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From the 9/17/2021 release of VAERS data:

Found 15,386 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 71 out of 154

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VAERS ID: 934764 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2020-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, C-reactive protein normal, Chronic obstructive pulmonary disease, Condition aggravated, Death, Dyspnoea, Fibrin D dimer normal, Fluid balance assessment, Forced expiratory volume decreased, Hepatic enzyme, Oxygen saturation decreased, PCO2 increased, Respiratory failure, Restlessness
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (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), Dementia (broad), Akathisia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-03
   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: PREDNISOLON ACTAVIS; IPRAMOL; LYSANTIN; QUETIAPIN ACCORD; VENTOLINE [SALBUTAMOL SULFATE]; PARACETAMOL ORIFARM; QUETIAPIN ARROW; BUPRENORPHINE/NALOXONE MYLAN; XEPLION; TRELEGY ELLIPTA; PHENERGAN [PROMETHAZINE HYDROCHLORIDE]
Current Illness: Alcohol abuse chronic; Anxiety; Chronic obstructive airways disease exacerbated; Dyspnoea; Hallucination; Hypoxic (Hypoxic down to 60 %); Insomnia; Opioid abuse; Pain; Paranoid schizophrenia; Psychosis; Tobacco abuse; Treatment noncompliance
Preexisting Conditions: Medical History/Concurrent Conditions: Amphetamine abuse; Chronic obstructive airways disease exacerbated
Allergies:
Diagnostic Lab Data: Test Name: C-reactive protein; Result Unstructured Data: Test Result:normal; Test Date: 20201227; Test Name: C-reactive protein; Result Unstructured Data: Test Result:16; Test Date: 20201231; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:Normal; Test Date: 20201227; Test Name: Fluid balance assessment; Result Unstructured Data: Test Result:Normal; Test Date: 2018; Test Name: FEV 1; Test Result: 37 %; Test Date: 20201227; Test Name: Hepatic enzyme; Result Unstructured Data: Test Result:Normal; Test Name: Oxygen saturation; Test Result: 64 %; Test Date: 20201220; Test Name: Oxygen saturation; Test Result: 60 %; Test Date: 20201227; Test Name: Oxygen saturation; Test Result: 58 %; Test Date: 20201231; Test Name: Oxygen saturation; Test Result: 62 %; Test Date: 20201231; Test Name: Oxygen saturation; Test Result: 35 %; Comments: in the ambulance; Test Date: 20201231; Test Name: Oxygen saturation; Test Result: 100 %; Comments: on oxygen-treatment; Test Date: 20210102; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:40-60 %; Comments: 12:47 pm; Test Date: 20210102; Test Name: Oxygen saturation; Test Result: 58 %; Comments: 09:00 am in the ambulance; Test Date: 20210102; Test Name: Oxygen saturation; Test Result: 30 %; Comments: 04:24 am; Test Date: 20210102; Test Name: Oxygen saturation; Test Result: 99 %; Comments: on oxygen-treatment; Test Name: PCO2; Result Unstructured Data: Test Result:up to 12.8 (Unit not specified); Test Name: PO2; Result Unstructured Data: Test Result:Down to 4.8 (Unit not specified)
CDC Split Type: DKPFIZER INC2021013449

Write-up: Hypoxic respiratory failure; Dyspnea exacerbated; This is a spontaneous report downloaded from the Medicines Agency (MA) WEB DK-DKMA-WBS-0028232. The report was received from a contactable physician via The Medicines Agency (MA). A 45-year-old male patient received BNT162B2 (COMIRNATY) (Lot #: EJ6797, Expiration Date: 30Apr2021), via intramuscular on 30Dec2020 at single dose for Covid-19 vaccination. Medical history included ongoing treatment noncompliance, ongoing alcohol abuse chronic, ongoing psychosis, dyspnoea from 20Dec2020 and ongoing, ongoing hallucination, ongoing tobacco abuse, ongoing paranoid schizophrenia, chronic obstructive airways disease exacerbated from Aug2020 and ongoing, chronic obstructive airways disease exacerbated from Nov2020 to an unknown date (not ongoing), hypoxic down to 60 % from 20Dec2020 and ongoing, Amphetamine abuse (not ongoing), ongoing pain, ongoing opioid abuse, ongoing anxiety, and ongoing insomnia. There is no information regarding past medication. Concomitant medication included prednisolone (PREDNISOLON ACTAVIS) from 20Nov2020 for Chronic obstructive airways disease, ipratropium bromide, salbutamol sulfate (IPRAMOL) from 20Nov2020 for Chronic obstructive airways disease exacerbated, orphenadrine hydrochloride (LYSANTIN) from 02Dec2019 to 03Jan2021 for Anxiety aggravated, quetiapine fumarate (QUETIAPIN ACCORD) from 16Dec2020 to 03Jan2021 for Psychiatric symptom, salbutamol sulfate (VENTOLINE) from 03Nov2018 for Chronic obstruct airways disease, paracetamol (PARACETAMOL ORIFARM) from 30Nov2020 to 03Jan2021 for Pain, quetiapine fumarate (QUETIAPIN ARROW) from 15Aug2020 to 03Jan2021 for Psychiatric symptom, buprenorphine hydrochloride, naloxone hydrochloride (BUPRENORPHINE/NALOXONE MYLAN) from 29Jun2020 to 03Jan2021 for Opioid abuse, paliperidone palmitate (XEPLION) from 19Dec2019 to 03Jan2021 for Psychiatric disorder prophylaxis, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA) from 04Jul2019 to Jul2019 for Chronic obstruct airways disease, promethazine hydrochloride (PHENERGAN) from 24Sep2020 to 03Jan2021 for Insomnia. The patient experienced hypoxic respiratory failure on 31Dec2020, dyspnea exacerbated on 31Dec2020. Patient treatment: On the 31Dec2020 it is recorded that the patient did not want resuscitation in the event of cardiac arrest or respiratory treatment in the event of respiratory failure. Initially the patient did not want to transfer to somatic treatment. But because of anxiety after dyspnoea the patient got treatment with oxygen. On 01Jan2021 the patient denied again treatment despite clear indication for oxygen therapy and COPD exacerbations treatment with ipratropium bromide and salbutamol sulfate (IPRAMOL) and inhalations. On 02Jan2021 the patient received oxygen-treatment, but the patient did not want further somatic treatment. It was stated in the patient journal that the patient did not want treatment and that in the given situation there was nothing more to do. Therefore the patient was returned to department with palliative treatment in the form of oxygen, midazolam subcutaneous (S.C.) and morphine S.C. On the 03Jan2021 the patient''s respiration was calm. The patient was unreachable. At 14:00 he was restless and got palliative treatment with midazolam and morphine. The patient underwent lab tests and procedures which included c-reactive protein: normal on an unspecified date, 16 on 27Dec2020, fibrin D dimer: normal on 31Dec2020, fluid balance assessment: normal on 27Dec2020, forced expiratory volume (FEV 1): 37 % on 2018, hepatic enzyme: normal on 27Dec2020, oxygen saturation: 64 % on an unspecified date, 60 % on 20Dec2020, 58 % on 27Dec2020, 62 % on 31Dec2020, 35 % (in the ambulance) on 31Dec2020, 100 % (on oxygen-treatment) on 31Dec2020, 40-60% on 02Jan2021 12:47 pm, 58 % (in the ambulance) on 02Jan2021 09:00 am, 30 % on 02Jan2021 04:24 am, 99 % (on oxygen-treatment) on 02Jan2021, PCO2 up to 12.8 (Unit not specified) on an unspecified date, PO2 Down to 4.8 (Unit not specified) on an unspecified date. The patient died on 03Jan2021. An autopsy was not performed. The outcome of the events was fatal. Causality: The reporter assessed that even though the patient''s symptoms have occurred long before the vaccination, it can not be ruled out that the patient''s dyspnoea and hypoxia due to COPD have been aggravated by the vaccine. If the Medicines Agency receives supplemental significant information regarding this case the case will be re-submitted.; Reported Cause(s) of Death: Dyspnea exacerbated; Hypoxic respiratory failure


VAERS ID: 934765 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-03
Onset:2021-01-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia with Lewy bodies; Hypertension; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021013357

Write-up: Dyspnoea; suspected pulmonary edema; This is a spontaneous report downloaded from the regulatory authority DK-DKMA-WBS-0028304. Report was received from a contactable physician via from the regulatory authority. An 80-year-old female patient received bnt162b2 (COMIRNATY, lot EJ6797, expiration date 30Apr2021), intramuscularly on 03Jan2021 at single dose for covid-19 immunisation. Medical history included dementia with lewy bodies from an unknown date and unknown if ongoing, osteoporosis from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. No previous drug was given. The patient''s concomitant medications were not reported. On 04Jan2021 around 12, approximately 25 hours after the vaccination the patient developed dyspnoea and pulmonary edema. 4 hours later she died. The patient did not experience any allergic symptoms. Events reported as dyspnoea and suspected pulmonary edema. The ADRs were by the reporter reported as fatal. No treatment due to the ADRs was reported. Reported cause of death was pulmonary edema. Outcome of event dyspnoea also reported as not recovered. There was no information regarding test results. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Pulmonary edema; Dyspnoea


VAERS ID: 934781 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-15
Onset:2020-12-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-19
   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:
CDC Split Type: GBPFIZER INC2021009059

Write-up: Sepsis; Acute bronchopneumonia; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (GB-MHRA-EYC 00236063 and GB-MHRA-ADR 24546059). An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, on 15Dec2020 as a single dose for COVID-19 vaccination. The patient''s medical history was not reported. Concomitant medications included pregabalin (MANUFACTURER UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), candesartan (MANUFACTURER UNKNOWN), and levothyroxine (MANUFACTURER UNKNOWN). The patient experienced acute bronchopneumonia on 18Dec2020 and sepsis on an unspecified date. The events caused hospitalization and were reported as fatal. The clinical course was reported as follows: The patient was brought to the hospital by ambulance with severe sepsis and bronchopneumonia. She was resuscitated but unfortunately died shortly after arriving. The family reported that the patient received the coronavirus vaccine on 15Dec2020. It was reported that it is unclear from the family history whether she was unwell before she received the vaccine. The clinical outcome of acute bronchopneumonia and sepsis was fatal. The patient died on 19Dec2020. The cause of death was reported as acute bronchopneumonia and sepsis. It was not reported if an autopsy was performed. No follow-up attempts are possible; information on batch number cannot be obtained.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular the following relevant information is not available: medical history, autopsy report.; Reported Cause(s) of Death: Sepsis; Acute bronchopneumonia


VAERS ID: 934782 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-18
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Living in residential institution, Lower respiratory tract infection, Viral test negative
SMQs:, Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; ; SODIUM VALPROATE; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Frailty (severely); Vascular dementia
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:Settled - before giving vaccine Centigrade; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative - swab test
CDC Split Type: GBPFIZER INC2021009085

Write-up: Lower respiratory tract infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority GB-MHRA-EYC 00236087, Safety Report Unique Identifier: GB-MHRA-ADR 24546153 . A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 18Dec2020 at single dose for covid-19 immunization. Medical history included vascular dementia from an unknown date and unknown if ongoing, severely frail from an unknown date and unknown if ongoing. This patient was severely frail as a result of vascular dementia and was a permanent nursing home resident. Concomitant medication included amoxicillin, doxycycline, sodium valproate, quetiapine, omeprazole, paracetamol. The patient experienced lower respiratory tract infection (LRTI) on an unspecified date. Patient died on 22Dec2020 within 5 days of receiving Covid vaccine, had been on antibiotics for LRTI for 2 days and had appeared to be improving, temperature was settled before vaccine was administered. She had a negative Covid swab at the onset of her symptoms. It would seem more likely that this patient died as a result of an evolving LRTI than as a result of receiving Covid vaccination. She was changed to amoxicillin 2 days before she died. The other outcome for Death was: Died 22Dec2020 but cause of death felt to be due to LRTI not vaccine. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender''s Comments: The underlying predisposing condition (severely frail, lower respiratory tract infection) have been assessed to have played a major role toward the event.; Reported Cause(s) of Death: Lower respiratory tract infection


VAERS ID: 934826 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-20
Onset:2020-12-01
Submitted: 0000-00-00
Entered: 2021-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-01
   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: Chronic obstructive pulmonary disease; Depression; Hypertension; Ischaemic heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021009370

Write-up: Death; This is a spontaneous report from a contactable consumer and a physician downloaded from the Regulatory Authority number GB-MHRA-WEBCOVID-20201222043330 and Safety Report Unique Identifier GB-MHRA-ADR 24545938. A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT: EJ0553) via an unspecified route of administration on 20Dec2020 around 15:45 at single dose in left upper arm for COVID-19 vaccination. The patient ongoing medical history included Depression, Hypertension, chronic obstructive pulmonary disease and ischaemic heart disease. Patient is not enrolled in clinical trial. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient has not had symptoms associated with COVID-19. Concomitant medication included citalopram taken for Depression. The patient was taking unspecified concomitant medications for hypertension, chronic obstructive pulmonary disease (COPD) and ischaemic heart disease. The patient experienced death in Dec2020 (reported as in the evening of the 20Dec2020 or morning of 21Dec2020). Specifically, it was reported that the patient had the first dose of the vaccine at around 15:45 on 20Dec2020 and was observed for 15 minutes after with no side effects, the patient then left the site with family member. He was well that evening, he lived alone but spoke on the phone in the evening and felt well. On the 21Dec2020, after went to check on him and he was found in his bed passed away. When seeing the body, it was assumed that he had passed away in the evening of the 20Dec2020 or morning of 21Dec2020. Although unlikely, it was less than 24 hours after taking the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. The patient was found dead in his flat the next day on 21Dec2020 by next of kin. He was dropped of home by family after the vaccination, he spoke to his family on the night after having the vaccination and told them he was feeling fine and was going to bed. He did not respond to telephone calls the next day (on Monday 21Dec2020) so the family went over to his flat and found he had passed away. The patient was registered at another surgery. Screening questions were asked, no contra indication found. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 934881 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Palliative care, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021009471

Write-up: Fever; This is a spontaneous report from a newsletter, from a contactable consumer (profession unspecified). Regulatory authority report number was not provided. An elderly female patient received bnt162b2 (COMIRNATY, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included ongoing dementia in a palliative state. The patient''s concomitant medications were not reported. The verbatim narrative was reported as follows: ''Status report on suspected side effects from vaccination against covid-19. The report on the second death was received on 05Jan2020. It concerns an elderly female with dementia in a palliative state. The female was vaccinated with Comirnaty, had fever on an unspecified date and passed away three days later. The information in the report is very brief and will seek additional information from the reporter. Currently, has no information on the female''s confirmed cause of death and there is no established causality with the vaccine.'' The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible; information about LOT/batch number cannot be obtained.; Reported Cause(s) of Death: had fever and passed away three days later


VAERS ID: 934882 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC2021009992

Write-up: heart attack; This is a spontaneous report from a non-contactable consumer (discovered on news page and heard in news). An elderly female patient (elderly than 90-year old from home for elderly) received bnt162b2 (COMIRNATY) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization (other details not reported). Medical history included heart attack. Concomitant medications were not reported. patient experienced heart attack six hours after vaccination that obviously occurred after repeated heart attack. It was stated that heart attack was not connected to the vaccination. There was no acute allergic reaction. Case was further investigated (independent committee) and confirmed the vaccination was not reason of death. Patient died from heart attack, it was unknown if autopsy was done. Information on batch number has been request.; Sender''s Comments: Fatal heart attack is not related to bnt162b2 use; the advanced old patient had pre-existing medical condition including previous episode of heart attack thus the underlying cardiovascular provided an explanation for the event onset.; Reported Cause(s) of Death: heart attack


VAERS ID: 936170 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2020-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Death, Myocardial infarction
SMQs:, Anaphylactic reaction (narrow), Myocardial infarction (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), Embolic and thrombotic events, arterial (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-31
   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: ; ; BETNOVATE; ; ; ; ; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; Basal cell carcinoma; Cataract; Chronic kidney disease; Colitis ischaemic; Debridement (Arthroscopic debridement of patella); Essential hypertension; Mitral valve incompetence; Myocardial ischaemia; Neoplasm malignant (other/unspecified site); Transurethral bladder resection; Comments: Patient has not had symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021012711

Write-up: Myocardial infarct; Circulatory collapse; This is a spontaneous report from a contactable physician from the regulatory authroity. The regulatory authority report number is GB-MHRA-ADR 24553112 and GB-MHRA-WEBCOVID-20210104143047. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1688), via an unspecified route of administration, on 31Dec2020 at a single dose for COVID-19 vaccination. Medical history included mitral valve incompetence from 08May2020, myocardial ischaemia from 07May2020, acute myocardial infarction from 07May2020, cataract from 29Nov2019, chronic kidney disease from 03Oct2013, colitis ischaemic from 23May2013, basal cell carcinoma from 20Apr2012, transurethral bladder resection on 06Sep2005, neoplasm malignant (other/unspecified site) from 16Aug2005, debridement (arthroscopic debridement of patella) on 12Jan2005, and essential hypertension from 2005. The patient had not had symptoms associated with COVID-19. The patient was not been tested/or had an inconclusive test for COVID-19. The patient was not enrolled in clinical trial. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), betamethasone valerate (BETNOVATE), bisoprolol (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN), glyceryl trinitrate (MANUFACTURER UNKNOWN), loperamide (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), phenoxymethylpenicillin (MANUFACTURER UNKNOWN), and ramipril (MANUFACTURER UNKNOWN). The patient experienced myocardial infarct and circulatory collapse on 31Dec2020. The event, myocardial infarct, was reported as fatal. It was reported that the patient collapsed at home the evening after vaccination. The clinical outcome of myocardial infarct was fatal and of circulatory collapse was not recovered. The patient died on 31Dec2020. The cause of death was reported as myocardial infarct. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Myocardial infarct


VAERS ID: 937724 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021006738

Write-up: Death in connection with the vaccination and/or COVID-19 disease/positivity; Death in connection with the vaccination and/or COVID-19 disease/positivity; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date, there was death in connection with the vaccination and/or COVID-19 disease/positivity. It was reported that: two deceased were autopsied, whose death was in connection with the vaccination or COVID-19 disease/positivity. The clinical outcome of death in connection with the vaccination and/or COVID-19 disease/positivity was fatal. The patient died on an unspecified date. The cause of death was reported as: death in connection with the vaccination and/or COVID-19 disease/positivity. An autopsy was performed, and the results were not reported.; Sender''s Comments: The association between the event lack of effect (death was in connection with the vaccination or COVID-19 disease positivity) with BNT162b2 can not be fully excluded given the limited information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-2021006905 same reporter, same product, same event, different patient; Reported Cause(s) of Death: Death in connection with the vaccination and/or COVID-19 disease/positivity; Death in connection with the vaccination and/or COVID-19 disease/positivity


VAERS ID: 937998 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-17
Onset:2020-12-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Death, General physical health deterioration, Malaise, Tachycardia, Urinary tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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: MATRIFEN; ; ; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Dementia Alzheimer''s type; Frailty; Recurrent urinary tract infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021009353

Write-up: Tachycardia; Unwell; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB GB-MHRA-EYC 00235994, Safety Report Unique Identifier GB-MHRA-ADR 24545770, received from Regulatory Authority. An 85-years-old patient of an unspecified gender received bnt162b2 (BNT162B2) (batch/lot number unknown), intramuscular on 17Dec2020 at single dose for covid-19 immunisation. Medical history included chronic kidney disease, frailty, recurrent urinary tract infection, dementia alzheimer''s type, all from an unknown date and unknown if ongoing. Concomitant medication included fentanyl (MATRIFEN), folic acid (FOLIC ACID), colecalciferol (COLECALCIFEROL), omeprazole (OMEPRAZOLE), citalopram (CITALOPRAM), paracetamol (PARACETAMOL), all taken from unknown date for unspecified indication. The patient experienced unwell and tachycardia on 18Dec2020. The events were medically significant. The event outcome was unknown. Detail clinical course was provided as patient received vaccine on 17Dec2020, the following day she seemed unwell and tachycardic. No evidence of allergy, fever or coronavirus symptoms. Patient deteriorated over the weekend and passed away 3 days later. Cause of death on certificate was probable urinary tract infection. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: urinary tract infection


VAERS ID: 938038 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiopulmonary failure, Death
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Communication disorder NOS; Frailty; Memory impairment; Mobility decreased
Preexisting Conditions: Medical History/Concurrent Conditions: Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Test Date: 202012; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Test Date: 20201218; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative
CDC Split Type: GBPFIZER INC2021012517

Write-up: Acute cardio-respiratory event and died a few hours later; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-20210107093111. Safety Report Unique Identifier GB-MHRA-ADR 24565959. An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose, on 04Jan2021, for COVID-19 immunisation. Patient was elderly and frail and gradually declining in mobility, communication and memory over the last 12 months. Relevant medical history also included vascular dementia form an unspecified date and unknown if ongoing. Concomitant medications were unknown. Patient was not enrolled in clinical trial. COVID-19 virus test was performed twice on an unspecified date, in Dec2020 and on 18Dec2020 and the results were negative. On 04Jan2021, at 06:00 PM, the patient experienced acute cardio-respiratory event and died a few hours later. It was unknown if autopsy was done. Since the vaccination, the patient has not been tested for COVID-19. Patient did not have symptoms associated with COVID-19. The patient was kept comfortable in the nursing home in these last few hours. There was no way to know whether the vaccine was to blame at all, it was unlikely. No follow-up attempts are possible, information about lot number cannot be obtained.; Reported Cause(s) of Death: Cardio-respiratory failure


VAERS ID: 939332 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-03
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type (Vascular and Alzheimer''s mixed dementia); Fluid intake reduced (patient known to not be eating or drinking); General physical health deterioration (Patient known to be declining); Oral intake reduced (patient known to not be eating or drinking); Vascular dementia (advanced dementia)
Allergies:
Diagnostic Lab Data: Test Date: 20201227; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021012468

Write-up: Death; Malaise; Vomiting; This is a spontaneous report received from a contactable physician from the Regulatory Agency (RA). The Regulatory Authority report number is GB-MHRA-WEBCOVID-20210105172532, Safety Report Unique Identifier GB-MHRA-ADR 24558660. An 81-year-old female patient received bnt162b2 (BNT162B2) (lot# EJ1688), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. Medical history included vascular dementia (advanced dementia), dementia Alzheimer''s type (vascular and Alzheimer''s mixed dementia), oral intake reduced (patient known to not be eating or drinking), fluid intake reduced, (patient known to not be eating or drinking), general physical health deterioration (patient known to be declining); all from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced death on 03Jan2021, malaise on 01Jan2021 with fatal outcome, vomiting on 01Jan2021 with fatal outcome. It was reported that 48 hours after vaccination the patient became unwell, vomited and then died on 03Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 27Dec2020. Patient has been not tested positive for COVID-19 since having the vaccine. It was not reported if an autopsy was performed. It was not known whether vaccine caused reaction. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Malaise; Vomiting; Death


VAERS ID: 939334 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea exertional, SARS-CoV-2 test negative
SMQs:, Pulmonary hypertension (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-02
   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: Basal cell carcinoma; Bowen''s disease; Chronic kidney disease; Essential hypertension
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021012521

Write-up: breathless on exertion; This is a spontaneous report received from a contactable other health professional received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-ADR 24561910, other case identifier number: GB-MHRA-WEBCOVID-20210106094618. An 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot no: EJ1688), via an unspecified route of administration on 30Dec2020 single dose for covid-19 immunisation. Medical history included Bowen''s disease, basal cell carcinoma, chronic kidney disease and essential hypertension, all unknown if ongoing. Concomitant medication included alfacalcidol (unknown manufacturer), amlodipine (unknown manufacturer), atorvastatin (unknown manufacturer), clopidogrel (unknown manufacturer), prazosin (unknown manufacturer), sodium bicarbonate (unknown manufacturer), folic acid (unknown manufacturer), furosemide (unknown manufacturer). The patient experienced breathless on exertion on 02Jan2021. The patient died on 02Jan2021 due to the event. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on unknown date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Dyspnoea exertional


VAERS ID: 940902 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   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 INC2021016328

Write-up: Death 2 hours after vaccination in a retirement home; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (COMIRNATY; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ6796), via an unspecified route of administration on 08Jan2021 as first single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 08Jan2021, at 19:24, death 2 hours after vaccination in a retirement home was noted. The patient died on 08Jan2021. It was not reported if an autopsy was performed.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death 2 hours after vaccination in a retirement home


VAERS ID: 940935 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BJ1688 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:no-negative COVID-19 test
CDC Split Type: GBPFIZER INC2021017066

Write-up: Death; Vomiting; This is a spontaneous report from a contactable other health professional from the Regulatory Agency. The regulatory authority report number is GB-MHRA-ADR 24573192. An elderly female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: BJ1688 and EJ1688; as reported), via an unspecified route of administration on 05Jan2021 at 12:26 at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had not had symptoms associated with COVID-19; and was not enrolled in the clinical trial. On 05Jan2021 at 12:51, the patient experienced vomiting (non-serious); 25 minutes post vaccine (had further vomiting episodes). On 07Jan2021 at 01:00, the patient experienced death; which caused death, and was medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative COVID-19 test on an unspecified date. The clinical outcome of the event, vomiting, was unknown. The clinical outcome of the event, death, was fatal. The patient died on 07Jan2021 at 01:00 due to unknown cause of death. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 940940 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-03
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4175 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cardio-respiratory arrest, Resuscitation
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: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder (intended for valve replacement surgery); Diabetes mellitus; Mobility decreased
Allergies:
Diagnostic Lab Data: Test Name: monitor; Result Unstructured Data: Test Result:asystole; Test Name: heart sounds; Result Unstructured Data: Test Result:without heart sounds; Test Name: pupils; Result Unstructured Data: Test Result:pupils do not respond to light
CDC Split Type: ILPFIZER INC2021019507

Write-up: heart pain; cardiac and respiratory arrest; cardiac and respiratory arrest; This is a spontaneous report from a contactable consumer or other non hcp received via regulatory authority. This consumer reported different fatal events for four patients. This is the first of four reports. A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4175) via an unspecified route of administration on 03Jan2021 at single dose for covid-19 immunisation. Medical history included Nursing background, cardiac, intended for valve replacement surgery, diabetes mellitus (DM). The patient''s concomitant medications were not reported. The patient was vaccinated on 03Jan2021 with the first dose. From the moment of the vaccine he complained about heart pain. Cardiopulmonary resuscitation (CPR) was performed by the persons on call without an electric shock, emergency services arrived after 5 minutes, resuscitation continued asystole on the monitor, received 4 doses of adrenaline IV, respiration through mask and ambu. After 20 minutes of resuscitation pupils do not respond to light, without heart sounds. The patient died from cardiac and respiratory arrest in Jan2021. It was not reported if an autopsy was performed. The outcome of event heart pain was unknown.; Sender''s Comments: Linked Report(s) : IL-PFIZER INC-2021019632 Same reporter, same product, different patient/events.;IL-PFIZER INC-2021019633 Same reporter, same product, different patient/events.;IL-PFIZER INC-2021019634 Same reporter, same product, different patient/events.; Reported Cause(s) of Death: cardiac and respiratory arrest; cardiac and respiratory arrest


VAERS ID: 940941 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Feeling abnormal
SMQs:, Dementia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   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: Cancer; Diabetes; Hypercholesterolemia; Osteoarthrosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021019634

Write-up: felt bad; This is a spontaneous report from a contactable consumer. This consumer reported different fatal events for four patients.This is the fourth of four reports. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK4238) via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunisation. Medical history included oncological patient, diabetes, hypercholesterolemia, osteoarthrosis. Concomitant medications were not reported. The patient went out for work a day after he received the vaccine, he felt bad on 08Jan2021 and MDA was called, shortly afterwards his death was determined by MDA. The date of death was on 08Jan2021. The cause of death was felt bad. The outcome of event was fatal. It was unknown if an autopsy was performed.; Sender''s Comments: Linked Report(s) : IL-PFIZER INC-2021019507 Same reporter, same product, different patient/events; Reported Cause(s) of Death: felt bad


VAERS ID: 941173 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
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: CAPFIZER INC2021018220

Write-up: died of COVID-19/developing symptoms 18 days after his inoculation; died of COVID-19/developing symptoms 18 days after his inoculation; This is a spontaneous report received from a contactable consumer A 90-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 14Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient died of COVID-19 on Wednesday (06Jan2021) at the Hospital. The patient was given the vaccine on 14Dec2020 and was due to be vaccinated 21 days later. His second dose was delayed because of provincial plan to vaccinate as many people as quickly as possible. The patient started developing symptoms 18 days after his inoculation so the second dose would not have helped him. No other details provided. Information on lot/batch number has been requested.; Reported Cause(s) of Death: died of COVID-19


VAERS ID: 941174 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-24
Onset:2020-12-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood pressure decreased, Death, Heart rate increased, Restlessness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-29
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 20201226; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20201226; Test Name: pulse; Result Unstructured Data: Test Result:increased; Test Date: 20201227; Test Name: home doctor examination; Result Unstructured Data: Test Result:stable with persistent sensitivity to pressure of; Comments: stable with persistent sensitivity to pressure of the abdomen
CDC Split Type: CHPFIZER INC2021017201

Write-up: first death case due to Covid-19 vaccination in this country/deterioration in the general condition; stomach was hard and caused pain under pressure; Urethral and abdominal pain; abdominal pain/stomach was hard and caused pain under pressure; restless; his blood pressure dropped; pulse increased; This case was originally submitted under WWID AT-PFIZER INC-2020519756. Upon follow-up, reporter with regulatory authority was considered as primary reporter; as a result of this update case is being resubmitted under new WWID CH-PFIZER INC- 2021017201. As a consequence, this follow-up report will be indicated as an initial report. This is a spontaneous report from six contactable consumers and a contactable other health professional. A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; COMIRNATY), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 vaccination. Medical history included dementia and urinary tract infection from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The resident had previously reacted negatively to a flu vaccine and therefore no further vaccinations were recommended. The patient experienced urethral and abdominal pain, restless, his blood pressure dropped, pulse increased all on 26Dec2020, deterioration in the general condition and death on 29Dec2020. On Christmas Eve, the residents of a nursing home for dementia were vaccinated with the Pfizer/Biontech vaccine. The affected, otherwise healthy resident, suffered from pain in the urethra and abdomen two days later. The examination by the home doctor revealed a decrease in blood pressure and an increase in the pulse on 26Dec2020. At the last consultation on Sunday evening, 27Dec2020, the patient was stable with persistent sensitivity to pressure of the abdomen. The family doctor in charge examined the patient one last time on Sunday evening, 27Dec2020. He was calm, but his stomach was hard and caused pain under pressure. The following day, the management of the institution did not report back to the home doctor. On the morning of 29Dec2020, the nursing home informed the doctor about a deterioration of the general condition. By the time the doctor was called back the same morning, the patient had already died, vaccinated on Christmas Eve and dead five days later. The patient underwent lab tests and procedures also included home doctor examination: condition was stable with persistent sensitivity to pressure of the abdomen on 27Dec2020. The patient died on 29Dec2020, which was the first death case due to COVID-19 vaccination in this country. It was not reported if an autopsy was performed. The news of the death of a 91-year-old person after he was vaccinated against COVID-19 is circulating on social media channels and information platforms. Investigations by the health authorities have shown that due to the medical history and the course of the disease, a connection between death and the COVID-19 vaccination is unlikely. Neither the medical history nor the acute course of the disease suggest a direct causal connection between the COVID-19 vaccination and death. The comprehensive information available indicates the pre-existing diseases as a natural cause of death. This was also noted on the death certificate. It soon became clear that the home physician, who had implied a connection between vaccination and the death of his elderly patient, was himself. Quoted from the medical record and message spread by email, it was possibly overlooked that patient had symptoms of a urinary tract infection and did not prescribe antibiotics. Event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. Information on the Lot/Batch number has been requested. Follow-up (05Jan2021): New information received from Pfizer Employee, who sent a follow-up from another source included medical history urinary tract infection and cause of death updated. Information on the Lot/Batch number has been requested. Follow-up (08Jan2021): New information received clarified that Reporter with regulatory authority is to be considered as primary reporter. Information on the Lot/Batch number has been requested.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported events due to temporal association. However patient old age of 91 years and other underlying medical conditions could have played a contributory role. Further information including autopsy reports would be helpful for a meaningful medical assessment The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.; Reported Cause(s) of Death: first death case due to Covid-19 vaccination in this country/deterioration in the general condition


VAERS ID: 944114 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-19
Onset:2020-12-29
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, 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: 2020-12-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; LANSOPRAZOL;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ankle swelling (slight ankle swelling awaiting head ct scan and bloods.); Cerebrovascular accident (previous CVA.); Cholesterol; Memory impairment (Recent memory problems.); Oesophagitis; Waldenstrom''s macroglobulinemia; Comments: Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021016664

Write-up: Sudden death; This is a spontaneous report from a contactable physician from the regulatory authority. The regulatory authority report number is GB-MHRA-ADR 24556755. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ0553), via an unspecified route of administration on 19Dec2020 as single dose for COVID-19 immunization. Medical history included Waldenstrom''s macroglobulinemia for Waldenstrom''s macroglobulinaemia, memory impairment, with recent memory problems, cerebrovascular accident , with previous CVA, joint swelling , reported as slight ankle swelling awaiting head CT scan and bloods, oesophagitis, and cholesterol, all from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (MANUFACTURER UNKNOWN) for Waldenstrom''s macroglobulinaemia, lansoprazol (MANUFACTURER UNKNOWN) for oesophagitis, simvastatin (MANUFACTURER UNKNOWN) for blood cholesterol. The patient had sudden death on 29Dec2020. The patient died on 29Dec2020. It was not reported if an autopsy was performed. The reporter did not think the COVID vaccination caused the patients death; It did not appear to be related. The patient was seen by the physician on the 24th (not otherwise specified), and was fine. The patients son also saw the patient on the 28th (not otherwise specified) and also fine with no side effects from the jab. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information currently provided, the company considers the patient death is unrelated to the vaccine use; the advance old patient having multiple pre-existing medical conditions including Waldenstrom''s macroglobulinaemia and cerebrovascular accident, which more likely led the patient to sudden death.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 944118 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2020-12-27
Submitted: 0000-00-00
Entered: 2021-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021016254

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician received by Regulatory Agency . The regulatory authority report number is GB-MHRA-ADR 24558365 & GB-MHRA-WEBCOVID-20210105143744. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. The patient experienced SARS-coV-2 infection on 27Dec2020. The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive covid-19 test on an unspecified date. The clinical outcome of SARS-coV-2 infection was fatal. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 944121 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-23
Onset:2020-12-31
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Death, SARS-CoV-2 test negative
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-31
   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: Dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion; Comments: Patient has not had symptoms associated with COVID-19 Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021016800

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-20210105171610, Safety Report Unique Identifier GB-MHRA-ADR 24558665. A male patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 23Dec2020, at single dose for covid-19 vaccination. Medical history included ongoing dementia, and cardiac pacemaker insertion on an unknown date. Patient has not had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest on 31Dec2020. Had spontaneous cardiac arrest 9 days (to be clarified) after vaccination doubtful implicated but new vaccine of course. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. The patient died of cardiac arrest on 31Dec2020. It was not reported if an autopsy was performed. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 944154 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Dementia; Depression; Gastrointestinal disorder; Heart failure; Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: heart sounds; Result Unstructured Data: Test Result:asystole without heart sounds
CDC Split Type: ILPFIZER INC2021019632

Write-up: This is a spontaneous report from a contactable consumer. This consumer reported different fatal events for four patients. This is the second of four reports. An 82-year-old female patient in a nursing home received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4238) via an unspecified route of administration on 04-Jan-2021 at a single dose for COVID-19 immunisation. Medical history included background of asthma, dementia, depression, gastrointestinal and heart failure. Concomitant medications were not reported. 4 Hours after the receipt of the vaccine, she was found in her room on the floor with a bruise on her forehead apparently from a fall, CPR was performed by nursing home staff. Staff performed CPR, asystole without heart sounds, CPR continued for 23 minutes without any change and death was declared. The events occurred in Jan 2021. The date of death was in Jan 2021. The outcome of events was fatal. It was unknown if an autopsy was performed. Sender''s Comments: Linked Report(s): IL-PFIZER INC-2021019507 Same reporter, same product, different patient/events; Reported Cause(s) of Death: was found in her room on the floor with a bruise on her forehead apparently from a fall; was found in her room on the floor with a bruise on her forehead apparently from a fall.


VAERS ID: 944155 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-21
Onset:2020-12-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood test, Death, Dyspnoea, Haemolytic anaemia, Hypotension, Jaundice, Lymphocytosis, Resuscitation, Tremor
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal (treated with nifedipine and TRITACE COMP); Drug hypersensitivity; Hyperlipidemia (treated with statins); Keratitis; Prostate cancer; Prostatectomy
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Date: 20201228; Test Name: blood tests; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ILPFIZER INC2021019633

Write-up: hemolytic anemia; reduced air entrance; passed away; low blood pressure; jaundice appeared on the whole body with lymphocytosis; jaundice appeared on the whole body with lymphocytosis; shortness of breath in mild efforts; weakness which expressed by shortness of breath in mild efforts; hands tremor; shortness of breath; This is a spontaneous report from a contactable consumer received via regulatory authority. This consumer reported different fatal events for four patients. This is the third of four reports. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was not specified) via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunisation. Medical history included Kerattis, prostatectomy other, blood pressure problems (treated with nifedipine and hydrochlorothiazide/ramipril (TRITACE COMP)), hyperlipidemia (treated with statins), oncological patient-underwent radical restriction of the prostate, and sensitivity to phenylephrin. Concomitant medications were not reported. Three days after the vaccine (on 24Dec2020) he started to feel shortness of breath, arrived for hospitalization 10 days after vaccination. Five days after vaccination (on 26Dec2020) he experienced weakness which expressed by shortness of breath in mild efforts, hands tremor. 6 days after vaccination (on 27Dec2020) jaundice appeared on the whole body with lymphocytosis. On the day after, he referred to the physician and blood tests were sent. He was hospitalized following diagnosis of hemolytic anemia. He received two blood doses and steroids. Two hours before he passed away, low blood pressure was measured and reduced air entrance, CPR was performed without success and the patient passed away. The date of death was unknown. The cause of death was unknown. It was unknow if an autopsy was performed. The outcome of event unknown cause of death was fatal, and of other events was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : IL-PFIZER INC-2021019507 Same reporter, same product, different patient/events; Reported Cause(s) of Death: passed away


VAERS ID: 945725 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Death, Hypotension, Malaise, Mobility decreased, Oxygen saturation decreased, SARS-CoV-2 test negative, Speech disorder
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
   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: Comments: The resident had got heart failure. The out of hours GP visited 10/01/2021 and advised she maybe poorly due to having the Covid-19 vaccine. The resident passed away at 7.20am this morning 11/01/2021 Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210110; Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Date: 20210110; Test Name: sats; Result Unstructured Data: Test Result:low; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:no-negative COVID-19 test
CDC Split Type: GBPFIZER INC2021020138

Write-up: heart failure; Death; feeling sick; changes with speech and mobility; changes with speech and mobility; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-20210111094207, Safety Report Unique Identifier: GB-MHRA-ADR 24577774. A 97-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1688), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 10Jan2021, the patient experienced feeling sick (medically significant), changes with speech and mobility (speech disorder) (medically significant). On 11Jan2021, the patient experienced death (death, medically significant). On an unspecified date, the patient experienced heart failure (death, medically significant). The clinical course was reported as follows: "The resident had got heart failure." The patient was feeling sick on 10Jan2021 and was concerned as there were changes with speech and mobility. Emergency was called, and the ambulance arrived. It was stated the sats were low and blood pressure was low. The ambulance crew called for an out of hours general practitioner (GP) to come and see the patient. The out of hours general practitioner (GP) visited on 10Jan2021 and advised "she maybe poorly due to having the Covid-19 vaccine" that was administered on the 08Jan2021. The resident passed away at 07:20 on morning 11Jan2021. The patient had not tested positive for COVID-19 since having the vaccine. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative COVID-19 test on an unspecified date, oxygen saturation (sats): low on 10Jan2021, blood pressure: low on 10Jan2021. The clinical outcome of the event, death and heart failure, was fatal. The clinical outcome of the event, feeling sick and changes with speech and mobility, was unknown. The patient died on 11Jan2021 due to heart failure. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: heart failure


VAERS ID: 947270 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021027057

Write-up: patient died while there were no other complaints at that time; This is a spontaneous report received from a contactable consumer (Pfizer colleague). A 99-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient died 3 days after the vaccination while there were no other complaints at that time on 10Jan2021. The patient died on 10Jan2021. It was not reported if an autopsy was performed. The family assessed there was a causal relationship with the vaccine. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died 3 days after the vaccination while there were no other complaints


VAERS ID: 947332 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-05
   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: ; ; ; ; ; FULTIUM D3; ; ; ; LOTRIDERM; ; MAROL; ; ; ; SENNA [SENNA SPP.]; FLUCELVAX TETRA
Current Illness: Bedridden (Patient bed bound following a craniotomy for an acute subdural haematoma in 2019)
Preexisting Conditions: Medical History/Concurrent Conditions: Acute subdural haematoma; Craniotomy; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021016371

Write-up: Died in sleep; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number was GB-MHRA-ADR 24556999 with Safety Report Unique Identifier of GB-MHRA-WEBCOVID-20210105122200. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1688), via an unspecified route of administration on 31Dec2020 as a single dose for COVID-19 vaccination. Medical history included craniotomy in 2019, acute subdural haematoma in 2019, and ongoing bedridden following a craniotomy for an acute subdural haematoma from 2019. The patient was not enrolled in clinical trial. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN), ferrous sulfate (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN), flucloxacillin (MANUFACTURER UNKNOWN), colecalciferol (FULTIUM D3), gabapentin (MANUFACTURER UNKNOWN), hypromellose (MANUFACTURER UNKNOWN), levothyroxine sodium (MANUFACTURER UNKNOWN), betamethasone dipropionate/clotrimazole (LOTRIDERM) , macrogol (MANUFACTURER UNKNOWN), tramadol hydrochloride (MAROL), omeprazole (MANUFACTURER UNKNOWN), oxybutynin (MANUFACTURER UNKNOWN), paracetamol (MANUFACTURER UNKNOWN), senna spp. (MANUFACTURER UNKNOWN), and influenza vaccine inact sag 4v (FLUCELVAX TETRA). On 05Jan2021, the patient died in his sleep. The clinical course was as follows: The patient had not had symptoms associated with COVID-19. The patient received the vaccination on 31Dec2020. The patient had tested negative for COVID-19 since having the vaccine on an unknown date. There were no other reactions noted but the patient died in his sleep overnight on 05Jan2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Died in sleep


VAERS ID: 947357 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-19
Onset:2021-01-03
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Fall, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-03
   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: Test Date: 20210103; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021019774

Write-up: tested Covid positive/suspected COVID-19; tested Covid positive/suspected COVID-19; Shortness of breath; Fall; This is a spontaneous report from a contactable physician from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-20210106123053. An 81-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection, shortness of breath on 03Jan2021. Reaction to vaccine is none. Patient was admitted with fall and on the floor for 5 hours on 03Jan2021. He was tested COVID positive on admission on 03Jan2021. So he tested positive about two weeks after first dose of Pfizer COVID-19 vaccine. Patient was suspected COVID-19 from 03Jan2021. The patient underwent lab test included COVID-19 virus test: Yes - Positive COVID-19 test (03Jan2021). Outcome of the events was fatal. The patient died on 03Jan2021. It was unknown if an autopsy was performed. Cause of death reported as SARS-CoV-2 infection/suspected COVID-19, shortness of breath and fall. No follow-up attempts possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection/suspected COVID-19; SARS-CoV-2 infection/suspected COVID-19; shortness of breath; Fall


VAERS ID: 947362 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2020-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia with Lewy bodies; Frailty; Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: examination; Result Unstructured Data: Test Result:no signs of sepsis; Comments: she had no signs of sepsis, she had no fever, her chest was clear and she had no difficulty breathing
CDC Split Type: GBPFIZER INC2021019690

Write-up: Death; Unresponsive to stimuli; This is a spontaneous report received from a contactable physician by Pfizer from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-20210106141652 and GB-MHRA-ADR 24563112. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1688) via unspecified route of administration on 30Dec2020 at single dose for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. Medical history included ongoing asthenia, ongoing Parkinson''s disease and ongoing dementia with Lewy bodies. The patient experienced unresponsive to stimuli on 31Dec2020, death on 01Jan2021. The reporter described that this lady was extremely frail with a history of Parkinson''s and Lewy Body dementia. However, on the day that she received the injection she was not acutely unwell. The reporter visited her the following day (31Dec2020) and found her unresponsive and clearly dying. On examination she had no signs of sepsis, she had no fever, her chest was clear and she had no difficulty breathing. She died the next day 01Jan2021. This could simply be a coincidence of course but this was a sudden change after receiving the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. The patient died on 01Jan2021. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death; Unresponsive to stimuli


VAERS ID: 947363 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-22
Onset:2020-12-31
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0724-L456 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acidosis, Acute kidney injury, Blood creatine phosphokinase increased, Circulatory collapse, Death
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (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), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-31
   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: Chronic kidney disease stage 3; Diabetic (well controlled for 8 years)
Preexisting Conditions: Medical History/Concurrent Conditions: Gout
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: Creatine kinase; Result Unstructured Data: Test Result:significantly raised.; Test Date: 20201231; Test Name: Blood glucose; Result Unstructured Data: Test Result:43
CDC Split Type: GBPFIZER INC2021019684

Write-up: Death; Acidosis; Acute kidney injury; Blood creatine phosphokinase increased; Circulatory collapse; This is a spontaneous report from a contactable physician. This is a report received from the Pfizer from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-ADR 24563115. An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ0724-L456), via an unspecified route of administration on 22Dec2020, as single dose for covid-19 immunization. Medical history included ongoing chronic kidney disease, ongoing diabetes mellitus, well controlled for 8 year and gout from an unknown date. Concomitant medication included allopurinol (MANUFACTURER UNKNOWN) for gout, felodipine (MANUFACTURER UNKNOWN) for hypertension, metformin (MANUFACTURER UNKNOWN) for diabetes mellitus, ramipril (MANUFACTURER UNKNOWN) for hypertension, simvastatin (MANUFACTURER UNKNOWN) for diabetes mellitus. The patient experienced death on 31Dec2020 ( reported as diabetes mellitus inadequate control), acidosis on 31Dec2020, which was medically significant with outcome of not recovered; acute kidney injury on 31Dec2020, which was medically significant with outcome of not recovered; blood creatine phosphokinase increased on 31Dec2020, which was medically significant with outcome of not recovered; circulatory collapse on 31Dec2020, which was medically significant with outcome of not recovered. The events were acidosis, acute kidney injury, blood creatine phosphokinase increased and circulatory collapse were serious as they were medically significant. The patient underwent lab tests and procedures which included creatine kinase, which was significantly raised on 31Dec2020, and blood glucose was 43 on 31Dec2020. Details were as follows: Had vaccine on 22Dec2020. Attended A+E via ambulance after being found on floor 31Dec2020. The patient was found to have extremely high sugars (43) and was acidotic. Acute kidney injury and creatine kinase significantly raised were noted. The patient died on 31Dec2020. It was not reported if an autopsy was performed. Cause of death, was put down as diabetes, but the physician indicated concert as the patients diabetes had been well controlled for eight years. Obviously not an immediate reaction but concerned as to unexpected death. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in a clinical trial.; Reported Cause(s) of Death: Diabetes mellitus inadequate control; Diabetes mellitus


VAERS ID: 947365 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-21
Onset:2020-12-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / UNK - / -

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: 2020-12-24
   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: ASPIRINE; ; ; ; ; ZOLADEX LA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Heart disease, unspecified
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021019671

Write-up: sudden death; This is a spontaneous report received from a contactable physician from the. The regulatory authority report number is GB-MHRA-WEBCOVID-20210106143746. A 90 years old male patient received BNT162B2 (Batch/lot number: EJ0553) on 21Dec2020 at single dose for COVID-19 immunization. Medical history was Chronic kidney disease, heart disease. Concomitant drug was acetylsalicylic acid (ASPIRINE) for Myocardial ischaemia, atorvastatin for Myocardial ischaemia, bisoprolol for Myocardial ischaemia, levothyroxine sodium for Hypothyroidism, ramipril for Hypertension, goserelin acetate (ZOLADEX LA) for Prostate cancer. No reaction noted but sudden death 3 days after vaccination (24Dec2020), although had history of heart disease. Cause of death not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Outcome of the event was fatal. Unknown whether autopsy done or not. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 947382 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-17
Onset:2020-12-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553/V0001 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Death, SARS-CoV-2 test negative
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), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ; ; ; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathy; IHD
Allergies:
Diagnostic Lab Data: Test Date: 20201221; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021019867

Write-up: stroke; This is a spontaneous report from a contactable physician received by Pfizer from the regulatory authority. The regulatory authority report number is GB-MHRA-ADR 24566618 & GB-MHRA-WEBCOVID-20210107104558. An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ0553/V0001), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. Relevant medical history included: ischemic heart disease (IHD) and arteriopathy. Patient has not had symptoms associated with COVID-19 and is not enrolled in clinical trial. Concomitant medications included: clopidogrel (MANUFACTURER UNKNOWN), taken for transient ischaemic attack (TIA) from Jul2012 to an unspecified date, furosemide (MANUFACTURER UNKNOWN) taken from Jul2012 to an unspecified date, lansoprazole (MANUFACTURER UNKNOWN), taken from Nov2012 to an unspecified date, nebivolol (MANUFACTURER UNKNOWN), taken for left ventricular dysfunction from 01Jul2014 to an unspecified date, ramipril (MANUFACTURER UNKNOWN), taken from 2012 to an unspecified date and simvastatin (MANUFACTURER UNKNOWN) taken for hypercholesteremia from Nov2012 to an unspecified date. The patient experienced stroke on 19Dec2020, which caused hospitalization. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 21Dec2020. The clinical outcome of stroke was fatal. The patient died of the stroke in the hospital on an unspecified date. An autopsy was not performed. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 947426 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-07
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart attack (at age 50)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021026804

Write-up: heart attack; This is a spontaneous report from a contactable consumer (relative). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. Medical history included heart attack (at age 50) on an unspecified date. The patient''s concomitant medications were not reported. The patient experienced a heart attack on 07Jan2021, which was reported as fatal. The patient died of a heart attack about a week after the vaccine was given. The clinical outcome of heart attack was fatal. The patient died on 07Jan2021. The cause of death was reported as heart attack. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: heart attack


VAERS ID: 955204 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-10
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Death
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: calcium channel blocker
Current Illness:
Preexisting Conditions: Psoriasis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Our friend passed away 6 days after receiving the first dose of the Pfizer vaccine. He experienced a general weakness on the evening prior to hid death.


VAERS ID: 952914 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2020-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Discoloured vomit
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-31
   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: Autoimmune encephalopathy (Especially autoimmune encephalopathy of paraneoplastic origin); Urothelial carcinoma bladder
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021023705

Write-up: Death (death certificate: uncertain type of death); evening vomiting; This is a spontaneous report from a non-contactable physician the Regulatory Authority. This is a report received from the Regulatory Authority. Regulatory authority report number was DE-PEI-CADRPEI-2021011672. A 79-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: EJ6796), intramuscular on 30Dec2020 as a single dose for COVID-19 immunization. Medical history included especially autoimmune encephalopathy of paraneoplastic origin and suspected urothelial carcinoma of the bladder. The patient''s concomitant medications were not reported. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) on 03Dec2020 for immunization and was tolerated. On 31Dec2020 (also reported as 30Dec2020), the patient developed evening vomiting which was dark in color and most likely food related. On 31Dec2020 at 04:35, the patient died. It was not reported if an autopsy was performed. The clinical outcome of vomiting was reported as fatal; however, the cause of death was reported as unknown cause of death. The vomiting and unknown cause of death were reported as medially significant and fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 953012 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Illness, Limb discomfort, Malaise, SARS-CoV-2 test negative, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Claudication; Essential hypertension; Living in residential institution; Type 2 diabetes mellitus; Vascular dementia (Vascular dementia with frailty); Comments: Residential care home resident, Vascular dementia with frailty, 2006 Type 2 DM, 2006 Essentia hypertension, 2006 Claudication in legs Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210106; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021022839

Write-up: further sickness; vomited; felt unwell; Sudden death unexplained; slightly sore arm; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-20210108094947 & GB-MHRA-ADR 24571609. A 93-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included residential care home resident, vascular dementia with frailty, type 2 diabetes mellitus (DM) from 2006 to an unknown date, essential hypertension from 2006 to an unknown date, claudication in legs from 2006 to an unknown date. The patient''s concomitant medications were not reported. The patient had not had symptoms associated with COVID-19 and is not enrolled in a clinical trial. The patient experienced slightly sore arm on 05Jan2021, sudden death unexplained on 07Jan2021 and vomited and felt unwell on 07Jan2021 10:00 PM and further sickness on 07Jan2021 10:15 PM. The patient was entirely well after vaccine apart from a slightly sore arm that resolved. On 07Jan2021, 2 days after the vaccine administration, the patient vomited and felt unwell at 10:00 PM. Observation was stable, then further sickness at 10:15pm. Thereafter slumped to the side and died peacefully. There were no signs of other allergic reaction. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 06Jan2021. The outcome of sudden death unexplained was fatal, of slightly sore arm was recovered in Jan2021 and of vomited, felt unwell and further sickness was unknown. The patient died on 07Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 953036 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2021-01-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Consciousness decreased; Hypermobility syndrome; Pain NOS; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021004985

Write-up: Death; The initial case was missing the following minimum criteria: reporter with first-hand knowledge. Upon receipt of follow-up information on 14Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician downloaded from the regulatory authority. This is a report received from the regulatory authority. Regulatory authority report number was IS-IMA-1518. A 75-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EJ6796), via an unspecified route of administration on 29Dec2020 as a single dose for COVID-19 immunization. Medical history included hypermobility syndrome, consciousness decreased, pain, and Parkinson''s disease. The patient''s concomitant medications were not reported. On 01Jan2021, the patient died. The clinical course was as follows: The patient had impaired consciousness for a few days. On 29Dec2020 the patient was vaccinated with BNT162B2. On 31Dec2020 end-of-life care was initiated. The patient''s condition was worsening with hypermobility, dementia and pain (not otherwise specified). The patient had impaired consciousness for the past 6 days. The patient passed away on 01Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. The physician did not consider that there was a reason to suspect a causal association between the death and the vaccination; however, in the light of the circumstances it was reported.; Sender''s Comments: The association between the event death with BNT162b2 can not be fully excluded based on the temporal relationship and the limited information available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 953037 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; VIT D; ; ; RISPERIDON KRKA; ACIDOPHILUS BIFIDUS; ; ; BETMIGA; SOBRIL; ; BETOLVEX [CYANOCOBALAMIN]; ; AMLODIPIN [AMLODIPINE]; VAGIFEM;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Dementia; Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021005061

Write-up: Death; The initial case was missing the following minimum criteria: (no first-hand knowledge). Upon receipt of follow-up information on (14Jan2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician and healthcare professional. This is a report downloaded from the regulatory authority. The regulatory authority report number IS-IMA-1491. An 88-year-old female patient received BNT162B2 (COMIRNATY; Lot number EJ6796, Expiration date 30Apr2021), via an unspecified route of administration on 30Dec2020 as single dose for covid-19 immunization. Medical history included pneumonia, chronic obstructive pulmonary disease and dementia from an unknown date, and not ongoing. Concomitant medication included vitamin b complex (MANUFACTURER UNKNOWN), ergocalciferol (VIT D), enalapril (MANUFACTURER UNKNOWN), ciprofloxacin (MANUFACTURER UNKNOWN), risperidone (RISPERIDON KRKA) , bifidobacterium animalis, lactobacillus acidophilus (ACIDOPHILUS BIFIDUS), escitalopram (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), mirabegron (BETMIGA), oxazepam (SOBRIL) , quetiapine (MANUFACTURER UNKNOWN), cyanocobalamin (BETOLVEX [CYANOCOBALAMIN]), folic acid (MANUFACTURER UNKNOWN), amlodipine (AMLODIPIN), estradiol (VAGIFEM), vitamins nos (also reported as Vitaplus), Magical mouthwash, B-kombin, Progastro. The patient experienced worsening of condition on 31Dec2020, which was serious as it was life-threatening and had fatal outcome; the patient experienced death on 01Jan2021. The patient died on 01Jan2021. Details were as follows: patient was diagnosed with pneumonia 1.5 weeks prior to immunization with BNT162B2. The patients condition had deteriorated for the past days and weeks. The patient was vaccinated on 30Dec2020, and on 30Dec2020 . The patient condition continued to worsen. On 01Jan2021, the patient passed away. It was not reported if an autopsy was performed. Reporter''s comments: There is not an obvious causal association between the death and immunisation with Comirnaty due to worsening of the patients condition prior to immunisation.; Sender''s Comments: Based on the close temporal relationship, the association between the event death with BNT162b2 can not 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.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 953450 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-28
Onset:2020-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza like illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021023631

Write-up: Exitus letalis; Influenza like illness; This is a spontaneous report from a non-contactable consumer downloaded from the Medicines Agency (MA) WEB (DE-PEI-CADRPEI-2020011585). A 93-year-old male patient received BNT162B2 (COMIRNATY), intramuscularly, on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension arterial. The patient''s concomitant medications were not reported. The patient experienced influenza like illness and exitus letalis on 29Dec2020, which were reported as medically significant and fatal. It was reported that two days after vaccination, the patient developed influenza like illness (previously asymptomatic) and then found lifeless the following day (as reported). The clinical outcome of influenza like illness and exitus letalis was fatal. The patient died on 29Dec2020. The cause of death was influenza like illness (reported as unknown cause of death). It was unknown if an autopsy was performed. The causality assessment to both of the events was reported as unclassifiable by Regulatory Authority. No follow-up attempts possible; information about batch number cannot be obtained.; Reporter''s Comments: Previously asymptomatic, then found lifeless the following day.; Reported Cause(s) of Death: Influenza like illness


VAERS ID: 953452 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2020-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Death, Pulmonary embolism
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2020-12-31
   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: Diabetes; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021023752

Write-up: Letal death; Asystolia; Pulmonary embolism; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) WEB (DE-PEI-PEI2021000071). An 82-year-old female patient received BNT162B2 (COMIRNATY; Lot number: EJ6797), intramuscularly from 30Dec2020 at 0.3 mL, single for COVID-19 immunization. Medical history included diabetes and hypertension. The patient''s concomitant medications were not reported. At the time of vaccination there was no evidence of decompensation of the underlying disease. The patient experienced letal death, asystolia and pulmonary embolism on 31Dec2020, which were reported as life-threatening and fatal. The outcome of letal death, asystolia and pulmonary embolism was fatal. The patient died on 31Dec2020. An autopsy was not performed. The causality assessment for the events, death, asystolia and pulmonary embolism to the suspect product was reported as inconsistent causal association.; Reported Cause(s) of Death: Asystolia; Pulmonary embolism; Letal death


VAERS ID: 953468 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-17
Onset:2020-12-01
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cataract extraction; Intraocular lens implant; Left inguinal hernia; Osteoarthritis knee (right knee); Polymyalgia rheumatica; Postoperative care (Postop wound management gen secondary care done by practice); Pressure sore; Prostate cancer; Radiofrequency ablation (Radiofrequency ablation of varicose vein of leg); Retention urine; Total hip replacement (Total prosthetic replacement of hip joint using cement - left.); Total knee replacement (Total prosthetic replacement of knee joint using cement - left.); Total knee replacement (Primary total knee replacement NEC); Transurethral prostatectomy (Bladder outlet and prostate operations); Ventricular tachycardia; Wound dressing
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021022507

Write-up: patient passed away 4 days after receiving vaccination, not known if related but patient was seen 2 days before at the surgery and was fit and well at that time. Death was unexpected.; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority, RA. Regulatory authority report number was GB-MHRA-ADR 24546873 with Safety Report Unique Identifier of GB-MHRA-EYC 00236252. A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ0553), intramuscular on 17Dec2020 as 0.3 ml single dose for COVID-19 immunisation. Medical history included cataract operation on 23Oct2020, intraocular lens implant on 23Oct2020, atrial fibrillation from 10May2018 and unknown if ongoing, ventricular tachycardia from 11Sep2003 and unknown if ongoing, polymyalgia rheumatica from 31Mar2008 and unknown if ongoing, total prosthetic replacement of left hip joint using cement on 24Feb2011, total prosthetic replacement of left knee joint using cement on 28Nov2011, osteoarthritis of right knee from 02Jul2012 and unknown if ongoing, prostate cancer from 28Feb2017 and unknown if ongoing, pressure sore from 01Sep2017 and unknown if ongoing, postoperative care from 10Jan2018 and unknown if ongoing, left inguinal hernia from 07Jun2017 and unknown if ongoing, urine retention from 11Nov2016 to 04Feb2017, transurethral prostatectomy from 17Feb2017 to 13May2017, total knee replacement on 26Oct2018 to 18Jan2019 (as reported), high frequency ablation from 03Jul2019 to 25Sep2019, and wound dressing from 03Jan2019 and unknown if ongoing. Concomitant medications included apixaban (MANUFACTURER UNKNOWN), paracetamol (MANUFACTURER UNKNOWN), propafenone (MANUFACTURER UNKNOWN), and zopiclone (MANUFACTURER UNKNOWN). The patient previously took codeine (MANUFACTURER UNKNOWN) from 29Oct2018 to an unknown date for an unknown indication and experienced adverse reaction. In Dec2020 (reported as 4 days after the vaccination), the patient passed away. It was not known if it was related to the vaccine but the patient was seen 2 days before at the surgery and was fit and well at that time. The death was unexpected. An autopsy was performed, and the results were not provided. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 953471 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-20
Onset:2020-12-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Hypotension, Livedo reticularis, Loss of consciousness, Peripheral coldness, Respiratory rate increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; ; ; ; CO-CODAMOL; ; ; ; ; GLYCERYL TRIACETATE; ; LAXIDO; ; MICRALAX MACROGOL; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal abscess (Chronic); Aortic stenosis; Cervical myelopathy; Chronic kidney disease stage 3; Clammy (Started 2 days prior to vaccine); Dyspnoea (Started 2 days prior to vaccine); Essential hypertension; Feeling cold (Started 2 days prior to vaccine); Fracture of humerus (Closed fracture distal right humerus); Heart failure; Ischaemic foot (Critical left foot ischamia); Ischaemic heart disease; Lethargy (Started 2 days prior to vaccine); Lipodermatosclerosis; Mitral incompetence; Non STEMI (Acute); Peripheral vascular disease; Postmenopausal bleeding (Unidentified cause); Sweaty (Started 2 days prior to vaccine); Unwell (Started 2 days prior to vaccine); Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20201221; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1; Test Date: 20201221; Test Name: low blood pressure; Result Unstructured Data: Test Result:low; Test Date: 20201221; Test Name: respiratory rate; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC2021022784

Write-up: Death within 24 hours of vaccine; Livedo reticularis; Hypotension; Respiratory rate increased; Peripheral coldness; Loss of consciousness; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-EYC 00236256. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), subcutaneous on 20Dec2020 at first single dose for covid-19 immunization. Medical history included malaise from Dec2020, Started 2 days prior to vaccine; cold sweat from Dec2020, started 2 days prior to vaccine; dyspnoea from Dec2020, started 2 days prior to vaccine; feeling cold from Dec2020, started 2 days prior to vaccine; lethargy from Dec2020, started 2 days prior to vaccine; hyperhidrosis from Dec2020, started 2 days prior to vaccine, peripheral vascular disorder from 1982, peripheral ischaemia from 1982, Critical left foot ischemia; essential hypertension from 2003; myocardial ischaemia from 2005; Chronic kidney disease from 2006; myelopathy from 2007; Acute myocardial infarction in 2012; Mitral valve incompetence in 2012; Cardiac failure in 2013; Post thrombotic syndrome in 2015; Vascular dementia in 2017; Aortic stenosis in 2017; humerus fracture in 2019, Closed fracture distal right humerus; Postmenopausal haemorrhage 2019, unidentified cause; abdominal abscess in Jul2020, chronic, . Concomitant medication included acetylsalicylic acid (ASPIRIN), atorvastatin (MANUFACTURER UNKNOWN), bisoprolol fumarate (MANUFACTURER UNKNOWN), bumetanide (MANUFACTURER UNKNOWN), codeine phosphate, paracetamol (CO-CODAMOL) , colecalciferol (MANUFACTURER UNKNOWN), dimeticone (MANUFACTURER UNKNOWN), docusate sodium (MANUFACTURER UNKNOWN), doxycycline hyclate (MANUFACTURER UNKNOWN), glyceryl triacetate (MANUFACTURER UNKNOWN), isosorbide mononitrate (MANUFACTURER UNKNOWN), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXIDO), melatonin (MANUFACTURER UNKNOWN), macrogol (MICRALAX MACROGOL), paracetamol (MANUFACTURER UNKNOWN), senna spp. (SENNA SPP.), tramadol hydrochloride (MANUFACTURER UNKNOWN). The patient previously took trimethoprim, penicillin and ace inhibitors and angiotensin ii receptor blockers and experienced adverse drug reaction, not specified. On 21Dec2020, the patient experienced death within 24 hours of vaccine, livedo reticularis, hypotension, respiratory rate increased, peripheral coldness, loss of consciousness. The events were serious as it lead to death. The patient underwent lab tests and procedures which included body temperature of 38.1 on 21Dec2020. The patient died on 21Dec2020. It was not reported if an autopsy was performed. Details were as follows: Death within 24 hours of first vaccination dose occured. Patient had been unwell two days prior to the vaccination. New onset dyspnoea at rest and lethargy were noted. No fever at that time was noted. Noted to be cold, clammy and sweaty and this persisted for the following two or three days. No doctor notified of these developments. Over the following two days patient remained in a similar condition. She remained cold, clammy and dyspnoeic. Few observations appear to have been taken over this time; I do not know if she was fevered at any point due to lack of data. She was administered her first Covid-19 vaccine dose on 20Dec2020. On the morning of 21Dec2020, she was found unrousable in bed. Paramedics were called. She was noted to be cold and mottled, temperature was 38.1, low blood pressure (BP) and high respiratory rate. She died a couple of hours later. The case was reported to the procurator fiscal (PF) as cause of death was unknown, and death happened within 24 hours of a new vaccine, also with some concerns over patient care after she became unwell, not notifying general practitioner (GP) of deterioration in health. Post mortem was agreed by PF, but date not known. The other outcome for death within 24 hours of first vaccination dose was not known (NK) if death caused by vaccine. The patient was unwell prior to the dose. Cause of death was reported as unknown. The reporter did not know if the Pfizer COVID-19 vaccine caused or accelerated or contributed to this patient''s death. The patient''s deterioration was not informed until after her death. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 953488 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021023785

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number was GB-MHRA-ADR 24569457 with Safety Report Unique Identifier of GB-MHRA-WEBCOVID-20210107171332. An 80-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1688), via an unspecified route of administration on 06Jan2021 as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown if the patient had had symptoms associated with COVID-19. The patient was not enrolled in the clinical trial. Concomitant medications included edoxaban (MANUFACTURER UNKNOWN) taken for blood caffeine (as reported) from 06Dec2019 and unknown if ongoing. The patient previously received the first dose of BNT162B2 on an unknown date for COVID-19 immunization and had no known adverse effects. On 07Jan2021, the patient died due to an unknown cause of death. 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: Unknown cause of death


VAERS ID: 953501 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-16
Onset:2020-12-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Death, Fall
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), Accidents and injuries (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ISTIN; ; ;
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021023371

Write-up: cardiac arrest; suddenly went funny colour, odd noise, and fell back in chair; suddenly went funny colour, odd noise, and fell back in chair; Death; This is a spontaneous report received from a contactable physician from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20210109135858 and GB-MHRA-ADR 24575544. An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ0553), via an unspecified route of administration, on 16Dec2020 at a single dose for COVID-19 vaccination. The patient''s medical history was not reported. Concomitant medications included amlodipine besilate (ISTIN), propranolol (MANUFACTURER UNKNOWN) taken for anxiety from 17Dec2020, levothyroxine (MANUFACTURER UNKNOWN), and ramipril (MANUFACTURER UNKNOWN). The patient previously received the influenza vaccine (reported as flu vaccine; MANUFACTURER UNKNOWN) for immunization on 07Oct2020. The patient suddenly went funny colour, odd noise, and fell back in chair and experienced cardiac arrest on an unspecified date. The patient experienced death on 21Dec2020, which was reported as fatal. The clinical course was reported as follows: The patient was well and suddenly went funny colour, odd noise, and fell back in chair. The emergency services were called and taken in cardiac arrest. The patient died in the emergency department. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. The clinical outcome of suddenly went funny colour, odd noise, and fell back in chair was unknown and of cardiac arrest and death was fatal. The patient died on 21Dec2020. The cause of death was reported as cardiac arrest. It was unknown if an autopsy was performed. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 953522 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ELO141/V1009 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; FERROUS SULPHATE [FERROUS SULFATE]; HUMAN INSULATARD; ; ; NOVORAPID; ; ; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Amputation; Chronic obstructive pulmonary disease; Chronic osteomyelitis involving lower leg; Diabetic neuropathy; Living in nursing home; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210110; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021024072

Write-up: Death; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-ADR 24584912. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number ELO141/V1009), via an unspecified route of administration on 08Jan2021 as single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, chronic osteomyelitis, diabetic neuropathy, amputation, alcohol misuse, chronic obstructive pulmonary disease, patient cared for in nursing home- self neglect, all from an unknown date. Concomitant medication included duloxetine (MANUFACTURER UNKNOWN) from 10Oct2019 for diabetic neuropathy, ferrous sulphate (MANUFACTURER UNKNOWN) from 24Jun2020 for Iron deficiency anemia, insulin human injection, isophane (HUMAN INSULATARD) from 16Mar2020 for type II diabetes mellitus, lansoprazole (MANUFACTURER UNKNOWN) from 16Oct2013 for dyspepsia, macrogol (MANUFACTURER UNKNOWN) from 01Jul2020 to 22Oct2020 for constipation, insulin aspart (NOVORAPID) from 16Oct2020 for type II diabetes mellitus, paracetamol (MANUFACTURER UNKNOWN) for chronic osteomyelitis (involving lower leg) from 11Sep2013, pregabalin (MANUFACTURER UNKNOWN) from 24Jun2020 for chronic osteomyelitis, tadalafil (MANUFACTURER UNKNOWN) from 19Nov2013 to 20Jul2020 for erectile dysfunction, thiamine (MANUFACTURER UNKNOWN) from 26Sep2019 for alcohol problem, tramadol (MANUFACTURER UNKNOWN) from 22Jul2011 for chronic osteomyelitis (involving lower leg). The patient died on 12Jan2021. Patient died of unknown causes about 84hrs after 1st Covid-19 vaccination. Nil to suggest that this was directly related to vaccine but as it was unknown cause of death and not expected, then it is considered significant adverse event. Patient had not tested positive for COVID-19 since he received the vaccine. Post-Mortem details were pending. The patient underwent lab tests which included COVID-19 virus test that was negative on 10Jan2021. The patient died on 12Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 953527 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-22
Onset:2021-01-12
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0724 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute cardiac event, Death, Electrocardiogram, Electrocardiogram ST segment abnormal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; ; ; ; ; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm repair; Coronary artery bypass graft; Depression (under mental health secondary care/consultant led service); Micturition urgency; Myocardial ischaemia; Comments: under mental health secondary care/consultant led service Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210112; Test Name: ECG; Result Unstructured Data: Test Result:significant ST changes in keeping with acute; Comments: significant ST changes in keeping with acute cardiac event
CDC Split Type: GBPFIZER INC2021024582

Write-up: Death NOS; significant ST changes in keeping with acute cardiac event; Sudden collapse; significant ST changes in keeping with acute cardiac event; This is a spontaneous report received from a contactable physician by Pfizer from the Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-20210112181704. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ0724), via an unspeciifed route of administration on 22Dec2020 at sigle dose for COVID-19 immunisation. Medical history included myocardial ischaemia, coronary artery bypass graft (CABG), abdominal aortic aneurysm (AAA) repair, micturition urgency and depression (under mental health secondary care/consultant led service). Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included acetylsalicylic acid for myocardial ischaemia, lansoprazole for unknown indication, mirabegron for micturition urgency, olanzapine for depression, pregabalin for depression, INFLUENZA VACCINE on 23Sep2020 for immunisation, simvastatin for myocardial ischaemia, tamsulosin for micturition urgency and venlafaxine for depression. The patient experienced death NOS on 12Jan2021. It was reported: patient has past history of ischaemia heart disease (IHD) - previous CABG and AAA repair. Also has significant psychiatric history and remains under consultant led service (previously was detained Agency S3). Sudden collapse this evening (12Jan2021) and Ambulance led resuscitation unsuccessful. During resuscitation regained cardiac output briefly and ECG at that time (12Jan2021) by ambulance crew showed significant ST changes in keeping with acute cardiac event. Patient has been breathless for last 1w. Received Pfizer covid vaccine 22Dec2020 so reported due to proximity of this novel treatment to event rather than definite causation or effect. the reporter noted that they were the OOH GP who has dealt with this patient and Ambulance on the evening and had no other involvement. More information will be available from patient''s registered GP. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of events sudden collapse and significant ST changes in keeping with acute cardiac event was unknown. The patient died on 12Jan2021. It was not reported if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 953532 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: 2021-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021027103

Write-up: cardiac arrest; This is a spontaneous report from a contactable consumer. An about 45 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jan2021 evening, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was without background illnesses. On 10Jan2021 the patient experienced cardiac arrest and deceased. The patient died in the night of 10-11Jan2021. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 955741 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2021-01-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Depressed level of consciousness, Diarrhoea, Dyspnoea, Gene mutation identification test, Influenza like illness, Malaise, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-02
   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: EMCONCOR CHF; ELIQUIS; SPIRIX; TRIATEC [RAMIPRIL]; SOMAC; BURINEX; SELEXID [PIVMECILLINAM HYDROCHLORIDE]; DOLCONTIN [MORPHINE SULFATE]; PARACET [PARACETAMOL]; ZYPREXA; XALATAN; BETULAC;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antidiuretic hormone increased; Anxiety; Aortic stenosis; Atelectasis; Atrial fibrillation; Cardiac pacemaker insertion; Cerebral ischemia; Cognitive impairment; Dementia; Dilated cardiomyopathy; Gastric acid increased; Glaucoma secondary; Heart attack; Heart failure; Obstipation; Oedema; Osteopetrosis; Pain; Pain back; Palliative care; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Name: Gene mutation identification test; Result Unstructured Data: Test Result:Heterozygot: R 33 Q in LMNA
CDC Split Type: NOPFIZER INC2021006702

Write-up: Vomiting; Increased shortness of breath; Short episodes of decreased consciousness after toilet visits; Diarrhea; felt unwell, the patient herself says that it feels like the flu; felt unwell, the patient herself says that it feels like the flu; The initial case was missing the following minimum criteria: reporter had no first hand knowledge. Upon receipt of follow-up information on 14Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report downloaded from the Regulatory Authority WEB NO-NOMAADVRE-FHI-2021-U427R, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013732. A contactable other health professional reported that an 81-year-old female patient received her first dose of bnt162b2 (COMIRNATY, batch/lot number: EJ6796), via intramuscular route on 29Dec2020, at single dose administered into left arm for covid-19 immunisation. Medical history included heart attack, cerebral ischaemia from 2017, aortic stenosis, atelectasis, osteopetrosis, antidiuretic hormone increased, urinary tract infection from 26Dec2020, dilated cardiomyopathy, palliative care, atrial fibrillation, heart failure, gastric acid increased, oedema, pain, pain back, anxiety, glaucoma secondary, obstipation, pacemaker in 2017, increased cognitive impairment and possibly dementia. Concomitant medication included bisoprolol fumarate (EMCONCOR CHF) for an unspecified indication, apixaban (ELIQUIS) for atrial fibrilation, spironolactone (SPIRIX) for heart failure, ramipril (TRIATEC) for heart failure, pantoprazole sodium sesquihydrate (SOMAC) for gastric acid increased, bumetanide (BURINEX) for heart failure and oedema, pivmecillinam hydrochloride (SELEXID) for urinary tract infection, morphine sulfate (DOLCONTIN) for pain, paracetamol (PARACET) for pain back, olanzapine (ZYPREXA) for anxiety, latanoprost (XALATAN) for glaucoma secondary, lactulose (BETULAC) for obstipation and selenium oxide (SELENIUM OXIDE) for urinary tract infection. The patient experienced vomiting, increased shortness of breath, short episodes of decreased consciousness after toilet visits, diarrhea and felt unwell, the patient herself says that it feels like the flu; all on 02Jan2021 and died on the same day. The patient underwent lab tests and procedures which included gene mutation identification test: positive - heterozygot: R 33 Q in LMNA on an unspecified date. It was not reported if an autopsy was performed. The Center assessed the causality between bnt162b2 and all events as Possible. Outcome of the events was fatal. Reporter Comment: Regulatory Authority has requested additional information. This is a preliminary report. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: NIPH has requested additional information. This is a preliminary report.; Reported Cause(s) of Death: Increased shortness of breath; Short episodes of decreased consciousness after toilet visits; Diarrhea; felt unwell, the patient herself says that it feels like the flu; felt unwell, the patient herself says that it feels like the flu; Vomiting


VAERS ID: 955746 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-28
Onset:2020-12-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood albumin, Blood creatinine, Blood potassium, Blood pressure diastolic decreased, Blood pressure measurement, Body temperature, Body temperature decreased, Brain natriuretic peptide, C-reactive protein, Confusional state, General physical health deterioration, Glomerular filtration rate, Heart rate, Oxygen saturation, Physical examination, SARS-CoV-2 test, Urine analysis, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), 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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-02
   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: BURINEX; LOSARTAN KRKA [LOSARTAN]; BETULAC; NYCOPLUS B TOTAL; ; ATROVENT; ZOPIKLON MYLAN; METOPROLOL SANDOZ [METOPROLOL SUCCINATE]; PARALGIN FORTE [CODEINE PHOSPHATE;PARACETAMOL]; CIRCADIN; SOBRIL; VENTOLIN; SOMAC
Current Illness: Atrial fibrillation; Dyspnoea; Hypertension; Mitral valve insufficiency; Polymyalgia rheumatica
Preexisting Conditions: Medical History/Concurrent Conditions: Agitation; Decompensated heart failure; Obstipation; Oedema; Pneumonia; Sleep disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210101; Test Name: Serum albumin; Result Unstructured Data: Test Result:34 g/l; Test Date: 20210101; Test Name: Serum creatinine; Result Unstructured Data: Test Result:303 umol/l; Test Date: 20210101; Test Name: Serum potassium; Result Unstructured Data: Test Result:5.1 mmol/L; Test Date: 20210101; Test Name: Blood pressure; Result Unstructured Data: Test Result:96/55 mmHg; Test Date: 20210101; Test Name: Body temperature; Result Unstructured Data: Test Result:33.1 Centigrade; Test Date: 20210101; Test Name: Brain natriuretic peptide; Result Unstructured Data: Test Result:30345 ng/L; Test Date: 20210101; Test Name: C-reactive protein; Result Unstructured Data: Test Result:30 mg/l; Test Date: 20210101; Test Name: Estimated glomerular filtration rate; Result Unstructured Data: Test Result:11 ml/min; Comments: additional information provided for unit: {1.73_m2} (mL/min/{1.73_m2}); Test Date: 20210101; Test Name: Pulse rate; Result Unstructured Data: Test Result:irregular; 64 bpm; Test Date: 20210101; Test Name: Oxygen saturation; Test Result: 90 %; Test Date: 20210101; Test Name: Physical examination; Result Unstructured Data: Test Result:oedema; Comments: Pitting oedema legs; pulmonary sound reduced; reduced general condition; afebrile; Test Date: 20210101; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210101; Test Name: Urine analysis; Result Unstructured Data: Test Result:No findings; Test Date: 20210101; Test Name: Leukocyte count; Result Unstructured Data: Test Result:7.8 x10 9/l
CDC Split Type: NOPFIZER INC2021006701

Write-up: ACUTE RENAL FAILURE; body temperature: 33.1 centigrade; blood pressure: 96/55 mmhg; CONFUSION; REDUCED GENERAL CONDITION; The initial case was missing the following minimum criteria: reporter had no first-hand knowledge. Upon receipt of follow-up information on 15Jan2021, this case now contains all required information to be considered valid. This is a spontaneous follow up report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-UGYJ2 Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013718. A 95-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number and expiration date unknown), intramuscular on 28Dec2020, at single dose for covid-19 immunisation. The patient also received salbutamol (VENTOLINE) at 5 mg (x 4 as needed) for dyspnea and pantoprazole sodium sesquihydrate (SOMAC, 20 mg) at 20 mg, once per day for gastric ulcer prophylaxis. Medical history included ongoing mitral valve insufficiency, pneumonia from Feb2020 to an unknown date, ongoing polymyalgia rheumatica, decompensated heart failure from Jan2019 to an unknown date, ongoing hypertension, ongoing atrial fibrillation, and oedema, obstipation, ongoing dyspnea, sleep disorder and agitation. Concomitant medication included bumetanide (BURINEX) for oedema, losartan (LOSARTAN KRKA) for hypertension, lactulose (BETULAC) for obstipation, calcium pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (NYCOPLUS B-TOTAL), reported as "Biotin 30 ug, Folic acid 200 ug, Niacin 20 mg, Pantotensyre 5 mg, Riboflavin 1.7 mg, Tiamin 1.5 mg, Vitamin B6 1.6 mg, Vitamin B12 2 ug (Nycoplus B-kompleks)" for Vitamin supplementation, paracetamol for pain relief, ipratropium bromide (ATROVENT) for dyspnoea, zopiclone (ZOPIKLON MYLAN) for sleep disorder, metoprolol succinate (METOPROLOL SANDOZ) for atrial fibrillation, codeine phosphate, paracetamol (PARALGIN FORTE) for pain relief, melatonin (CIRCADIN) for sleep disorder, oxazepam (SOBRIL) for agitation. The patient experienced acute renal failure on 30Dec2020 and required hospitalization on an unspecified date. The patient experienced confusion and reduced general condition on 30Dec2020. The patient died on 02Jan2021 due to acute renal failure, confusion and reduced general condition. The patient underwent lab tests and procedures on 01Jan2021 which included serum albumin: 34 g/l, blood creatinine: 303 umol/l, serum potassium: 5.1 mmol/l, blood pressure: 96/55 mmHg, body temperature: 33.1 centigrade, brain natriuretic peptide: 30345 ng/l, C-reactive protein: 30 mg/l, estimated glomerular filtration rate: 11 ml/min, additional information provided for unit: {1.73_m2} (mL/min/{1.73_m2}), heart rate: irregular; 64 bpm, oxygen saturation: 90 %, physical examination: Pitting oedema legs; pulmonary sound reduced; reduced general condition; afebrile, COVID-19 virus test: negative, urine analysis: no findings, leukocyte count: 7.8 x10 9/l. The patient died on 02Jan2021 due to acute renal failure, confusion and reduced general condition. An autopsy was not performed. The outcome of the rest events was unknown. Event assessment for COMIRNATY, VENTOLINE and SOMAC to Confusion, Acute renal failure, and Reduced general condition: possible (Regional Pharmacovigilance Center). Reported case narrative from Regional Pharmacovigilance Center: 95 year old female with numerous co-morbidities. Post-vaccination reduced general condition. Hospitalized 4 days after immunisation with Comirnaty with acute renal failure, serum creatinine levels $g 300. History of low-grade renal impairment, with habitual creatinine approx 70. No signs of infection. General condition deteriorated quickly, died the following day, 5 days after immunisation. Sender comment: The patient was a female in her 90''s with comorbidity in the form of amongst other hypertension, atrial fibrillation and heart failure. From previously, known reduced kidney function (creatinine around 70). Was admitted to the hospital with acute kidney failure, 4 days after vaccination with Comirnaty. No sign of infection. Rapid deterioation of the condition and the patient died the day after admittance to the hospital. The patient is assessed as having a high risk of developing kidney failure in the first place. When vaccinating marginal, older patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccination could have contributed to worsening of the patients underlying disease. In the individual case it is hard to know if the death was caused by the vaccination, the patient''s underlying disease or some other, coincidential, concurrent cause which does not have any relationship to the vaccination. The causality is assessed as possible - due to the concurrence in timing, and a causal relationship to the vaccination cannot be ruled out. No follow-up attempts are possible, information about batch number cannot be obtained.; Reporter''s Comments: 08Jan2021: Agency: this is a preliminary report; Reported Cause(s) of Death: Acute renal failure; confusion; reduced general condition


VAERS ID: 955787 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-27
Onset:2020-12-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-30
   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: Chronic disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021028577

Write-up: The patient died on 30Dec2020 with multiple, serious, chronic illnesses. Suspected reaction to Covid vaccination on 27Dec2020 cannot be ruled out.; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority WEB DE-PEI-CADRPEI-2021011745. An 89-year-old male patient received bnt162b2 (COMIRNATY, batch/lot number: EJ6796, exp. date unknown), intramuscularly on 27Dec2020 at single dose for prophylaxis. The patient''s medical history included several multiple chronic diseases. The patient''s concomitant medications were not reported. The patient died on 30Dec2020 with multiple serious chronic illnesses, suspected reaction to COVID vaccination on 27Dec2020 cannot be ruled out. The patient died on 30Dec2020. It was not reported if an autopsy was performed. The patient suffered of several multiple chronic diseases. 4 days after vaccination the patient developed unknown cause of death. Death cause was reported as unknown cause of death. Reporters comment: After the vaccination on 27Dec2020, the patient''s condition deteriorated increasingly until he died on 30Dec2020. It cannot be ruled out with certainty that the previous vaccination had a negative effect on the patient''s condition. Senders comment: Multiple serious, chronic diseases No follow-up attempts possible. No further information expected.; Reporter''s Comments: After the vaccination on 27Dec2020, the patient''s condition deteriorated increasingly until he died on 30Dec2020. It cannot be ruled out with certainty that the previous vaccination had a negative effect on the patient''s condition.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 955789 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-13
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   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: Asthma bronchial; Atrial fibrillation; Carcinoma colon; Hypertension; Iron deficiency anaemia; Osteoporosis; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039284

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory authority report number DE-PEI-PEI2021000724. A 99-year-old female patient started to receive bnt162b2 (COMIRNATY, batch/lot number EM0477, expiration date unknown) via an unspecified route of administration on "14Jan2021" at single dose for COVID-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, iron deficiency anaemia from an unknown date and unknown if ongoing, asthma bronchial from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, type 2 diabetes mellitus from an unknown date and unknown if ongoing, Carcinoma colon from an unknown date and unknown if ongoing, osteoporosis from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 13Jan2021 after vaccination the patient developed Unknown cause of death. Vaccinated in the morning, died in the afternoon. No complaints immediately after the vaccination. It was not reported if an autopsy was performed. Event Assessment: Agency / D. Unclassifiable.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 955790 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021032465

Write-up: died apprioximately one hour later; This is a spontaneous report from a non-contactable other healthcare professional (HCP) from a lay media. An 89-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Jan2021 at 12:00 at single dose for Covid-19 immunisation. The relevant medical history and concomitant medications were not reported. Afterwards she was for 15 minutes under medical observation. At that time there were no visible allergy-typical symptoms. The patient was generally fit and at the timepoint of the vaccination well oriented. At 12:45 a situation took place that the patient must be resuscitated. However, she died apprioximately one hour later on 13Jan2021. Autopsy was ordered. The outcome of the event was fatal. Information on the lot/ batch number has been requested.; Sender''s Comments: Current information is very limited for full assessment. The advanced old patient died one hour following the vaccine use; further information such as complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 955791 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-27
Onset:2020-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Culture, Cytology abnormal, Echocardiogram, Investigation, Magnetic resonance imaging, Pulmonary function test, SARS-CoV-2 test, Sleep study, 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: 2020-12-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL FUMARATE]; COLCHIMAX [COLCHICINE;DICYCLOVERINE HYDROCHLORIDE]; ABASAGLAR; ; ; SPIRIVA RESPIMAT
Current Illness: Atrial fibrillation; Chronic myelomonocytic leukaemia (chronic myelomonocytic leukemia diagnosed in May 2019 under regular treatment with EPO); Dyslipidaemia; Hypertension (HTN); Morbid obesity; Obstructive sleep apnoea syndrome; Pericardial effusion (Recent admission 11Nov2020 to 23Nov2020, signs of tamponade that requires pericardiocentesis.); Sleep apnoea syndrome (in treatment with CPAP (Continuous positive airway pressure therapy)); Type 2 diabetes mellitus (insulin-dependent diabetes mellitus/grade II diabetic retinopathy)
Preexisting Conditions: Medical History/Concurrent Conditions: Activities of daily living impaired; Anticoagulant therapy; Arrhythmia (due to atrial fibrillation); Arthralgia (on 24Dec2020, paracetamol was prescribed); Arthralgia (MRI shows complete supraspinatus and partial subscapularis rupture); Chronic bronchitis; Depression (Long-term depression, chronic depressive syndrome); Diarrhea (compatible with ulcerative colitis due to diarrheal syndrome without specific treatment or follow-up); Drug allergy; Hospitalization (for severe pericardial effusion with signs of tamponade that requires pericardiocentesis.); Mild mental retardation; Polymyalgia rheumatica (intermediate dose corticosteroid therapy was started with partial response.); Restrictive pulmonary disease; Ulcerative colitis (compatible with ulcerative colitis due to diarrheal syndrome without specific treatment or follow-up)
Allergies:
Diagnostic Lab Data: Test Name: Thoracoabdominal CT; Result Unstructured Data: Test Result:without significant alterations, nonspecific tumor; Comments: without significant alterations, nonspecific tumor markers, autoimmunity and pending serologies.; Test Name: culture; Test Result: Negative ; Test Name: cytology for malignant cells; Test Result: Negative ; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Echocardiogram to control mild residual pericardia; Comments: Echocardiogram to control mild residual pericardial effusion.; Test Date: 2019; Test Name: Autoimmune study; Test Result: Negative ; Comments: negative in 2019 in treatment with colchicine.; Test Date: 2012; Test Name: MRI; Result Unstructured Data: Test Result:complete supraspinatus and partial subsc; Comments: MRI shows complete supraspinatus and partial subscapularis rupture; Test Name: bronchodilator test; Test Result: Negative ; Test Date: 202011; Test Name: PCR COVID19; Test Result: Negative ; Test Date: 201909; Test Name: respiratory polygraphy; Result Unstructured Data: Test Result:respiratory polygraphy in September 2019 with an A; Comments: respiratory polygraphy in September 2019 with an AHI (apnea-hypopnea index) 47. CT90 (sleep time with saturation lower than 90%) 59%, SpO2m 89% and compatible pulse oximetry recording.
CDC Split Type: ESPFIZER INC2021028328

Write-up: sudden death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority EB, ES-AEMPS-710884. A 71-year-old female patient received her first dose of bnt162b2 (COMIRNATY, lot number: EJ6796), via intramuscular on 27Dec2020 at single dose in deltoids for covid-19 vaccination. Medical history included obstructive sleep apnoea syndrome from 2019 and ongoing, hypertension from 2004 and ongoing, type 2 diabetes mellitus from 2004 and ongoing, ongoing dyslipidaemia, pericardial effusion from 2014 and ongoing, atrial fibrillation from 2019 and ongoing, morbid obesity from 2013 and ongoing, chronic myelomonocytic leukaemia from May2019 and ongoing. Pathological history included NSAID allergy, mild mental retardation, moderate functional dependence. In 2003 diagnosis compatible with ulcerative colitis due to diarrheal syndrome without specific treatment or follow-up. Right subacromial syndrome 2012 (MRI shows complete supraspinatus and partial subscapularis rupture), insulin-dependent diabetes mellitus, grade II diabetic retinopathy, HTN, Long-term depression, chronic depressive syndrome, chronic bronchitis, chronic myelomonocytic leukemia diagnosed in May2019 under regular treatment with EPO (Erythropoietin). Previous Complete arrhythmia due to atrial fibrillation, anticoagulated with acenocoumarol. Restrictive lung disease since 2018. Negative bronchodilator test. Severe OSAHS (sleep apnea-hypopnea syndrome in treatment with CPAP (Continuous positive airway pressure therapy): respiratory polygraphy in Sep2019 with an AHI (apnea-hypopnea index) 47, CT90 (sleep time with saturation lower than 90%) 59%, SpO2m 89% and compatible pulse oximetry recording. Labeled polymyalgia rheumatica 2018 without meeting criteria and intermediate dose corticosteroid therapy was started with partial response in outpatient follow-up. Chronic pericardial effusion known since 2014. Autoimmune study negative in 2019 in treatment with colchicine. Recent admission 11Nov2020 to 23Nov2020 for severe pericardial effusion with signs of tamponade that requires pericardiocentesis. Negative cytology for malignant cells, negative culture. Colchicine is introduced. Favorable subsequent evolution. Thoracoabdominal CT without significant alterations, nonspecific tumor markers, autoimmunity and pending serologies. Echocardiogram to control mild residual pericardial effusion. Outpatient monitoring. During admission, a COVID19 PCR was performed with a negative result (Nov2020). The patient previously received regular chronic treatment included folic acid (ACFOL), spironolactone (ALDACTONE), bisoprolol, furosemide (SEGURIL), ipratropium bromide (ATROVENT), tiotropium bromide (SPIRIVA), apixaban (ELIQUIS), metformin, pravastatin, quetiapine, venlafaxine, lorazepam. Concomitant medication included beclometasone dipropionate, formoterol fumarate (FOSTER) for bronchitis chronic from 2018, colchicine, dicycloverine hydrochloride (COLCHIMAX) for pericardial effusion from Nov2020, insulin glargine (ABASAGLAR) from 2018 for Type 2 diabetes mellitus, quetiapine from 2016 for major depression, venlafaxine from 2016 for Major depression, tiotropium bromide (SPIRIVA RESPIMAT) from 2018 for Bronchitis chronic. This patient with multiple pathologies admitted to a senior residence and experienced sudden death less than 24 hours after receiving COVID19 vaccine. According to the clinical course of the residence, on 24Dec2020 she was seen by the physician of the residence for left subacromial syndrome and paracetamol was prescribed. On 26Dec2020 in the morning she experienced nausea and malaise resolved and later reappeared again the next day in the morning (27Dec2020), so she did not eat breakfast. She remained afebrile the whole time. They explain that on 27Dec2020 in the afternoon she presented a better general condition and that she was walking around the residence, in the afternoon she was vaccinated. She didn''t want to have dinner. On 28Dec2020 in the morning the patient was found without signs of life in the bed of her room at the residence. Given that the causes of death are not obvious, it was decided to perform a clinical autopsy (performed 29Dec2020) to rule out a relationship with COVID19 vaccination. The patient died on 28Dec2020. Results of the clinical autopsy performed on 29Dec2020 are pending. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 955792 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-22
Onset:2020-12-01
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Angioedema, Blood culture, Coma scale abnormal, Depressed level of consciousness, Dyspnoea, Hypotension, Hypothermia, Malaise, Multiple organ dysfunction syndrome, Oxygen saturation decreased, Pruritus, Rash, Rash maculo-papular, Skin exfoliation, Stevens-Johnson syndrome, Swelling face, Toxic epidermal necrolysis
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (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 (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-29
   Days after onset: 28
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: Eczema; Fruit allergy
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Test Result: Negative
CDC Split Type: GBPFIZER INC2021028075

Write-up: Angioedema; Depressed level of consciousness; Toxic epidermal necrolysis; Oxygen saturation decreased; Hypotension; Skin exfoliation; Coma scale abnormal; Rash maculo-papular; Hypothermia; Pruritus; Rash; Swelling face; shortness of breath; felt a bit unwell; Possible anaphylaxis; Multi-organ failure; Steven Johnson syndrome; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB GB-MHRA-ADR 24566668. An 86-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unknown route on 22Dec2020 at single dose for covid-19 vaccination. Medical history included food allergy: pineapple from an unknown date and unknown if ongoing, and eczema. The patient''s concomitant medications were not reported. The patient experienced swelling face on 25Dec2020, angioedema, depressed level of consciousness, rash maculo-papular, hypotension, hypothermia, pruritus, oxygen saturation decreased, rash, skin exfoliation, coma scale abnormal, toxic epidermal necrolysis on 28Dec2020. All these events were reported as serous per death and hospitalization. Outcome was reported as fatal. The patient also experienced Multi-organ failure, possible anaphylaxis, Steven Johnson syndrome on an unspecified date in Dec2020, felt a bit unwell on 25Dec2020, shortness of breath on 27Dec2020. Seriousness for these events was not provided. Outcome of these events was not provided. The patient died on 29Dec2020. An autopsy was not performed. Medical cause of death was reported as toxic epidermal necrolysis and multi-organ failure. Event details: Family noted on Christmas day he had dinner with them all and noticed his face was swollen and he felt a bit unwell. Possible anaphylaxis, Steven Johnson syndrome as a result of covid-19 vaccination. Patient presented 5 days post COVID-19 vaccine with shortness of breath. On Examination: peeling skin and widespread macula-papular rash and brown scaling over scalp, angiodema, itchy, reduced conciousness, desaturating, hypothermia and hypotensive. Multi-organ failure. Administered hydrocortisone IV (intravenous) and 2 x 0.5mL of adrenaline + fluids - some improvement in GCS (Glasgow coma scale) but not fully rousable onward - decision was made to place on ICP (integrated care pathway). Blood cultures negative. No follow-up attempts are possible, information on batch numbers cannot be obtained.; Reported Cause(s) of Death: multi-organ failure; Toxic epidermal necrolysis


VAERS ID: 955793 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0379 / 1 - / -

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: 2021-01-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021033850

Write-up: Cardiac arrest; This is a spontaneous report received from a contactable other HCP by Pfizer from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 24593178. A 53-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0379, Expiry date: Apr2021, use by 16Jan2021, 09:50), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. The patient had no known previous medical history. Concomitant medications were not reported. On 14Jan2021, the patient experienced cardiac arrest. It was reported patient who was a social worker, attended a medical practice this morning at 09:32 and received 1st Pfizer vaccination. This was the 3rd dose of the batch. She was apyrexial, and no issues in the immediate 15 minutes observation. It had been notified that this patient collapsed this afternoon with a cardiac arrest and had died. Outcome of event was fatal. The patient died on 14Jan2021. It was not reported if an autopsy was performed. The cause of death was cardiac arrest. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 955794 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201227; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021038747

Write-up: Death within 28 days of vaccination; This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-ADR 24595279. A 94 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number:EJ1688), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. On 01Jan2021 the patient experienced death within 28 days of vaccination. The patient died on 01Jan2021. The cause of death was not reported. It was unknown if an autopsy was performed. The patient underwent lab tests and procedures which included COVID-19 virus test on 27Dec2020: no - negative covid-19 test. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: DEATH


VAERS ID: 955796 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Cardiac arrest, Cough, Electrocardiogram, Heart rate, Monofilament pressure perception test, Syncope, Ultrasound scan, Urine analysis
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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Age-related macular degeneration (Also reported on 03Dec2020 and 08Dec2020); Chronic kidney disease stage 3 (Also reported on 03Dec2020.); Chronic kidney disease stage 4; Diabetes mellitus (In remission.); Diabetic foot (Left and right. At low risk. Also on 11Sep2020); Ex-smoker (10-19/day); Hypertension (Also reported on 03Dec2020.); Medical observation (Weight and height. Also on 11Sep2020.); Social alcohol drinker (Trivial drinker - <1u/day)
Preexisting Conditions: Medical History/Concurrent Conditions: Dyspnoea
Allergies:
Diagnostic Lab Data: Test Date: 20200214; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:unknown results; Comments: ongoing; Test Date: 20200629; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:unknown results; Test Date: 20200715; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:unknown results; Test Date: 20200911; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:unknown results; Test Date: 20201203; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:unknown results; Test Date: 20200214; Test Name: Blood test; Result Unstructured Data: Test Result:All component measured and reported.; Comments: ongoing; Test Date: 20200710; Test Name: Blood test; Result Unstructured Data: Test Result:All component measured and reported; Test Date: 20200911; Test Name: Blood test; Result Unstructured Data: Test Result:All component measured and reported.; Test Date: 20200703; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:unknown results; Comments: ongoing; Test Date: 20200214; Test Name: HEART RATE; Result Unstructured Data: Test Result:normal; Comments: Left and right posterior tibial pulse and dorsalis pedis palpable, ongoing; Test Date: 20200911; Test Name: HEART RATE; Result Unstructured Data: Test Result:normal; Comments: Left and right posterior tibial pulse and dorsalis pedis palpable; Test Date: 20200214; Test Name: monofilament pressure perception test; Result Unstructured Data: Test Result:Left foot normal.; Comments: ongoing; Test Date: 20200911; Test Name: monofilament pressure perception test; Result Unstructured Data: Test Result:Left foot normal.; Test Date: 20200803; Test Name: Ultrasound scan of heart; Result Unstructured Data: Test Result:unknown results; Comments: ongoing; Test Date: 20200911; Test Name: Urine analysis; Result Unstructured Data: Test Result:All components measured and reported; Comments: ongoing
CDC Split Type: GBPFIZER INC2021033407

Write-up: Cardiac arrest; Cough; Syncope; This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is: GB-MHRA-ADR 24588335. An 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EK1768, Concentrate for suspension for injection multi, expiry date: 11Jan2021) via intramuscular route of administration on 08Jan2021 at 0.3 mL, single for COVID-19 vaccination. Ongoing medical history included hypertension from 08Oct2020 (patient medical comments: also reported on 03Dec2020), chronic kidney disease stage 3 from 08Oct2020 (patient medical comments: also reported on 03Dec2020), age-related macular degeneration from 08Oct2020 (patient medical comments: also reported on 03Dec2020 and 08Dec2020), chronic kidney disease stage 4 from 18Sep2020, diabetes mellitus from 18Sep2020 (In remission), ex-tobacco user from 11Sep2020 (10-19/day), social alcohol drinker from 11Sep2020 (Trivial drinker - <1u/day), diabetic foot from 14Feb2020 (Left and right, at low risk, also on 11Sep2020), medical observation from 14Feb2020 and ongoing (Weight and height, also on 11Sep2020). Other medical history included dyspnoea. Concomitant medication included fluticasone furoate 110ug once daily (27.5micrograms/dose, two sprays to be used in each nostril) via nasal route of administration from 26Nov2020 for dyspnoea. The patient previously took influenza virus on 23Sep2020 for flu immunization, pneumococcal polysaccharide vaccine for pneumococcal immunization, angiotensin receptor blockers from 27Feb2020 and experienced drug intolerance and ace inhibitor from 27Feb2020 and experienced drug intolerance. On 09Jan2021, the patient experienced cardiac arrest, cough and syncope. Patient had COVID-19 vaccination, during the following night at about 3:00 am patient had a cough attack, collapsed, had a cardiac arrest and died, 999 was called, cardiopulmonary resuscitation (CPR) was started, adrenaline was given. The patient had ongoing (as reported) Blood pressure measurement from 14Feb2020 (Patient Medical comments: Also on 29Jun2020, 15Jul2020, 11Sep2020 and 03Dec2020), ongoing blood test from 14Feb2020 (Patient Medical comments: All component measured and reported. Also reported on 11Sep2020 and 10Jul2020), ongoing Electrocardiogram from 03Jul2020, ongoing monofilament pressure perception test from 11Sep2020 (Left foot normal, patient medical comments: also on 14Feb2020), ongoing heart rate normal from 11Sep2020 (Left and right posterior tibial pulse and dorsalis pedis palpable, also on 14Feb2020), ongoing urine analysis from 11Sep2020 (All components measured and reported), ongoing ultrasound scan of heart from 03Aug2020. The outcome of cardiac arrest was fatal. The outcome of cough and syncope and the time of death was unknown. The patient died on 09Jan2021. It was not reported if an autopsy was performed. it was reported that the coroner was assessing/investigating, unclear if events are related to the vaccination or not. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 955799 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-16
Onset:2020-12-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Bundle branch block right, Cardiac arrest, Circulatory collapse, Cyanosis, Electrocardiogram, Heart rate, Hypothermia, Malaise, Pulseless electrical activity, Respiratory arrest, Respiratory rate, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (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 (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-16
   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: ; ; ANORO; ; ; ; CO-CODAMOL; ; ; HUMULIN I; ; MONOMIL XL; ; ; ; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Analgesic therapy; Angina pectoris; Benign prostatic hyperplasia; Chronic kidney disease stage 3; Constipation; COPD; Diabetes; Diabetic neuropathy; Dry eye; Dyspepsia; Gout; Heart failure; Hypercholesteremia; Hypercholesterolaemia; Ischemic heart disease; Neuropathy peripheral; Osteoarthritis; Pulmonary embolism; Comments: Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20201216; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:showed bradycardia, right bundle branch block; Test Date: 20201216; Test Name: Heart rate; Result Unstructured Data: Test Result:40; Comments: beats per minute; Test Date: 20201216; Test Name: respiration; Result Unstructured Data: Test Result:8; Comments: dropped to 8 per minute
CDC Split Type: GBPFIZER INC2021031242

Write-up: Cardiac arrest; Respiratory arrest; Unresponsive to stimuli; did not feel well; cyanosed; right bundle branch block; collapsed; Pulseless electrical activity; Hypothermic; Bradycardia; This is a spontaneous report received from a contactable pharmacist by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-ADR 24547306 and GB-MHRA-WEBCOVID-20201224141239. A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EJ0553), via an unspecified route of administration on 16Dec2020 17:22 at single dose for COVID-19 vaccination. Medical history included chronic kidney disease, myocardial ischaemia, neuropathy peripheral, osteoarthritis, angina pectoris, cardiac failure, chronic obstructive pulmonary disease, diabetes mellitus and benign prostatic hyperplasia, all from an unspecified date and unknown if ongoing; gout, dyspepsia, constipation, hypercholesteremia, dry eye, pulmonary embolism, analgesic therapy, diabetic neuropathy and hypercholesterolaemia. Patient had not had symptoms associated with COVID-19. Patient had not been tested/or has had an inconclusive test for COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included allopurinol for gout, amoxicillin for chronic obstructive pulmonary disease, umeclidinium bromide, vilanterol trifenatate (ANORO) for chronic obstructive pulmonary disease, apixaban for pulmonary embolism, bisoprolol for cardiac failure, carbocisteine for chronic obstructive pulmonary disease, codeine phosphate, paracetamol (CO-CODAMOL) for analgesic therapy, duloxetine for diabetic neuropathy, furosemide for cardiac failure, insulin human injection, isophane (HUMULIN I) for diabetes mellitus, lansoprazole for dyspepsia, isosorbide mononitrate (MONOMIL XL) for angina pectoris, prednisolone for chronic obstructive pulmonary disease, salbutamol for chronic obstructive pulmonary disease, senna alexandrina for constipation, simvastatin for hypercholesterolaemia, guaraprolose (Systane eye drops) for dry eye and tamsulosin for benign prostatic hyperplasia. It was reported: Patient was vaccinated on 16Dec2020 at 17:22, he remained in the vaccination hub for 15 minutes to rule out any anaphylaxis or side effects. He felt fine after 15 minutes so went home. Within 30 minutes of going home he didn''t feel well and collapsed in the garden. An ambulance was called at 18:21 and arrived on the scene at 18:27. The ambulance documented in their notes the reason for the call was patient did not feel well 30 minutes after having the vaccine and collapsed. Patient did not complain of chest pain prior to collapse. Patient became unresponsive to stimuli at 18:50, low respiratory effort after collapse, patient went into respiratory arrest at 18:55 and went into cardiac arrest at 18:57. Advanced life support was given to the patient. Patient was pronounced dead at hospital emergency department at 20:14 on 16Dec2020. Cause of death was noted as cardiac arrest. Patient had not tested positive for COVID-19 since having the vaccine. Patient initially breathing independently with 5 liters nasal specs. Patient stated he couldn''t breathe before collapse so administered 6 liters via mask, respirations dropped to 8 per minute before respiratory arrest. Patient appeared cyanosed, assisted ventilation throughout, good rise and fall of chest, good equal air entry bilaterally. Circulation, initial radial pulse felt thread and slow HR (heart rate) 40 bpm (beats per minute), 12 lead ECG (electrocardiogram) showed bradycardia, right bundle branch block. Patient went into cardiac arrest at 18:57, witnessed by crew so immediate compressions commenced. Patient in PEA (pulseless electrical activity) rhythm throughout. Initially alert and orientated but appeared distressed. Became unresponsive at 18:50. Patient was hypothermic, so dose interval for adrenaline was doubled. Full ALS (advanced life support) protocol followed throughout. Patient died at the hospital on 16Dec2020 at 20:14. The cause of death was reported to be cardiac arrest. It was not reported if an autopsy had been performed. At the time death the outcome of the following events was reported to be not recovered: collapsed, respiratory arrest, unresponsive to stimuli, did not feel well. The outcome of the following events was unknown: pulseless electrical activity, hypothermic, right bundle branch block, cyanosed, bradycardia. No seriousness criteria were provided for the non-fatal events. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 955800 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-17
Onset:2020-12-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EI0553 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-21
   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: ; ; MONOMIL XL; ; ORAMORPH; PREDNISON;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic lymphocytic leukaemia; IHD; Lung cancer metastatic (FROM CA LUNG); NIDDM
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021034127

Write-up: Vomiting; 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-20201230095817, Sender''s Safety Report Unique Identifier GB-MHRA-ADR 24548721. A 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot/Batch number EI0553), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. Medical history included metastatic neoplasm (from CA lung), myocardial ischaemia (IHD) and type 2 diabetes mellitus (NIDDM) from unknown dates and unknown if ongoing and chronic lymphocytic leukaemia from 2019. Concomitant medication included amlodipine for IHD, atorvastatin for IHD, isosorbide mononitrate (MONOMIL XL) for IHD, omeprazole for hyperacidity, morphine sulfate pentahydrate (ORAMORPH) for palliative care, prednisone for palliative care, influenza vaccine (INFLUENZA VACCINE SEQIRUS) on 10Oct2020 for immunization, ticagrelor for IHD and steroids at 65 mg. The patient experienced vomiting on 18Dec2020, which was fatal. This man was terminally ill but commenced vomiting approximately 12 hours after vaccine administration. This vomiting continued for three days until his death. The patient died on 21Dec2020 due to vomiting. It was not reported if an autopsy was performed. Patient has not tested positive for Coronavirus disease 2019 since having the vaccine. Patient has not had symptoms associated with Coronavirus disease 2019. Patient has not been tested/or has had an inconclusive test for Coronavirus disease 2019. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vomiting


VAERS ID: 955803 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Pain; UTI (urinary tract infection few months prior to report); Comments: relatively fit and well. greatly managed hypertension and bits of aches and pains. and some eye drops. last contact was few months ago with UTI Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021032504

Write-up: Death; This is a spontaneous report received from a contactable physician by Pfizer from the regulatory authority. The regulatory authority report number is GB-MHRA-ADR 24573305 and GB-MHRA-WEBCOVID-20210108150224. A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK1768), on 07Jan2021 at single dose for COVID-19 immunisation. Medical history included relatively fit and well; greatly managed hypertension and bits of aches and pains and some eye drops. Last contact was few months ago with urinary tract infection. Patient had not had symptoms associated with COVID-19. Patient had not been tested/or had an inconclusive test for COVID-19. Unsure if patient was enrolled in clinical trial. Concomitant medications included acetylsalicylic acid, paracetamol, pregabalin, all for unknown indication and ramipril for hypertension. On 07Jan20201 the patient died. It was reported: patient died at home few hours after receiving the vaccine at home. Coroner called to see if there was any possible cause based on her medical history but was not sure. REDACTED coroner office was going to do post mortem and toxicology. It was unknown if autopsy was done or not at the time of the report. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: DEATH


VAERS ID: 955806 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0739 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   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: Diverticular disease; Hypertension; Idiopathic pulmonary fibrosis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021027923

Write-up: short of breath; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-20210108221409, Safety Report Unique Identifier: GB-MHRA-ADR 24575002. An 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0739), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. Medical history included atypical idiopathic pulmonary fibrosis, hypertension and diverticular disease. Concomitant medications included alendronic acid, calcium carbonate;colecalciferol, ezetimibe, omeprazole, prednisolone for Idiopathic pulmonary fibrosis and ramipril, all from unknown date. Reporter stated that they do not know the vaccine was related to this death (it probably was not) but as it occurred within 24 hours of the vaccine, it was being reported. The patient became short of breath on the morning of the 08Jan2021. Paramedics attended the home and performed CPR (cardiopulmonary resuscitation) which was unsuccessful. Patient had not tested positive for COVID-19 since having the vaccine. Unsure if patient has had symptoms associated with COVID-19. Unsure if patient is enrolled in clinical trial. The patient died on 08Jan2021. It was not reported if an autopsy was performed. Outcome of short of breath was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: short of breath


VAERS ID: 955814 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-12
Onset:2021-01-01
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210101; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021031721

Write-up: COVID-19 virus test and revealed yes - positive COVID-19 test/SARS-CoV-2 infection; COVID-19 virus test and revealed yes - positive COVID-19 test/sars-cov-2 infection; This is a spontaneous report downloaded from the Regulatory Authority. Regulatory authority number: GB-MHRA-ADR 24581491. A contactable physician reported that an elderly male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Dec2020 at single dose for COVID-19 immunisation. Medical history was not reported. The patient''s concomitant medications were not reported. Patient is not enrolled in clinical trial. The patient was suspected COVID-19 but unsure when symptoms started. She underwent COVID-19 virus test and revealed yes - positive COVID-19 test on 01Jan2021. She experienced sars-cov-2 infection on 01Jan2021 with outcome of fatal. The patient died on 08Jan2021, cause of death was COVID-19 virus test and revealed yes - positive COVID-19 test/sars-cov-2 infection. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: The association between the event lack of effect (fatal SARS CoV2 infection) with BNT162b2 can not be fully 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.; Reported Cause(s) of Death: COVID-19 virus test and revealed yes - positive COVID-19 test/sars-cov-2 infection; COVID-19 virus test and revealed yes - positive COVID-19 test/sars-cov-2 infection


VAERS ID: 955823 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / 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: 2021-01-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021029514

Write-up: Sudden death unexplained/Presumed cause cardiac arrest; This is a spontaneous report received from a contactable physician by Pfizer from the agency and Healthcare products Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-ADR 24587484 and GB-MHRA-WEBCOVID-20210113100039. A 79 years old female patient received to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1688) on 07Jan2021 17:08 at single dose for covid-19 vaccination. The patient medical history included: Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. It was reported: the patient had vaccination at 17:08 07Jan2021. No problems identified during 15min waiting period. Patient went home, had supper with son who left her at 22:00. She was found the next day by her son, and pronounced dead at 13:30 08Jan2021. Presumed cause cardiac arrest. Death referred to coroner 11Jan2021. No significant history or risk of cardiovascular disease apart from age no clear link to vaccine, but yellow card recommended by colleagues for completeness. Patient has not tested positive for COVID-19 since having the vaccine. It was not reported if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death unexplained/Presumed cause cardiac arrest


VAERS ID: 955824 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; ; ; CLENIL MODULITE; VENTOLIN [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Atrial fibrillation; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021032745

Write-up: Passed away overnight on 10Jan2021. Assumed cardio-respiratory arrest; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 24590954 and GB-MHRA-WEBCOVID-20210113174906. An 86-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL0141) via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history included asthma, atrial fibrillation and hypertension. Concomitant medications included amlodipine for hypertension, apixaban for atrial fibrillation, atorvastatin for primary prevention, beclometasone dipropionate (CLENIL MODULATE) for asthma and salbutamol sulfate (VENTOLIN) for asthma. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. It was reported: Patient attended for 2nd Covid vaccination on 09Jan2021. No significant preceding symptoms. Passed away overnight on 10Jan2021. Assumed cardio-respiratory arrest. For post-mortem. Patient has not had symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. The reporter considered the event life-threatening and therefore serious. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Assumed cardio-respiratory arrest


VAERS ID: 955825 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, 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: 2021-01-11
   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: LAXIDO; ; SERETIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Breast cancer (recent diagnosis); Constipation; Hypertension; Comments: Hypertension, mild asthma, recent diagnosis of breast cancer Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: tested; Result Unstructured Data: Test Result:has not tested positive for COVID-19
CDC Split Type: GBPFIZER INC2021029884

Write-up: Haemorrhage brain; Haemorrhagic stroke; This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20210113180138, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 24591328. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EJ1688) on 06Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension, mild asthma, recent diagnosis of breast cancer and constipation. The patient has not had symptoms associated with COVID-19. The patient is not enrolled in clinical trial. The patient has not tested positive for COVID-19 in Jan2021 since having the vaccine. Concomitant medication included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXIDO) from 13Dec2020 for constipation, ramipril from 14Jul2014 for hypertension and fluticasone propionate, salmeterol xinafoate (SERETIDE) from 11Feb2020 for asthma. The patient had haemorrhage brain and haemorrhagic stroke on 09Jan2021, seriousness reported as death. The patient died on 11Jan2021. It was unknown if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Haemorrhagic stroke; Haemorrhage brain


VAERS ID: 955826 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2020-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, Malaise, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-30
   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: MATRIFEN;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20201210; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021033570

Write-up: Death; Malaise; Diarrhoea; Vomiting; Pyrexia; This is a spontaneous report received by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20210113180506 and Safety Report Unique Identifier GB-MHRA-ADR 24591279. A contactable physician reported that an 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1688), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included dementia, and vitamin b12 deficiency. Patient had not had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. Concomitant medications included fentanyl (MATRIFEN) from 2016 at 25 mcg/hr, paracetamol from 2015 and non-medicinal product (no details reported). Patient previously received influenza vaccine inact sag 3v (FLUAD) on 20Oct2020 for influenza immunization. The patient experienced death, malaise, diarrhoea, vomiting, and pyrexia; all on 30Dec2020. It was stated that the patient had the vaccine then the following day she became unwell with diarrhoea and vomiting and a fever. The patient became quickly unwell and passed away on 30Dec2020. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No-negative COVID-19 test on 10Dec2020. Outcome of event death was fatal, and of other events was unknown. The patient died on 30Dec2020. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 955828 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fall, Pneumonia aspiration, SARS-CoV-2 test, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypoglycaemia (broad), COVID-19 (broad)

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:
Preexisting Conditions: Medical History/Concurrent Conditions: IHD; Indigestion; Iron low; Prostatism; Vitamin deficiency; Comments: Patien quite frail. Had vaccine on 31/12/20 then had a fall on 05/02/21 became very drowsy ? Aspiration pneumonia and died on the 6th January Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20201220; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021033283

Write-up: accidental fall; aspiration pneumonia; quite frail; drowsy off legs; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 24594577. A 93 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number:EJ1688), at single dose for COVID-19 immunization on 31Dec2020. Medical history included IHD (myocardial ischaemia), vitamin deficiency , iron low, prostatism and indigestion. Concomitant medication included acetylsalicylic acid from 15Oct2001 for myocardial ischaemia, calcium and colecalciferol from 24Dec2020 for vitamin deficiency, ferrous fumarate from 24Dec2020 for iron low, finasteride from 09Apr2010 for prostatism, omeprazole from 20Jan2012 for Dyspepsia, pravastatin from 05Nov2012 for myocardial ischaemia and tamsulosin from 16Jul2017 for Prostatism. The patient had vaccine on 31Dec2020. He had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. On 05Jan2021, the patient experienced accidental fall. He was quite frail, became drowsy off legs, and experienced aspiration pneumonia. The outcome of accidental fall was fatal. The patient died on 06Jan2021. It was not reported if an autopsy was performed. The outcome of events quite frail, drowsy off legs, aspiration pneumonia was unknown. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test (20Dec2020): no - negative covid-19 test. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: accidental fall


VAERS ID: 955829 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-10
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201226; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021039434

Write-up: Death within 28 days of vaccination; 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-202101141348291580, safety Report Unique Identifier GB-MHRA-ADR 24595288. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EJ1688, expiration date unknown), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient''s medical history was reported as patient had not had symptoms associated with COVID-19, patient was not enrolled in clinical trial. COVID-19 virus test on 26Dec2020 was "No - Negative COVID-19 test". Concomitant medications were not reported. On 10Jan2021, the patient experienced death within 28 days of vaccination. The patient died on 10Jan2021. It was not reported if an autopsy was performed. The cause of death was not reported. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death within 28 days of vaccination


VAERS ID: 955830 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Lower respiratory tract infection, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   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: Heart rate abnormal
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response); Comments: short course of fludrocortisone for postural hypotension, approx 1-2w stopped before vaccination Unsure if patient has had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210109; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021033613

Write-up: Chest infection; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority report number GB-Regulatory Authority-WEBCOVID-202101141450098130, and Sender''s (Case) Safety Report Unique Identifier GB-Regulatory Authority-ADR 24595672. A 92-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. Medical history included immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response) from an unknown date and unknown if ongoing and ongoing heart rate abnormal. Concomitant medication included bisoprolol from 10Dec2020 for heart rate abnormal. The patient previously took a short course of fludrocortisone for postural hypotension, stopped approximately 1-2 weeks before vaccination. It was unsure if patient has had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced chest infection on 08Jan2021. The patient was very frail, bedbound. Given COVID vaccine due to wishes of family. The patient had previous MRTI likely unrelated to vaccine but death within days of being vaccinated. The patient underwent lab test which included COVID-19 virus test: negative on 09Jan2021. The patient died on 10Jan2021. It was not reported if an autopsy was performed. The outcome of the event chest infection was fatal. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Chest infection


VAERS ID: 955837 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Gastrointestinal haemorrhage, Glomerular filtration rate, Haemoglobin, Platelet count, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   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: CALCIGRAN FORTE; ZOPICLONE ACTAVIS; ENALAPRIL KRKA; FURIX [FUROSEMIDE]; PARACET [PARACETAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthropathy psoriatic; Atherosclerosis; Bladder cancer; Coxarthrosis; Dementia; Heart failure; Hypertension; Renal failure; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20201123; Test Name: Creatinine; Result Unstructured Data: Test Result:135 IU/l; Comments: Units:U/L (enzyme unit per litre); Test Date: 20201123; Test Name: Estimated GFR; Result Unstructured Data: Test Result:42 ml/min; Comments: Units: mL/min/{1.73_m2}; Test Date: 20201123; Test Name: Hemoglobin; Result Unstructured Data: Test Result:13.7 g/dl; Test Date: 20201123; Test Name: Platelets; Result Unstructured Data: Test Result:138 x10 9/l; Test Date: 20201231; Test Name: Platelets; Result Unstructured Data: Test Result:132 x10 9/l; Test Date: 20201123; Test Name: White blood cells; Result Unstructured Data: Test Result:7.6 x10 9/l
CDC Split Type: NOPFIZER INC2021027029

Write-up: BLEEDING GASTROINTESTINAL; The initial case was missing the following minimum criteria: reporter had no firsthand knowledge. After receiving Follow up information on 15Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report downloaded from the Regulatory Authority NO-NOMAADVRE-FHI-2021-U9ngz, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013839. A contactable physician reported that an 83-year-old male patient had received bnt162b2 vaccine (COMIRNATY, batch/lot number EJ6795), via intramuscular route on 06Jan2021, at single unspecified dose (first dose) for Covid-19 immunisation. Medical history included hypertension, arteriosclerosis, osteoarthritis, renal failure, bladder cancer, dementia, cardiac failure, type 2 diabetes mellitus and psoriatic arthropathy, all from an unknown date and unknown if ongoing. Concomitant medications included calcium carbonate, colecalciferol (CALCIGRAN FORTE, 500 mg/400 iU), zopiclone (ZOPICLONE ACTAVIS, 5 mg), enalapril maleate (ENALAPRIL KRKA, 10 mg) at a dose of 10 mg once daily, furosemide (FURIX 20 mg) and paracetamol (PARACET 500 mg) at a dose of 1 g up to 3 times per day. No information that the patient was taking blood thinners or had known GI pathology. The patient experienced bleeding gastrointestinal on 08Jan2021. The patient underwent lab tests and procedures which included blood creatinine: 135 iu/l on 23Nov2020 Units:U/L (enzyme unit per litre), glomerular filtration rate: 42 ml/min on 23Nov2020 Units: mL/min/1.73_m2, haemoglobin: 13.7 g/dl on 23Nov2020, platelet count: 138 x10 9/l on 23Nov2020, and 132 x10 9/l on 31Dec2020, and white blood cell count: 7.6 x10 9/l on 23Nov2020. The patient died on 08Jan2021 after been flown to the hospital as a result of the event. It was not reported if an autopsy was performed. The Center has assessed the causal relationship between the suspect product and the reported event as Possible. Reported as an uncertain, possible new, unexpected and serious side effect to the vaccine Comirnaty. Additional information from Sender''s comments (Health Authority comments): "According to the approved Summary of Product Characteristics (SPC) for Comirnaty, gastrointestinal bleeding is not a known side effect of the vaccine. It is stated in the report that the patient had several underlying diseases before the vaccination. Based on the event description, it is more likely that something other than the vaccine is the cause of the event in question. However, it cannot be ruled out that the vaccine may have contributed to the deterioration of the patient''s general condition. We have considered it to be a possible causal link between the vaccination and GI bleeding. The report is classified as serious according to current criteria". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: BLEEDING GASTROINTESTINAL


VAERS ID: 955838 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 RA / 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: 2021-01-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Multimorbidity; Pneumonia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021027016

Write-up: Sudden death; This is a spontaneous report from two contactable physicians downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-UDMAY, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013809. An 83-year-old female patient received the first dose of bnt162b2 (COMIRNATY, batch/lot number EJ6795) intramuscular in the right arm on 06Jan2021 10:57 at single for covid-19 immunisation. Medical history included dementia, pneumonia, multimorbidity, all ongoing. The patient''s concomitant medications included treatment for pneumonia. The patient experienced sudden death on 06Jan2021. It was not reported if an autopsy was performed. The causality between the suspect product(s) and the event(s) were assessed as possible by the Regional Pharmacovigilance Center. Case narrative: According to reporter, it is doubtful that there is a causal link between vaccination and death, but it cannot be ruled out that vaccination may have helped to speed up death for other reasons. The patient was an elderly demented multi-morbid female who was considered terminal shortly before death. Was at the time undergoing treatment for a suspected pneumonia. Treatment was apparently successful and it was considered that the patient should receive the vaccine. Vaccination was administered approximately 6 hours before the patient was found dead in her own bed. She was observed, without any remarks, by nursing staff 1 hour before she was found dead. Sender''s comments (Health Authority comments): Thank you for reporting a suspected side effect after vaccination. The information is registered in the national adverse reaction register (the Norwegian Medicines Agency), and then forwarded to international adverse reaction databases. In this way, your message becomes part of an important international collaboration that is continuously ongoing to monitor and maintain safe vaccination worldwide. It is stated in the report that the patient had underlying diseases before vaccination. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. As the incident is described, it is more likely that these diseases are behind the incident. However, it cannot be ruled out that the vaccine has contributed to any of the symptoms. It is also conceivable that the incident had a completely different cause that only happened by chance after the vaccination. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 955839 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Diarrhoea, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac arrest; Cerebral infarction; Chronic kidney disease; Cognitive impairment; Pulmonary sarcoidosis
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: blood pressure; Result Unstructured Data: Test Result:fall
CDC Split Type: NOPFIZER INC2021033035

Write-up: NAUSEA; ACUTE DIARRHEA; FALL IN BLOOD PRESSURE; This is a spontaneous report downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB NO-NOMAADVRE-FHI-2021-Ugyxy, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013811. A contactable other hcp reported that a 79-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, lot number: EJ6795), via intramuscular route at left arm on 06Jan2021 12:44 at single dose for COVID-19 vaccination. Medical history included cerebral infarction, chronic kidney disease, ongoing diabetes, mild cognitive impairment, pulmonary sarcoidosis, and cardiac arrest. The patient''s concomitant medications were not reported. The patient experienced nausea, acute diarrhea and fall in blood pressure, all on 07Jan2021. The seriousness criteria of all events was death. It was reported that "Nursing home patient with diabetes, previous history of cardiac arrest, kidney disease, pulmonary sarcoidosis and cognitive impairment. Patient died the day after vaccination with Comirnaty". The patient died on 07Jan2021. It was not reported if an autopsy was performed. The Regional Pharmacovigilance Center assessed the causal relationship between the suspect product and the reported events as possible. Reporter comment: 14-JAN-2021, NIPH: requested additional information. This is a preliminary report. Sender''s comments (Health Authority comments): "Thanks for the report of suspected adverse reaction after vaccination. It is stated in the report that the patient had underlying diseases before vaccination. When vaccinating marginal patients who are ill with many underlying diseases, some serious incidents, including deaths, may occur occur shortly after vaccination without having a connection with the vaccination. Based on the description of the incident, it is more likely that these diseases have caused the incident. However, it cannot be ruled out that the vaccine has contributed to any of the symptoms. It is also conceivable that the incident had a completely different cause that only happened by chance after the vaccination". No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: 14-JAN-2021, NIPH: requested additional information. This is a preliminary report.; Reported Cause(s) of Death: NAUSEA; ACUTE DIARRHEA; FALL IN BLOOD PRESSURE


VAERS ID: 955840 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; NOVORAPID; OXYNORM; FLUCONAZOL KRKA; ALBYL-E; INSULATARD [INSULIN HUMAN INJECTION, ISOPHANE];
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Diabetes mellitus; Infection; Pain; Reduced general condition
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: C-reactive protein; Result Unstructured Data: Test Result:177 mg/l; Test Date: 20210106; Test Name: C-reactive protein; Result Unstructured Data: Test Result:127 mg/l
CDC Split Type: NOPFIZER INC2021033068

Write-up: infection without known focus; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory authority -WEB NO-NOMAADVRE-FHI-2021-Uq8mm, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013862. A contactable physician reported that a 93-year-old female patient received bnt162b2 (COMIRNATY, batch/lot number EJ6795, expiry date: not reported) via intramuscular route on 05Jan2021, at a single dose (first dose, administered into left arm) for covid-19 immunization. Medical history included dementia, diabetes mellitus and pain. In addition patient had impaired general condition the day before vaccination and the same day as vaccination Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]) from 28May2020, at a dose of 1 sachet 4 days per week, insulin aspart (NOVORAPID FLEXPEN, 100 iU) from 03Feb2020 to , oxycodone hydrochloride (OXYNORM, 5 mg) from 25Nov2019, at a dose of 5 mg as needed (up to 2 times per day) for pain, fluconazole (FLUCONAZOL KRKA, 100 mg) from 17Jul2020, at a dose of 100 mg weekly, acetylsalicylic acid, magnesium oxide (ALBYL-E, 75 mg) from 27Apr2020, at a dose of 75 mg once daily, insulin human injection, isophane (INSULATARD FLEXPEN, 100 iU) from 11Jun2020, at a dose of 30 IU in the morning, and paracetamol (PARACETAMOL, 500 mg) from 21Nov2020, at a dose of 1 g, 3 times per day. Insulin NOVORAPID FLEXPEN and INSULATARD FLEXPEN, macrogol (MOVICOL), acetylsalicylic acid (ALBYL-E), Fluconazole, oxycodone (OXYNORM) were discontinued at the same time as initiating palliative care. Patient was afebrile and no respiratory symptoms, but CRP was 177 mg/l at night (05Jan2021) on the same day as vaccination. The day after the gradual deterioration of the general condition and finally not contactable. CRP 127 mg/l (06Jan2021), afebrile and was treated with paracetamol 1 gram x 3. Palliative care was initiated with morphine and midazolam. The patient died two days after vaccination. Reporter (physician) has assessed that the woman had an infection that started before she received the vaccine COMINARTY. The patient experienced infection without known focus on 05Jan2021. The patient died on 07Jan2021. It was not reported if an autopsy was performed. The regional pharmacovigilance center has assessed the causality between concomitant drug OXYNORM and the event as possible. Additional information in Sender''s comments (Health authority comments): "It is stated in the report that the patient had underlying diseases before vaccination, and based on his report, an infection that started before the vaccination. It cannot be completely ruled out that the vaccine may have contributed to the deterioration of the patient''s basic condition and the presumed already established infection. We have considered it to be a possible causal link between the fatal outcome and the vaccination with Cominarty. The report is classified as serious according to current criteria". No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Reporter qualification: Physician.; Reported Cause(s) of Death: infection without known focus


VAERS ID: 955841 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Apathy, Confusional state, Coordination abnormal, Decreased appetite, Vaccination site inflammation, Vaccination site swelling, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (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 (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NITROGLYCERIN; SOBRIL; AFIPRAN; IMOVANE; ISOPTIN [VERAPAMIL HYDROCHLORIDE]; CALCIGRAN FORTE; PLAVIX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (cognitive impairement); Fracture (with falling tendency); Heart attack; Hypertension; Hypertrophic obstructive cardiomyopathy; Malnutrition; Non STEMI; Orthostatic hypotension; Osteoporosis; TIA
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021033075

Write-up: Local reaction with swelling and redness; VOMITING; Coordination difficulties; Local reaction with swelling; Confusion; Poor appetite; Loss of initiative; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB NO-NOMAADVRE-FHI-2021-Uy9gq, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013840. A 90-year-old female patient received bnt162b2 (COMIRNATY, batch/lot number EJ6795, expiration date Apr2021) via intramuscular route in the left arm on 07Jan2021, at a single dose for covid-19 immunisation. The patient''s medical history included hypertension, orthostatic hypotension, osteoporosis, heart attack, malnutrition, hypertrophic obstructive cardiomyopathy, transient ischemic attack (TIA),and dementia (cognitive disorder), Non-ST-elevation myocardial infarction (NSTEMI) and fractures (falling tendency) all from an unknown date and unknown if ongoing. Concomitant medications included nitroglycerin (NITROGLYCERIN TAKEDA, 0.5 mg), oxazepam (SOBRIL, 10 mg), metoclopramide hydrochloride (AFIPRAN, 10 mg) as needed, zopiclone (IMOVANE, 7.5 mg), verapamil (ISOPTIN [VERAPAMIL HYDROCHLORIDE], 40 mg), calcium carbonate, colecalciferol (CALCIGRAN FORTE, 1000 mg/800 iU), and clopidogrel bisulfate (PLAVIX, 75 mg). On 07Jan2021, the patient experienced loss of initiative. On 08Jan2021, patient experienced confusion had poor appetite, coordination difficulties and a local reaction with swelling. On 09Jan2021, the patient had local reaction with swelling and redness, and experienced vomiting. The patient died on 09Jan2021 due the events loss of initiative, confusion, poor appetite, coordination difficulties, local reaction with swelling, local reaction with swelling and redness, and vomiting. It was not reported if an autopsy was performed. It was further reported that the patient gradually decreased general condition over time, unable to eat by herself, increasing confusion and coordination difficulties. Vomited twice a few hours before the patient was found dead in bed. The Regional Pharmacovigilance Center has assessed the causality between the suspect product and the events of confusional state, apathy, decreased appetite, vomiting and coordination abnormal as possible, and between the suspect product and the events of vaccination site redness and vaccination site swelling as probable. Senders Comment: It is stated in the report that the patient had several underlying diseases before the vaccination. Based on the event description, it is more likely that these diseases are behind the event in question. However, it cannot be ruled out that the vaccine may have contributed to the deterioration of the patient''s general condition. It is also conceivable that the incident had a completely different cause that only happened by chance after the vaccination. We have considered it to be a possible causal relationship between the vaccination and the overall symptom picture described, but specifically local reaction with swelling and redness is considered to have a probable causal relationship with the vaccination. The report is classified as serious according to current criteria". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Loss of initiative; Poor appetite; Local reaction with swelling and redness; VOMITING; Coordination difficulties; Local reaction with swelling; Confusion


VAERS ID: 955842 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2020-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Disease recurrence, Dyspnoea, General physical health deterioration, Pyrexia, Rales, Respiratory rate increased, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-02
   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: MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; LEVAXIN; DUROGESIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Asthma; Constipation; Dementia; Frailty; Hallucination NOS; Hypothyreosis; Malnutrition; Memory impaired; Pain NOS; Rales; Terminal state; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: COVID-19 virus test negative; Test Result: Negative
CDC Split Type: NOPFIZER INC2021027026

Write-up: REDUCED GENERAL CONDITION; RALES; RALES; DYSPNEA; Fever, decreased general condition, dyspnoea, rales, cough, increased respiration; COUGH; BREATHING RATE INCREASED; This is a spontaneous report from downloaded from the Medicines Agency (MA) EudraVigilance-WEB NO-NOMAADVRE-FHI-2021-UZDZE, Safety Report Unique Identifier NO NOMAADVRE-E2B_00013778. A contactable other Health Professional and a contactable physician reported that a 75-years-old female patient received the first dose of bnt162b2 (COMIRNATY, Batch/lot number: EJ6796), intramuscular at right arm on 30Dec2020 11:25 at single dose for COVID-19 immunization. Medical history included terminal state, frailty, memory impaired, rales, hallucination NOS, dementia, asthma, type 2 diabetes mellitus, malnutrition, anxiety, constipation, hypothyreosis, pain NOS. Patient with a permanent place in an institution. Bedridden, often experienced hallucinations, was outspoken and had uncritical behavior. Concomitant medication included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) taken for constipation, levothyroxine sodium (LEVAXIN) taken for hypothyreosis, fentanyl (DUROGESIC) taken for pain NOS. No other medication had been given in connection with vaccination, except the listed treatments. The patient experienced reduced general condition, rales, dyspnea, fever, cough, increased respiration on 30Dec2020. According to reporter the patient was calm on the day of vaccination, which was different from the patient''s habitual condition. After vaccination the patients develops symptoms as mentioned. No vital measurement was performed on the patient, as it was known that the patient would have opposed this. The patient has been gradually reduced over time, but had not been considered to be in the terminal phase. The events outcome was fatal. The patient underwent lab test included sars-cov-2 test negative on 31Dec2020. The patient died on 02Jan2021. It was not reported if an autopsy was performed Health authority''s comments: Thank you for reporting a suspected side effect after vaccination. The information is registered in the national adverse reaction register (the Medicines Agency), and then forwarded to international adverse reaction databases. In this way, your message becomes part of an important international collaboration that is continuously ongoing to monitor and maintain safe vaccination worldwide. It is stated in the report that the patient has underlying diseases before vaccination. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. As the incident is described, it is more likely that these diseases are behind the incident. It cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. It is also conceivable that the incident had a completely different cause that only happened by chance after the vaccination. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Reduced general condition; Rales; Dyspnea; Fever; Cough; Breathing rate increased


VAERS ID: 958809 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-16
Onset:2020-12-01
Submitted: 0000-00-00
Entered: 2021-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein increased, Chills, Computerised tomogram head normal, Confusional state, Death, Echocardiogram abnormal, Fall, Headache, Hypoglycaemia, Hypophagia, Hypotension, Hypothermia, Hypoxia, Malaise, Oedema peripheral, Oxygen saturation, Skin ulcer, Somnolence, Tachypnoea, Unresponsive to stimuli, White blood cell count normal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-29
   Days after onset: 28
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: Aortic stenosis (moderate); Atrial fibrillation; Cardiac valve fibroelastoma; Lethargy; Pulmonary hypertension
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: blood sugar; Result Unstructured Data: Test Result:improved; Test Date: 20201228; Test Name: blood sugar; Result Unstructured Data: Test Result:hypoglycaemia/ hypoglycaemic; Test Date: 20201229; Test Name: Blood pressure; Result Unstructured Data: Test Result:hypotension/ hypotensive; Test Date: 20201226; Test Name: Body temperature; Result Unstructured Data: Test Result:hypothermia/ hypothermic; Test Name: Computerised tomogram head; Result Unstructured Data: Test Result:no bleed; Test Name: C-reactive protein; Result Unstructured Data: Test Result:37; Test Date: 201906; Test Name: Echocardiogram; Result Unstructured Data: Test Result:possible papillary fibroelastoma- not investigated; Test Date: 20201229; Test Name: Heart rate; Result Unstructured Data: Test Result:tachypnoea/ tachypnoeic; Test Date: 20201229; Test Name: National Early Warning Score; Result Unstructured Data: Test Result:14; Comments: hypotensive, hypoxic, tachypnoeic, unresponsive; Test Date: 202012; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased/ low; Test Name: White blood cell count; Result Unstructured Data: Test Result:Normal
CDC Split Type: GBPFIZER INC2021028062

Write-up: Hypotension/ hypotensive; Hypoxia/ hypoxic; Tachypnoea/ tachypnoeic; Unresponsive to stimuli/ unresponsive; Death; Somnolence/ Drowsy; Hypoglycaemia/ hypoglycaemic; Hypothermia/ hypothermic; Hypophagia/ reduced oral intake; Fall; Confusional state/ confused; Headache; Chills; Skin ulcer/ Leg ulcers; Oedema peripheral/ bilateral leg oedema; Oxygen saturation decreased/ low saturations; feel unwell; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency, manufacturer report number GB-MHRA-ADR 24566650. A 95-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, moderate aortic stenosis from an unknown date and unknown if ongoing, pulmonary hypertension from an unknown date and unknown if ongoing, possible papillary fibroelastoma from Jun2019 and unknown if ongoing, non-specifically lethargic from Dec2020 and unknown if ongoing. The patient had been non-specifically lethargic for 1-2 weeks in early Dec2020. The patient''s concomitant medications were not reported. In the 24-48 hours following vaccine, developed headache and chills. Daughter thought it was all post-vaccination inflammatory response and that it would settle. Continued to feel unwell, reduced oral intake, 2x falls and became confused on 25Dec2020. The patient was admitted on 26Dec2020, hypothermic. Consultant review 27Dec2020 and no diagnosis documented. Leg ulcers and bilateral leg oedema noted, supplemental oxygen commenced due to low saturations in Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to 29Dec2020, given intravenous treatment and blood sugars improved. National Early Warning Score (NEWS) of 14 (hypotensive, hypoxic, tachypnoeic, unresponsive) on 29Dec2020 and Medical Emergency Team (MET) call put out at 06:50. By the time MET team arrived the patient had died. The patient experienced headache on Dec2020 , chills on Dec2020, hypophagia on 25Dec2020, fall on 25Dec2020, confusional state on 25Dec2020 , hypothermia on 26Dec2020, skin ulcer on Dec2020, oedema peripheral on Dec2020, oxygen saturation decreased on Dec2020, somnolence on 28Dec2020, hypoglycaemia on 28Dec2020, hypotension on 29Dec2020, hypoxia on 29Dec2020, tachypnoea on 29Dec2020, unresponsive to stimuli on 29Dec2020, death on 29Dec2020 , feel unwell on 25Dec2020. All the events except feel unwell were reported as serious as hospitalization and death. The patient underwent lab tests and procedures which included computerised tomogram head: no bleed, C-reactive protein: 37, echocardiogram: possible papillary fibroelastoma- not investigated in Jun2019, white blood cell count: normal. The patient died on 29Dec2020. An autopsy was not performed. The outcome of the event feel unwell was unknown, while other remain events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Headache; Chills; Fall; Hypophagia/ reduced oral intake; Confusional state/ confused; Skin ulcer/ Leg ulcers; Oedema peripheral/ bilateral leg oedema; Oxygen saturation decreased/ low saturations; Somnolence/ Drowsy; Death; Hypoglycaemia/ hypoglycaem


VAERS ID: 960052 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-02
Onset:2021-01-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Bedridden, Condition aggravated, Death, Dyspnoea, 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 (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arthrosis multiple; Cardiac disorder; Chronic anaemia; Chronic pain; Dyspnoea; Exsiccosis; Reduced general condition; Renal insufficiency (grade 4); Weakness
Preexisting Conditions: Medical History/Concurrent Conditions: Carcinoma cervix; Leukoencephalopathy; Maxillary sinusitis; Renal failure; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210102; Test Name: O2 saturation; Test Result: 97 %; Test Date: 20210102; Test Name: lungs; Result Unstructured Data: Test Result:clear; Test Name: apid antigen test; Test Result: Negative
CDC Split Type: DEPFIZER INC2021039336

Write-up: Die 50 hours after vaccination; Especially kidney failure; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory authority report number DE-PEI-PEI2021000192. A female patient of 88 years old received bnt162b2 (COMIRNATY, batch/lot number EJ6797, expiration date unknown) , via an unspecified route of administration on 02Jan2021 at single dose for covid-19 immunisation. Medical history included renal failure from Dec2018 to an unknown date , Maxillary sinusitis from 2018 and unknown if ongoing , ongoing reduced general condition , leukoencephalopathy from 2018 and unknown if ongoing , ongoing Weakness, Exsiccosis from 2018 and ongoing , ongoing Dyspnoea, ongoing Chronic anaemia, ongoing renal insufficiency(grade 4), ongoing arthrosis multiple, Ongoing Cardiac disorder, Carcinoma cervix from an unknown date and unknown if ongoing, ongoing Chronic pain, wheelchair dependent. The patient''s concomitant medications were not reported. On 04Jan2021, the patient developed die 50 hours after vaccination and especially kidney failure, lasting for unknown. The patient was dead on 04Jan2021. Death cause was reported as die (unknown cause of death). Injection site showed no abnormalities. Patient had Renal insufficiency grade 4. No suspicion of vaccination complication due to disease course and clinical course. General condition deterioration already before vaccination since Christmas, bedridden since 1st day before vaccination, on the day of vaccination lungs were clear, O2 saturation at 97%. Symptoms shortly before death: Dyspnea, weakness, injection site unremarkable. A rapid antigen test was done before vaccination (result: negative). There will be no autopsy, the family decided against it. The patient died on 04Jan2021. Outcome of especially kidney failure was unknown. An autopsy was not performed. Event Assessment was unclassifiable.; Reported Cause(s) of Death: die 50 hours after vaccination.


VAERS ID: 960053 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dementia of the Alzheimer's type, with delirium
SMQs:, Dementia (narrow), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039328

Write-up: Dementia of the Alzheimer''s type, with delirium; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021000428. This is a report received from the Regulatory Authority. An 85-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6795), via intramuscular on 30Dec2020 at single dose for prophylactic vaccination. The relevant medical history included Dementia Alzheimer''s type from an unspecified date and unknown if ongoing. The patient''s concomitant medications were not reported. On 01Jan2021 after vaccination the patient developed Dementia of the Alzheimer''s type, with delirium, lasting for unknown. The patient died on 01Jan2021. Death cause was reported as Dementia of the Alzheimer''s type, with delirium. An autopsy was not performed. The outcome of the event was fatal.; Reported Cause(s) of Death: Dementia of the Alzheimer''s type, with delirium


VAERS ID: 960054 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Demented; Exsiccosis; Markedly reduced food intake
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039270

Write-up: Exitus letalis/died; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory authority report number DE-PEI-PEI2021000474. A 94-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, lot/batch number and expiry date were not provided), intramuscular in upper arm on 07Jan2021 at single dose for COVID-19 immunisation. Medical history included Demented, Exsiccosis, Markedly reduced food intake. The patient''s concomitant medications were not reported. The patient experienced exitus letalis (death, medically significant) on 09Jan2021. 2 day(s) after vaccination the patient died. Death cause was reported as unknown cause of death. The patient died on 09Jan2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Reporter Comment: Exitus letalis the morning after the vaccination, probably only temporal connection, no causality, 94-year-old demented patient, incipient desiccosis with insufficient food intake. No symptoms developed after vaccination. Information on the lot/batch number has been requested.; Reporter''s Comments: Exitus letalis the morning after the vaccination, probably only temporal connection, no causality, 94-year-old demented patient, incipient desiccosis with insufficient food intake. No symptoms developed after vaccination.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 960055 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2020-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Fall, Head injury, Peripheral vascular disorder
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Artificial cardiac pacemaker user; Cerebellar infarction; Duodenal ulcer; Myocardial infarction; Stent insertion NOS; Ulcus ventriculi; Vagotomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039320

Write-up: Heart attack; Head injury; Circulatory problems; Fall; This is a spontaneous report from a non-contactable Consumer or other non-HCP downloaded from the Regulatory Authority WEB DE-PEI-PEI2021000493. This is a report received from the Regulatory Authority. A 91-year-old male patient received his first dose of bnt162b2 (COMIRNATY, batch number not reported) via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included duodenal ulcer, vagotomy in 1988, ulcus ventriculi, myocardial infarction, cerebellar infarction, angina pectoris, stent insertion NOS, artificial cardiac pacemaker user from 2019. Patient had previous illnesses. The patient''s concomitant medications were not reported. Two hours after vaccination, the patient developed circulatory problems/ circulatory disorder peripheral, fall, head injury. The patient experienced acute myocardial infarction. The patient was dead on 04Jan2021 and death cause was reported as Acute myocardial infarction. It was not reported if an autopsy was performed. Relatedness of drug to all reactions/events: (Source of assessment: Regulatory Authority) C. Inconsistent causal association.; Reported Cause(s) of Death: circulatory problems; Acute myocardial infarction; fall; head injury


VAERS ID: 960056 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-03
Onset:2021-01-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Circulatory collapse
SMQs:, Anaphylactic reaction (narrow), Myocardial infarction (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), Embolic and thrombotic events, arterial (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   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: Medical History/Concurrent Conditions: Adipositas; Angina pectoris CCS class II; Coronary artery disease (Severe 3-vessel disease); Defibrillation; Ex-smoker; Hypertension arterial; Triple vessel disease (Condition after recanalization and stending); Type II diabetes mellitus; Ventricular fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039296

Write-up: Cardiac arrest; Suspected myocardial infarction; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-Regulatory Authority-2021000509. A 59-year-old male patient was vaccinated with the first dose of BNT162B2 (COMIRNATY, lot/batch number: EM0477) on 03Jan2021 at single dose for COVID-19 immunization, route of administration was not reported. Medical history included: coronary artery disease from 2019 (Severe 3-vessel disease), angina pectoris CCS class II from 2019, triple vessel disease from 2019 (Condition after recanalization and stending), hypertension arterial, adipositas, type II diabetes mellitus, ex-smoker, ventricular fibrillation from 19Aug2019, defibrillation from 19Aug2019, all unknown if ongoing. Concomitant medication was not reported. 3 days after vaccination the patient developed death and suspected myocardial infarction and cardiac arrest (failure circulatory) and frustrating resuscitation, lasting for unknown. The patient was dead on 06Jan2021 and was hospitalized and condition was life threatening. Death cause was reported as arrest cardiac. It was unknown if Autopsy was performed. Follow-up information has been requested.; Reported Cause(s) of Death: Frustrating resuscitation; Suspected myocardial infarction; Arrest cardiac


VAERS ID: 960057 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: 2021-01-01
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse; Apoplexy; Chronic renal insufficiency (Stat. 2); Dementia; Hip prosthesis user; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039317

Write-up: Acute kidney failure; Emesis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021000557. A 80-year-old female patient received first dose bnt162b2 (COMIRNATY) (Batch/lot number: EJ6796), intramuscular on 07Jan2021 at single dose for covid-19 immunisation. Medical history included Chronic renal insufficiency(Stat. 2), Hypertension, Dementia, Alcohol abuse, Hip prosthesis user, all from an unknown date and unknown if ongoing, and Apoplexy(stop). The patient''s concomitant medications were not reported. 24 hours after vaccination(08Jan2021) the patient developed Emesis and Acute renal failure, lasting for unknown. The patient was dead in Jan2021. Death cause was reported as Acute renal failure. Outcome of Emesis was unknown, of acute renal failure was fatal. It was not reported if an autopsy was performed. Event Assessment was unclassifiable.; Reported Cause(s) of Death: Acute renal failure


VAERS ID: 960058 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Bedridden, Fatigue, Hypotonia, Irregular breathing, Rhonchi
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   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: ASS; AZATHIOPRIN; CALCIMAGON [CALCIUM]; DULCOLAX [BISACODYL]; FOLSAURE SANAVITA; FUROSEMID; HYLO-VISION; MIRTAZAPIN; MELPERON; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; RISPERIDON; TIANEURAX; TOLTERODIN;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039370

Write-up: Decreased muscle tone; Pauses for breath; Rattling noises; Fatigue; Increasing weakness; Powerlessness; Bedridden; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB DE-PEI-PEI2021000644. A 78-year-old female patient received 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 prophylaxis. Medical history included cardiac insufficiency from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (ASS), azathioprine (AZATHIOPRIN), calcium (CALCIMAGON), bisacodyl (DULCOLAX), folic acid (FOLSAURE SANAVITA), furosemide (FUROSEMID), hyaluronate sodium (HYLO-VISION), mirtazapine (MIRTAZAPIN), melperone hydrochloride (MELPERON), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL), risperidone (RISPERIDON), tianeptine sodium (TIANEURAX), tolterodine l-tartrate (TOLTERODIN), and acetylcysteine (TURANT), all taken from an unknown date to an unknown date for an unknown indication. The patient experienced increasing weakness (death), fatigue (death), powerlessness (death) and bedridden (death) on 09Jan2021, rattling noises (death), decreased muscle tone (death), pauses for breath (death) on 12Jan2021. The outcome of events was fatal. The patient died on 12Jan2021. It was not reported if an autopsy was performed. Relatedness of drug to all reactions/events: (Source of assessment: Regulatory Authority) D. Unclassifiable Clinical course: 2 day(s) after vaccination the patient developed Weakness and Tiredness and Strength loss of and Bedridden and Irregular breathing and Rhonchus and Hypotonia, lasting for unknown. The patient was dead. Follow-up information has been requested.; Reported Cause(s) of Death: Increasing weakness; Rattling noises; Fatigue; Decreased muscle tone; Pauses for breath; Powerlessness; Bedridden


VAERS ID: 960059 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2021-01-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 011035926710001 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cerebrovascular accident, Death, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   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 Name: PCR; Test Result: Positive
CDC Split Type: DEPFIZER INC2021039253

Write-up: Unknown cause of death; COVID-19; COVID-19; Apoplexy; This is a spontaneous report from a non-contactable physician. This is a report received from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory authority or other manufacturer number DE-PEI-PEI2021000691. An 87-year-old male patient received BNT162B2 (COMIRNATY, lot/batch number 0110359267100013) intramuscularly at a single dose on 29Dec2020 for COVID-19 prophylaxis. The patient''s medical history and concomitant medications were not reported. On 01Jan2021, the patient developed Apoplexy, on 02Jan2021, patient developed COVID-19 and on 04Jan2021, patient experienced unknown cause of death. The patient was dead and condition was life threatening. Lab tests included PCR positive on an unspecified date. Follow-up information has been requested.; Reported Cause(s) of Death: Covid-19; Covid-19; Apoplexy; Unknown cause of death


VAERS ID: 960060 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? Yes
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 INC2021039247

Write-up: Death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority WEB DE-PEI-PEI2021000692. This is a report received from the Regulatory Authority. An 89-year-old female patient received first dose of bnt162b2 (COMIRNATY, batch number: not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 prophylaxis. The patient''s medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. The patient died on an unspecified date. An autopsy was performed, and results were not provided. 1 hour after vaccination the patient developed unknown cause of death, lasting for unknown. The patient was dead, and condition was life threatening. Death cause was reported as unknown cause of death. Relatedness of drug to reaction(s)/event: (Source of assessment: Regulatory Authority) D. Unclassifiable. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 960061 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency; Food refusal; Pneumonia hypostatic; Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039278

Write-up: Lethal death less than 24 hours after vaccination; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority number DE-PEI-PEI2021000698. An 88-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 prophylaxis. Medical history included cardiac insufficiency, renal insufficiency, pneumonia hypostatic, food refusal. The patient''s concomitant medications were not reported. Less than 24 hours after vaccination the patient developed death. The patient was dead in Jan2021. It was not reported if an autopsy was performed. Source of assessment PEI, Result of Assessment was unclassifiable.; Reported Cause(s) of Death: Lethal death less than 24 hours after vaccination


VAERS ID: 960062 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   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: Atrial fibrillation; Dementia; Depression; Gastritis; Hepatic cirrhosis; Hypertension; Incontinence; Renal insufficiency (Grade 3)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039276

Write-up: Died in a palliative situation; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB [DE-PEI-PEI2021000719]. A female 93-year-old patient, was vaccinated with the first dose of Comirnaty, (lot/batch no.: EM0477) for COVID-19 prophylaxis on 13Jan2021. Medical history included: Hepatic cirrhosis, Renal insufficiency, Dementia, Depression, Hypertension, Atrial fibrillation, Incontinence, Gastritis, all from an unknown date and unknown if ongoing, General condition fluctuating in the last few months. Concomitant medication was not reported. 6 hours after vaccination(on 13Jan2021) the patient died in the afternoon, died in a palliative situation. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 960063 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Huntington's disease, Seizure
SMQs:, Systemic lupus erythematosus (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Huntington''s chorea
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039295

Write-up: Death on 14Jan2021, mainly convulsions in Huntington''s disease; Death on 14Jan2021, mainly convulsions in Huntington''s disease; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA)Regulatory authority-WEB [DE-PEI-PEI2021000739]. A 56-year-old female patient received bnt162b2 (COMIRNATY, Batch/lot number: EJ6797), intramuscular on 01Jan2021 at single dose for COVID-19 immunization (covid-19 prophylaxis). Medical history included Huntington''s chorea. The patient''s concomitant medications were not reported. The patient was died on 14Jan2021 due to mainly convulsions in Huntington''s disease on 14Jan2021. It was not reported if an autopsy was performed. Additional information included: The following differential diagnoses were excluded: no clarifying examination. No outpatient treatment necessary. Outcome of the events was fatal.; Reported Cause(s) of Death: Death on 14Jan2021, mainly convulsions in Huntington''s disease; Death on 14Jan2021, mainly convulsions in Huntington''s disease


VAERS ID: 960064 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   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:
CDC Split Type: DEPFIZER INC2021039301

Write-up: Vd. a. delayed allergic reaction; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) WEB. Regulatory authority report number DE-PEI-PEI2021000779. A female patient of 66 years old received the first dose of BNT162B2 (COMIRNATY, batch/lot number unknown, expiration date unknown), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. 2 days after vaccination on 11Jan2021 the patient developed vd. a. delayed allergic reaction, lasting for 4 days. The patient was dead on 14Jan2021 and condition was life threatening. It was not reported if an autopsy was performed. Event Assessment: PEI / D. Unclassifiable.; Reported Cause(s) of Death: vd. a. delayed allergic reaction


VAERS ID: 960065 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Drug ineffective, Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 202101; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021039308

Write-up: COVID-19 pneumonia/ Covid-19 disease; Acute dyspnea; COVID-19 pneumonia/ Covid-19 disease/ COVID-19 PCR test: positive, SARS-CoV-2 test: positive; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB [DE-PEI-PEI2021000799]. An 87-year-old male patient received the first dose of bnt162b2 (COMIRNATY, batch/lot number: EJ6797), via an unspecified route of administration on 04Jan2021 at single dose (1 dose form) for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 07Jan2021 (pending clarification), 4 days after vaccination the patient developed Acute dyspnea and COVID-19 pneumonia/ Covid-19 disease, lasting for 6 days. The patient was dead in Jan2021 and condition was life-threatening. In Jan2021, COVID-19 PCR test: positive, SARS-CoV-2 test: positive. Death cause was reported as COVID-19 pneumonia and acute dyspnea. It was unknown if an autopsy was performed. The outcome of the events was fatal.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19 pneumonia/ Covid-19 disease/ COVID-19 PCR test: positive, SARS-CoV-2 test: positive; acute dyspnea


VAERS ID: 960066 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021033073

Write-up: exitus letalisin temporary association with vaccination; This is a spontaneous report from a contactable other healthcare professional received via local supervisory health authority. An 86-year-old female patient received her first dose of bnt162b2 (COMIRNATY, lot number EJ6796), via an unspecified route of administration on left arm on 11Jan2021 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was vaccinated with Comirnaty on 11Jan2021, after about 36 hours she died (exitus letalisin temporary association with vaccination). The patient died in Jan2021. It was not reported if an autopsy was performed. Autopsy for clarification of cause of death will be carried out.; Sender''s Comments: The event death is assessed as related to BNT162b2 vaccine and documented as such in the global safety database until sufficient information is available to allow an unrelated causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: died


VAERS ID: 960067 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021038935

Write-up: death after vaccination; This is a spontaneous report from a contactable consumer via newspaper. This report was received via a sales representative. This reporter reported the same event for two patients. This is the 1st of the two reports. A patient of unspecified age and gender received BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced death on the day of vaccination in a retirement home. It was unknown if autopsy was performed. Outcome of the event was fatal. Information on the Batch/Lot number has been requested.; Reported Cause(s) of Death: death after vaccination


VAERS ID: 960068 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039425

Write-up: deaths on the day of vaccination; This is a spontaneous report from a contactable consumer via newspaper via a sales representative. This consumer reported same event for two patients. This is the second of two reports. A patient of unspecified age and gender started to receive bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The consumer reported of 2 deaths on the day of vaccination in a retirement home. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021038935 Same reporter/drug/event, different patient; Reported Cause(s) of Death: deaths on the day of vaccination


VAERS ID: 960071 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021039083

Write-up: died; This is a spontaneous report received from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date to at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had this vaccine 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: DEATH


VAERS ID: 960081 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-18
Onset:2020-12-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553/V0003 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Vaccination site discomfort
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; ; ; ; ; FENBID; ; ; HYLO-FORTE
Current Illness: Disease risk factor (High risk of heart disease and diabetes mellitus (DM))
Preexisting Conditions: Medical History/Concurrent Conditions: Epiretinal membrane; Gout; Hypertension; Lumbar spondylosis; Osteoarthritis; Sciatica; Swelling of legs
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021031446

Write-up: heavy sensation in arm following jab; Death; This is a spontaneous report from a contactable physician. Report downloaded from the Agency Regulatory Authority-WEBGB-MHRA-EYC 00236211 with Safety Report Unique Identifier of GB-MHRA-ADR 24546700. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch: EJ0553/V0003), intramuscular in arm on 18Dec2020 at 30 ug single (30micrograms/0.3ml dose) for COVID-19 immunization. Medical history included gout, hypertension, Lumbar spondylosis, Epiretinal membrane, Swelling of legs, Sciatica, Osteoarthritis (all unknown if ongoing), had ongoing high risk of heart disease and diabetes mellitus (DM). Concomitant medication included allopurinol, acetylsalicylic acid, simvastatin, amitriptyline, tramadol hydrochloride, ibuprofen (FENBID) gel, buspirone, atenolol, hyaluronate sodium (HYLO-FORTE) eye drops. Patient died of unknown cause 2 days later (on 20Dec2020). Daughter has confirmed he had heavy sensation in arm following jab, but no other symptoms, he was found dead in bed. The outcome of heavy sensation in arm was not recovered. Awaiting coroners post-mortem (PM) for medical certificate cause of death (MCCD). The reporting physician did not think that the death is likely to be related to the administration of the vaccine. It was unknown if an autopsy was performed. No follow-up attempts needed. No further information expected.; Sender''s Comments: The 85-year-old male patient had medical history included gout, hypertension, lumbar spondylosis, epiretinal membrane, swelling of legs, sciatica, osteoarthritis, ongoing high risk of heart disease and diabetes mellitus (DM), and was on multiple concomitant medications. He received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020, and died of unknown cause 2 days later. He had heavy sensation in arm following jab, but no other symptoms, and he was found dead in bed. The company concurs with the reporting physician that the death is not likely to be causally related to the administration of the vaccine.; Reported Cause(s) of Death: Death


VAERS ID: 960085 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Age: 89 Years on 14/01/2021.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021041290

Write-up: Death; This is a spontaneous report from a contactable pharmacist from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-MIDB-24bf16e9-34d0-4256-9367-73d873ad0e9a and GB-MHRA-ADR 24596015. An 89-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0141), intramuscularly in the right arm, on 13Jan2021 at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death on 14Jan2021, which was reported as fatal. The clinical course was reported as follows: On 13Jan2021, the patient received the first dose of the vaccine at approximately 14:00-15:00 and died during the night. The pharmacist reported that the exact cause of death was unknown but think likely to be due to natural causes but unable to rule out. The patient had reported feeling generally well immediately following administration of the vaccine dose and before going to bed but didn''t wake up. The patient died on 14Jan2021 (as reported). The cause of death was reported as unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: DEATH


VAERS ID: 960093 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-19
Onset:2020-12-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Haematemesis, Loss of consciousness, Pyrexia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2020-12-21
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201116; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021031481

Write-up: Loss of consciousness; Dizziness; High temperature; Vomiting blood; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority WEB (Regulatory Authority number GB-MHRA-WEBCOVID-20201223182431, Safety Report Unique Identifier GB-MHRA-ADR 24546960). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020, at single dose, for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. The patient underwent a COVID-19 virus test on 16Nov2020 with negative result. The patient experienced vomiting blood on 21Dec2020. On an unspecified date he experienced also loss of consciousness, dizziness and high temperature. All the events were reported as serious as fatal, per hospitalization, disability, medically significant, life threatening. They were reported as serious also per congenital anomaly (no further information provided). Therapeutic measures were taken as a result of all the reported events. The patient died on 21Dec2020. It was not reported if an autopsy was performed. Verbatim EMA narrative: Vomiting blood, vomiting, dizziness, loss of consciousness, fainting, high temperature very often. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: loss of consciousness; Dizziness; High temperature; Vomiting blood


VAERS ID: 960101 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553-L449 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-31
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: Medical History/Concurrent Conditions: Urinary tract infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021027969

Write-up: drug ineffective; COVID-19; Sepsis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB manufacturer report number GB-Regulatory Authority-WEBCOVID-20210107092914. An 82-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: EJ0553-L449), via an unspecified route of administration on 16Dec2020 at single dose for covid-19 immunisation. The patient medical history included urinary tract infection. Patient has not had symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications included antibiotics for urinary tract infection. The patient died on 31Dec2020. Probably unrelated to vaccine but patient died of covid. The patient had a minor urinary tract infection and was on antibiotics. Clinically well and no sepsis. However admitted to hospital soon after with sepsis and died. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts possible. No further information expected. Lot/batch number was provided.; Reported Cause(s) of Death: COVID-19; Sepsis


VAERS ID: 960111 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acidosis, Blood lactic acid, Blood lactic acid increased, Confusional state, Death, Echocardiogram, Electrocardiogram ST segment elevation, Hemiparesis, Right ventricular enlargement
SMQs:, Cardiac failure (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Pulmonary hypertension (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Tumour lysis syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypercholesterolaemia; Hypertension; Comments: Unsure if patient has had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: blood lactic acid; Result Unstructured Data: Test Result:increased; Test Date: 20210107; Test Name: Echocardiography; Result Unstructured Data: Test Result:normal left ventricle but large right ventricle; Test Date: 20210107; Test Name: Electrocardiogram ST segment elevation; Result Unstructured Data: Test Result:widespread and then inferolateral ST elevation
CDC Split Type: GBPFIZER INC2021031416

Write-up: Death unexplained; Electrocardiogram ST segment elevation; Hemiparesis/right-sided facial weakness; Confusional state; Acidosis/acidemia; high lactate/blood lactic acid increased; Right ventricular enlargement; This is a spontaneous report from a contactable physician. This is a report received from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-20210107154410, Safety Report Unique Identifier GB-MHRA-ADR 24568917. An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not known) via an unspecified route of administration on 05Jan2021 at a single dose for covid-19 immunization. Medical history included hypercholesterolaemia, hypertension and diabetes mellitus from unknown dates and unknown if ongoing, however fully active and mobile. Unsure if patient has had symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. Two days following vaccination she presented with widespread and then inferolateral ST elevation on ECG, hemiparesis and right-sided facial weakness, confusion state, high lactate/blood lactic acid increased and acidosis/acidemia. Echocardiography showed a normal left ventricle but large right ventricle. The differential was pulmonary embolism, intracranial haemorrhage/thrombosis and/or myocardial infarction. Unfortunately, she rapidly deteriorated and died. She has been referred to the coroner, so cause of death will hopefully be clarified. We are not referring as a definite side-effect, however, the temporal association and clinical findings, and after discussion with our lead pharmacist (and in my role as a medical examiner) we felt we should complete this as a possible reaction/complication. The patient died on 07Jan2021. The outcome of the events inferolateral ST elevation on ECG, hemiparesis and right-sided facial weakness, confusion state, high lactate/blood lactic acid increased and acidosis/acidemia was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 960117 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-05
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Haematemesis, Illness, Mobility decreased
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Parkinson-like events (broad), Gastrointestinal haemorrhage (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-05
   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: Dementia; Frailty; Comments: Frailty and alzheimer''s dementia Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021032294

Write-up: looked ill; feeling tired; not mobilising as normal; single large vomit of coffee grounds; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Authority. The regulatory authority report number is GB-Regulatory Authority-WEBCOVID-20210108074254, Safety Report Unique Identifier GB-Regulatory Authority-ADR 24571133. An 84 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number not known) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. Patient very frail and end stage dementia. Patient has not had symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 05Jan2021, the patient experienced haematemesis. The patient was unwell post vaccine which was given 5 days prior to reaction occurring - looked ill, feeling tired, not mobilising as normal, off food, no fevers, not vomited until 5th January - single large vomit of coffee grounds. Ambulance called but died in the community. The post-mortem was not being done. Patient has not tested positive for COVID-19 since having the vaccine. The patient died on 05Jan2021. An autopsy was not performed. The outcome of haematemesis was fatal and the outcome of the events looked ill, feeling tired, not mobilising as normal was unknown. No follow-up attempts possible; information regarding batch/lot cannot be obtained.; Reported Cause(s) of Death: single large vomit of coffee grounds


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