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From the 11/19/2021 release of VAERS data:

Found 19,249 cases where Vaccine is COVID19 and Patient Died

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1076579 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   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: INSULINE ASPARTE; PERINDOPRIL; ATORVASTATINE [ATORVASTATIN]; SPIRONOLACTON; FENPROCOUMON; METOPROLOL; FUROSEMIDE; INSULINE DETEMIR; TRAMADOL/PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident; COVID-19 (hospitalization); Decompensation cardiac; Peripheral arterial disease (Fontaine intravenously)
Allergies:
Diagnostic Lab Data: Test Date: 20201222; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021222049

Write-up: no cause of death was found; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA). Regulatory Authority Report Number: NL-LRB-00450839. This is a spontaneous report received from a contactable physician. A 79 years old male patient received bnt162b2 (COMIRNATY, Lot Number and Expiration Date unknown) via an unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 (22Dec2020), decompensation cardiac, cerebrovascular accident, peripheral arterial disease (Fontaine intravenously). Concomitant medication included atorvastatine tablet 40mg, phenprocoumon (FENPROCOUMON) tablet 3mg, furosemide tablet 40mg, insuline detemir injection 100 units/ml, metoprolol modified-release tablet 200mg, (tartrate) insuline aspart injection 100 units/ml, perindopril tablet 4mg (erbumine), spironolacton tablet 25mg, paracetamol, tramadol hydrochloride (TRAMADOL/PARACETAMOL) film-coated tablet 37.5mg/325mg. 2 days after administration, patient was death on 08Feb2021. The reporter described that autopsy (obduction) was done. At time of reporting, only the macroscopic result was known: no cause of death was found. Lab test included corona, confirmed with positive test on 22Dec2020. Sender Comment: Based on the reporter''s narrative the outcome of the reaction (death) was adjusted from not recovered to fatal by the assessor. Case Summary and Reporter''s Comments Text : Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): No. Death. Additional information on adverse drug reaction: patient was found dead on 08Feb2021 in the morning by healthcare workers. BSN available: Yes. Confounding factors: Cardiac decompensation, CVA (cerebrovascular accident), PAV fontaine IV (which stands for tissue loss, necrosis). Previous COVID-19 infection: disease symptoms: hospitalization. Other - diagnostic procedures: Obduction, only macroscopic result known so far. No cause of death was found. The results of the microscopy, pathology and possibly brain obduction will follow. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: no cause of death was found


VAERS ID: 1076580 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-17
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201028; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021221957

Write-up: resulted in death; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB NL-LRB-00451820. A 79-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 from 28Oct2020 to an unknown date (disease symptoms: quite). The patient''s concomitant medications were not reported. Past drug therapy BioNTech/Pfizer vaccin (Comirnaty) reported as no. The patient experienced death on 17Feb2021. The cause of death was unknown. The patient underwent lab tests and procedures which included corona, confirmed with test: positive on 28Oct2020. The patient died on 17Feb2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1076581 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Confusional state, Depressed level of consciousness, Epilepsy, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (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 (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; PASSIFLORA ALATA EXTRACT; OMEPRAZOL; EUTHYROX; MACROGOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (with no symptoms)
Allergies:
Diagnostic Lab Data: Test Date: 20201216; Test Name: corona, bevestigd met test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021221962

Write-up: CVA; sudden confusion / gibberish; Consciousness decreased; Fever; with vomiting; epileptic seizure; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB manufacturer report number NL-LRB-00452103. A 95-years-old male patient received bnt162b2 (COMIRNATY, lot# EM0477), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 with no symptoms from 16Dec2020. Concomitant medications included paracetamol, passiflora alata extract, omeprazole (OMEPRAZOL), levothyroxine sodium (EUTHYROX), macrogol. No past drug therapy. The patient was died 3 days after vaccination due to sudden confusion / gibberish, consciousness decreased, fever, with vomiting, epileptic seizure, the events onset date was on 05Feb2021. It started with a confusional state and fever, followed by a decreased level of consciousness and seizure with vomiting. After this the patient did not regain consciousness again. Confounding factors: CVA (cerebrovascular accident) / epileptic seizure. No diagnostic procedures. The patient underwent lab tests and procedures which included corona confirmed by test: positive on 16Dec2020. The patient died on 07Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: CVA; sudden confusion / gibberish; Consciousness decreased; Fever; with vomiting; epileptic seizure


VAERS ID: 1076582 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: QUETIAPINE; OXAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: Body temperature; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Comments: Fever: 38 to 40.5 degrees Celsius
CDC Split Type: NLPFIZER INC2021226258

Write-up: Fatigue; Pyrexia; Decreased appetite; Malaise; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA), regulatory Authority Report Number NL-LRB-00452721. A 77-years-old female patient received second dose of bnt162b2 (COMIRNATY) (lot number: EJ6795), via an unspecified route of administration on 09Feb2021 at single dose for COVID-19 immunisation. Medical history included dementia. Concomitant medication included quetiapine and oxazepam. Historical Vaccine included first dose of bnt162b2 (COMIRNATY) on 19Jan2021 at single dose for prophylactic vaccination, first covid-19 vaccine pfizer vaccination with no adverse event. The patient experienced fatigue, pyrexia, decreased appetite and malaise on 11Feb2021 following the second administration of covid-19 vaccine Pfizer injection. The report was reported as serious with the criteria of death. The outcome of the events was fatal. The patient died on 2021. Cause of death was reported as not feeling well, fever: 38 to 40.5 degrees Celsius, Loss of appetite and fatigue. It was not reported if an autopsy was performed. Reporter''s Comments: Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes. Adverse drug reactions: None. Date: 19Jan2021. Loss of appetite. Additional information adverse drug reaction: No need more food and drink. Confounding factors: Dementia. Previous COVID-19 infection: No. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: not feeling well; Fever: 38 to 40.5 degrees Celsius; Loss of appetite; fatigue


VAERS ID: 1076583 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, Dyspnoea, Pneumonia aspiration
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), 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: Medical History/Concurrent Conditions: Multiple system atrophy
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021226273

Write-up: Aspiration pneumonia; Swallowing impaired; Dyspnoea; This is a spontaneous report from a contactable consumer (patient''s daughter) downloaded from the Medicines Agency (MA) WEB manufacturer report number NL-LRB-00452923. A 92-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 01Feb2021 at single dosefor covid-19 immunisation. Medical history included multiple system atrophy (MSA). The patient''s concomitant medications were not reported. The patient experienced aspiration pneumonia, swallowing impaired, dyspnoea on 01Feb2021, which occurred 5 hours after started. Events were treated with antibiotics. The patient died on an unspecified date. Cause of death was reported as aspiration pneumonia, swallowing impaired, dyspnoea. It was not reported if an autopsy was performed. Reporter''s comment: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no pneumonia Additional information ADR: severe tightness of the chest and inability to swallow BSN available: yes confounding factors confounding factors: MSA COVID19 Previous COVID-19 infection: No Other diagnostic procedures: was no longer welcome in hospital, blood pressure measurement, oxygen measurement Comments on report form: It is possible that this case has already been reported. I am the daughter and am only now getting around to it. The doctor mentioned choking pneumonia. This is because of the MSA.; Reporter''s Comments: Additional information ADR: severe tightness of the chest and inability to swallow BSN available: yes confounding factors: MSA Previous COVID-19 infection: No Other diagnostic procedures: was no longer welcome in hospital, blood pressure measurement, oxygen measurement Comments on report form: It is possible that this case has already been reported. I am the daughter and am only now getting around to it. The doctor mentioned choking pneumonia. This is because of the MSA.; Reported Cause(s) of Death: Swallowing impaired; Dyspnoea; choking pneumonia


VAERS ID: 1076584 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Blood test, Dyspnoea, Nausea, Ultrasound abdomen, Vomiting, X-ray
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diaphragmatic hernia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Name: ultrasound; Result Unstructured Data: Test Result:unknown results; Test Name: X-ray abdomen; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021226256

Write-up: shortness of breath; upset stomach: Nausea; upset stomach: Nausea; stomach complaints: Vomiting; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB NL-LRB-00453181. A 92-years-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number EJ6134), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing diaphragmatic hernia. The patient''s concomitant medications were not reported. The patient experienced shortness of breath on an unspecified date, upset stomach: nausea, stomach complaints: vomiting on 29Jan2021, 2 hours after vaccination. The patient was hospitalised due to shortness of breath. The patient underwent lab tests and procedures which included blood test, ultrasound abdomen, x-ray: unknown results. Therapeutic measures were taken as a result of events included tube feeding and antibiotics. The patient died on 08Feb2021. It was not reported if an autopsy was performed. The outcome of events was fatal.; Reported Cause(s) of Death: shortness of breath; vomiting; Nausea; upset stomach


VAERS ID: 1076585 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Death, Urinary tract infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   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: MORFINE; MIDAZOLAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: blood tests; Result Unstructured Data: Test Result:increased infection parameters
CDC Split Type: NLPFIZER INC2021226280

Write-up: Death; infection (probably a complicated urinary tract infection) / increased infection parameters; This is a spontaneous report from contactable physician downloaded from the Medicines Agency (MA) WEB NL-LRB-00453421. A 91-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, lot number: EM0477), via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included morfine, midazolam. Following the first administration of bnt162b2, 8 days after, the patient experienced death on 10Feb2021. It was unknown if an autopsy was performed. According to the reporter, the patient deceased due to an infection (probably a complicated urinary tract infection) (Feb2021). Blood test showed increased infection parameters (Feb2021). In the reporter''s opinion, death as a result of infection, but report due to not long after COVID vaccination. Confounding factors: infection (probably complicated urinary tract infection). The patient didn''t have previous COVID-19 infection. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death; infection (probably a complicated urinary tract infection) / increased infection parameters


VAERS ID: 1076586 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRIAMCINOLONACETONIDE; PRAVASTATIN; ACENOCOUMAROL; OMEPRAZOL; CARBOMER; COLECALCIFEROL; LISINOPRIL; FUROSEMIDE; HYLAN; TEMAZEPAM; NITROGLYCERINE; DOXYCYCLINE; METOPROLOL; ALLOPURINOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021226300

Write-up: SARS COV2 test was appeared to be positive; COVID-19; fever; cough; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB regulatory authority NL-LRB-00455159. A 92-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunisation. Medical history included cardiac failure. Concomitant medication included triamcinolone acetonide (TRIAMCINOLONACETONIDE, strength: 1 mg), pravastatin (strength: 40 mg), acenocoumarol (strength: 1 mg), omeprazole (OMEPRAZOL, strength: 20 mg), carbomer, colecalciferol (strength: 5600 IU), lisinopril, furosemide, carbomer, hyaluronate sodium (HYLAN), temazepam (strength: 10 mg), glyceryl trinitrate (NITROGLYCERINE), doxycycline (strength: 100 mg), metoprolol (strength: 100 mg), allopurinol (strength: 100 mg). The patient experienced fever (death) on 04Feb2021, cough (death) on 04Feb2021 and covid 19 (death) on 05Feb2021, then deceased. Clinical course: The patient experienced fever and cough one day after vaccination on 04Feb2021. The patient was seen by the general practitioner 2 days after vaccination and a SARS-COV-2 test was performed and appeared to be positive on 05Feb2021. The patient was treated with antibiotics. The outcome of events was fatal. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. Senders note: Comedication Vaseline cetomacrogol cream and liquid food with vitamin K was delicited as comedicaiton because this started after the day of vaccination Reporters comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Death Additional information ADR: Patient was vaccinated on 03Feb2021; I saw him on 05Feb2021 because of fever, which can be stressful for someone with severe heart failure. Because he also had a cough, he took a Covid test which turned out positive on 05Feb2021. Confounding factors confounding factors: COVID19. Previous COVID-19 infection: disease symptoms: quite. No other diagnostic procedures.; Reported Cause(s) of Death: COVID-19; Cough; Fever; positive corona test


VAERS ID: 1076587 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart failure; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (Advanced disease.); Multimorbidity (several diseases)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021226264

Write-up: Death; fatigue; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB NO-NOMAADVRE-FHI-2021-U9jqz, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00016057. A 94 years old female patient received her second dose of bnt162b2 (COMIRNATY, Batch/lot no: EK9788), intramuscularly on 04Feb2021 at single dose, left arm, for vaccination(The reporter thought the vaccine was given 10Feb2021, but data confirmed it was given 04Feb2021). No information given on concomitant medication. The medical history included ongoing living in nursing home, dementia (advanced disease), ongoing heart failure, multimorbidity. In Feb2021, the patient experienced fatigue. Around 12Feb2021, the patient developed reduced general condition. She died peacefully on 17Feb2021. It was not known what caused the deterioration in the patient''s general condition, but she died within weeks after her second dose of bnt162b2 and therefore this death was reported. In the death report, multimorbidity (dementia, heart failure ++ (not specified further diseases) was set as the cause of death. The patient''s outcome was fatal, at the time of the report. No autopsy was done. The case was considered to be serious. Relatedness of drug to the events Reduced general condition, Death: Possible, Source of assessment: Pharmacovigilance Center. Sender Comments: The report concerns a nursing home patient in her 90s, who a week after the second dose of the Covid-19 vaccine Comirnaty became more fatigued and had a drop in her general condition. The patient died peacefully approximately two weeks after vaccination. It is not known what caused the drop in the general condition. The patient had advanced dementia, heart failure and several diseases (not stated which), and this is set as the cause of death on the death report. It is reported due to the close time relationship between vaccination and death (Reporter was somewhat uncertain about the vaccination date and stated 10Feb, but a search confirmed the vaccination date to be 04Feb, in other words, almost a week earlier). In pre-marketing studies with Comirnaty, the most common side effects were injection site pain, fatigue, headache, myalgia and chills, arthralgia, fever and injection site swelling. The reactions occurred within 1-2 days after vaccination, were usually of mild or moderate intensity and resolved after a few days. However, we cannot rule out that relatively mild side effects may become more pronounced and / or lead to a more serious course in severely debilitated patients. Data from use in frail patients with comorbidity is limited, and such lack of information will be obtained in post-marketing studies. In a study of patients on long-term stays in nursing homes, a high degree of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International, retrospective studies have similar findings and show, among other things, that the risk of death is increased in the first four months after nursing-home admission, and that patients who have recently been hospitalized have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In the individual case, however, it is difficult to know whether the symptoms prior to the death are due to a vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. When vaccinating vulnerable / frail, multi-diseased elderly patients, some serious events, including death, may occur shortly after vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. Based on the information in the report, the causal connection with vaccination is considered as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: multimorbidity (dementia, heart failure ++ (not specified further diseases); multimorbidity (dementia, heart failure ++ (not specified further diseases); REDUCED GENERAL CONDITION; fatigue


VAERS ID: 1076591 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; METFORMIN; RAMIPRIL ACTAVIS; FURIX [FUROSEMIDE]; METOPROLOL SANDOZ [METOPROLOL SUCCINATE]; KALEORID; ALBYL-E
Current Illness: Aortic stenosis (Severe); Heart failure (Severe)
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Ischemic heart disease; Living alone; Syncope (had syncopated several times in connection to her serious aortic stenosis.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021221990

Write-up: A cardiac event that was unrelated to the vaccination is strongly suspected; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB NO-NOMAADVRE-FHI-2021-Uwweg, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00015837. An 84-year-old female patient received her first single dose of BNT162B2 (COMIRNATY, lot number EJ6789) intramuscularly in her right arm on 11Feb2021 for COVID-19 immunisation. Patient had a history of living alone, ongoing severe heart failure, ongoing severe aortic stenosis, diabetes, ischemic heart disease and had syncopated several times. Concomitant medications included apixaban (ELIQUIS) for heart failure, metformin for diabetes, ramipril (RAMIPRIL ACTAVIS) for heart failure, furosemide (FURIX) for heart failure, metoprolol succinate (METOPROLOL SANDOZ), potassium chloride (KALEORID), and acetylsalicylic acid, magnesium oxide (ALBYL-E) for ischemic heart disease. The patient died on 12Feb2021. No autopsy performed. Woman in her 80s with severe aortic stenosis and severe heart failure got her medicines delivered by the community nurse system, but she organized the rest herself. She had been considered too frail for TIVA in 2017. She was in her normal condition when she came for vaccination of the first dose against Covid-19 accompanied by relatives. After vaccination she was observed for 20 minutes and the relatives escorted her home, a journey of at least 45 minutes. No symptoms occurred. After the relatives tried to call her and she did not answer the phone, they found her dead in her bed. This was two days after vaccination, but she had probably died the day before. Lots of medicines could be found in her kitchen cupboard, so the woman had obviously not taken the drugs as prescribed. According to the reporter, no symptoms like fever, feeling unwell or suspicion of an allergic reaction had been reported. On previous occasions the patient had syncopated several times in connection to her serious aortic stenosis. A cardiac event that was unrelated to the vaccination is strongly suspected, especially since important medicines had not been taken as they should. The death is reported since it is happened closely to the vaccination. No autopsy performed. Sender''s Comment: When vaccinating patients with frailty who are ill with many underlying diseases, some serious events, including deaths, may occur shortly after vaccination without any connection to vaccination. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or another, random, concurrent cause that has nothing to do with the vaccination in question. Here, there is no observation of the patient in the time around the death. Based on the information in the report, we have assessed the causal relationship with vaccination as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. The reporter has stated that there is no suspicion of a connection with vaccination, and therefore the reporter''s assessment of the causal connection with the vaccination is set as unlikely. An unlikely causal relationship is defined as a reaction, including pathological laboratory tests, that occurs in such a temporal relationship to the use of a drug that a causal relationship is unlikely (but not impossible), and where underlying disease, other drugs or chemicals may explain the reaction. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: This 84-year-old female had medical history of severe heart failure, severe aortic stenosis, diabetes, ischemic heart disease and syncopated several times, and was on multiple concomitant medications. The reported fatal event cardiac disorder was most likely due to underlying cardiac disorder, and unlikely causally related to the first single dose of BNT162B2 (COMIRNATY).; Reported Cause(s) of Death: unknown cause of death; A cardiac event that was unrelated to the vaccination is strongly suspected


VAERS ID: 1076647 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH HAS BEEN REQUES / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Myocardial infarction, Pneumonia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021222110

Write-up: pneumonia; Vomiting; Dyspnoea; heart attack; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB, regulatory authority number SE-MPA-2021-004762. An 87-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on an unspecified date at 0.3 mL, single for covid-19 immunisation. Medical history included Alzheimer''s disease. The patient''s concomitant medications were not reported. The patient experienced vomiting on Jan2021, dyspnoea on Jan2021. Events were report assessed as serious, death. Event description: the woman suffered from vomiting, shortness of breath, unknown time after vaccination. Hospitalized due to pneumonia. Discharged home, hospitalized again eleven days after vomiting and shortness of breath started. Died of a heart attack after three days. It was not reported if an autopsy was performed. information on the lot/batch number has been requested.; Reported Cause(s) of Death: vomiting; dyspnoea; Myocardial infarct


VAERS ID: 1076648 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Overweight; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021222111

Write-up: Felt sick; Cardiac arrest; acute heart attack; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-005185. Other case identifier number SE-MPA-1613570887217. A 61-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration at single dose for covid-19 immunisation. Medical history included overweight, smoker. The patient''s concomitant medications were not reported. The patient suffered from prehospital cardiac arrest, about a week after vaccination, arrived at hospital and died when CPR was interrupted in the emergency room on Jan2021 with outcome of fatal. The reporter writes presumed to be an acute heart attack as findings do not suggest other genesis. The patient felt sick with outcome of unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. Report assessed as serious, Death. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: cardiac arrest; Acute myocardial infarction


VAERS ID: 1076649 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, C-reactive protein increased, General physical health deterioration, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased, Respiratory rate increased, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Cardiac failure; Osteoporosis; Seropositive rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Test Date: 202102; Test Name: CRP; Result Unstructured Data: Test Result:246 mg/ml; Test Date: 202102; Test Name: oxygen saturation; Result Unstructured Data: Test Result:75-80 %; Test Date: 202102; Test Name: ESR; Result Unstructured Data: Test Result:63; Comments: ref.<30 mm
CDC Split Type: SEPFIZER INC2021222116

Write-up: SR 63 (ref.<30 mm); Fever 38.4 degrees; saturation 75-80 %; CRP 246 (ref.<5 mg/ml); Wheezing; breathless, frequency 34; reduced AT-included; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) regulatory authority-WEB, regulatory authority number SE-MPA-2021-005206. Other case identifier number SE-MPA-1613570038064. An 83-years-old female patient received second dose of bnt162b2 (COMIRNATY, lot number: EJ6136), intramuscular at left arm in Feb2021 at 0.3 mL, single for covid-19 immunisation. Medical history included cardiac failure, Seropositive rheumatoid arthritis, anaemia, osteoporosis. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: EJ6136) in Jan2021 for COVID-19 immunization. The patient experienced SR 63, fever 38.4 degrees, saturation 75-80 %, CRP 246, wheezing, breathless, frequency 34, reduced at-included in Feb2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Clinical course reported as: The patient developed fever 38.4 degrees, breathlessness, frequency 34, reduced general condition, CRP increased, 246 (ref.<5 mg/ml), ESR increased, 63 (ref.<30 mm), oxygen saturation decreased, 75-80%, wheezing. On suspicion of pneumonia, phenoxymethylpenicillin 1 g x 3, first 2 doses 2 g, was prescribed four days after the vaccination. The woman improved in her breathing, became free from fever but her general condition deteriorated and the woman died one week after the vaccination. Case was reported as serious fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SR 63 (ref.<30 mm); Fever 38.4 degrees; saturation 75-80 %; CRP 246 (ref.<5 mg/ml); Wheezing; breathless, frequency 34; reduced AT-included


VAERS ID: 1080086 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-27
Onset:2021-02-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Loss of consciousness, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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), 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: 2021-02-28
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive disturbance; Hypertension; Knee replacement; Myocardial infarction; Parkinson''s disease; Peripheral vascular disease
Allergies:
Diagnostic Lab Data: Test Date: 20210227; Test Name: temperature; Result Unstructured Data: Test Result:36.6
CDC Split Type: AUPFIZER INC2021226235

Write-up: unresponsive; potential cardiac arrest; He was not noted to have been unwell at the time of the injection; This is a spontaneous report from a contactable other hcp via VOC. A 76-years-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Feb2021 16:34 at single dose for covid-19 immunisation. Medical history included Parkinson''s disease, hypertension, Peripheral vascular disease (PVD) and cognitive decline. He had undergone a knee replacement in Nov2020. He had had a previous Myocardial Infarction in 2015. The patient was a long term rehab patient at a local hospital, as he could no longer be cared for in his home, and had been in the past 2 weeks transferred to the facility on respite to be closer to family. The patient''s concomitant medications were not reported. The patient experienced potential cardiac arrest on 28Feb2021, unresponsive on 28Feb2021 17:14. Reported as "After vaccination no redness or swelling was noted and his temperature was 36.6degC. He was not noted to have been unwell at the time of the injection. No other adverse events have been noted to have been observed post injection. He was reviewed for regular observations at 16.00 pm on Sunday 28Feb2021 and then was found unresponsive at 17.14pm on Sunday 28Feb2021. A preliminary cause of death is potential cardiac arrest. Consent for the vaccination was obtained prior to the vaccination. The family were present during the resuscitation and are saddened but not aggrieved and are accepting and a comment was made by the nursing home that the family may think there is a link to the vaccine. This matter has already been referred to the coroner."The patient underwent lab tests and procedures which included body temperature: 36.6 on 27Feb2021. The patient died on 28Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained; Reported Cause(s) of Death: potential cardiac arrest


VAERS ID: 1081776 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   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: TORASEMID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021236716

Write-up: death; This is a spontaneous report downloaded from the Medicines Agency (MA) WEB, Regulatory authority report number is DE-PEI-PEI2021003039. A non-contactable physician reporting information for the same patient. This is first of two reports. A 96 years old female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Feb2021 at single dose for covid-19 immunisation. The patient''s medical history was not reported, no major previous illnesses. Concomitant medication included torasemide (TORASEMID). The patient received the first dose of bnt162b2 (COMIRNATY) on 27Jan2021 for covid-19 immunisation and experienced General physical health, muscle tremors, refusal to eat, tiredness and immobility and 08Feb2021: abnormal urine status, suspected urinary tract infection. The patient experienced 3 days after vaccination the patient developed Death. The patient died on 20Feb2021. 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.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021242330 same patient and same product, different event for different dose.; Reported Cause(s) of Death: Death


VAERS ID: 1081797 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Death, Dyspnoea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (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: 2021-01-30
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (advanced)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021236722

Write-up: Death; Vomiting; Abdominal pain; Dyspnoea; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the Regulatory Authority (FI-FIMEA-20210955). An 86-year-old male patient received BNT162B2 (COMIRNATY; Lot number EL1491) intramuscular on 28Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included advanced Alzheimer''s disease. Concomitant medications were not reported. On 29Jan2021, the patient experienced vomiting, abdominal pain and dyspnoea and on 30Jan2021 he died. The cause of death was unknown. It was not reported if an autopsy was performed. The events of vomiting, abdominal pain and dyspnoea were reported with a fatal outcome. The patient was a patient of respite care and the death was expected, however there was a clear time connection to the vaccine. Treatment according to the symptoms with painkillers on the respite care. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1081802 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-17
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   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: ENANTONE [LEUPRORELIN]; KARDEGIC; CASODEX; INEXIUM [ESOMEPRAZOLE MAGNESIUM]; PRAVASTATIN; MIRTAZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer of prostate; Cognitive disturbance; Dyslipidaemia; Hypertension arterial; Myocardial infarction; Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021232802

Write-up: progressive deterioration of the general state; Death NOS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (FR-AFSSAPS-AN20210572). A 100-year-old male patient received the second dose of BNT162B2 (COMIRNATY; Lot number: EJ6795), intramuscularly, on 11Feb2021 at a single dose for COVID-19 immunisation. Medical history included renal insufficiency, dyslipidaemia, hypertension arterial, myocardial infarction, cognitive disturbance, and cancer of prostate. Concomitant medication included leuprorelin (ENANTONE), acetylsalicylate lysine (KARDEGIC), bicalutamide (CASODEX), esomeprazole magnesium (INEXIUM), pravastatin (MANUFACTURER UNKNOWN), and mirtazapine (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (COMIRNATY) on 21Jan2021 for COVID-19 immunisation. The patient experienced progressive deterioration of the general state on an unspecified date. The patient experienced death NOS on 17Feb2021, which was reported as fatal. The clinical course was reported as: The patient was at risk of developing a severe form of COVID-19 disease. The patient presented with a progressive deterioration of the general state for several weeks, with slip syndrome. The clinical outcome of progressive deterioration of the general state was unknown. The patient died on 17Feb2021. The cause of death was reported as unknown. It was not reported if an autopsy was performed. The reporter assessed the causality the event as unrelated to the suspect vaccine. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1081806 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: General physical condition abnormal; Hospitalization
Preexisting Conditions: Medical History/Concurrent Conditions: Deglutition disorder; Dementia NOS aggravated; Disease Parkinson''s; Hypothermia; Tonic-clonic seizures
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021232796

Write-up: Died in sleep; This is a spontaneous report downloaded from the Regulatory Authority [Regulatory Authority Report Number: FR-AFSSAPS-BR20210383]. A contactable physician reported an 89-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY batch EP9598), intramuscular on the right arm on 23Feb2021 at SINGLE DOSE for COVID-19 immunization. Medical history included Parkinson''s disease, deglutition disorder, and dementia NOS aggravated. Concomitant medications were not reported.The patient received the first dose of COMIRNATY (Lot/batch number not provided) on an unknown date as COVID-19 immunization. It was reported that the patient was hospitalized in palliative care. Her general condition was very altered and prompted the recent initiation of antiepileptic treatment due to tonic clonic seizures. She also has episodes of fluctuating hypothermia. On 23Feb2021, the patient received a 2nd injection of the COMIRNATY vaccine. On the night of 24Feb2021, she died. For the clinician, the death was not related to the vaccination but was related to a significant deterioration in the general condition. It was not reported (unknown) if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the close temporal relationship, the association between the event death with COMIRNATY use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1081810 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Antidepressant drug level, Aspartate aminotransferase, Blood albumin, Blood alkaline phosphatase, Blood calcium, Blood chloride, Blood creatinine, Blood gases, Blood glucose, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Brain natriuretic peptide, C-reactive protein increased, Coma, Coma scale, Gamma-glutamyltransferase, Glomerular filtration rate, Haemoglobin, Heart rate, Hypoxia, Lipase, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet count, Protein total, Prothrombin time, Quadriplegia, Troponin, White blood cell count
SMQs:, Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VERATRAN; LERCAN; NEURONTIN; FUMAFER; LEVOTHYROX; XARELTO; UVEDOSE; TAREG; CALCIDOSE [CALCIUM CARBONATE]; PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Activities of daily living impaired; Atrial fibrillation; Cognitive disorders (advanced); Embolism pulmonary; General physical health deterioration; Hypertension arterial; Meningoencephalitis (with hippocampal involvement); Osteoporosis; Uterine cancer NOS
Allergies:
Diagnostic Lab Data: Test Name: alat; Result Unstructured Data: Test Result:30; Test Name: TCA; Result Unstructured Data: Test Result:40; Test Name: ASAT; Result Unstructured Data: Test Result:25; Test Name: albumin; Test Result: 37 g; Test Name: PAL; Result Unstructured Data: Test Result:103; Test Name: Ca; Result Unstructured Data: Test Result:2.37; Test Name: Cl; Result Unstructured Data: Test Result:99 mmol/L; Test Name: creatinine; Result Unstructured Data: Test Result:45 umol/l; Test Name: blood gasses; Result Unstructured Data: Test Result:7,11 pH units; Test Name: blood glucose; Result Unstructured Data: Test Result:10 mmol/L; Test Name: blood sugar; Result Unstructured Data: Test Result:1.56 g/l; Comments: fasting; Test Name: K; Result Unstructured Data: Test Result:5 mmol/L; Test Name: blood pressure; Result Unstructured Data: Test Result:170/70 mmHg; Test Name: Na; Result Unstructured Data: Test Result:141 mmol/L; Test Name: Urea; Result Unstructured Data: Test Result:9.9 mmol/L; Test Name: BNP; Result Unstructured Data: Test Result:56; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:3; Test Name: CRP; Result Unstructured Data: Test Result:0,8; Test Name: GammaGT; Result Unstructured Data: Test Result:13; Test Name: GFR; Result Unstructured Data: Test Result:95 ml/min; Test Name: Hb; Test Result: 16.4 g; Test Name: heart rate; Result Unstructured Data: Test Result:80; Test Name: Lipase; Test Result: 37 g; Test Name: PNN; Result Unstructured Data: Test Result:8.4 x10 9/l; Test Name: Saturation; Result Unstructured Data: Test Result:63%; Test Name: Saturation; Result Unstructured Data: Test Result:93%; Comments: under 9l of O2; Test Name: PCO2; Result Unstructured Data: Test Result:131; Test Name: platelets; Result Unstructured Data: Test Result:331 x10 9/l; Test Name: po2; Result Unstructured Data: Test Result:232; Test Name: protein; Result Unstructured Data: Test Result:69 g/l; Test Name: prothrombin time; Result Unstructured Data: Test Result:52%; Test Name: troponin; Result Unstructured Data: Test Result:10.9; Comments: without further details; Test Name: Leukocyte count; Result Unstructured Data: Test Result:10.4 x10 9/l
CDC Split Type: FRPFIZER INC2021232797

Write-up: Coma; Hypoxia/Severe hypoxia (O2 Sat 63%); flaccid quadriplegia; This is a spontaneous report downloaded from the Regulatory Authority, regulatory authority report number: FR-AFSSAPS-BX20211195. A contactable physician reported that an 88-year-old female patient received bnt162b2 (COMIRNATY solution for injection; lot number: EJ6795; expiry date: unknown) intramuscular on 02Feb2021 at 14:30, at a single dose, for COVID-19 immunisation. Medical history included hypertension arterial, embolism pulmonary, uterine cancer NOS, atrial fibrillation, and osteoporosis. Patient with an extensive history including meningoencephalitis in 2002 with hippocampal involvement, advanced cognitive disorders, assistance requried in all daily activities, patient communicating with slate, with a deterioration of the general condition for several days. Concomitant medication included clotiazepam (VERATRAN), lercanidipine hydrochloride (LERCAN), gabapentin (NEURONTIN), ferrous fumarate (FUMAFER), levothyroxine sodium (LEVOTHYROX), rivaroxaban (XARELTO), colecalciferol (UVEDOSE), valsartan (TAREG), calcium carbonate (CALCIDOSE), and pantoprazole. The morning of the vaccination, apathetic patient, found slumped on the right side with a doubt of a facial paralysis, but with responses to simple orders, without sensory-motor deficit or frank facial paralysis demonstrated by the nurse. No notion of choking in the last few days. Vaccination at 2:30 p.m., mention of the lack of immediate effect on the report. The patient experienced severe hypoxia (O2 Sat 63%) and unfavorable coma after vaccination, cause of death not found. According to the declarant, 20 minutes after vaccination, sudden desaturation (Sat O2 63%) with hypovigilance increasing to coma, flaccid quadriplegia observed during transport. Arrival at emergency at 3:54 p.m., GCS 3, TA 170/70 mmHg, HR 80 bpm, blood glucose 10 mmol / l, 98% saturation under 9L of oxygen, auscultation with symmetrically reduced mV, breathing through the mouth, absence of polypnea, abdomen supple without guarding. Neurological examination with flaccid quadriplegia, no ROT, reactive symmetrical pupils, (suspicion of anisocoria), suspicion of right facial paralysis. Biological Examination were as follows: Blood gas: pH 7,11 - PO2 232 - PCO2 131. NF with leucoytes 10.4 G / L, PNN 8.4 G / L, Hb 16.4 g / l, platelets 331 G / L, PT 52%, TCA 40, CRP 0,8, Na + 141 mmol / l, K + 5 mmol / l, Ca 2.37, Cl 99 mmol / l, creatinine 45 micromol / l, DFG 95 ml / min, Urea 9.9 mmol / l, protein 69 g / L, albumin 37 g, ASAT 25, ALAT 30, GammaGT 13, PAL 103, Lipase 35, fasting blood sugar, 1.56 g / l, troponin 10.9 (without further details), BNP 56, Other explorations: RSR ECG, no polarization disorder, brain MRI: no stroke, sequelae of old stroke, no bleeding. Development: With regard to the general condition and risk of death, decision on comfort care after collegial discussion. In the hypothesis of an aa status epilepticus, treatment with levetiracetam 3.5 g slow IV, no improvement. Treatment with morphine and midazolam in the face of pain and polypnea facies (40 rpm). Death noted at 10:30 am the next day (03Feb2021). Autopsy information was unknown. Details of treatment, pre-vaccination context, exploratory workup and death, cause of death and date. N.B.: Accountability "without prejudice to elements of investigations that might be performed for legal or indemnity purposes." No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Death; Hypoxia/Severe hypoxia (O2 Sat 63%); flaccid quadriplegia


VAERS ID: 1081820 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer of prostate; CVA; Ischaemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive; Comments: no variant search
CDC Split Type: FRPFIZER INC2021232869

Write-up: COVID-19 aggravated; COVID-19 PCR test positive; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority [FR-AFSSAPS-MP20210273]. A 96-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Lot no.: EJ6788), intramuscular in the right arm on 21Jan2021 at single dose for covid-19 immunization. Medical history included ischaemic heart disease, cancer of prostate, and CVA (cerebrovascular accident). The patient''s concomitant medications were not reported. The patient experienced covid-19 aggravated on 02Feb2021. The patient was vaccinated as part of the COVID-19 vaccination campaign. The patient considered to be at risk of developing a severe form of COVID-19 disease. It was not specified if the patient had a history of COVID-19. On 26Jan2021: performance of a positive PCR test (no variant search) and on 02Feb2021: Onset of symptoms of COVID-19. The patient was treated in the nursing home. The patient died on 05Feb2021. The cause of death was COVID-19 aggravated and COVID-19 PCR test positive. The outcome of the events was fatal. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 aggravated; COVID-19 PCR test positive


VAERS ID: 1081821 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ9788 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   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:
Current Illness: Renal insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Dwarfism
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021232877

Write-up: COVID-19 AGGRAVATED; COVID-19 PCR test positive; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MP20210274. An 82-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EJ9788), via intramuscular on 21Jan2021 at single dose in right arm for COVID-19 immunisation. Medical history included dwarfism from an unknown date and unknown if ongoing, ongoing renal insufficiency, dementia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient was considered to be at risk of developing a severe form of COVID-19 disease (age). Patient vaccinated as part of the COVID-19 vaccination campaign. It was reported on 26Jan2021: performance of a positive COVID-19 PCR test (no variant search). On 02Feb2021, onset of symptoms of COVID-19, COVID-19 aggravated. Patient treated in the nursing home. Duration was reported as 5 days. Evolution: On 06Feb2021, death of the patient. It was unknown if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: COVID-19 PCR test positive; COVID-19 AGGRAVATED


VAERS ID: 1081822 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   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: Arteritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: no variant research
CDC Split Type: FRPFIZER INC2021232864

Write-up: COVID-19 aggravated; COVID-19 PCR test positive; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-MP20210275. A 90-year-old male patient received first dose of bnt162b2 (COMIRNATY; lot number: EJ6788), intramuscular on 21Jan2021 at single dose in right arm for covid-19 immunisation. Medical history included ongoing arteritis. The patient''s concomitant medications were not reported. On 28Jan2021, the patient Symptoms of COVID-19 appear Covid-19 aggravated was reported, performance of a positive PCR test (no variant search). Patient treated in the nursing home. EVOLUTION: On 03Feb2021: Death of the patient. It was not reported if an autopsy was performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: COVID-19 aggravated; COVID-19 PCR test positive


VAERS ID: 1081823 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   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: AFib; CVA; Heart failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: COVID-19 PCR; Test Result: Positive ; Comments: no research for a variant
CDC Split Type: FRPFIZER INC2021232860

Write-up: COVID-19 PCR test positive; COVID-19 aggravated; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MP20210277. A 78-year-old male patient received he first dose of bnt162b2 (COMIRNATY; lot number: EJ6788), intramuscular on the left arm, on 21Jan2021 at a single dose for covid-19 immunisation. Ongoing medical history included Afib, heart failure, and CVA (cerebrovascular accident). The patient''s concomitant medications were not reported. On 23Jan202, symptoms of COVID-19 appear/ COVID-19 aggravated. On 25Jan2021: performed a positive PCR test (no variant search)/ COVID-19 PCR test positive. The patient died on 28Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: COVID-19 PCR test positive; COVID-19


VAERS ID: 1081824 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROCORTISONE; LOXEN [NICARDIPINE HYDROCHLORIDE]; PANTOPRAZOLE; SERESTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenal insufficiency; Cholelithiasis; Chondrocalcinosis; Diarrhoea (1-day); Hip prosthesis user; Hypertension arterial; Obstruction bronchial; Renal insufficiency; Rhizomelic pseudopolyarthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: SARS CoV2 test; Test Result: Negative ; Test Date: 20210204; Test Name: SARS CoV2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021232886

Write-up: Sudden death; This is a spontaneous report downloaded from the Medicines Agency (MA) WEB with the regulatory authority report number is FR-AFSSAPS-NC20210527. A contactable physician reported that a 95-year-old female patient received her first dose of bnt162b2 (COMIRNATY; lot number: EJ6789; expiration date: unknown) at unknown vaccination age intramuscular in the left deltoid on 11Feb2021 12:00 at a single dose for covid-19 immunisation. Medical history included adrenal insufficiency, hypertension arterial, chondrocalcinosis, mild renal insufficiency, cholelithiasis, right hip prosthesis, rhizomelic pseudopolyarthritis, diarrhoea on 24Jan2021 and bronchial obstruction (bronchial episode) from 28Jan2021 to 02Feb2021. Concomitant medication included hydrocortisone (HYDROCORTISONE), nicardipine hydrochloride (LOXEN), pantoprazole and oxazepam (SERESTA). The patient previously took racecadotril (TIORFAN) on 24Jan2021 for diarrhea, amoxicillin, clavulanate potassium (AUGMENTIN) from 28Jan2021 to 02Feb2021 for bronchial episode and salbutamol (VENTOLINE) from 28Jan2021 to 02Feb2021 for bronchial episode. She presented a 1-day diarrheal episode on 24Jan2021 which resolved under Tiorfan * and a bronchial episode on 28Jan treated with Augmentin * + Ventolin * for 6 days. The physician reported that the vaccination was carried out on 11Feb2021 (D1) at 12 noon in the facility for dependent elderly people in the left deltoid. On 12Feb2021, the patient was found dead in her bed in the morning. This is a patient residing in facility for dependent elderly people, usually tending to communicate the slightest unusual problem. On the day of vaccination, the patient was in good shape, ate well at lunchtime and in the evening and reported no complaints (no pain at the vaccination site, no flu-like condition after vaccination). She was found dead in the morning when she usually woke up. It was concluded that the patient had sudden death the day after vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 24Jan2021 and on 04Feb2021. The patient died on 12Feb2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1081826 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-10
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Lung disorder, Myocardial infarction, Pneumonitis, SARS-CoV-2 test, Troponin
SMQs:, Interstitial lung disease (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Kyphoscoliosis; Restrictive respiratory insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: ECG; Result Unstructured Data: Test Result:indicated myocardial infarction; Test Name: COVID-19 test; Result Unstructured Data: Test Result:did not develop covid-19; Test Date: 20210212; Test Name: troponins; Result Unstructured Data: Test Result:elevated
CDC Split Type: FRPFIZER INC2021232882

Write-up: Infarct myocardial/experienced chest pain, the troponins came back elevated and the ECG indicated myocardial infarction; Pneumopathy; bilateral pneumonitis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority with regulatory authority report number FR-AFSSAPS-NT20210360. A 93-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number and expiry date unknown), intramuscularly on the left arm, on 27Jan2021, at single dose, for covid-19 immunization. Medical history included kyphoscoliosis with restrictive respiratory failure GIR1. Covid-19 history: The patient did not develop covid-19 (test performed but no date). The patient''s concomitant medications were not reported. The patient experienced pneumopathy on 10Feb2021, and infarct myocardial on 12Feb2021. Description of the adverse effect: Vaccination on 27Jan2021 with a first injection of COMIRNATY. Onset of bilateral pneumonitis on 10Feb2021. Two days later, on 12Feb2021, the patient experienced chest pain, the troponins came back elevated and the ECG indicated myocardial infarction. Evolution: Death of the patient. The outcome of the adverse events was fatal. The patient died on an unknown date in 2021. It was unknown if an autopsy was performed. Notabene: Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal procedures. No follow-up attempts are possible, information about the lot/batch number cannot be obtained.; Reported Cause(s) of Death: bilateral pneumonitis; Infarct myocardial; Pneumopathy


VAERS ID: 1081827 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-15
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021232969

Write-up: Status epilepticus; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB. Regulatory authority report number FR-AFSSAPS-NT20210430. A 93-years-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, lot number EK9788), intramuscular on the left arm on 04Feb2021 at a single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received a first dose of the bnt162b2 vaccine against COVID-19 on 04Feb2021. The patient was diagnosed with status epilepticus on 15Feb2021, with no known history of epilepsy in this patient. The patient had COVID-19 test with negative result on an unspecified date. The patient died on 15Feb2021. Cause of death was status epilepticus. It was not reported if autopsy was performed. NB: Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal procedures. No follow-up attempts are possible, information on batch number already obtained.; Reported Cause(s) of Death: Status epilepticus


VAERS ID: 1081829 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Blood test, Death
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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: KARDEGIC; LERCANIDIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive disorder; Disorder gait; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:good
CDC Split Type: FRPFIZER INC2021232768

Write-up: Abdominal pain; stomach aches; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB regulatory authority FR-AFSSAPS-PC20210394. An 85-year-old male patient received second dose of bnt162b2 (COMIRNATY; lot: EM6950) intramuscular, at the age of 85-year-old, on 18Feb2021, at single dose for covid-19 immunisation. Medical history included gait disturbance from an unknown date and unknown if ongoing, cognitive disorder from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylate lysine (KARDEGIC) and lercanidipine. The patient previously received first dose of bnt162b2 (COMIRNATY; lot number and expiry date not reported) on 28Jan2021, single dose for covid-19 immunisation and had no adverse effect. He was an elderly patient who has been treated for his hypertension for several years, with good blood tests. He introduced significant cognitive disorders also affecting his walking (in a relieving chair), a pathology of walking for several years as well. On 18Feb2021, the patient was in normal state during the day and then in the evening, he complained of stomach aches. Spasfon + laxative were given in response to the event. The patient was in bed but died around 9 p.m. No other clinical signs to the reporters knowledge and no identified cause of death. The patient was expected a decline in cognitive faculties, but not such a sudden departure. He received the 2nd injection of the vaccine the same morning and seems to have spent the day in a normal state then only complained of stomach aches a few hours before death. Outcome of the event stomach aches was unknown. The patient had sudden and unexpected death on 18Feb2021. It was unknown if an autopsy was performed. Reporter Comments: Patient in nursing home since 22Jan2021. Had the 1st injection of the vaccine against Covid-19 on January 28, no adverse effect reported. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden and unexpected death


VAERS ID: 1081832 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-27
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Aplasia, Blood bicarbonate, Blood bicarbonate decreased, Blood calcium, Blood chloride, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Blood creatinine, Blood glucose, Blood osmolarity, Blood potassium, Blood pressure measurement, Blood sodium, Blood sodium increased, Blood urea, Body temperature, Glomerular filtration rate, Haemoglobin, Haemoglobin decreased, Heart rate, Investigation, Laboratory test abnormal, Lactic acidosis, Myelofibrosis, Neutrophil count, Neutrophil count decreased, Oxygen saturation, Platelet count, Platelet count decreased, Protein total, SARS-CoV-2 antibody test, SARS-CoV-2 test, Sepsis, Shock, White blood cell count, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Agranulocytosis (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Congenital, familial and genetic disorders (narrow), Blood premalignant disorders (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 0
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: CACIT VITAMIN D3; DIAZEPAM; METFORMIN; OXAZEPAM; XATRAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (Alzheimer dementia); Bedridden; Diabetes; Loss of personal independence in daily activities; Malnutrition; Starvation
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: CPK; Result Unstructured Data: Test Result:198 IU/l; Comments: 198 UI/l; Test Date: 20210127; Test Name: creatinine; Result Unstructured Data: Test Result:352 umol/l; Test Date: 20210127; Test Name: glycemia; Result Unstructured Data: Test Result:27.5 mmol/L; Test Date: 20210127; Test Name: glycemia; Result Unstructured Data: Test Result:4.95 g/l; Test Date: 20210127; Test Name: Calculated plasma osmolarity; Result Unstructured Data: Test Result:357 mmol/L; Test Date: 20210127; Test Name: K; Result Unstructured Data: Test Result:4.3 mmol/L; Test Date: 20210119; Test Name: blood pressure; Result Unstructured Data: Test Result:12/7; Test Date: 20210119; Test Name: blood pressure; Result Unstructured Data: Test Result:12/6; Test Date: 20210119; Test Name: blood pressure; Result Unstructured Data: Test Result:12/6; Test Date: 20210119; Test Name: blood pressure; Result Unstructured Data: Test Result:13/7; Test Date: 20210119; Test Name: blood pressure; Result Unstructured Data: Test Result:10/7; Test Date: 20210120; Test Name: blood pressure; Result Unstructured Data: Test Result:9/5; Test Date: 20210120; Test Name: blood pressure; Result Unstructured Data: Test Result:10/6; Test Date: 20210120; Test Name: blood pressure; Result Unstructured Data: Test Result:10/8; Test Date: 20210127; Test Name: Na; Result Unstructured Data: Test Result:145 mmol/L; Test Date: 20210127; Test Name: Na corrected/glycemia; Result Unstructured Data: Test Result:152 mmol/L; Test Date: 20210127; Test Name: Urea; Result Unstructured Data: Test Result:31.2 mmol/L; Test Date: 20210119; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210119; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210119; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210119; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210119; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Test Date: 20210120; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210120; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210120; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210127; Test Name: GFR per MDRD; Result Unstructured Data: Test Result:14.2 ml/min/1.73; Comments: 14.2 ml/min/1.73 (Caucasian subject) or 17.2 ml/min/1.73 (African subject); Test Date: 20210127; Test Name: Hb; Result Unstructured Data: Test Result:10.5 g/dl; Test Date: 20210119; Test Name: heart rate; Result Unstructured Data: Test Result:89; Test Date: 20210119; Test Name: heart rate; Result Unstructured Data: Test Result:80; Test Date: 20210119; Test Name: heart rate; Result Unstructured Data: Test Result:79; Test Date: 20210119; Test Name: heart rate; Result Unstructured Data: Test Result:84; Test Date: 20210119; Test Name: heart rate; Result Unstructured Data: Test Result:83; Test Date: 20210120; Test Name: heart rate; Result Unstructured Data: Test Result:80; Test Date: 20210120; Test Name: heart rate; Result Unstructured Data: Test Result:82; Test Date: 20210120; Test Name: heart rate; Result Unstructured Data: Test Result:80; Test Date: 20210127; Test Name: anionic Hole; Result Unstructured Data: Test Result:22 mmol/L; Test Date: 20210127; Test Name: neutrophil; Result Unstructured Data: Test Result:0.33 g/l; Test Date: 20210119; Test Name: oxygen saturation; Result Unstructured Data: Test Result:95; Test Date: 20210119; Test Name: oxygen saturation; Result Unstructured Data: Test Result:97; Test Date: 20210119; Test Name: oxygen saturation; Result Unstructured Data: Test Result:97; Test Date: 20210119; Test Name: oxygen saturation; Result Unstructured Data: Test Result:95; Test Date: 20210120; Test Name: oxygen saturation; Result Unstructured Data: Test Result:98; Test Date: 20210127; Test Name: Platelet; Result Unstructured Data: Test Result:92 g/l; Test Date: 20210127; Test Name: Protides; Result Unstructured Data: Test Result:56 g/l; Test Date: 20210127; Test Name: anti-SARS-CoV-2 serology; Test Result: Negative ; Test Date: 20210127; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210127; Test Name: Leukocytes; Result Unstructured Data: Test Result:0.45 g/l; Test Date: 20210127; Test Name: Bicarbonates; Result Unstructured Data: Test Result:16 mmol/L; Test Date: 20210127; Test Name: Calcium; Result Unstructured Data: Test Result:2.06 mmol/L; Test Date: 20210127; Test Name: Cl; Result Unstructured Data: Test Result:107 mmol/L
CDC Split Type: FRPFIZER INC2021232899

Write-up: Shock; Aplasia; septic; lactic acidosis; complicated acute renal insufficiency; myelofibrosis; Na corrected/glycemia 152 mmol/l (N=136-145 mmol/l); bicarbonates 16 mmol/l (N=22-29 mmol/l); anionic hole 22 mmol/l (N=8-16 mmol/l); CPK 198 UI/l (N=25-190); leukocytes 0.45 g/l (N=4-10g/l); neutrophils 0.33 g/l (N=1.5-7.0g/l); Hb 10.5 g/dl (N=13-17g/dl); platelets 92 g/l (N=150-400); This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) WEB FR-AFSSAPS-PS20210336. This is a report received from the Regulatory Authority. A 91-year-old male patient received the first dose of bnt162b2 (COMIRNATY; lot: EJ6795, expiry: unknown), intramuscular on 19Jan2021 at a single dose for covid-19 immunisation. Medical history included diabetes, starvation and Alzheimer''s disease. The patient was suffering from Alzheimer dementia, diabetic, bedridden with extreme malnutrition, no autonomy, and was unable to be treated. Concomitant medications included calcium carbonate, colecalciferol (CACIT VITAMIN D3), diazepam if agitation or oxazepam is not taken, metformin, oxazepam, alfuzosin hydrochloride (XATRAL). On 19Jan2021, in the morning before vaccination, patient''s temperature (T): 36.2 C, heart rate (HR): 89, saturation (sat): 95, and blood pressure (BP): 12/7. 15 min after vaccination, T: 36.6 C, HR: 80, Sat: 97, BP: 12/6. 2 hours (H) after vaccination, T: 36.4 C, HR: 79, Sat: 97, BP: 12/6. At 18:00 on 19Jan2021, T: 36.6 C, HR: 84, Sat: 95, BP: 13/7. At 22:00 on 19Jan2021, T: 36.9 C, HR: 83, BP: 10/7. At 07:00 on 20Jan2021, T: 36.2 C, HR: 80, Sat: 98, BP: 9/5. At 11:00 on 20Jan2021, T: 36.2 C, HR: 82, BP: 10/6. At 18:00 on 20Jan2021, T: 36.2 C, HR: 80, BP: 10/8. On 27Jan2021, the patient arrived at Emergency in a state of shock, probably septic, but also possibility of lactic acidosis due to metformin (but metformin was not given for some time a "priori"), complicated acute renal insufficiency on an unknown renal function baseline. The patient of 91 years old in hitherto unknown aplasia (myelofibrosis??). The patient was very malnourished (weight 35kg) and significant change to his general state on his arrival at Emergency. Lab test on 27Jan2021 includes: Na 145mmol/l, Na corrected/glycemia 152 mmol/l (N=136-145 mmol/l), K 4.3 mmol/l, Cl 107 mmol/l, bicarbonates 16 mmol/l (N=22-29 mmol/l), anionic hole 22 mmol/l (N=8-16 mmol/l), protides 56 g/l (N=65-80 g/l), urea 31.2 mmol/l (N=3.0-7.0 mmol/l), creatinine 352 Umol/l (N=62-106 umol/l), GFR per MDRD 14.2 ml/min/1.73 (Caucasian subject) or 17.2 ml/min/1.73 (African subject), glycemia 27.5 mmol/l (N=3.9-6.1 mmol/l) or 4.95 g/l (N=0.7-1.1), calcium 2.06 mmol/l (N=2.25-2.6 mmol/L), calculated plasma osmolarity 357mmol/l, CPK 198 UI/l (N=25-190), leukocytes 0.45 g/l (N=4-10g/l), neutrophils 0.33 g/l (N=1.5-7.0g/l), Hb 10.5 g/dl (N=13-17g/dl), platelets 92 g/l (N=150-400). Negative rapid SARS-CoV-2 test and Ac anti-SARS-CoV-2 serology done on the same day and negative. The patient had massive filling, empirical antibiotic treatment with C3G + flash of gentamicin, and hospitalisation. The patient died in a state of shock on 27Jan2021. Overall, the patient was hospitalised for less than 12 hours. The patient was suffering from Alzheimer dementia, diabetic, bedridden with extreme malnutrition, no autonomy, and unable to be treated. The patient has no known haematological history. No reference blood test. The patient died on 27Jan2021 due to shock and aplasia. It was unknown if an autopsy was performed. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected. Reported Cause(s) of Death: shock; Aplasia


VAERS ID: 1081833 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Brain stem haemorrhage, Coma, Coma scale, Haemorrhagic stroke, International normalised ratio, International normalised ratio increased, Investigation, Mydriasis, Oxygen saturation, Pupils unequal, Scan brain
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   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: AMLODIPINE; LASILIX [FUROSEMIDE]; RENITEC [ENALAPRIL MALEATE]; TEMERIT; XELEVIA; ZYLORIC
Current Illness: AFib; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Artificial cardiac pacemaker user; Basal cell carcinoma (of the forehead with complete resection in Jun2018); Squamous cell carcinoma of skin (in the left cheek with complete resection in Jun2018); Surgery; Transient ischaemic attack (without sequelae)
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: BP; Result Unstructured Data: Test Result:83/62; Test Date: 20210126; Test Name: Glasgow; Result Unstructured Data: Test Result:3; Comments: a reactive bilateral mydriasis, no reflex; Test Date: 20191115; Test Name: INR; Result Unstructured Data: Test Result:between 2 and 3; Test Date: 20201231; Test Name: INR; Result Unstructured Data: Test Result:between 2 and 3; Test Date: 20201231; Test Name: INR; Result Unstructured Data: Test Result:1.69; Test Date: 20210123; Test Name: INR; Result Unstructured Data: Test Result:4.93; Comments: two days before vaccination.; Test Date: 20210126; Test Name: investigation; Result Unstructured Data: Test Result: anisocoria, reactive right mydriasis, probab; Comments: anisocoria, reactive right mydriasis, probable inhalation.; Test Date: 20210126; Test Name: oxygen saturation; Test Result: 94 %; Comments: Patient put under 15 L of O2, 94% saturation;; Test Date: 20210126; Test Name: oxygen saturation; Test Result: 57 %; Comments: At 9PM 57% saturation under 15 L of O2.; Test Date: 20210126; Test Name: brain scan; Result Unstructured Data: Test Result:reveals a hematoma of the brainstem
CDC Split Type: FRPFIZER INC2021232785

Write-up: International normalised ratio increased; Brain stem haemorrhage; TOTAL, haemorrhagic stroke of the trunk with fatal progression; in a coma; anisocoria; reactive right mydriasis; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB regulatory authority FR-AFSSAPS-PV20210357. An 89-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, lot number:EJ6788, expiry date was not reported) (at 89 years of age), intramuscular in the right arm on 25Jan2021 at 0.3 mL, single for COVID-19 immunisation; acetylsalicylate lysine (KARDEGIC, strength: 75 mg), oral from an unspecified date at 75 mg, 1x/day for atrial fibrillation; and warfarin sodium (COUMADINE, strength: 2 mg), oral from an unspecified date at 1.25 DF, 1x/day for atrial fibrillation. Medical history included ongoing hypertension arterial, squamous cell carcinoma of skin in the left cheek with complete resection in Jun2018, basal cell carcinoma of the forehead with complete resection in Jun2018, transient ischaemic attack in 2011 without sequelae, ongoing atrial fibrillation, complete arrhythmia and patient was with a pacemaker. Concomitant medication included amlodipine, furosemide (LASILIX [FUROSEMIDE]), enalapril maleate (RENITEC [ENALAPRIL MALEATE]), nebivolol hydrochloride (TEMERIT), sitagliptin phosphate (XELEVIA), and allopurinol (ZYLORIC). The patient experienced international normalised ratio increased on an unspecified date and brain stem haemorrhage on 26Jan2021, both events with fatal outcome. It was reported that the patient was an autonomous patient, no cognitive impairment, living alone. On 25Jan2021, she received 1st injection of COMIRNATY. On 26Jan2021 at 2 p.m., call from her daughter, everything was fine. At 7:40 p.m., his daughters called back, no answer, goes home and found him in a coma in the toilet at 8:05 p.m. When the fire brigade arrived, the patient responded to simple orders on the hands at 8.15 p.m. Anisocoria, reactive right mydriasis, probable inhalation. Patient put under 15 L of O2, 94% saturation and administration of 250 mL of MANNITOL. At 9:20 p.m .: a brain scan in the emergency room, which revealed a hematoma of the brainstem. The clinical examination found a Glasgow at 3, a reactive bilateral mydriasis, no reflex. 57% saturation under 15 L of O2. Very likely inhalation. TA at 83/62. After collegial specialist opinion, no therapeutic resource, patient not antagonized. EVOLUTION: Death of the patient in the evening. DIFFERENTIAL DIAGNOSIS: Balanced arterial hypertension for several years according to the attending physician. INR between 15Nov2019 and 31Dec2020: between 2 and 3. 31Dec2020: INR = 1.69. 23Jan2021, i.e. two days before vaccination: INR = 4.93. Most probable hypothesis of a cerebral hemorrhage linked to an overdose of AVK (anti-vitamin K) with imbalance of the INR(international normalized ratio). TOTAL, haemorrhagic stroke of the trunk with fatal progression occurring the day after a 1st vaccination with COMIRNATY in an 89-year-old patient in a context of overdose of COUMADINE (INR 4.93 two days before vaccination) and a treatment with KARDEGIC. The action taken in response to the event for acetylsalicylate lysine and warfarin sodium was not applicable. The outcome of coma, anisocoria and reactive right mydriasis was unknown. The patient died on 26Jan2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Brain stem haemorrhage; International normalised ratio increased; TOTAL, haemorrhagic stroke of the trunk with fatal progression


VAERS ID: 1081836 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrioventricular block complete, Bradycardia, Dyspnoea, Electrocardiogram, Fatigue, Loss of consciousness, Nausea, Sudden death
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), Conduction defects (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   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: DETENSIEL [BISOPROLOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210213; Test Name: bradycardia; Result Unstructured Data: Test Result:37/min; Test Date: 20210213; Test Name: ECG; Result Unstructured Data: Test Result:AVB (atrioventricular block) 2 or even 3
CDC Split Type: FRPFIZER INC2021232918

Write-up: Sudden death; suddenly loses consciousness; Atrioventricular block, complete; bradycardia at 37/min; Fatigue; Nausea; Respiration labored; This is a spontaneous report from a contactable physician from the regulatory authority-WEB FR-AFSSAPS-RS20210251. An 88-year-old male patient received the first dose of bnt162b2 (COMIRNATY) lot number: EJ6789, intramuscular on 09Feb2021 at a single dose for covid-19 immunisation. Medical history included hypertension arterial and Alzheimer''s disease. Concomitant medication included bisoprolol (DETENSIEL [BISOPROLOL]) for hypertension. Since 12Feb2021, the patient experienced unusual fatigue (need to stop twice on a 1 km walk outdoors), nausea, episode of labored respiration, without syncope, without discomfort. The patient had a medical consultation on 13Feb2021. Poor clinical examination apart from bradycardia at 37 / min, AVB (atrioventricular block) 2 or even 3 on ECG. No cardiac decompensation. Immediate hospitalization was done. The patient had to be fitted (with a device) on 15Feb2021 for this AVB and on 14Feb2021, the patient has his wife on the phone and shows no complaints or disturbances but fifteen minutes later, he suddenly loses consciousness and dies. The patient died on 14Feb2021. It was not reported if an autopsy was performed. The outcome of other events was unknown at the time of death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1081837 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Pneumonia aspiration, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Drug allergy; Feeling sick; Starvation
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021232903

Write-up: Emesis/episode of vomiting; Pneumonia aspiration; recovery of the state of consciousness; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB. The regulatory authority report number is FR-AFSSAPS-RS20210260. A 96-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, lot number: EJ6789), intramuscularly on 11Feb2021 at a single dose for COVID-19 immunization. Medical history included starvation, drug allergy, dementia and feeling sick, all from an unknown date and unknown if ongoing. It was also reported that she was a very dependent patient, GIR 1 (as reported). The patient''s concomitant medications were not reported. The patient previously took paracetamol and experienced allergy. The patient previously received first dose of BNT162B2 (lot number and expiry date were not reported) for COVID-19 immunization and was well tolerated by the patient. The patient experienced emesis/episode of vomiting and pneumonia aspiration on 11Feb2021. It was reported that the patient received second injection of BNT162B2 on 11Feb2021, and good immediate tolerance was reported. Two hours later, during the meal, onset of emesis/episode of vomiting (no cough, no dyspnea, no fever). Wrong route with significant inhalation. Patient was put in recovery position, aspiration, oxygen therapy; saturation recovered after putting on O2, but the recovery of the state of consciousness was moderate. The patient was put on Augmentin. Family was informed and the decision was to not hospitalize the patient. The evolution was unfavorable the following days; the patient died on an unspecified date in Feb2021 (reported as during the night of February 13 to 14). The physician mentioned a death linked to aspiration pneumonia in this patient whose state of health was very precarious. The reporter assessed the events emesis/episode of vomiting and aspiration pneumonia as serious (death). The patient died on an unspecified date of Feb2021. It was not reported if an autopsy was performed. No follow-up attempts were possible. No further information is expected. Information on lot and batch numbers were already obtained.; Reported Cause(s) of Death: Pneumonia aspiration; Emesis/episode of vomiting


VAERS ID: 1081847 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Blood creatinine, Blood pressure measurement, Body temperature, Brain natriuretic peptide, C-reactive protein, Cardiovascular disorder, Coma scale, Cyanosis, Dehydration, Dyspnoea, Electrocardiogram, Heart rate, Hyperkalaemia, Hypernatraemia, Investigation, Oxygen saturation, Oxygen saturation decreased, Renal failure, Respiratory rate
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   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:
Current Illness: Heart failure; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Knee arthroplasty (PAO); Pulmonary embolism (left PE); Unspecified disorder of thyroid
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: Creatinine; Result Unstructured Data: Test Result:423; Comments: renal failure with creatinine 423; Test Date: 20210215; Test Name: Blood pressure; Result Unstructured Data: Test Result:hypotension; Test Date: 20210215; Test Name: Blood pressure; Result Unstructured Data: Test Result:96/67 mmHg; Test Date: 20210215; Test Name: Body Temperature; Result Unstructured Data: Test Result:Afebrile; Test Date: 20210215; Test Name: Body Temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Test Date: 20210215; Test Name: BNP; Result Unstructured Data: Test Result:1000; Comments: BNP (ventricular natriuretic protein) 1000; Test Date: 20210215; Test Name: GCS; Result Unstructured Data: Test Result:E3V2M6; Comments: obeying commands, incomprehensible speech, eye opening in response to speech; there was no localization sign; Test Date: 20210215; Test Name: C-reactive protein; Result Unstructured Data: Test Result:170; Test Date: 20210215; Test Name: ECG; Result Unstructured Data: Test Result:130 bpm; Comments: rapid atrial fibrillation (rapid ACFA) 130 bpm with diffuse repolarization disturbances; Test Date: 20210215; Test Name: Heart rate; Result Unstructured Data: Test Result:decreased; Test Date: 20210215; Test Name: Pulse; Result Unstructured Data: Test Result:60; Test Date: 20210215; Test Name: Tachycardia; Result Unstructured Data: Test Result:130; Test Date: 20210215; Test Name: Hyperkalaemia; Result Unstructured Data: Test Result:6.1; Test Date: 20210215; Test Name: Hypernatremia; Result Unstructured Data: Test Result:158; Test Date: 20210215; Test Name: Clinical examination; Result Unstructured Data: Test Result:borderline blood pressure, tachycardia 130; Comments: borderline blood pressure, tachycardia 130, afebrile, rapid BDC (rapid heart sound disturbances), no OMI (legs oedema), superficial polypnea, and bilateral crackles; Test Date: 20210215; Test Name: Clinical examination; Result Unstructured Data: Test Result:clinically dehydrated; Test Date: 20210216; Test Name: Clinical examination; Result Unstructured Data: Test Result:progressive degradation of hemodynamics; Comments: progressive degradation of hemodynamics, and with cyanosis; Test Date: 20210215; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:100/2 L/min oxygen; Test Date: 20210215; Test Name: Respiratory rate; Result Unstructured Data: Test Result:20
CDC Split Type: FRPFIZER INC2021232772

Write-up: progressive degradation of hemodynamics; Cyanosis; AFib / rapid atrial fibrillation (rapid ACFA) 130 bpm with diffuse repolarization disturbances; Major dehydration/ clinically dehydrated; Oxygen saturation decreased/ desaturation; Dyspnoea; renal failure with creatinine 423, BNP (ventricular natriuretic protein) 1000, and CRP (C-reactive protein) 170; This is a spontaneous report from a contactable physician downloaded from the regulatory authority WEB; the Regulatory Authority Report Number is: FR-AFSSAPS-TS20210392. A 95-year-old female patient received the first dose of the BNT162B2 (COMIRNATY; lot/batch number and expiry date were unknown), intramuscular on 11Feb2021 at SINGLE DOSE for COVID-19 immunisation. The patient''s medical history included ongoing hypertension arterial and heart failure; Patient had periacetabular osteotomy (PAO), left pulmonary embolism (PE), atrial fibrillation, and dysthyroidism, all from an unknown date and unknown if ongoing. Patient was in a nursery home. Concomitant medications were not reported. On 15Feb2021, day 4 after the first dose of Comirnaty, the patient experienced a rapid outbreak of ACFA that was poorly tolerated with desaturation and major dehydration. It was reported that the patient was admitted in the emergency room for dyspnea on 15Feb2021. The patient underwent lab tests and procedures on 15Feb2021 which included: Pulse: 60, Blood pressure left arm (Max/Min): 96/67 mmHg, Oxygen saturation: 100/2 L/min oxygen, Respiratory rate: 20, and Temperature: 37.3 degrees Centigrade. Per clinical examination, patient had borderline blood pressure, tachycardia 130, afebrile, rapid BDC (rapid heart sound disturbances), no OMI (legs oedema), superficial polypnea, and bilateral crackles. GCS (Glasgow coma scale) E3V2M6 (obeying commands, incomprehensible speech, eye opening in response to speech; there was no localization sign). On ECG, the following was noted: rapid atrial fibrillation (rapid ACFA) 130 bpm with diffuse repolarization disturbances. Faced with poorly tolerated ACFA, patient was administered with 300mg cordarone over 30 min plus 80mg of lasilix. Upon reassessment, the following were observed: decrease in heart rate, hypotension, and patient was clinically dehydrated. Other laboratory assessments performed in 15Feb2021 showed hypernatremia at 158, hyperkalaemia at 6.1, renal failure with creatinine 423, BNP (ventricular natriuretic protein) 1000, and CRP (C-reactive protein) 170. The following were conducted: probabilistic antibiotic therapy by C3G (third generation cephalosporins), rehydration by NaCl 1000/24h, and anxiolysis by midazolam 0.5 mg/h. On 16Feb2021 patient had progressive degradation of hemodynamics, and with cyanosis. Comfort treatment with 0.5 mg/h of morphine was initiated and patient died on 16Feb2021 at 7:10 am. No autopsy was performed. No follow-up attempts are possible; information on lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Oxygen saturation decreased/ desaturation; Major dehydration/ clinically dehydrated; Renal failure; AFib / rapid atrial fibrillation (rapid ACFA) 130 bpm with diffuse repolarization disturbances; progressive degradation of hemodynamics; Cyanosis


VAERS ID: 1082415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4244/PF/IM / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, Cough, Death, Pulmonary function test, Respiratory acidosis, Respiratory failure, SARS-CoV-2 test
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Respiratory failure
Allergies:
Diagnostic Lab Data: Test Name: Respiratory test; Result Unstructured Data: Test Result:non infective exacerbation of COPD and respiratory; Comments: revealed non infective exacerbation of COPD and respiratory acidosis; Test Date: 20210226; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:no - negative covid-19 test
CDC Split Type: GBPFIZER INC2021239390

Write-up: type 2 respiratory failure; respiratory acidosis; cough; non infective exacerbation of COPD; Death; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202103021834112350, and Safety Report Unique Identifier is GB-MHRA-ADR 24864762. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK4244/PF/IM, via an unspecified route of administration on an unspecified date in 2021 at single dose for COVID-19 immunisation. Medical history included respiratory failure and COPD (chronic obstructive pulmonary disease). Patient has not had symptoms associated with COVID-19 and patient was not enrolled in clinical trial. The patients concomitant medications were not reported. The patient experienced type 2 respiratory failure on an unspecified date, respiratory acidosis on an unspecified date, cough on an unspecified date, death on 01Mar2021 also reported as 24Feb2021 and non-infective exacerbation of COPD on an unspecified date. It was reported that patient had moderate COPD but had good quality of life. She was well through shielding time from Mar2020 until Feb2021.She had vaccine and 12 days later developed chesty cough. Collapsed two days later and was admitted to ITU with type 2 respiratory failure and died 3 days later. Patient never previously had a COPD related hospital admission. Patient has not tested positive for COVID-19 since having the vaccine. ITU tests (respiratory test) revealed non infective exacerbation of COPD and respiratory acidosis. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 26Feb2021, and respiratory test: revealed non infective exacerbation of COPD and respiratory acidosis on an unspecified date. The outcome of the events was fatal. The patient died on 01Mar2021 also reported as 24Feb2021. 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: type 2 respiratory failure; respiratory acidosis; cough; death; non-infective exacerbation of COPD


VAERS ID: 1082464 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Depressed level of consciousness, Oral discharge, SARS-CoV-2 test
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Subarachnoid haemorrhage (7 + years ago required full care however had been medically well for several years.); Comments: Patient had a SAH 7 + years ago required full care however had been medically well for several years. Patient had COVID in Jan 2020 caught in a care home. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021238920

Write-up: Death NOS; Symptoms included an increase in Oral secretions and a reduction in alertness.; Symptoms included an increase in Oral secretions and a reduction in alertness.; This is a spontaneous report from a contactable other HCP. This is a report received from the Regulatory Agency RA)(. Regulatory authority report number GB-MHRA-WEBCOVID-202103031027278470, Safety Report Unique Identifier GB-MHRA-ADR 24867272. A 71-year-old female patient received the first dose of BNT162B2 (P FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunisation. Medical history included subarachnoid haemorrhage (7 + years ago required full care however had been medically well for several years) and COVID in Jan2020 (the patient had COVID in Jan2020 caught in a care home.) The 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 was vaccinated on Monday 08Feb2021 and she had a slow deterioration over the week. The patient had complex care needs however she was medically well and being looked after at home. Symptoms included an increase in oral secretions and a reduction in alertness. The outcome of oral secretions and a reduction in alertness was unknown. The patient died on 14Feb2021. The cause of death was not reported; it was unknown if an autopsy was performed. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1082667 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       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: 2021-02-11
   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: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Arresto cardio-circolatorio; A regulatory authority report (Italy) was received from a physician concerning a female patient of 87-year-old, who was received Moderna''s COVID-19 vaccine(mRNA-1273) and experienced arrest cardiac. The patients'' medical history was not provided. No relevant Concomitant medications were reported. On 08 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273(Lot number: 300042721) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient experienced cardiac arrest and passed away. The event was also considered medically significant. Treatment information was not provided. Action taken with the mRNA-1273 was not applicable. The outcome of event was fatal as patient died on 11 Feb 2021 due to arresto cardio-circolatorio. The autopsy details were not provided.; Reporter''s Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. The autopsy details were not provided. However, the patient''s age may be a confounding factor for causality assessment.; Reported Cause(s) of Death: Arresto cardio-circolatorio


VAERS ID: 1082764 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (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: PLPFIZER INC2021237485

Write-up: Pulmonary edema; This is a spontaneous report from a contactable consumer through the Medical Information Team. A female patient of an unspecified age received BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient had pulmonary edema. The patient had died on an unspecified due to pulmonary edema. It was unknown if an autopsy was performed. Information on the batch/lot number has been requested.; Reported Cause(s) of Death: Pulmonary edema


VAERS ID: 1083580 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-19
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fall
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GANFORT; SIMBRINZA; KARDEGIC; fluoxetine hcl; BROMAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Falling down; Glaucoma; Lyme disease; Rhizomelic pseudopolyarthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021232825

Write-up: Falling down; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB regulatory authority FR-AFSSAPS-AN20210501. A 93-year-old male patient received their second dose of bnt162b2 (COMIRNATY; lot number and expiry date were not reported), intramuscular on 10Feb2021 at single dose for covid-19 immunisation, acetylsalicylate lysine (KARDEGIC), oral from an unspecified date to 18Feb2021 at 1 DF, 1x/day for cardiovascular event prophylaxis, fluoxetine hcl, oral from an unspecified date to 18Feb2021 at 10 mg, 1x/day for anxiodepressive syndrome, bromazepam (BROMAZEPAM), oral from an unspecified date to 18Feb2021 at 2 DF, 1x/day for anxiodepressive syndrome. Medical history included glaucoma, anxiodepressive syndrome, Lyme disease, falling down and Rhizomelic pseudopolyarthritis; all from an unknown date and unknown if ongoing. The patient received their first dose of bnt162b2 (COMIRNATY; lot number and expiry date not reported) on 20Jan2021 for covid-19 immunisation. Concomitant medication included bimatoprost, timolol maleate (GANFORT) and brimonidine tartrate, brinzolamide (SIMBRINZA). It was reported that the patient died following a fall/falling down 9 days after a second injection of COMIRNATY and during treatment with FLUOXETINE, BROMAZEPAM and KARDEGIC on 19Feb2021. The action taken in response to the event for acetylsalicylate lysine, fluoxetine hcl and bromazepam was not applicable. The patient died on 19Feb2021. An autopsy was not performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected. Information about the batch/lot number cannot be obtained.; Reported Cause(s) of Death: Falling down


VAERS ID: 1083701 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-01-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chest X-ray, Dyspnoea, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: FINASTERIDE; SIMVASTATIN; MONOKET; ZOLOFT; ACETYLSALICYLIC ACID; CERCHIO; SELOKEN [METOPROLOL SUCCINATE]
Current Illness: Chronic ischaemic heart disease, unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Thorax X-ray; Result Unstructured Data: Test Result:increase in cardiac damage markers
CDC Split Type: ITPFIZER INC2021226253

Write-up: cardiocirculatory arrest; dyspnea; fever; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB IT-MINISAL02-686372. An 88-year-old male patient received second dose of BNT162B2 (COMIRNATY, lot number EJ6136, Expiration Date 30Apr2021), intramuscularly on 30Jan2021 11:30 on left shoulder at 0.3 mL, single dose for COVID-19 immunization. Medical history included ongoing chronic ischaemic heart disease, unspecified. Concomitant medications included finasteride, simvastatin, isosorbide mononitrate (MONOKET), sertraline hydrochloride (ZOLOFT), acetylsalicylic acid, cetirizine hydrochloride (CERCHIO), metoprolol succinate (SELOKEN). Historical Vaccine included first dose of COMIRNATY (lot number EL1484, Expiration date 30Apr2021) on 07Jan2021 18:40 on right shoulder for COVID-19 immunization and experienced signs of pulmonary congestion for which patient institutionalized. On 31Jan2021 at 23:00 the patient experienced dyspnea and fever. Emergency Services alerted at 01:25 and conducted to Emergency Room at 02:40. On 01Feb2021 04:30 am patient experienced cardiocirculatory arrest and death after ineffective resuscitation maneuvers. Lab data included thorax X-ray showed increase in cardiac damage markers on unspecified date. The patient died on 01Feb2021 due to dyspnea, fever and cardiocirculatory arrest. Autopsy was done and showed cardiac decompensation, myocardiosclerotic myocardial hypertrophy. The outcome of the events were fatal.; Reported Cause(s) of Death: dyspnea; fever; cardiocirculatory arrest


VAERS ID: 1083756 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug allergy (Co-Amoxicillin and Codein)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; COPD; Depression; Hypothyreosis; Renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; A regulatory report was received from a regulatory authority concerning a 96-years-old female patient, who was administered with Moderna''s Covid-19 vaccine and was died. Patient''s medical history included Renal failure, COPD, Hypertension arterial, Depression, and Hypothyroidism. Patient had allergy towards Co-amoxicillin and Codein. No relevant concomitant medications were mentioned. On 26-JAN-2021, prior to the onset of events patient received mRNA-1273 vaccine (Lot/Batch: unknown) for prophylaxis of Covid-19 infection. After vaccination, she had no local reaction, no fever, no discomfort. On 30-JAN-2021, she died acutely (patient found dead in bed, an hour before her condition was inconspicuous). Outcome for the event was considered fatal. Patient was dead on 30-JAN-2021 and the probable cause of death was heart attack or heart rhythm disorder.; Reporter''s Comments: Based on reporter''s causality of unlikely and patient''s advanced age along with multiple underlying conditions, the event of death is also assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1083758 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Hypertension, Respiratory distress, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Hypertension (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathic disease (1st grade arteriopathy of lower limbs); Extrasystoles ventricular; Hypertension arterial (benign); Insulin-requiring type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210208; Test Name: blood pressure; Result Unstructured Data: Test Result:170/100 mmHg; Test Date: 20210208; Test Name: heart rate; Result Unstructured Data: Test Result:130 bpm
CDC Split Type: FRPFIZER INC2021232821

Write-up: Hypertension arterial; Tachycardia; Distress respiratory; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB FR-AFSSAPS-BR20210377. An 88-year-old female patient received first dose of bnt162b2 (COMIRNATY; lot number: EJ6788), intramuscular on 05Feb2021 at single dose in left arm for covid-19 immunisation. Medical history included 1st grade arteriopathy of lower limbs, Insulin-requiring type 2 diabetes mellitus, Extrasystoles ventricular, Hypertension arterial benign. The patient''s concomitant medications were not reported. On 08Feb2021, appearance of sudden onset respiratory distress. Tachycardia at 130 bpm, blood pressure at 170/100 mmHg. Impression of imminent death. Evolution towards death at 8:30 p.m., in 15 to 20 minutes. No physician on site. The patient underwent lab tests and procedures which included blood pressure measurement: 170/100 mmhg on 08Feb2021, heart rate: 130 bpm on 08Feb2021. The patient died on 08Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Hypertension arterial; tachycardia; Distress respiratory


VAERS ID: 1084861 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac insufficiency; COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Viral hepatitis B
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC2021221786

Write-up: COVID-19 respiratory infection; This is a spontaneous report a contactable physician downloaded from the Regulatory Authority [regulatory authority AT-BASGAGES-2021-04880]. The reporter reported similar events for 2 patients, this is the 1st of 2 reports. A 90-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number EL1491) via an unspecified route of administration on 15Jan2021 at a single dose for covid-19 immunisation. The patient''s medical history included Heart failure (continuing), Viral hepatitis B, COVID-19 (continuing). The patient''s concomitant medications were not reported. The patient was positive tested for Sars-CoV2 by means of PCR (25Jan), on 30Jan2021 21:05 and died in the home from COVID-19 respiratory infection. The patient was already palliative before COVID-19 and considered as a terminal patient. No autopsy was done. Causality between the event and vaccine was assessed as unlikely by the HA. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-2021242520 same reporter, same vaccine, similar events in different patient; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1084862 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-02-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast carcinoma (Mammary gland right)
Preexisting Conditions: Medical History/Concurrent Conditions: Infarct cerebral (ischemic infarction)
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC2021221799

Write-up: SARS-COV2-POSITIVE INFECTION/ COVID-19 respiratory infection/ COVID-19; SARS-COV2-POSITIVE INFECTION/ COVID-19 respiratory infection/ COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB regulatory authority AT-BASGAGES-2021-04886. A 94-year-old female patient received bnt162b2 (COMIRNATY, lot/batch number: EL1491) , via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation . Medical history included ongoing breast carcinoma (Mammary gland right) and Infarct cerebral (ischemic infarction) from an unspecified date and not ongoing. The patient''s concomitant medications were not reported. The patient experienced sars-cov2-positive infection/ covid-19 respiratory infection/ covid-19 (drug ineffective) (death) on Feb2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 05Feb2021. Narrative case summary and further information was reported as "possible association between deaths and COVID vaccinations given promptly before is suspected. The individuals were all vaccinated against COVID-19 on Jan152021 (1st partial vaccination with Comirnaty, batch EL1491), tested positive 4 to 13 days later (One patient 32 days later), and died 10 to 20 days after vaccination (said patient 37 days later). A similar cluster of deaths did not occur at the nursing home in recent years. COVID infection has been circulating in the home since 01Jan2021. All 12/14 decedents have tested positive for Sars-CoV2 by PCR. The patient in this NW report also tested pos. for Sars-CoV2 by PCR (05Feb2021), then died at the home on 11Feb2021. " The patient died on 11Feb2021 from COVID-19. An autopsy was not performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: SARS-COV2-POSITIVE INFECTION/ COVID-19 respiratory infection/ COVID-19


VAERS ID: 1084863 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-02-16
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 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: 2021-02-21
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210216; Test Name: Covid-19; Result Unstructured Data: Test Result:positive
CDC Split Type: ATPFIZER INC2021242520

Write-up: drug ineffective; COVID-19; This is a spontaneous report a contactable physician reporting on different patients, this is the second case. The first case report was downloaded from the Regulatory Authority [regulatory authority AT-BASGAGES-2021-04880]. A elderly patient of an unspecified gender received the first dose bnt162b2 (COMIRNATY; Lot # EL1491) vaccine , via an unspecified route of administration 15Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive to SARS-COV-2 on 16Feb2021 and died from it on 21Feb2021. It is unknown if an autopsy was carried out. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-2021221786 same reporter, same vaccine, similar events in different patient.; Reported Cause(s) of Death: Covid-19


VAERS ID: 1084864 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021230129

Write-up: death; This is a spontaneous report from a contactable other healthcare professional via VOC. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration, on unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected. ; Sender''s Comments: The event Death may be an intercurrent occurrence. However, based on the plausible temporal relation, the association between the event death and vaccination cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1084866 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrioventricular block complete, Bradycardia, Cardiac arrest, Cardiovascular disorder, Electrocardiogram, General physical health deterioration, Investigation, Loss of consciousness, Respiration abnormal, Rhythm idioventricular, Serum ferritin, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (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 (broad), Respiratory failure (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: IRON; SALAZOPYRINE; ARANESP; ATENOLOL; LERCANIDIPINE; D-CURE; INDAPAMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Bechterew''s disease; Chronic renal failure; Hiatus hernia; Hyperuricaemia; Nephroangiosclerosis; Rheumatoid arthritis; Type II diabetes mellitus; Wrist fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210207; Test Name: ECG; Result Unstructured Data: Test Result:3rd degree AV block; Comments: with intermittent total AV block. In between acceptable sinsual rhythm and ventricular escape rhythm <30.; Test Date: 20210208; Test Name: ECG; Result Unstructured Data: Test Result:relapse 3rd degree AV block; Comments: with symptomatic bradycardia with very slow ventricular escape rhythm (<20bpm); Test Name: Acute renal insufficiency; Result Unstructured Data: Test Result:Acute renal insufficiency KDIGO; Comments: presumably based on low flow with underlying CKD (chronic kidney disease) gr 4.; Test Date: 202011; Test Name: High ferritinemia; Result Unstructured Data: Test Result:505 ng/ml; Comments: Exceptionally High ferritinemia
CDC Split Type: BEPFIZER INC2021221941

Write-up: symptomatic bradycardia; However, rapid progression with deterioration to asystole; However, rapid progression with deterioration to asystole; Cardiovascular problem; Unresponsive; groaning breaths; Loss of consciousness based on 3rd degree AV block with intermittent total AV block; Loss of consciousness based on 3rd degree AV block with intermittent total AV block; very slow ventricular escape rhythm (<20bpm); This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA). Regulatory Authority Report Number : BE-FAMHP-DHH-N2021-77518. A 96-years-old female patient received second dose of bnt162b2 (COMIRNATY, lot number unknown), via an unspecified route of administration on 05Feb2021 at single dose for COVID-19 immunisation. Medical history included bechterew''s disease, nephroangiosclerosis, diabetes mellitus type II, arterial hypertension, chronic renal failure, rheumatoid arthritis, hyperuricaemia, wrist fracture, hiatus hernia, all from an unknown date. Concomitant medication included iron (IRON), sulfasalazine (SALAZOPYRINE), darbepoetin alfa (ARANESP), atenolol (ATENOLOL), lercanidipine (LERCANIDIPINE), colecalciferol (D-CURE), indapamide (INDAPAMIDE). The historical vaccination included first dose of bnt162b2 (COMIRNATY) on 15Jan2021 for COVID-19 Vaccination. Reported adverse drug reactions included Cardiovascular disorder, Unresponsive to stimuli, Abnormal breathing, Loss of consciousness, Atrioventricular block, Bradycardia, Ventricular escape rhythm, General physical health deterioration, Asystolia. On 05Feb2021, 2nd dose of Comirnaty vaccine. On 07Feb2021, unresponsive, moaning breathing for which Mobile Emergency and Resuscitation service call. Loss of consciousness based on 3rd degree AV (atrioventricular) block with intermittent total AV block. In between acceptable sinsual rhythm and ventricular escape rhythm <30. On 08Feb2021: Recovery, conversation possible. On 08Feb2021 in the evening: Relapse 3rd degree AV block with symptomatic bradycardia with very slow ventricular escape rhythm (<20bpm) suddenly areactive. Gasping breathing. Atropine 1x with short-term recovery rhythm. However, rapid progression with deterioration to asystole. No more resuscitation started given very old age and presumably sick heart. Treatment was reported as No. Evolution of the adverse drug reaction was Died. The serious critieria reported for the events were fatal, life-threatening and hospitalization. The patient underwent lab tests and procedures which included electrocardiogram: 3rd degree AV block with intermittent total AV block. In between acceptable sinsual rhythm and ventricular escape rhythm <30 on 07Feb2021, electrocardiogram: Relapse 3rd degree AV block with symptomatic bradycardia with very slow ventricular escape rhythm (<20bpm) on 08Feb2021, Serum ferritin: Exceptionally High ferritinemia, Last ferritin 505 ng/ml on Nov2020, Examinations included high ferritinemia; investigation: Acute renal insufficiency KDIGO (Clinical practice guideline) 1 presumably based on low flow with underlying CKD (chronic kidney disease) gr 4 on unspecified date. The patient died on 08Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cardiovascular problem; Unresponsive; groaning breaths; Loss of consciousness based on 3rd degree AV block with intermittent total AV block; Loss of consciousness based on 3rd degree AV block with intermittent total AV block; symptomatic bradycardia;


VAERS ID: 1084875 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021222140

Write-up: This is a spontaneous report from a non-contactable Physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021002906. A 80 years old male patient received BNT162B2 (Comirnaty, lot number EK9788), via an unspecified route of administration on 18Feb2021 at the 80 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient experienced lethal outcome on 18Feb2021. On the same day after vaccination the patient developed Death. The patient died on 18Feb2021. It''s unknown if an autopsy was performed. The cause of death was unknown. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: lethal outcome


VAERS ID: 1084886 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Choking, Decreased appetite, Fatigue, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Encephalopathy; Epilepsy; Infection; Rett''s disorder; Scoliosis (dorsolumbar scoliosis with left convexity)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021232815

Write-up: Choked on food; Fever; asthenia; Anorexia; Fatigue; This is a spontaneous report from a consumer downloaded from the Agency Regulatory Authority FR-AFSSAPS-BR20210378. A 33-year-old female patient received the first dose of bnt162b2 (COMIRNATY; lot number EJ6790), intramuscular in the right arm on 18Feb2021 at a single dose for covid-19 immunisation. Medical history included rett''s syndrome, epilepsy, encephalopathy, dorsolumbar scoliosis with left convexity, severe constipation, and repeated infectious and comital episodes. The patient''s concomitant medications were not reported. After the vaccination, the person went home. Fatigue appeared on 18Feb2021; fever, asthenia, and anorexia on 19Feb2021, patient did not eat. On 21Feb2021, patient had less temperature. In the evening, she had dinner and took a wrong turn leading to death, patient choked on food. The patient died on 21Feb2021. It was not reported if an autopsy was performed. The events were reported as serious (fatal). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Fatigue; fever; asthenia; anorexia; choked on food


VAERS ID: 1084887 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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: 2021-02-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Aregenerative anemia; Atrioventricular block complete (Complete AVB with cardiac pacemaker installation in 2020); Cardiac pacemaker insertion; Chronic renal failure; Cirrhosis liver; Cognitive disturbance (neurocognitive disorders of mixed origin (degenerative and vascular)); Fracture of neck of femur; Hypertension arterial; Hypertensive heart disease NOS; Insulin-requiring type 2 diabetes mellitus; Kappa light chain analysis; Pertrochanteric fracture of femur, closed
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021232806

Write-up: Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-BR20210400. An 82-year-old male patient received the second dose of bnt162b2 (COMIRNATY, lot number: EK9788), intramuscular on 08Feb2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included non-deficiency aregenerative anemia, atrioventricular block complete (Complete AVB with cardiac pacemaker installation in 2020), aortic stenosis, cirrhosis liver from 2020, hypertensive heart disease, hypertension arterial, cognitive disturbance (neurocognitive disorders of mixed origin (degenerative and vascular), cardiac pacemaker insertion in 2020, insulin-requiring type 2 diabetes mellitus, fracture of neck of femur from 2019, chronic renal failure, right pertrochanteric fracture from 2019, kappa light chains anomaly from May2020. The patient''s concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY, lot number: EJ6795) on 18Jan2021 for COVID-19 Immunisation with no adverse effect. On 13Feb2021, the patient experienced infarct myocardial. Intervention by the doctor in the morning, then by the on-call resident in the afternoon, cardiological advice requested by telephone. The event resulted to fatal outcome. The patient died on 14Feb2021. 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: Infarct myocardial


VAERS ID: 1084889 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac failure, Myocardial infarction, Myocardial ischaemia, Oedema peripheral, Oxygen saturation, Oxygen saturation decreased, Pulmonary oedema, Troponin
SMQs:, Cardiac failure (narrow), Angioedema (broad), Myocardial infarction (narrow), Supraventricular tachyarrhythmias (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 17
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: Atrial flutter; Auricular fibrillation; Diabetes
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: Desaturation; Test Result: 85 %; Test Date: 20210202; Test Name: Troponins; Result Unstructured Data: Test Result:High
CDC Split Type: FRPFIZER INC2021232835

Write-up: cardiac decompensation; Atrial fibrillation; pulmonary edema; Arterial oxygen saturation decreased/85% desaturation; cardiac decompensation with suspicion of a massive infarction; myocardial ischemia (high troponins, no quantified value).; ankle edema; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-MA20210498. A 97-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, lot number: EK9788, expiry date: unknown), intramuscular on 28Jan2021 (at the age of 97 years old) at a single dose in the right arm for covid-19 immunisation. Medical history included diabetes, auricular fibrillation, and atrial flutter. The patient''s concomitant medications were not reported. Covid-19 PCR test was not performed. The patient had no history of covid-19. History of allergy or hypersensitivity was unknown. On 30Jan2021, approximately 2 days after vaccination, the patient had appearance of ankle edema reported by the home nurse. On 02Feb2021, the patient presented with cardiac decompensation, atrial fibrillation, with pulmonary edema, 85% desaturation (also reported as arterial oxygen saturation decreased), change to poorly tolerated AF (atrial flutter) and myocardial ischemia (high troponins, no quantified value). The patient was hospitalized and treated with isosorbide dinitrate (RISORDAN) and diuretics. No coronary angiography performed. On 15Feb2021, the patient experienced new cardiac decompensation with suspicion of a massive infarction. Therapeutic measures were taken as a result of the events cardiac decompensation, atrial fibrillation, pulmonary edema and arterial oxygen saturation decreased/85% desaturation. Outcome of the events cardiac decompensation, atrial fibrillation, pulmonary edema and arterial oxygen saturation decreased/85% desaturation was fatal. Outcome of all the other events was unknown. The patient died on 16Feb2021 due to cardiac decompensation, atrial fibrillation, pulmonary edema and arterial oxygen saturation decreased/85% desaturation. It was not reported whether an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac decompensation; atrial fibrillation; pulmonary edema; arterial oxygen saturation decreased/85% desaturation


VAERS ID: 1084890 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: AFib; Dementia; Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: no variant search
CDC Split Type: FRPFIZER INC2021232874

Write-up: symptoms of COVID-19 appeared; symptoms of COVID-19 appeared and performance of a positive PCR test (no variant search); This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory Authority Report Number is FR-AFSSAPS-MP20210276. A 93-year-old female patient received the first dose of bnt162b2 (COMIRNATY; lot number EJ6788), intramuscular in the left arm on 21Jan2021 at a single dose for covid-19 immunisation. Medical history included ongoing diabetes, ongoing dementia, and ongoing Afib. The patient''s concomitant medications were not reported. Declaration made through the national portal, made by a health professional. Patient considered to be at risk of developing a severe form of COVID-19 disease was yes (age). History of COVID-19 was not specified. Patient was vaccinated on 21Jan2021 as part of the COVID-19 vaccination campaign. On 26Jan2021, symptoms of COVID-19 appeared and performance of a positive PCR test (no variant search). Patient was treated in the nursing home. On 27Jan2021, the patient died. Accountability made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. It was not reported if an autopsy was performed. The events are serious, fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: symptoms of COVID-19; positive PCR test


VAERS ID: 1084891 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Epilepsy
Preexisting Conditions: Medical History/Concurrent Conditions: CVA; Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021232855

Write-up: COVID-19 PCR test positive/ COVID-19 aggravated; This is a spontaneous report from a contactable physician downloaded from Regulatory Authority, regulatory authority FR-AFSSAPS-MP20210278. A 77-year-old male patient received first dose of BNT162B2 (COMIRNATY; lot number: EJ6788) on left arm, intramuscular on 21Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing epilepsy, cerebrovascular accident (CVA) from 2011 to 2013, and dementia. The patient''s concomitant medications were not reported. The patient experienced COVID-19 PCR test positive and COVID-19 aggravated on 25Jan2021. The patient was considered to be at risk of developing a severe form of COVID-19 disease. The patient was vaccinated as part of the COVID-19 vaccination campaign. It was also reported that on 25Jan2021, symptoms of COVID-19 appeared. Additionally on 25Jan2021, performance of a positive PCR test (no variant search). Patient was treated in the nursing home. On 28Jan2021, death of the patient. The patient died on 28Jan2021. 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: COVID-19 PCR test positive


VAERS ID: 1084892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Decubitus ulcer, Dyspnoea, Hypoxia, Peripheral ischaemia, Pneumonia aspiration, Pulmonary congestion, SARS-CoV-2 test, Sepsis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 2
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: Arterial hypertension; Arteriopathy; Morbid obesity; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: SARS CoV2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021233020

Write-up: pressure ulcers; toe ischemia; disorders of consciousness; possible aspiration pneumonia; sudden congestion; Septicaemia/sepsis; Respiration labored; Hypoxia/desaturation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-NC20210580. A 77-year-old female patient received BNT162B2 (COMIRNATY, Batch number: EJ6788), intramuscular on the left deltoid, first dose on 26Jan2021 at single dose, for COVID-19 immunisation. Medical history included Type II diabetes, arteriopathy obliterating of the lower limbs, arterial hypertension and morbid obesity from unspecified dates. The patient''s concomitant medications were not reported. It was reported that vaccination carried out on 26Jan2021 (D1) done in the left deltoid. Clinical signs and chronology of facts was death in hospital, 3 days after vaccination, however with no obvious link to vaccination; cause of death indicated by the hospital was septicaemia/sepsis on 27Jan2021 starting on the skin (pressure ulcers and toe ischemia from unspecified dates). Patient was initially sent to the emergency room on 27Jan2021 for sudden congestion and hypoxia/desaturation attributed to disorders of consciousness (from unspecified date) with possible aspiration pneumonia (from unspecified date). Patient also experienced respiration labored on 27Jan2021. Summary of management was hospitalization. Evolution: Death due to the effect on 29Jan2021. Conclusion was sepsis with fatal course 3 days post vaccination. The patient underwent lab tests and procedures which included test against SARS CoV2 negative (no date specified). The patient died on 29Jan2021. It was not reported if an autopsy was performed. The pharmacovigilant notes: Accountability score (s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. Official Bulletin of the Minister in charge of Health no 84/50, January 24, 1985. Published in Therapy 1985; 40: 111-8. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Septicaemia/sepsis


VAERS ID: 1084893 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-02-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac arrest, Cerebrovascular accident, Dropped head syndrome, Faecaloma, SARS-CoV-2 test
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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   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: Cerebral hemorrhage; Manic depressive illness
Allergies:
Diagnostic Lab Data: Test Name: SARS CoV2 test; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021233032

Write-up: Fecaloma; Cardiac arrest; Asthenia; suspicion of stroke; Dropped head syndrome; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The Regulatory Authority report number is FR-AFSSAPS-NC20210581. An 82-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: EJ6788, expiration date not reported), intramuscular in the left deltoid on 26Jan2021 at a single dose for COVID-19 immunisation. Medical history included Manic depressive illness and cerebral haemorrhage from 2015. The patient''s concomitant medications were not reported. On 01Feb2021, the patient experienced asthenia, suspicion of stroke (leaned to the side) and dropped head syndrome and was referred to the emergency room on 02Feb2021. The patient was then hospitalized on 02Feb2021 for gastroenterology fecaloma. The patient died during the night of 02Feb2021 due to cardiac arrest depending on the hospital. It was concluded that Suspicion of stroke then cardiac arrest one week after vaccination. Other treatments included AVK. The patient underwent lab tests and procedures which included SARS CoV2 test which was negative on an unspecified date. It was not reported if an autopsy was performed. The pharmacovigilant notes: Accountability score (s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest; Fecaloma; Dropped head syndrome; suspicion of stroke; Asthenia


VAERS ID: 1084896 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Auricular fibrillation; Chronic kidney disease (on dialysis); Dialysis; Hyperlipidemia; Hypertension arterial; Obesity; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: Blood pressure; Result Unstructured Data: Test Result:110/47; Comments: before; Test Date: 20210128; Test Name: Blood pressure; Result Unstructured Data: Test Result:106/45; Comments: after; Test Date: 20210130; Test Name: Blood pressure; Result Unstructured Data: Test Result:141/56; Comments: before; Test Date: 20210130; Test Name: Blood pressure; Result Unstructured Data: Test Result:101/54; Comments: after; Test Date: 20210128; Test Name: pulse; Result Unstructured Data: Test Result:87; Comments: before; Test Date: 20210128; Test Name: pulse; Result Unstructured Data: Test Result:69; Comments: after; Test Date: 20210130; Test Name: pulse; Result Unstructured Data: Test Result:71; Comments: before; Test Date: 20210130; Test Name: pulse; Result Unstructured Data: Test Result:74; Comments: after
CDC Split Type: FRPFIZER INC2021232972

Write-up: Death unexplained/died; This is a spontaneous report from the regulatory authority-WEB, regulatory authority report number: FR-AFSSAPS-PS20210359. A contactable physician reported that a 73-year-old female patient received first dose of bnt162b2 (COMIRNATY solution for injection; lot number: EJ6788; expiry date: unknown) intramuscular in the right arm, on 28Jan2021, at a single dose, for COVID-19 immunisation. Medical history included chronic kidney disease on dialysis, type 2 diabetes mellitus, hypertension arterial, obesity, hyperlipidemia, atrial fibrillation (auricular fibrillation). The patient had no medical history of COVID-19. Concomitant medications were not reported. On Thursday, 28Jan2021, the patient underwent dialysis before the vaccination, without any noticeable event. The declarant indicated that she did not present any undesirable effects following the vaccination which could have unbalanced one of the chronic pathologies (no flu-like syndrome, no tachycardia, no feeling of chest tightness). On 28Jan2021, day of dialysis, the patient''s blood pressure (BP) before was 110/47, pulse (before) 87; BP (after) 106/45, pulse (after) 69. Treatments carried out during the session were Venofer, 2 skin diastop. On 30Jan2021, the patient also had a dialysis without any noticeable event. On the same day of dialysis (30Jan2021), BP (before) was 141/56, pulse (before) 71 BP (after) 101/54 Pulse (after) 71. Treatments carried out during the session were Venofer, 2 skin diastop, and Aranesp 150 ug. A diabetology consultation was scheduled for 01Feb2021. According to the declarant, the patient was rather stabilized for some time. On 31Jan2021, the patient died due to an unknown cause at her home. No autopsy was performed. Patient had no recent blood test. The declarant was briefed by the paramedics. In total, an unexplained death occurring 3 days after vaccination in a patient with numerous comorbidities. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained/died


VAERS ID: 1084897 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Blood sodium, Blood sodium increased, Death, Dehydration, Heart rate, Hypotension, Malaise, Oxygen saturation, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   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: DOLIPRANE; FOLIC ACID; JOSIR; LASILIX [FUROSEMIDE]; METFORMIN; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; SERESTA; ZOPICLONE; ZYMA-D2
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hypertensive heart disease NOS; Insulin-requiring type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: hemoglucotest; Result Unstructured Data: Test Result:10.4 mmol/L; Test Date: 20210127; Test Name: blood pressure; Result Unstructured Data: Test Result:still low but better tolerated; Test Name: blood pressure; Result Unstructured Data: Test Result:low but better torated mmHg; Test Date: 20210126; Test Name: blood pressure; Result Unstructured Data: Test Result:85/56 mmHg; Test Date: 20210126; Test Name: blood pressure; Result Unstructured Data: Test Result:149/86 mmHg; Test Date: 20210127; Test Name: natremia; Result Unstructured Data: Test Result:150 mmol/L; Test Date: 20210126; Test Name: pulse; Result Unstructured Data: Test Result:115 bpm; Test Date: 20210126; Test Name: saturation; Test Result: 94 %; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:negative; Test Date: 20210111; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021232913

Write-up: died (death unexplained); dehydration with natremia at 150 mmol / L; dehydration with natremia at 150 mmol / L; Feeling sick; Tachycardia; Arterial hypotension; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB. Regulatory authority report number is FR-AFSSAPS-RS20210217. A 91-year-old male patient received first dose of BNT162b2 (COMIRNATY, lot number: EJ6788, expiry date not reported), intramuscular in the left arm on 25Jan2021 at single dose for COVID-19 immunization. Medical history included insulin-requiring type 2 diabetes mellitus, dementia, and hypertensive heart disease. Concomitant medications included paracetamol (DOLIPRANE), folic acid, tamsulosin hydrochloride (JOSIR), furosemide (LASILIX), metformin, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]), oxazepam (SERESTA), zopiclone, and ergocalciferol (ZYMA-D2). On 26Jan2021, the patient was feeling sick with outcome of recovered on an unspecified date, had tachycardia with outcome of unknown, arterial hypotension with outcome of not recovered. The clinical course was reported as follows: The patient received a COVID test 3 days before entering care home on 11Jan2021: negative result. On 26Jan2021 afternoon, the patient vagal discomfort with arterial hypotension at 85/56 mmHg; pulse at 115 bpm; 94 percent saturation; t ? C at 36 ? C (hemoglucotest (HGT) 10.4 mmol / L during the midday meal). Recovery after a few minutes with BP controlled at 149/86 mmHg. Then, recurrence of drop in blood pressure at night without discomfort with blood pressure at 67/38 mmHg. Stopping the following medicines, JOSIR and SERESTA. On 27Jan2021, blood pressure still low but better tolerated. No discomfort. Treatment by administration of NaCl and compression stockings. Subsequently blood pressure still low. On balance, evidence of dehydration with natremia 150 mmol / L. Change from NaCl to G5%. No improvement in the patient''s condition, which is deteriorating. Administration of midazolam and oxycodone from 03Feb2021. The patient died (death unexplained) on 04Feb2021. It was not reported if an autopsy was performed.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: the fatal event is handled as related to suspect drug Comirnaty as a cautionary measure and for reporting purposes. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1084898 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Wrong patient received product
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Palliative care
Preexisting Conditions: Medical History/Concurrent Conditions: Cachexia; Malnutrition; Starvation
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021232776

Write-up: Death NOS; received injection of the vaccine when the family had not given their consent (error in the listing of patients at the (name of accommodation facility)); This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. Regulatory authority report number is FR-AFSSAPS-TO20210921. A 97-year-old female patient received BNT162B2 (COMIRNATY; Solution for injection, Lot number: EJ6788, unknown expiration), intramuscular on 09Feb2021 at a single dose for COVID-19 immunisation. Medical history included malnourished, starvation (unknown if ongoing), cachexia (unknown if ongoing), and palliative care since 07Oct2020. The patient''s concomitant medications were not reported. On 09Feb2021, the patient received injection of the vaccine when the family had not given their consent (error in the listing of patients at the (name of accommodation facility)) in a malnourished and cachectic person and in the unit protected in palliative care since 07Oct2020. The patient experienced death NOS without any particular symptoms on 16Feb2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1084917 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood test, Body temperature, Cholelithiasis, Culture urine, Fatigue, Hepatitis, Hypotonia, Pyrexia, Ultrasound abdomen
SMQs:, Hepatitis, non-infectious (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: T4; CARVEPEN; COZAAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (mild hypertension without medication)
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: blood test; Result Unstructured Data: Test Result:cholelithiasis and liver inflammation; Test Date: 20210203; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 202102; Test Name: URINE CULTURE; Result Unstructured Data: Test Result:cholelithiasis and liver inflammation; Test Date: 202102; Test Name: upper lower abdominal ultrasound; Result Unstructured Data: Test Result:cholelithiasis and liver inflammation
CDC Split Type: GRPFIZER INC2021226195

Write-up: Abdominal pain; Fatigue; low grade fever/38 degree Celsius fever; atonia; cholelithiasis; liver inflammation; This is a spontaneous report from a contactable physician from the Regulatory Authority-WEB GR-GREOF-20211364. A 93-years-old female patient received first dose of bnt162b2 (COMIRNATY, lot number EJ6134 and Expiration Date unknown) via intramuscular on 01Feb2021 at single dose for COVID-19 immunisation. Medical history included mild hypertension without medication. Concomitant medication included levothyroxine sodium (T4), carvedilol (CARVEPEN), losartan potassium (COZAAR). The next day (02Feb2021) she presented fatigue, low grade fever and atonia and on 03Feb2021 she presented 38 degree Celsius fever and abdominal pain. After several days in Feb2021, the symptoms did not retreat and the patient was examined by physician and did blood test, urine culture and upper lower abdominal ultrasound that diagnosed cholelithiasis and liver inflammation. She started Zinadol medication. On 18Feb2021 (15 days since the beginning of Zinadol per os administration, 2 dosage form per day, indication fever, possible cholecystitis) since there was no improvement, she was admitted to hospital, did examinations, hospitalization not needed and received guideline to continue Zinadol and undergo further check when there is improvement. Patient died on 21Feb2021 early hours. Seriousness criteria was provided as death and medically significant. The patient underwent lab tests and procedures which included 38 centigrade on 03Feb2021; blood test, urine culture and upper lower abdominal ultrasound that diagnosed cholelithiasis and liver inflammation in Feb2021. Treatment was received for fever, possible cholecystitis. The outcome of all events was fatal. An autopsy was not performed. Reporter comments: No medical history except for mild hypertension without medication. The patient received the first dose of Comirnaty on 01Feb2021. The next day she presented low grade fever and atonia and on 03Feb2021 she presented 38 degree Celsius fever and abdominal pain. After several days the symptoms did not retreat and the patient was examined by physician and did blood test, urine culture and upper lower abdominal ultrasound that diagnosed cholelithiasis and liver inflammation. She started Zinadol medication. On 18Feb2021 (15 days since the beginning of Zinadol per os administration, 2 dosage form per day, indication fever, possible cholecystitis) since there was no improvement, she was admitted to hospital, did examinations, hospitalization not needed and received guideline to continue Zinadol and undergo further check when there is improvement. She died on 21Feb2021 early hours. Sender comments: initial report with additional information. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: low grade fever/38 degree Celsius fever; atonia; abdominal pain; cholelithiasis; liver inflammation; fatigue


VAERS ID: 1084920 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Nausea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (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)

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: COLECALCIFEROL; VASELINE CETOMACROGOL CREAM; MOVICOLON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia vascular; TIA
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021221943

Write-up: vomiting, a few minutes after administration; Loss of consciousness; Nausea; This is a spontaneous report a contactable physician downloaded from the Regulatory Authority [regulatory authority NL-LRB-00449312]. A 88-years-old female patient received BNT162B2 (COMIRNATY, lot number:EM0477) , via an unspecified route of administration on 27Jan2021 at single dose for covid-19 immunisation. Medical history included dementia vascular, transient ischaemic attack. Concomitant medication included colecalciferol, cetomacrogol, paraffin, liquid, propylene glycol, white soft paraffin (VASELINE CETOMACROGOL CREAM), macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON). Ten minutes following the vaccination, the patient became nauseous, had to vomit and became unconscious. The patient was treated with adrenaline which was not effective. The patient deceased after an unknown period.The patient died on an unspecified date. It was not reported if an autopsy was performed. All events were fatal. Case Summary and Reporter''s Comments Text : BioNTech / Pfizer vaccine (Comirnaty) -Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no -vomiting, few minutes after administration- Additional information ADR: then loss of consciousness -confounding factors-confounding factors: dementia Not Otherwise Specified (mixed, vascular component with TIA)-COVID19-Previous COVID-19 infection: No-Other- diagnostic procedures: no 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 -vomiting, few minutes after administration- Additional information ADR: then loss of consciousness -confounding factors-confounding factors: dementia Not Otherwise Specified (mixed, vascular component with TIA)-COVID19-Previous COVID-19 infection: No-Other- diagnostic procedures: no; Reported Cause(s) of Death: nausea; loss of consciousness; vomit


VAERS ID: 1084921 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   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: XARELTO
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021226298

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-NL-LRB-00450128, Safety Report Unique Identifier NL-LRB-00454199. A 87-year-old female patient received bnt162b2 (COMIRNATY, lot: EJ6790), via an unspecified route of administration on 19Feb2021 at 0.3 mL, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included rivaroxaban (XARELTO). One day after vaccination (20Feb2021), the patient was death. The reporter described that it is suspected that the patient already deceased on the day of vaccination. It is unknown whether the patient had complaints after vaccination or not. The cause of death is unknown. The outcome of the event was fatal. The patient died on 20Feb2021. No autopsy was performed. Health Authority Comment: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. Death Additional information ADR: the patient was found dead the day after the vaccination, there is not known information about possible complaints after the vaccination. It is suspected that the patient has already died on the day of the vaccination. Previous COVID-19 infection: No Follow-up received dated 23Jan021: I cannot answer most of the questions as I do not know enough about the patient and no access got her file. I had the inspection during a shift from the GP. In answer to the 1st question I can say that the primary cause of death in the patient is unknown. In answer to the last question: no autopsy was performed. For the other questions I want you refer to patient''s GP COMIRNATY batch EJ6790 No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on Pfizer policy, all death cause unknown events are assessed to be related to the subject drugs. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1084923 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal obstruction, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diaphragmatic hernia
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite; Fracture; Swallowing difficult (had some trouble eating and swallowing for years)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021226257

Write-up: Nausea; spontaneous total gastric occlusion/ spontaneous gastric closure; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB NL-LRB-00454720. A 92-year-old female patient received bnt162b2 (COMIRNATY, lot number: EJ6134), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. Medical history included ongoing diaphragmatic hernia, fracture in the diaphragm (she had had some trouble eating and swallowing for years); the patient was healthy before the vaccination. She recently became very sick following an administered tetanus vaccination for a dog bite. The patient''s concomitant medications were not reported. The patient experienced nausea on 29Jan2021, the event was reported as serious per death and hospitalization. At the same date as the day of vaccination, the patient experienced nausea. According to the reporter, the nausea lead to a spontaneous total gastric occlusion which was diagnosed at the hospital. The cause was a diaphragmatic hernia. The patient was treated by a laparoscopy and the occlusion was repaired. The outcome of nausea is fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no, Nausea. Hospitalization information: The nausea has resulted in a spontaneous gastric closure in which the hospital found that the stomach was quite high and tilted due to a fracture in the diaphragm (she had had some trouble eating and swallowing for years) confounding factors confounding factors, allergy: my mother did not take any asperient yet. never been ill in her life but coincidentally last bit on a bicycle by a dog and then teatanus injection and penicillin treatment which also made her very nauseous and even dead ill. Previous COVID-19 infection: No. Other diagnostic procedures: all kinds of investigations in X. No follow-up attempts are needed. No further information expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no, Nausea. Hospitalization information: The nausea has resulted in a spontaneous gastric closure in which the hospital found that the stomach was quite high and tilted due to a fracture in the diaphragm (she had had some trouble eating and swallowing for years) confounding factors confounding factors; Reported Cause(s) of Death: nausea; spontaneous total gastric occlusion/ spontaneous gastric closure


VAERS ID: 1084924 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-02-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Gastrointestinal haemorrhage, Influenza like illness
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BARNIDIPINE; SIMVASTATINE; CLOPIDOGREL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021226270

Write-up: Death; Gastrointestinal bleeding; Influenza like illness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory Authority Report Number : NL-LRB-00454938. An 83-year-old female patient received bnt162b2 (COMIRNATY) , via an unspecified route of administration on 22Feb2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included barnidipine, simvastatine, and clopidogrel. The patient experienced death on 24Feb2021, influenza like illness (non-serious) on 22Feb2021. Additional information: ''This serious spontaneous report from a physician concerns a female aged 83 years influenza like illness and who deceased following administration of covid-19 vaccin pfizer injvlst (action taken: not applicable) for covid 19 immunisation. On the day of vaccination, the patient experienced flu like symptoms, but she felt better on the following day. Two days after vaccination, the patient was found deceased. She probably died of a gastro-intestinal bleeding since bloody stool were seen at the place she was found. The patient was not known with gastro-intestinal problems. Drugs and latency: 1. covid-19 vaccin pfizer injection. Death: 2 days after start. Influenza like illness: 1 day after start''. Reporter''s Comment: Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): No. Death. Additional information on adverse drug reaction: the day of vaccination some flu-like symptoms reported in family, a day later she reported feeling better again. Patient died 2 days after vaccination. probably had gastrointestinal bleeding because of bloody stools where they were found. She was not familiar with gastrointestinal complaints or rectal bleeding. She did use clopidogrel, barnidipine and simvastatin (for several years) without complaints. So whether the death is related to the vaccination is difficult to prove but I do mention it . BSN available: Yes. Previous COVID-19 infection: No. Other diagnostic procedures: no, family does not want autopsy. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: Summary of Reporter Comment: Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): No. Death. Additional information on adverse drug reaction: the day of vaccination some flu-like symptoms reported in family, a day later she reported feeling better again. Patient died 2 days after vaccination. probably had gastrointestinal bleeding because of bloody stools where they were found. She was not familiar with gastrointestinal complaints or rectal bleeding...; Reported Cause(s) of Death: Gastrointestinal bleeding; Death


VAERS ID: 1084926 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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: AFIPRAN; ELIQUIS; SOBRIL; NITROGLYCERIN; VENTOLINE [SALBUTAMOL]; PARACET [PARACETAMOL]; SELO-ZOK
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive lung disease (Severe COPD); Hypertension; Lung embolism (Previous); Oxygen therapy (at home)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021221988

Write-up: FOUND DEAD; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB manufacturer report number NO-NOMAADVRE-FHI-2021-Ux338, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00016100. An 89-years-old female patient received bnt162b2 (COMIRNATY, LOT# EJ6789), intramuscular in left arm on 17Feb2021 17:00 at second single dose for covid-19 immunization. Medical history included severe chronic obstructive lung disease (COPD) and previous lung embolism, oxygen therapy at home, hypertension. Concomitant medication included metoclopramide hydrochloride (AFIPRAN), apixaban (ELIQUIS) for lung embolism, oxazepam (SOBRIL), nitroglycerin, salbutamol (VENTOLINE) for chronic obstructive lung disease, paracetamol (PARACET), metoprolol succinate (SELO-ZOK) for hypertension. The patient previously took first dose bnt162b2 (LOT# EM0477) on 28Jan2021 for covid-19 immunization and experienced back pain on 03Feb2021, increasing dyspnea on 10Feb2021, confusion (known from before) on 13Feb2021 and hypertension on 13Feb2021. One day after dose number 2 (18Feb2021), the patient was found dead in her home on the kitchen floor 10:55 am. It was unknown if an autopsy was performed. Reporter''s assessment: Elderly patient with several underlying diseases who was found dead the day after vaccination. Difficult to establish any connection with the vaccine, but still sends a routine report about this. Sender''s Comments: The most commonly reported adverse reactions with this vaccine were injection site pain (92%), fatigue (weakness) (70%), headache (65%), muscle pain (62%), joint pain (46%), chills (45%), nausea / vomiting (23%), swelling / tenderness in the shoulder area (20%), fever (16%), swelling (15%) or redness (10%) at the injection site. Most reactions were mild and transient, lasting a few days. Side effects were more pronounced after the second dose than after the first dose. Back pain, dyspnoea, confusion and hypertension are not listed as known side effects of the vaccine in the approved Summary of Product Characteristics (SPC) for Comirnaty. In general, the cause of death in multimorbid elderly and / or nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death is usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio- and cerebrovascular diseases were accounted for 1 out of 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (about 20%), respiratory and infectious diseases (including pneumonia and sepsis) (about 15%), and cancer (about 10%). When vaccinating frail patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease(s). In the case in question, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease(s) or another random, concurrent cause that has nothing to do with the vaccination in question. Based on the information in the report and in accordance with international criteria, the causal relationship between the side effects and the vaccine is considered as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. Relatedness of drug to reaction(s)/event(s) Comirnaty/all events Source of assessment Regional Pharmacovigilance Center: Result of Assessment: Possible.; Reporter''s Comments: Elderly patient with several underlying diseases who was found dead the day after vaccination. Difficult to establish any connection with the vaccine, but still sends a routine report about this; Sender''s Comments: Linked Report(s) : NO-PFIZER INC-2021242202 Same patient, same suspect product, different vaccine dose and different events; Reported Cause(s) of Death: dead


VAERS ID: 1084928 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-09
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: 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: PLPFIZER INC2021233391

Write-up: one person had heart attack and died; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date the patient had a heart attack and died. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1084929 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20210

Write-up: Death; A regulatory authority report (Poland) was received from a physician concerning a 73-years old, patient who received Moderna''s COVID-19 Vaccine (mRNA-1273) and the patient died. The patient''s medical history was not provided by the reporter. On 17 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot number G26761A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient died. Death occurred several days after vaccination . The Reporter described as uncertain of the effect of the vaccination on death. There is a time relationship between vaccination and the occurrence of side effects. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The cause of death was not reported. Autopsy performed was unknown.; Reporter''s Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Sender''s Comments: Zgon wystapil kilka dni po szczepieniu u starszej osoby. Nieznana jest historia medyczna pacjenta. Lekarz opisal jako niepewny wplyw szczepionki na zgon. Istnieje zwiazek czasowy miedzy szczepieniem a wystapieniem dzialan niepozadanych. Osoba zglaszajaca NOP zakwalifikowala go jako ciezki. URPL ocenil NOP jako ciezki.; Reported Cause(s) of Death: death


VAERS ID: 1085212 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood creatinine, Blood glucose fluctuation, Dyspnoea, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), 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), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID CARDIO; LOSARTAN POTASSIUM; TORSEMIDE; FLUVASTATIN SODIUM; TAMSULOSIN HYDROCHLORIDE; PREDNISOLONE; PREGABALIN; NALOXONE HYDROCHLORIDE; METAMIZOLE SODIUM; PARACETAMOL; OMEPRAZOLE; SODIUM BICARBONATE; MAGNESIUM ASPARTATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy (known for allergy to Klacid.); Omarthrosis (the patient was known for severe pain from bilateral massive omarthrosis.)
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: creatinine; Result Unstructured Data: 94 mcmol/l; Test Date: 20210122; Test Name: blood sugar; Result Unstructured Data: 6.3 mmol/L
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: severe pain; hardly eaten, asthenic, very tired; Dyspnoea; high temperature 2 days; A regulatory authority report was received from a physician concerning a 88 years old male patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and died. The reported patient''s medical history includes that he was a polymorbid (list of diagnoses not known) patient known for severe pain from bilateral massive omarthrosis. He was in palliative care according to the reporter. Allergic to Klacid. Concomitant medications included ASS Cardio Spirig 100mg 1x1, Losartan Spirig 25mgx1, Torasemid Sandoz 10mg 2x2, Fluvastatin Sandoz 20mg 1x1, Tamsulosin 0.4mg 1x1, Targin 5 / 2.5mg 2X1, Lyrica 75mg 2x1, Novalgin 500mg 3x1 (+ in reserve max 3x1), Paracetamol SA 160mg 2x1 (+ in reserve max 4x1), Omeprazil Sandoz 20mg 1x1, Macrogol Sandoz 1x1, Magnesiocard 10mmol 1x1, and Spiricot 5mg 1x1. The patient was generally weak, deconditioned and no longer mobile, so they had proceeded with a conservative approach and purely palliative. On 20-Jan-2021, eight days prior to the death, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly at an unspecified site for prophylaxis of COVID-19 infection. On 21-Jan-2021, the patient appeared weak and bedridden. On 22-Jan-2021, the patient had hardly eaten, was very tired, asthenic with blood pressure 98/60, temperature 37.8 ? C, dyspneic, received 2L of oxygen. In the evening he experienced pain in the shoulders and in the whole body, was very thirsty with blood sugar of 6.3 mmol / L and from this moment on the usual pharmacotherapy was no longer given. On an unknown date in Jan 2021 the creatinine level was 94 mcmol/L . On 23-Jan-2021, the patient had severe pain and could only eat 1 yogurt. He was afebrile. On 24-Jan-2021, from this moment the patient had difficulty to awaken but remained afebrile. On 25-Jan-2021, the patient could no longer be awakened and a fixed morphine dose was set. On 28-Jan-2021 in the morning, the patient died. Further course was not known. Death occurred 8 days after the administration of the Covid-19-Moderna vaccine. Reporter stated that immediately after vaccination, the patient did not experience any adverse reactions, in particular none were observed symptom attributable to a possible anaphylactic allergic reaction. In consideration of the palliative context, in the absence of laboratory and imaging data (not performed), only in the presence of a data of high temperature 2 days after the vaccine, which however normalized the following day, no other elements were emerged suggestive for a possible causal correlation between the vaccine and death. The reporter stated they believed there was unlikely the causal correlation between the Covid-19-Moderna vaccine and the death of this patient. Treatment of the event was not available. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of event, death was fatal. The patient died on 28-Jan-2021. The cause of death was unknown. The autopsy report was not provided.; Reporter''s Comments: Based on reporter''s causality and rationale, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Asthenia; Dyspnoea; High temperature; pain


VAERS ID: 1085213 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   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: AMANTADINE; SCOPODERM [HYOSCINE HYDROBROMIDE]; AMLODIPINE; METOPROLOL
Current Illness: COPD; Multiple sclerosis; Syndrome respiratory distress adult (restrictive respiratory syndrome (CV 14% of the predetermined value) with the installation of a non-ventilated invasive (VNI)); Tetraplegia; Urinary infection (recurrent); Von Willebrand''s disease (Type 2 A)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Cardiac arrest; A regulatory report was received from a physician concerning a 53-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced cardiac arrest and died. The patient''s medical history included restrictive respiratory syndrome, multiple sclerosis, tetraplegia, COPD, urinary infection, and von Willebrand''s disease. The concomitant medications included amantadine, amlodipine, metoprolol, scopolamine/hyoscine. On 22-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 300042460) intramuscularly for prophylaxis of COVID-19 infection. On 26-Jan-2021, 4 days after receiving the vaccine, the patient experienced cardiac arrest and was transported to the hospital in an ambulance. The patient died before arriving. Treatment information was not reported. Action taken with mRNA-1273 was not applicable. On 26-Jan-2021, the patient died due to cardiac arrest. Autopsy details were unknown.; Reporter''s Comments: Very limited information regarding these events has been provided at this time. Patient''s underlying conditions may have been contributory for the occurrence of this fatal event. No further follow-up information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1086537 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC2021242195

Write-up: acute shortness of breath, immediately transferred to the hospital; Death NOS; COVID-19 respiratory infection; This is a spontaneous report downloaded from the regulatory authority-WEB [Regulatory Authority number AT-BASGAGES-2021-04883] from a contactable physician. An 87-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY) (lot# EL1491), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced death NOS (death) on 29Jan2021, acute shortness of breath, immediately transferred to the hospital (death, caused hospitalization on 27Jan2021) on 27Jan2021, COVID-19 respiratory infection (death) on 26Jan2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 26Jan2021. 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: COVID-19 respiratory infection; Acute dyspnea; Death NOS


VAERS ID: 1086540 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension (Art HT); Atrial fibrillation (VHF); COPD (COPD); Palliative care (palliative Situation)
Preexisting Conditions: Medical History/Concurrent Conditions: Infarct cerebral (St.p. ischemic. Infarct); Pulmonary embolism (St p pulmonary embolism)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021242203

Write-up: Cardiovascular failure; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the Regulatory Authority (AT-BASGAGES-2021-07101). An 81-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot number EL1491) via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included ongoing palliative care, ongoing arterial hypertension, ongoing chronic obstructive pulmonary disease (COPD), infarct cerebral (St.p. ischemic. Infarct) on an unspecified date and unknown if ongoing, pulmonary embolism on an unknown date and not ongoing (St p pulmonary embolism) and ongoing atrial fibrillation (VHF). Concomitant medications were not reported. In Jan2021, the patient experienced cardiovascular failure (cardio-respiratory arrest) with fatal outcome; the patient died on 29Jan2021. An autopsy was not performed. The patient was not suffering from COVID-19. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiovascular failure


VAERS ID: 1086548 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOCETIRIZINE; FRAXIPARINE; BURINEX; ATORVASTATIN; D-VITAL CALCIUM; DAFALGAN; CETIRIZIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Dependence on oxygen therapy; Intestinal operation (10 years ago); Pacemaker insertion (cardiac) (since 1 year); Peripheral venous disease (Blood circulation in the legs: was continuously bothered by this; had artificial veins); Surgery (Blood circulation in the legs: was continuously bothered by this; had artificial veins); Weakness
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021236712

Write-up: death received vaccine on Thursday 4 February; death on Sunday 7 February afternoon; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority BE-FAMHP-DHH-N2021-78388. An 87-year-old male patient received the first dose of bnt162b2 (COMIRNATY) (Lot # EJ6789), via an unspecified route of administration at single dose on 04Feb2021 for COVID-19 immunisation. Medical history included that the patient was very weak; blood circulation in the legs: was continuously bothered by this; had artificial veins; no more surgery possible; pacemaker since 1 year; bowel surgery: 10 years ago; oxygen dependent; bedridden. Concomitant medication included levocetirizine, nadroparin calcium (FRAXIPARINE), bumetanide (BURINEX), atorvastatin, ascorbic acid, calcium carbonate, colecalciferol, ergocalciferol (D-VITAL CALCIUM) , paracetamol (DAFALGAN), cetirizine hydrochloride (CETIRIZIN). The patient experienced death received on Thursday 4 February; death on Sunday 7 February afternoon The patient died on 07Feb2021. It was not reported if an autopsy was performed. Reporter''s comment: Treatment - Evolution of the ADR - Death ADR description - Death vaccine received on Thursday 4 February; death on Sunday 7 February afternoon. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - Evolution of the ADR - Death ADR description - Death vaccine received on Thursday 4 February; death on Sunday 7 February afternoon; Reported Cause(s) of Death: death


VAERS ID: 1086549 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-02-04
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Oxygen saturation abnormal
SMQs:, Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021236701

Write-up: COVID-19 16day infection after vaccination; COVID-19 16day infection after vaccination; putting on high flow oxygen, then going to intensive care.; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB BE-FAMHP-DHH-N2021-79019. A 76-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), Lot# EM0477, via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that on 04Feb2021 the patient was put on high flow oxygen due to oxygen saturation abnormal, then he went to intensive care. The following was also reported: "COVID-19 16day infection after vaccination requiring hospitalization with high-flow oxygen". On an unspecified date few days after admission the patient died. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Oxygen saturation abnormal


VAERS ID: 1086550 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-02-08
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, General physical health deterioration, Renal failure, Respiratory distress
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: BELLOZAL; TAMSULOSIN; OLANZAPINE; LORAZEPAM; PARACETAMOL; MELATONINE; PRAZEPAM; DESMOPRESSIN; HALDOL; QUETIAPIN; CALCIFEROL [COLECALCIFEROL]; INDAPAMIDE; L-THYROXINE [LEVOTHYROXINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Chronic renal failure worsened; Mental retardation; Osmolality abnormal NOS; Paranoid schizophrenia; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021236705

Write-up: COVID-19; COVID-19; Respiratory distress; Renal failure; General physical health deterioration; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB regulatory authority BE-FAMHP-DHH-N2021-79023. A 68-year-old male patient received first dose bnt162b2 (COMIRNATY, lot: EM0477), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunisation. Medical history included Mental retardation, paranoid schizophrenia, potomania, severe chronic renal failure, benign prostatic hyperplasia, heavy smoking. Concomitant medication included bilastine (BELLOZAL), tamsulosin, olanzapine, lorazepam, paracetamol, melatonine, prazepam, desmopressin, haloperidol (HALDOL), quetiapine fumarate (QUETIAPIN), colecalciferol (CALCIFEROL), indapamide, levothyroxine (L-THYROXINE). The patient experienced respiratory distress, renal failure, general physical health deterioration, covid-19, all on 08Feb2021 with fatal outcome. It was reported that severe Covid-19 infection requiring hospitalization for respiratory distress and deterioration of general condition, aggravation of respiratory distress and increase in renal failure requiring intensive care. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. BNT162B2 for all events reported by FAMHP as unlikely. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: covid-19; covid-19; respiratory distress; renal failure; general physical health deterioration


VAERS ID: 1086566 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-02-12
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, 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: 2021-02-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CELLCEPT [MYCOPHENOLATE MOFETIL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myositis
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021236718

Write-up: Covid-19; Covid-19; This is a spontaneous report from a non-contactable physician from the regulatory authority-WEB DE-PEI-PEI2021003038 . A 80-year-old female patient received two doses bnt162b2 (COMIRNATY) , via an unspecified route of administration on 04Jan2021 and 25Jan2021 both at single doses for covid-19 immunisation. Medical history included myositis. Concomitant medication included immunotherapy with mycophenolate mofetil (CELLCEPT) for myositis. On 12Feb2021 after vaccination the patient developed COVID-19 and death on 12Feb2021. Diagnosis was confirmed by COVID-19 PCR test (result: positive) in Feb2021. Death cause was reported as COVID-19. The patient died on 12Feb2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19; COVID-19


VAERS ID: 1086568 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: routine rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021241865

Write-up: routine rapid tests was positive; routine rapid tests was positive; This is a spontaneous report from a contactable physician. A 94-years-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The 94-year-old woman who died in the days that followed in 2021, routine rapid tests was positive 2021. The patient underwent lab tests and procedures which included coronavirus test: positive on 2021. The patient died in 2021. It was not reported if an autopsy was performed. It was reported that: residents and staff in a nursing home were administered the first dose of Comirnaty on 27Jan2021. During routine rapid tests in the days that followed, a large number of residents and staff were positive. Most of these were asymptomatic or with only minor symptoms of illness, and none required hospitalization. In the end, there was a 94-year-old woman who died in the days that followed. The physician assume that the germ was already in the house in the run-up to the vaccination. In his/her opinion, the vaccination had the effect that there were no severe courses. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the information available, a causal association between BNT162b2 and the reported event cannot be excluded. The patient''s immunocompromised state due to age and the current pandemic may provide an alternative explanation for the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: there was a 94-year-old woman who died in the days that followed; there was a 94-year-old woman who died in the days that followed


VAERS ID: 1086569 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-24
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, C-reactive protein, Dyspnoea, Microbiology test, Oropharyngeal pain, Pneumonia, Pyrexia, Respiratory failure, SARS-CoV-2 test, Transplant failure, X-ray
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PANTOPRAZOL SANDOZ; PRAVASTATIN STADA; MYFENAX [MYCOPHENOLATE MOFETIL]; FELODIPIN ACTAVIS; PREDNISOLONE; SULFAMETHOXAZOLE; PREGABALIN KRKA; CIQORIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung transplant; Nephropathy
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: C-reactive protein; Result Unstructured Data: Test Result:400 mg/l; Test Date: 202101; Test Name: Microbiology test; Test Result: Negative ; Comments: Microbiology test after BAL, negative; Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 202101; Test Name: X-ray; Result Unstructured Data: Test Result:infiltrates on a chest radiograph
CDC Split Type: DKPFIZER INC2021241783

Write-up: Mechanical ventilator-dependent respiratory failure; ARDS; fever; OBS pneumonia.; over one day, the patient developed progressive breathing difficulty; Sore throat; Graft failure; This is a spontaneous report downloaded from the Regulatory Authority-WEB DK-DKMA-WBS-0035761. The case was received from a contactable physician via The Danish Medicines Agency (DKMA). A 49-years-old male patient started to receive first dose of bnt162b2 (COMIRNATY) , from lot number: EM0477 Expiration date :30APR2021 via intramuscular on 07Jan2021 at single dose for covid-19 immunisation . Medical history included lung transplant on 15Aug2020 (not ongoing) and nephropathy (not ongoing) Failure.Patient has no concurrent conditions. Concomitant medication included pantoprazole sodium sesquihydrate (PANTOPRAZOL SANDOZ) for Gastroesophageal reflux prophylaxis from 15Aug2020, pravastatin sodium (PRAVASTATIN STADA) for Hypercholesterolaemia from 15Aug2020, mycophenolate mofetil (MYFENAX [MYCOPHENOLATE MOFETIL]) for Prophylaxis against lung transplant rejection from 15Aug2020 , felodipine (FELODIPIN ACTAVIS) for Cardiac disorder prophylaxis from 08Dec2020, prednisolone (Prednisolon "DAK") for Steroid therapy from 15Aug2020 , sulfamethoxazole for Infection prophylaxis from 23Sep2020, pregabalin (PREGABALIN KRKA) for Pain prophylaxis from 15Aug2020, ciclosporin (CIQORIN) Prophylaxis against lung transplant rejection from 15Aug2020. All concomitant drugs are given prophylactically in connection with lung transplantation.On 24Jan2021 the patient developed ARDS, graft failure, fever, pneumonia, difficulty breathing and sore throat. On 26Jan2021 the patient developed respiration failure. As a consequence of Respiration failure, the patient needed mechanic respiratory therapy on the 26Jan2021. The ADRs, fever, pneumonia, difficulty breathing and sore throat, were by the physician reported as resulting in hospitalization (on 25Jan2021). The ADRs ARDS, graft failure and respiration failure were reported as fatal. The patient was treated with antibiotic (drug name or substance not specified) and empiric antifungal therapy (drug name or substance not specified) due to the ADRs. The patient was connected to a respirator (26Jan2021) and was connected to an ECMO the 28Jan2021 in 4 days due to the ADRs. After the patient came off the ECMO, mechanical ventilator was still needed. The outcome for the ADRs; fever, pneumonia, Difficulty breathing, difficulty breathing and sore throat was unknown. The outcome for the ADRs; ARDS and graft failure and respiration failure was fatal (date of death: 12Feb2021). Reported cause of death: Respiration failure (date of death (12Feb2021). Post mortem examination was performed: Comments of autopsy findings (24Feb2021): The lung tissue showed severe changes (areas of black discoloration). No Abnormal findings on other organs. The physician assumes that the lung disease could explain the cause of death. Microscopic examination of lung tissues. Result: NA. TEST: C-reactive protein (test date: Jan2021). Test result: 400 mg/L.COVID-19 virus test (test date: Jan2021). Test result: Negative. X-ray (test date: Jan2021). Test result: infiltrates on a chest radiograph. Microbiology test (test date: Jan2021). Test result: Microbiology test after BAL, negative. Causality: No signs of transplant rejection after the transplantation. This was biopsy-confirmed (biopsy scores: 0-3), where all the biopsies were scored as grade 0. The patient had no concomitant conditions in the time around the transplantation and until the patient was hospitalized (25Jan2021). The physician informs that he suspects that the COVID-19 vaccine has triggered the immune system to trigger an inappropriate immune response which eventually lead to the patient''s death. If the Danish Medicines Agency receives supplemental significant information regarding this case the case will be re-submitted. ADDITIONAL INFORMATION ON DRUG PROVIDED IN PRODUCT NOTES Product notes for Comirnaty: Previous given: No No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: ARDS; Graft failure; Respiration failure


VAERS ID: 1086572 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-12
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypotension, Oxygen saturation, Oxygen saturation decreased, Petit mal epilepsy
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (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: Medical History/Concurrent Conditions: Cognitive deterioration; Colon diverticulitis; COVID-19; Dysthymic disorder; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:90/50; Test Name: saturation; Test Result: 71 %
CDC Split Type: ESPFIZER INC2021236711

Write-up: Absence seizure; Arterial oxygen saturation decreased; Hypotension; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB (Regulatory Authority number ES-AEMPS-756661). A 90-year-old female patient received BNT162B2 (COMIRNATY, lot number EK9788), intramuscularly on 03Feb2021 at single dose for COVID-19 immunisation. It was reported the patient received another dose of BNT162B2 (COMIRNATY, lot number EM0477) on 13Feb2021 at single dose (clarification pending). Medical history included hypertension arterial, dysthymic disorder, COVID-19 from Dec2020, colon diverticulitis, cognitive deterioration. The patient''s concomitant medications were not reported. The patient previously took alopurinol, enalapril, torasemide (TORASEMIDA), donezepil hydrochloride (ARICEPT), trazodone hydrochloride (DEPRAX), simvastatin (SIMVASTATINA). It was reported that on 12Feb2021 the patient experienced absence seizure, arterial oxygen saturation decreased, hypotension. The patient died from the events on an unspecified date. It was not reported if an autopsy was performed. Clinical course was reported as follows: an 88-year-old patient (as reported) with the history described that this morning is taken to the nursing consultation for presenting episodes (in number of 3) of absence, with significant desaturation and increased work of breathing, presenting hypotension in episodes (90/50) cold sweating and desaturation (71%) in pulse oximetry. They do not report fever or cough, or respiratory distress in the previous days. Upon arrival at the hospital, the patient was admitted as a corpse.; Reported Cause(s) of Death: Absence seizure; Arterial oxygen saturation decreased; Hypotension


VAERS ID: 1086583 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Blood glucose, Body temperature, C-reactive protein increased, Chest X-ray, Culture urine, Escherichia infection, Heart rate, Leukocytosis, Miosis, Oxygen saturation, SARS-CoV-2 test, Sepsis, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VIPDOMET; GALANTAMINE; DEPRAX [FLUOXETINE HYDROCHLORIDE]; LORMETAZEPAM; ADIRO; PARACETAMOL; ENALAPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial; Recurrent UTI; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: Blood culture; Result Unstructured Data: Test Result:Negative x 3; Comments: Negative x 3; Test Date: 20210203; Test Name: blood glucose; Test Result: 241 mg/dl; Test Name: Temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Name: chest x-ray; Result Unstructured Data: Test Result:infiltrate in the right lung base is observe; Test Name: C-reactive protein increased; Test Result: 13.2 mg/dl; Test Date: 20210203; Test Name: C-reactive protein increased; Test Result: 13.1 mg/dl; Test Date: 20210203; Test Name: Culture urine; Result Unstructured Data: Test Result:Escherichia Coli; Comments: Escherichia Coli; Test Date: 20210203; Test Name: HR; Result Unstructured Data: Test Result:158; Test Name: leukocytosis; Result Unstructured Data: Test Result:17200; Test Date: 20210203; Test Name: miotic pupils; Result Unstructured Data: Test Result:miotic pupils; Test Date: 20210203; Test Name: Oxygen saturation; Test Result: 72 %; Test Date: 20210203; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210203; Test Name: WBC; Result Unstructured Data: Test Result:17.2; Comments: Units:10*3/uL
CDC Split Type: ESPFIZER INC2021236713

Write-up: Escherichia coli infection; Sepsis/sepsis of respiratory origin; This is a spontaneous report downloaded from the Medicines Agency (MA) WEB, regulatory authority report number: ES-AEMPS-768748. A contactable physician reported that a 93-year-old female patient received second dose of bnt162b2 (COMIRNATY solution for injection; lot number: EK9788; expiry date: unknown) intramuscular, on 29Jan2021, at 0.3 mL, single, for COVID-19 immunisation. Medical history included hypertension arterial, type 2 diabetes mellitus (DM), and recurrent urinary tract infections (UTIs). Concomitant medications included alogliptin benzoate, metformin hydrochloride (VIPDOMET), galantamine, fluoxetine hydrochloride (DEPRAX), lormetazepam, acetylsalicylic acid (ADIRO), paracetamol, and enalapril. The patient previously received first dose of bnt162b2 (COMIRNATY; lot number: EM0477) intramuscular on 08Jan2021 at 0.3 mL, single, for COVID-19 vaccination. The patient has already received the 2 doses of Pfizer''s SARS-CoV2 vaccine, the 2nd dose was on 29Jan2021. She has had no other changes in situation or treatments. On 03Feb2021, patient was referred from the residence, with suspicion of acute stroke, because around 8:00 p.m. they find that she does not react to stimuli, with respiratory rhonchi, saturation of 72% baseline, HR: 158, miotic pupils and blood glucose of 241 mg / dL. Exploration: Temperature 36.2 centigrade poor general condition, stuporous, cold sweating, tachypneic. AP: crackles in bases. Neurological examination: miotic pupils, remove limbs to pain. Evolution: A 100% KMV was placed, a bladder catheter with a clear urine outlet without objectifying. Acute retention of urine and a complete blood count, biochemistry, coagulation, portable and elemental chest X-ray, and urine sediment and urine culture are requested. 1 ampoule of furosemide was administered. In laboratory tests, hyperglycemia was observed, so patient was prescribed 6 IU of rapid insulin, and elevated RFA (CRP of 13.2 and leukocytosis of 17200). In chest x-ray, infiltrate in the right lung base was observed. Requested blood cultures and start empirical antibiotic therapy with piperacillin / tazoabactam. SARS-CoV2 nasopharyngeal swab requested as admission protocol. On 03Feb2021, patient was diagnosed with was sepsis of respiratory origin and escherichia coli infection. On 04Feb2021, the patient was admitted for sepsis of respiratory origin, who has not responded to antibiotic therapy and shows clear signs of claudication with rattling breathing, work of breathing. The patient died on 04Feb2021 due to escherichia coli infection and sepsis. Autopsy information was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sepsis/sepsis of respiratory origin; Escherichia coli infection


VAERS ID: 1086584 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Echocardiogram, Ischaemic cerebral infarction, Ischaemic stroke, Pneumonia aspiration, Ultrasound Doppler
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   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: DUPHALAC [LACTULOSE]; ALDACTONE [SPIRONOLACTONE]; CARDYL; OPIREN; KEPPRA; DEPRAX [FLUOXETINE HYDROCHLORIDE]; DUODART; ESCITALOPRAM; FOLI-DOCE; TARDYFERON
Current Illness: Living in nursing home (Partially dependent)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial therapeutic procedure; Arteriopathy (peripheral artery disease with complete occlusion of left popliteal artery to distal trunks); Atrial fibrillation (chronic complete arrhythmia due to atrial fibrillation anticoagulated with Sintrom.); Atrial fibrillation with slow ventricular response; Cardiac failure chronic aggravated; Carotid artery stenosis; Chronic iron deficiency anemia; Cognitive deterioration (mild-moderate cognitive impairment); Cor pulmonale; Dyslipidaemia; Hypertension arterial; Post herpetic neuralgia; Pulmonary arterial hypertension; Sinus node dysfunction; Syncope vasovagal (Vaso-vagal/orthostatic syncope, admission to hospital in 2017); TIA (with asymptomatic bilateral carotid stenosis)
Allergies:
Diagnostic Lab Data: Test Date: 20210208; Test Name: Brain CT; Result Unstructured Data: Test Result:Acute ischemic infarction in the left temporal lob; Comments: Acute ischemic infarction in the left temporal lobe; Test Date: 2018; Test Name: Echocardiography; Result Unstructured Data: Test Result:Severe binaural dilatation; Comments: Mild-moderate AoS. LVEF 55-60%. Moderately dilated RV. Moderate-severe TR.; Test Date: 2017; Test Name: TSA Doppler; Result Unstructured Data: Test Result:no significant stenosis
CDC Split Type: ESPFIZER INC2021236704

Write-up: Aspiration pneumonia; Ischaemic stroke; Acute ischaemic infarction in the left temporal lobe; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (Regulatory Authority number ES-AEMPS-769325). An 84 years old male patient received the second dose of BNT162B2 (COMIRNATY; lot EK9788) intramuscular, on 30Jan2021, 0.3 ml single, for COVID-19 immunization. The patient was institutionalised in a nursing home (partially dependent). Medical history included syncope vasovagal from 2017 (vaso-vagal/orthostatic syncope, admission to hospital in 2017), cognitive deterioration (mild-moderate cognitive impairment), dyslipidaemia, hypertension arterial, arteriopathy in 1993 (peripheral artery disease with complete occlusion of left popliteal artery to distal trunks with posterior tibial and fibula recanalization in 1993, cardiac failure chronic aggravated from Oct2020, chronic iron deficiency anemia from Oct2020, atrial fibrillation (in 2018 slow AF), cor pulmonale with PAH, TIA in 2006 with asymptomatic bilateral carotid stenosis, sinus dysfunction, postherpetic neuralgia. The patient had chronic complete arrhythmia due to atrial fibrillation anticoagulated with acenocoumarol (SINTROM) from2014 until 2019. The first dose of Comirnaty was given on 08Jan2021, batch/lot number EM0477, intramuscular, for COVID-19 immunization. Echocardiogram 2018: severe biauricular dilatation. Mild-moderate AoS. LVEF 55-60%. Moderately dilated RV. Moderate-severe TR. Last TSA Doppler 2017: no significant stenosis. Concomitant medications included oral lactulose (DUPHALAC) one for breakfast and another for lunch, oral spironolactone (ALDACTONE; 25 mg film-coated tablet) 25 mg, 1x/day, oral atorvastatin calcium (CARDYL; 20 mg film-coated tablet), oral lansoprazole (OPIREN; 15 mg capsule) 15 mg, 1x/day, oral levetiracetam (KEPPRA; 500 mg film-coated tablet), 500 mg, 1x/day, oral fluoxetine hydrochloride (DEPRAX; 100 mg film-coated tablet) 50 mg, 1x/day (1/2 tablet for dinner), dutasteride, oral tamsulosin hydrochloride (DIODART) one tablet during supper, oral escitalopram (10 mg tablet) 10 mg, 1x/day (1-0-0 ), oral cyanocobalamin, folic acid (FOLI-DOCE) 1 tablet during breakfast and ferrous sulfate (TARDYFERON) once daily (1-0-0). On 07Feb2021 the patient experienced ischaemic stroke with a fatal outcome. The patient referred to the emergency department for clonus in EESS and right EEII, deviation of the labial commissure to the right and constant blinking of the OD since 08Feb2021 morning. The nurse of the Residence also reported hypotonia and that he was not very reactive. On 08Feb2021 brain CT revealed acute ischaemic infarction in the left temporal lobe. He was assessed by personnel: ischaemic stroke in the left MCA territory with cardioembolic profile in the context of non-anticoagulated AF + acute symptomatic focal crises. Given the situation of baseline dependence, and having decided to withdraw anticoagulation, it was decided to maintain a conservative approach. On 09Feb2021: high fever and increased respiratory secretions were reported. Diagnostic impression: possible bronchoaspiration. The patient died on 11Feb2021. It was unknown if an autopsy was done. Aspiration pneumonia was reported as cause of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Aspiration pneumonia; Ischaemic stroke; Acute ischaemic infarction in the left temporal lobe


VAERS ID: 1086591 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-15
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Antimicrobial susceptibility test, Asthenia, Bacterial test positive, Blood glucose, Blood glucose increased, Blood pressure measurement, Body temperature, C-reactive protein, Culture urine, Death, Fatigue, Glomerular filtration rate, Heart rate, Hypertension, Infection, Malaise, Muscle twitching, Nausea, Pyelonephritis, Pyrexia, SARS-CoV-2 test, Urine analysis, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARA-TABS; FURESIS; TRAJENTA; PEGORION; NORSPAN [BUPRENORPHINE]; IMOVANE; MINIFOM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Dementia; Flatus; Insomnia; Mild mental retardation; Pain; Swelling; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: susceptibility test; Result Unstructured Data: Test Result:Ciprofloxacin is a suitable drug for its treatment; Test Date: 20210215; Test Name: Blood sugar; Result Unstructured Data: Test Result:high, around 33; Test Date: 20210216; Test Name: Blood sugar; Result Unstructured Data: Test Result:high; Test Date: 20210218; Test Name: Blood sugar; Result Unstructured Data: Test Result:still high, about 20; Comments: even on fasting; Test Date: 20210219; Test Name: Blood sugar; Result Unstructured Data: Test Result:around 20-25; Comments: high; Test Date: 20210220; Test Name: Blood sugar; Result Unstructured Data: Test Result:high; Test Date: 20210221; Test Name: Blood sugar; Result Unstructured Data: Test Result:high; Test Date: 20210222; Test Name: Blood sugar; Result Unstructured Data: Test Result:high; Test Date: 20210215; Test Name: Blood pressure; Result Unstructured Data: Test Result:184/96; Test Date: 20210216; Test Name: Body temperature; Result Unstructured Data: Test Result:up to 39.4 Centigrade; Test Date: 20210218; Test Name: Body temperature; Result Unstructured Data: Test Result:maximum of 39 Centigrade; Test Date: 20210215; Test Name: CRP; Result Unstructured Data: Test Result:5; Test Date: 20210216; Test Name: CRP; Result Unstructured Data: Test Result:11; Comments: low; Test Date: 20210218; Test Name: CRP; Result Unstructured Data: Test Result:remains low; Test Date: 20210219; Test Name: CRP; Result Unstructured Data: Test Result:2; Test Date: 20210222; Test Name: CRP; Result Unstructured Data: Test Result:38; Test Date: 20210219; Test Name: urine culture; Result Unstructured Data: Test Result:in urine grows coliform rodent bacteria; Test Date: 20210216; Test Name: glomerular filtration rate (GfR); Result Unstructured Data: Test Result:40; Comments: fall; Test Date: 20210215; Test Name: heart rate; Result Unstructured Data: Test Result:96; Test Date: 20210216; Test Name: Covid test; Test Result: Negative ; Test Date: 20210216; Test Name: urine; Result Unstructured Data: Test Result:erythrocytes ++, nitrite +, leukocytes ++.
CDC Split Type: FIPFIZER INC2021236702

Write-up: Death; Fatigue; Muscle twitching; weakened; Bacteria urine identified; Pyrexia; Pyelonephritis; the focus of the infection is unclear; Nausea; Malaise; vomiting; Blood glucose increased; Blood pressure 184/96; This is a spontaneous report from a contactable nurse downloaded from the Medicines Agency (MA) WEB FI-FIMEA-20210954. A 95-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot: EL0725), intramuscular on 10Feb2021 at 0.3 mL, single for covid-19 immunization. Medical history included type 2 diabetes, mild mental retardation, dementia, pain, constipation, insomnia, Flatus, swelling. Concomitant medication included paracetamol (PARA-TABS) for Pain from Sep2016, furosemide (FURESIS) for Swelling from Oct2020, linagliptin (TRAJENTA) for Diabetes from Oct2020, macrogol 4000 (PEGORION) for Constipation from Oct2017, buprenorphine (NORSPAN) for pain from Dec2015, zopiclone (IMOVANE) for Insomnia from Nov2018, simeticone (MINIFOM) for Flatus from Jan2019. The patient experienced death on 22Feb2021 18:20; nausea, malaise, vomiting, blood glucose increased, blood pressure 184/96 on 15Feb2021; pyrexia, pyelonephritis, the focus of the infection is unclear on 16Feb2021; bacteria urine identified on 19Feb2021; fatigue, muscle twitching, weakened on 20Feb2021. The events were reported as serious as death. On 15Feb2021 at breakfast and lunch malaise and vomiting. High blood sugar around 33 observed at 3 p.m., Blood pressure 184/96, heart rate 96, rapid CRP 5. Received Novorapid and Paracetamol as adviced by a physician, however, no clear response. 16Feb blood sugar still high, fever up to 39.4, , however rapid CRP low: 11. Consumer relatively well-being, urine with precipitation, no upper respiratory or skin symptoms, no abdominal symptoms. Clean-catch urine taken: erythrocytes ++, nitrite +, leukocytes ++. Started treatment for a incipient pyelonephritis : Ciprofloxacin 250 mg x 2, a reduced dose was decided because glomerular filtration rate (GfR) in the fall approximately 40, now possibly even lower. Blood tests could not be taken very easily from the consumer. However, the focus of the infection is unclear, that is why a Covid sample was taken and found to be negative. On 18Feb The fever continued, with a maximum of 39. Condition relatively good, cheerfully chatted. Sugars were still high, about 20 even on fasting, received Novorapid. Decided to temporarily take Lantus 10 IU (this dose was also before), in addition to blood sugar further corrected with Novorapid x 3 / day (morning + lunch + dinner). The idea arose as to whether fever could be associated with a covid vaccine received on 10Feb because CRP remains low. On 19Feb fever still and high blood sugar values ??(around 20-25), continued despite paracetamol and insulin treatment, CRP 2. Urine culture result and susceptibility test completed, found that in urine grows coliform rodent bacteria and Ciprofloxacin is a suitable drug for its treatment. But clear focus of infection still not found. A hospice care decision has been made. More painkillers prescribed : BuTrans ad 10 micrograms, and whenever needed. Oxynorm 5-10 mg at a time without upper limit. Paracetamol extended orally / rectally. It was agreed that regular medication will be given as soon if the consumer takes it. On 20-21Feb the consumer condition has remained the same, despite insulin treatment, blood sugar values ??remained high and fever despite receiving paracetamol. consumer tired and weakened, meals have gone variably. She did not appear suffering, with occasional twitching in the upper body. On 22Feb CRP 38, consumer eating significantly reduced, was really weakened, fever and high blood sugar values still despite paracetamol and insulin use. Looks painless, twitching from time to time in the upper body. At 18.20 the consumer died. The outcome of the events was fatal. The patient died on 22Feb2021 18: 20 due to events. 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: Vomiting; Bacteria urine identified; Fatigue; Muscle twitching; weakened; Nausea; Malaise; Blood glucose increased; Blood pressure 184/96; Pyrexia; Pyelonephritis; the focus of the infection is unclear; death


VAERS ID: 1086592 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Cough, Death, General physical health deterioration, Pneumonia, Secretion discharge
SMQs:, Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   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: Alzheimer''s disease (Alzheimer''s disease with frontal features); Cognitive disorders (progressing cognitive symptoms since 1997)
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Respiratory tract infection; Swallowing difficult
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:70; Test Name: CRP; Result Unstructured Data: Test Result:50
CDC Split Type: FIPFIZER INC2021236721

Write-up: Death; Pneumonia; General physical health deterioration; Mucus; cough; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB FI-FIMEA-20210957. A 80-years-old male patient started to receive bnt162b2 (COMIRNATY), Lot #EL1491 intramuscular on 28Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included progressing cognitive symptoms from 1997 and ongoing, dementia alzheimer''s type Alzheimer''s disease with frontal features ongoing, respiratory tract infection, epilepsy, dysphagia. The patient''s concomitant medications were not reported. On 04Feb2021 the patient experienced mucus and cough, pneumonia treated with intravenous antibiotics, general physical health deterioration, and death. The patient underwent lab tests and procedures which included c-reactive protein:70 and 50. The patient died on 08Feb2021. Expected death, but chronological connection to the vaccine. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Pneumonia; General physical health deterioration; Death


VAERS ID: 1086607 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021242206

Write-up: Died in sleep; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-BR20210421. An 89-year-old female patient received first dose of BNT162B2 (COMIRNATY, lot number: EP9598), intramuscular at arm left on 24Feb2021 at single dose for COVID-19 immunisation. Medical history included cardiac failure on an unspecified date. The patient''s concomitant medications were not reported. The patient died in sleep on 25Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Died in sleep


VAERS ID: 1086624 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Blood pressure diastolic decreased, Blood pressure measurement, Body temperature, Coma scale, Crepitations, Death, Electrocardiogram, Heart rate, Heart rate decreased, Investigation, Laboratory test, Oxygen saturation, Renal function test, SARS-CoV-2 test, Scan brain, Therapeutic response unexpected
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NADOLOL; OXAZEPAM; CARBIMAZOLE; PARACETAMOL; NEBIVOLOL; FUROSEMIDE [FUROSEMIDE SODIUM]; COLECALCIFEROL; BROMAZEPAM; RENUTRYL BOOSTER; OPTIVE
Current Illness: Asthenia; Cachexia
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Aortic stricture (Tight RA (aortic stenosis) w/ global cardiac decompensation at the end of 2019, stable in June 2020 (LVEF) 45%, HVG conce); Cognitive impairment (Unexplored neurocognitive disorder); Dehydration; Disorientation; Fall (impossibility of getting up.); Hematoma; Hospitalization (hospitalized in this context of repeated falls and difficult home maintenance); Hyperthyroidism (on carbimazole); Left ventricular hypertrophy; Oral rehydration; Papillitis (Pseudopapillite vasculaire en 2000); Tachycardia paroxysmal; Varicose veins (compression stockings); Walking aid user
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: blood culture; Test Result: Negative ; Test Date: 20210215; Test Name: BP; Result Unstructured Data: Test Result:102/77; Test Date: 20210216; Test Name: BP; Result Unstructured Data: Test Result:165/72; Test Date: 20210217; Test Name: BP; Result Unstructured Data: Test Result:108/57; Test Date: 20210217; Test Name: BP; Result Unstructured Data: Test Result:110/56; Test Date: 20210218; Test Name: BP; Result Unstructured Data: Test Result:107/59; Test Date: 20210218; Test Name: BP; Result Unstructured Data: Test Result:112/55; Test Date: 20210218; Test Name: BP; Result Unstructured Data: Test Result:107/59; Test Date: 20210217; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade; Test Date: 20210218; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade; Test Date: 20210215; Test Name: Coma Scale; Result Unstructured Data: Test Result:15; Comments: small temporo-spatial disorientation; Test Date: 20210215; Test Name: ECG; Result Unstructured Data: Test Result:regular sinus rhythm at 65 bpm, a left axis and le; Comments: regular sinus rhythm at 65 bpm, a left axis and left ventricular hypertrophy.; Test Date: 202102; Test Name: Pulse rate; Result Unstructured Data: Test Result:between 52 and 68 bpm; Comments: no fever, eupneic in ambient air.; Test Date: 20210215; Test Name: Pulse rate; Result Unstructured Data: Test Result:63 bpm; Test Date: 20210215; Test Name: investigation; Result Unstructured Data: Test Result:Presence of a hematoma localized to the right zygo; Test Date: 20210215; Test Name: clinical examination; Result Unstructured Data: Test Result:unremarkable; Comments: no neurological deficit; Test Date: 20210218; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:96; Test Date: 20210215; Test Name: renal clearance; Result Unstructured Data: Test Result:28 ml/min; Comments: 28 ml / min / 1.73m2 (usual clearance at 47 ml / min / 1.73m2) in favor of dehydration (dry tongue).; Test Date: 20210218; Test Name: renal clearance; Result Unstructured Data: Test Result:48 ml/min; Comments: 1.73m2; Test Date: 20210215; Test Name: covid-19 pcr test; Test Result: Negative ; Test Date: 20210215; Test Name: Brain scan; Result Unstructured Data: Test Result:scheduled
CDC Split Type: FRPFIZER INC2021232837

Write-up: few sub-crackles located in the 2 fields, without functional repercussions; Death unexplained; Renal function improved with an estimate of GFR (Glomerular filtration rate) by the Agency formula at 48 ml / min / 1.73m2; values of 108/57 and 110/56 on 17Feb2021 and 112/55 then 107/59 on 18Feb2021; pulse oscillated between 52 and 68 bpm during the stay; This is a spontaneous report from a contactable physician reporting for a patient downloaded from the regulatory authority FR-AFSSAPS-DJ20210313. An 87-year-old female patient received bnt162b2 (COMIRNATY; Lot number EM6950), intramuscular on 17Feb2021 at SINGLE DOSE for covid-19 immunisation. Medical history included anxiety; hyperthyroidism on carbimazole; Aortic stricture, described as Tight RA (aortic stenosis) with global cardiac decompensation at the end of 2019, stable in June 2020 (LVEF ( Left ventricular ejection fraction) 45%, HVG (left ventricular hypertrophy) conce; Cognitive impairment, Unexplored neurocognitive disorder; and tachycardia paroxysmal from an unknown date and unknown if ongoing, papillitis, Pseudopapillite vasculaire en 2000 on 2000, unknown if ongoing; and ongoing asthenia; ongoing cachexia; walk with a cane / walker from an unknown date. The patient was reported as asthenic cachetic patient, and lives alone at home. The patient would have fallen twice, on February 14 and 15 (2021) in the evening with the impossibility of getting up. On 15Feb2021, she was hospitalized in this context of repeated falls and difficult home maintenance. BP emergencies was at 102/77 (15Feb2021), pulse at 63 bpm; no fever, eupneic in ambient air. Presence of a hematoma localized to the right zygomatic bone, no other complaint. CS (Coma Scale) at 15, small temporo-spatial disorientation. The rest of the clinical examination is unremarkable, no neurological deficit is observed. On 15Feb2021, the biology shows a clearance at 28 ml / min / 1.73m2 (usual clearance at 47 ml / min / 1.73m2) in favor of dehydration (dry tongue). Blood cultures are negative and COVID-19 PCR is negative. The ECG taken on 15Feb2021 shows a regular sinus rhythm at 65 bpm, a left axis and left ventricular hypertrophy. On 15Feb2021, a brain scan was scheduled for 19Feb2021. In view of the clinical and biological elements, furosemide is suspended (15Feb2021), oral hydration and by G (dextrose) 5% in sc at night is prescribed (15Feb2021), compression stockings are prescribed for varicose veins and bromazepam is discontinued (15Feb2021) in favor of oxazepam. Concomitant medication included nadolol, oxazepam, paracetamol, nebivolol, furosemide sodium, colecalciferol, bromazepam, carbohydrates nos, fats nos, minerals nos, proteins nos, vitamins nos (RENUTRYL BOOSTER), carmellose sodium, glycerol (OPTIVE), therapy dates and indication unspecified; and carbimazole for hyperthyroidism. On 17Feb2021, the patient received a first dose of COMIRNATY vaccine (batch EM6950). It was reported the patient died of death unexplained on 18Feb2021. On 18Feb 2021, the doctor was the last to see the patient at 3 PM (15:00). He mentions a few sub-crackles located in the 2 fields, without functional repercussions felt by the patient (does not complain of anything) and furosemide is prescribed for the next day at a dosage of 40 mg per day. The BP is 107/59, the 02 saturation in ambient air is 96%. The temperature is 37 deg C. At 6:45 PM (18:45), the nurse enters the room and finds the patient in the process of wasting, then death was declared. The patient is found in a semi-seated position in her bed. There is no sign of a struggle. On the semiological level, the patient did not present any sign of PAO (acute lung edema) before her death. She did not show any sign of reactogenicity after vaccination (no fever: t DEG C at 37 DEG C on February 17 at 3 p.m. and at 37 DEG C at 3 p.m. on 18Feb2021). The highest blood pressure during his stay was 165/72 on 16Feb2021 with values of 108/57 and 110/56 on 17Feb2021 and 112/55 then 107/59 on 18Feb2021, the last blood pressure having was taken at 3 p.m., 4 hours before his death. The pulse oscillated between 52 and 68 bpm during the stay, the lowest value having been found before vaccination. Renal function improved with an estimate of GFR (Glomerular filtration rate) by the Agency formula at 48 ml / min / 1.73m2 on 18Feb2021, the day of his death. The doctor thinks first of a death related to the severe aortic stenosis of the patient. However, due to the context of the COVID-19 vaccination the day before death, a pharmacovigilance declaration was also made. Outcome of Death unexplained was fatal while unknown for all other events. It was unknown if an autopsy was done. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1086633 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-24
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood albumin, Blood count, Blood electrolytes, Liver function test, Renal function test, 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: 2021-02-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM; OMEPRAZOLE; DEPAKOTE; ACEBUTOLOL; MODOPAR; MACROGOL; ZYMA; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bipolar disorder; Normal pressure hydrocephaly; Phlebitis; Tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 202009; Test Name: albumin; Result Unstructured Data: Test Result:44 g/l; Test Date: 202009; Test Name: blood count; Result Unstructured Data: Test Result:Normal; Test Date: 202009; Test Name: ion balance; Result Unstructured Data: Test Result:Normal; Test Date: 202009; Test Name: liver assessment; Result Unstructured Data: Test Result:Normal; Test Date: 202009; Test Name: renal function; Result Unstructured Data: Test Result:Normal
CDC Split Type: FRPFIZER INC2021242187

Write-up: Death sudden; This is a spontaneous report downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LM20210366. A contactable physician reported that a 76 years old female patient received the second dose of BNT162B2 (COMIRNATY, Lot. EJ6788) intramuscularly, at single dose, on 09Feb2021, for COVID-19 immunisation. Relevant medical history included bipolar disorder, phlebitis, tachycardia and normal pressure hydrocephaly, all from an unspecified date and unknown if ongoing. Past drug event included facial edema due to cortisone. Concomitant medications included escitalopram 10 (unit unspecified) once daily; omeprazole 20 (unit unspecified) once daily; valproate semisodium (DEPAKOTE) 500 (unit unspecified) once daily; acebutolol 200 (unit unspecified) 1/2 / day; benserazide hydrochloride, levodopa (MODOPAR) 125 (unit unspecified), thrice daily, for stiffness; macrogol; enzymes nos (ZYMA) 80000 (unit unspecified), 1 dose / month and paracetamol if needed. On 24Feb2021, death sudden was reported (resident found dead in bed this morning at 5:30 a.m). No current acute pathology, no complaints or grievances during previous visits by the IDE. She did not call or ring the bell. Last organic assessment Sep2020 normal in terms of blood count, ion balance and renal function albumin 44 g/l normal liver assessment. Attending physician selected sudden death as the reason for death. No autopsy was done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1086634 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Back pain, Blood pressure measurement, Body temperature, Cardio-respiratory arrest, Coma scale, Exercise electrocardiogram, Heart rate, Loss of consciousness, Oxygen saturation, Pain assessment, Sensory disturbance
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (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), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   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: IRBESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: High weight; Hypertension arterial (treated with ATACAND 8mg, stopped 1 month ago)
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:10; Test Name: body temperature; Result Unstructured Data: Test Result:afebrile; Test Name: Glasgow score; Result Unstructured Data: Test Result:15; Test Name: ETT; Result Unstructured Data: Test Result:didn''t show dilation of the ascending thoracic; Comments: aorta, absence of flaps and tamponades, no pericardial effusion and dilation of the right ventricle; Test Name: heart rate; Result Unstructured Data: Test Result:90; Comments: 90 bpm with heavy sweating; Test Name: oxygen saturation; Test Result: 99 %; Test Name: VAS pain scale; Result Unstructured Data: Test Result:9/10
CDC Split Type: FRPFIZER INC2021242198

Write-up: Cardio-respiratory arrest; Loss of consciousness; Hyperalgesic lumbar pain; Sensory disorders; Severe abdominal pain; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB Regulatory Authority number FR-AFSSAPS-LY20211088. A 49-years-old male patient (firefighter) received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), batch # EK9788, via intramuscular route in the left arm on 10Feb2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unknown date treated with candesartan cilexetil (ATACAND) 8 mg, stopped 1 month before this report and being overweight. It was reported that hypertension was stabilized but still a little high. In Jan2021 the patient had received the first injection of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), via intramuscular route (batch unknown). The doctor didn''t report any adverse event between the first and second dose. Concomitant medication included irbesartan. On 20Feb2021 the patient was taken care of by the fire brigade for hyperalgesic lumbar pain with notion of irradiation in the legs with sensory disorders. On the same date he had 99% oxygen saturation and 9/10 VAS pain scale. The patient was afebrile with a blood pressure of "10" (no units provided) and a heart rate of 90 bpm with heavy sweating. Glasgow score of 15. During transport, the patient presented with severe abdominal pain with discomfort and loss of consciousness. He went in cardiopulmonary arrest (ACR) 2 minutes before arriving to the emergency room. In emergencies (arrival at 9:30 am): ACR with rhythm in electromechanical dissociation was found then asystole after 30 minutes of cardiopulmonary resuscitation (CPR) occurred (no shockable rhythm). In total 10 mg of adrenaline (1mg every 3 to 5 minutes in IV) were administered and the patient was intubated (Cormack and Lehane score of 1). No concept of inhalation, no "CE"; ETT (performed during CPR) didn''t show dilation of the ascending thoracic aorta, absence of flaps and tamponades, no pericardial effusion and dilation of the right ventricle. Cardiopulmonary resuscitation was continued for a total of 45 minutes. The cardio-respiratory arrest was fatal and patient''s death was declared at 10:15 am the same day. Concerning the cause of death, strong anamnestic presumption of a rupture of the abdominal aorta or a dissection of the descending thoracic aorta was done. 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: Cardio-respiratory arrest


VAERS ID: 1086637 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Hypotension
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Respiratory failure (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: End stage renal failure ((GFR 23ml / min)); Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021242193

Write-up: Cardio-respiratory arrest; Hypotension; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB FR-AFSSAPS-MA20210654. A 77-years-old male patient received the second dose bnt162b2 (COMIRNATY) from lot EM6950 left arm intramuscular on 16Feb2021 at single dose for covid-19 immunisation . Age at vaccination :77 years. Medical history included hypertension unknown if ongoing , end stage renal disease (GFR 23ml / min) unknown if ongoing. The patient''s concomitant medications were not reported. The patient received the second anticovid19 vaccination COMIRNATY vaccine and was unwell following moderate hypotension and then 48 hours later, cardiopulmonary arrest resulting in death.Clincial course was reported as follows: On 17Feb2021, the patient presented discomfort with moderate hypotension (no numerical value). His relatives take him to a doctor near his home, on 19Feb2021, where he will suffer cardiopulmonary arrest, not recovered after an attempt at resuscitation by the SMUR.The patient died on 19Feb2021. It was not reported if an autopsy was performed.The otucome of the other event was unknown.Covid 19 PCR test performed: no covid19 history: no No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1086641 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Blood pressure measurement, Body temperature, Cardiac arrest, Chest pain, Heart rate, Pain, 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   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: Breast cancer (breast cancer G); Dyslipidaemia (dyslipidemia); Hypertension; Peripheral arterial occlusive disease (PAD with femoral angioplasty (2012)); Peripheral artery angioplasty
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: Blood pressure; Result Unstructured Data: Test Result:138/86 mmHg; Test Date: 20210211; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210211; Test Name: Heart rate; Result Unstructured Data: Test Result:84; Test Date: 20210125; Test Name: COVID-19 test; Result Unstructured Data: Test Result:No
CDC Split Type: FRPFIZER INC2021232980

Write-up: Cardiac arrest; Chest pain; body aches; anxiety; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-NT20210435. A 93-year-old female patient received first dose of bnt162b2 (COMIRNATY, Batch number: EJ6789), intramuscular on 11Feb2021 10:00 (at 93-year-old) at single dose (right arm) for COVID-19 immunization. Medical history included Peripheral artery angioplasty, Hypertension, Breast cancer (breast cancer G) from 1994, Dyslipidaemia/dyslipidemia, Peripheral arterial occlusive disease from 2012 (PAD with femoral angioplasty); all unknown if ongoing. The patient returned to nursery home at the end of Jan2021 (also reported as 25Jan2021), the COVID-19 screening PCR test/ COVID-19 test at the entrance was negative (No). The patient has not developed COVID-19. The patient is considered eligible for vaccination on 09Feb2021, therefore she received first dose of the bnt162b2 vaccine against COVID-19 on 11Feb2021 at 10:00 am (temperature at 36.6?C, blood pressure at 138/86 mmHg, heart rate at 84, cardiopulmonary auscultation without particularity). Within hours of the vaccination, she complained about body aches and anxiety (11Feb2021), which subsided in the evening. Nothing special was noticed the following days until 16Feb2021, on day 5 of the vaccination, at 13:00, she experienced chest pain with cardiac arrest. The workers initiated an attempt at resuscitation (oxygen + external electric shock + cardiac massage) until the arrival of the SAMU (emergency medical aid service) which, despite their intervention, was unable to revive the flat path of heart rate. Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal procedures. The outcome of the events body aches and anxiety was recovering. Chest pain and cardiac arrest were reported as fatal. Death was on 16Feb2021 at 14:00. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Cardiac arrest; Chest pain


VAERS ID: 1086668 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-05
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Decreased appetite, Oxygen saturation, Oxygen saturation decreased, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 8
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: Arrhythmia; Diabetes; Hypertension arterial; Hypothyroidism; Iron deficiency anemia; Psychosis
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: Oxygen saturation; Test Result: 91 %; Test Date: 20210205; Test Name: Fever; Result Unstructured Data: Test Result:38 and 39 Centigrade
CDC Split Type: FRPFIZER INC2021232907

Write-up: COVID-19 aggravated; fever between 38 and 39 C; desaturation (91%); loss of appetite; isolated cough; This is a spontaneous report from a contactable physician from the Medicines Agency (MA)WEB. The Regulatory Authority report number is FR-AFSSAPS-RS20210256. A 71-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EJ6788, expiration date not reported), intramuscular in the left arm on 27Jan2021 at a single dose for COVID-19 immunisation. Medical history included Hypertension arterial, Iron deficiency anemia, arrhythmia, Diabetes, Delusional psychosis, and hypothyroidism. The patient''s concomitant medications were not reported. The patient is considered to be at risk of developing a severe form of COVID19 disease (diabetes, heart disease). The patient experienced COVID-19 aggravated on 05Feb2021. It was further reported that on 05Feb2021, onset of fever between 38 and 39 C, desaturation (91%), loss of appetite and isolated cough. The patient was hospitalized on an unspecified date in Feb2021 due to the events. On 13Feb2021, death of the patient due to complicated COVID following according to the declaring doctor. 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: isolated cough; COVID-19 aggravated; fever between 38 and 39 C; desaturation (91%); loss of appetite


VAERS ID: 1086669 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Acute respiratory failure, Blood creatinine, Blood gases, Blood potassium, Blood sodium, Brain natriuretic peptide, Bronchitis, C-reactive protein, COVID-19 pneumonia, Carbon dioxide, Coma scale, Computerised tomogram, Discomfort, Drug ineffective, Dyspnoea, Exposure to SARS-CoV-2, Fibrin D dimer, Fraction of inspired oxygen, Haemoglobin, Heart rate, Muscular weakness, Oxygen saturation, PO2, Pyrexia, Respiratory disorder, SARS-CoV-2 test, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 40
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: ALLOPURINOL; ALPRAZOLAM; SMECTA [ALUMINIUM HYDROXIDE-MAGNESIUM CARBONATE GEL;ALUMINIUM MAGNESIUM SILICATE;GLUCOSE MONOHYDRATE; TAMSULOSIN; UVEDOSE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic pancreatitis; Colorectal adenocarcinoma (operated in 2009 with ostomy since this intervention); Hypotension orthostatic (with venous retention); Operation NOS; Pneumopathy (Right lung pneumopathy in 1956, 2002, 2005 and 2011); Pneumopathy; Prostatic adenoma (with urinary leaks since 2007); Stoma care; Urinary incontinence
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: Creatinine level; Result Unstructured Data: Test Result:76; Test Date: 20210207; Test Name: Creatinine level; Result Unstructured Data: Test Result:76; Test Date: 20210207; Test Name: Creatinine level; Result Unstructured Data: Test Result:116; Comments: increase from 76; Test Date: 20210206; Test Name: Gasometry; Result Unstructured Data: Test Result:7.43 pH units; Test Date: 20210206; Test Name: Potassium level; Result Unstructured Data: Test Result:4.2; Test Date: 20210206; Test Name: Sodium level; Result Unstructured Data: Test Result:136; Test Date: 20210206; Test Name: BNP; Result Unstructured Data: Test Result:86; Test Date: 20210206; Test Name: Carbon dioxide pressure; Result Unstructured Data: Test Result:34.6; Test Date: 20210206; Test Name: GCS; Result Unstructured Data: Test Result:15; Test Date: 20210206; Test Name: CT scan; Result Unstructured Data: Test Result:ground-glass opacity; Comments: no sign favouring a pulmonary embolism but a large zone of ground-glass opacity spread across the ensemble of the pulmonary parenchyma with Crazy-Paving pattern and a strip of parenchymatous condensation; Test Date: 20210206; Test Name: CRP; Result Unstructured Data: Test Result:204.9; Test Date: 20210206; Test Name: CRP; Result Unstructured Data: Test Result:80.9; Test Date: 20210206; Test Name: D dimers; Result Unstructured Data: Test Result:1806; Test Date: 20210206; Test Name: FiO2; Test Result: 85 %; Test Date: 20210207; Test Name: FiO2; Test Result: 50 %; Test Date: 20210208; Test Name: FiO2; Test Result: 100 %; Test Date: 20210209; Test Name: FiO2; Test Result: 100 %; Test Date: 20210206; Test Name: Haemoglobin; Result Unstructured Data: Test Result:14.8; Test Date: 20210206; Test Name: Heart rate; Result Unstructured Data: Test Result:100/min; Test Date: 20210206; Test Name: Heart rate; Result Unstructured Data: Test Result:32/min; Test Date: 20210206; Test Name: Saturation; Test Result: 60 %; Test Date: 20210207; Test Name: Saturation; Result Unstructured Data: Test Result:100 with high flow O2 %; Test Date: 20210209; Test Name: Saturation; Test Result: 90 %; Test Date: 20210206; Test Name: Oxygen pressure; Result Unstructured Data: Test Result:72; Comments: with a flow of 70/min; Test Date: 20210208; Test Name: Oxygen pressure; Result Unstructured Data: Test Result:50; Test Date: 20210209; Test Name: Oxygen pressure; Result Unstructured Data: Test Result:60; Test Date: 20210208; Test Name: Fever; Result Unstructured Data: Test Result:38.3; Test Date: 202101; Test Name: COVID-19 PCR test; Test Result: Negative ; Comments: during hospitalization 26-29Jan2021, patient had been contact with a COVID case; Test Date: 202101; Test Name: COVID-19 PCR test; Test Result: Negative ; Comments: during hospitalization 26-29Jan2021, patient had been contact with a COVID case; Test Date: 20210224; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: post-mortem RT-PCR; no sequencing was available; Test Date: 20210206; Test Name: Leucocytes; Result Unstructured Data: Test Result:9.700
CDC Split Type: FRPFIZER INC2021232944

Write-up: Discomfort; Acute renal insufficiency; severe COVID-19 pneumopathy/ post-mortem RT-PCR on 24Feb2021 came back positive; severe COVID-19 pneumopathy/ post-mortem RT-PCR on 24Feb2021 came back positive; Acute respiratory failure; Respiratory problems; patient has been in contact with a COVID case; Weakness in the lower limbs; Dyspnoea; Bronchitis; This is a spontaneous report from a contactable other healthcare professional (also reported as physician) downloaded from the Medicines Agency (MA) WEB; the Regulatory Authority Report Number is FR-AFSSAPS-RS20210310. An 86-year-old male patient received BNT162B2 (COMIRNATY; lot/batch number and expiry date were unknown), intramuscular on 21Jan2021 at a SINGLE DOSE for COVID-19 immunisation. The patient''s medical history included right lung pneumopathy in 1956, 2002, 2005 and 2011; Chronic pancreatitis in 1995; Prostatic adenoma with urinary leaks since 2007; Orthostatic hypotension with venous retention; Colorectal adenocarcinoma operated in 2009 with ostomy since this intervention. Concomitant and patient''s usual medications included allopurinol (ALLOPURINOL), alprazolam (ALPRAZOLAM ) at 0.75mg, daily; aluminium hydroxide-magnesium carbonate gel, aluminium magnesium silicate, glucose monohydrate, glycyrrhiza glabra (SMECTA), tamsulosin (TAMSULOSIN), and colecalciferol (UVEDOSE); all from an unknown date for an unspecified indication. It was reported that patient had no signs of intolerance immediately after vaccination on 21Jan2021. Then, patient was admitted to the hospital geriatric unit from 26Jan2021 to 29Jan2021 for weakness in the lower limbs and dyspnoea. Patient was diagnosed with bronchitis on an unknown date in Jan2021 leading to a prescription of Augmentin, 3g/day. During the hospitalization, the patient has been in contact with a COVID case on an unknown date in Jan2021 but since that date, 2 PCR tests have come back negative. The situation deteriorated again on 04Feb2021, with respiratory problems that required hospital admittance on 06Feb2021. Upon admittance, no signs of cardiac insufficiency, regular rhythm at 100/min, Glasgow (GCS scale) at 15, no sensory-motor deficit, and no abnormal abdominal pains. Regarding respiratory issues, patient had frequency at 32/min, saturation at 60%, labored respiration, paradoxical breathing, and blockage sounds in the two sites of auscultation. Gasometry carried out under Optoflow showed pH at 7.43, pCO2 (Carbon dioxide pressure) at 34.6, PO2 (Oxygen pressure) at 72 with a flow of 70/min, and FiO2 (Fraction of inspired oxygen) at 85%. C-reactive protein (CRP) was at 204.9 down to a value at 80.9. BNP (brain natriuretic peptide) was at 86, and D dimers at 1806. FBC (full blood count) showed: leukocytes at 9,700, Hb (Haemoglobin) at 14.8. Ionogram with Na (sodium) was at 136, K (potassium) at 4.2, and Creatinine at 76. An injected CT scan showed that there was no sign favouring a pulmonary embolism, but a large zone of ground-glass opacity spread across the ensemble of the pulmonary parenchyma with Crazy-Paving pattern and a strip of parenchymatous condensation. On 06Feb2021, hypothesis of a severe COVID pneumopathy was referred to because it reached 50 to 75% of the parenchyma. Treatment included non-invasive means with initiation of a primary treatment with Dexamethasone 6 mg/d, Lovenox 40mg twice a day, Rocephin 1g, and Spiramycin 1.5M three times a day. On 07Feb2021: the situation remained worrying but with a stable hemodynamic. Patient had superficial polypnea and draw, diffuse bruits in the 2 fields; the P/F ratio (Horowitz index) was at 100 on high flow O2 with FiO2 at 50%. On 07Feb2021, start of acute renal insufficiency with creatinine went from 76 to 116. Dose of spiramycin was increased to 3M three times a day. On 08Feb2021, the patient was exhausted, dyspnoea was mostly exhalation with labored respiration and paradoxical breathing and blockage sounds in the two sites of auscultation. Oxygen was at a flow of 50 and FiO2 (fraction of inspired oxygen) at 100%. Low fever was at 38.3 and Ceftriaxone was replaced with Taxocilline. On 09Feb2021, patient had new worsening of the respiratory state with motricity agitation. Optiflow was at a flow of 60 and FiO2 at 100%, enabling O2 saturation at 90%. Significant discomfort was experienced by the patient on 09Feb2021, who agreed to be sedated with midazolam 0.5mg/hour. On 10Feb2021, the patient died. It was unknown if an autopsy was performed. The post-mortem RT-PCR on 24Feb2021 came back positive; no sequencing was available. No follow-up attempts are possible; information on lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: severe COVID-19 pneumopathy/ post-mortem RT-PCR on 24Feb2021 came back positive; severe COVID-19 pneumopathy/ post-mortem RT-PCR on 24Feb2021 came back positive


VAERS ID: 1086678 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood lactic acid, Blood pressure measurement, Brain natriuretic peptide, C-reactive protein, Cardiac failure, Echocardiogram, Fibrin degradation products, Heart rate, Investigation, Oxygen saturation, Oxygen saturation decreased, Pulmonary function test, Pulmonary sepsis, Renal function test, Respiratory distress, SARS-CoV-2 test, Supraventricular tachyarrhythmia, Troponin, Weight, White blood cell count, pH body fluid
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Aortic valve disease (Tight calcified aortic stenosis with retained LVEF); Cardiac valve disease; Chronic atrial fibrillation (under Cordarone treatment); Chronic renal insufficiency; Cognitive disorder (probably of a MMS 20/30 vascular origin); COVID-19; Dyslipidemia; Hypertension arterial; TAVI (2016)
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: lactic acid; Result Unstructured Data: Test Result:3.8 mmol/L; Test Date: 20210211; Test Name: BP; Result Unstructured Data: Test Result:106/62 mmHg; Test Date: 20210212; Test Name: BP; Result Unstructured Data: Test Result:240/120 mmHg; Test Date: 20210212; Test Name: BNP; Result Unstructured Data: Test Result:7647 pg/mL; Test Date: 20210212; Test Name: CRP; Result Unstructured Data: Test Result:238 mg/l; Test Date: 20210212; Test Name: CRP; Result Unstructured Data: Test Result:247 mg/l; Test Date: 20210212; Test Name: heart ultrasound; Result Unstructured Data: Test Result:bable sequelae of the anteroseptal MI concordant w; Comments: bable sequelae of the anteroseptal MI concordant with the EG, increased left and right pressure, ultrasound subject to respiratory distress with tachycardia at 150min.; Test Date: 20210212; Test Name: D-dimer; Result Unstructured Data: Test Result:1150 ng/ml; Test Date: 20210211; Test Name: pulse; Result Unstructured Data: Test Result:94/min; Test Date: 20210212; Test Name: pulse; Result Unstructured Data: Test Result:110/min; Test Date: 20210212; Test Name: pulse; Result Unstructured Data: Test Result:150/min; Test Date: 20210212; Test Name: pulse; Result Unstructured Data: Test Result:116; Test Date: 20210212; Test Name: pulse; Result Unstructured Data: Test Result:122; Test Date: 20210212; Test Name: pulse; Result Unstructured Data: Test Result:133; Test Date: 20210212; Test Name: pulse; Result Unstructured Data: Test Result:120; Test Date: 20210212; Test Name: pulse; Result Unstructured Data: Test Result:140; Test Date: 20210208; Test Name: routine consultation; Result Unstructured Data: Test Result:complained of brief thoracic pains; Comments: complained of brief thoracic pains that stopped spontaneously; Test Date: 20210211; Test Name: saturation; Test Result: 89 %; Test Date: 20210212; Test Name: saturation; Result Unstructured Data: Test Result:desaturation on 3l/min of O2 %; Test Date: 20210212; Test Name: saturation; Test Result: 87 %; Test Date: 20210212; Test Name: pH; Result Unstructured Data: Test Result:7.29; Test Date: 20210208; Test Name: pulmonary bases; Result Unstructured Data: Test Result:bruits; Test Date: 20210212; Test Name: renal function; Result Unstructured Data: Test Result:40; Test Date: 20210212; Test Name: PCR Sars-CoV-2; Test Result: Negative ; Test Date: 20210212; Test Name: troponin; Result Unstructured Data: Test Result:150; Test Date: 20210208; Test Name: weight; Result Unstructured Data: Test Result:increase in weight of 2kg in 1 month; Comments: increase in weight of 2kg in 1 month; Test Date: 20210208; Test Name: WBC; Result Unstructured Data: Test Result:5250; Test Date: 20210212; Test Name: WBC; Result Unstructured Data: Test Result:11460/mm3; Test Date: 20210212; Test Name: WBC; Result Unstructured Data: Test Result:17500
CDC Split Type: FRPFIZER INC2021232976

Write-up: Pulmonary sepsis; Supraventricular tachyarrhythmia; Arterial oxygen saturation decreased; Distress respiratory; Decompensation cardiac; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB FR-AFSSAPS-ST20210446. An 88-year-old female patient received second dose of bnt162b2 (COMIRNATY; lot EJ6789), intramuscular on 11Feb2021 at 0.3 mL, single (left arm) for COVID-19 immunisation. Medical history included valvular cardiopathy with severe aortic stenosis, Transcatheter aortic valve implantation (TAVI) in 2016, post TAVI chronic atrial fibrillation (under Cordarone treatment), chronic renal insufficiency, chronic arterial dyslipidemia, mild cognitive disorder (probably of a MMS 20/30 vascular origin), aortic valve disease (tight calcified aortic stenosis with retained LVEF), Hypertension arterial, and COVID-19 on 27Apr2020. The patient''s concomitant medications were not reported. The patient received first dose of bnt162b2 for COVID-19 immunisation on an unspecified date. The patient had a routine consultation on 08Feb2021, she complained of brief thoracic pains that stopped spontaneously. Upon examination, bruits at the pulmonary bases and evidence of an increase in weight of 2kg in 1 month, the white blood cell (WBC) was at 5250, no dosage of the cardiac enzymes available at that moment. On 11Feb2021, the patient experienced arterial oxygen saturation decreased, distress respiratory, and decompensation cardiac. On 12Feb2021, the patient experienced pulmonary sepsis, and supraventricular tachyarrhythmia. The patient was hospitalized due to the events on an unspecified date. She had the second injection of bnt162b2 vaccine on 11Feb2021 and patient was not febrile before vaccination and did not have dyspnea. Then 15 minutes after the vaccination, during post-vaccination monitoring, saturation was at 89%, blood pressure was at 106/62mmHg, with pulse at 94bpm, apyretic, and no dyspnoea. The desaturation persisted without any fever or pulmonary indications. On 12Feb2021, she had a consultation with her general practitioner, persistent desaturation on 3 L/min of O2, BP maintained, apyretic at the auscultation of the bruits, and pulse at 110bpm. The lab test of 12Feb2021 showed CRP at 238mg/l, WBC at 11,460/mm3, BNP: 7647pg/ml (NV<125), and D dimers at 1150ng/ml (NV<500). The general practitioner suggested the start of cardiac decompensation or a pulmonary infection or a pulmonary embolism. Patient was put on Lasilix and Augmentin started on 12Feb2021 with an increase in the flow of O2. Rapid deterioration in the evening with polypnea and cyanosis. Patient was transferred to accident and emergency: patient had tachycardia at 116-122-133-120-140, saturation to 87% put on a Boussignac. Specialist''s opinion included heart ultrasound was probable sequelae of the anteroseptal myocardial infarction (MI), concordant with the EG, increased left and right pressure, ultrasound subject to respiratory distress with tachycardia at 150 minutes. The emergency staff refer to recent-onset cardiac decompensation on atrial fibrillation with rapid ventricular response on pneumopathy and probable unexplored prior MI. The patient was put on LOVENOX 0.8*2/d, Digoxin, Cordarone, Boussignac then NIV, Risordan, Lasilix and tazocilline. Desaturation at 82% on positive-pressure airflow 15 L, renal function at 40, draw, BP at 240/120mmHg, Boussignac CPAP + risordan was given. Patient had polypnea, bruits in the totality of the two field and predominantly on the right. PCR Sars-CoV-2 was negative, CRP at 247mg/L, troponin 150, NT$g11,000, WBC at 17,500, and lactic acid at 3.8mmol/L. There was deterioration of the patient at pH: 7.29, hypoxia and lactic acid at 3.8. The physician reported a completely unexpected and brutal death. The patient presented 3 entangled sign with: an acute respiratory distress syndrome (ARDS) within the context of an infectious pneumopathy with a CRP at 238 on D1 post-vaccination which does not argue in favour of the imputability of the vaccine; probable sequelae of an unrecognized MI; and rapid-onset cardiac decompensation on atrial fibrillation. The patient died on 13Feb2021. An autopsy was not performed. No follow-up attempts are possible, information on batch number already obtained.; Reported Cause(s) of Death: Decompensation cardiac; Pulmonary sepsis; Supraventricular tachyarrhythmia; Arterial oxygen saturation decreased; Distress respiratory


VAERS ID: 1086681 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Babinski reflex test, Blood potassium, Blood pressure measurement, C-reactive protein, Computerised tomogram, Failure to thrive, Fall, Haemorrhagic stroke, Hypertension, Orbital haematoma, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Accidents and injuries (narrow), Hypertension (narrow), Optic nerve disorders (broad), Retinal disorders (broad), Neonatal disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: GARDENAL [PHENOBARBITAL]; ZOLPIDEM; LACTULOSE; TEGRETOL; KEPPRA; RISPERDAL; TARDYFERON
Current Illness: Epilepsy (sequelae epilepsy of absence type (focal epilepsy involving the temporal regions)); Hospitalization
Preexisting Conditions: Medical History/Concurrent Conditions: Consciousness disturbed; Hypokalaemia (hospitalized for hypokalaemia from 30 to 31Jan2021); Ischemic stroke; Memory disturbance (memory disorders (disorder of access to lexical stock) sequelae); Meningoencephalitis bacterial (due to Mycoplasma pneumonia); Pneumonia mycoplasmal; Psychiatric decompensation; Refusal of treatment by patient
Allergies:
Diagnostic Lab Data: Test Name: Babinski; Result Unstructured Data: Test Result:bilateral positive; Test Name: potassium; Result Unstructured Data: Test Result:2.94; Test Date: 20210201; Test Name: blood pressure (BP); Result Unstructured Data: Test Result:115/80 mmHg; Test Date: 20210203; Test Name: blood pressure (BP); Result Unstructured Data: Test Result:195/110 mmHg; Test Date: 20210204; Test Name: blood pressure (BP); Result Unstructured Data: Test Result:160/90 mmHg; Test Name: CT scan; Result Unstructured Data: Test Result:hematoma; Comments: Left 5 cm capsulolenticulo-thalamic intra-parenchymal hematoma causing a local mass effect and intraventricular contamination in the left lateral ventricle; no hydrocephalus and no sign of engagement; Test Name: C-reactive protein (CRP); Result Unstructured Data: Test Result:80; Test Name: leukocytes (leuco); Result Unstructured Data: Test Result:10.6
CDC Split Type: FRPFIZER INC2021232924

Write-up: Haemorrhagic stroke; Hypertensive episode; hematoma around the left orbit of yellow color (possible fall?); hematoma around the left orbit of yellow color (possible fall?); Syndrome de glissement; This is a spontaneous report from a contactable physician, downloaded from the regulatory authority-WEB (regulatory authority number: FR-AFSSAPS-ST20210479). An 83-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection; lot number: EJ6788, expiration date was unknown), intramuscularly (IM) in the left arm on 01Feb2021 at 0.3 mL, single for COVID-19 immunization and acetylsalicylate lysine (KARDEGIC; lot number and expiration date were unknown), orally from an unspecified date to an unspecified date at 75 mg, once a day for cerebrovascular accident prophylaxis. Relevant medical history included a history of 2 ischemic strokes (May2014 and May2020); meningoencephalitis bacterial due to mycoplasma pneumonia in 1973 with ongoing epilepsy from 1973, further described as sequelae epilepsy of absence type (focal epilepsy involving the temporal regions) and memory disorders (disorder of access to lexical stock) sequelae; she was hospitalized for hypokalaemia from 30Jan2021 to 31Jan2021; impaired consciousness; refusal to take her anti-epileptic drugs; and behavioral decompensation. Concomitant medications included phenobarbital (GARDENAL, 100 mg tablet); zolpidem; lactulose; carbamazepine (TEGRETOL, 400 mg tablet); levetiracetam (KEPPRA, 500 mg film-coated tablet); risperidone (RISPERDAL, 1 mg film-coated tablet); and ferrous sulfate (TARDYFERON, 80 mg coated tablet). The patient had no history of COVID-19. On 03Feb2021, the patient experienced haemorrhagic stroke and hypertensive episode, which were considered life threatening, and had led to hospitalization and death. It was further reported that two (2) days after vaccination on 03Feb2021, the patient was hospitalized for right hemiplegia, trismus. On 03Feb2021, she has had "Syndrome de glissement" for 2 days, but appeared to be in her normal state at 12 noon. At 3 p.m., left facial paralysis as well as hemiparesis, with no verbal response was discovered. The patient was reported to have a concept of refusal of treatment for several days. On physical examination on an unspecified date, the patient''s general condition showed no response to verbal solicitation and apyretic. Neurological examination revealed bilateral positive Babinski. There was left heminegligence, right hemiparesis, grasping to the left, and hematoma around the left orbit of yellow color (possible fall?) on an unspecified date. The patient was reported to have hypertension on admission on 03Feb2021 with blood pressure (BP) of 195/110 mmHg, while at the time of vaccination on 01Feb2021, she had normal BP at 115/80 mmHg. On an unspecified date, biologically, the patient had hypokalaemia with potassium of 2.94, biologic inflammatory syndrome, C-reactive protein (CRP) of 80, and leukocytes (leuco) of 10.6 (hospitalized for hypokalaemia from 30Jan2021 to 31Jan2021). Computed tomography (CT) scan on an unspecified date revealed left 5 cm capsulolenticulo-thalamic intra-parenchymal hematoma causing a local mass effect and intraventricular contamination in the left lateral ventricle with no hydrocephalus and no sign of engagement. On 04Feb2021, the patient was noted to have hypertension at 160/90 mmHg with stable clinical condition, right hemiplegia, mutism, and symmetrical and reactive pupils. "LOXEN discontinuation attempt, patient with blood pressure targets" was reported. The patient died on 04Feb2021, after returning to nursing home. The conclusion of hospitalization was reported as haemorrhagic stroke with hypertensive peak. The reporter specified that the patient had been unstable for several days, particularly before the vaccination, with impaired consciousness, refusal to take her anti-epileptic drugs, behavioral decompensation. The patient was hospitalized for haemorrhagic stroke and hypertensive episode from 03Feb2021 to an unknown date. The action taken in response to the events for acetylsalicylate lysine was permanently withdrawn on an unspecified date. Therapeutic measures were taken as a result of hypertensive episode. The patient died on 04Feb2021. An autopsy was not performed. The outcome of the rest of the events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Haemorrhagic stroke; Hypertensive episode


VAERS ID: 1086690 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haematoma, Cerebral haemorrhage, Hemiplegia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   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: Cerebral amyloid angiopathy; Haematoma (Right and left occipitals); Knee prosthesis insertion (left); Status epilepticus
Allergies:
Diagnostic Lab Data: Test Date: 20200908; Test Name: COVID-19 test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC2021232935

Write-up: Cerebral haemorrhage; Left hemiplegia; large right fronto parietal hematoma; This is a spontaneous report downloaded from the regulatory authority-WEB FR-AFSSAPS-TO20210803. A contactable physician reported that an 83-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EJ6788), intramuscular in the left arm on 02Feb2021 at a single dose for COVID-19 immunisation. The patient''s medical history included status epilepticus from Mar2018, knee prosthesis insertion (left), cerebral amyloid angiopathy, right and left occipital hematomas in 2004 and 2017, all unknown if ongoing. Concomitant medications were not reported. On 04Feb2021, the patient experienced left hemiplegia on cerebral hemorrhage with large right fronto parietal hematoma. The patient underwent lab tests and procedures which included COVID-19 test with unknown results on 08Sep2020. The patient died on 04Feb2021 due to the events. It was not reported if an autopsy was performed. The events left hemiplegia and cerebral hemorrhage were reported as serious with medically significant and death criteria from HA. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Left hemiplegia; Cerebral haemorrhage; large right fronto parietal hematoma


VAERS ID: 1086790 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, Malaise, Pulmonary oedema, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC2021239067

Write-up: Unable to swallow; malaise; lungs filled up with fluid; This is a spontaneous report received by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202103022224085310, Safety Report Unique Identifier: GB-MHRA-ADR 24865631. A contactable consumer reported that an 81-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19. The patient is not enrolled in clinical trial. The patient experienced unable to swallow (also reported as problems swallowing food and chewing) on 27Jan2021. The patient also experienced malaise and lungs filled up with fluid on an unspecified date in 2021. The patient''s general practitioner (GP) had seen him. The patient died on 10Feb2021. It was unknown if an autopsy was performed. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unable to swallow; malaise; lungs filled up with fluid


VAERS ID: 1086793 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 48
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENDROFLUMETHIAZIDE; PERINDOPRIL; SALBUTAMOL; SERTRALINE; SIMVASTATIN; TRELEGY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Aortic aneurysm; BPH; Depression; Fall (admitted to hospital); Hearing impaired; Hospitalization (due to fall); Sarcopenia; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210213; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021244100

Write-up: aspiration pneumonia; Fatigue; unwell; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202103031538237850, Safety Report Unique Identifier GB-MHRA-ADR 24869685. A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not known) solution for injection, via an unspecified route of administration on 14Jan2021 at a single dose for Covid-19 immunization. Medical history included fall (admitted to hospital), aortic aneurysm, depression, anxiety, benign prostatic hyperplasia (BPH), steroid therapy (taking regular steroid treatment (e.g. orally or rectally)), type 2 diabetes mellitus from an unknown date and unknown if ongoing, hearing impaired from an unknown date and unknown if ongoing, and sarcopenia from an unknown date and unknown if ongoing. Concomitant medication included bendroflumethiazide for hypertension, perindopril for hypertension, salbutamol for COPD (Chronic obstructive pulmonary disease), sertraline, simvastatin, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY) for COPD (Chronic obstructive pulmonary disease). Unsure if patient has had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. The family stated that the patient became unwell shortly after receiving his Covid vaccine on 14Jan2021. He was fatigued on 15Jan2021. Patient had a fall (prior to vaccination) and was then admitted to hospital. In the hospital he was treated for possible aspiration pneumonia on an unknown date, but he failed to respond to the treatment. Patient died on 03Mar2021 due to aspiration pneumonia. The events caused prolonged hospitalization, considered life-threatening, and medically significant. The patient underwent lab tests which included COVID-19 virus test: no - negative covid-19 test on 13Feb2021. Outcome of the event aspiration pneumonia was fatal while unwell and fatigue was unknown. 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: Aspiration pneumonia


VAERS ID: 1086794 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-02-18
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EE8492 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Myocardial infarction, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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: Flu; Heart attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021239162

Write-up: Heart attack; Heart attack; Sudden death; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202103031624390100, Safety Report Unique Identifier GB-MHRA-ADR 24870125. A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EE8492), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included flu and heart attack. Patient had annual flu jabs (INFLUENZA VACCINE) for immunization. Not sure when last one was, possibly within the last three months. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. The patients concomitant medications were not reported. Patient was talking normally before leaving for an afternoon walk. No signs of illness. The patient had heart attack on an unspecified date and never returned home. The event of heart attack was considered serious (life threatening). The patient had a sudden death on 18Feb2021. Patient has not tested positive for COVID-19 since having the vaccine. An autopsy was carried out. The outcome of the heart attack was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1086796 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-02-25
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Death
SMQs:, 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), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LISINOPRIL; TILDIEM LA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021244504

Write-up: Death; collapsed; This is a spontaneous report from a contactable pharmacist. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202103041412267780, Safety Report Unique Identifier GB-MHRA-ADR 24875612. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJ1688) via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. Relevant medical history was not reported. Unsure if patient has had symptoms associated with COVID-19; the patient has not had a COVID-19 test and he was not enrolled in clinical trial. Concomitant medications included lisinopril and diltiazem hydrochloride (TILDIEM LA). The patient died on 25Feb2021. He went to shopping center, collapsed and died. The cause of death was unknown but could be linked to vaccine that was given month before. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1086799 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic renal failure; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021243998

Write-up: diarrhoea; unknown cause of death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority [HU-OGYI-074621]. A 74-year-old male patient received bnt162b2 (COMIRNATY, lot number: EJ6134), intramuscularly on the left arm on 30Jan2021 at 0.3 mL, single dose for COVID-19 immunisation. Medical history included ongoing hypertension and ongoing chronic renal failure. Concomitant medications were not reported. On 01Feb2021, the patient experienced diarrhoea. The outcome of diarrhoea was unknown. The patient was hospitalized in 03Feb2021 for diarrhoea and died due to an unknown cause of death on 06Feb2021. It was not reported if an autopsy was performed. The case was described as follows: This serious, spontaneous case was reported by a physician on 15Feb2020, concerning the occurrence of diarrhoea after the use of Comirnaty concentrate for dispersion for injection (MAH: BioNTech Manufacturing GmbH). On 30Jan2021, the 74-year-old male patient received 0.3 ml Comirnaty concentrate for dispersion for injection (tozinameran; batch number: EJ6134, expiry date: not reported, intramuscularly, in the left upper arm) for COVID-19 immunisation.On 01Feb2021, the patient experienced diarrhoea. The patient was treated with unknown medicinal therapy but his medical condition did not improve. On 03Feb2021, the patient was hospitalized. On 06Feb2021, the patient died. The patient''s medical condition was hypertension and chronic renal failure. The patient''s concomitant medicinal products were not reported. Senders comment: According to the SmPC of Comirnaty concentrate for dispersion for injection, diarrhoea is not listed but expected. TTO is 1 day. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered possible. The case is considered serious due to hospitalization and fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1086800 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-07
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VEROSPIRON; TALLITON; TORVALIPIN; ASTRIX
Current Illness: Dilated cardiomyopathy
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Decompensation cardiac; Helicobacter pylori infection; Retrosternal pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021244003

Write-up: death; brief loss of consciousness; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [HU-OGYI-083821]. An 89-year-old female patient received the first dose of bnt162b2 (COMIRNATY) lot number: EJ6134, via an unspecified route of administration on 30Jan2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included COVID-19 from 09Dec2020 to 22Dec2020, helicobacter pylori infection from 2000, decompensation cardiac on 2012, dilated cardiomyopathy from 2011 and ongoing, retrosternal pain from 2005. Concomitant medication included spironolactone (VEROSPIRON), carvedilol (TALLITON), atorvastatin calcium (TORVALIPIN) and acetylsalicylic acid (ASTRIX). The patient previously took syncumar from 2006 to 2011. On 07Feb2021, eight days after vaccination, the patient experienced brief loss of consciousness and after the patient had basic life support then advanced resuscitation but both failed, the patient died. At the time of death, the outcome of the event brief loss of consciousness was unknown. The patient died on 07Feb2021. An autopsy was performed, and results were not provided. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1086801 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-02-18
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anal incontinence, Asthenia, Death, Hyperhidrosis, Pallor
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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: CITROKALCIUM; TAMSULOSIN; FURON [FUROSEMIDE]; KALIUM-R; DOXAZOSIN; NOVORAPID; SORBIFER DURULES [ASCORBIC ACID;FERROUS SULFATE]; TRESIBA; BISOPROLOL; MEZITAN; CO VALSACOR; METFORMIN
Current Illness: Atherosclerosis of arteries of the extremities; Atrial fibrillation; Benign prostatic hyperplasia; Gastroesophageal reflux; Hypertension; Non-insulin-dependent diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021244011

Write-up: pale; sweating; unable to keep stool; very poor condition; death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority -WEB [HU-OGYI-085221]. This spontaneous, serious case was reported by an other health care professional on 18Feb2021 concerning death after the administration of Comirnaty concentrate for dispersion for injection (30 micrograms of COVID-19 mRNA Vaccine, MAH: BioNTech Manufacturing GmbH/ Pfizer). On 31Jan2021, the 88-year-old male patient, who was a resident of a social care institute, received the first dose of Comirnaty (COVID-19 mRNA Vaccine (nucleoside modified)/Tozinameran) concentrate for dispersion for injection (strength: 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine, intramuscularly, left arm, batch number: EJ6134). (Date of admission to the hospital: 16Feb2021). On 16Feb2021, the patient was transported to the hospital in a very poor condition, he was pale, sweating, unable to keep stool. On 18Feb2021 the department of infectious diseases of the hospital reported the patient''s death to the social care institute. No documentation was available. Medical history included atherosclerosis of arteries, atrial fibrillation, benign prostatic hyperplasia, gastroesophageal reflux, hypertension, and non-insulin-dependent diabetes mellitus, all ongoing. Concomitant medication was CO-VALSACOR 160 mg/25 mg film-coated tablet (valsartan; hydrochlorothiazide, once daily), CITROKALCIUM tablet (calcium citrate, once daily), MEZITAN 35 mg modified-release film-coated tablet (trimetazidine, twice daily), NovoRapid (insulin aspart, 22-20-20 IU daily), Tresiba (Insulin degludec, 30 IU daily, SORBIFER DURULES 320 mg film-coated tablet (ferrous sulphate, dried, ascorbic acid, once daily), Furon (furosemide, once daily), KALIUM-R tablet (potassium chloride, once daily), unknown tamsulosin 0.4 mg daily, unknown bisoprolol 5 mg daily, unknown metformin 1000 mg daily, and unknown doxazosin 2 mg daily. The outcome of the events very poor condition, he was pale, sweating, unable to keep stool was unknown. Senders comment: The 88- year-old patient died 18 days after Comirnaty vaccination. There is no information about whether autopsy was performed and what cause of death was. The causal relationship between the event and Comirnaty is unassessable due to lack of information. The case is serious due to fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1086802 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-01-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Condition aggravated, Dysphagia, Loss of consciousness, Pyrexia
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), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BEN-U-RON; ATORVASTATIN; AMLODIPINE; ASACTAL; CLEXANE
Current Illness: Aphasia motor; Cerebral ischaemia; Hemiparesis (right); Hyperlipidaemia; Hypertension; Ischaemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic alcoholism
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021244005

Write-up: dysphagia; Loss of consciousness; His state was gradually worsening; fever/febrile several times; weakness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is HU-OGYI-098221. A 71-year-old male patient received the second dose of bnt162b2 (COMIRNATY, lot: EL1484, expiry date: Apr20210), intramuscular at 0.3ml single in the left upper arm on 30Jan2021 for covid-19 immunization. The patient''s medical history included ongoing hemiparesis and motor aphasia due to cerebral ischaemia since 2014 resulted of chronic alcoholism from unknown date an unknown if ongoing. The patient had ischaemic heart disease, hypertension and hyperlipidaemia all from unknown date and ongoing. He was in a nursing home since 2014, and his general state was reported to be satisfactory. He was able to sit in a wheelchair and could eat without help. Concomitant medication included paracetamol (BEN-U-RON), atorvastatin, amlodipine, acetylsalicylic acid (ASACTAL) and enoxaparin sodium (CLEXANE). On the next day, 31Jan2021, the patient experienced weakness, he became febrile several times/fever, for which he received ALGOPYRIN. His state was gradually worsening, he developed dysphagia and loss of consciousness. The patient died on 03Feb2021 at 9:15 a.m. An autopsy was not performed. Senders comment: Weakness and fever are expected adverse events of COMIRNATY, listed in the product information. Dysphagia and loss of consciousness were presumably the result of the worsening of the patient''s state. Time to onset is reasonable. Causality between weakness, fever and COMIRNATY is probable. The case is serious because the patient died. No further information is expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: weakness; fever/febrile several times; dysphagia; loss of consciousness; His state was gradually worsening


VAERS ID: 1086803 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021240115

Write-up: got sick with Corona ,one of them also died; got sick with Corona ,one of them also died; This is a spontaneous report from a contactable physician. The physician reported same event for four patients, this is the first of four reports. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE of first dose, via an unspecified route of administration on an unspecified date at SINGLE DOSE of second dose for covid-19 immunisation. Medical history included kidney transplant. The patient''s concomitant medications were not reported. The patient received 2 doses of BNT162b2 and got sick with Corona and died. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information about Batch/Lot number has been requested.; Sender''s Comments: Based on the limited information provided, the Company (Pfizer) cannot exclude that the suspect medication may have contributed to the reported events in this patient. Additional information regarding onset dates of drug administration/ events and concomitant medications will aid in comprehensive assessment of the case. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2021240116 same drug/event in different patients;IL-PFIZER INC-2021240117 same drug/event in different patients;IL-PFIZER INC-2021240118 same drug/event in different patients; Reported Cause(s) of Death: got sick with Corona ,one of them also died; got sick with Corona ,one of them also died


VAERS ID: 1086814 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aneurysm (Abdominal aneurysm operated (2013)); Fracture multiple (hosp. for accidental fall resulting in fracture of the femur and rib fractures with mild ir type i.); Heart disease, unspecified (HYPOKINETICODILATORY HEART DISEASE); Heart failure NYHA class IV (cardiac insufficiency EF(ejection fraction) 31%); Hemorrhage cerebral (post traumatic brain hemorrhage (2017)); Laparocele; Monoclonal gammopathy; Paroxysmal supraventricular tachycardia (associated with hemodynamic instability undergoing slow pathway cryoablation surgery); Prosthesis user (Wearer of right knee prosthesis (2003), left knee prosthesis (2002) and shoulder prosthesis (2000)); Thrombopenia (plateletopenia in monoclonal gammopathy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021242209

Write-up: after more than 24 hours from administration, patient (already suffering from heart failure class IV NYHA) in a soporous state with worsening of dyspnea. Death after about another 5 hours.; after more than 24 hours from administration, patient (already suffering from heart failure class IV NYHA) in a soporous state with worsening of dyspnea. Death after about another 5 hours.; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the Regulatory Authority-WEB (Regulatory authority number IT-MINISAL02-687060). A 95-year-old male patient received BNT162B2 (COMIRNATY; Lot number EP9598; expiration date 30Jun2021) intramuscular in the left arm on 24Feb2021 at 10:00 at single dose for COVID-19 immunisation. Relevant medical history included paroxysmal supraventricular tachycardia from an unknown date and unknown if ongoing (associated with hemodynamic instability undergoing slow pathway cryoablation surgery), prosthesis user from an unknown date and unknown if ongoing (wearer of right knee prosthesis (2003), left knee prosthesis (2002) and shoulder prosthesis (2000)), Heart failure NYHA class IV from 2018 to an unknown date (cardiac insufficiency ejection fraction (EF) 31%), cardiac disorder (hypokineticodilatory heart disease) from an unknown date and unknown if ongoing, post traumatic brain hemorrhage (2017), monoclonal gammopathy from an unknown date and unknown if ongoing, thrombocytopenia from an unknown date and unknown if ongoing (plateletopenia in monoclonal gammopathy), laparocele from an unknown date and unknown if ongoing, multiple fractures from Jan2021 to an unknown date (hospitalization for accidental fall resulting in fracture of the femur and rib fractures with mild ir type I; pathologies ascertained: right femur fracture due to accidental fall in a domestic environment subjected to head prosthesis surgery; tsvp associated with haemodynamic instability subjected to cryoblation of the slow pathway; for multiple vertebral somatic collapses, with somatic collapse of d7 d10 and d12) and abdominal aneurysm from 2013 to an unknown date (abdominal aneurysm operated (2013); at the cardiological visit in Dec2020: precarious general clinical compensation; the cardiologist suggested increasing the diuretic therapy bringing to 2 the 25 mg LASIX tablets per day and the need for a reassessment also of the blood tests (BNP, blood counts electrolytes, creatinine, glycemia, holter ECG of 24h for finding frequent extrasystole) and to perform X-ray of the chest)). Concomitant medications were not reported. On 25Feb2021, after more than 24 hours from administration, the patient (already suffering from heart failure class IV NYHA) was in a soporous state with worsening of dyspnea. Death occurred after about another 5 hours on 25Feb2021. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: dyspnea; sopor


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