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From the 1/7/2022 release of VAERS data:

Found 21,745 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1234914 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-18
Onset:2020-12-28
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJO55J / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; ATORVASTATIN; CLOPIDOGREL; LANSOPRAZOLE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201228; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021416439

Write-up: Haemorrhagic stroke; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104141137596280. Safety Report Unique Identifier GB-MHRA-ADR 25139081. A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJO55J), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included amlodipine, atorvastatin, clopidogrel and lansoprazole all for an unspecified indication. On 28Dec2020 the patient had haemorrhagic stroke, the event was reported as fatal. On 28Dec2020 the patient had a negative covid-19 test. The date of death was not reported. An autopsy was not performed.; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1234958 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-03-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA-156571 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cellulitis, Drug ineffective, Erysipelas, Respiratory failure, Thrombophlebitis
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021421597

Write-up: drug ineffective; COVID-19 induced respiratory insufficiency; respiratory insufficiency; thrombophlebitis; erysipelas; phlegmon; This is a spontaneous report from a contactable physician downloaded from the regulatory authority HU-OGYI-196821. Case narrative: This spontaneous, serious report received on 27Mar2021 from a physician describes the occurrence of adverse events after vaccination with COMIRNATY (tozinameran). On 13Feb2021 at 8:20 a.m., the 77 years old male patient received COMIRNATY (concentrate for dispersion injection; active substance: tozinameran - 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA vaccine; batch number: PAA156571, expiry date: Mar2021, MAH: BioNTech Manufacturing GmbH) applied intramuscularly to the left upper arm for COVID-19 immunisation. Following vaccination, in Mar2021, the patient reported to have erysipelas, thrombophlebitis and phlegmon. The patient was hospitalised, the symptoms were resolving, but in the hospital, the patient had acquired COVID-19 and developed respiratory insufficiency, and died. Discharge summary is not available. The patient general condition, medical history and concomitant medicines were not reported. Sender comment: Erysipelas, thrombophlebitis and phlegmon are not expected adverse events of COMIRNATY. Alternatively, they might have been in relation with the patient underlying diseases, but there is no detailed information about them. Time to onset might have been several weeks, it is not correctly known either. Causality between the adverse events and COMIRNATY is unlikely. The patient acquired COVID-19 infection in hospital several weeks after the presumably first dose of vaccine. Immunity might have not developed within this time frame. The case is serious because the patient died. Further information is expected.; Reported Cause(s) of Death: COVID-19 respiratory insufficiency; COVID-19 respiratory insufficiency; drug ineffective


VAERS ID: 1234962 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Cough, Death, Pyrexia
SMQs:, Anaphylactic reaction (broad), 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: 2021-03-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021403430

Write-up: died; cough; Chills; subfebrility; This is a spontaneous report received from a contactable consumer (wife of the patient).A 65-year-old male patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot No: ET7205, expiration date: unknown) via an unspecified route of administration in left arm on 26-MAR-2021 at at single dose for COVID-19 immunization.Patient medical history included non-smoker, had known algopyrin allergy.on 26Mar2021 (Friday), patient experienced chills, subfebrility, little cough by Saturday, and dies on Sunday at dawn. She has not yet have information about the cause of death and the result of autopsy. The patient wife enquired about the presence of algopyrin in vaccine.The outcome of events was fatal.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1234964 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, General physical health deterioration, Oxygen saturation decreased, Respiratory rate decreased, Respiratory tract infection, SARS-CoV-2 test
SMQs:, Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Respiratory failure (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aspiration; Lower respiratory tract infection (Secondary to aspirations); Oral cancer stage unspecified; Rectal cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: Oxygen saturation decreased; Result Unstructured Data: Test Result:Reduced O2; Test Date: 20210203; Test Name: Respiratory rate decreased; Result Unstructured Data: Test Result:Reduced respiratory rate; Test Date: 20210128; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive via PCR nasal / pharyngeal swab; Comments: Positive via PCR nasal / pharyngeal swab
CDC Split Type: IEPFIZER INC2021409448

Write-up: Respiratory tract infection; REDUCED RESPIRATION RATE, O2; REDUCED RESPIRATION RATE, O2; WEAK; PHYSICAL DETERIORATION; COVID-19; This is a spontaneous report from a contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-066080. An 88-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 21Jan2021 (Lot Number: EJ6134) as Single Dose for COVID-19 immunisation. Medical history included lower respiratory tract infection secondary to aspirations, rectal cancer from 2013, oral cancer stage unspecified from 2010. The patient''s concomitant medications were not reported. The reporter outlined that no adverse reactions were noted post vaccination. On 28Jan2021, the patient tested positive for COVID-19 via PCR nasal/pharyngeal swab. It was reported that the patient''s condition deteriorated in the days prior to his death (onset date: Feb2021). On 03Feb2021, the patient was last seen by his General Practitioner (GP). The patient''s condition was comfortable but weak and the patent experienced a reduced respiration rate and O2. The patient''s GP was contacted. Therapeutic measures were taken as a result of reduced respiration rate and O2. The patient was treated for a respiratory tract infection (RTI) (onset date not reported) with antibiotics, intramuscular Rocephin and oxygen (O2) therapy. The patient also experienced physical deterioration on Feb2021. On 04Feb2021, at 11:40 am, the patient died. It was reported that the patient did not have any COVID-19 symptoms prior to vaccination, however, his death occurred as a result of COVID-19 seven days later. Other causes of death reported included weak, reduced respiration rate and O2, and physical deterioration. It was unknown if an autopsy was performed. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: Linked Report(s) : IE-HPRA-2021-066081 HPRA; Reported Cause(s) of Death: REDUCED RESPIRATION RATE, O2; REDUCED RESPIRATION RATE, O2; PHYSICAL DETERIORATION; WEAK; COVID-19


VAERS ID: 1234965 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN [ATORVASTATIN CALCIUM]; CLODEL [CLOPIDOGREL HYDROCHLORIDE]; OMESAR PLUS; PANTUP; NUPRIN [ACETYLSALICYLIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antiplatelet therapy; Carotid artery stenosis; Hypertension; Non-Hodgkin''s lymphoma (PAST HISTORY OF NON HODGKINS LYMPHOMA)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021370917

Write-up: DEATH; ARRESTED; CHEST PAIN; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB (regulatory authority number IE-HPRA-2021-070180). An 80-year-old male patient received BNT162B2 (COMIRNATY) dose 1 via an unspecified route of administration on 13Mar2021 (lot number EP9605) at 0.3 mL, single for COVID-19 immunisation. Medical history included hypertension, non-hodgkin''s lymphoma (past history of non hodgkins lymphoma), carotid artery stenosis, and on anti-platelet. Concomitant medications included atorvastatin calcium from 01Jan2020 to 17Mar2021 for an unspecified indication; clopidogrel hydrochloride (CLODEL) from 01Jan2020 to 17Mar2021 as anti-platelet; hydrochlorothiazide/olmesartan medoxomil (OMESAR PLUS) from 01Jan2020 to 17Mar2021 for hypertension; pantoprazole sodium sesquihydrate (PANTUP) from 01Dec2019 to 17Mar2021 for an unspecified indication; acetylsalicylic acid (NUPRIN) from 01Jan2020 to 17Mar2021 as anti-platelet. The patient experienced death, arrested, and chest pain on 17Mar2021 which were reported as fatal. On 17Mar2021, the patient passed away. It was reported that the patient had been taken to the Accident and Emergency (A+E) department with chest pain, then transferred to the catherterisation (cath) lab in a different hospital, where he arrested. It was reported that the patient was managed by the cardiology team and the duration of the reaction was a few hours. It was noted that time to onset was no reaction, but he died on 17Mar2021, "?cause". It was unknown if an autopsy was performed. The reporter did not know whether the patient''s vaccination with BNT162B2 was linked to his death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: DEATH; ARRESTED; Chest pain


VAERS ID: 1234966 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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: Hip replacement (18 months previously); Living in residential institution; Renal disorder (Treatment in (Redacted name) Clinic)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021409452

Write-up: DEVELOPED COVID 19; This is a spontaneous report from a contactable consumer or other non healthcare profesional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-070505. A 88-years-old female patient received BNT162B2 (COMIRNATY, BioNTech Covid-19 mRNA vaccine), via an unspecified route of administration on 14Jan2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included living in residential institution, renal disorder receiving treatment in clinic; and hip arthroplasty from 2019 (18 months previously). Patient was recovering in nursing home after treatment in Clinic for kidney issues. The patient was not taking any concomitant medication. On 15Jan2021, the patient developed COVID-19. It was reported that the patient had been doing well in residential care but then crashed very quickly and it was decided not to send her to hospital as it was felt the patient would not have wanted that. The patient received palliative care for three days before she died. The patient died on 23Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1234967 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pH, Blood pH decreased, Carbon dioxide increased, Cardiac arrest, Nervous system disorder, Respiratory failure, Tidal volume, Tidal volume decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lactic acidosis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOLPIDEM; MAGNESIUM VERLA; CHLORHEXIDINE MOUTHWASH; MYCOSTATIN MOUTHWASH; OXYNORM LIQUID; LANSOPRAZOLE; FLUDROCORTISONE; ENOXAPARIN; PARACETAMOL; LEVETIRACETAM; NICOTINE PATCH; MELATONIN; SENNA; FERROUS FUMARATE; SODIUM CHLORIDE; SANDOS K;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asystole (Experiencing frequent episodes of asystole. 10/Mar/2021 or 11/Mar/2021- last episode of asystole); Bacterial endocarditis; Dependence on ventilator; Hospitalization (had been an in-patient for four months); Paralysed (quadriplegic secondary to septic embolus to high cervical cord, secondary to bacterial endocarditis); Respiratory disorder (Ventilation issues had occurred the previous weekend i.e. 14/Mar/2021.); Septic embolus
Allergies:
Diagnostic Lab Data: Test Date: 20210320; Test Name: pH; Result Unstructured Data: Test Result:Decreased; Test Date: 20210320; Test Name: Carbon dioxide increased; Result Unstructured Data: Test Result:raised; Test Date: 20210320; Test Name: Tidal volume; Result Unstructured Data: Test Result:Periods of very low
CDC Split Type: IEPFIZER INC2021409436

Write-up: PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW TIDAL VOLUMES WITH RAISED CO2 AND DECREASED PH.; PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW TIDAL VOLUMES WITH RAISED CO2 AND DECREASED PH.; PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW TIDAL VOLUMES WITH RAISED CO2 AND DECREASED PH.; EPISODES OF ASYSTOLE; respiratory failure; respiratory failure secondary to severe neurological disease; This is a spontaneous from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. This is a report received from Regulatory authority report number IE-HPRA-2021-070650 with Safety Report Unique Identifier IE-HPRA-2021-070650. A 47-year-old male patient received bnt162b2 (COMIRNATY, Lot/Batch number: ER7812), dose 1 via an unspecified route of administration on 19Mar2021 15:45 as SINGLE DOSE for covid-19 immunisation. Medical history included septic embolus, experiencing frequent episodes of asystole with the last episode occurring on 10Mar2021 or 11Mar2021, dependence on ventilator, bacterial endocarditis, and paralysed. It was reported that the patient had been an in-patient for four months. The patient was ventilator dependent and quadriplegic secondary to septic embolus to high cervical cord, secondary to bacterial endocarditis. It was reported that the patient''s condition was extremely precarious and it was not considered likely that the patient would be discharged from hospital so a ceiling of care had been agreed upon. It was noted that the previous weekend, on 14Mar2021, these ventilation issues had also occurred. Concomitant medications included zolpidem from 23Feb2021 to 20Mar2021; magnesium aspartate (MAGNESIUM VERLA) from 17Mar2021 to 19Mar2021; chlorhexidine (CHLORHEXIDINE MOUTHWASH) and nystatin (MYCOSTATIN MOUTHWASH), both taken for mouthcare from 23Feb2021 to 20Mar2021; oxycodone hydrochloride (OXYNORM LIQUID) from 18Mar2021 to 18Mar2021; lansoprazole taken for gastroprotection from 23Feb2021 to 20Mar2021; fludrocortisone from 01Mar2021 to 20Mar2021; enoxaparin taken for venous thromboembolism (VTE) prophylaxis from 23Feb2021 to 20Mar2021; paracetamol from 18Mar2021 to 18Mar2021; levetiracetam from 23Feb2021 to 20Mar2021; nicotine (NICOTINE PATCH) from 04Mar2021 to 20Mar2021; melatonin from 23Feb2021 to 20Mar2021; sennoside a+b (SENNA) from 09Mar2021 to 20Mar2021; ferrous fumarate from 19Mar2021 to 20Mar2021; sodium chloride from 23Feb2021 to 20Mar2021; potassium bicarbonate, sodium bicarbonate, sodium phosphate monobasic (anhydrous) (SANDOS K) from 17Mar2021 to 19Mar2021; and midodrine from 12Mar2021 to 20Mar2021. The patient experienced problems with ventilation i.e. periods of very low tidal volumes with raised carbon dioxide (CO2) and decreased pH and episodes of asystole, all on 20Mar2021. The patient died on 20Mar2021 at 16:15. It was not reported if an autopsy was performed. It was outlined that the patient''s cause of death was captured in the notes as respiratory failure secondary to severe neurological disease. The patient''s death notification form recorded medical cause of death as "septic emboli to brain and spinal cord due to (or as a consequence of) bacterial endocarditis." The report outlined there was an interval of months between onset of this cause and death. The report outlined that the only link between the patient''s death and the vaccine was timing; there was no clinical suspicion of causation. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the limited information, a causal relationship between bnt162b2 and the reported events cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .; Reported Cause(s) of Death: PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW TIDAL VOLUMES WITH RAISED CO2 AND DECREASED PH.; PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW TIDAL VOLUMES WITH RAISED CO2 AND DECREASED PH.; PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW


VAERS ID: 1235025 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Diarrhoea, Oxygen saturation, Pyrexia, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonectomy (From a previous malignancy the deceased had been subjected to the removal of a lung)
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210305; Test Name: body temperature; Result Unstructured Data: Test Result:39.5 Centigrade; Test Date: 20210305; Test Name: saturation; Result Unstructured Data: Test Result:76-80; Test Date: 20210316; Test Name: molecular swab for SARS CoV 2; Test Result: Positive
CDC Split Type: ITPFIZER INC2021408982

Write-up: After vaccine fever and respiratory crisis/fever 39 C/fever at 39.5; After vaccine fever and respiratory crisis; diarrhea; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB [IT-MINISAL02-711588]. An 82-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via intramuscular at 0.3 mL single in right shoulder on 05Mar2021 for COVID-19 immunisation. Medical history included from a previous malignancy the deceased had been subjected to the removal of a lung. Concomitant medication was not reported. Patient experienced after vaccine fever and respiratory crisis on 05Mar2021. Patient also experienced diarrhea the same day. About one hour after the administration of the vaccine, patient had fever 39 C and respiratory crisis (the ambulance was called 3 times) and oxygen was administered. Then with the fourth ambulance he was transferred to the hospital where he died. It was unknown if an autopsy was performed. Actions taken included oxygen, hospital transport. Impact on quality of life was 10/10. The outcome of events was fatal. Reporter comments: From a previous malignancy the deceased had been subjected to the removal of a lung. A control visit was carried out in December and the patient was in good condition. He used to go for walks and take care of the garden, the day of the vaccination he was fine and after the administration he only reported a weight in the stomach. A few hours later he began to feel ill with a fever at 39.5 controlled by tachipirina, then diarrhea. On day 8 only tenths and wheezing, saturation 76-80 on 05Mar2021. Sender comments: 08Apr2021 Contact with the reporter: patient positive with molecular swab for SARS CoV 2 performed on March 16; all family members were positive except the niece with a positive serologic for IgG Regional PV Center: a request for a clinical report is sent to the PRIVACY. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Reporter comments: From a previous malignancy the deceased had been subjected to the removal of a lung. A control visit was carried out in December and the patient was in good condition. He used to go for walks and take care of the garden, the day of the vaccination he was fine and after the administration he only reported a weight in the stomach. A few hours later he began to feel ill with a fever at 39.5 controlled by tachipirina, then diarrhea. On day 8 only tenths and wheezing, saturation 76-80 on 05Mar2021.; Reported Cause(s) of Death: Fever; respiratory crisis; diarrhea


VAERS ID: 1235026 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-05
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / 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: 2021-04-05
   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: SINTROM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021409006

Write-up: Cardiocirculatory arrest at home. Rescued by the Emergency 112 with helicopter, Cardiopulmonary resuscitation with return of spontaneous circulation (ROSC). Later received in the intensive care unit and died.; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-711663. An 86-years-old female patient received bnt162b2 (COMIRNATY; COVID 19 COMIRNATY VACCINE (PFIZER)), dose 1 intramuscular on 29Mar2021 (Batch/Lot Number: ER9470; Expiration Date: 31Jul2021) as 0.3 mL, single for covid-19 immunisation. Medical history included atrial fibrillation and dementia, both from an unknown date and unknown if ongoing. Concomitant medication included acenocoumarol (SINTROM) taken for atrial fibrillation and anticoagulant therapy, start and stop date were not reported. The patient experienced cardiocirculatory arrest at home. rescued by the emergency 112 with helicopter, cardiopulmonary resuscitation with return of spontaneous circulation (rosc). later received in the intensive care unit and died on 05Apr2021. Therapeutic measures were taken as a result of event included: Cardiopulmonary resuscitation [CPR] Orotracheal intubation infusion of Adrenaline. The patient died on 05Apr2021. An autopsy was not performed. Reporter''s comments: Irreversible cardiac arrest occurred on 05Apr2021 in a patient aged 86 with a history of dementia and atrial fibrillation, anticoagulated with Sintrom. The Patient was a subject to vaccination with Comirnaty on 29Mar2021 (the 1 dose) Sender''s comments: Regional Pharmacist: autopsy not performed (not requested). No follow-up attempts possible. No information expected.; Reporter''s Comments: Irreversible cardiac arrest occurred on 05Apr2021 in a patient aged 86 with a history of dementia and atrial fibrillation, anticoagulated with Sintrom. The Patient was a subject to vaccination with Comirnaty on 29Mar2021 (the 1 dose); Reported Cause(s) of Death: Arrest cardiac


VAERS ID: 1235028 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   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: METFORAL; PLAVIX; BISOPROLOL FUMARATE
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210321; Test Name: Echocardiogram; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC2021409246

Write-up: pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea; pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea; pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number IT-MINISAL02-712070. An 82-year-old male patient received the second dose of bnt162b2 (COMIRNATY) intramuscularly administered in left arm on 16Mar2021 (Lot Number: ET1831; Expiration Date: 30Jun2021) at single dose for COVID-19 immunisation. Medical history included diabetes from 01Jan2010 to 20Mar2021. Concomitant medications included metformin hydrochloride (METFORAL) taken for diabetes mellitus; clopidogrel bisulfate (PLAVIX) taken for secondary prevention; bisoprolol fumarate taken for cardiac failure chronic. The patient previously received the first dose of bnt162b2 on 23Feb2021 for COVID-19 immunisation. The patient experienced pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea (death) on 20Mar2021. Clinical course: Indicative of massive pulmonary embolism. The patient underwent lab tests and procedures which included Echocardiogram with unknown results on 21Mar2021. Therapeutic measures were taken as a result of pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea which included treatment with resuscitation and thrombolysis. The patient died on 21Mar2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. Reporters comments: Administered first dose on 23Feb and second dose on 16Mar2021 Health Authority Comment: no autopsy examination was required.; Reporter''s Comments: Administered first dose on 23Feb and second dose on 16Mar2021; Reported Cause(s) of Death: pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea; pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea; pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea


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