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

Found 17,128 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

This is page 110 out of 172

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VAERS ID: 1268717 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-03-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood creatinine, Blood potassium, Blood pressure measurement, Blood sodium, Body temperature, C-reactive protein, Coma scale, Haemoglobin, Heart rate, Oxygen saturation, Parkinson's disease, Platelet count, Pyrexia, Respiratory rate, Urinary retention, Urinary sediment, Urinary tract infection, Urosepsis, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: OXAZEPAM; SIMVASTATINE; CHOLECALCIFEROL; ACETYLSALICYLIC ACID; BUMETANIDE; CARBASALATE CALCIUM; MICONAZOL [MICONAZOLE]; OMEPRAZOL; PARACETAMOL; ASCAL [CARBASALATE CALCIUM]
Current Illness: Parkinsonism; Vascular dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Amblyopia (amblyopia right eye); Transient ischaemic attack; VIth nerve paresis
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: creatinine; Result Unstructured Data: Test Result:71; Test Date: 20210401; Test Name: kalium; Result Unstructured Data: Test Result:3.8; Test Date: 20210401; Test Name: BP; Result Unstructured Data: Test Result:100/55; Test Date: 20210401; Test Name: BP; Result Unstructured Data: Test Result:105/74; Comments: Capillary refill 3sec; Test Date: 20210401; Test Name: sodium; Result Unstructured Data: Test Result:139; Test Date: 20210331; Test Name: pyrexia; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Test Date: 20210401; Test Name: pyrexia; Result Unstructured Data: Test Result:37 Centigrade; Test Date: 20210401; Test Name: Coma scale; Result Unstructured Data: Test Result:E3M5V4; Test Date: 20210401; Test Name: CRP; Result Unstructured Data: Test Result:33; Test Date: 20210401; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.9; Test Date: 20210401; Test Name: pulse; Result Unstructured Data: Test Result:78; Comments: regular; Test Date: 20210401; Test Name: Normopnoea sat; Result Unstructured Data: Test Result:98 %; Comments: normal; Test Date: 20210401; Test Name: sat 97% with KL; Result Unstructured Data: Test Result:97; 98 %; Test Date: 20210401; Test Name: thrombocyte; Result Unstructured Data: Test Result:192; Test Date: 20210401; Test Name: RR; Result Unstructured Data: Test Result:16; Test Date: 20210401; Test Name: urine sediment; Result Unstructured Data: Test Result:71-200; Test Date: 20210401; Test Name: leucocytes; Result Unstructured Data: Test Result:400; Test Date: 20210401; Test Name: leucocytes; Result Unstructured Data: Test Result:8.2
CDC Split Type: NLPFIZER INC2021453660

Write-up: next day urosepsis; Retention of urine; weakness; Fever: 38 to 40.5 degrees Celcius; first day after administration fever; Worsening of Parkinson''s disease, making it virtually impossible for him to drink, eat and speak: severe, will probably die from it; urinary tract infection; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00509789. This is first of two reports. A contactable physician reported that a 81-year-old male patient received second dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, lot number: ET3674) via an unspecified route of administration on 30Mar2021 as single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, lot number: ET3674) via an unspecified route of administration on 25Feb2021 at 0.3ml as single dose for COVID-19 immunisation, the patient experienced reduced general condition from first dose. Medical history included transient ischaemic attack on 20Jan2011, sixth nerve paresis from 20Jan2011, vascular dementia(ongoing) , amblyopia right eye from 01Jan2010, parkinsonism (ongoing). Concomitant medication(s) included oxazepam 10mg 1 dose once a day, simvastatine 40mg 1 dose once a day, cholecalciferol 5600 IU; acetylsalicylic acid tablet 80mg, bumetanide tablet 1mg 1 dose once a day, carbasalate calcium powder 100mg, miconazol [miconazole] creame creme 20mg/g,omeprazole (OMEPRAZO) tablet gastro-resistant 20mg 1 dose once a day, paracetamol, carbasalate calcium (ASCAL) 80mg once a day. The patient did not had previously Covid-19 infection.On 31Mar2021, the day after vaccination patient got pyrexia (38 to 40.5 degrees celcius) and parkinson''s disease aggravated, the next day (On 01Apr2021) he was severely weakened, had urinary retention and urosepsis. A urinary tract infection was diagnosed in hospital. Also the patient developed aggravation of Parkinson''s disease, which caused a reduced oral intake, which caused dehydration. Aggravation of Parkinson''s disease making it virtually impossible for him to drink, eat and speak. Patient also was not responsive. The events were treated with intravenous antibiotics, later oral Augmentin and intravenous fluids. On 01Apr2021, lab test performed were blood pressure was 100/55 and 105/74, oxygen saturaion 97%, respiratory rate 16 and Urinary sediment test include Leucocytes 400 and erytrocytes 71-200, hemoglobin 8.9, leucocytes 8.2, thrombocytes 192, Sodium 139, Kalium 3.8, Creatynine 71, C-reactive protein 33 ,oxygen saturation was 98%, Powerful pulse, 100/55 pulse 78 regular, not pale, not clammy, not sweaty and Glasgow coma scale result was E3M5V4. On 01Apr2021, Since the morning acutely worse reaction, reduced EMF, reacts enormously variable. On urine stick erythrocytes + leucocytes + and 600cc catheter and was taken to emergency room presented with impaired consciousness, possibly with hypotension, or with delirium in infection. The patient was speaking with words and a few sentences and was not bothered by anything. There was a urinary tract infection, started at the emergency room with augmentin gentamycin. The outcome of event pyrexia, severely weakened, urinary retention and urosepsis was recovering and outcome of event urinary tract infection was unknown. On unspecified date patient died due to parkinson''s disease aggravated. No follow-up attempts possible. No further information expected. Information on lot and batch numbers already obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021456614 the same patient/reporter but different events/doses; Reported Cause(s) of Death: Parkinson''s disease aggravated


VAERS ID: 1268723 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Mental retardation; Psychotic episode
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021453396

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable nurse downloaded from a regulatory authority- WEB, regulatory authority number SE-MPA-2021-029257. A 61-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: EP2163) via unspecified route single dose for COVID-19 immunisation on unknown date in Mar2021. Medical history included: asthma, slightly mentally retarded with psychotic episodes; all ongoing. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 (COMIRNATY, lot number: EL0725) for COVID-19 immunization on 11Feb2021. The patient had pulmonary embolism 3 weeks after second vaccination in Apr2021. The patient was in sudden death, autopsy was done and showed it was pulmonary embolism. Cause of death was pulmonary embolism. Outcome of the event was fatal. It was assessed as serious due to death. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1269866 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   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: LORMETAZEPAM; FUROSEMIDE; METFORMIN; CONGESCOR; SOLDESAM; PANTOPRAZOLE; CARDIOASPIRIN
Current Illness: Antiinflammatory therapy; Anxiety; Cardiac failure; Cardiomyopathy; Chronic gastritis; Diabetes; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death; This regulatory authority case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. The patient''s past medical history included Antiinflammatory therapy since an unknown date. Concurrent medical conditions included Cardiomyopathy, Chronic gastritis, Cardiac failure, Diabetes, Hypertension arterial and Anxiety. Concomitant products included DEXAMETHASONE SODIUM PHOSPHATE (SOLDESAM) from 07-Apr-2021 to an unknown date for Antiinflammatory therapy, LORMETAZEPAM from 07-Apr-2021 to an unknown date for Anxiety, BISOPROLOL FUMARATE (CONGESCOR) from 07-Apr-2021 to an unknown date for Cardiac failure, ACETYLSALICYLIC ACID (CARDIOASPIRIN) from 07-Apr-2021 to an unknown date for Cardiomyopathy, PANTOPRAZOLE from 07-Apr-2021 to an unknown date for Chronic gastritis, METFORMIN from 07-Apr-2021 to an unknown date for Diabetes, FUROSEMIDE from 07-Apr-2021 to an unknown date for Hypertension arterial. On 07-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 08-Apr-2021 The patient died on 08-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were not provided. Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1269867 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Gaze palsy, Heart rate, Oxygen saturation, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   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: TARGINIQ; DICLOREUM [DICLOFENAC]; OXATOMIDE
Current Illness:
Preexisting Conditions: Comments: Relevant medical history still needs to be translated
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: blood pressure; Result Unstructured Data: 110/80; Test Date: 20210409; Test Name: heart rate; Test Date: 20210409; Test Name: SO2; Result Unstructured Data: 100 %
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death; BP 110/80 P 100 SO2 100% This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021. The most recent information was received on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), GAZE PALSY and SEIZURE. BP 110/80 P 100 SO2 100% in a 68-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3001655) for COVID-19 vaccination. Relevant medical history still needs to be translated. Concomitant products included NALOXONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE (TARGINIQ), DICLOFENAC (DICLOREUM [DICLOFENAC]) and OXATOMIDE for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced GAZE PALSY (seriousness criterion medically significant) and SEIZURE (seriousness criterion medically significant). On 11-Apr-2021, GAZE PALSY and SEIZURE outcome was unknown. The patient died on 11-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Blood pressure measurement: 110/80 110/80. On 09-Apr-2021, Heart rate: 100. On 09-Apr-2021, Oxygen saturation: 100 % 100 %. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Death event added, the outcome were changed for other than death event.; Reporter''s ; Sender''s Comments: Limited translated information regarding the events has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1272743 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ARJNJFOC20210455424

Write-up: DEATH; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 08-APR-2021, the patient died from unknown cause of death three days after vaccination (vaccinated on 05-APR-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death); Sender''s Comments: 20210455424-Covid-19 vaccine ad26.cov2.s-death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1272749 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-04-01
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, Immobilisation syndrome, Marasmus, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AKINETON RETARD; CITALOPRAM; TRITTICO; HALDOL; JANUVIA [SITAGLIPTIN PHOSPHATE]
Current Illness: Dementia; Depression; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Carcinoma breast; Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: PCR-Test; Test Result: Positive ; Comments: after the 2nd vaccination
CDC Split Type: ATPFIZER INC2021463125

Write-up: Geromarasmus/Marasmus senilis; Immobilisation/Immobilisation prolonged; asymptomatic positive Covid-19 test after the second vaccination; asymptomatic positive Covid-19 test after the second vaccination; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB with regulatory authority number AT-BASGAGES-2021-22236. An 85-year-old female patient received bnt162b2 (COMIRNATY), dose 2 on 02Feb2021 (Lot Number: EL1491; Expiration Date: 30Apr2021); and dose 1 on 14Jan2021 (Lot Number: EJ6797; Expiration Date: 30Apr2021), both intramuscularly as a single dose for covid-19 immunisation. Medical history included ongoing dementia, ongoing depression, ongoing type 2 diabetes mellitus, mamma carcinoma from 2014 to an unknown date (reported as not ongoing) and lived in a retirement home. The patient''s weight was not reported, and height was not reported. Concomitant medications included biperiden hydrochloride (AKINETON RETARD); citalopram; trazodone hydrochloride (TRITTICO); haloperidol (HALDOL); and sitagliptin phosphate (JANUVIA), all indication, start and stop date were not reported. It was reported that the patient had lack of efficacy after 2 vaccinations (vaccine failure) and died on 09Apr2021. The patient had his first dose on 14Jan2021 but did not have symptoms after vaccination while on the second dose on 02Feb2021, the patient was positive PCR test after the second vaccination. The patient was asymptomatic, and the test reason was a screening project. The patient was not hospitalization as the patient lived in a retirement home. No signs of infection at the time of vaccination. On 01Apr2021, the patient experienced COVID-19 PCR test positive. On 09Apr2021, the patient experienced asymptomatic COVID-19. The patient experienced also Geromarasmus (marasmus senilis) on an unspecified date. The patient also had immobilization (immobilisation prolonged) on an unspecified date. The outcome of the events was fatal. It was also reported that the outcome of asymptomatic COVID-19 was not recovered. The patient died on 09Apr2021. An autopsy was not performed. The cause of death was reported as geromarasmus, immobilisation prolonged, asymptomatic covid-19 and vaccination failure. No follow-up attempts needed. No further information is expected.; Reported Cause(s) of Death: Immobilisation/Immobilisation prolonged; asymptomatic positive Covid-19 test after the second vaccination; Marasmus senilis/Geromarasmus; asymptomatic positive Covid-19 test after the second vaccination


VAERS ID: 1272752 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-18
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: Obesity; Hypertension (Hypertension); Type 2 diabetes mellitus (diabetes mellitus II)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021463123

Write-up: central pulmonary embolism on both sides; deep vein thrombosis on the right popliteal vein; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB local regulatory authority number AT-BASGAGES-2021-23461. A 79-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 02Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing hypertension, ongoing adipositas, ongoing type 2 diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced central pulmonary embolism on both sides and deep vein thrombosis on the right popliteal vein on 18Apr2021. Therapeutic measures were taken as a result of the events which included systemic lysis therapy. The patient died on the intensive care unit on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts needed, batch/lot. no. will be followed-up by RA and automatically provided as soon as available. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolism; Popliteal vein thrombosis


VAERS ID: 1272761 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysarthria, Fine motor skill dysfunction, Lethargy, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021469687

Write-up: Dysarthria; Fine motor skill dysfunction; Lethargy; Loss of consciousness; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority. Regulatory authority report number is 539728. A 91-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced dysarthria, fine motor skill dysfunction, lethargy, loss of consciousness on 01Apr2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. The reported cause of death was dysarthria, fine motor skill dysfunction, lethargy, loss of consciousness. Outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Dysarthria; Fine motor skill dysfunction; Lethargy; Loss of consciousness


VAERS ID: 1272762 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease progression
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470404

Write-up: Concomitant disease progression; This is a spontaneous report from a contactable other health professional received from a regulatory authority, regulatory authority report number is 539893. An 87-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced concomitant disease progression on an unspecified date and died on an unspecified date due to the event. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Concomitant disease progression


VAERS ID: 1272763 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-07
Submitted: 0000-00-00
Entered: 2021-04-30
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: AUPFIZER INC2021470406

Write-up: adverse event following immunization and caused death; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 542243. A 94-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. It is unknown if the patient is pregnant at the time of vaccination. On 07Apr2021, patient experienced adverse event following immunization and caused death. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: adverse event following immunization and caused death


VAERS ID: 1272764 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-21
Submitted: 0000-00-00
Entered: 2021-04-30
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: 2021-04-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470407

Write-up: Adverse event following immunisation with fatal outcome; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 542302. A 91-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced adverse event following immunisation with fatal outcome on 21Apr2021. 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: Adverse event following immunisation with fatal outcome


VAERS ID: 1272765 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-07
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Depressed level of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470408

Write-up: Depressed level of consciousness; This is a spontaneous report from a contactable other health professional via a regulatory authority. Regulatory authority report number is 542222. An 85-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced depressed level of consciousness on 07Apr2021. The outcome of the event was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Depressed level of consciousness


VAERS ID: 1272766 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470409

Write-up: General physical health deterioration; This is a spontaneous report from a contactable health professional via the Regulatory Authority. Regulatory authority report number is 539895. A 93-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced general physical health deterioration (death) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1272767 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-16
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470410

Write-up: Pneumonia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 539979. An 81-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 16Apr2021, the patient experienced pneumonia. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1272768 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-04
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470411

Write-up: Dyspnoea; Vomiting; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 540098. An 82-years-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. The patient experienced dyspnoea and vomiting (both seriousness criteria: death) on 04Apr2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Event outcome for events was fatal. No follow up attempts are possible; Information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Dyspnoea; Vomiting


VAERS ID: 1272769 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-18
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease progression
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470412

Write-up: Concomitant disease progression; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 540595. A 100-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced concomitant disease progression on 18Apr2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Concomitant disease progression


VAERS ID: 1272770 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-19
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypotension, Loss of consciousness, Nausea, Pain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470413

Write-up: Hypotension; Loss of consciousness; Nausea; Pain; This is a spontaneous report from a contactable other health professional via a regulatory authority, regulatory authority report number is 540763. A 92-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. It was unknown if the patient was pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. On 19Apr2021, the patient experienced hypotension, loss of consciousness, nausea, and pain. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Hypotension; Loss of consciousness; Nausea; Pain


VAERS ID: 1272771 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-16
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock
SMQs:, Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470414

Write-up: Cardiogenic shock; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 541164. A 90-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cardiogenic shock (death) on 16Apr2021 with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiogenic shock


VAERS ID: 1272772 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock
SMQs:, Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470415

Write-up: Cardiogenic shock; This is a spontaneous report from a contactable other health professional via a regulatory authority. Regulatory authority report number is 541331. A 91-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cardiogenic shock (death) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiogenic shock


VAERS ID: 1272790 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemoptysis, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASAFLOW; NEXIAM [ESOMEPRAZOLE MAGNESIUM]; VENORUTON FORTE; ZESTRIL; FURADANTINE MC; CALCIUM; LORMETAZEPAM EG; KREDEX; MS DIRECT; D-CURE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer (operated in ''89); Cancer surgery (operated in ''89); Cardiac pacemaker replacement; Cholecystectomy; Gastric ulcer; Glaucoma; Ischiopubic fracture; Knee osteoarthritis; Knee replacement; Lung disease; Myocardial infarction; Omentectomy; Pyelonephritis; Sepsis; Skin cancer; Spinal compression fracture; Total hysterectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021463080

Write-up: She woke up in the middle of the night and couldn''t breathe; She coughed up some blood; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority- WEB, regulatory authority number BE-FAMHP-DHH-N2021-87602. This spontaneous COVID-19 report received by the Belgian authorities on 07Apr2021. An 87-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included myocardial infarction from 01Jan2002 to an unknown date, pyelonephritis (with sepsis), gastric ulcer, spinal compression fracture of the pelvis on 20Dec2012, new branch ilio and ischiopubic fracture left on 10Feb2016, infectious right lung disease on 17Dec2018, breast cancer right operated on an unknown date (reported as "in ''89"), skin cancer in the back from an unknown date and unknown if ongoing, total knee replacement left on 15May2013, total radical hysterectomy and omentectomy in the context of a large adnexal cystic mass left (mucinous cystadenocarcinoma) on 04Jul2019, cholecystectomy and eventration treatment (plaque) on 10Jul2019, had a pacemaker in 2004, knee osteoarthritis from 18Jul2012, and glaucoma from 18Jul2012. Concomitant medications included acetylsalicylic acid (ASAFLOW), esomeprazole magnesium (NEXIAM [ESOMEPRAZOLE MAGNESIUM]), troxerutin (VENORUTON FORTE), lisinopril (ZESTRIL), nitrofurantoin (FURADANTINE MC), calcium lormetazepam (LORMETAZEPAM EG), carvedilol (KREDEX), morphine sulfate (MS DIRECT), and colecalciferol (D-CURE), all taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin and amoxicillin and experienced drug hypersensitivity with both. The patient (reporter''s mother in law) was vaccinated on April 2 and died the night of April 3-4. She woke up in the middle of the night and couldn''t breathe. She coughed up some blood. By the time help arrived, she was gone. They tried to revive her but was unsuccessful. She was 87 years old and had worn a pacemaker for over 20 years. But was in good shape the days before. The outcome of the events was fatal. The patient died on 04Apr2021. It was not reported if an autopsy was performed. Relatedness of drug to reactions/events: Result of Assessment: unclassifiable. Reporter''s comments: My mother-in-law was vaccinated on April 2 and died the night of April 3-4. She woke up in the middle of the night and couldn''t breathe. She coughed up some blood. By the time help arrived, she was gone. They tried to revive her but was unsuccessful. She was 87 years old and had worn a pacemaker for over 20 years. But was in good shape the days before. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: My mother-in-law was vaccinated on April 2 and died the night of April 3-4. She woke up in the middle of the night and couldn''t breathe. She coughed up some blood. By the time help arrived, she was gone. They tried to revive her but was unsuccessful. She was 87 years old and had worn a pacemaker for over 20 years. But was in good shape the days before.; Reported Cause(s) of Death: She woke up in the middle of the night and couldn''t breathe; She coughed up some blood


VAERS ID: 1272793 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   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: ATORSTATINEG
Current Illness: Cognitive impairment (marked cognitive decline in the last 2 years)
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Double vision; Memory impairment
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021463118

Write-up: death in bed; felt unwell; Vomited once; Nausea; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority -WEB, regulatory authority number BE-FAMHP-DHH-N2021-88073. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 08Apr2021 (Batch/Lot Number: ET3674) as single dose for covid-19 immunisation. Medical history included ongoing marked cognitive decline in recent months (in the last 2 years), double vision, and cannot be remembered for longer than a few hours. The patient, his wife and son say, has shown marked cognitive decline in recent months. The stories that both do are in any case very suspicious of an incipient dementia. The degree of self-reliance was definitely on the decline in recent months. The patient no longer dared to drive a car, did not go shopping anymore did not take care of the garden anymore. Concomitant medication(s) included atorvastatin calcium (ATORSTATINEG) taken for an unspecified indication, start and stop date were not reported. the patient experienced nausea, feeling unwell, vomiting and died in his sleep. Around 7 am on Friday (09Apr2021) afternoon, patient felt unwell, brief episode of nausea and vomited once, afterwards he felt better. Just go to sleep on a Friday night. Sleeping peacefully on Saturday morning at 6 am. He went to sleep on a Friday night and was sleeping peacefully on Saturday (10Apr2021) morning at 6 am. His wife gets up at 6 o''clock and goes to wake the patient at 8 o''clock but found him quite cooled in bed. The patient died on 10Apr2021. It was not reported if an autopsy was performed. Result of assessment: Comirnaty/ Events: Nausea, Feeling unwell, Vomiting, Died in sleep/Regulatory Authority: unclassifiable No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1272794 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Back pain, Blood alkaline phosphatase, Blood alkaline phosphatase increased, Blood culture, Blood potassium, Burning sensation, C-reactive protein, Chills, Coagulopathy, Cutaneous vasculitis, Fibrin D dimer increased, Fibrin degradation products, Immunology test, International normalised ratio, Investigation, Magnetic resonance imaging, Malaise, Mini mental status examination, Nausea, Pyrexia, SARS-CoV-2 test, Skin disorder, Spinal pain, Sudden death, Urticaria, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (broad), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vasculitis (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LIXIANA; SERTRALINE; SOTALOL; GLUCENORM; GALVUS; INDAPAMIDE; D CURE; LYRICA; BROMAZEPAM; L THYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia (Permanent VK Flutter, min 45 / min. Max pause 2.5 sec. R); Attention impaired; Bone disorder (Pathological bone structure in the corpus of Th9 advocating for hemangioma); Breast neoplasm malignant female; Chemo cauterization (left chemo cauterization in the context of recurrent epistaxis left); Cholangitis (Episode of cholangitis, probably due to passage of a gallstone, cholelithiasis); Cholecystectomy; Chronic cholecystitis (APO: Chronic Cholecystitis. Perop cholangio negative for CDL (choledocholithiasis)); Depression (Exhaustion-depressive board); Endoscopic retrograde cholangiopancreatography (ERCP due to residual lithiasis in the bile ducts); Epistaxis (left chemo cauterization in the context of recurrent epistaxis left); Folic acid deficiency; Hospitalization (Admission with fever and shivering); Irritable; Lithiasis (ERCP due to residual lithiasis in the bile ducts); Mastectomy (2 mastectomies of which 1 with proven local malignancy); Migraine (migraine in her early years); Sepsis (E coli sepsis, presumably urinary); Thyroid disorder NOS; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 201806; Test Name: CT angio; Result Unstructured Data: Test Result:reticular injury both lower lobes; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:108 U/L; Test Date: 20210404; Test Name: hemoculture; Test Result: Negative ; Comments: hemocultures on 04Apr2021 negative (result on 10Apr2021); Test Date: 20210404; Test Name: K; Result Unstructured Data: Test Result:3.1 mmol/L; Test Date: 20210405; Test Name: K; Result Unstructured Data: Test Result:2.8 mmol/L; Test Date: 20210404; Test Name: CRP; Result Unstructured Data: Test Result:6.7; Test Date: 20210405; Test Name: CRP; Result Unstructured Data: Test Result:135 mg/dl; Test Date: 20210404; Test Name: highly increased D dimers; Result Unstructured Data: Test Result:3227; Test Date: 20210405; Test Name: highly increased D dimers; Result Unstructured Data: Test Result:934; Test Date: 20210405; Test Name: IEF; Result Unstructured Data: Test Result:IEF: monoclonal IgG type lambda, (previously unkno; Comments: IEF: monoclonal IgG type lambda, (previously unknown, new); Test Date: 20210404; Test Name: INR; Result Unstructured Data: Test Result:1.33; Test Date: 20210405; Test Name: INR; Result Unstructured Data: Test Result:1.52; Test Date: 20210406; Test Name: clinical examination; Result Unstructured Data: Test Result:clinical examination was not abnormal except for v; Comments: clinical examination was not abnormal except for vasculitis.; Test Name: Other colestatic tests; Result Unstructured Data: Test Result:normal; Test Date: 201807; Test Name: NMR; Result Unstructured Data: Test Result:NMR shows some old vasculo-ischemic lesions; Test Date: 201807; Test Name: MMSE; Result Unstructured Data: Test Result:22/30; Test Date: 20210406; Test Name: PCR; Test Result: Negative ; Comments: post mortem PCR covid negative; Test Date: 20210406; Test Name: RXTX and RX abdomen; Result Unstructured Data: Test Result:RXTX and RX abdomen showed no major signs
CDC Split Type: BEPFIZER INC2021463115

Write-up: On the back a zone of redness / urticarial up to the spine; Shivering; Malaise; Painful feeling at the spine / back, band-shaped to the front of the thorax; Extensive zone of vasculitis from armpit to right hip crest (A4 size vertical); Nausea; Burning feeling; Painful feeling at the spine / back, band-shaped to the front of the thorax; alk phosphatases very slightly increased (108 U / l); Blood clotting problem; Fever; Sudden death; Skin problem; Highly elevated D dimers 3227; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-88081. A 87-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, lot number was not reported), via an unspecified route of administration on 26Mar2021 at a single dose for covid-19 immunisation. Medical history included migraine( migraine in her early years), depression (Exhaustion-depressive board), attention disorder, irritable, arrhythmia from May2020 (Permanent VK Flutter, min 45 / min. Max pause 2.5 sec. R), pathological bone from Jun2018 (Pathological bone structure in the corpus of Th9 advocating for hemangioma. Concave indentation of the cover plate Th12 with wedge-shaped ventral flattening), recurrent epistaxis (left chemocauterization in the context of recurrent epistaxis left), chemocauterisation from Oct2018 (left chemocauterization in the context of recurrent epistaxis left), diabetes type 2, thyroid disease, folic acid deficiency, cholangitis from Jul2018 (Episode of cholangitis, probably due to passage of a gallstone, cholelithiasis), hospitalization (Admission with fever and shivering. Suspicion of small abscesses or fluid collections due to cholangitis. A total of 12 days of antibiotic treatment, to continue cirpoxin after discharge. No evidence for autoimmune hepatitis or PSC (primary sclerosing cholangitis)), laparoscopic cholecystectomy from 13Sep2018, chronic cholecystitis (APO: Chronic Cholecystitis. Perop cholangio negative for CDL (choledocholithiasis)), lithiasis (ERCP (endoscopic retrograde cholangiopancreatography) due to residual lithiasis in the bile ducts), endoscopic retrograde cholangiopancreatography from 02Oct2018 (ERCP (endoscopic retrograde cholangiopancreatography) due to residual lithiasis in the bile ducts), E coli sepsis from Jun2018 (E coli sepsis, presumably urinary), mastectomies (2 mastectomies of which 1 with proven local malignancy), and breast malignancy. Concomitant medication(s) included edoxaban tosilate (LIXIANA) taken for an unspecified indication, start and stop date were not reported; sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported; sotalol (SOTALOL) taken for an unspecified indication, start and stop date were not reported; glibenclamide, metformin hydrochloride (GLUCENORM) taken for an unspecified indication, start and stop date were not reported; vildagliptin (GALVUS) taken for an unspecified indication, start and stop date were not reported; indapamide (INDAPAMIDE) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D CURE) taken for an unspecified indication, start and stop date were not reported; pregabalin (LYRICA) taken for an unspecified indication, start and stop date were not reported; bromazepam (BROMAZEPAM) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (L THYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took lixiana on Jun2020 and experienced hemianopia; Jun2020 partial right hemianopsia and left frontal / occipital, shortly after starting with lixiana and sotalex. He previously took sotalex on Jun2020 as well; Jun2020 partial right hemianopsia and left frontal / occipital, shortly after starting with lixiana and sotalex. The patient experienced on the back a zone of redness / urticarial up to the spine (urticaria) (death, hospitalization) on 04Apr2021, shivering (chills) (death, hospitalization) on 04Apr2021, malaise (malaise) (death, hospitalization) on 04Apr2021, sudden death (sudden death) (death) on 06Apr2021, painful feeling at the spine / back, band-shaped to the front of the thorax (back pain) (death, hospitalization) on 04Apr2021, extensive zone of vasculitis from armpit to right hip crest (a4 size vertical) (cutaneous vasculitis) (death, hospitalization) on 04Apr2021, fever (pyrexia) (death) on 06Apr2021, alk phosphatases very slightly increased (108 u / l) (blood alkaline phosphatase increased) (death) on an unspecified date, blood clotting problem (coagulopathy) (death) on an unspecified date, nausea (nausea) (death, hospitalization) on 04Apr2021, highly elevated d dimers 3227 (fibrin d dimer increased) (death) on 04Apr2021, burning feeling (burning sensation) (death, hospitalization) on 04Apr2021, skin problem (skin disorder) (death) on 04Apr2021, painful feeling at the spine / back, band-shaped to the front of the thorax (spinal pain) (death, hospitalization) on 04Apr2021. The patient was hospitalized from 04Apr2021 to 06Apr2021. The patient underwent lab tests and procedures which included angiogram: reticular injury both lower lobes on Jun2018, blood alkaline phosphatase: 108 u/l on unknown date, blood culture: negative on 04Apr2021 hemocultures on 04Apr2021 negative (result on 10Apr2021), blood potassium: 3.1 mmol/l on 04Apr2021, blood potassium: 2.8 mmol/l on 05Apr2021, c-reactive protein: 6.7 on 04Apr2021, c-reactive protein: 135 mg/dl on 05Apr2021, fibrin degradation products: 3227 on 04Apr2021, fibrin degradation products: 934 on 05Apr2021, immunology test: ief: monoclonal igg type lambda, (previously unknown) on 05Apr2021 IEF: monoclonal IgG type lambda, (previously unknown, new) , international normalised ratio: 1.33 on 04Apr2021, international normalised ratio: 1.52 on 05Apr2021, investigation: clinical examination was not abnormal except for v on 06Apr2021 clinical examination was not abnormal except for vasculitis , investigation: normal on unknown date, magnetic resonance imaging: nmr shows some old vasculo-ischemic lesions on Jul2018. Outcome of all events are fatal. The patient died on 06Apr2021. An autopsy was performed, and results were not provided. Reporter''s comments: Examinations - On 04Apr2021 Highly increased D dimers 3227, INR (international normalised ratio) 1.33, CRP (C-reactive protein) 6.7 and K 3.1 On 05Apr D dim 934, INR 1.52, IEF: monoclonal IgG type lambda, (previously unknown, new) CRP 135 mg / dl , K 2.8 mmol / l death 06Apr2021 sudden and unexpected in the morning On 06Apr post mortem PCR covid negative one RXTX and RX abdomen showed no major signs. clinical examination was not abnormal except for vasculitis. A chest CT was not performed, given too few arguments for this on 04Apr2021. An abdominal ultrasound / endoscopy was still planned for Tuesday 04May2021, given the period of cholangitis in 2018 on stone after a CCE (cholecystectomy). Given differential diagnosis with cholangitis as the cause of shivering. alk phosphatases very slightly increased (108 U / l), other cholestatic tests normal. hemocultures on 04Apr2021 negative (result on 10Apr2021) complement factors: result not yet known This study could not continue, patient was found dead in the morning of 06Apr2021, after blood collection. Therapy: chronic medication when admitted on 04Apr2021 lixiana 30 mg per os sertraline 50 mg per day sotalol 2-40 mg per day glurenorm 3 * 1 co per day galvus 2 * 50 mg per day indapamide 2.5 mg per day D cure 1 amp 1-15th of the month lyrica 2 * 25 mg per day bromazepam sometimes L thyroxine 125 mcg per day on 04Apr2021 additional therapy was started augmentin 4 * 1 g iv. enterol 2 * 250 mg per day infusion with glucose 5% and 4 g Nacl, 20 meq Kcl, 1 amp magnesium, 1 amp litican / 12 hours, to be repeated three times. lixiana was replaced by clexane 2 * 60 mg per day on 05/04, 20 meqKcl was replaced by 40 meq Kcl over 12 hours, due to increased hypokalaemia. this was administered with a volumetric pump. 04Apr2021: Hospital admisison: Extensive zone of vasculitis from the armpit to the hip crest on the right (the size of an A4 sheet vertically). On the back a zone of redness / urticarial up to the spine. Burning feeling. Painful feeling at the spine / back, band-shaped to the front of the thorax. nausea, chills, malaise 05Apr2021: no extension of the injuries. at the back of the back less swelling / urticaria, still light brown vasculitis residual injuries 06Apr2021: sudden death in the morning. On 06Apr2021 post mortem pcr covid negative a RXTX and RX abdomen showed no major issues. clinical examination was not abnormal except for vasculitis. text for relevant medical history: CEREBROVASCULAR: - Migraine in her early years - Exhaustion-depressive board -Jul2018 NMR (nuclear magnetic resonance) shows some old vasculo-ischemic lesions. Sertraline therapy was continued. Attention disorders, irritable. To reevaluate. - Jun2020 partial right hemianopsia and left frontal / occipital, shortly after starting with lixiana and sotalex. MMSE 22/30. CARDIORENAL May2020 Permanent VK Flutter, min 45 / min. Max pause 2.5 sec. R / lixiana 30 mg and sotalol 2x40 m LOCOMOTOR: Jun2018 Pathological bone structure in the corpus of Th9 advocating for hemangioma. Concave indentation of the cover plate Th12 with wedge-shaped ventral flattening. RESPIRATORY: Jun2018 CT angio: reticular injury both lower lobes. Oct2018 left chemocauterization in the context of recurrent epistaxis left GASTRO INTESTINAL AND METABOLIC: Diabetes type 2-thyroid disease -folic acid deficiency -Jul2018 Episode of cholangitis, probably due to passage of a gallstone, cholelithiasis. Admission with fever and shivering. Suspicion of small abscesses or fluid collections due to cholangitis. A total of 12 days of antibiotic treatment, to continue cirpoxin after discharge. No evidence for autoimmune hepatitis or PSC (primary sclerosing cholangitis). 13Sep2018: lap cholecystectomy. APO: Chronic Cholecystitis. Perop cholangio negative for CDL (choledocholithiasis). 02Oct2018: ERCP (endoscopic retrograde cholangiopancreatography) due to residual lithiasis in the bile ducts UROGENITAL: - Jun2018 E coli sepsis, presumably urinary 2 mastectomies of which 1 with proven local malignancy. 26Mar2021 had Pfizer vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: on the back a zone of redness / urticarial up to the spine; shivering; malaise; sudden death; painful feeling at the spine / back, band-shaped to the front of the thorax; extensive zone of vasculitis from armpit to right hip crest (a4 size vertical);


VAERS ID: 1272795 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram thorax, Fatigue, Malaise, Respiratory disorder, Sudden death, Ultrasound kidney
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   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: MESTINON; ASAFLOW; COMBODART; PROSTA URGENIN; SIMVASTATIN SANDOZ; BRILIQUE; EMCONCOR; BURINEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute respiratory insufficiency; Arterial hypertension; Atrial fibrillation; Cerebral malaria; Chronic renal failure; Diabetes mellitus; Hemorrhagic cystitis (Negaban, AKI); Hospitalization; Hydronephrosis; Lung carcinoma; Lung lobectomy; Nephrolithiasis; Nephroureterectomy (robot-assisted laparoscopic radical nephro-ureterectomy left); Non STEMI; Peritonitis; Polymyalgia rheumatica (disease recurrence with phenotype of polymyalgia rheumatica); Pulmonary edema; Respiratory infection; Splenic hamartoma; Supraventricular tachycardia; Temporal arteritis; Transient ischemic attack (admission to geriatrics in connection with TIA with stenosis)
Allergies:
Diagnostic Lab Data: Test Date: 201911; Test Name: CT chest; Result Unstructured Data: Test Result:2 nodular abnormalities; Comments: Consultation pneumo because of determining 2 nodular abnormalities on CT chest for which further elaboration is ongoing; Test Date: 2019; Test Name: kidney ultrasound; Result Unstructured Data: Test Result:mass and hydronephrosis appear to have disappeared
CDC Split Type: BEPFIZER INC2021463119

Write-up: Respiratory disorder; Sudden acute death; morning after vaccine administration woke up tired; General malaise; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-88328. An 81-year-old male patient received the first dose of BNT162B2 (COMIRNATY; lot number: EW8904), via an unspecified route of administration on 09Apr2021 at a single dose for COVID-19 immunization. Medical history included arterial hypertension, peritonitis from 1951 to an unknown date, cerebral malaria from 1989 to an unknown date, diabetes mellitus from Aug2009 to an unknown date, polymyalgia rheumatica from Jan2021 to an unknown date (disease recurrence with phenotype of polymyalgia rheumatica ), nephrolithiasis from 02May2019 to an unknown date, hemorrhagic cystitis from Oct2019 to an unknown date, limited left hydronephrosis, hypertensive pulmonary edema and respiratory infection from Oct2019 to an unknown date for which intensive care admission (non-invasive ventilation), supraventricular tachycardia, atrial fibrillation, chronic renal failure from Nov2019 to an unknown date, VATS lobectomy of the left upper lobe from 21Feb2020 to an unknown date (for the two primary tumors: invasive spinocellular carcinoma pT2 and 1 or stage 2B with visceral pleural invasion (EGFR IHC 80%. PDL1 2%), mucinous adenocarcinoma pT1B and 0 or stage 1A2 (EGFR IHC 0%. ALK IHC negative. Ros1 IHC negative. PDL1 0%, partly given the age and comorbidity no adjuvant chemo post op), spinocellular lung carcinoma from Dec2019 to an unknown date, laparoscopic radical nephro-ureterectomy left (robot-assisted laparoscopic radical nephro-ureterectomy left), acute respiratory insufficiency, spleenoma, transient ischemic attack from Aug2020 to an unknown date (admission to geriatrics in connection with TIA with stenosis), arthritis temporalis from Mar2009 to an unknown date, and NSTEMI postop. Concomitant medications included pyridostigmine bromide (MESTINON, strength: 60 mg); acetylsalicylic acid (ASAFLOW, strength: 80 mg); dutasteride (strength: 0.5 mg), tamsulosin hydrochloride (strength: 0.4 mg)(COMBODART); serenoa repens (PROSTA URGENIN); simvastatin (SIMVASTATIN SANDOZ, strength: 20 mg); ticagrelor (BRILIQUE, strength: 90 mg); bisoprolol fumarate (EMCONCOR, strength: 2.5 mg); bumetanide (BURINEX, strength: 1 mg). The patient previously took Tazocin and Biclar for infection and hypertensive pulmonary edema; Medrol for polymyalgia rheumatica and arthritis temporalis. On 10Apr2021, the morning after vaccine administration patient woke up tired; had general malaise and respiratory disorder. Sudden acute death was reported on 10Apr2021. The patient did not receive any treatment for the reported events. The patient underwent lab tests and procedures which included CT chest which showed 2 nodular abnormalities, consultation pneumo because of determining 2 nodular abnormalities on CT chest for which further elaboration is ongoing in Nov2019 and kidney ultrasound and revealed mass and hydronephrosis appear to have disappeared in 2019. The outcome of the events was fatal. The patient died on 10Apr2021. It was not reported if an autopsy was performed. Reporter''s comments: Treatment: No. Evolution of the ADR: Died. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: Treatment: No. Evolution of the ADR: Died.; Reported Cause(s) of Death: Respiratory disorder; Sudden acute death; morning after vaccine administration woke up tired; General malaise


VAERS ID: 1272851 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-30
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: 2021-04-13
   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: Dementia with Lewy bodies; Prostate cancer; Stent insertion NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021453720

Write-up: surprisingly passed away; This is a spontaneous report from a non-contactable consumer or other non-HCP downloaded from the regulatory authority-WEB. Regulatory authority report number: DE-PEI-202100039476. A 75-year-old male patient received bnt162b2 (COMIRNATY) dose 1 via an unspecified route of administration on 08Apr2021 (Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included stent placement, Lewy body dementia, and prostate cancer. The patient''s concomitant medications were not reported. The patient surprisingly passed away on 13Apr2021. It was not reported if an autopsy was performed. This report is serious - death. Cause of death was reported as " Unknown cause of death." Sender Comment: On 08Apr2021 ... received his first Corona vaccination by Biontech. He did not have complaints after the vaccination. Unfortunately, he died very surprisingly on the following Tuesday, 13Apr2021, at the age of 75 years. He had multiple previous diseases like stents, Lewy body dementia and an already treated prostate cancer. On Monday, 12Apr2021, he still was seeing his dentist. On this day, I did not notice anything that he is doing worse. I would even say that his physical condition was pretty good. On Tuesday in the evening I found him dead lying down on the ground in his kitchen. According to the emergency physician he passed away at noon. Reported causality assessment: Source of assessment: PEI, Result of Assessment: Unclassifiable No follow-up attempts are needed, follow-up is automatically provided by EMA. Information about batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1272853 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute right ventricular failure, Angiogram, Circulatory collapse, Computerised tomogram, Echocardiogram, Electrocardiogram, Neurone-specific enolase, Pulmonary embolism
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure (Significant diseases according to the death certificate); Anoxic brain damage (Significant diseases according to the death certificate)
Allergies:
Diagnostic Lab Data: Test Name: Angio CT; Result Unstructured Data: Test Result:unknown results; Test Name: cranial CT; Result Unstructured Data: Test Result:brain edema; Test Name: CT thorax; Result Unstructured Data: Test Result:proof of a fresh pulmonary embolism; Test Name: ECHO; Result Unstructured Data: Test Result:massive right-heart load; Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Name: NSE; Result Unstructured Data: Test Result:high
CDC Split Type: DEPFIZER INC2021453723

Write-up: Exitus letalis/Acute right ventricular failure; fulminant lung embolism; Collapse with pre-clinical reanimation; This is a spontaneous report from a non-contactable healthcare professional downloaded from the Regulatory Authority-WEB. This is a report received from an Institute, regulatory authority report number: DE-PEI-202100039699. An 81-year-old male patient received bnt162b2 (COMIRNATY; lot number EP2163), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunisation. Medical history included severe anoxic brain damage and acute renal failure (significant diseases according to the death certificate). The patient''s concomitant medications were not reported. On 09Mar2021, the patient experienced exitus letalis/acute right ventricular failure, fulminant lung embolism and collapse with pre-clinical reanimation. According to the family doctor, there were no relevant previous diagnoses. The patient underwent lab tests and procedures on an unspecified date which included angio CT and ECG with unknown results, cranial CT showed a brain edema and it speaks for a very bad neurologic prognosis due to this palliative procedure; CT thorax showed a proof of a fresh pulmonary embolism, High NSE value, and echocardiogram showed a massive right-heart load. The patient died on 09Mar2021 due to the events. It was not reported if an autopsy was performed. Sender Comment: Date of death according to the death certificate: 09Mar2021 (according to report: 04Mar2021). Angio CT. According to the family doctor no relevant previous diagnoses. Significant diseases according to the death certificate: severe anoxic brain damage, acute renal failure. "Presentation under continuous reanimation. ECHO showed a massive right-heart load. CT thorax showed a proof of a fresh pulmonary embolism. High NSE value, ECG, cranial CT showed a brain edema. It speaks for a very bad neurologic prognosis. Due to this palliative procedure." Reported causality assessment: Source of assessment: An Institute Result of Assessment: Unclassifiable (for all events) No follow-up attempts needed; follow-up automatically provided by EMA.; Reported Cause(s) of Death: fulminant lung embolism; Collapse with pre-clinical reanimation; Acute right ventricular failure


VAERS ID: 1272855 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021453755

Write-up: COVID-19 pneumonia; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority report number: DE-PEI-202100039831). A non-contactable consumer reported that an 89-year-old female patient received BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) on 12Jan2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient''s medical history was not reported. There were no concomitant medications. On 18Jan2021, the patient had COVID-19 pneumonia. The patient was hospitalized in Jan2021 due to the event, and the event was reported to be life-threatening. The patient had died on 25Jan2021 due to COVID-19 pneumonia. It was unknown if an autopsy was performed. The reporter''s assessment on the causal relationship between the suspect vaccine and the event was ''unclassifiable''. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1272856 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021453767

Write-up: Death; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100039833. A 90-year-old male patient received bnt162b2 (COMIRNATY) (at 90 years of age), via an unspecified route of administration on 12Jan2021 (Batch/Lot Number: Unknown) as 0.3 mL, single for COVID-19 immunisation and Prophylactic vaccination. Medical history included COVID-19 from 14Jan2021 to an unknown date. The patient''s concomitant medications were not reported. Patient''s death was reported. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are needed; follow-up automatically provided by Regulatory Authority. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1272857 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Cardiac ventricular thrombosis, Cardiogenic shock, Coronary artery disease, Electrocardiogram, Myocardial infarction
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Other ischaemic heart disease (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   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: Aortic stenosis; Arterial hypertension; Chronic renal failure; Hip replacement (right); Hyperuricemia; Multiple vessel coronary artery disease; Pacemaker insertion (cardiac) (AV block III. Grade); Percutaneous coronary intervention; Polycythaemia vera
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:unknown result
CDC Split Type: DEPFIZER INC2021463130

Write-up: Malignant cardiac arrhythmias as a result of myocardial infarction in coronary 2-vessel disease; Large ventricular thrombus; Malignant cardiac arrhythmias as a result of myocardial infarction in coronary 2-vessel disease; Malignant cardiac arrhythmias as a result of myocardial infarction in coronary 2-vessel disease; cardiogenic shock; This is a spontaneous report from a non-contactable healthcare professional downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-202100040589. A 73-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Apr2021 (Batch/Lot Number: Unknown) as 0.3 mL, single dose for COVID-19 immunisation. Medical history included multiple vessel coronary artery disease, circumflex branch percutaneous coronary intervention, aortic stenosis, DDD pacemaker implantation (AV block III grade) in Nov2018, arterial hypertension, chronic renal failure, Polycythaemla vera, hyperuricemia and hip replacement (right) in 2011. The patient''s concomitant medications were not reported. On 13Apr2021, the patient experienced cardiac arrhythmia, infarct myocardial and large ventricular thrombosis. The patient''s death was most likely in the context of a malignant heart rhythm stomping with cardiogenic shock as a result of a myocardial infarction with known coronary 2-vessel disease. The events resulted in death and reported as life threatening. The patient was hospitalized due to events. The patient had ECG on unspecified date with unknown result. The patient died on 13Apr2021. It was not reported if an autopsy was performed. COMIRNATY and all events was reported as unclassifiable per PEI. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: cardiogenic shock; Malignant cardiac arrhythmias as a result of myocardial infarction in coronary 2-vessel disease; Malignant cardiac arrhythmias as a result of myocardial infarction in coronary 2-vessel disease; Large ventricular thrombus; Malignant


VAERS ID: 1272859 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021463075

Write-up: Infarct myocardial; This is a spontaneous report from a non-contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100040756. A 69-year-old female patient received bnt162b2 (COMIRNATY, Strength: 0.3 mL, lot number was not reported), via an unspecified route of administration on 14Apr2021 (at the age of 69-years-old) as a single dose for prophylactic vaccination (covid-19 immunisation). The patient medical history included coronary disease from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced infarct myocardial on 14Apr2021. The outcome of the event was fatal. Cause of death was infarct myocardial. The patient died on 18Apr2021. An autopsy was not performed. Comirnaty/ Infarct myocardial/Regulatory Authority/ Unclassifiable. Sender Comment: Course: No actual symptoms after vaccination known, in the night of 17Apr to 18Apr. deceased, connection with vaccination cannot be excluded, autopsy refused by the family. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1272861 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dyskinesia, Dyspnoea, Fatigue, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dyskinesia (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adipositas per magna; Coughing; Depression; Leg oedema; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021463122

Write-up: Asystole; Dyspnea; Tiredness; Tremor; Jerkiness; This is a spontaneous report from a non-contactable other health professional, downloaded from the Agency Regulatory Authority-WEB, Regulatory authority report number: DE-PEI-202100041173. A 52 years old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: ET3045) as a single dose for COVID-19 immunization. Medical history included adipositas per magna, coughing, leg oedema, depression, and smoker - from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 15Apr2021, the patient experienced tremor and jerkiness. On 18Apr2021, the patient experienced tiredness. On 19Apr2021, the patient experienced asystole and dyspnea. The patient died on 19Apr2021. Autopsy was performed and results were not provided. This report is serious - death. The patient died from asystole, while the outcome of the rest of the events was unknown. Sender Comment: On 19Apr2021, he did not get up, he was tired and did not communicate any complaints. He did not show any pain symptoms. The partner who is severely disabled and uses a wheelchair heard the patient lying in bed sniffing around 1 p.m. and called for ambulance with a delay because the phone was out of reach. The emergency physician stated the death was due to asystole, and the resuscitation was unsuccessful. The post-mortem examination revealed adipositas per magna and slight bilateral oedema of the both legs. According to the patient''s partner, the patient used to suffer from permanent cough (non-prescription cough medications were found in a cupboard) and had been a smoker for a long time. No headache or fever was reported after the vaccination. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Asystole


VAERS ID: 1272862 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock
SMQs:, Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021463085

Write-up: most likely cardiogenic shock; This is a spontaneous report from a non-contactable other healthcare professional (HCP) downloaded from the regulatory authourity-WEB. The regulatory authority report number is [DE-PEI-202100041900]. A 79-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 14Apr2021 (at the age of 79-years-old) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of COMIRNATY at 0.3mL on an unspecified date for COVID-19 immunisation. On 16Apr2021, the patient experienced death, most likely cardiogenic shock. The patient died on 16Apr2021. It was unknown if an autopsy was performed. Sender Comment: temporal connection to vaccination 14Apr2021 but had no spec. Complaints according to relatives. The causality assessment for suspect drug Comirnaty to all events was reported as follows: Source of assessment: PEI, Result of Assessment: D. Unclassifiable No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiogenic shock


VAERS ID: 1272864 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-21
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Hyponatraemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021463093

Write-up: Unknown cause of death; This is a spontaneous report downloaded from the Agency Regulatory Authority (Regulatory Authority report number: DE-PEI-202100041903). A non-contactable physician reported that an 83-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: ET3045; Expiration date was not reported, Lot Number: ET3045; Expiration date was not reported) on 17Apr2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included arterial hypertension and hyponatraemia; both were unknown if ongoing. The patient''s concomitant medications were not reported. On 21Apr2021, the patient had died of an unknown cause. The cause of death was not reported. It was unknown if an autopsy was performed. The reporter''s assessment on the causal relationship between the suspect vaccine and the event was unclassifiable. No follow-up attempts are possible. No further information is expected. Information on batch/lot number was already obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1272865 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-04-05
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021463083

Write-up: Cerebral haemorrhage; Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100042007. An 85-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 24Mar2021, single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 05Apr2021 the patient experienced Cerebral haemorrhage, Unknown cause of death. The patient''s outcome was: fatal for Cerebral haemorrhage, fatal for Unknown cause of death. This report is serious - death, hospitalization, life threatening. Patient died on 05Apr2021, unknown if autopsy was performed. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage; Death in the hospital


VAERS ID: 1272867 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Artificial cardiac pacemaker user; Dialysis (dialysis patient); Vascular shunt
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke (four months ago (unspecified date))
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021463120

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021051718. A 70-year-old male patient received the second dose of bnt162b2 (COMIRNATY, lot number was not reported), via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunisation. Medical history included ongoing dialysis, ongoing shunt in hydrocephalus, ongoing pacemaker, stroke four months ago (unspecified date). Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 17Mar2021 for COVID-19 immunisation and experienced pneumonia. It was reported that patient had stroke four months ago (unspecified date). The patient was in care level 5, dialysis patient, received the first vaccination on 17Mar2021. He landed in in hospital with pneumonia in 2 days with no fever, then discharged. And on 14Apr2021, he got the second vaccination. He had no fever, no complaints, and died after 4 days. The emergency doctor could not determine the cause of death. The patient experienced unknown cause of death on 19Apr2021. The patient died on 19Apr2021. An autopsy was not performed. No follow-up attempts are possible; Information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1272868 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Adipositas; Diabetes; Heart disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021463124

Write-up: Unknown cause of death; Fatigue; Vomiting; Nausea; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021051843. A 50-year-old male patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: unknown) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing adipositas, ongoing diabetes and ongoing heart disorder. The patient''s concomitant medications were not reported. The patient died on 14Apr2021 (unknown cause of death). The patient also experienced fatigue, vomiting and nausea on 08Apr2021. An autopsy was not performed. Outcome of the events fatigue, vomiting and nausea was not recovered. Relatedness od drug to the events: Nausea, Vomiting, Fatigue was assessed as D. Unclassifiable by Regulatory Authority. Relatedness od drug to the event Unknown cause of death was assessed as Inconsistent causal association to immunization by Regulatory Authority. No follow-up attempts possible, information on batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1272869 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-19
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021463086

Write-up: Cerebral haemorrhage; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021051941, Sender''s Safety Report Unique Identifier DE-PEI-202100040458. An 88-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Lot number was not reported), via an unspecified route of administration on 13Apr2021 at 0.3 mL, single dose for covid-19 immunization. Medical history included ongoing hypertension from an unspecified date. The patient''s concomitant medications were not reported. The patient experienced cerebral haemorrhage on 19Apr2021 which led to death. The patient died on 19Apr2021. It was not reported if an autopsy was performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no information on risk factors or previous illnesses. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1274839 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Coagulation test, Internal haemorrhage, Platelet count, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: coagulation parameters; Result Unstructured Data: Test Result:normal; Test Name: platelets count; Result Unstructured Data: Test Result:normal
CDC Split Type: DEPFIZER INC2021432675

Write-up: syncope under internal bleeding of HCC; syncope under internal bleeding of HCC; This is a spontaneous report from a contactable physician. A 76-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 01Apr2021 at 15:00 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The medical history included LZ, Zn, HCV, HCC (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were unknown. It was reported that patient with HCC multifocal (as reported) on the day of vaccination came to syncope under internal bleeding of HCC, last coagulation test and platelets were normal, the state at the time point of vaccination was good. On 02Apr2021 (as reported), the patient experienced syncope under internal bleeding of HCC; the patient was hospitalized due to the events for 3 days (as reported). On unknown date, the patient underwent lab tests and procedures which included platelet count (normal) and coagulation test (normal). Therapeutic measures were taken as a result of syncope under internal bleeding of HCC (operation). Since the vaccination, the patient has not been tested for COVID-19. The patient died on 03Apr2021 due to syncope and bleeding. It was not reported if an autopsy was performed. Lot/batch number has been requested.; Sender''s Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: bleeding; syncope


VAERS ID: 1274844 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-28
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
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 INC2021454099

Write-up: pulmonary embolism; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 44411], license party for Comirnaty. A contactable consumer reported that a 78-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number and expiration date were not reported), via an unspecified route of administration on 28Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pulmonary embolism. The patient died on 15Apr2021. It was reported that patient saw a pulmonologist because the "functions were impaired there," but nothing has been detected. According to initial medical investigations, patient died of pulmonary embolism which would have to be confirmed by a pulmonologist. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: pulmonary embolism


VAERS ID: 1274845 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-09
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021454370

Write-up: died; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age received bnt162b2 (COMIRNATY; Lot Number: ER7812) via an unspecified route of administration, on 17Mar2021, as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient died on 09Apr2021. Cause of death was unknown. It was unknown if an autopsy was performed.; Sender''s Comments: Linked Report(s) Same reporter, same drug and event, different patient; Reported Cause(s) of Death: patient died


VAERS ID: 1274874 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-04-02
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Cerebellar stroke, Deep vein thrombosis, Multiple organ dysfunction syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 18
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: Medical History/Concurrent Conditions: Hip surgery; Hypoacusis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021463102

Write-up: Venous thrombosis deep (limbs); Cerebellar stroke; Cardio-respiratory arrest; Multiple organ failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB regulatory authority number ES-AEMPS-832255. An 89-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number: ET3620) intramuscular on 18Mar2021 at a single dose for SARS-CoV-2 vaccination. Medical history included hip surgery and hypoacusis. The patient''s concomitant medications were not reported. The patient previously received first dose of Comirnaty on 25Feb2021 for SARS-CoV-2 vaccination (lot number: EL0725, intramuscular). The patient experienced venous thrombosis deep (limbs) on 18Apr2021 and cerebellar stroke on 02Apr2021, events were considered serious, death, hospitalization, disability, life threatening. Patient experienced cardio-respiratory arrest and multiple organ failure on an unspecified date. The patient died on 20Apr2021 due to Venous thrombosis deep (limbs), Cerebellar stroke, Cardio-respiratory arrest and Multiple organ failure. 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: venous thrombosis deep (limbs); cerebellar stroke; Cardio-respiratory arrest; Multiple organ failure


VAERS ID: 1274876 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-04-14
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous thrombosis, Computerised tomogram head abnormal
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: TOPIRAMATE; ALOPURINOL; PALIPERIDONA; SIMVASTATIN; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Obesity; Paranoid schizophrenia
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Computerised tomogram head abnormal; Result Unstructured Data: Test Result:extensive venous thrombosis; Comments: and occlusion of DIC with obliteration of cisternae of the base.
CDC Split Type: ESPFIZER INC2021453702

Write-up: Cerebral venous thrombosis; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number ES-AEMPS-833579. A 45-year-old male patient received the second dose of bnt162b2 (COMIRNATY, lot number: ep2166), intramuscular on 04Mar2021 as a single dose for COVID-19 vaccination. The patient medical history included dyslipidaemia, obesity and paranoid schizophrenia; all from an unknown date. The patient previously received the first dose of bnt162b2 (COMIRNATY, lot number was not reported), intramuscular on 11Feb2021 for covid-19 immunisation. Concomitant medications included topiramate; alopurinol; paliperidona; simvastatin; and sertraline; all were taken for an unspecified indication, start and stop date were not reported. The patient experienced cerebral venous thrombosis on 14Apr2021. The outcome of the event was fatal. The patient underwent lab tests and procedures which included computerised tomogram head abnormal: extensive venous thrombosis and occlusion of DIC with obliteration of cisternae of the base on 14Apr2021. The patient died on an unspecified date. Cause of death was cerebral venous thrombosis. It was unknown if an autopsy was performed. Case Summary and Reporter''s Comments Text; CEREBRAL VENOUS THROMBOSIS without THROMBOPENIA despite having passed more than 1 month since the last dose. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: CEREBRAL VENOUS THROMBOSIS without THROMBOPENIA despite having passed more than 1 month since the last dose.; Reported Cause(s) of Death: Cerebral venous thrombosis


VAERS ID: 1274877 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Investigation, Prostatic specific antigen, 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: 2021-04-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Prostate cancer (Diagnosed in 2010, with irregular controls and last PSA of 5.4 micrograms/L (Normal max. 3.2))
Allergies:
Diagnostic Lab Data: Test Name: Examination; Result Unstructured Data: Test Result:no vital signs; Test Name: PSA; Result Unstructured Data: Test Result:5.4 ug/L
CDC Split Type: ESPFIZER INC2021463099

Write-up: Death sudden; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB, regulatory authority number is ES-AEMPS-835044. A contactable healthcare professional reported that a 91-year-old male patient received first dose of BNT162B2 (COMIRNATY), intramuscular on 06Apr2021 (lot number: EW2243) at 0.3 mL, single for COVID-19 immunisation. Medical history included hypertension; and prostate cancer diagnosed in 2010, with irregular controls and last PSA of 5.4 micrograms/L (normal max. 3.2). The patient''s concomitant medications were not reported. The patient had death sudden on 06Apr2021. The patient who died less than 24 hours after receiving the first dose of the vaccine. The patient went home on 06Apr2021 following notification of probable death. On arrival at the home, the relative commented that he had gone to his outpatient clinic in the morning for a vaccination and received the first dose of the Pfizer COVID 19 vaccine. He went alone because he was independent in his daily activities and did not have any serious illnesses. In the afternoon, he was found sitting on the sofa, unresponsive to stimuli. On examination, the patient had no vital signs. Sudden death of unknown cause (sudden death unexplained). It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1274878 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram cerebral, Auscultation, Basophil count, Blood creatinine, Blood electrolytes, Blood fibrinogen, Blood glucose, Blood potassium, Blood pressure measurement, Blood sodium, Blood test, Blood urea, Cerebral thrombosis, Chest X-ray, Computerised tomogram, Computerised tomogram head, Dizziness, Dysarthria, Electrocardiogram, Eosinophil count, Eyelid ptosis, Facial paresis, Gait disturbance, Glomerular filtration rate, Haematocrit, Haemoglobin, Heart rate, Hemiplegia, International normalised ratio, Lymphocyte count, Lymphocyte count decreased, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Monocyte count, Nervous system disorder, Neutrophil count, Neutrophil count increased, Oedema peripheral, Physical examination, Platelet count, Platelet count decreased, Prothrombin level, Pupils unequal, Pyrexia, Red blood cell analysis, SARS-CoV-2 test, Somnolence, White blood cell count, White blood cell count increased
SMQs:, Cardiac failure (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINO [AMLODIPINE]; QUINAPRIL/HYDROCHLOROTHIAZIDE; ESCITALOPRAM [ESCITALOPRAM OXALATE]; DILIBAN; SITAGLIPTINA [SITAGLIPTIN]; PAZITAL; PRANDIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac valve sclerosis (aortic sclerosis without stenosis (2015)); Dyslipidaemia; Hypertension arterial; Liver cirrhosis; Penicillin allergy; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: cerebral arteriography; Result Unstructured Data: Test Result:occlusion; Test Name: Cardiac Auscultation; Result Unstructured Data: Test Result:Rhythmic Heart Sounds; Test Name: Cardiac Auscultation; Result Unstructured Data: Test Result:Rhythmic heart sounds; Test Name: Pulmonary Auscultation; Result Unstructured Data: Test Result:murmur; Test Name: basophils; Result Unstructured Data: Test Result:0.02; Comments: 0.02 / ul; Test Name: BASOPHILS; Test Result: 0.2 %; Test Name: CREATININE; Test Result: 0.79 mg/dl; Test Name: Ions; Result Unstructured Data: Test Result:normal; Test Name: Fibrinogen; Result Unstructured Data: Test Result:766; Test Name: GLUCOSE; Test Result: 191.0 mg/dl; Test Name: POTASSIUM; Result Unstructured Data: Test Result:3.3 mEq/l; Test Name: Blood pressure; Result Unstructured Data: Test Result:146/71 mmHg mmHg; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/70 mmHg; Test Name: SODIUM; Result Unstructured Data: Test Result:136.0 mEq/l; Test Name: APTT RATIO; Result Unstructured Data: Test Result:0.92; Test Name: MPV; Result Unstructured Data: Test Result:11.1; Comments: MPV 11.1 fl; Test Name: RDW; Test Result: 11.8 %; Test Name: TTPAm; Result Unstructured Data: Test Result:29.5; Comments: TTPAm 29.5 sg; Test Name: UREA; Test Result: 45.0 mg/dl; Test Name: 2P CHEST X-RAY; Result Unstructured Data: Test Result:redistribution with fluid; Comments: 2P CHEST X-RAY: Signs of redistribution with fluid in fissure and posterior impingement of the sinuses costophenics; Test Name: Angio-CT; Result Unstructured Data: Test Result:decreased flow; Comments: Angio-CT of supra-aortic trunks: Absence of flow in the right internal carotid at 16mm from the bifurcation, with repermeabilization in the polygon of Willis, observing smaller caliber and enhancement with respect to the contralaterals in the right MCA and its branches. Angio-CT perfusion: Large area of ??increased transit time and decreased flow throughout the entire territory of the right MCA, with a fully preserved volume, compatible with penumbra.; Test Name: CRANIAL CT; Result Unstructured Data: Test Result:No bleeding; Comments: CRANIAL CT: No images suggesting acute intracranial bleeding, mass effect, or deviation of the midline structures. Left frontal corticosubcortical hypodensity area in relation with chronic ischemic injury.; Test Name: CRANIAL CT; Result Unstructured Data: Test Result:hypodensity; Comments: A cranial CT scan was performed that showed an area of ??left frontal corticosubcortical hypodensity in relation to a chronic ischemic lesion. Left frontal chronic ischemic lesion; Test Name: CRANIAL CT; Result Unstructured Data: Test Result:no hemorrhage; Comments: There are no recently established ischemic lesions or signs of intra- or extra-axial hemorrhage.; Test Date: 20210329; Test Name: CRANIAL CT; Result Unstructured Data: Test Result:hypodensity; Comments: Corticosubcortical hypodensity in the anterior region of the right insula, compatible with subacute ischemic lesion. It does not condition a mass effect nor does it show signs of hemorrhagic transformation. Centered midline and permeable base cisterns. Chronic ischemic left frontal corticosubcortical encephalomalacia area. High-density images in left frontal and right parietal sulci compatible with calcium emboli. Calcific atheromatosis of the intracranial portion of both internal carotids. Conclusions: Subacute ischemic lesion in the anterior region of the right insula.; Test Name: ECG; Result Unstructured Data: Test Result:Atrioventricular Block; Comments: ECG: Sinus rhythm at 75 bpm. 1st degree Atrioventricular Block (AVB) (240 msec). Right Bundle Branch Block of Hiss. Complete Right Bundle Branch Block.. Ruling out significant bradycardia; Test Name: eosinophils; Result Unstructured Data: Test Result:0.01; Comments: 0.01 / ul; Test Name: EOSINOPHILS; Test Result: 0.1 %; Test Name: CKDEPI; Result Unstructured Data: Test Result:82.0 ml/min; Test Name: HEMATOCRIT; Test Result: 39.4 %; Test Name: hemoglobin; Result Unstructured Data: Test Result:12.9; Test Name: HEMOGLOBIN; Result Unstructured Data: Test Result:13.6 g/dl; Test Name: Heart Rate; Result Unstructured Data: Test Result:80; Comments: bpm; Test Name: INR; Result Unstructured Data: Test Result:1.44; Test Name: INR; Result Unstructured Data: Test Result:1.61; Test Name: LYMPHOCYTES; Result Unstructured Data: Test Result:0.98; Test Name: LYMPHOCYTES; Test Result: 7.6 %; Test Name: MCH; Test Result: 30.4 pg; Test Name: MCHC; Result Unstructured Data: Test Result:34.5 g/dl; Test Name: MCV; Result Unstructured Data: Test Result:88.1; Comments: 88.1 fl; Test Name: MONOCYTES; Result Unstructured Data: Test Result:1.2; Comments: 1.2 / ul; Test Name: MONOCYTES; Test Result: 9.3 %; Test Name: NEUTROPHILES; Result Unstructured Data: Test Result:10.76; Comments: 10.76 / ul; Test Name: NEUTROPHILES; Test Result: 82.8 %; Test Name: Physicial Examination; Result Unstructured Data: Test Result:Conscious; Comments: Conscious and oriented. Good tolerance to decubitus. Eupneic at rest. Head and Neck: Without Jugular Engorgement at 45?. Abdomen: Soft, not painful. Extremities: Pitting edema up to the knee. Palpable and symmetrical peripheral pulses.; Test Name: Physicial Examination; Result Unstructured Data: Test Result:facial paresis; Comments: Sleepy ? (1), obeys orders x 2, questions x2, gaze with a tendency to look to the right (2), with anisocoria (DI), bilateral ptosis. HHI due to confrontation (2), moderate left central facial paresis (2), left hemiplegia predominantly brachial (4), femoral (3), no sensory alteration. Moderate dysarthria (1). NIHSS: 14.; Test Date: 20210325; Test Name: Platelet count; Result Unstructured Data: Test Result:129; Test Date: 20210330; Test Name: Platelet count; Result Unstructured Data: Test Result:121; Test Name: Prothrombin; Test Result: 51 %; Test Name: Red blood cell; Result Unstructured Data: Test Result:4.47; Test Name: PCR COVID-19; Result Unstructured Data: Test Result:Undetectable; Comments: PCR COVID 19: Det. of SARS-Cov2 RNA. Undetectable and SARS Cov2 Antigen; Test Name: SARS Cov2 Antigen; Result Unstructured Data: Test Result:Undetectable; Comments: PCR COVID 19: Det. of SARS-Cov2 RNA. Undetectable and SARS Cov2 Antigen; Test Name: Leukocytes; Result Unstructured Data: Test Result:9430; Comments: Leukocytes 9430 with 80% Neutrophils (Ne).; Test Name: Leukocytes; Result Unstructured Data: Test Result:12.97
CDC Split Type: ESPFIZER INC2021463096

Write-up: Edema in the lower limbs; Gait deterioration; Neurological deficit; Sleepy; Anisocoria; Bilateral ptosis; Moderate left central facial paresis; Left hemiplegia; Moderate dysarthria; Platelets 129.0 (150.0 - 450.0); Leukocytes 12.97 (3.7 - 11.0); Neutrophiles% 82.8% (40.0 - 80.0); Lymphocytes% 7.6% (15.0 - 50.0); Cerebral thrombosis; Fever; Dizziness; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB. Regulatory authority number is ES-AEMPS-835105. An 83-year-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 18Mar2021 (Lot Number: ET3620, expiry date not reported) as single dose for COVID-19 immunization. Medical history included dyslipidaemia, cardiac valve sclerosis from 2015 to an unknown date aortic sclerosis without stenosis (2015), type 2 diabetes mellitus, hypertension arterial, allergy to penicillin, and liver cirrhosis. Concomitant medications included amlodipino [amlodipine], hydrochlorothiazide, quinapril hydrochloride (QUINAPRIL/HYDROCHLOROTHIAZIDE), escitalopram oxalate, paracetamol, tramadol hydrochloride (DILIBAN), sitagliptina, paracetamol, tramadol hydrochloride (PAZITAL) and repaglinide (PRANDIN); all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of Comirnaty, intramuscualr on Feb2021 for COVID-19 immunization. The patient experienced cerebral thrombosis (cerebral thrombosis) (death, medically significant) on 30Mar2021; dizziness on 25Mar2021; edema in the lower limbs, gait deterioration, neurological deficit, sleepy, anisocoria, bilateral ptosis, moderate left central facial paresis, left hemiplegia, moderate dysarthria, all on unspecified dates with outcome unknown; platelets 129.0 (150.0 - 450.0), leukocytes 12.97 (3.7 - 11.0), neutrophiles% 82.8% (40.0 - 80.0), lymphocytes% 7.6% (15.0 - 50.0), all on unspecified dates with unknown outcome; fever on 29Mar2021 with outcome unknown. Case Summary and Reporter Comments Text: Second dose, 25Mar2021, The patient reports that a week ago he had an episode of dizziness when he was walking through the hall when he left the bathroom, he leaned against the wall for a few seconds until it passed and he was able to walk again. A few days later he presented an episode of intense dizziness while sitting in the kitchen, without loss of consciousness. 24 hours before admission another episode that was witnessed by his family, they reported that he was speaking normally and that he suddenly stopped speaking, eye rolling and loss of tone, leaning his body against the wall and recovering in less than 1 minute. No chest pain. Without dyspnea. Edema in the lower limbs of several weeks of evolution. He also refers that in the course of the last month he presents progressive gait deterioration, currently he needs help to stay upright at the beginning of ambulation, because he falls backwards and walks shuffling, something that previously did not happen to him; PHYSICAL EXPLORATION, Blood Pressure: 146/71 mmHg. Conscious and oriented. Good tolerance to decubitus. Eupneic at rest. Head and Neck: Without Jugular Engorgement at 45?, Chest: Cardiac Auscultation: Rhythmic Heart Sounds at 80 bpm. II / VI systolic murmur in aortic focus radiating to the rest of the foci, with 2nd audible noise; Pulmonary Auscultation: preserved vesicular murmur. Abdomen: Soft, not painful. Extremities: Pitting edema up to the knee, Palpable and symmetrical peripheral pulses; SUPPLEMENTARY TESTS SUMMARY, ECG: Sinus rhythm at 75 bpm. 1st degree Atrioventricular Block (AVB) (240 msec). Right Bundle Branch Block of Hiss. Complete Right Bundle Branch Block, - Analysis: Hb 12.9. Leukocytes 9430 with 80% Neutrophils (Ne). INR 1.44. Fibrinogen 766. Crfeat 0.83. Normal ions. TROPONIN I ULTRASENSITIVE 1st determination 317 ? 2nd determination 538.2 ? 3rd determination 1610, PCR 110.6 NT-PROBNP 2367, 2P CHEST X-RAY: Signs of redistribution with fluid in fissure and posterior impingement of the sinuses costophenics, - CRANIAL CT: No images suggesting acute intracranial bleeding, mass effect, or deviation of the midline structures. Left frontal corticosubcortical hypodensity area in relation with chronic ischemic injury. To see described findings. No recommendations, - PCR COVID 19: Det. of SARS-Cov2 RNA. Undetectable and SARS Cov2 Antigen, EVOLUTION AND COMMENTS, Patient with one syncope and two presyncope who presents trifascicular block on the ECG, so it is decided admission to cardiology ward for monitoring and ruling out significant bradycardia. On the other hand, he presents symptoms of right heart failure of weeks of evolution, without significant cardiopathy known so far. In the emergency department, a determination of markers of myocardial damage is requested in a patient without symptoms of ischemia and when mentioned determination is elevated, a serialization is decided in which these markers continue to rise. Given the symptoms of deterioration in gait of a few weeks of evolution, with disability in the last days of living an independent life, a cranial CT scan is performed in which urgent neurological pathology is ruled out. Assess during admission applies for neurology consultation. 83-year-old male allergic to penicillin, hypertension arterial, Non-insulin-dependent diabetes mellitus(NIDDM), Dyslipidemia, aortic sclerosis without stenosis (2015), liver cirrhosis, Child A (2013), admitted for syncope and presyncope, admitted to cardiology ward for monitoring and ruling out significant bradycardia, associated with symptoms of heart failure. Presents cardiac markers with ascending profile, probably related to heart failure. Monitoring with telemetry ECG is carried out and we request echocardiography to see the evolution of his aortic sclerosis without significant stenosis (Vao trivalve with grad max 21 mmHg in 2015), LVEF, etc. It also presents deterioration of the gait of a few weeks of evolution. A cranial CT scan was performed that showed an area of left frontal corticosubcortical hypodensity in relation to a chronic ischemic lesion. Current illness: admitted to Cardiology since Mar25 due to dizziness episodes. In an etiological study, Severe Aortic Stenosis (Transcatheter Aortic Valve Implantation pending) and left frontal chronic ischemic lesion on cranial CT scan. Today around 5.30 p.m. he presents a sudden neurological deficit. Assessed by cardiology at 6:00 p.m. with partial improvement (no motor deficit, although ocular), showed again at 20:00 due to clinical worsening. Physical examination: Monitor in Sinus rhythm. Blood Pressure: 130/70. Sleepy (1), obeys orders x 2, questions x2, gaze with a tendency to look to the right (2), with anisocoria (DI), bilateral ptosis. HHI due to confrontation (2), moderate left central facial paresis (2), left hemiplegia predominantly brachial (4), femoral (3), no sensory alteration. Moderate dysarthria (1). NIHSS: 14. Cardiopulmonary Auscultacion: Rhythmic heart sounds, Active stroke code 20:30 , Computed axial tomography (20:58): baseline CT: There are no recently established ischemic lesions or signs of intra- or extra-axial hemorrhage. ASPECTS 10 scale. Angio-CT of supra-aortic trunks: Absence of flow in the right internal carotid at 16mm from the bifurcation, with repermeabilization in the polygon of Willis, observing smaller caliber and enhancement with respect to the contralaterals in the right MCA and its branches. Angio-CT perfusion: Large area of increased transit time and decreased flow throughout the entire territory of the right MCA, with a fully preserved volume, compatible with penumbra. Analytics: RED BLOOD CELLS 4.47 (4.0 - 6.0), HEMOGLOBIN 13.6 g / dl (13.0 - 17.0), HEMATOCRIT 39.4% (39.0 - 51.0), MCV 88.1 fl (80.0 - 100.0), MCH 30.4 pg (26.0 - 32.0), MCHC 34.5 g / dl (32.0 - 37.0), RDW 11.8% (10.0 - 18.0), PLATELETS 129.0 (150.0 - 450.0), MPV 11.1 fl (6.0 - 15.0) [000015 - F.LEUCOCITARIA], LEUKOCYTES 12.97 (3.7 - 11.0), NEUTROPHILES% 82.8% (40.0 - 80.0), NEUTROPHILES / ul 10.76 (1.8 - 9.8), LYMPHOCYTES% 7.6% (15.0 - 50.0), LYMPHOCYTES / ul 0.98 (0.5 - 4.8), MONOCYTES% 9.3% (2.0 - 12.0), MONOCYTES / ul 1.2 (0.0 - 0.8), EOSINOPHILS % 0.1% (0.0 - 7.0), EOSINOPHILS / ul 0.01 (0.0 - 0.6), BASOPHILS % 0.2% (0.0 - 1.8), BASOPHILS / ul 0.02 (0.0 - 0.2) [000047 - BASIC COAGULATION], PROTHROMBIN RATE 51.0% (), QUICK Time (M) 17.7 (), INR 1.61 (0.6 - 1.2), [000054 - TTPA], TTPAm 29.5 sg (), APTT RATIO 0.92 (0.7 - 1.35), [000102 - BIOCHEMISTRY], GLUCOSE 191.0 mg / dL (65.0 - 100.0), UREA 45.0 mg / dL (10.0 - 60.0), CREATININE 0.79 mg / dL (0.7 - 1.4), CKDEPI 82.0 mL / min / 1.73 m? (60.0 - 0.0), SODIUM 136.0 mEq / L (136.0 - 145.0), POTASSIUM 3.3 mEq / L (3.5 - 5.0). Clinical judgment: Acute right carotid obstruction. Hospital treatment: omeprazole 20 mg (1-0-0), insulin abasaglar 10 IU at dinner, rescue lispro, Adiro 100 (0-1-0), seguril 40 mg (1-0-1), ramipril 2.5 mg at breakfast, paracetamol, escitalopram 10 mg (1-0-0). Previously Enoxaparin 40/24 h, last dose on Mar27. MAIN DIAGNOSTIC Syncope and recurrent presyncope in a patient with trifascicular block, Acute heart failure, Elevation of myocardial damage markers on an upward slope without symptoms of ischemic heart disease, Aortic sclerosis without prior significant stenosis (2015), Impairment of the recently established gait. TREATMENT recommendations Start 25Mar2021 01:10 - Oxygen therapy if required for SatO293%. - Keep going; Start 25Mar2021 01:10 - Weigh - Every 48 hours (9h); Start 25Mar2021 01:10 - Diuretic control - Every 1 day at 07:00, 14:00, 21:00; Start 25Mar2021 01:10 - Constant control - Every 12 hours (9 am-9pm); Start 25Mar2021 01:10 - 1800 KCAL. WITHOUT SALT - Dno-Cda-Mda-Cna (9h-13h-17h-20h); Start 25Mar2021 01:10 - Absolute rest - Continuous; Start 25Mar2021 01:10 - Headland at 30-45? - Continuous; Start 25Mar2021 01:10 - Capillary blood glucose - pre-DNO-pre-CDA-pre-CAN; Start 25Mar2021 01:03 - Telemetry - Continuous; Drugs PARACETAMOL 650 MG COMP - 1 g (If headache) - Every 8 hours (9h-17h-1h), ENOXAPARIN 40 MG / 0.4 ML JER - 40 mg - Every 24 hours (21h), QUETIAPINE 25 MG COMP - 25 mg - At night at bedtime (23h), RAMIPRIL 5 MG COMP - 2.5 mg - Every 12 hours (9 am-9pm), FUROSEMIDE 20 MG / 2 ML INJ - 20 mg - Every 8 hours (9h-17h-1h), INSULIN ABASAGLAR - 10 IU - Every 24 hours (21h), INSULIN HUMALOG INY - 3 - 4 - 3 IU (If GC 80: administer half of the schedule, 150-199: add 1U, 200-249: add 2U, 250-299: add 3U 300: add 4U) - Every 1 day at 09:00, 13:00, 20:00, OMEPRAZOLE 20 MG CAPS - 20 mg - Every 24 hours (9h / NO). ACETYLSALICILIC ACID 100 MG COMP - 100 mg - With Food (13h). MFG - 1 (ESCITALOPRAM 10 MG: 1-0-0) - Every 24 hours (9h / DNO). Mechanical thrombectomy (28Mar2021) An urgent cerebral arteriography was performed in a patient with acute ischemic stroke (NIHHS 14), with established damage of less than 50% of the ischemic tissue, confirming an occlusion of a right TICA branch that was recanalized with a good angiographic result (TICI 3) without complications. Puncture time: 11:14 p.m. // Recanalization time: 11:59 p.m. Number of passages: 2 Fibrinolytic or antithrombotic drugs were not administered. Fail closure, manual compression. DynaCT is performed in the angiography room, observing minimal self-limiting SAH in the right Silvio valley. Control cranial CT (29Mar2021): Corticosubcortical hypodensity in the anterior region of the right insula, compatible with subacute ischemic lesion. It does not condition a mass effect nor does it show signs of hemorrhagic transformation. Centered midline and permeable base cisterns. Chronic ischemic left frontal corticosubcortical encephalomalacia area. High-density images in left frontal and right parietal sulci compatible with calcium emboli. Calcific atheromatosis of the intracranial portion of both internal carotids. Conclusions: Subacute ischemic lesion in the anterior region of the right insula. EVOLUTION AND COMMENTS 83-year-old patient who was admitted for right stroke with occlusion of the TICA, undergoing mechanical thrombectoma with good angiographic results. He remained stable in the following hours in the stroke unit, presenting fever on 29Mar2021 with suspected respiratory focus, starting ab with levofloxacin (allergic to penicillin) with good evolution. Control head CT scan was performed, showing a small ischemic lesion in the anterior region of the right insula. The patient evolves favorably, currently maintaining left hemiparesis (MSI 3/5, MII 4/5), with possible sensory deficit, without another clear focus. In telemetry, in RS with some EV. He maintains serum therapy and absolute diet, as well rest in bed. It is discussed with the Stroke Unit of and today he will be transferred there again. Discharge Clinical Report. MAIN DIAGNOSTIC Right hemispheric ischemic stroke due to occlusion of TICA. Probable embolic origin in a patient with severe aortic valve stenosis pending TAVI intervention. Mechanical thrombectomy. Fever with leukocytosis and elevated CRP. Possibly respiratory. TREATMENT recommendations Drugs, Acetylsalicylic acid ADIRO 100 mg tab 100 mg 1 tab, Oral, De, Enoxaparin 40 mg 0.4 mL jer prec 40 mg 1 jer, SC, every 24h, Furosemide 20 mg 2 mL amp 20 mg 2 mL, Slow Direct IV, every 12h, ACTRAPID soluble insulin 4 IU + Potassium chloride ClK 10 mEq + Sodium chloride 20% 11 mEq + Glucose 4 IU 0.04 ml, IV Intermittent Perf, every 4h (free), Levofloxacin 500 mg 100 ml, IV Intermittent Perf, every 12h (free), Omeprazole + Physiological 0.9% 100 ml 40 mg 10 ml, IV Intermittent Perf, every 24h, Continuous: (0), PRN: (3), Glucose 20 mL, Slow Direct IV, every 24h, Labetalol 100 mg 20 mL amp 10 mg 2 mL, Slow Direct IV, every 20min, Paracetamol 1,000 mg 100 ml, IV Intermittent Perf, every 8h. Therapeutic measures were taken as a result of cerebral thrombosis. The patient died on 13Apr2021. 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: Cerebral thrombosis


VAERS ID: 1274879 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-03-09
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anuria, Arteriosclerosis coronary artery, Aspiration, Cardio-respiratory arrest, Computerised tomogram, Haemodynamic instability, Hyperglycaemia, Lung consolidation, Paraesthesia, Pulmonary embolism, Pulseless electrical activity
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiac arrhythmia terms, nonspecific (narrow), Other ischaemic heart disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute pulmonary oedema; Chronic kidney disease (CKD on haemodialysis (without arteriovenous fistula due to patient''s refusal)); Coronary bypass; Diabetes mellitus (with poor control); Haemodialysis (CKD on haemodialysis (without arteriovenous fistula due to patient''s refusal)); Hospitalization (in intensive care unit for 2 days in Sep2020); Hypertension arterial; Respiratory infection; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210309; Test Name: CT scan; Result Unstructured Data: Test Result:basal pulmonary thromboembolism D; Comments: aortocoronary atheromatosis with coronary bypass by sternotomy, pulmonary consolidations suggestive of bronchoaspiration
CDC Split Type: ESPFIZER INC2021463089

Write-up: Pulmonary embolism/pulmonary thromboembolism; cardiorespiratory arrest; pulseless electrical activity; haemodynamically unstable; hyperglycaemic; anuric; aortocoronary atheromatosis; pulmonary consolidations; bronchoaspiration; paraesthesia; This is as spontaneous report from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is ES-AEMPS-835288. A 74-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number and expiry date unknown), via an unspecified route of administration on 23Feb2021 at a single dose (also reported as "0.5 mL") for covid-19 immunisation. Medical history included hypertension arterial, diabetes mellitus type 2 with poor control, stroke from 2014, last admission for acute pulmonary oedema + respiratory overinfection (in intensive care unit for 2 days in Sep2020), CKD on haemodialysis (without arteriovenous fistula due to patient''s refusal), and history of coronary bypass. Concomitant medications were not reported. The patient has no history of covid-19. The patient experienced pulmonary embolism on 09Mar2021 that required emergency room visit and hospitalization with treatment received. On 09Mar2021, almost at the end of the haemodialysis session, the patient presented with paraesthesia (non-serious) and, later cardiorespiratory arrest so basic cardiopulmonary resuscitation maneuvers were started, and the emergency medical system was notified. The patient was found in cardiorespiratory arrest with pulseless electrical activity. After 4 minutes of advanced cardiopulmonary resuscitation he recovered, presenting 5 new episodes of cardiorespiratory arrest during the assistance. He was transferred to the hospital, where he required high doses of noraadrenaline and dobutamine, remaining haemodynamically unstable, hyperglycaemic, anuric. He does not tolerate continuous haemofiltration. CT scan on 09Mar2021 showed basal pulmonary thromboembolism right (D), also showed aortocoronary atheromatosis with coronary bypass by sternotomy, pulmonary consolidations suggestive of bronchoaspiration. The patient died on 10Mar2021. The outcome of events pulmonary embolism/pulmonary thromboembolism and cardiorespiratory arrest was fatal. The outcome of all other remaining adverse events was unknown. It was unknown if an autopsy was performed. Follow-up attempts are not possible; information on the lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardio-respiratory arrest; pulmonary embolism/pulmonary thromboembolism


VAERS ID: 1274880 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-03
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Sudden death, Urine analysis, 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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDA [FUROSEMIDE]; SIMVASTATINA; LISINOPRIL; CARVEDILOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute pancreatitis (Admission in December 2018 - Acute pancreatitis of biliary origin, mild); Allergy to antibiotic; Chronic kidney disease; Diverticulosis of colon (without mention of haemorrhage); Dyslipidaemia; Hiatus hernia; Hypercholesterolaemia; Hypertension arterial (HTA of 10-15 years of evolution.); Iron deficiency anaemia; Nephrolithiasis (left renal lithiasis, with nephritic colic (at least 5)); Non-smoker; Osteoporosis; Renal colic; Urinary infection
Allergies:
Diagnostic Lab Data: Test Name: Creatinine; Test Result: 2 mg/dl; Test Name: urine; Result Unstructured Data: Test Result:clear urine. No haematuria, not frothy
CDC Split Type: ESPFIZER INC2021463097

Write-up: Sudden death; Vomited; This is as spontaneous report received from a contactable pharmacist downloaded from the Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-836497. A 92-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular, administered in the arm on 01Mar2021 (Lot Number: EP2166) as single dose for COVID-19 immunisation. Medical history included allergies to beta-lactam antibiotics, non-smoker, hypertension arterial (HTA) of 10-15 years of evolution, no DM, dyslipidaemia, no known heart disease, no surgical interventions, diverticulosis in colon, iron deficiency anaemia, hiatus hernia, osteoporosis, admission in December 2018 for acute pancreatitis of biliary origin (mild), AF: Not remarkable, Nephrourological history: follow-up in Nephrology Consultation, since 2004 with CKD of unaffiliated aetiology (Creatinine 2mg/dl), usual urinary infections, left renal lithiasis, with nephritic colic (at least 5), expulsion of clear urine, no haematuria, not frothy, and hypercholesterolaemia. Concomitant medications included furosemide (FUROSEMIDA) taken for an unspecified indication from 16Mar2018 to an unspecified stop date; simvastatina taken for hypercholesterolaemia from 04May2007 to an unspecified stop date; lisinopril taken for hypertension from 20Dec2018 to an unspecified stop date; carvedilol taken for hypertension, start and stop date were not reported. On 03Apr2021 (also reported as 03Mar2021) on waking up she was found inert with signs of death (sudden death). It was also reported that the patient vomited on 03Apr2021 (also reported as 02Mar2021), no fever or dyspnoea. 112 was called who administered primperan and prescribed hydration with oral serum for the event vomited. It was explained that it will be self-limited to 24-48 hours as a reaction to the vaccine. The patient died on 03Apr2021. It was not reported if an autopsy was performed. The outcome of the event vomited was unknown and sudden death was fatal. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers already obtained.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1274892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-03-24
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood albumin, Blood lactate dehydrogenase, Blood potassium, Blood sodium, Blood thyroid stimulating hormone, Body temperature, C-reactive protein, COVID-19, Gamma-glutamyltransferase, Haemoglobin, Lymphocyte count, Oxygen saturation, Platelet count, SARS-CoV-2 test, Vaccination failure, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; DOLIPRANE; ECONAZOLE; ELIQUIS; FUROSEMIDE; FUROSEMIDE; LEVOTHYROX; LEVOTHYROX; SERESTA; TRANSIPEG [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE;SODIUM SULFATE ANHYDR; VENTOLIN [SALBUTAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome (Chronic anxiety-depressive syndrome); Dysfunction thyroid (Thyroid insufficiency); Hypercholesterolaemia; Hypertension arterial; Hypertensive heart disease NOS (Hypertensive and rhythmic heart disease); Permanent atrial fibrillation; Permanent cardiac pacemaker insertion
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: ALAT; Result Unstructured Data: Test Result:19 IU/l; Test Date: 20210326; Test Name: AST; Result Unstructured Data: Test Result:65 IU/l; Test Date: 20210326; Test Name: Serum albumin; Result Unstructured Data: Test Result:32 g/l; Test Date: 20210326; Test Name: LDH; Result Unstructured Data: Test Result:705 IU/l; Test Date: 20210324; Test Name: Potassium; Result Unstructured Data: Test Result:3.3 mmol/L; Test Date: 20210326; Test Name: Potassium; Result Unstructured Data: Test Result:3.6 mmol/L; Test Date: 20210326; Test Name: Sodium; Result Unstructured Data: Test Result:143 mmol/L; Test Date: 20210326; Test Name: TSH; Result Unstructured Data: Test Result:0.69 uiU/mL; Test Date: 20210325; Test Name: temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210401; Test Name: temperature; Result Unstructured Data: Test Result:39.4 Centigrade; Test Date: 20210326; Test Name: CRP; Result Unstructured Data: Test Result:20.6 mg/l; Test Date: 20210326; Test Name: GGT; Result Unstructured Data: Test Result:69 IU/l; Test Date: 20210326; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.6 g/dl; Test Date: 20210326; Test Name: lymphocytes; Result Unstructured Data: Test Result:644 /mm3; Test Name: saturation; Test Result: 90 %; Test Date: 20210325; Test Name: saturation; Test Result: 90 %; Test Date: 20210401; Test Name: saturation; Result Unstructured Data: Test Result:82% %; Test Date: 20210326; Test Name: platelet; Result Unstructured Data: Test Result:121 x10 9/l; Comments: thrombocytopenia; Test Date: 20210324; Test Name: PCR test; Test Result: Positive ; Test Date: 20210326; Test Name: Leukocytes; Result Unstructured Data: Test Result:3.6 x10 9/l; Comments: with polymorphonuclear basophils at 0.029 G / L, polymorphonuclear eosinophils 0.059 G / L, lymphocytes at 0.677 G / L, monocytes 0.406 G / L, polymorphonuclear neutrophils 2.489 G / L).
CDC Split Type: FRPFIZER INC2021453415

Write-up: Vaccination failure; PCR carried out on 24Mar2021 is positive for SarsCov-2; This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-AN20211330. Safety Report Unique Identifier is FR-AFSSAPS-2021039336. A 86-years-old female patient received bnt162b2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on 12Feb2021 (Lot Number: EJ6789), dose 1 via intramuscular route, in Arm Left on 19Jan2021 (Lot Number: EJ6795), both as single dose for covid-19 immunization. Medical history included arterial hypertension, permanent atrial fibrillation, mixed anxiety and depressive disorder (chronic anxiety-depressive syndrome), hypercholesterolemia, hypertensive and rhythmic heart disease, thyroid insufficiency and cardiac pacemaker insertion. The patient had no history of anaphylactic shock. Concomitant medications included: bisoprolol (2.5 mg) tablet, 1 DF in the morning, paracetamol (DOLIPRANE) 1 gram morning, noon and evening, econazole (ECONAZOLE) 1% powder, 1 application morning and evening, apixaban (ELIQUIS) (2.5 mg) 1 morning and evening, furosemide (40 mg) 1 in the morning, furosemide (500 g) 1/2 in the morning and at noon, levothyroxine sodium (LEVOTHYROX) 125 ?g in the morning, levothyroxine sodium (LEVOTHYROX) (25 ?g) 1/2 in the morning, oxazepam (SERESTA) 10 mg as needed, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride, sodium sulfate anhydrous (TRANSIPEG [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE;SODIUM SULFATE ANHYDROUS]) as needed and salbutamol (VENTOLIN [SALBUTAMOL]) (100 ?g / dose) 2 doses morning, noon and evening. The patient considered to be at risk of developing a serious form of COVID based on her age. Previously the patient was not infected with Covid-19. On 23Mar2021, the patient worsened clinically with the onset of a fatty cough, clear sputum, oxygen regression (90% Sat under oxygen), crackles in the left base, afebrile. The patient had already felt very asthenic the previous days and was lying more and more in her bed. From 23Mar2021, she is initially put on Augmentin 1gram / 125 mg three times a day for 7 days, and oxygen therapy. The hypotheses put forward are a new cardiac decompensation, a lung infection or a COVID infection. The PCR carried out on 24Mar2021 is positive for SarsCov-2, an English variant found and had vaccination failure. She was then transferred to a hospital unit for further care. She had received the second dose of the vaccine by Comirnaty 6 weeks before. On 24Mar2021, the patient''s hypokalaemia at 3.3 mmol / l was demonstrated on the blood test but there was no inflammatory syndrome. Augmentin is stopped and Diffu K is introduced. On 25Mar2021, the patient was increasingly asthenic, became confused, saturation was 90% under 3L of O2, had some nausea during meals, fever at 38 C. The PCR came back positive that day and she was transferred for further treatment. The patient was conscious, not oriented, respiratory distress with slight pulling and invasion of the 2 lungs with crackles with spasticity. On 26Mar2021, pulmonary auscultation improved, the patient remained very asthenic, was febrile, presented serious risk factors (with lymphopenia at 644 / mm3, thrombocytopenia at 121 G / L). She probably has an associated cardio-renal syndrome. On 26Mar2021, the patient underwent lab tests and procedures which included: ALAT: 19 iu/l, AST: 65 iu/l, serum albumin: 32 g/l, LDH: 705 iu/l, potassium: 3.6 mmol/l, sodium: 143 mmol/l, TSH: 0.69 uiu/ml, CRP: 20.6 mg/l, GGT: 69 iu/l, haemoglobin: 14.6 g/dl, lymphocyte count: 644 /mm3 and oxygen saturation: 90 %. On 29Mar2021, there was a deterioration in his respiratory state with desaturation requiring a high concentration mask. The cracklings are present in a diffuse way. She is very asthenic, and every word spoken is extremely short of breath, she is dehydrated and there is a sudden increase in ferritin at 1700, witnessing the inflammatory passage of COVID. The IV hydration, corticosteroid therapy and PES furosemide are set up. On 01Apr2021, she was still feverish at 39.4 C sweating with 82% saturation under 9L of O2, there was cyanosis of the extremities. On 05Apr2021, she deteriorates more and more at the respiratory level, then enters a state of coma, is reactive. She died during the day at 12:45 p.m. An autopsy was not performed. The outcome of events was fatal. No follow-up attempts possible. No further information expected. Amendment: This follow-up report is being submitted to amend previously reported Information: Amended Listedness of vaccination failure from listed to unlisted and added new event Covid-19.; Reported Cause(s) of Death: Respiratory distress following vaccine failure


VAERS ID: 1274901 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-28
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EFFERALGAN C; ARANESP
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Primary myelofibrosis (treated with infusion sometimes)
Allergies:
Diagnostic Lab Data: Test Date: 20210316; Test Name: COVID-19; Test Result: Negative
CDC Split Type: FRPFIZER INC2021463114

Write-up: Cerebrovascular accident; Myalgia; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BX20213375. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 16Feb2021 (Lot Number: EJ6789) as SINGLE DOSE for COVID-19 immunization. Medical history included primary myelofibrosis treated with infusion sometimes from an unknown date and unknown if ongoing. Concomitant medications included ascorbic acid, paracetamol (EFFERALGAN C) and darbepoetin alfa (ARANESP) taken for an unspecified indication, start and stop date were not reported. The patient experienced cerebrovascular accident on 25Mar2021 that caused death and myalgia on 28Feb2021. The outcome of myalgia was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Mar2021. The patient died on 25Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebrovascular accident


VAERS ID: 1274906 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-03-30
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TRESIBA; PAROXETINE; PANTOPRAZOLE; NEBIVOLOL; FUROSEMIDE; GABAPENTIN; INSULIN RAPID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of colon (lieberkuhnien type treated with right colectomy then laparotomy); Arterial hypertension; Chronic renal failure; Colectomy (right); Diabetes mellitus insulin-dependent; Esophagitis; Fall; Fracture femur (per-trochanteric fracture of the left femur further a fall); Hemorrhage of digestive tract (with anemia of blood loss); Laparotomy; Myelocytic leukaemia (motivating palliative care decision); Transfusion (several transfusions)
Allergies:
Diagnostic Lab Data: Test Date: 20210402; Test Name: temperature; Result Unstructured Data: Test Result:hyperthermia; Test Date: 20210403; Test Name: temperature; Result Unstructured Data: Test Result:hyperthermia; Test Name: Glasgow scale; Result Unstructured Data: Test Result:5; Test Date: 20210403; Test Name: oxygen saturation; Result Unstructured Data: Test Result:desaturation; Test Date: 20210330; Test Name: RT-PCR; Result Unstructured Data: Test Result:positive, no variant
CDC Split Type: FRPFIZER INC2021463073

Write-up: Vaccination failure; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-DJ20210921. An 81-year-old female patient received her first and second dose of bnt162b2 (COMIRNATY) on 29Jan2021 (Lot Number: EJ6788) and on 19Feb2021 (Lot Number: EM6950) both intramuscular as single dose for covid-19 immunisation. Medical history included arterial hypertension, Esophagitis, right colectomy from 2018, Fracture femur (per-trochanteric fracture of the left femur further a fall), fall, Adenocarcinoma of colon (type treated with right colectomy then laparotomy), chronic kidney failure, Myelocytic leukaemia from 2007 (motivating palliative care decision), Diabetes mellitus insulin-dependent, Hemorrhage of digestive tract (with anemia of blood loss), transfusion and laparotomy. Concomitant medications included insulin degludec (TRESIBA); paroxetine (PAROXETINE); pantoprazole; nebivolol; furosemide; gabapentin; insulin human (INSULIN RAPID). The patient experienced vaccination failure and covid-19 pneumonia and the patient developed bronchial congestion on 30Mar2021. The same day, SARS-CoV-2 RT-PCR test was positive with absence of variants. On 02Apr2021, the patient experienced hyperthermia. On 03Apr2021, hyperthermia persisted with oxygen desaturation which required hospitalization via the emergency room for acute respiratory distress syndrome in a COVID-19 pneumonia context at day5 of infection. The patient experienced respiratory failure on an unspecified date. The patient also experienced cardiopulmonary arrest on 04Apr2021. The patient was hospitalized for vaccination failure and covid-19 pneumonia, from 03Apr2021 to an unknown date. The patient underwent lab tests and procedures which included RT-PCR: positive, no variant on 30Mar2021, body temperature: hyperthermia on 02Apr2021, temperature: hyperthermia, oxygen saturation: desaturation, on 03Apr2021 and coma scale: 5 on an unspecified date. The patient died on 04Apr2021. Outcome of the events was fatal. An autopsy was not performed.; Reported Cause(s) of Death: Vaccination failure; covid-19


VAERS ID: 1274932 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 RA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarction; Permanent cardiac pacemaker insertion
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021463117

Write-up: Decompensation cardiac; sweating; thoracic discomfort; cardiac arrest; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The Regulatory Authority report number is FR-AFSSAPS-MP20211463. A 90-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EP2163 and expiration date not reported), intramuscular administered in right arm on 02Mar2021 as a single dose for COVID-19 immunisation. Medical history included Permanent cardiac pacemaker insertion and myocardial infarction. The patient''s concomitant medications were not reported. It was reported that the patient was considered to be at risk of developing a severe form of COVID-19 disease and has no history of COVID-19. The patient was vaccinated as part of the COVID-19 vaccination campaign. The vaccination took place without incident. On the morning of 09Mar2021, the patient presented with sweating, a thoracic discomfort and "mucus". The patient''s daughter called the emergency. On arrival, the patient was in cardiac arrest and was declared dead. The patient experienced decompensation cardiac on 09Mar2021. The patient died on 09Mar2021 due to the events. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Decompensation cardiac; sweating; thoracic discomfort; cardiac arrest


VAERS ID: 1274939 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-04-01
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARDENSIEL; KARDEGIC; LEVOTHYROX; SERESTA; ZYMAD; DAFALGAN; DEXERYL [CHLORPHENAMINE MALEATE;DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORID; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORI
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Bradycardia; COVID-19; Dementia Alzheimer''s type; Falling down; Hypothyroidism; Lower limb fracture; Myocardial infarction; Road traffic accident; Starvation
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210411; Test Name: O2 saturation; Test Result: 96 %; Test Date: 20210401; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: variant
CDC Split Type: FRPFIZER INC2021447089

Write-up: death of the patient; Vaccination failure/ positive COVID PCR test (screening: variant); Vaccination failure/ positive COVID PCR test (screening: variant); This is a spontaneous report from contactable pharmacist downloaded from a regulatory authority-WEB, regulatory authority report number: FR-AFSSAPS-NT20211117, Safety Report Unique Identifier: FR-AFSSAPS-2021039449. An 88-year-old female patient received bnt162b2 (COMIRNATY), second dose on 11Feb2021 (lot number: EJ6789) and first dose on 21Jan2021 (lot number: EJ6795), both via intramuscular as single dose for COVID-19 immunisation. Medical history included dementia alzheimer''s type, starvation, myocardial infarction, falling down, bradycardia, hypothyroidism, fracture of the 2 lower limbs, road accident, Arterial hypertension, and COVID-19. Concomitant medications included bisoprolol fumarate (CARDENSIEL); acetylsalicylate lysine (KARDEGIC); levothyroxine sodium (LEVOTHYROX); oxazepam (SERESTA); colecalciferol (ZYMAD); paracetamol (DAFALGAN); chlorphenamine maleate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride (DEXERYL); macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL); and dietary supplement. The patient experienced death of the patient on 12Apr2021, and vaccination failure/ positive covid pcr test (screening: variant) on 01Apr2021 with outcome of unknown. The event ''vaccination failure/ positive covid pcr test'' was assessed as medically significant. The clinical course was reported as follows: Resident of nursing home GIR1 - ambulation - Person prone to swallowing disorder. On 21Jan2021: 1st dose of COMIRNATY and on 11Feb2021: 2nd dose of COMIRNATY. On 01Apr2021, patient was positive COVID PCR test (screening: English variant). The patient did not develop a severe form of the disease: no cough, no fever, no desaturation, no polypnea, but severe fatigue. On 11Apr2021: fatigue, eats very little. Body temperature at 36.6 C and minimum 96% O2 saturation. On 12Apr2021: resident crowded at breakfast, eats little. At lunch, also eat very little. The patient left for a walk after lunch, fell suddenly and died quickly. She was found with phlegm in her mouth. Doctor was called then patient was put into immediate burial (no autopsy). NB: mouth treatments had been carried out to see if there was any foreign body but nothing had been found. On 12Apr2021: death of the patient. NB: Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal procedures. The patient died on 12Apr2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death of the patient


VAERS ID: 1274975 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19, Chronic kidney disease, Creatinine renal clearance, Decreased appetite, Dehydration, Fall, General physical health deterioration, Hallucination, Incoherent, Liver function test, Malaise, Malnutrition, SARS-CoV-2 test, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CARDENSIEL; LASILIX [FUROSEMIDE]; COVERSYL [PERINDOPRIL ARGININE]; KARDEGIC; XATRAL; CALCIUM
Current Illness: Cardiac arrhythmia (NOS); Chronic renal insufficiency; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Adult T-cell leukemia-lymphoma (in remission with CT); Benign hepatic neoplasm; Gastrectomy; Radiotherapy
Allergies:
Diagnostic Lab Data: Test Date: 20210405; Test Name: Cl; Result Unstructured Data: Test Result:25 ml/min; Test Name: liver markers; Result Unstructured Data: Test Result:normal; Test Date: 20210406; Test Name: SARS-Cov-2 PCR test; Test Result: Negative ; Test Date: 20210413; Test Name: SARS-Cov-2 PCR test; Result Unstructured Data: Test Result:undetermined; Test Date: 20210414; Test Name: SARS-Cov-2 PCR test; Result Unstructured Data: Test Result:positive (weakly)
CDC Split Type: FRPFIZER INC2021463135

Write-up: Reduced general condition; incoherent remarks; hallucinations; anorexia; 2 falls; malaise; ARDS; Vaccination failure; Vaccination failure/ ARDS linked to covid-19 infection; degradation of his chronic renal failure (Cl at 25 mL/min); dehydrated; malnourished; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority number is FR-AFSSAPS-PA20210562. An 83-year-old male patient received BNT162B2 (COMIRNATY, lot number and expiration date were unknown), intramuscular on 19Feb2021 as first dose and on 19Mar2021 as second dose at 0.3 mL, single for COVID-19 immunisation. Medical history included adult T-cell leukemia-lymphoma which was not ongoing (in remission with CT), radiotherapy (RT) and gastrectomy in 1996, ongoing cardiac arrhythmia (NOS), ongoing hypertension arterial, ongoing chronic renal insufficiency, and concept of benign liver tumor but normal liver markers. Concomitant medications included bisoprolol fumarate (CARDENSIEL); furosemide (LASILIX); perindopril arginine (COVERSY); acetylsalicylate lysine (KARDEGIC); and alfuzosin hydrochloride (XATRAL), calcium and PPI. The patient experienced reduced general condition on 19Mar2021 and vaccination failure on 14Apr2021. The course of events was as follows: Notion of incoherent remarks/hallucinations reported by the family in the aftermath of this second dose associated with an alteration of the general condition (anorexia, 2 falls on malaise) on an unspecified date in 2021 leading to hospitalization in geriatrics from 05Apr2021 to 15Apr2021. The patient was dehydrated and malnourished on an unspecified date in 2021 with degradation of his chronic renal failure (Cl at 25 mL/min) on arrival (05Apr2021). 3 PCR tests were carried out during hospitalization: negative on 06Apr2021, undetermined on 13Apr2021 and positive (weakly) on 14Apr2021 (search for mutation not done because too little virus). On 14Apr2021, appearance of respiratory distress requiring high flow oxygen (OPTIFLOW) but not sufficient. On 15Apr2021, the patient died from ARDS linked to COVID-19 infection. Note that the service hosts a COVID-19 unit. In total, death of an 83-year-old man, hypertensive and chronic renal failure, as a result of a severe form of COVID-19 in a context of SAE since second dose and confirmed vaccine failure. The patient underwent lab tests and procedures which included SARS-COV-2 PCR test: negative on 06Apr2021, undetermined on 13Apr2021, and positive (weakly) on 14Apr2021; creatinine clearance: 25 mL/min on 05Apr2021; and liver markers: normal on an unspecified date. The patient died on 15Apr2021. The causes of death were ARDS linked to COVID-19 infection and vaccination failure. An autopsy was not performed. The outcome of the event reduced general condition was not recovered and unknown for all other events. No follow-up attempts are possible; information on lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: ARDS; Vaccination failure; Vaccination failure/ ARDS linked to covid-19 infection


VAERS ID: 1275064 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XARELTO; IRBESARTAN; LOXEN L P; TAHOR; ANORO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Bronchial disorder; COPD; Embolism pulmonary; Ex-tobacco user; Hypercholesterolaemia; Prothrombin mutation G20210A
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021463078

Write-up: Sudden death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PC20210835. A female patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY, lot number: ET3620), intramuscular on 22Mar2021 (at the age of 85-year-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included prothrombin mutation G20210A, arterial hypertension, embolism pulmonary, chronic obstructive pulmonary disease (COPD), hypercholesterolaemia, bronchodilatation, and ex-tobacco user. Concomitant medications included rivaroxaban (XARELTO); irbesartan; nicardipine hydrochloride (LOXEN L P); atorvastatin calcium (TAHOR); and umeclidinium bromide, vilanterol trifenatate (ANORO). On 23Mar2021, the patient experienced sudden death. It was further reported that on 23Mar2021, without prodrome, fatigue or post-injection manifestation, the patient died overnight. She was found lying in her bed like a gun dog, no vomiting or externalized bleeding. An autopsy was not performed.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1275070 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Atrial fibrillation; Decompensation cardiac
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021453490

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-PO20211821 and received via Regulatory Authority (AFSSAPS). A 90-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EW2239), first dose intramuscular, administered in left arm on 07Apr2021 as SINGLE DOSE for Covid-19 immunization. Medical history included recent discovery of cardiac decompensation on ACFA (complete arrhythmia due to atrial fibrillation. The patient''s concomitant medications were not reported. On 15Apr2021: sudden death of the patient. She was found in cardio respiratory arrest, no etiology found. Normal constants during the day. The patient is considered at risk of developing a severe form of Covid-19, she has not had it and was tested on 15Apr2021. It was not reported if an autopsy was performed. Outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1275079 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-23
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Drug ineffective, Oxygen saturation, Respiratory rate, 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: 2021-04-01
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BACTRIM FORTE; ZELITREX; LEDERFOLINE; PARACETAMOL; ESOMEPRAZOLE; MIANSERIN; SPASFON [PHLOROGLUCINOL]; BILASTINE; ZOPICLONE; LEVOTHYROX; BRUKINSA; GAZYVARO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Hypothyroidism; In situ follicular lymphoma; Shoulder arthroplasty (right shoulder)
Allergies:
Diagnostic Lab Data: Test Date: 20210325; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 20210325; Test Name: oxygen; Test Result: 87 %; Test Date: 20210401; Test Name: oxygen; Test Result: 85 %; Test Date: 20210323; Test Name: SARS-CoV-2 test/antigen test; Result Unstructured Data: Test Result:positive; Test Date: 20210325; Test Name: SARS-CoV-2 test/antigen test; Result Unstructured Data: Test Result:positive to stain; Test Date: 20210401; Test Name: respiratory frequency; Result Unstructured Data: Test Result:30
CDC Split Type: FRPFIZER INC2021463106

Write-up: COVID antigen test positive/sars-cov-2 test PCR: positive stain; COVID antigen test positive/sars-cov-2 test PCR: positive stain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number FR-AFSSAPS-RN20211105. An 82-year-old female patient received BNT162B2 (COMIRNATY) dose 1 via unspecified route of administration (Batch/Lot Number: Unknown) in Jan2021; and dose 2 intramuscular (Batch/Lot Number: EJ6788) in Feb2021 for COVID-19 immunization. Medical history included in situ follicular lymphoma, shoulder arthroplasty, hypothyroidism and COVID-19. Concomitant medications included sulfamethoxazole, trimethoprim (BACTRIM FORTE); valaciclovir hydrochloride (ZELITREX); calcium folinate (LEDERFOLINE); paracetamol; esomeprazole; mianserin (MIANSERIN); phloroglucinol (SPASFON); bilastine; zopiclone; levothyroxine sodium (LEVOTHYROX); all taken for an unspecified indication, start and stop date were not reported; and 3 courses of the association zanubrutinib (BRUKINSA) and obinutuzumab (GAZYVARO) taken for lymphoma from an unspecified start date to Mar2021. The patient experienced degradation of general health status in the middle of Mar2021: antigen test positive on 23Mar2021. On 25Mar2021, patient hospitalized for general health status degradation with fever at 38.5 degrees, saturation at 87% in ambient air requiring oxygen supplementation, sars-cov-2 test PCR: positive stain. Dexamethasone was introduced. On 01Apr2021, no improvement, patient was still hospitalized and treated with dexamethasone, increase of oxygen supplementation as saturation was 85%, strong asthenia, respiratory frequency at 30, sweating, dry cough, diffuse crackling. The patient died on 01Apr2021. It was not reported if an autopsy was performed. The events were reported as serious-fatal. Reporter''s comment: degradation of general health status in the middle of Mar2021 : antigen test positive on 23Mar2021. On 25Mar2021, patient hospitalized for general health status degradation with fever at 38.5 degrees, saturation at 87% in ambient air requiring oxygen supplementation. Dexamethasone introduced. On 01Apr2021, no improvement, patient still hospitalized and treated with dexamethasone, increase of oxygen supplementation as saturation was 85%, strong asthenia, respiratory frequency at 30, sweating, dry cough, diffuse crackling. death of patient on 01Apr2021; Reported Cause(s) of Death: antigen test positive/sars-cov-2 test PCR: positive stain; antigen test positive/sars-cov-2 test PCR: positive stain


VAERS ID: 1275085 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Cardiac arrest, Choking, Cyanosis, Death, Food refusal, Livedo reticularis, Oxygen saturation, Oxygen saturation decreased, Pallor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PERINDOPRIL; METFORMIN; LAMICTAL; TERCIAN [CYAMEMAZINE]; URBANYL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anoxia cerebral (at birth); Communication disorder; Diabetes mellitus; Disability; Epilepsy (balanced; successfully managed with medical treatments); Fibrosis liver (stable, no liver failure); Turner''s syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: Blood pressure; Result Unstructured Data: Test Result:100/80 mmHg; Test Date: 20210419; Test Name: O2 saturation; Result Unstructured Data: Test Result:50%; Comments: very low
CDC Split Type: FRPFIZER INC2021463109

Write-up: death unexplained/death from undetermined cause; choking; cardiac arrest; refused to eat; turned pale; cyanosis; mottled skin; 100/80 mm Hg; oxygen saturation was very low, at 50%; one episode of vomiting; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, Regulatory authority report number FR-AFSSAPS-RS20210946. A 28-year-old female patient received first dose of BNT162B2 (COMIRNATY), intramuscular on 12Apr2021 (at the age of 28 years old) (Lot Number: EW2246, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included epilepsy (balanced; successfully managed with medical treatments), anoxia cerebral at birth complicated by multiple disability, incapable of communication, turner''s syndrome, diabetes mellitus, and fibrosis liver (stable, no liver failure). Concomitant medications included perindopril; metformin; lamotrigine (LAMICTAL); cyamemazine (TERCIAN); and clobazam (URBANYL). A tolerability seemed to be good (the patient was incapable of communication); in any case, no fever or changes and in usual behavior were observed. On 19Apr2021, in the morning, the patient was undergoing hygiene procedures in a bed with the nursing aid without any particular problem, the patient was smiling, no changes in usual behaviour. The patient was transported in a wheelchair to have her breakfast. There, she refused to eat, turned pale. Then cyanosis and mottled skin appeared. The patient was transported to the nursing unit at about 09:05 am. The blood pressure was 100/80 mm Hg. The oxygen saturation was very low, at 50%. The patient was placed in the recovery position. She had one episode of vomiting and then very quickly a cardiac arrest occurred. On site, nursing staff started cardiopulmonary resuscitation (chest compressions), which were then continued by an emergency team. Death was pronounced at 09:50 am. No defibrillator was used. In the medical certificate of death, the emergency physician stated choking (according to the facility coordinating physician such hypothesis seemed unlikely in this patient as she did not eat in the morning). There have been no recent changes in the patient''s therapy. There will be no autopsy. It should also be noted that in Nov2020, the patient was seen by a cardiologist for her diabetes mellitus follow-up, who had found no abnormalities. Overall, death unexplained/death from undetermined cause of the 28-year-old woman with multiple disabilities 1 week after the first dose of COVID-19 vaccine. The patient died on 19Apr2021 at 09:50 am. Outcome of the remaining events was unknown. The patient died on 19Apr2021. An autopsy was not performed. No follow-up attempts are possible; information about batch number was already obtained.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified and assessed as unrelated. The events choking and cardia arrest are also assessed as related. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: choking; Death unexplained


VAERS ID: 1275092 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-04-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Facial bones fracture, Fall, Humerus fracture, Oxygen saturation, Pain, SARS-CoV-2 test, Vaccination failure, Weight decreased, Wound
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Accidents and injuries (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FORLAX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Bedridden; Choked on food; Chronic renal insufficiency; Collapsed vertebra; Deglutition disorder; Extrapyramidal syndrome; Falling down; Gastritis; Malnutrition; Osteoporosis; Prostate adenoma; Starvation; Vascular atheroma; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: o2 saturation; Result Unstructured Data: Test Result:90-92 %; Comments: under 2 L of O2, Beginning of O2 desaturation; Test Date: 20210407; Test Name: o2 saturation; Result Unstructured Data: Test Result:not exceed 84% %; Comments: not exceed 84%; Test Date: 20210408; Test Name: o2 saturation; Result Unstructured Data: Test Result:gradual desaturation under 6L of O2 %; Comments: gradual desaturation under 6L of O2; Test Date: 20210402; Test Name: Covid-19 virus test; Test Result: Negative ; Comments: PCR; Test Date: 20210404; Test Name: Covid-19 virus test; Test Result: Positive ; Comments: antigen test; Test Date: 20210407; Test Name: Covid-19 virus test; Result Unstructured Data: Test Result:positive. No variant; Comments: PCR test. No variant.
CDC Split Type: FRPFIZER INC2021446954

Write-up: hospitalized following a fall; increase in the weight loss; Vaccination failure; COVID-19; wound on the bridge of the nose; open nose fracture; o the emergency room and there was a fracture of the left humerus; persistence of pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB FR-AFSSAPS-ST20211495, Safety Report Unique Identifier FR-AFSSAPS-2021038673 A 93-year-old male patient received bnt162b2 (COMIRNATY), then second dose intramuscular on 15Mar2021 (Batch/Lot Number: ET3620) as (reported as 0.3 mL, single) and first dose intramuscular on 23Feb2021 (Batch/Lot Number: EK9788) as Single Dose (reported as 0.3 mL, single); both for covid-19 immunisation. It was added that there was no adverse event between the doses on 15Mar2021 and 31Mar2021. Medical history included extrapyramidal syndrome, vascular dementia, prostate adenoma, Choked on food, gastritis, Deglutition disorder, Collapsed vertebra, osteoporosis, Chronic renal insufficiency (reported as chronic renal failure), Starvation, anemia, Falling down (reported as history of fall), Vascular atheroma, undernutrition and Bedridden patient; all from an unknown date and unknown if ongoing. Concomitant medication included macrogol 4000 (FORLAX) taken for an unspecified indication, start and stop date were not reported. It was reported that on 31Mar2021, the patient was hospitalized following a fall. On 01Apr2021, faced with the persistence of pain, the patient was referred to the emergency room and there was a fracture of the left humerus: Zimmer splint and lesion of the nose treated with Steristrip. On 02Apr2021, new fall, wound on the bridge of the nose with open nose fracture. A Covid-19 PCR is performed and is negative. 04Apr2021, deterioration of the general condition. Positive Covid-19 antigen test. On 05Apr2021, the general condition continued to deteriorate in this patient with an increase in the weight loss due to the fractures. On 07Apr2021, a PCR test is positive. No variant. Beginning of O2 desaturation. 90-92% saturation under 2 L of O2; does not exceed 84% even by increasing the flow of O2. On 08Apr2021, gradual desaturation under 6L of O2. 09Apr2021: Death. It was concluded that: confirmed vaccine failure. Time Interval between Beginning of Drug Administration was 41 days (as reported) and Time Interval between Last Dose of Drug: 21 days (as reported). The patient died on 09Apr2021. An autopsy was not performed. The outcome of other events was unknown. Based on the information currently available, the company assessed the relationship of COMIRNATY, concentrate for injection. COVID-19 mRNA vaccine(modified nucleoside) to the events, vaccination failure. Reporters'' comments: COVID-19 HISTORY: NO, Bedridden patient. (goes from bed to chair). No more information expected/was available.; Reported Cause(s) of Death: Covid-19; vaccine failure


VAERS ID: 1275103 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Brain natriuretic peptide, C-reactive protein, C-reactive protein increased, COVID-19, Computerised tomogram head, Cyanosis, Fall, Fibrin D dimer, Fibrin D dimer increased, Oxygen saturation, Physical examination, Respiratory alkalosis, SARS-CoV-2 test, Sudden death, Troponin, Troponin increased, Ventilation/perfusion scan
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haemorrhage laboratory terms (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Constipation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: proBNP; Result Unstructured Data: Test Result:311; Test Date: 202102; Test Name: Cerebral CT scan; Result Unstructured Data: Test Result:without abnormality; Test Date: 202102; Test Name: CRP; Result Unstructured Data: Test Result:29; Test Date: 202102; Test Name: D Dimers; Result Unstructured Data: Test Result:2680; Test Date: 20210222; Test Name: desaturation; Result Unstructured Data: Test Result:Unknown result; Test Date: 202102; Test Name: examination; Result Unstructured Data: Test Result:soft calves, no bleeding; Test Date: 20210222; Test Name: SARS-CoV2 test; Result Unstructured Data: Test Result:positive; Test Date: 202102; Test Name: Troponin; Result Unstructured Data: Test Result:37; Test Date: 202102; Test Name: lung scan; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021463081

Write-up: positive COVID-19 test with symptoms; Death unexplained/Sudden death; cyanotic appearance of the upper body (seen a few hours before); asthenia; fall; respiratory alkalosis; CRP at 29; D Dimers at 2680; Troponin at 37; This is a spontaneous report from a contactable physician downloaded from the regulatory Agency-WEB. The regulatory authority number is FR-AFSSAPS-TS20211312. A 92-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EK9788), intramuscular, on 19Feb2021, as single dose, for COVID-19 immunisation. The patient medical history included constipation. Concomitant medication included an unspecified laxative for constipation. The patient received the first dose on 19Feb2021. On 20Feb2021, next day, the patient experienced asthenia and had a fall. A cluster of COVID cases in his residence was reported. On 22Feb2021, day 4, the patient was coughing and tested positive for SARS-CoV2 with respiratory symptomatology with desaturation (value not reported) justifying his hospitalization from 23Feb2021 to 25Feb2021. In Feb2021, the patient underwent examination which showed soft calves and no bleeding; D Dimers at 2680; CRP at 29; Troponin at 37; proBNP at 311; and normal lung scan. In Feb2021, respiratory improvement was noted after an episode of respiratory alkalosis. On 25Feb2021, day 7, the patient got better and was able to return on home with hospitalization at home request. On 26Feb2021, day 8, the patient was found deceased in his bed (death unexplained/sudden death), his phone in his hand with cyanotic appearance of the upper body (seen a few hours before). It was reported that "Overall, unexplained death on D8 of the 1st dose of COMIRNATY in an elderly patient but independent and without medical history, with recent symptomatic COVID, but stabilized the day before death." The outcome of the events positive COVID-19 test with symptoms and respiratory alkalosis was recovering, and the remaining events was unknown. The patient died on 26Feb2021. Autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained/Sudden death


VAERS ID: 1275576 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Myocardial infarction, Off label use
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EDOXABAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021454981

Write-up: Off label use; Inappropriate schedule of vaccine administered; Heart attack; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202104220901356500-SBDDI, Safety Report Unique Identifier GB-MHRA-ADR 25179487. A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: ER1741) as single dose for covid-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test, and was not enrolled in clinical trial. Concomitant medication included edoxaban taken for an unspecified indication, start and stop date were not reported. Patient took first dose of BNT162B2 on 16Jan2021 for COVID-19 immunization. The patient experienced heart attack on 01Apr2021, off label use and inappropriate schedule of vaccine administered on an unspecified date. The patient died on 15Apr2021. It was not reported if an autopsy was performed. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1275578 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Dyspnoea, Embolism, Haemorrhage, Myocardial infarction
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   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: ANTI-D [ANTI-D IMMUNOGLOBULIN]; ASPIRIN [ACETYLSALICYLIC ACID]; EPLERENONE; OMEPRAZOLE SODIUM; PRASUGREL; ROSUVASTATIN
Current Illness: Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Gallstones; Myocardial infarction; Stent insertion NOS
Allergies:
Diagnostic Lab Data: Test Name: Autopsy; Result Unstructured Data: Test Result:cause of death: Myocardial infarction
CDC Split Type: GBPFIZER INC2021455043

Write-up: haemorrhage; thromboembolic event; dyspnoea; myocardial infarction; Myocardial infarct; 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-202104222024143180-IIH84, Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25184738. A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER1741 (also reported as ER1791 pending clarification) and expiration date not provided), via an unspecified route of administration second dose on 14Apr2021 15:30 at single dose for covid-19 immunisation. The patient''s medical history included Myocardial infarction and stent; both in 2012, Cholelithiasis, and ongoing smoker. The patient''s concomitant medications included anti-d immunoglobulin; aspirin [acetylsalicylic acid] taken for myocardial infarction from 01Jul2012; eplerenone taken for cardiac failure from 01Jul2012; omeprazole sodium taken for prophylaxis from 01Jul2012; prasugrel taken for myocardial infarction from 01Jul2012; and rosuvastatin taken for blood cholesterol from unspecified date in Jul2012. The patient previously took Heparin. 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. On an unspecified date, the patient experienced haemorrhage, thromboembolic event, dyspnoea, and myocardial infarction. On 14Apr2021, the patient experienced Myocardial infarct. The myocardial infraction was diagnosed on post mortem. The reporter assesses the events as serious (death, medically significant, life threatening). The outcome of the events was fatal. The patient died on 14Apr2021. Autopsy was performed and autopsy result on an unspecified date includes cause of death: myocardial infarction. No follow-up attempts possible. No further information expected. Information on lot number already obtained.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1275579 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-20
Onset:2021-02-01
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Computerised tomogram, Fall, Gait inability, General physical health deterioration, Guillain-Barre syndrome, Laboratory test, Magnetic resonance imaging spinal, Muscular weakness, Neurological examination, Respiratory disorder, SARS-CoV-2 test negative, Sensory disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Demyelination (narrow), Respiratory failure (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   Days after onset: 20
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: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Pancytopenia (treated with corticosteroids.)
Allergies:
Diagnostic Lab Data: Test Name: Post mortem findings; Result Unstructured Data: Test Result:Post mortem findings fit with that diagnosis of Gu; Comments: Post mortem findings fit with that diagnosis of Guillain-Barre syndrome; Test Name: CT scan; Result Unstructured Data: Test Result:no results provided; Test Name: Laboratory test; Result Unstructured Data: Test Result:no results provided; Test Name: Magnetic resonance imaging spinal; Result Unstructured Data: Test Result:no results provided; Test Name: Neurological examination; Result Unstructured Data: Test Result:no results provided; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021469257

Write-up: guillain-barre syndrome; Respiratory disorder; had a fall; Sensory disturbance; leg weakness; Gait inability; began to deteriorate; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104231602017210-PWDP1. Safety Report Unique Identifier GB-MHRA-ADR 25188795. An 81-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 20Dec2020 (Batch/Lot Number: Not known) as single dose at the age of 81-year-old for COVID-19 immunisation. Medical history included immunodeficiency (has an illness or condition, not listed, which reduces the immune response (e.g. immunodef.), pancytopenia treated with corticosteroids. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced Guillain-Barre syndrome on an unspecified date, gait inability in Feb2021, leg weakness in Feb2021, respiratory disorder on 19Feb2021, sensory disturbance in Feb2021, she began to deteriorate a few days after the first vaccine in Feb2021, she had a fall on 06Feb2021. The patient underwent lab tests and procedures which included computerised tomogram, laboratory test, magnetic resonance imaging spinal, neurological examination, Sars-cov-2 test: negative. The patient died on 21Feb2021. An autopsy was performed and results fitted with that diagnosis of Guillain-Barre syndrome. The clinical course was reported as follows: Main medical problem before the vaccination had been moderate pancytopenia, which was treated with corticosteroids. According to the family, she began to deteriorate a few days after the first vaccine. She had a fall on the 6th of February and was admitted to a hospital. No significant acute injury was detected, but she did not recover, and she complained of leg weakness. Soon she lost the ability to walk and developed sensory symptoms. Respiratory problems started on 19th of February, and she died on 21st of February. Clinical suspicion was Guillain-Barre syndrome. Post mortem findings fit with that diagnosis. Patient has not tested positive for COVID-19 since having the vaccine. Reaction. The report does not relate to possible blood clots or low platelet counts. The outcome of Guillain-Barre syndrome, leg weakness, gait inability, respiratory disorder and sensory disturbance was fatal, of gait inability, fall was not recovered, of respiratory disorder, sensory disturbance was unknown. Follow-up attempts are completed, Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Guillain-Barre syndrome


VAERS ID: 1275581 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-04-20
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Magnetic resonance imaging, Pain in jaw, Paraesthesia, SARS-CoV-2 test, Scan brain, Subdural haematoma
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Osteonecrosis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:No results provided; Test Date: 20210215; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test; Test Name: Scan brain; Result Unstructured Data: Test Result:No results provided
CDC Split Type: GBPFIZER INC2021469121

Write-up: Subdural haematoma; pins and needles; Pain in jaw; Stroke; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104251801555410-R0TFQ. Safety Report Unique Identifier GB-MHRA-ADR 25194574. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: Not known) as single dose for COVID-19 immunisation. Relevant medical history was not provided. The patient has not had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. Concomitant medication included acetylsalicylic acid (ASPIRIN) taken for cardiac disorder from an unspecified start date to Apr2021. On an unspecified date, the patient experienced pins and needles and pain in jaw; on 20Apr2021 she experienced subdural haematoma for which she was hospitalized and on 23Apr2021 she had a stroke with a fatal outcome. The patient died on 24Apr2021 due to stroke; it was unknown if an autopsy was performed. The outcome of subdural haematoma was not recovered; the outcome of pins and needles and pain in jaw was unknown. The patient underwent lab tests and procedures which included magnetic resonance imaging and scan brain on an unspecified date with unknown results and a COVID-19 virus test on 15Feb2021 which was negative. The clinical course was reported as follows: subdural haematoma. The patient had pins and needles in her arm, a pain in her jaw. She was diagnosed with bleed on the brain first. She was discharged the following day. She stopped her aspirin for a heart condition. She had a magnetic resonance imaging (MRI) scan the day after. 2 days later, she had the same symptoms again, ambulance was phoned, and she had a massive stroke. Hospital told she was brain dead and switched her machine off the following day. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Stroke


VAERS ID: 1275582 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 162B2 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Dyspnoea, Glycosylated haemoglobin, Headache, Malaise, Nausea, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; APIXABAN; ATORVASTATIN; BISOPROLOL; OLMESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis (severe; under cardiology); Atrial fibrillation; Cardiac arrest; Hypertension (under cardiology); Low sodium diet; Type 2 diabetes mellitus (well controlled with diet)
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Body temperature; Result Unstructured Data: Test Result:Unknown results; Comments: Fevers; Test Name: HbA1c; Test Result: 6.6 %
CDC Split Type: GBPFIZER INC2021469041

Write-up: Cardiac arrest; vomiting; shortness of breath; headache; nausea; felt unwell; fevers; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104261256053370-PDPVL. An 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 162b2), via an unspecified route of administration on 17Apr2021 as a single dose for COVID-19 immunisation. Medical history included cardiac arrest, hypertension and also severe aortic stenosis under cardiology, low sodium diet, type 2 diabetes mellitus that was well controlled with diet, and atrial fibrillation. The patient has not had symptoms associated with covid-19, has not had a covid-19 test, and was not enrolled in a clinical trial. Concomitant medications included apixaban taken for atrial fibrillation, atorvastatin taken for diabetes, and amlodipine, bisoprolol, and olmesartan, all taken for hypertension. The patient previously took the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced cardiac arrest on 19Apr2021 and vomiting, shortness of breath, headache, nausea, felt unwell and fevers all on unspecified date in Apr2021. The reporter denied that the report relates to possible blood clots or low platelet counts. It was reported that the patient felt unwell 24 hours after receiving the Pfizer vaccine. The patient reportedly had a headache, fevers, nausea, vomiting, and shortness of breath, and had cardiac arrest 20Apr2021. The cause of the arrest is currently unknown. The patient underwent lab tests and procedures, which included HbA1c (Unknown date): 6.6 %. The patient has not tested positive for COVID-19 since having the vaccine. The patient died on 20Apr2021. It was not reported if an autopsy was performed and the reported cause of death was cardiac arrest. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1275585 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-26
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Platelet count, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HIV positive (with symptoms or reduction in immune response); Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Name: Platelet count; Result Unstructured Data: Test Result:166; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021469009

Write-up: Massive saddle pulmonary embolus; Death; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104262008542490-GBRDA. Safety Report Unique Identifier GB-MHRA-ADR 25096240. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), via an unspecified route of administration on 12Apr2021 (Batch/Lot Number: Not known) as single dose for covid-19 immunisation. Medical history included HIV test positive with symptoms or reduction in immune response, patient also had pulmonary embolism (PE) in 2012. Patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced death on 26Apr2021 and had massive saddle pulmonary embolus on an unspecified date. The patient underwent lab test included platelet count: 166 and COVID-virus test: no - negative covid-19 test on unspecified date. Outcome of the event massive saddle pulmonary embolus was unknown. The patient died on an 26Apr2021. An autopsy was not performed. Patient has not tested positive for COVID-19 since having the vaccine. When asked about the report if related to any possible blood clots or low platelet counts, the answer was not as per physician. Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1275668 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Myocardial infarction
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive lung disease; Diabetes; Hypertension; Psychiatric disorder NOS (long-term psychiatric patient)
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRPFIZER INC2021462494

Write-up: Myocardial infarction; Breathing difficult (complained of difficulty breathing shortly before death); This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HR-HALMED-300046663. A 69-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 09Apr2021 (Lot Number: EW2246) as 0.3 mL, single dose for covid-19 immunisation. Medical history included psychiatric disorder NOS (long-term psychiatric patient), diabetes, chronic obstructive pulmonary disease (COPD) and hypertension, all were unknown if ongoing. The patient had no previous doses, or reactions to same preparation and no previous reactions to other immunobiological. The patient''s concomitant medications were not reported. On 11Apr2021, the patient experienced breathing difficult (complained of difficulty breathing shortly before death) and myocardial infarction. It was further mentioned that shortly before, she complained of difficulty breathing and resident technician was notified. Ambulance was called, and heart massage was started. The treatment received was reported as reanimation. Death report stated as cause myocardial infarction. The outcome of the events was fatal. The patient died on 11Apr2021 22:15 hours. It was not reported if an autopsy was performed. Sender Comment: 21Apr2021: Additional documentation is requested. No routine follow-up attempts are foreseen for reports received from Regulatory Authority-WEB. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction; breathing difficult


VAERS ID: 1275674 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-02-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Full blood count abnormal
SMQs:, Haematopoietic leukopenia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   Days after onset: 36
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210220; Test Name: blood test; Result Unstructured Data: Test Result:full blood count abnormal
CDC Split Type: HUPFIZER INC2021455370

Write-up: blood count collapsed; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-205121. A 78-years-old patient of an unspecified gender received bnt162b2 (COMIRNATY, concentrate for dispersion injection), intramuscular on 20Feb2021 (active substance: tozinameran - 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA vaccine; batch number: unknown, expiry date: unknown, MAH: BioNTech Manufacturing GmbH) for COVID-19 immunization (age at vaccination: unknown). The patient medical history and concomitant medications were not reported. The patient experienced blood count collapsed (full blood count abnormal) on 20Feb2021 she was submitted to hospital, she received blood transfusion. 10 days after, the patient was discharged, but remained totally disabled until her death on 29Mar2021. The patient died on 29Mar2021. It was not reported if an autopsy was performed. Cause of death was full blood count abnormal. Full blood count abnormal was not expected for COMIRNATY. Time to onset was 1 day after the second vaccination. In the lack of detailed medical information, causality between the adverse event and COMIRNATY is not assessable. The case is serious because the patient died. Further information is expected. Follow-up activities closed. No routine follow-up is possible for WEB ICSRs. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: blood count collapsed


VAERS ID: 1275675 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Condition aggravated, Death, Hypotonia, Loss of consciousness, Psychiatric symptom, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 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: Cerebral infarction; Hallucinations; Hypertension; Prostatic hypertrophy
Preexisting Conditions: Medical History/Concurrent Conditions: Psychiatric symptom
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021462683

Write-up: worsening of his psychiatric symptoms; worsening of his psychiatric symptoms; his right arm was hypotonic; death; collapsed; lost consciousness; his blood pressure decreased; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-217121. An 87-year-old male patient received BNT162B2 (COMIRNATY), second dose intramuscular on 25Feb2021 at 11:30 (batch/lot number: EP2163) as 0.3 mL, single for COVID-19 immunisation. Medical history included ongoing cerebral infarction, hallucination from 1986 and ongoing, ongoing prostatic hypertrophy, ongoing hypertension, and psychiatric symptoms. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 first dose on 04Feb2021 for COVID-19 immunisation. On 25Feb2021 at 11:30 a.m., the patient received the second dose of BNT162B2 for COVID-19 immunisation. On 27Feb2021, the patient was admitted to the psychiatry due to worsening of his psychiatric symptoms. He has been treated by psychiatry since 1986, his disease was in balance for long time, but worsening has been occurred in the recent months. On 03Mar2021, the patient collapsed, lost consciousness, his blood pressure decreased. After stabilisation of conditition, he remained unconscious and his right arm was hypotonic. Cranial CT was requested, but the patient has died before, at 9:50 a.m. Autopsy has not been done. No relationship was suspected with vaccination by the patient''s physician. The patient died on 03Mar2021. An autopsy was not performed. Sender Comment: Death is not expected for COMIRNATY. Time to onset was 6 days after the second vaccination. In the lack of further medical information, causality between the death and COMIRNATY is not assessable. The case is serious because the patient died. No further information is expected. Follow-up activities are closed. No routine follow-up is possible for Regulatory Authority-WEB.; Reported Cause(s) of Death: death


VAERS ID: 1275794 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Haematemesis, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VIDAZA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myelodysplastic syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade
CDC Split Type: ITPFIZER INC2021463091

Write-up: On 13Apr2021 1 COMIRNATY vaccine dose was administered, on 14Apr2021 slight temperature rise 37.5C and nausea with remission appeared. On 15Apr2021, hematemesis appeared; On 13Apr2021 1 COMIRNATY vaccine dose was administered, on 14Apr2021 slight temperature rise 37.5C and nausea with remission appeared. On 15Apr2021, hematemesis appeared; On 13Apr2021 1 COMIRNATY vaccine dose was administered, on 14Apr2021 slight temperature rise 37.5C and nausea with remission appeared. On 15Apr2021, hematemesis appeared; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number [IT-MINISAL02-717611]. A 68-years-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number and expiry date were unknown), intramuscular on 13Apr2021 as single dose for Covid-19 immunization. Medical history included myelodysplastic syndrome. Concomitant medication included azacitidine (VIDAZA) taken for myelodysplastic syndrome from an unknown date to 29Mar2021 and transfusions. This patient has a high risk myelodysplastic syndrome. On 13Apr2021 bnt162b2 vaccine dose was administered, on 14Apr2021 slight temperature rise 37.5 C and nausea with remission appeared. On 15Apr2021 at 4:37 am, hematemesis appeared and was taken to the Emergency Room of the hospital. Outcome of the events were fatal. The patient died on 15Apr2021. Cause of death were slight temperature rise 37.5 C, nausea and hematemesis. It was unknown if an autopsy was performed. Reporter comment: Patient treated with AZACITINA 75mg /, sc 7 days per month (last cycle 29Mar2021) and transfusions. Sender Comment: On 20Apr2021 the report on the death received by the reporter is uploaded. In consideration of the fact that the event took place in another hospital, the reporter was not in possession of other information.; Reporter''s Comments: Reporter comment: Patient treated with AZACITINA 75mg /, sc 7 days per month (last cycle 29Mar2021) and transfusions; Reported Cause(s) of Death: hematemesis; slight temperature rise 37.5C; Nausea


VAERS ID: 1275795 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 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: 2021-04-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANOXIN; TRITTICO; COUMADIN; LASIX [FUROSEMIDE]; CITALOPRAM; METOPROLOL; LUVION [CANRENONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (fibrillating heart disease on oral anticoagulant therapy); Senile dementia (senile dementia on a vascular basis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021463095

Write-up: Death; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (RA)-WEB. The regulatory authority report number is IT-MINISAL02-717643. A 90-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in right deltoid on 15Apr2021 12:50 (Lot Number: EW2246; Expiration Date: 31Jul2021) as 0.3 mL, single for COVID-19 immunisation. Medical history included atrial fibrillation (fibrillating heart disease on oral anticoagulant therapy) and senile dementia on a vascular basis; both from an unknown date and unknown if ongoing. Concomitant medications included digoxin (LANOXIN) taken for an unspecified indication, start and stop date were not reported; trazodone hydrochloride (TRITTICO) taken for an unspecified indication, start and stop date were not reported; warfarin sodium (COUMADIN) taken for an unspecified indication, start and stop date were not reported; furosemide (LASIX) taken for an unspecified indication, start and stop date were not reported; citalopram taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported; canrenone (LUVION) taken for an unspecified indication, start and stop date were not reported. The patient experienced death (sudden death) on 17Apr2021. It was unknown if an autopsy was performed. Sender''s comments: 19Apr2021: Request clinical report from the reporter 20Apr2021: Attached is a clinical report acquired today by the reporter. The concomitant drugs section was updated in light of what the reporter indicated in the report. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1275796 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Decreased appetite, Diarrhoea, Hyperpyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021463098

Write-up: Hyperpyrexia; Diarrhea; Vomiting; Inappetence; cardio-respiratory arrest; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (RA)-WEB. The regulatory authority report number is IT-MINISAL02-717676. A 91-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in right arm on 07Apr2021 (Lot Number: ET7205) as 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Following administration of the first Comirnaty Pfizer vaccination, on 14Apr2021, hyperpyrexia appeared with little response to antipyretics, diarrhea, vomiting, and inappetence. Symptoms were treated until cardio-respiratory arrest on 14Apr2021. Death of the patient was noted on 14Apr2021. All reported events were noted to be fatal. 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: Hyperpyrexia; Diarrhea; Vomiting; Inappetence; cardio-respiratory arrest


VAERS ID: 1275797 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246-07-038 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, C-reactive protein, Electroencephalogram, Eye movement disorder, Hemiparesis, Investigation, Lens disorder, SARS-CoV-2 test, Seizure, Tongue biting
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Lens disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASA; THEOPHYLLINE [THEOPHYLLINE SODIUM AMINOACETATE]
Current Illness: Benign prostatic hypertrophy; Bronchitis asthmatic (Asthmatic bronchitis in therapy with Theophylline); Chronic atrial fibrillation (in therapy with ASA (for bleeding risk)); Chronic venous insufficiency (Chronic venous insufficiency in the lower limbs); Hypertension arterial; Hypertensive heart disease (Hypertensive, chronic ischemic and valvular heart disease (IA, FE 44%,)); Peripheral neuropathy (Peripheral sensory-motor neuropathy in the lower limbs); Pneumonitis; Respiratory insufficiency; Retinopathy hypertensive
Preexisting Conditions: Medical History/Concurrent Conditions: Carcinoma colon (Stenosing colon cancer with intestinal subocclusion); Cerebral haemorrhage (Evacuative craniotomy for cerebral haemorrhage during (2017)); Craniotomy; Macrocytic anemia due to folate deficiency (Last Geriatric evaluation on Feb2021 folate and vitB12 deficiency macrocythemia); Right hemicolectomy (Laparoscopic right hemicolectomy for stenosing colon cancer with subocclusion)
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: C-reactive protein; Result Unstructured Data: Test Result:15.5 mg/l; Test Date: 20210415; Test Name: Electroencephalogram; Result Unstructured Data: Test Result:unknown results; Test Date: 202102; Test Name: Geriatric evaluation; Result Unstructured Data: Test Result:folate and vitB12 deficiency macrocythemia; Test Date: 20210415; Test Name: SARS-CoV-2 PCR test; Test Result: Negative
CDC Split Type: ITPFIZER INC2021463112

Write-up: hemiparesis; tongue bite; Generalized seizure; ocular deviation; aphasia; Left frontal lens anomalies; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, with regulatory authority number IT-MINISAL02-717973. An 89-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EW2246-07-038), intramuscular, administered in left arm on 13Apr2021 at 0.3 mL, single for COVID-19 immunization. Medical history included laparoscopic right hemicolectomy on 10Aug2020 for stenosing colon cancer with subocclusion; ongoing hypertensive heart disease [Hypertensive, chronic ischemic and valvular heart disease (IA, FE 44%,)]; ongoing chronic atrial fibrillation from 01Mar2018 [in therapy with ASA (for bleeding risk)]; ongoing bronchitis asthmatic [Asthmatic bronchitis in therapy with Theophylline]; ongoing respiratory insufficiency; ongoing pneumonitis; cerebral haemorrhage from 06Apr2017 to an unknown date for which patient underwent evacuative craniotomy during (2017); ongoing chronic venous insufficiency in the lower limbs; ongoing peripheral neuropathy [Peripheral sensory-motor neuropathy in the lower limbs]; carcinoma colon from 10Aug2020 (Stenosing colon cancer with intestinal subocclusion); ongoing benign prostatic hypertrophy; macrocytic anemia due to folate deficiency (Last Geriatric evaluation on Feb2021 folate and vitB12 deficiency macrocythemia); ongoing retinopathy hypertensive; and ongoing hypertension arterial. Concomitant medications included ASA taken for chronic atrial fibrillation (for bleeding risk); and theophylline sodium aminoacetate (THEOPHYLLINE) taken for asthmatic bronchitis. The patient previously received the first dose of COMIRNATY on 24Mar2021 for COVID-19 immunization; and took canrenone and experienced hyperkalaemia. On 15Apr2021, the patient experienced generalized seizure, aphasia, hemiparesis, tongue bite and ocular deviation. The patient experienced left frontal lens anomalies on Apr2021. Lab tests and procedures on 15Apr2021 included C-reactive protein: 15.5 mg/l, electroencephalogram: unknown results, and SARS-CoV-2 PCR test: negative. Therapeutic measures taken as a result of hemiparesis, tongue bite, generalized seizure, ocular deviation and aphasia included admission to neurology (Apr2021), antiepileptic therapy and diagnostic study in progress. The patient died on 19Apr2021 due to generalized seizure, aphasia, hemiparesis, tongue bite and ocular deviation. Additional cause of death was respiratory failure/respiratory insufficiency. The outcome of left frontal lens anomalies was unknown. It was not reported if an autopsy was performed. Reporter comment: Precautionary report for unclear causal relationship between vaccine and seizure. Sender Comment: Death occurred on 19Apr2021, the system does not allow you to enter dates after the date of compilation, the data will be corrected on the national network 20Apr2021 updated concomitant and predisposing factors, description and ADR code, correct date of death, including laboratory and instrumental tests, attached clinical report, the autopsy was requested by PRIVACY. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Precautionary report for unclear causal relationship between vaccine and seizure.; Reported Cause(s) of Death: Respiratory failure/Respiratory insufficiency; ocular deviation; aphasia; hemiparesis; tongue bite; Generalized seizure


VAERS ID: 1275803 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary bypass (Bypass following heart attack 17 years ago); Heart attack (Bypass following heart attack 17 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021463077

Write-up: Unexpected death; This is as spontaneous report received from a contactable consumer downloaded from the Regulatory Authority (RA)-WEB. The regulatory authority report number is IT-MINISAL02-718427. A 69-years-old male patient received first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: ex0893), intramuscular on 15Apr2021 10:00 as 0.3 mL, single for COVID-19 immunization. Medical history included Bypass following heart attack 17 years ago. The patient''s concomitant medications were not reported. The patient experienced unexpected death on 18Apr2021. Patient was found lying in the bathroom, after 10 minutes of absence, no warning symptoms. Impact on quality of life (10/10). The patient died on 18Apr2021 at "01:30". It was not reported if an autopsy was performed. Sender''s comments: Mail 18Apr2021: I dose on 15Apr2021 at 10:00 died on 18Apr2021 at 01:30. Request additional information and data to the GP to contact him and for the medical history report Reporter Comment: Bypass following heart attack 17 years ago. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: Bypass following heart attack 17 years ago; Reported Cause(s) of Death: Unexpected death


VAERS ID: 1275805 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-25
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM ALTER
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021463090

Write-up: cardiac arrest (duration of 30 minutes); This is as spontaneous report received from a contactable healthcare professional downloaded from the Regulatory Authority (RA)-WEB. The regulatory authority report number is IT-MINISAL02-718853. A 92-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 13Mar2021 (Lot Number: EP2166) as single dose for covid-19 immunisation. The patient received the 1st dose of bnt162b2 (COMIRNATY; lot number EJ6790) on 19Feb2021 for covid-19 immunization with no adverse reaction reported. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (ESCITALOPRAM ALTER). On 25Mar2021, the patient experienced cardiac arrest (duration of 30 minutes), causing death on 25Mar2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1275806 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-29
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: TOTALIP; PLAVIX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021463094

Write-up: Respiratory insufficiency; This is a spontaneous report received from a contactable Other Health Professional downloaded from the Agency Regulatory Authority WEB. The regulatory authority report number is IT-MINISAL02-718863. A 97-year-old female patient received second dose of bnt162b2 (COMIRNATY; Lot Number: EP2166), intramuscularly on 12Mar2021 as single dose for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included atorvastatin calcium (TOTALIP) and clopidogrel bisulfate (PLAVIX). Historical vaccine includes first dose of bnt162b2 (COMIRNATY; Lot Number: EJ6790) on 19Feb2021 for COVID-19 immunization and experienced no adverse effect. The patient experienced respiratory insufficiency on 29Mar2021 for 8 days. It was also reported that the patient was hospitalized on an unspecified date and died due to respiratory insufficiency on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Respiratory insufficiency


VAERS ID: 1275808 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Blood glucose, Hyperglycaemia, Hyperpyrexia, Hypotension
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SMOFKABIVEN; CARBOPLATIN TAXOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Oesophageal carcinoma (squamous cell carcinoma of the esophagus)
Allergies:
Diagnostic Lab Data: Test Date: 20210417; Test Name: blood glucose; Test Result: 226 mg/dl
CDC Split Type: ITPFIZER INC2021463105

Write-up: about 12 hours after vaccination, hyperglycemia (226 mg/dl), hypotension (blood pressure not noted), hyperpyrexia, atrial fibrillation; about 12 hours after vaccination, hyperglycemia (226 mg/dl), hypotension (blood pressure not noted), hyperpyrexia, atrial fibrillation; about 12 hours after vaccination, hyperglycemia (226 mg/dl), hypotension (blood pressure not noted), hyperpyrexia, atrial fibrillation; about 12 hours after vaccination, hyperglycemia (226 mg/dl), hypotension (blood pressure not noted), hyperpyrexia, atrial fibrillation; This is a spontaneous report from a contactable physician downloaded from the Regulator Authority (RA)-WEB, regulatory authority number IT-MINISAL02-719096. A 75-year-old male patient received the first dose of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: EX0893; Expiration Date: 31Jul2021), via an unspecified route of administration on 16Apr2021 as 0.3 mL, single for COVID-19 immunisation. The patient''s medical history included hypertension, and oesophageal carcinoma (squamous cell carcinoma of the esophagus in concomitant radio and chemotherapy treatment since 07Apr2021 with schedule: CARBOPLATIN +TAXOL) from 01Feb2021. Concomitant medications included alanine, arginine, calcium chloride, fish oil, glucose monohydrate, glycine, glycine max seed oil, histidine, isoleucine, leucine, lysine acetate, magnesium sulfate, medium-chain triglycerides, methionine, olea europaea oil, phenylalanine, potassium chloride, proline, serine, sodium acetate, sodium glycerophosphate, taurine, threonine, tryptophan, l-, tyrosine, valine, zinc sulfate (SMOFKABIVEN) taken for nutritional support, start and stop date were not reported; and radiotherapy and chemotherapy carboplatin, paclitaxel (CARBOPLATIN TAXOL) taken for squamous cell carcinoma of the esophagus from 07Apr2021 to 07Apr2021. On 17Apr2021, about 12 hours after vaccination, the patient experienced hyperglycemia (226 mg/dl), hypotension (blood pressure not noted), hyperpyrexia, and atrial fibrillation. It was reported that emergency was contacted but the patient had refused admission in ordinary care, so he was given the necessary care with oxygen therapy, steroids, and hydration. The patient died on 18Apr2021 due to hyperglycemia (226 mg/dl), hypotension (blood pressure not noted), hyperpyrexia, and atrial fibrillation. It was not reported if an autopsy was performed. Reporter''s comments: The last cycle of chemotherapy was administered to the patient on 07Apr2021 with no effect attributable to the treatment administered.; Reporter''s Comments: The last cycle of chemotherapy was administered to the patient on 07Apr2021 with no effect attributable to the treatment administered.; Reported Cause(s) of Death: hyperglycemia (226 mg/dl); hypotension (blood pressure not noted); hyperpyrexia; atrial fibrillation


VAERS ID: 1275814 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-21
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood glucose increased, Dyspnoea, Fatigue
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 48
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: Cardiomyopathy; Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood sugar; Result Unstructured Data: Test Result:very high
CDC Split Type: ITPFIZER INC2021468159

Write-up: the father had difficulty breathing; very high blood sugar; a lot of fatigue,; This is a spontaneous report from a contactable consumer, who reported for her father. A 88-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing diabetes, ongoing cardiomyopathy. The patient''s concomitant medications were not reported. The patient received the first administration of Comirnaty on 21Mar2021, about a week after administration in Mar2021, the father had difficulty breathing, very high blood sugar and a lot of fatigue, he was monitored by the General Practitioner constantly but following the worsening of events on 18Apr2021 he was hospitalized. On date 19Apr2021 the patient died. The outcome of the events was fatal. The patient died on 19Apr2021. It was not reported if an autopsy was performed. Information about batch/lot number has been requested.; Reported Cause(s) of Death: difficulty breathing; very high blood sugar; a lot of fatigue,


VAERS ID: 1276022 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Aspiration, Gait disturbance, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Diabetes mellitus; End stage cancer; Hepatic cirrhosis; Hepatocellular carcinoma; Hypertension; Markedly reduced food intake
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021467515

Write-up: asphyxiation by accidental ingestion; asphyxiation by accidental ingestion; Vomiting; became limp; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21103665. An 88-year and 8-month-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: ER9480; Expiration Date: 31Jul2021), via an unspecified route of administration, on 23Apr2021 at 13:45 (at the age of 88-years and 8-months-old) as a single dose for COVID-19 immunisation. Medical history included cirrhosis type B, hepatocellular carcinoma, hypertension, diabetes mellitus, asthma, end stage cancer, and poor food intake. The patient had no family history. The patient''s concomitant medications were not reported. The patient experienced asphyxiation by accidental ingestion and vomiting on 23Apr2021 at 19:00, which were reported as fatal. The patient also became limp on 23Apr2021 at 19:00. The events occurred 5 hours and 15 minutes after vaccination. The clinical course was reported as follows: On 23Apr2021 at 13:45 (the day of vaccination), the patient was vaccinated with BNT162B2 at another clinic. The patient''s condition was unchanged. Around 19:00 (the day of vaccination), the patient called from his room. When a care worker visited there, the patient vomited and became limp. Around 19:30 (the day of vaccination), a nurse arrived and confirmed respiratory arrest. Around 20:00 (the day of vaccination), the physician arrived and confirmed the patient was dead. The clinical outcome of asphyxiation by accidental ingestion and vomiting was fatal and of became limp was unknown. The patient died on 23Apr2021 at 20:00. The cause of death was reported as asphyxiation by accidental ingestion and vomiting. It was not reported if an autopsy was performed. The reporting physician assessed the events as unrelated to BNT162B2. Other possible causes of the event, such as any other diseases, were reported as end stage cancer and poor food intake by the physician.; Sender''s Comments: Based on the current available information and in agreement with the reporter'' assessment, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug.; Reported Cause(s) of Death: asphyxiation by accidental ingestion; asphyxiation by accidental ingestion; Vomiting


VAERS ID: 1276023 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Blood pressure increased, Blood pressure measurement, Body temperature, Cerebral haemorrhage, Coma scale, Computerised tomogram head, Depressed level of consciousness, Hemiplegia, Pupils unequal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Polycythaemia vera
Allergies:
Diagnostic Lab Data: Test Date: 20210424; Test Name: blood pressure; Result Unstructured Data: Test Result:176/93 mmHg; Test Date: 20210421; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination; Test Date: 20210424; Test Name: coma scale; Result Unstructured Data: Test Result:2; Test Date: 20210424; Test Name: Head CT; Result Unstructured Data: Test Result:right thalamus haemorrhage (11.9 cc); Comments: at 12:43; Test Date: 20210424; Test Name: Head CT; Result Unstructured Data: Test Result:right thalamus haemorrhage (28.7 cc); Comments: at 16:18; Test Date: 20210425; Test Name: Head CT; Result Unstructured Data: Test Result:right thalamus haemorrhage (about 60 cc); Comments: at 7:29
CDC Split Type: JPPFIZER INC2021467636

Write-up: Cerebral haemorrhage; left hemiplegia; blood pressure was 176/93mmHg; it became difficult for the patient to maintain body balance; depressed level of consciousness was present; her JCS became 100 and pupils unequal appeared.; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21103640. A 91-year and 2-month-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: ER7449; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration on 21Apr2021 14:00 as single dose for covid-19 immunisation. Medical history included polycythaemia vera. Concomitant medication(s) included acetylsalicylic acid (BAYASPIRIN). Body temperature before vaccination was 36.9 degrees centigrade. On 24Apr2021 at 11:30 (2 days, 21 hours and 30 minutes after the vaccination), the patient developed cerebral haemorrhage. When the patient was contacted by the member of the emergency response team, left hemiplegia was confirmed and then she was urgently transported to the reporting hospital. When the patient was carried to the hospital, her coma scale was 2 and blood pressure was 176/93mmHg. Left hemiplegia was observed and manual muscle testing (MMT) of upper and lower extremities showed its grade: 2/5. Head CT conducted at 12:43 led to the diagnosis of right thalamus haemorrhage (11.9 cc). The patient was admitted to the hospital and started conservative treatment with blood-pressure control and administration of hemostatic agent. From around 16:00 on the same date, depressed level of consciousness was present, her JCS became 100 and pupils unequal appeared. At 16:18, head CT showed that right thalamus haemorrhage accompanied by cerebral ventricular rupture and cerebral ventriculomegaly increased to 28.7 cc. Due to his advanced age, the patient was scheduled to continue conservative treatment according to the treatment plan and the family member of the patient did not desire life-prolonging treatment. Head CT conducted on 25Apr2021 at 07:29 (4 days after the vaccination) showed that haemorrhage further increased to about 60 cc and cerebral ventriculomegaly worsened. The patient would be observed and was confirmed to be dead on 26Apr2021 at 05:42 (5 days after the vaccination). On 26Apr2021 (5 days after the vaccination), patient died. The outcome of the event cerebral haemorrhage was fatal and unknown for other events. The reporting physician classified cerebral haemorrhage as serious (death/ hospitalization), but could not assess the causality. Other possible causes of the event included polycythaemia vera and an ongoing antiplatelet agent of acetylsalicylic acid (BAYASPIRIN, 100 mg). The reporting physician commented as follows: The patient receiving an antiplatelet agent had risk of cerebral haemorrhage and developing it seriously. The causality to vaccine could not be assessed.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1276024 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210424; Test Name: autopsy imaging (AI); Result Unstructured Data: Test Result:no significant intracranial lesion
CDC Split Type: JPPFIZER INC2021470491

Write-up: Acute cardiac death; malaise; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number is v21103746. An 85-year-old male patient received the first dose of the bnt162b2 (COMIRNATY), via an unspecified route of administration on 21Apr2021 at a single dose for covid-19 immunisation. Medical history included diabetes mellitus and arrhythmia. Body temperature before vaccination and family history were not reported. The patient''s concomitant medications were not reported. On 22Apr2021, the patient experienced malaise. On 24Apr2021 at 21:00, the patient experienced acute cardiac death, which required emergency room visit. The clinical course was as follows: on 21Apr2021 (the day of vaccination), the patient received the bnt162b2. On 22Apr2021 (1 day after the vaccination), malaise was noted. On 24Apr2021 at 21:00 (3 days after the vaccination), the patient experienced acute cardiac death. On 24Apr2021 at 21:54 (3 days after the vaccination), it was confirmed that the patient had died. The course of the event was as follows: on 21Apr2021 (the day of vaccination), the patient received corona vaccine at another hospital. Malaise was noted on the next day. The patient had no pyrexia. On 24Apr2021 (3 days after the vaccination), the patient was emergently transported with cardiopulmonary arrest. Intubation and cardiopulmonary resuscitation were performed and heartbeat temporarily resumed, but cardiac arrest again. On 24Apr2021 at 21:54 (3 days after the vaccination), the patient''s death was confirmed. No significant intracranial lesion was observed on autopsy imaging (AI) on 24Apr2021. The patient had medical history of diabetes mellitus and arrhythmia. Cause of death was acute cardiac death. The clinical outcome of the event, malaise, was unknown. The clinical outcome of the event, acute cardiac death, was fatal. The patient died on 24Apr2021 at 21:54 due to acute cardiac death. It was unknown if an autopsy was performed. The reporting physician classified acute cardiac death as serious (death) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was arrhythmia. REPORTER COMMENT: the association with vaccination was unknown. The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Acute cardiac death


VAERS ID: 1276025 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 Alzheimer''s type
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: Body temperature; Result Unstructured Data: Test Result:37.3 Centigrade
CDC Split Type: JPPFIZER INC2021470493

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21103724. The patient was a 101-year and 7-month-old female received first dose BNT162B2 (COMIRNATY, Formulation: Solution for injection) via unspecified route of administration (Lot number: ER7449, Expiration date 30Jun2021) on 23Apr2021 at 15:45 as a single dose for COVID-19 immunisation. Body temperature before vaccination was 37.3 degrees Centigrade. Medical history included ongoing severe dementia Alzheimer''s type. On 23Apr2021 (the day of vaccination), although low grade fever was noted, the patient was lively. Since the patient had no pyrexia of 37.5 degrees Centigrade or more, the vaccine was administered. After that, there was no obvious side reaction or pyrexia during the course. On 26Apr2021 (3 days after the vaccination), the patient could communicate until after lunch. On the same date around 14:30, the patient was unable to communicate. After that, the patient was in cardiopulmonary arrest and did not resuscitate. On 26Apr2021 at 14:30 (3 days after the vaccination), the patient experienced cardio-respiratory arrest. On the same date, the outcome of the event was fatal. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was dementia. The reporting physician commented as follows: Although the patient was elderly and geromarasmus was suspected, it was difficult to assess the causal relationship with the vaccination.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1276032 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   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: Alzheimer''s disease; Carotid artery stenosis (for 4 to 5 years)
Allergies:
Diagnostic Lab Data: Test Date: 20201111; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Negative; Test Date: 20210220; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Negative
CDC Split Type: LUPFIZER INC2021463101

Write-up: Cardiac arrest; Vaccination adverse reaction; Pneumonia aspiration; Febrile reaction; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number LU-ALMPS-202102248. An 88-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), dose 1 intramuscular on 04Mar2021 (also reported as 03Apr2021, pending clarification) (batch/lot number EP2163 and expiry date not reported) at 88 years of age as single dose for covid-19 immunization. Medical history included carotid artery stenosis for 4 to 5 years, Alzheimer''s disease. The patient''s concomitant medications were not reported. On 04Mar2021, the patient experienced vaccination adverse reaction, pneumonia aspiration, febrile reaction. On 09Mar2021, the patient experienced cardiac arrest. The physician informed that on 09Mar2021, the patient died of cardiac arrest and it was also noted on death certificate that death was due to febrile state, inhalation pneumonia and a probable secondary reaction to the Covid-19 vaccination since 5 days (also reported 5 days for the duration of all events, and time Interval between beginning of drug administration and start of reaction for events febrile reaction and pneumonia aspiration was 5 days; pending clarification). The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 11Nov2020 and negative on 20Feb2021. The patient died on 09Mar2021 due to the events. It was not reported if an autopsy was performed. The physician informed that the relatedness of drug to event febrile reaction from source of assessment: Regulatory Authority and method of assessment: imputability method was result of assessment: C1 S1 (I1 dubious) B3; relatedness of drug to events: pneumonia aspiration, vaccination adverse reaction, cardiac arrest from source of assessment: Regulatory Authority with method of assessment: imputability method was result of assessment: C1 S1 (I1 dubious) B1.; Reported Cause(s) of Death: Vaccination adverse reaction; Cardiac arrest; Pneumonia aspiration; Febrile reaction


VAERS ID: 1276091 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Burn oral cavity, Drug hypersensitivity, Hyperhidrosis, Mouth swelling, Night sweats, Paraesthesia, Rash, Thermal burn, Toxic epidermal necrolysis, Toxicity to various agents
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 43
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: MXPFIZER INC2021464419

Write-up: allergy; LYELL; burns appeared on the skin and inside the mouth; burns appeared on the skin and inside the mouth; many blisters appeared on the skin; mouth began to swell to the degree of burning; sweated too much during the night; sweated too much during the night; rash appeared As if it were an intoxication; intoxication/ drug intoxication; felt tingling all over his body; This is a spontaneous report from a contactable consumer. A male patient (reporter''s father) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 12Mar2021 at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had an allergy, some doctors have treated him, and they say it was LYELL, this was usually from a drug, and to this day my father was hospitalized and without improvements. The patient was vaccinated on 12Mar2021, that same day he said that he felt tingling all over his body, on March 13 he sweated too much during the night, that day a rash appeared As if it were an intoxication, they went to the private doctor to check him and said that it could be an intoxication, on 14Mar2021, many blisters appeared on the skin and the mouth began to swell to the degree of burning, they took him to A private doctor gave him medication for intoxication, and he did not improve, he got worse, he checked it again because burns appeared on the skin and inside the mouth, and the reporter predicted that it was LYELL syndrome, he improved they discharged him but already at home He did not improve, on the contrary, they put him in the hospital again, unfortunately he could not recover, and on April 25 he died and it was the vaccine. the hospitals did not want to declare it in the medical file that the cause was the vaccine. They did not receive any support from the government or from Pfizer. And the reporter was not referring to financial support, if they do not require research support such as a biopsy to find out what drug caused LYELL syndrome because what it causes was drug intoxication. The patient died on 25Apr2021 due to the events. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Tingling; sweated too much during the night; sweated too much during the night; rash appeared As if it were an intoxication; rash appeared As if it were an intoxication; many blisters appeared on the skin; mouth began to swell to the degree of burnin


VAERS ID: 1276092 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021470364

Write-up: got infected with COVID-19; got infected with COVID-19; This is a spontaneous report from a non-contactable consumer via the Pfizer-sponsored program,. A male patient of an unspecified age received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got infected with COVID-19 on an unspecified date. He got infected with COVID-19, only the first dose of Pfizer had been applied. The patient died on 26Apr2021. 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: got infected with COVID-19; got infected with COVID-19


VAERS ID: 1276136 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-04-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Cardiac failure aggravated; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Cardiac failure aggravated) in a 63-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Cardiac failure. Previously administered products included for an unreported indication: COVID-19 VACCINE (Moderna COVID-19 Vaccine) on 02-Mar-2021. On 02-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC FAILURE (Cardiac failure aggravated) (seriousness criteria death and hospitalization). The patient died on 12-Apr-2021. The reported cause of death was Cardiac failure. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were provided. The outcome of the event was fatal ,so the action taken for the second dose of Moderna COVID -19 vaccine was not applicable. Company comment: Very limited information regarding this event of aggravated Cardiac Failure has been provided at this time. Further information cannot be obtained as the reporter did not allow further contact.; Sender''s Comments: Very limited information regarding this event of aggravated Cardiac Failure has been provided at this time. Further information cannot be obtained as the reporter did not allow further contact.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1276139 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-29
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise, Musculoskeletal discomfort
SMQs:, Rhabdomyolysis/myopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   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: SEROQUEL; PROMETHAZINE - CODEINE [CITRIC ACID;CODEINE PHOSPHATE;PROMETHAZINE HYDROCHLORIDE;SODIUM CITRATE ACID; HALOPERIDOL 1A PHARMA; METFORMINE [METFORMIN]; ACETYLSALICYLZUUR; COLECALCIFEROL; SIMVASTATINE; LORAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ischaemia myocardial
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Malaise; Neck discomfort; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Neck discomfort) and MALAISE (Malaise) in a 61-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. The patient''s past medical history included Ischaemia myocardial. Concomitant products included QUETIAPINE FUMARATE (SEROQUEL), CITRIC ACID, CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, SODIUM CITRATE ACID, SULFOGAIACOL (PROMETHAZINE - CODEINE [CITRIC ACID;CODEINE PHOSPHATE;PROMETHAZINE HYDROCHLORIDE;SODIUM CITRATE ACID;SULFOGAIACOL]), HALOPERIDOL (HALOPERIDOL 1A PHARMA), METFORMINE [METFORMIN], ACETYLSALICYLZUUR, COLECALCIFEROL, SIMVASTATINE and LORAZEPAM for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Neck discomfort) (seriousness criterion death) and MALAISE (Malaise) (seriousness criterion death). The patient died on 30-Mar-2021. The reported cause of death was Sudden death, Pulmonary congestion, Congestive hepatopathy and Arrhythmia. An autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment of these events were not reported. Reporter did not allow further contact; Reported Cause(s) of Death: Sudden death; Pulmonary congestion; Congestive hepatopathy; Arrhythmia


VAERS ID: 1276142 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-04-13
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cardiopulmonary failure, Crepitations, Dyspnoea, Haemoptysis, Hypoxia, Oxygen saturation, Productive cough, Pyrexia, Unresponsive to stimuli
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   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: MELATONINE; QUETIAPINE; OXAZEPAM; PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: No relevant medical history provided
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: body temperature; Result Unstructured Data: 38 tot 40.5 Celcius; Test Date: 20210413; Test Name: SaO2 69%; Test Result: 69 %; Result Unstructured Data: 69%; Test Date: 20210413; Test Name: sputum; Result Unstructured Data: bloody
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: sputum; SaO2 69%; 38 tot 40.5 Celcius; Pulm: over; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIOPULMONARY FAILURE, HAEMOPTYSIS (sputum), HYPOXIA (SaO2 69%), PYREXIA (: 38 tot 40.5 Celcius), UNRESPONSIVE TO STIMULI , CREPITATIONS (Pulm: over) and DYSPNOEA in an 86-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No relevant medical history provided. Concomitant products included MELATONINE, QUETIAPINE, OXAZEPAM and PARACETAMOL for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced CARDIOPULMONARY FAILURE (seriousness criterion death), HAEMOPTYSIS (sputum) (seriousness criterion death), HYPOXIA (SaO2 69%) (seriousness criterion death), PYREXIA (38 tot 40.5 Celcius) (seriousness criterion death), UNRESPONSIVE TO STIMULI (seriousness criterion death), CREPITATIONS (Pulm: over) (seriousness criterion death) and DYSPNOEA (seriousness criterion death). The patient died on 13-Apr-2021. The reported cause of death was: It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: 38 tot 40.5 celcius (abnormal) 38 tot 40.5 Celcius. On 13-Apr-2021, Oxygen saturation: 69 % (abnormal) 69%. On 13-Apr-2021, Productive cough: bloody (abnormal) bloody. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided.; Sender''s Comments: This is a case of sudden death in a 86-year-old male patient with an unknown medical history died of cardiopulmonary failure 1 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death:


VAERS ID: 1276145 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   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: Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021453674

Write-up: heavy bleeding in the brain/Cerebral haemorrhage; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00514341. A 75-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced heavy bleeding in the brain/cerebral haemorrhage on 04Apr2021. There was no treatment received for the event. The patient died on 04Apr2021. It was unknown if an autopsy was performed. Reporter''s comment: Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): NO. Passed away. Additional information ADR: On 01Apr my mother was vaccinated with Pfizer and on 04Apr she died of a heavy brain haemorrhage. Confounding factors: my mother suffered from arthrosis / rheumatism. Previous COVID-19 infection: No. Other: diagnostic procedures: NO No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): NO. Passed away.Additional information ADR: On 01Apr my mother was vaccinated with Pfizer and on 04Apr she died of a heavy brain haemorrhage. Confounding factors: my mother suffered from arthrosis / rheumatism. Previous COVID-19 infection: No. Other: diagnostic procedures: NO; Reported Cause(s) of Death: heavy bleeding in the brain


VAERS ID: 1276147 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: DICLOFENAC POTASSIUM; NOVORAPID; RYZODEG FLEXTOUCH; LOSEC MUPS; FUROSEMIDE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021463116

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number NL-LRB-00514944. A 74-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 19Apr2021 as single dose for covid-19 immunization. Medical history was not reported. The patient has no previous COVID-19 infection. Concomitant medications included diclofenac potassium; insulin aspart (NOVORAPID); insulin aspart, insulin degludec (RYZODEG FLEXTOUCH); omeprazole magnesium (LOSEC MUPS); and furosemide taken for an unspecified indication. The physician reported patient''s death on 20Apr2021 following administration of Covid-19 vaccine on 19Apr2021. The cause of death was not reported. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1276148 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; LOSARTAN; PANTOZOL CONTROL; SIMVASTATIN
Current Illness: Vascular dementia (vascular dementia)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Previous COVID-19 infection: disease symptoms: little)
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021463113

Write-up: not feeling well; Unknown cause of death; This is a spontaneous report from a contactable consumer reporting for a patient downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00514958. An 84-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing vascular dementia vascular dementia from an unspecified date and covid-19 from 05Jan2021 (Previous COVID-19 infection: disease symptoms: little). Concomitant medications included clopidogrel (CLOPIDOGREL); losartan (LOSARTAN); pantoprazole sodium sesquihydrate (PANTOZOL CONTROL) and simvastatin (SIMVASTATIN) all co-medication taken for an unspecified indication and start and stop date were not reported. The patient experienced not feeling well on 25Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Jan2021. The patient died on an unspecified date in 2021 due to unknown cause of death and not feeling well. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot number cannot be obtained. Sender''s comment: BioNTech / Pfizer vaccine (Comirnaty); Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no; BSN available: yes; confounding factors; confounding factors: vascular dementia; COVID-19, Previous COVID-19 infection: disease symptoms: little; Other diagnostic procedures: no; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty); Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no; BSN available: yes; confounding factors; confounding factors: vascular dementia; COVID-19, Previous COVID-19 infection: disease symptoms: little; Other diagnostic procedures: no; Reported Cause(s) of Death: Unknown cause of death; not feeling well


VAERS ID: 1276149 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Basophil count, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood cholesterol, Blood creatinine, Blood electrolytes, Blood glucose, Blood lactate dehydrogenase, Blood phosphorus, Blood potassium, Blood sodium, Blood triglycerides, Blood urea, C-reactive protein, CYP2C19 gene status assay, Cerebrovascular accident, Computerised tomogram head, Electrocardiogram, Eosinophil count, Gamma-glutamyltransferase, Glomerular filtration rate, Haematocrit, Haemoglobin, High density lipoprotein, International normalised ratio, Low density lipoprotein, Lymphocyte count, Mean cell volume, Neutrophil count, Platelet count, Red cell distribution width, Renal function test, Respiratory failure, Respiratory rate increased, Total cholesterol/HDL ratio, White blood cell count
SMQs:, Anaphylactic reaction (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; SPIRONOLACTONE; PANTOPRAZOLE; GLIMEPIRIDE; SINTROM; SIMVASTATIN
Current Illness: Breathing difficult (difficulty breathing for no apparent cause); Diabetes (diabetes)
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarction (sometime had myocardial infarction)
Allergies:
Diagnostic Lab Data: Test Name: ALT; Result Unstructured Data: Test Result:15 U/L; Test Name: AST; Result Unstructured Data: Test Result:14 U/L; Test Name: basophils; Result Unstructured Data: Test Result:<0.1 10e9/L; Test Name: albumin; Result Unstructured Data: Test Result:35 g/l; Test Name: Alkaline Phosphatase; Result Unstructured Data: Test Result:76 U/L; Test Name: bilirubin; Result Unstructured Data: Test Result:10 umol/l; Test Name: Ca; Result Unstructured Data: Test Result:2.59 mmol/L; Test Date: 20210305; Test Name: Ca; Result Unstructured Data: Test Result:slightly elevated mmol/L; Test Name: Cholesterol; Result Unstructured Data: Test Result:3.7 mmol/L; Test Name: CREATININE; Result Unstructured Data: Test Result:160 umol/l; Test Date: 20210305; Test Name: CREATININE; Result Unstructured Data: Test Result:160 umol/l; Test Date: 20210305; Test Name: Electrolytes; Result Unstructured Data: Test Result:Na,K : normal: Ca; slightly elevated; Test Name: glucose; Result Unstructured Data: Test Result:13.9 mmol/L; Test Date: 20210305; Test Name: glucose; Result Unstructured Data: Test Result:13.9 mmol/ (= elevated) mmol/L; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:211 U/L; Test Name: phosphate; Result Unstructured Data: Test Result:0.85 mmol/L; Test Name: k; Result Unstructured Data: Test Result:4.3 mmol/L; Test Date: 20210305; Test Name: k; Result Unstructured Data: Test Result:normal mmol/L; Test Name: Na; Result Unstructured Data: Test Result:139 mmol/L; Test Date: 20210305; Test Name: Na; Result Unstructured Data: Test Result:normal mmol/L; Test Name: TRIGLYCERIDES; Result Unstructured Data: Test Result:1.3 mmol/L; Test Name: UREA; Result Unstructured Data: Test Result:9.2 mmol/L; Test Date: 20210305; Test Name: UREA; Result Unstructured Data: Test Result:9.2 mmol/L; Test Date: 20210305; Test Name: CT brain; Result Unstructured Data: Test Result:Extensive white matter abnormalities. Hypodenal ar; Comments: Extensive white matter abnormalities. Hypodense area left frontal, new, suspected of subacute infarction.; Test Name: CRP; Result Unstructured Data: Test Result:6 mg/l; Test Name: CYP2C19 * 17 +; Result Unstructured Data: Test Result:follows; Test Name: CYP2C19 * 2 +; Result Unstructured Data: Test Result:follows; Test Name: CYP2C19 *3+; Result Unstructured Data: Test Result:follows; Test Name: CYP2C19 +; Result Unstructured Data: Test Result:follows; Test Date: 20210305; Test Name: Ecg; Result Unstructured Data: Test Result:sinus rhythm 84 / min with PVCs, (premature vent; Comments: sinus rhythm 84 / min with PVCs, (premature ventricular contractions) intermediate cardiac axis, no conduction disturbances, no ST deviations; Test Name: eosinophils; Result Unstructured Data: Test Result:<0.1 10e9/L; Test Name: Gamma-GT; Result Unstructured Data: Test Result:16 U/L; Test Name: eGFR; Result Unstructured Data: Test Result:24 ml/min; Test Date: 20210305; Test Name: eGFR; Result Unstructured Data: Test Result:24 ml/min; Test Name: hematocrit; Result Unstructured Data: Test Result:0.45 L/L; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.4 mmol/L; Test Name: HDL-Cholesterol; Result Unstructured Data: Test Result:1.5 mmol/L; Test Name: INR: 1.5; Result Unstructured Data: Test Result:1.5 INR; Test Name: LDLC; Result Unstructured Data: Test Result:1.6 mmol/L; Test Name: lymphocytes; Result Unstructured Data: Test Result:1.1 10e9/L; Test Name: MVC; Result Unstructured Data: Test Result:92 fL; Test Name: neutrophils; Result Unstructured Data: Test Result:9.0 10e9/L; Test Name: thrombocytes; Result Unstructured Data: Test Result:319 10e9/L; Test Date: 20210305; Test Name: thrombocytes; Result Unstructured Data: Test Result:319; Test Name: RDW; Test Result: 23.7 %; Test Date: 20210305; Test Name: renal funciton; Result Unstructured Data: Test Result:eGFR (CKD-EPI) 24 ml / min; urea 9.2 mmol / l; kre; Comments: eGFR (CKD-EPI) 24 ml / min; urea 9.2 mmol / l; kreat 160 umol / l; Test Name: Ratio Cholesterol / HDL-Cholesterol; Result Unstructured Data: Test Result:2.5; Test Name: leucocytes; Result Unstructured Data: Test Result:11.2 10e9/L
CDC Split Type: NLPFIZER INC2021463103

Write-up: Respiratory insufficiency; with high respiratory rate and oxygen demand, for no apparent cause; CVA left hemisphere.The morning after the vaccination,patient woke up with a crooked face and aphasia/dysarthria.In the hospital there was a stroke,despite the use of a well-regulatedsintrom/acenocoumarol; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number NL-LRB-00515083. A 94-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EP9598) as single dose (dose 1) for COVID-19 immunisation. Medical history included myocardial infarction, ongoing difficulty breathing for no apparent cause and ongoing diabetes mellitus diabetes. No previous COVID-19 infection. Concomitant medications included furosemide; spironolactone; pantoprazole; glimepiride; acenocoumarol (SINTROM); and simvastatin. The patient experienced cerebrovascular accident (CVA left hemisphere) 1 day after start of vaccine on 05Mar2021; and respiratory insufficiency and breathing rate increased (with high respiratory rate and oxygen demand, for no apparent cause) 12 days after start of vaccine on 16Mar2021. The morning after vaccination, the patient woke up with a crooked face and aphasia / dysarthria. In the hospital there was evidence of a stroke, despite the use of a well-regulated sintrom / acenocoumarol. Diagnostic procedures included CT-brain on 05Mar2021 which showed "Extensive white matter abnormalities. Hypodense area left frontal, new, suspected for subacute infarction". ECG on 05Mar2021, showed "rhythm 84 / min with PVCs, (premature ventricular contractions) intermediate cardiac axis, no conduction disturbances, no ST deviations". On 05Mar2021, lab tests included Electrolytes: Na (sodium),K (potassium): normal; Ca (calcium): slightly elevated; glucose 13.9 mmol/ (= elevated); thrombocytes 319; and renal function: eGFR (CKD-EPI) 24 ml / min; urea 9.2 mmol / l; creatinine 160 umol / l. The blood test on unspecified date included Hemoglobin 8.4 mmol / L, Hematocrit 0.45 L / L, MCV (mean corpuscular volume) 92 fL, RDW (Red cell distribution width) 23.7%, Platelets 319 10e9 / L, Leucocytes 11.2 10e9 / L, Basophils <0.1 10e9 / L, Lymphocytes 1.1 10e9 / L, Eosinophils <0.1 10e9 / L, Neutrophils 9.0 10e9 / L, Monocytes 1.1 10e9 / L, Ratio Cholesterol / HDL-Cholesterol 2.5, Creatinine 160 ?mol / L, eGFR (CKD-EPI) 24 mL / min, Urea 9.2 mmol / L, Sodium 139 mmol / L, Potassium 4.3 mmol / L, Calcium 2.59 mmol / L, Phosphate 0.85 mmol / L, Albumin 35 g / L, Bilirubin 10 ?mol / L, Gamma GT (gamma glutamyltransferase) 16 U / L, Alkaline phosphatase 76 U / L, AST (aspartate aminotransferase) 14 U / L, ALT (alanine aminotransferase) 15 U / L, LDH (Lactate dehydrogenase) 211 U / L, Cholesterol 3.7 mmol / L, HDL-Cholesterol (High density lipoprotein) 1.5 mmol / L, LDLC (Low density lipoprotein) 1.6 mmol / L, Triglycerides 1.3 mmol / L, Glucose 13.9 mmol / L, CYP2C19 (Cytochrome P450 2C19) + follows, CYP2C19 * 3 + follows, CYP2C19 * 2 + follows, CYP2C19 * 17 + follows, CRP 6 mg / L and INR: 1.5. The patient died on 16Mar2021. An autopsy was not performed. Reporter comment: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. CVA left hemisphere. Additional information ADR: The morning after vaccination, patient woke up with a crooked face and aphasia / dysarthria. In the hospital there was evidence of a stroke, despite the use of a well-regulated sintrom / acenocoumarol. Confounding factors: diabetes, sometime had myocardial infarction, difficulty in breathing for no apparent cause. COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: CT brain: Extensive white matter abnormalities. Hypodense area left frontal, new, suspected of subacute infarction. ECG: Sinus rhythm 84 / min with PVCs (premature ventricular contractions), intermediate cardiac axis, no conduction disturbances, no ST deviations. Blood test: Hemoglobin 8.4 mmol / L, Hematocrit 0.45 L / L, MCV (mean corpuscular volume) 92 fL, RDW (Red cell distribution width) 23.7%, Platelets 319 10e9 / L, Leucocytes 11.2 10e9 / L, Basophils <0.1 10e9 / L, Lymphocytes 1.1 10e9 / L, Eosinophils <0.1 10e9 / L, Neutrophils 9.0 10e9 / L, Monocytes 1.1 10e9 / L, Ratio Cholesterol / HDL-Cholesterol 2.5, Creatinine 160 ?mol / L, eGFR (CKD-EPI) 24 mL / min, Urea 9.2 mmol / L, Sodium 139 mmol / L, Potassium 4.3 mmol / L, Calcium 2.59 mmol / L, Phosphate 0.85 mmol / L, Albumin 35 g / L, Bilirubin 10 ?mol / L, Gamma GT (gamma glutamyltransferase) 16 U / L, Alkaline phosphatase 76 U / L, AST (aspartate aminotransferase) 14 U / L, ALT (alanine aminotransferase) 15 U / L, LDH (Lactate dehydrogenase) 211 U / L, Cholesterol 3.7 mmol / L, HDL-Cholesterol (High density lipoprotein) 1.5 mmol / L, LDLC (Low density lipoprotein) 1.6 mmol / L, Triglycerides 1.3 mmol / L, Glucose 13.9 mmol / L, P2C19 +(Cytochrome P450 2C19) follows, CYP2C19 * 3 + follows, CYP2C19 * 2 + follows, CYP2C19 * 17 + follows, CRP 6 mg / L, INR: 1.5. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. CVA left hemisphere. Additional information ADR: The morning after vaccination, patient woke up with a crooked face and aphasia/dysarthria. In the hospital there was evidence of a stroke, despite the use of a well-regulated sintrom/acenocoumarol. Confounding factors: diabetes, sometime had myocardial infarction, difficulty in breathing for no apparent cause. COVID-19 Previous COVID-19 infection: No.; Reported Cause(s) of Death: respiratory insufficiency; cva; with high respiratory rate and oxygen demand, for no apparent cause


VAERS ID: 1276150 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-05-01
Onset:2021-04-06
   Days after vaccination:706
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage, Haematochezia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   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: PERINDOPRIL ERBUMINE; MOVICOLON; COLECALCIFEROL; LIRAGLUTIDE; DIGOXIN; SPIRONOLACTONE; ATORVASTATIN; METFORMIN; CETOMACROGOL; GLIMEPIRIDE; METOCLOPRAMIDE; NEBIVOLOL; DORZOLAMIDE;TIMOLOL; CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021463108

Write-up: Hemorrhage digestive tract/Bleeding gastrointestinal; Vomiting; Blood in stool; This is a spontaneous report from a contactable physician, downloaded from the Regulatory Authority-WEB NL-LRB-00515913, received via Regulatory Authority. A 71-year-old female patient received the first dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on 03Feb2021 (Batch/Lot Number: EP9598) as a single dose for COVID-19 immunization; and rivaroxaban, via an unspecified route of administration from May2019 to 07Apr2021, at 1x day, 20mg for an unspecified indication. Medical history included obesity. Concomitant medications included perindopril erbumine; macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON; also reported as movic/molax/laxt/gen); colecalciferol; liraglutide; digoxin; spironolactone; atorvastatin; metformin; cetomacrogol; glimepiride; metoclopramide; nebivolol; dorzolamide/timolol; and citalopram, all taken for unspecified indications, start and stop dates were not reported. The patient previously took rivaroxaban 20mg and experienced no adverse event. The patient experienced hemorrhage digestive tract/bleeding gastrointestinal (reported as 62 days after start of BNT162b2 ; 23 months after start of rivaroxaban), vomiting (reported as 2 months after start of BNT162b2; 2 years after start of rivaroxaban), and blood in stool (reported as 2 months after start of BNT162b2; 2 years after start of rivaroxaban) on 06Apr2021. The action taken in response to the events for rivaroxaban was reported as permanently withdrawn on 07Apr2021. The patient died on 07Apr2021. Causes of death were hemorrhage digestive tract/bleeding gastrointestinal, vomiting, and blood in stool. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: hemorrhage digestive tract; vomiting; blood in stool


VAERS ID: 1276158 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-04-11
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Anxiety; Forgetfulness; Hallucinations; Overweight
Preexisting Conditions: Medical History/Concurrent Conditions: Reduced general condition
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021463129

Write-up: EMBOLISM PULMONARY; This is a spontaneous report from a contactable physician, downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-U8ejy5. A 75-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection), intramuscularly, administered in the left arm on 18Mar2021 at 12:00 (Batch/Lot number and Expiration date were unknown) as a single dose for COVID-19 immunization. Relevant medical history included reduced general condition from Oct2020 to an unknown date; ongoing anxiety; ongoing hallucinations, becoming forgetful, which was also ongoing; and ongoing overweight, from approximately 6 moths prior reporting. The patient''s concomitant medications were not reported. On 11Apr2021, the patient experienced embolism pulmonary, which led to hospitalization and death. It was further reported that the patient was hospitalized 3 1/2 weeks after vaccination due to acute onset dyspnoea with severe desaturation, which was diagnosed as pulmonary embolism. The patient died after two days. The physician stated that there was an uncertain connection between the incident and the COVID-19 vaccine, but still chose to report as one did not expect such a rapidly declining state of health after the vaccine was administered. The patient lived at home with her husband, but in the last 6 months she has had increasing health problems in the form of anxiety and hallucinations, becoming forgetful and overweight. The day before the incident in question, the patient was admitted to a short-term stay at a nursing home due to declining health. The patient died on 13Apr2021. It was not reported if an autopsy was performed. The Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and the reported event as possible. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Embolism pulmonary


VAERS ID: 1276181 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Renal failure
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disorder; Kidney disorder; Overweight; Prostatic hypertrophy; Urethral valves
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021467757

Write-up: Death in hospital from kidney failure and cardiac arrest (treated for several years, deterioration of health one month before the first dose of the vaccine); Death in hospital from kidney failure and cardiac arrest (treated for several years, deterioration of health one month before the first dose of the vaccine); This is a spontaneous case from a contactable consumer. An 82-year-old male patient received first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration, at 82-year-old administered in left arm on 25Mar2021 as single dose for covid-19 immunization. Medical history included urethral valves, problems with kidneys, overweight, prostate hypethropy, problems with circulation all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced death in hospital from kidney failure and cardiac arrest (treated for several years, deterioration of health one month before the first dose of the vaccine) on an unspecified date. No treatment received for cardiac arrest. The patient died on 19Apr2021. An autopsy was not performed. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn''t been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: kidney failure; Cardiac arrest


VAERS ID: 1276221 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Acute myocardial infarction, Death, Hypovolaemic shock, Infection, Loss of consciousness, Malaise, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: GLYTRIN [GLYCERYL TRINITRATE]; AMLODIPINE; TROMBYL; ATORVASTATIN; VALSARTAN/HYDROKLORTIAZID; ZYLORIC; METFORMIN; INSULATARD HUMAN; JANUVIA [SITAGLIPTIN PHOSPHATE]
Current Illness: Angina pectoris; Chronic kidney disease stage 3; Hypertension; Obesity; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021463132

Write-up: unconscious; clinically suspected hypovolemic shock; acute renal failure; possibly AMI (acute myocardial infarction); fell ill; suspected infection; vomiting; DEATH NOS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-028019, Safety Report Unique Identifier SE-VISMA-1618572064449. An 85-year-old male patient received second dose of bnt162b2 (COMIRNATY) (Lot Number: EW2239), via an unspecified route of administration on Apr2021 as a single dose for COVID-19 immunisation. Medical history included ongoing obesity, ongoing Type 2 diabetes mellitus, hyperlipidaemia on an unknown date, ongoing angina pectoris, ongoing Chronic kidney disease stage 3 and ongoing hypertension. The patient previously took first dose of bnt162b2 (COMIRNATY) for COVID-19 immunisation. Concomitant medications included glyceryl trinitrate (GLYTRIN [GLYCERYL TRINITRATE]); amlodipine; acetylsalicylic acid (TROMBYL); atorvastatin; hydrochlorothiazide, valsartan (VALSARTAN/HYDROKLORTIAZID); allopurinol (ZYLORIC); metformin; insulin human injection, isophane (INSULATARD HUMAN); sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]), all taken for an unspecified indication, start and stop date were not reported. Reported suspect adverse event was death NOS. The reporter states that the man fell ill with vomiting, suspected infection after consuming grilled chicken, but unclear cause, six days after the second dose of Comirnaty. Two days later found unconscious at home, could not be resuscitated. Cause of Death according to the reporter were unknown, clinically suspected hypovolemic shock, acute renal failure, possibly AMI (acute myocardial infarction). The patient died on Apr2021. An autopsy will be performed. Outcome: Fatal. Report assessed as serious, death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: DEATH NOS; unconscious; clinically suspected hypovolemic shock; acute renal failure; possibly AMI (acute myocardial infarction)


VAERS ID: 1276223 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-15
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Gait disturbance, Grip strength decreased, Haemoglobin, Hallucination, Muscular weakness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRONAXEN; LEVOCAR [CARBIDOPA;LEVODOPA]; OMEPRAZOLE; SASTRAVI; MOXALOLE; PARACETAMOL; FOLVIDON; LEVAXIN; MADOPARK QUICK MITE; BETOLVEX [CYANOCOBALAMIN]; DUROFERON
Current Illness: Hypothyreosis; Iron deficiency anemia; Parkinson''s disease; Pernicious anemia
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Cervical cancer; Malignant melanoma
Allergies:
Diagnostic Lab Data: Test Name: Hb; Result Unstructured Data: Test Result:111 g/l; Test Name: Hb; Result Unstructured Data: Test Result:59 g/l; Comments: decreased from 111 g/L to 111 g/L within four months
CDC Split Type: SEPFIZER INC2021463128

Write-up: Anaemia; Descending muscle weakness with difficulties standing, walking and to grip; Descending muscle weakness with difficulties standing, walking and to grip; Descending muscle weakness with difficulties standing, walking and to grip; Hallucinations; pain under the feet; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-029282.An 86-year-old female patient received her second dose of bnt162b2 (COMIRNATY, Lot Number: EL0725), via an unspecified route of administration on 03Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Hypothyreosis, cervical cancer, ongoing iron deficiency anaemia , malignant melanoma, ongoing parkinson''s disease, breast cancer and ongoing pernicious anaemia. Concomitant medications included naproxen (PRONAXEN); carbidopa, levodopa (LEVOCAR [CARBIDOPA;LEVODOPA]); omeprazole; carbidopa monohydrate, entacapone, levodopa (SASTRAVI); macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOXALOLE); paracetamol; folic acid (FOLVIDON); levothyroxine sodium (LEVAXIN); benserazide, levodopa (MADOPARK QUICK MITE); cyanocobalamin (BETOLVEX [CYANOCOBALAMIN]); ferrous sulfate (DUROFERON). The patient received her first dose of Comirnaty (lot number: EJ6795) on 07Jan2021 for covid-19 immunisation. The patient experienced anaemia and descending muscle weakness with difficulties standing, walking and to grip on 03Mar2021 and hallucinations and pain under the feet on 15Feb2021. The patient underwent lab tests and procedures which included Hb: 111 g/l and haemoglobin: 59 g/l (decreased from 111 g/L to 111 g/L within four months) on an unspecified date. The patient died on an unspecified date. Outcome of the events was fatal. 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: Descending muscle weakness with difficulties standing, walking and to grip; Descending muscle weakness with difficulties standing, walking and to grip; Anaemia; Hallucinations; pain under the feet; Descending muscle weakness with difficulties standin


VAERS ID: 1276224 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: Dementia; Vascular disorder NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021463079

Write-up: STROKE; cerebral bleeding; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-029407, other reference number SE-VISMA-1618913684756. A contactable consumer reported that a 77-year-old female patient received her second dose of bnt162b2 (COMIRNATY, lot EW2239), via an unspecified route of administration on Apr2021 as SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing dementia and ongoing vascular disorder. The patient''s concomitant medications were not reported. She had her first dose of bnt162b2 on Mar2021 (Lot EP2166). On Apr2021, the patient had symptom of facial paralysis, later total left paralysis then had a stroke. The patient died two days later (Apr2021) and cause of death reported as cerebral bleeding and stroke. Medical records are requested. It was not reported if an autopsy was performed. The outcome of facial paralysis was unknown; for other events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cerebral bleeding; stroke


VAERS ID: 1276228 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-03-04
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Neoplasm progression, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Malignancy related conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 33
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SERTRALIN [SERTRALINE]; FOLVIDON; OMEPRAZOL; BETAPRED; FORMATRIS NOVOLIZER; NOVOPULMON; VENTILASTIN; OXASCAND
Current Illness: Lung cancer
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021468705

Write-up: breathing difficulties 04Mar2021. At the hospital pulmonary embolism was established; breathing difficulties 04Mar2021. At the hospital pulmonary embolism was established; lung cancer in palliative state; This is a spontaneous report from a contactable nurse. A 79-year-old female patient (not pregnant) received BNT162B2 (COMIRNATY, Lot Number: EJ6790), via intramuscular, administered in right arm on 17Feb2021 12:00 (79-year-old at time of vaccination) at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included ongoing lung cancer and previous (not ongoing) breast cancer. The patient had not received any other vaccine within 4 weeks. The patient had no known allergies. Concomitant medications included sertraline (SERTRALIN); folic acid (FOLVIDON); omeprazole (OMEPRAZOL); betamethasone sodium phosphate (BETAPRED); formoterol fumarate (FORMATRIS NOVOLIZER); budesonide (NOVOPULMON); salbutamol sulfate (VENTILASTIN); and oxazepam (OXASCAND). The patient who had a cancer disease experienced "breathing difficulties on 04Mar2021. At the hospital pulmonary embolism was established" (seriousness criteria: hospitalization and life threatening) on 04Mar2021 10:00. The adverse event also resulted in emergency room visit. The patient received treatment for the events, the type of treatment unknown to the reporter. Patient had not been diagnosed with COVID-19 prior to vaccination and it was unknown if she had been tested since the vaccination. The outcome of breathing difficulties and pulmonary embolism was unknown. The patient died on 07Apr2021. It was unknown if an autopsy was performed. Cause of death was lung cancer in palliative state.; Sender''s Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. It is also noted by the reporter that Cause of death was lung cancer in palliative state. 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: lung cancer in palliative state


VAERS ID: 1276229 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-22
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / UNK RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CREON; KALEORID; AMLODIPINE; MIRTAZAPIN; SERETIDE DISCUS; FURIX [FUROSEMIDE]
Current Illness: Pancreas cancer (receiving treatment)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021469118

Write-up: passed away at home; This is a spontaneous report from a contactable other healthcare professional (HCP). A 75-year-old female patient (not pregnant at time of vaccination) received BNT162B2 (COMIRNATY, Lot Number: EW9127), via intramuscular, administered in right arm on 15Apr2021 10:00 (75-year-old at time of vaccination) at single dose for covid-19 immunization. Medical history included ongoing advanced pancreatic carcinoma spread to liver and lungs (for which she was receiving unspecified treatment). The patient had no known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Concomitant medications included pancreatin (CREON); potassium chloride (KALEORID); amlodipine; mirtazapine (MIRTAZAPIN); fluticasone propionate/ salmeterol xinafoate (SERETIDE DISCUS); and furosemide (FURIX). The patient was unexpectedly found having passed away at home on 22Apr2021 08:00. The patient died on 22Apr2021. No therapeutic measures were taken as a result of the event. Cause of death was reported as unknown. An autopsy was not performed. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: passed away at home


VAERS ID: 1276231 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC2021462444

Write-up: Death; This is a spontaneous report from a contactable physician, downloaded from the Agency Regulatory Authority-WEB, Regulatory Authority Report Number: SI-JAZMP-NCPHV-2021SI0546_0546. A 73-years-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 02Apr2021 (Batch/Lot Number: EW2239; Expiration Date: 31Jul2021) at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient died on 03Apr2021. The patient died due to unknown cause. It was unknown if an autopsy was performed. This case report was assessed as medically significant. No additional data arrived in the initial case report. Sender Comment: Further data and assessment is expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1276232 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-13
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   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: MONOPRIL; PLIVIT D3; EUTHYROX; EUTHYROX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: EKG; Result Unstructured Data: Test Result:asystole
CDC Split Type: SIPFIZER INC2021462460

Write-up: asystolia in EKG/Cardiac arrest; nausea; collapsed; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SI-JAZMP-NCPHV-2021SI0557_0557. A 69-year-old female patient received first dose of BNT162B2 (COMIRNATY), intramuscular on 01Apr2021 (Batch/Lot Number: EW2239; Expiration Date: 31Jul2021) at single dose for covid-19 immunization. The patient''s medical history was not reported. Concomitant medications included fosinopril sodium (MONOPRIL) at 20 mg taken for an unspecified indication from 01Jan2021 to 13Apr2021; colecalciferol (PLIVIT D3) at 4000 IU / ml taken for an unspecified indication from 01Jan2021 to 13Apr2021; levothyroxine sodium (EUTHYROX) at 50 mcg taken for an unspecified indication from 01Jan2021 to 13Apr2021 and levothyroxine sodium (EUTHYROX) at 25 mcg taken for an unspecified indication from 01Jan2021 to 13Apr2021. The patient experienced asystolia in ECG/cardiac arrest on 13Apr2021. It was reported that on 13Ap2021, the patient died due to cardiac arrest. While the patient was having walk, she experienced nausea and collapsed. Upon arrival of paramedics, EKG showed asystolia. The patient underwent lab tests and procedures which included electrocardiogram: asystole on 13Apr2021. The patient died on 13Apr2021. An autopsy was ordered but It was not reported if an autopsy was performed. No routine follow-up attempts are foreseen for reports received from Regulatory Authority-WEB. Information about lot number has already obtained. No further info is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1276238 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-23
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TFPFIZER INC2021474508

Write-up: died 3 weeks after the 2nd injection; This is a spontaneous report from a contactable consumer (reporting for his/her mother) received via a regulatory authority. A 72-year-old female patient received bnt162b2 (COMIRNATY) (at 72 years of age), dose 2 via an unspecified route of administration, administered in arm left on 30Mar2021 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included COMIRNATY dose 1, administered in arm left on 22Feb2021 (Batch/Lot Number: Unknown) COVID-19 immunisation. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 since the vaccination. It was reported that the patient died 3 weeks after the 2nd injection. The reporter commented that she/he was devastated and asked if this was cause and effect. The patient died on 23Apr2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: unknown cause of death


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