such information, we recommend calling the vaccine telephone (open every weekday from 13-14.30). No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: IPH: Additional information on previous illnesses and medications is obtained from primary reporter by telephone. Posted under "Person" and "Disease", and "Product". 27-mar-2021 IPH: Follow-up received as duplicate report. All information kept in NO-NOMAADVRE-FHI-2021-Uapp8g (this report). Report NO-NOMAADVRE-FHI-2021-Uxz44m has been nullified. 30-mar-2021 RELIS: Report updated. Vaccine changed from Moderna to Comirnaty.; Reported Cause(s) of Death: Cerebral hemorrhage; Subdural hematoma; Pancytopenia (anemia, leukopenia, trombocytopenia


VAERS ID: 1187679 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-19
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Acute myocardial infarction, Pancreatitis acute, Platelet count, Thrombocytopenia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (narrow), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AXTIL; PRIMACOR [LERCANIDIPINE HYDROCHLORIDE]
Current Illness: Arterial hypertension; Coronary heart disease; Degenerative joint disease (polyarticular degenerative disease)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Platelet count; Result Unstructured Data: Test Result:131 x10 9/l; Comments: the lowest level of platelets
CDC Split Type: PLPFIZER INC2021370936

Write-up: Acute renal failure; Acute transmural myocardial infarction of other sites; Thrombocytopenia; Acute pancreatitis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority PL-URPL-3-468-2021. A 73-years-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 10Mar2021 13:42 (Batch/Lot Number: ER7812; Expiration Date: 14Mar2021), age at vaccination of 73-years-old, 0.3 ml single for covid-19 immunisation. Medical history included ongoing osteoarthritis polyarticular degenerative disease, ongoing coronary artery disease, ongoing hypertension. Concomitant medications included ramipril (AXTIL) taken for an unspecified indication, start and stop date were not reported; lercanidipine hydrochloride (PRIMACOR [LERCANIDIPINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced acute renal failure (acute kidney injury) (death) on 19Mar2021 19:30, acute transmural myocardial infarction of other sites (acute myocardial infarction) (death) on 19Mar2021 19:30, thrombocytopenia (thrombocytopenia) (death) on 19Mar2021 19:30, acute pancreatitis (pancreatitis acute) (death) on 19Mar2021 19:30. The patient underwent lab tests which showed platelet count at 131 x10 9/l (the lowest level of platelets) on an unspecified date. The patient died on 19Mar2021. An autopsy was not performed (doctor did not order an autopsy). Description of the reaction: Death on 19Mar2021 at 19:30. Cause of death direct- I21-2 (acute myocardial infarction full-walled with a different location); cause of death secondary - N17.8 (Other acute renal failure); Baseline cause of death-K85 (acute pancreatitis). Relatedness of drug to reaction(s)/event: Source of assessment: Agency/Comirnaty/to events: Acute renal failure, Acute transmural myocardial infarction, Acute pancreatitis/Unlikely Source of assessment: Agency/Comirnaty/to event: Thrombocytopenia / Possible Reporter Comment : The doctor indicated acute pancreatitis as the direct cause of death, which may exacerbate concomitant chronic diseases and multi-organ failure, but it cannot be ruled out that thrombocytopenia also contributed to the patient''s complications. There is a time relationship between vaccination and death. The reporting person qualified NOP (undesirable post-vaccination reaction) as serious. Healthcare authority assessed the NOP as serious. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Direct cause of death - I21.2 Acute transmural myocardial infarction of other sites; Secondary cause of death - N17.8 Other acute renal failure; Underlying cause of death - K.85 Acute pancreatitis


VAERS ID: 1187680 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Death, Erythema, Fall, Head injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Atrial fibrillation; Heart failure; Polymyalgia
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021363345

Write-up: the patient experienced sudden cardiac arrest in the building of a medical clinic; Sudden cardiac arrest; Blunt head trauma.; Fall; Syncope/fainting; Erythema; This is a spontaneous report downloaded from a regulatory authority-WEB received from the a regulatory authority. The regulatory authority number is PL-URPL-DML MLP.4401.2.155.2021. A contactable consumer reported that an 86-year-old female patient received BNT162B2 (COMIRNATY Solution for injection, lot number: EJ6136, expiry date: unknown), intramuscular, on 02Feb2021. as single dose, for covid-19 immunisation; bisoprolol fumarate (CONCOR COR, lot number and expiry date unknown), oral, from an unspecified date to 02Feb2021, at 1/4 + obl 1xday (as reported), for atrial fibrillation; amiodarone hydrochloride (CORDARONE, lot number and expiry date unknown), oral, from an unspecified date to 02Feb2021, at 1/2+ from 5 day/7 (as reported), for atrial fibrillation; apixaban (ELIQUIS 5 mg tablet, lot number and expiry date unknown), oral, from an unspecified date to 02Feb2021, at 0.5 dosage form (2 x 0.5 tab), for atrial fibrillation; methylprednisolone sodium succinate (METYPRED 4 mg), via an unspecified route of administration, from an unspecified date to 02Feb2021, at 0.5 dosage form, alternate day (1 x 0.5 tab every other day) for polymyalgia; cilostazol (NOCLAUD 100 mg tablet), oral, from an unspecified date to 02Feb2021, at 100 mg (1 x 1 tablet), for atherosclerosis; and rosuvastatin calcium (ROSWERA 10 mg), oral, from an unspecified date to 02Feb2021, at unspecified dose, for atherosclerosis. Medical history included atrial fibrillation, atherosclerosis, polymyalgia and heart failure. The patient was not pregnant at the time of vaccination. The patient''s concomitant medications were not reported. On 02Feb2021, the patient experienced sudden cardiac arrest in the building of a medical clinic, fall, syncope/fainting, blunt head trauma, and erythema. An ambulance team was called, and resuscitation was given but was ineffective. The patient management included intubation, ventilator, passive oxygen therapy, defibrillation, ECG (asystole, PEA), cardiac massage, peripheral venous catheterization, and monitoring. Drugs used were adrenaline WZF 0.1% solution for injection 1 mg/ml: 7 mg; atropinum sulfuricum WZF solution for injection 1 mg ml: 3 mg; 0.9% Sodium Chloride BRAUN solution for infusion 9mg /ml 250ml. The events resulted to death on 02Feb2021. Autopsy was performed but the reporter did not have access to the autopsy results. The outcome of the events was fatal. The reporter did not classify the seriousness of the report. Due to the nature of the adverse reaction and the patient''s death, the health authority classified this report as serious (death, date of death: 02Feb2021, autopsy performed). The health authority assessed the causality of the events Head injury, Fall, Syncope, Cardiac arrest, Erythema to CONCOR COR, NOCLAUD, METYPRED, COMIRNATY, CORDARONE as possible (Source of assessment: unlisted; Method of assessment: unlisted); the events Head injury, Fall, Syncope, Cardiac arrest to ROSWERA, ELIQUIS as unlikely (Source of assessment: unlisted; Method of assessment: unlisted); and the event Erythema to ROSWERA, ELIQUIS as possible (Source of assessment: unlisted; Method of assessment: unlisted). Sender''s comments: Sudden unexpected cardiac arrest is an unexpected adverse reaction for Comirnaty, Eliquis, Roswera. At the same time, in the Summary of Product Characteristics for Cordarone, the expected adverse reaction was stated as: occurrence or intensification of arrhythmias, sometimes with cardiac arrest. Heart rate may decrease significantly in elderly patients. New types of arrhythmias or worsening of the arrhythmias treated, sometimes with fatal outcome, have been reported. It is important, but difficult to distinguish, whether this is due to the ineffectiveness of the pro-arrhythmic drug, or whether it is related to the severity of arrhythmias. There have been reports of an increase in ventricular defibrillation threshold and/or pacing of a pacemaker or implantable cardioverter defibrillator, particularly with long-term use of anti-arrhythmic drugs. The Summary of Product Characteristics for Metypred (methylprednisolone) states that glucocorticoids cause cardiovascular adverse reaction such as dyslipidaemia and high blood pressure. Therefore, the use of high doses and long-term treatment with glucocorticoids may predispose patients with known risk factors for cardiovascular events also to other adverse reaction involving the cardiovascular system. As expected in the Summary of Product Characteristics for Noclaud: Myocardial infarction, atrial fibrillation, congestive heart failure, supraventricular tachycardia, ventricular tachycardia and others. In turn, in the Summary of Product Characteristics of Concor Cor, a worsening of the existing heart failure and atrioventricular conduction disturbances were reported as possible. In addition, attention should be paid to potential drug interactions. The simultaneous use of Eliquis and Cordarone as well as Eliquis and Noclaud may increase the anticoagulant effect, and the simultaneous use of Cordarone and Concor Cor may, among others: slow down the heart rate or disturb its rhythm. The temporal relationship speaks for a cause-and-effect relationship. The patient''s death took place on the day of vaccination. Due to the close temporal relationship, it was decided to assign a possible cause-and-effect relationship between Comirnaty and death. Due to the simultaneous administration of several drugs, it is not possible to clearly identify only one that contributed to the patient''s death. The reporting person did not classify the seriousness of the report. Due to the nature of the adverse reaction and the patient''s death, agency classified the report as "serious". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Blunt head trauma.; fall; Syncope/fainting; Sudden cardiac arrest; erythema


VAERS ID: 1187696 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (14 days before the first dose); Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021376165

Write-up: one person who died performed the first dose of vaccine at 14 days after confirmation of the infection; This is a spontaneous report from three contactable physicians. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. It was reported that the patient received the dose 14 days after confirmation of the infection. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose. The patient died due to an unknown cause of death. It was unknown if an autopsy was performed. Regulatory authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. No follow-up attempts are possible, information about batch number cannot be obtained.; 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: 1187697 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021376166

Write-up: patient died post vaccination; This is a spontaneous report from two contactable physicians reporting same event under the same suspect product for 5 patients. This is one of 5 reports. A patient of an unspecified age and gender received BNT162b2 (COMIRNATY; Lot Number: UNKNWON) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date (between 27Dec2020-14Mar2021), the patient died post vaccination. It was unknown if an autopsy was performed. Cause of death was not reported. The death was investigated, and no causal relationship was found with regards to the vaccination. A regulatory authority commented that there was no causal mechanism between the vaccine administration and the cause of death. No follow-up attempts are possible, information about batch number cannot be obtained.; 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) : RO-PFIZER INC-2021385613 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385611 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385614 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385612 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1187698 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
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: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385258

Write-up: vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of an unspecified age and gender received the first and second doses of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN); both via unspecified routes of administration on unspecified dates as single doses for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the second dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 12 reported cases, the average date of onset of COVID-19 was 10 days after the second dose with the average days to death of 14 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19; Drug ineffective


VAERS ID: 1187699 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385611

Write-up: patient died post vaccination; This is a spontaneous report from two contactable physicians reporting same event under the same suspect product for 5 patients. This is one of 5 reports. A patient of an unspecified age and gender received BNT162b2 (COMIRNATY; Lot Number: UNKNWON) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date (between 27Dec2020-14Mar2021), the patient died post vaccination. It was unknown if an autopsy was performed. Cause of death was not reported. The death was investigated, and no causal relationship was found with regards to the vaccination. Regulatory Authority commented that there was no causal mechanism between the vaccine administration and the cause of death. No follow-up attempts are possible, information about batch number cannot be obtained.; 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) : RO-PFIZER INC-2021376166 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1187700 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385612

Write-up: patient died post vaccination; This is a spontaneous report from two contactable physicians reporting same event under the same suspect product for 5 patients. This is one of 5 reports. A patient of an unspecified age and gender received BNT162b2 (COMIRNATY; Lot Number: UNKNWON) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date (between 27Dec2020-14Mar2021), the patient died post vaccination. It was unknown if an autopsy was performed. Cause of death was not reported. The death was investigated, and no causal relationship was found with regards to the vaccination. Agency Regulatory Authority commented that there was no causal mechanism between the vaccine administration and the cause of death. No follow-up attempts are possible, information about batch number cannot be obtained.; 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) : RO-PFIZER INC-2021376166 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1187701 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385613

Write-up: patient died post vaccination; This is a spontaneous report from two contactable physicians reporting same event under the same suspect product for 5 patients. This is one of 5 reports. A patient of an unspecified age and gender received BNT162b2 (COMIRNATY; Lot Number: UNKNWON) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date (between 27Dec2020-14Mar2021), the patient died post vaccination. It was unknown if an autopsy was performed. Cause of death was not reported. The death was investigated, and no causal relationship was found with regards to the vaccination. Regulatory Authority commented that there was no causal mechanism between the vaccine administration and the cause of death. No follow-up attempts are possible, information about batch number cannot be obtained.; 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) : RO-PFIZER INC-2021376166 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1187702 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385614

Write-up: patient died post vaccination; This is a spontaneous report from two contactable physicians reporting same event under the same suspect product for 5 patients. This is one of 5 reports. A patient of an unspecified age and gender received BNT162b2 (COMIRNATY; Lot Number: UNKNWON) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date (between 27Dec2020-14Mar2021), the patient died post vaccination. It was unknown if an autopsy was performed. Cause of death was not reported. The death was investigated, and no causal relationship was found with regards to the vaccination. Institute commented that there was no causal mechanism between the vaccine administration and the cause of death. No follow-up attempts are possible, information about batch number cannot be obtained.; 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) : RO-PFIZER INC-2021376166 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1187703 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
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: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385725

Write-up: vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of an unspecified age and gender received the first and second doses of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN); both via unspecified routes of administration on unspecified dates as single doses for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the second dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 12 reported cases, the average date of onset of COVID-19 was 10 days after the second dose with the average days to death of 14 days. Institute assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19; Drug ineffective


VAERS ID: 1187704 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
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: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385726

Write-up: vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of an unspecified age and gender received the first and second doses of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN); both via unspecified routes of administration on unspecified dates as single doses for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the second dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 12 reported cases, the average date of onset of COVID-19 was 10 days after the second dose with the average days to death of 14 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19; Drug ineffective


VAERS ID: 1187705 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-09
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: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385727

Write-up: vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of an unspecified age and gender received the first and second doses of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN); both via unspecified routes of administration on unspecified dates as single doses for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the second dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 12 reported cases, the average date of onset of COVID-19 was 10 days after the second dose with the average days to death of 14 days. Health Authority (HA) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19; Drug ineffective


VAERS ID: 1187706 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
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: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385728

Write-up: vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of an unspecified age and gender received the first and second doses of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN); both via unspecified routes of administration on unspecified dates as single doses for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the second dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 12 reported cases, the average date of onset of COVID-19 was 10 days after the second dose with the average days to death of 14 days. A regulatory authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19; Drug ineffective


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