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

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



Case Details

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VAERS ID: 1044993 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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: OMEPRAZOLE; ZOPICLONE; FEROPLEX; TRAZODONE; DISTRANEURINE [CLOMETHIAZOLE]; CLOPIDOGREL; LEVETIRACETAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Chronic liver disease; Cognitive impairment; Dyslipidemia; Epilepsy; Hypertension; Living in nursing home
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021158467

Write-up: Heart arrest; This is a spontaneous report from a contactable other Healthcare Professional downloaded from the Regulatory Authority-WEB, Regulatory Authority number ES-AEMPS-738908. A 93-year-old male patient received the second dose of bnt162b2 (COMIRNATY), batch/lot number: EM0477, intramuscularly on 28Jan2021 at 0.3 mL, single for covid-19 immunization. Medical history included Chronic kidney disease, Chronic liver disease, Living in nursing home, cognitive impairment, epilepsy, hypertension, and dyslipidaemia. Concomitant medications included omeprazole 20 mg/12H, zopiclone 7.5 mg / night, iron succinyl-protein complex (FEROPLEX) 800mg / day, trazodone 100mg / night, clomethiazole (DISTRANEURINE) 2 / day, clopidogrel 75mg / day, levetiracetam 500mg / 8 hour. The patient previously received the first dose of bnt162b2 intramuscularly on 07Jan2021 at 0.3 mL, single for covid-19 immunisation. The patient experienced heart arrest on 30Jan2021 and died on 30Jan2021. They notify the Emergency Coordinating Center for sudden death. Death was certified. An autopsy was not performed. The outcome of heart arrest was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: heart arrest


VAERS ID: 1044995 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-31
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: OPTOVITE B12; ADIRO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021158470

Write-up: Hemorrhagic stroke; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB and received via Regulatory Authority ES-AEMPS-742671. A 91-year-old male patient received first dose of BNT162B2 (COMIRNATY, lot number: unknown) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 vaccination, (second dose via intramuscular on 04Feb2021 at 0.3 ml single for COVID-19 vaccination, as reported); acetylsalicylic acid (ADIRO, 100 mg tablet) oral from 2018 at unknown dose and frequency for an unspecified indication. Medical history included Vitamin B12 deficiency. Concomitant medications included cyanocobalamin (OPTOVITE B12) for Vitamin B12 deficiency. The patient experienced haemorrhagic stroke on 31Jan2021, the event caused the patient death (on 01Feb2021, as reported). COVID-19 has not happened. The action taken to the event for acetylsalicylic acid was not applicable. It was unknown if an autopsy was done or not. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1044997 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-19
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood cholesterol, Blood potassium, Blood triglycerides, Cardio-respiratory arrest, Drowning, Drug level, Haemoglobin, International normalised ratio, Laboratory test, 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), Accidents and injuries (narrow), Hostility/aggression (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: Adalimumab
Current Illness: Ventriculo-peritoneal shunt (after TBI)
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease; Traumatic brain injury
Allergies:
Diagnostic Lab Data: Test Name: cholesterol; Result Unstructured Data: Test Result:246; Comments: prior to 24Nov2020; Test Date: 20210119; Test Name: cholesterol; Result Unstructured Data: Test Result:229; Test Date: 20210119; Test Name: K; Result Unstructured Data: Test Result:4.36; Test Date: 20210119; Test Name: Triglycerides; Result Unstructured Data: Test Result:139; Test Name: pharmacokinetic study of adalimumab; Result Unstructured Data: Test Result:8030; Comments: prior to 24Nov2020; Test Date: 20210119; Test Name: pharmacokinetic study of adalimumab; Result Unstructured Data: Test Result:in the therapeutic range; Test Date: 20210119; Test Name: Hb; Result Unstructured Data: Test Result:15; Test Date: 20210119; Test Name: INR; Result Unstructured Data: Test Result:0.87; Test Date: 20210119; Test Name: laboratory tests; Result Unstructured Data: Test Result:normal; Test Date: 20200311; Test Name: an antigen test for COVID-19; Test Result: Negative
CDC Split Type: ESPFIZER INC2021158463

Write-up: drowning; cardiorespiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB manufacturer report number ES-AEMPS-745520. A 43-years-old male patient received fist dose of BNT162B2 (COMIRNATY), intramuscular on 13Jan2021 at 0.3 ml, single for COVID-19 immunisation; adalimumab, subcutaneous from 26Feb2020 to 2020 at 40 mg once a day (induction 160 mg), then via an unspecified route of administration, from 08May2020 to 2020 at 40 mg/ 10 days, then from 03Nov2020 to an unspecified date at 8 mg, then from an unspecified date to 15Jan2021 at 40 mg/14 days, for Crohn''s disease. Medical history included Traumatic brain injury (TBI) from 1998, ventriculo-peritoneal bypass valve (after TBI) in 1998, Crohn''s disease from 2011. Concomitant medications were not reported. On 19Jan2021 patient went for a digestive control visit, being asymptomatic of his digestive pathology, with normal laboratory tests and with pre-dose adalimumab levels in the therapeutic range. It is decided to keep the same treatment. On 19Jan2021: cholesterol 229, Triglycerides (TG) 139, Hb 15, international normalized ratio (INR) 0.87, K 4.36 (prior to 24Nov2020: Cholesterol 246 and pharmacokinetic study of adalimumab pre-dose adalimumab levels of 8030). On 19Jan2021 they notify the medical emergency service for finding the patient submerged in a public swimming pool. Advanced CPR measures are initiated without response, first recorded rhythm: asystole. Resuscitation maneuvers were stopped when the pool cameras verified that the patient had been submerged for 30 minutes. Death due to cardiorespiratory arrest due to drowning by immersion was reported. The family is notified, which is the one that communicates the information to the digestive service. Pending autopsy by court order. Lab data included: on 11Mar2020 an antigen test for COVID-19 by contact with a possible case, which was negative. The action taken to the events for adalimumab was permanently withdrawn on 15Jan2021. It was unknown if an autopsy was done or not. Pfizer is a marketing authorization holder of adalimumab in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of adalimumab has submitted the same report to the regulatory authorities No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: drowning; cardiorespiratory arrest


VAERS ID: 1044998 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-31
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Blood alkaline phosphatase, Blood lactate dehydrogenase, Gamma-glutamyltransferase, Haemoglobin, Haemophagocytic lymphohistiocytosis, Hepatic failure, Hepatitis acute, Lymphocyte count, Multiple organ dysfunction syndrome, Neutrophil count, Pharyngotonsillitis, Platelet count, Respiratory failure, Shock, White blood cell count
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Agranulocytosis (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), Oropharyngeal infections (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TOCILIZUMAB; PARACETAMOL; ATROVENT; PARACETAMOL; NOLOTIL [METAMIZOLE MAGNESIUM]; PREDNISONE; NOLOTIL [METAMIZOLE MAGNESIUM]; VENTOLINE [SALBUTAMOL]; AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]; SYMBICORT; URBASON [METHYLPREDNISOLONE]; ENANTYUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; COVID-19 pneumonia (Covid-19); Esophageal candidiasis; Herpes zoster; Mononucleosis; Pharyngotonsillitis; Pollen allergy; Tuberculous pneumonia (any form)
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:880; Test Date: 20210206; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:2714; Test Date: 20210204; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:1061; Test Date: 20210206; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:4708; Test Date: 20210206; Test Name: ALK phosph; Result Unstructured Data: Test Result:79; Test Date: 20210206; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:126000; Test Date: 20210204; Test Name: Gamma-glutamyltransferase; Result Unstructured Data: Test Result:76; Test Date: 20210205; Test Name: Gamma-glutamyltransferase; Result Unstructured Data: Test Result:127; Test Date: 20210204; Test Name: Haemoglobin; Result Unstructured Data: Test Result:14; Test Date: 20210206; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11,8; Test Date: 20210204; Test Name: Lymphocytes; Result Unstructured Data: Test Result:150; Test Date: 20210206; Test Name: Lymphocytes; Result Unstructured Data: Test Result:210; Test Date: 20210204; Test Name: Neutrophils; Result Unstructured Data: Test Result:2400; Test Date: 20210206; Test Name: Neutrophils; Result Unstructured Data: Test Result:500; Test Date: 20210204; Test Name: Platelet count; Result Unstructured Data: Test Result:132000; Test Date: 20210206; Test Name: Platelet count; Result Unstructured Data: Test Result:59000; Test Date: 20210204; Test Name: WBC; Result Unstructured Data: Test Result:2700; Test Date: 20210206; Test Name: WBC; Result Unstructured Data: Test Result:800
CDC Split Type: ESPFIZER INC2021159400

Write-up: Multiple organ failure; suspected hemophagocytic syndrome; Hepatitis acute; liver failure; refractory shock; pharyngotonsillitis; respiratory failure; increased transaminases; This is a spontaneous report from a contactable physician downloaded from the Agency ES-AEMPS-747344. A 26-year-old male patient received first dose of BNT162B2 (COMIRNATY) Lot number EL1491, Intramuscular on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 pneumonia on 26Oct2020 (Bilateral pneumonia. No mechanical ventilation. Confirmed by PCR), Esophageal candidiasis in 2015, Pollen allergy in 2008, Asthma in 2008, Mononucleosis in 2015, Tuberculous pneumonia (any form) in 2003, Herpes zoster on 03Jun2011, Pharyngotonsillitis in 2015. Concomitant medications included tocilizumab from Nov2020 for COVID-19 pneumonia, paracetamol administration in hospital emergencies on 30Jan2021 and 01Feb2021, ipratropium bromide (ATROVENT) administration in hospital emergencies on 30Jan2021, paracetamol tablet from 30Jan2021, metamizole magnesium (NOLOTIL) administration in hospital emergencies on 01Feb2021, prednisone tablet from 30Jan2021, metamizole magnesium (NOLOTIL) Capsule, hard from 01Feb2021, salbutamol (VENTOLINE) from 30Jan2021, amoxicillin, clavulanic acid (AUGMENTINE) from 01Feb2021, budesonide, formoterol fumarate (SYMBICORT) from 03Nov2020, methylprednisolone (URBASON) administration in hospital emergencies on 30Jan2021, dexketoprofen trometamol (ENANTYUM) administration in hospital emergencies on 01Feb2021, and salbutamol administration in hospital emergencies on 30Jan2021. The patient started with symptoms of pharyngotonsillitis on 31Jan2021, various antibiotic treatments Amoxicillin-clavulanic, cefditoren. He developed respiratory failure and increased transaminases. Evolution with liver failure, refractory shock, Hepatitis acute, suspected hemophagocytic syndrome, Multiple organ failure on 04Feb2021. The patient was hospitalized for all events. The patient died on 07Feb2021 due to liver failure, refractory shock, Hepatitis acute, suspected hemophagocytic syndrome, Multiple organ failure. Autopsy was done. In lung biopsy and liver postmortem, HSV-1 in high quantity. The patient underwent lab tests and procedures which included alanine aminotransferase: 880 on 04Feb2021, alanine aminotransferase: 2714 on 06Feb2021, aspartate aminotransferase: 1061 on 04Feb2021, aspartate aminotransferase: 4708 on 06Feb2021, ALK phosph: 79 on 06Feb2021, Lactate dehydrogenase: 126000 on 06Feb2021, gamma-glutamyltransferase: 76 on 04Feb2021, gamma-glutamyltransferase: 127 on 05Feb2021, haemoglobin: 14 on 04Feb2021, haemoglobin: 11,8 on 06Feb2021, Lymphocytes: 150 on 04Feb2021, Lymphocytes: 210 on 06Feb2021, Neutrophils: 2400 on 04Feb2021, Neutrophils: 500 on 06Feb2021, platelet count: 132000 on 04Feb2021, platelet count: 59000 on 06Feb2021, WBC: 2700 on 04Feb2021, WBC: 800 on 06Feb2021. The outcome of pharyngotonsillitis, respiratory failure, increased transaminases was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hepatitis acute; liver failure; refractory shock; suspected hemophagocytic syndrome; Multiple organ failure; Autopsy-determined Cause(s) of Death: HSV-1


VAERS ID: 1045000 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2021-01-05
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: 2021-01-25
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: COVID-19; Test Result: Positive
CDC Split Type: ESPFIZER INC2021163688

Write-up: COVID-19; This is a spontaneous report from a contactable consumer. This report was downloaded from Medicines Agency (MA) regulatory authority-WEB and received via Regulatory Authority ES-AEMPS-735202. An elderly (over 65 years old) male patient received the 1st dose bnt162b2 (COMIRNATY) , via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced covid-19 (positive for COVID-19) on 05Jan2021 with outcome of fatal. The patient died on 25Jan2021. It was not reported if an autopsy was performed. The cause of death was covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1045006 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-27
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Seizure, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), 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), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE HYDROCHLORIDE]; PANADOL FORTE [PARACETAMOL]; MELATONIN ORION; VENLAFAXIN KRKA; MEMANTIN ORION; AMLODIPIN ORION [AMLODIPINE BESILATE]; OPAMOX; OXYNORM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Depression; Gout; Hyperplasia of the prostate; Hypertension; Insomnia; Pain; Restlessness
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021159025

Write-up: Sudden death; sudden seizure; a sudden stroke of a brain or heart origin; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB FI-FIMEA-20210540. A 77-year-old male patient received his first dose of bnt162b2 (COMIRNATY, lot number EJ6795), intramuscular on 14Jan2021 at single dose for COVID-19 vaccination. Medical history included Alzheimer''s disease, hypertension, prostate hyperplasia, gout, depression, pain, insomnia and restlessness. Concomitant medication included cyanocobalamin, folic acid, pyridoxine hydrochloride (TRIOBE), paracetamol (PANADOL FORTE) for pain, melatonin (MELATONIN ORION) for insomnia, venlafaxine hydrochloride (VENLAFAXIN KRKA) for depression, memantine hydrochloride (MEMANTIN ORION) for Alzheimer''s disease, amlodipine besilate (AMLODIPIN ORION) for hypertension, oxazepam (OPAMOX) for restlessness and oxycodone hydrochloride (OXYNORM). The patient experienced sudden death on 27Jan2021. The patient died of a sudden seizure 13 days after the vaccination on 27Jan2021. There were no specific symptoms during or after administration of the vaccine and well-being was normal between administration and death. Sudden seizure appeared on the night of January 27, 2021, the patient was found in a semi-sitting position, gasping breathing, pale face, and no speech contact could be made with him. Shortly thereafter, he became lifeless. Resuscitation was not performed according to treatment guidelines. Underlying diseases: Alzheimer''s disease, hypertension, prostate hyperplasia, gout, depression. First dose of vaccine. Based on preliminary data and event data, reporter thought it wa unlikely that the administration of the vaccine would have resulted in death. Death compatible rather with a sudden stroke of a brain or heart origin, to which the underlying diseases were predisposing. The patient died on 27Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: sudden death; sudden seizure; a sudden stroke of a brain or heart origin


VAERS ID: 1045007 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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: THYROXIN; FRAGMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Hypertension; Pancreatic cancer metastatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021159024

Write-up: General physical health deterioration/The general well-being deteriorated rapidly; This is a spontaneous report from a non-contactable other healthcare professional downloaded from the Medicines Agency (MA) Regulatory authority-WEB FI-FIMEA-20210542. An 80-year-old female patient receive BNT162B2 (COMIRNATY, lot number was EJ6134 and expiration date was unknown) via intramuscular on 27Jan2021 at single dose for COVID-19 vaccination. Medical history included extensive metastatic pancreas cancer diagnosed in Dec2020, flimmer (atrial fibrillation) and hypertension (HTA). Patient received palliative care policy. Concomitant medication included levothyroxine sodium (THYROXIN) and dalteparin sodium (FRAGMIN). Patient had general physical health deterioration on 27Jan2021. The general well-being deteriorated rapidly from the day of vaccination (27Jan2021), although even before that the general well-being had decreased. The patient died due to general well-being deteriorated on 30Jan2021. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: General physical health deterioration/The general well-being deteriorated rapidly


VAERS ID: 1045010 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: Tahor; KEPPRA; DIFFU K; SERESTA; METFORMIN; IMOVANE; KARDEGIC; LASILIX FAIBLE; TIAPRIDAL; EUPANTOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use (quitted); Aortic stenosis (calcified); Arterial hypertension; Epilepsy (sequelae); Fall (without sequelae, without secondary clinical modification); Hospitalisation; NIDDM; Peripheral arterial occlusive disease; Stroke (sylvian); Tobacco user (quitted)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021159139

Write-up: Death unexplained; This is a spontaneous report from a contactable physician from PHYSICIAN downloaded from the Medicines Agency (MA) Regulatory authority-WEB FR-AFSSAPS-AM20210181. A 75-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6788) intramuscular on 19Jan2021 at single dose for covid-19 immunization, and atorvastatin calcium (TAHOR) film-coated tablet oral at 1 DF once a day, levetiracetam (KEPPRA) oral at 2 DF once a day, potassium chloride (DIFFU K) oral at 3 DF once a day, oxazepam (SERESTA) oral 3 DF once a day, Metformin oral 3 DF once a day, zopiclone (IMOVANE) oral at 1 DF once a day, acetylsalicylate lysine (KARDEGIC) oral at 1 DF once a day, furosemide (LASILIX FAIBLE) oral at 1 DF once a day, tiapride hydrochloride (TIAPRIDAL) oral at 145 mg once a day, for unspecified indications. Medical history included Stroke, Arterial hypertension, NIDDM, Aortic stenosis, Peripheral arterial occlusive disease, tobacco user, alcohol use, epilepsy (sequelae), hospitalized since 19Oct2020, fall on 17Jan2021 without sequelae, without secondary clinical modification. Patient well balanced with regard to his chronic pathologies and generally stable. The patient''s concomitant medications were not reported. The patient first injected on 19Jan2021, very well tolerated, no clinical degradation. On 24Jan2021, patient found deceased, death unexplained. No autopsy, no obvious clinical or biological explanation. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1045014 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy; Bronchial superinfection; COPD (Severe); Fall (Repeated); Heart failure (under diuretic therapy); Major neurocognitive disorder (of vascular origin); Prostate cancer (with bone metastases); Respiratory failure (Many episodes of); Steroid dependence (Cortico-dependence)
Allergies:
Diagnostic Lab Data: Test Name: PCR test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC2021159141

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB, Regulatory authority report number FR-AFSSAPS-CN20210263. A 92-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EM0477), via intramuscular at left arm on 14Jan2021 at 0.3 mL, single for COVID-19 vaccination. The patient''s medical history included severe chronic obstructive pulmonary disease (COPD), bronchial superinfection, many episodes of respiratory failure, cortico-dependence, heart failure under diuretic therapy, prostate cancer with bone metastases, major neurocognitive disorders of vascular origin, repeated falls and anticoagulant therapy. The patient had no history of COVID-19. Patient had PCR test history with unknown results. COVID-19 risk factors included heart and respiratory failure. Allergic history was unknown. Concomitant medications were not reported. Death was observed on 16Jan2021, without signs of poor tolerance since vaccination. Patient was found dead in bed in the morning. The patient died on 16Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1045017 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / 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: 2021-01-30
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic bronchitis; Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: PCR SARS-COV 2; Test Result: Positive
CDC Split Type: FRPFIZER INC2021159140

Write-up: COVID-19 aggravated/Fever/ PCR test which turns out to be positive/ suspicion of bronchitis/ deterioration of the patient''s condition; This is a spontaneous report from a contactable other HCP from the Medicines Agency (MA) regulatory authority-WEB FR-AFSSAPS-LY20210485. An 88-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6788), intramuscularly on 19Jan2021 at single dose, for covid-19 immunisation. Medical history included chronic bronchitis, autonomy: GIR 1, and living in nursing home from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Usual treatment not known. On 19Jan2021, in the morning, 1st injection of bnt162b2, after pre-vaccination consultation. At this time, no symptoms. Stable state of health throughout the day. On 20Jan2021, faced with the presence of a fever at the end of the day, he benefits from a PCR test which turns out to be positive (but the result will not be discovered by the nursing home until 23Jan2021). On 21Jan2021, prescription of antibiotics on suspicion of bronchitis. In the following days, deterioration of the patient''s condition, with several trips to / from the hospital with return to nursing home as soon as the patient''s condition stabilizes. On 28Jan2021, hospitalization. On 30Jan2021, death. COVID-19 cluster in the facility. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Jan2021. The outcome of the event was fatal. The patient died on 30Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 aggravated/Fever/ PCR test which turns out to be positive/ suspicion of bronchitis/ deterioration of the patient''s condition


VAERS ID: 1045021 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Oxygen saturation, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   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: APIXABAN; SERESTA; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Breast cancer NOS; Cardiac failure; Hypertension; Mitral valve replacement
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: oxygen saturation; Test Result: 74 %
CDC Split Type: FRPFIZER INC2021160040

Write-up: Death unexplained; Oxygen saturation decreased; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB FR-AFSSAPS-MA20210320. A 93-year-old female patient received first dose of bnt162b2 (COMIRNATY) (lot/batch number EJ6788), intramuscular on 28Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included cardiac failure/heart failure from an unknown date and unknown if ongoing, rhythm disturbances, bio-mitral prosthesis, left breast cancer, hypertension. Patient considered to be at risk of developing a severe form of COVID-19. Patient who did not have COVID-19. Concomitant medications included apixaban, oxazepam (SERESTA), paracetamol, mirtazepam. The patient experienced death unexplained on 02Feb2021, oxygen saturation decreased (death) on 29Jan2021. Appearance of a 74% in O2 desaturation with rapid degradation of the patient during the weekend of 30-31Jan. Unconfirmed suspicion of COVID-19 (no PCR performed). The patient died on 02Feb2021. 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 unexplained; Oxygen saturation decreased


VAERS ID: 1045024 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood pressure systolic decreased, Blood pressure systolic increased, Cardiac arrest, Fatigue, Hypoperfusion, Pain in jaw
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), 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), Hypertension (narrow), Cardiomyopathy (broad), Osteonecrosis (broad), Respiratory failure (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ISOPTINE; KARDEGIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial (main antecedent of hypertension treated and balanced with Isoptine 120 mg and Kardegic 75 mg)
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: blood pressure; Result Unstructured Data: Test Result:110/70 mmHg; Comments: At 10h, her blood pressure was 110/70 mmHg; Test Date: 20210202; Test Name: systolic pressure; Result Unstructured Data: Test Result:80 mmHg; Comments: her blood pressure (in self-measurement) was 80 mmHg systolic at 7 a.m.
CDC Split Type: FRPFIZER INC2021159195

Write-up: Cardiac arrest; Pain jaw; Hypoperfusion; Fatigue; 80 mmHg systolic; This is a spontaneous report from a contactable physician from the Medicines Agency (MA) Regulatory authority-WEB FR-AFSSAPS-PB20210242. A 93-year-old female patient received BNT162B2 (COMIRNATY, lot number: EK9788) first dose on 01Feb2021 intramuscular on Arm Left at single dose for COVID-19 immunisation. Medical history included Hypertension arterial (with the main antecedent of hypertension treated and balanced with Isoptine 120 mg and Kardegic 75 mg) from unspecified date and unknown if ongoing. Concomitant medication included verapamil hydrochloride (ISOPTINE) 120 mg and acetylsalicylate lysine (KARDEGIC) 75 mg, both for hypertension. Patient was described as being very active, autonomous (shopping alone), with the main antecedent of hypertension treated and balanced with Isoptine 120 mg and Kardegic 75 mg. No Covid test performed and patient not having had Covid. On 01Feb2021, she was vaccinated with COMIRNATY, the first intramuscular injection in the left arm. The day after the vaccination, on 02Feb2021, she presented with fatigue, cold hands, pain in the jaw and her blood pressure (in self-measurement) was 80 mmHg systolic at 7 a.m. At 10h, her blood pressure was 110/70 mmHg, then the patient went into cardiac arrest a few minutes later, after a first cardiac massage, her heart started again and then she had a second cardiac arrest with a sign of ischemia of the brainstem ( pronation of both upper limbs) motivating a second cardiac massage. Patient also had Hypoperfusion. After a deep breath, the patient died. It was unknown if autopsy was done. The outcome of events Pain jaw, Hypoperfusion, Fatigue was not recovered. The outcome of event 80 mmHg systolic was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1045025 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-30
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cholecystitis
SMQs:, Infectious biliary disorders (narrow), Gallbladder related disorders (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: Gallstones; Hypertension arterial; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021160042

Write-up: Cholecystitis; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-PB20210243. A 94-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6795), intramuscularly on 21Jan2021 at single dose for COVID-19 vaccination. Medical history included hypertension arterial, gallstones and stroke, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced cholecystitis on 30Jan2021. On 31Jan2021, cholecystitis prompting hospitalization, with fatal outcome. She had an anticoagulant for treatment (not specified), did not have Covid and did not have a test. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cholecystitis


VAERS ID: 1045028 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Alzheimer''s disease; Anxiodepressive syndrome; Behaviour disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021159196

Write-up: Intracranial haematoma; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB FR-AFSSAPS-PO20210283. An 85-year-old female patient received her first dose of bnt162b2 (COMIRNATY, lot EJ6788), intramuscularly on left arm on 02Feb2021 at single dose for COVID-19 immunization. Medical history included Alzheimer''s disease, Anxiodepressive syndrome, behaviour disorder, atrial fibrillation (AFib). The patient''s concomitant medications were not reported. On 03Feb2021, the patient was unwell. No particular symptoms, no change in general condition or behavior between vaccination and malaise. The patient was hospitalized urgently. An intracranial hematoma was detected. The evolution was rapidly pejorative leading to the death of the patient. The report was under investigation. The patient did not have COVID-19. She had not been tested. The patient died on 03Feb2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected. Batch/lot number already obtained.; Reported Cause(s) of Death: Intracranial haematoma


VAERS ID: 1045029 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic obstructive pulmonary disease; Chronic renal failure; Constipation (Before vaccination, the patient complained of constipation, but stool in the evening); Hypertension arterial; Insulin-requiring type 2 diabetes mellitus; Prosthesis implantation; Sleep apnea syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021160041

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-RE20210233. An 87-year-old male patient received first dose of BNT162B2 (COMIRNATY, batch/lot number: EJ6788) intramuscularly in the right arm on 29Jan2021 at single dose for covid-19 immunisation. Medical history included chronic renal failure, chronic obstructive pulmonary disease, insulin-requiring type 2 diabetes mellitus (Insulin-dependent diabetes), atrial fibrillation, sleep apnoea syndrome, hypertension arterial, aortic prosthesis. Before vaccination, the patient complained of constipation, but stool in the evening. The patient''s concomitant medications were not reported. Patient was considered to be at risk of developing a severe form of the disease COVID-19, not having contracted COVID-19 and not being tested. First vaccination with BNT162B2 in the right arm on 29Jan2021. After the vaccination, watched by her daughter during the day, at her home. Nothing to report, no clinical signs. Sudden death of the patient occurred at 14:00 on 30Jan2021, at his home noted by the caregiver. The patient died on 30Jan2021. Cause of death reported as sudden death. It was not reported if an autopsy was performed. Outcome is fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1045034 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
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, Diarrhoea, Heart rate, Hypotension, Malaise, Oxygen saturation, Oxygen saturation decreased, Respiratory depression, SARS-CoV-2 test, Septic shock, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   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: Dementia Alzheimer''s type; Hip prosthesis insertion (Total right hip replacement); Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer (right breast neoplasia); Depression
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: Blood pressure; Result Unstructured Data: Test Result:115 / 77 mmHg; Test Date: 20210204; Test Name: heart rate; Result Unstructured Data: Test Result:110 / minute; Test Date: 20210204; Test Name: desaturation; Test Result: 80 %; Comments: 80 percent desaturation; Test Date: 20210204; Test Name: desaturation; Result Unstructured Data: Test Result:91-92 %; Comments: a rise in saturation to 91-92 percent; Test Date: 20210205; Test Name: Covid-19 virus test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021159199

Write-up: septic shock; acute respiratory depression; Hypotension; Oxygen saturation decreased; Feeling sick; Diarrhea; Tachycardia; This is a spontaneous report from a contactable Physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB FR-AFSSAPS-TO20210407. This is a report received from the Regulatory Authority. A 92-year-old female patient received her first dose of bnt162b2 (COMIRNATY, lot number EJ6788), intramuscularly on right arm on 04Feb2021 at single dose for COVID-19 vaccination. Medical history included breast cancer (right breast neoplasia), ongoing dementia alzheimer''s type, ongoing hip prosthesis insertion (Total right hip replacement), ongoing hypothyroidism, depression from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced hypotension, oxygen saturation decreased, feeling sick, diarrhea and tachycardia on 04Feb2021. Serious criteria reported as death and hospitalization for events. Faint-like discomfort with profuse diarrhea, grayish face complexion, regular tachycardia 110 / minute, 80 percent desaturation. Placed in decubitus raised legs with emergency O2 put on (3 liters / minute with nasal glasses to obtain a rise in saturation to 91-92 percent). Follow-up 30 minutes after: blood pressure 115 / 77mm Hg, Regular heartbeats 85 bpm, Stay on watch. Suspicion of Covid-19 infection negative on 05Feb2021. Hospitalized for septic shock on 06Feb2021 at a urinary call point in a context of acute respiratory depression. Implementation of antibiotic therapy with Rocephin on 06Feb2021. The patient died on 06Feb2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers already obtained.; Reported Cause(s) of Death: Hypotension; Oxygen saturation decreased; Feeling sick; Diarrhea; Tachycardia; septic shock; acute respiratory depression; Respiration failure


VAERS ID: 1045037 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Oxygen saturation, Oxygen saturation decreased, Pyrexia
SMQs:, Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type (advanced); Fibrillation atrial; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: desaturation; Test Result: 77 %
CDC Split Type: FRPFIZER INC2021160106

Write-up: Fever; 77 percent desaturation; Acute respiratory distress syndrome; This is a spontaneous report from a contactable Physician downloaded from the regulatory authority-WEB FR-AFSSAPS-TO20210500. An 89-years-old female patient started to receive bnt162b2 (COMIRNATY, lot EJ6788), intramuscular on 02Feb2021 at 1 DF, single for covid-19 immunisation. Medical history included advanced Alzheimer''s dementia, arterial hypertension, atrial fibrillation. The patient''s concomitant medications were not reported. The patient experienced fever, 77 percent desaturation, acute respiratory distress syndrome on 05Feb2021 with urgent medical intervention and palliative care, leading to death on 7Feb2021. Therapeutic measures were taken as urgent medical intervention and palliative care. 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: Acute respiratory distress syndrome; 77 percent desaturation; fever


VAERS ID: 1045038 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Circulatory collapse, Diarrhoea, Faecal vomiting, Gastrointestinal haemorrhage, Hypotension, Oxygen saturation decreased, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (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), 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), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   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: PROPYLEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (Anticoagulated); Dementia; Hyperthyroidism (Hyperthyroidism under propylex); TIA
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021159198

Write-up: Haemorrhage of digestive tract; Fecal vomiting; Collapse cardiovascular; Anaphylactic shock; Hypotension; Tachycardia; Oxygen saturation decreased; Diarrhea/black diarrhea; This is a spontaneous report from a contactable physician from the Medicines Agency (MA) Regulatory authority-WEB FR-AFSSAPS-TO20210508. A 90-year-old female patient received bnt162b2 (COMIRNATY) (lot no EJ6788) intramuscularly on left arm on 26Jan2021 at a single dose for COVID-19 immunisation. Medical history included hyperthyroidism under propylex, atrial fibrillation (anticoagulated), transient ischaemic attack (TIA), dementia, all unknown if ongoing. Concomitant medication included propylthiouracil (PROPYLEX) for hyperthyroidism. CLINICAL SIGNS: 28Jan2021: picture of anaphylactic shock, hypotension, tachycardia, desaturation (oxygen saturation decreased) and diarrhea. 29Jan2021: picture of digestive hemorrhage with black diarrhea and fecal vomiting, collapse (collapse cardiovascular). EVOLUTION: Death. All events were considered serious as fatal. Patient died on 29Jan2021 due to anaphylactic shock, hypotension, tachycardia, desaturation (oxygen saturation decreased), diarrhea, digestive hemorrhage with black diarrhea, fecal vomiting, collapse (collapse cardiovascular). It was unknown if an autopsy was performed or not. Reporting physician considered COVID-19 vaccination caused the death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Haemorrhage of digestive tract; Anaphylactic shock; Collapse cardiovascular; Oxygen saturation decreased; Fecal vomiting; Tachycardia; Hypotension; Diarrhea/black diarrhea


VAERS ID: 1045039 (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: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Disease Parkinson''s; Ischaemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: General physical health deterioration (for 1 month); Living in nursing home; Myocardial infarction; Wheelchair user
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021160108

Write-up: Edema pulmonary; flare-up of heart failure; This is a spontaneous report from a contactable consumer from the Medicines Agency (MA) Regulatory authority-WEB regulatory authority number FR-AFSSAPS-TS20210221. A 91-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 21Jan2021 12:35 at single dose for covid-19 immunisation. Medical history included ongoing Ischaemic heart disease; ongoing Disease Parkinson''s; Living in nursing home (in EHPAD); myocardial infarction from 2009 and unknown if ongoing; Use a wheelchair from an unknown date and unknown if ongoing; Alteration of the general condition for 1 month. The patient''s concomitant medications were not reported. The patient experienced edema pulmonary on 23Jan2021 and died on 23Jan2021.Post-injection monitoring: no arterial hypertension. Monitoring for 48 hours: nothing to report. 23Jan2021 in the morning he did not feel well.Call from the doctor who came to see him in the morning.On arrival, there were clinical signs of the beginning of pulmonary edema. The patient received medical care but death at 4:32 p.m.In all, a fatal flare-up of heart failure on day 2 of vaccination with Comirnaty in a patient with ischemic heart disease who has had a deterioration in his general condition for 1 month. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: flare-up of heart failure; Edema pulmonary


VAERS ID: 1045309 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORIZAL PLUS; SPIRIVA; CELMANTIN; XOZAL
Current Illness: Arterial hypertension; Hyperlipidaemia
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021159093

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB GR-GREOF-20211011 and received via Regulatory Authority. An 86-year-old male patient received the first dose of bnt162b2 (COMIRNATY), lot number: EL1491, via an unspecified route of administration on 21Jan2021 at 0.3 mL, single for covid-19 immunisation. Medical history included pneumonia, ongoing arterial hypertension, ongoing hyperlipidaemia. Concomitant medications included amlodipine besilate, hydrochlorothiazide, olmesartan medoxomil (ORIZAL PLUS), tiotropium bromide (SPIRIVA), rosuvastatin calcium (CELMANTIN), levocetirizine dihydrochloride (XOZAL). The patient experienced death on 22Jan2021. The patient died on 22Jan2021. An autopsy was not performed. Serious criteria for the case was reported as fatal and medical significant. Reporter''s comments: the patient received the first dose of comirnaty on 21/1/2021. One week later his daughter called at the vaccination center and reported the patient''s death on 22/1/2021. According to the medical history he has presented pneumonia and on vaccination day he had arterial hypertension, hyperlipidaemia and was under medication (inhalation) with celmantin, orizal plus, spiriva and xozal. There was no problem during the vaccination and the patient was discharged from the vaccination center by the protocol. Clinically he was in very good condition. He didn''t present adverse reaction at the vaccination center. Sender''s comments: On 8/2/2021 the national organization received the first information. On 1/2/2021 started the investigation. On 9/2/2021 the case was examined by the national pharmacovigilance committee/working group. Initial report with additional information. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The patient received the first dose of comirnaty on 21/1/2021. One week later his daughter reported the patient''s death on 22/1/2021. According to the medical history he has presented pneumonia and on vaccination day he had arterial hypertension, hyperlipidaemia and was under medication (inhalation) with celmantin, orizal plus, spiriva and xozal. There was no problem during the vaccination and the patient was discharged from the vaccination center by the protocol. Continued in narraitve; Reported Cause(s) of Death: death


VAERS ID: 1045321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypotension, Melaena
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Gastrointestinal haemorrhage (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Cognitive impairment; Hospitalization (patient was a long stay resident); Hyperlipidemia; Hypernatremia; Hypertension; Normal pressure hydrocephalus; Panic attack; Peptic ulcer disease; Vertigo
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021158957

Write-up: HYPOTENSIVE; MELAENA; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB (IE-HPRA-2021-065097). An 86-year-old female patient received the first dose of bnt162b2 (COMIRNATY) on 14Jan2021 at a single dose for COVID-19 immunisation. Medical history included panic attack, hypernatremia, vertigo, anxiety, hypertension, peptic ulcer disease, hyperlipidemia, normal pressure hydrocephalus, cognitive impairment. Since 2009, the patient was a long stay resident. The patient''s concomitant medication was not outlined at the time of reporting. On 16Jan2021, the patient became hypotensive and developed melaena. The patient was treated conservatively. On 23Jan2021, the patient died. Cause of death was reported as hypotensive and melaena. The reporting physician outlined that the patient''s death was more coincidental than a reaction and the patient''s death was only reported due to the proximate time interval to the vaccine. The case was reported to the coroner who requested an autopsy. The reporting physician commented that had the patient not received the vaccine, the deterioration would have been treated the same way but she would not have had coroner involvement or the autopsy. The outcome of the events was fatal. An autopsy was cone but autopsy results was not available. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected. ; Reported Cause(s) of Death: MELAENA; HYPOTENSIVE


VAERS ID: 1045359 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Myalgia, Regurgitation, Somnolence, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   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: BISOPROLOL HEMIFUMARATE; TAREG; TAVOR [LORAZEPAM]; LASITONE; ELIQUIS; LASIX [FUROSEMIDE]; CACIT VITAMINA D3; PANTOPRAZOLE SODIUM SESQUIHYDRATE; ALENDRONATE SODIUM; PAROXETINE; TACHIDOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Decompensation cardiac; Depression; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021158456

Write-up: Regurgitation after dinner in the evening of vaccination day. Muscle pain and drowsiness already pre-existing to vaccination have been reported. Episode of bilious vomiting on the 30Jan following day death; Regurgitation after dinner in the evening of vaccination day. Muscle pain and drowsiness already pre-existing to vaccination have been reported. Episode of bilious vomiting on the 30Jan following day death; Regurgitation after dinner in the evening of vaccination day. Muscle pain and drowsiness already pre-existing to vaccination have been reported. Episode of bilious vomiting on the 30Jan following day death; Regurgitation after dinner in the evening of vaccination day. Muscle pain and drowsiness already pre-existing to vaccination have been reported. Episode of bilious vomiting on the 30Jan following day death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-673481. A 92-year-old female patient received BNT162B2 (COMIRNATY; Lot number EJ6797), intramuscular in the left arm on 25Jan2021 as the first single dose for covid-19 immunisation. Medical history included atrial fibrillation, decompensation cardiac, depression and hypertension from unknown dates and unknown if ongoing. Concomitant medication included bisoprolol fumarate (BISOPROLOL HEMIFUMARATE), valsartan (TAREG), lorazepam (TAVOR), furosemide, spironolactone (LASITONE), apixaban (ELIQUIS) , furosemide (LASIX), calcium carbonate, colecalciferol (CACIT VITAMINA D3), pantoprazole sodium sesquihydrate (MANUFACTURER UNKNOWN), alendronate sodium (MANUFACTURER UNKNOWN), paroxetine (MANUFACTURER UNKNOWN), codeine phosphate, paracetamol (TACHIDOL). On 26Jan2021, the patient experienced regurgitation after dinner in the evening of vaccination day. muscle pain and drowsiness already pre-existing to vaccination have been reported. episode of bilious vomiting on the 30Jan following day death. The events were serious as it lead to death. An end date of the events was reported as 31Jan2021. The patient died on 31Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Waiting for the clinical report and the indication of the lot number; Reported Cause(s) of Death: Regurgitation after dinner in the evening of vaccination day. Muscle pain and drowsiness already pre-existing to vaccination have been reported. Episode of bilious vomiting on the 30Jan following day death


VAERS ID: 1045454 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Cardiac arrest, Malaise, Myalgia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (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), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   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: MACROGOL; ENALAPRIL; ELIQUIS; CRANBERRY
Current Illness: Hospitalization
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:unknown results; Test Date: 20210203; Test Name: Body temperature; Result Unstructured Data: Test Result:increased
CDC Split Type: NLPFIZER INC2021158432

Write-up: dead on 05Feb2021, Acute cardiac arrest was considered the cause of death; Did not feel fit/malaise; Muscle pain/Myalgia; Subfebrile complaints/body temperature increased; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB regulatory authority number NL-LRB-00439119. An 88-year-old female patient received bnt162b2 (COMIRNATY, batch/lot: EM0477), via an unspecified route of administration on 02Feb2021 at single dose for covid-19 vaccination. Medical history included ongoing staying at a psychogeriatric ward. Concomitant medication included macrogol, enalapril tablet 10mg, apixaban (ELIQUIS) Film-coated tablet 5 mg, cranberry. The patient was staying at a psychogeriatric ward and experienced myalgia, body temperature increased and malaise on 03Feb2021, which had recovered the following day. Event details: The patient had subfebrile complaints the day after vaccination (03Feb2021) and did not feel fit; also had some muscle pain. The day after (04Feb2021), there was no fever and she was not sick. She was found dead in bed in the morning on 05Feb2021. Acute cardiac arrest was considered the cause of death for external examination. The patient underwent lab test included body temperature on an unspecified date with unknown results. The patient recovered from body temperature increased, malaise, and myalgia on 04Feb2021, and the outcome of cardiac arrest was fatal. The patient died on 05Feb2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Acute cardiac arrest


VAERS ID: 1045455 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic bronchitis; Diabetes mellitus non-insulin-dependent; Heart failure; Insufficiency renal (moderate renal insufficiency)
Preexisting Conditions: Medical History/Concurrent Conditions: Agitated (Patient was improving, but to what extent by which day is not clear); Bladder infection; Breast ductal carcinoma (declared "clean" in same year as diagnosis); Confusion (Patient was improving, but to what extent by which day is not clear); Consciousness decreased (Patient was improving, but to what extent by which day is not clear); Food refusal; Thrombosis leg
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: CT scan (brain); Result Unstructured Data: Test Result:unknown result; Comments: sent home; Test Date: 20210127; Test Name: COVID-19 test; Result Unstructured Data: Test Result:negative
CDC Split Type: NLPFIZER INC2021158436

Write-up: Her death on 05Feb2021 unexpected; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, Regulatory authority number NL-LRB-00441023. A 93-year-old female patient received BNT162B2 (COMIRNATY, Lot number: EJ6134) at single dose for COVID-19 immunization on 02Feb2021. Medical history included Breast ductal carcinoma in 1999 (declared "clean" in same year as diagnosis), chronic bronchitis, diabetes mellitus non insulin dependent, insufficiency renal, thrombosis leg, heart failure, bladder infection (Urinary tract infection) since 24Jan2021, confusion, agitated on 25Jan2021, food refusal, consciousness decreased since 27Jan2021. Relevant concomitant drugs were unknown. Past drug therapy included glimepiride tablet 1mg for Non-insulin-dependent diabetes mellitus, metformin tablet 500mg for Non-insulin-dependent diabetes mellitus, rivaroxaban tablet 20mg, pantoprazole tablet gastro-resistant 20mg, metoprolol tablet 100mg, isosorbide mononitrate tablet 20mg, ramipril tablet 10mg, bumetanide, beclerolometasone / formoterolometasone / formoterolometasone powder 100 / 6ug / dose, amoxicillin / clavulanic acid tablet 500 / 125mg, Xarelto for DVT prophylaxis, Foster inhalatie powder 100/6UG/DOSE, promocard, augmentin for Urinary tract infection since 24Jan2021. This 93-year old woman living indecently, with her daughter, needed more care over the past 3 months, but still did housework herself, eg ironing. Nine days prior to vaccination patient had fell ill, suspected urinary tract infection treated with amoxicillin / clavulan. Next day (GP home visit): confused and agitated., 2 days after (6 days prior to vaccination) that: refuses to eat and drink (including any medication), consciousness decreased, delirium. The patient was taken to Emergency: extensively tested, including CT scan of head, COVID test negative, sent home. 2 days later (4 days prior to vaccination) restarted taking glimeperide, xarelto, pantopraxol. As heart rhythm and blood pressure stayed within limits other medication not restarted at this point. Patients condition fluctuates but got increasingly better, back to eating lunch at the table. Day after vaccination was a good day and physician proposed to lower the frequency of house calls. Day 3 after vaccination found death (sudden death). Physician''s opinion on relationship with vaccination: ''we will never know''. Comments: This 93 year old was vaccinated with the Pfizer vaccine on 2-2-2021. (batch number: EJ6134) Her death on 05Feb2021 unexpectedly. She was a 93 year old woman living independently together with her daughter, single. In 1999 duct carcinoma and 1999 declared ''clean''. For years chronic bronchitis, requiring inhalation therapy. Also known with diabetes mellitus 2 and moderate renal insufficiency. Leg thrombosis and decompensation Cordis. Some inconveniences not contributing further. Medication: glimepiride and metformin. Xarelto and pantoprazole. Metoprolol, promocard, ramipril and bumetanide.Foster inhalation. On 24Jan she became ill and got augmentin from the General practice center doctor due to an alleged bladder infection. She became more in need of care in the last 3 months but did some things herself such as ironing. 25Jan home visit, confused and angry. 26Jan staying at home and letting nature take its course. 27Jan drinking and not eating and not being able to take medication. Emergency department assessment: Delirium, lowered consciousness. Completely checked up to CT brain with unknown result, Covid (-). Back home to fix up. 29Jan restart on the basis of the blood sugars glimepiride and xarelto. Pantoprazole also Other medications based on blood pressure and pulse. Because these values remained good, no restart has been done. The days after changing getting better and at the table before lunch. 03Feb suggested a good day and reduction of home visits. Vaccinated the day before. (EJ6134) Found 05Feb dead in the morning. You can see from the report that she was recovering. I dare not say whether the vaccine was the cause. Years ago an 80-year-old woman was vaccinated (flu), who was found dead and healthy the next day. I then passed that case on to regulatory authority. Conclusion: We will never know whether the death was caused by the vaccination. The woman had been ill. Died not following the vaccination. Hence my report, so that you and society can benefit from it. Don''t register, you don''t know. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: We will never know whether the death was caused by the vaccination. The woman had been ill. Died not following the vaccination. Hence my report, so that you and society can benefit from it. Don''t register, you don''t know.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1045456 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENALAPRIL MALEATE
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT scan of the brain; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021158442

Write-up: Cerebral haemorrhage; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00441065. Safety Report Unique Identifier is NL-LRB-00442329. An 86-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 06Feb2021 as single dose for covid-19 immunisation. Medical history included ongoing hypertension. Concomitant medication included enalapril maleate (MANUFACTURER UNKNOWN). The patient experienced cerebral haemorrhage on 06Feb2021, which was serious as it lead to death. The event occurred 3 hours after vaccination. The patient underwent lab tests and procedures which included CT scan of the brain with unknown results on an unspecified date. The patient died on 06Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty) Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no cerebral haemorrhage Additional information ADR: A few hours after the vaccination, this patient had a brain haemorrhage, which was so great that the patient died from it. There were no more treatment options. BSN available: yes confounding factors confounding factors: hypertension COVID19 Previous COVID-19 infection: No Other diagnostic procedures: CT scan of the brain; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1045457 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Glomerular filtration rate, 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: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FERROFUMARAAT; FOLIUMZUUR; LORAZEPAM; CLOPIDOGREL
Current Illness: Estimated glomerular filtration rate decreased (33 ml/min)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Estimated glomerular filtration rate; Result Unstructured Data: Test Result:33 ml/min; Comments: decreased
CDC Split Type: NLPFIZER INC2021158437

Write-up: Sudden death; This is a spontaneous report received from a contactable Physician, downloaded from the Regulatory Authority NL-LRB-00441525. A male aged 91 years received BNT162B2 (COMIRNATY, Lot number EM0477) on 30Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing estimated glomerular filtration rate decreased (33 ml/min). Concomitant medications included ferrofumaraat, clopidogrel, folic acid (FOLIUMZUUR), lorazepam. Physician reported that patient suffered from constipation, but was treated and recovered (as reported). Patient died after that. The patient suddenly passed away on 02Feb2021. The cause of death was suddenly passed away. It was unknown whether autopsy was done. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Suddenly passed away


VAERS ID: 1045458 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOL; ZOLPIDEM; LOPERAMIDE; FOLIUMZUUR; SOTALOL; CITALOPRAM; FUROSEMIDE
Current Illness: Cardiac disorder; Vascular dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Tuberculosis
Allergies:
Diagnostic Lab Data: Test Name: lab; Result Unstructured Data: Test Result:55
CDC Split Type: NLPFIZER INC2021158439

Write-up: Sudden death; This is a spontaneous report received from a contactable Physician, downloaded from the regulatory authority NL-LRB-00441531. An 82-year-old female patient received bnt162b2 (COMIRNATY, lot number EM0477), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunisation. Medical history included tuberculosis, ongoing cardiac disorder, ongoing vascular dementia. Concomitant medication included omeprazole (OMEPRAZOL), zolpidem, loperamide, folic acid (FOLIUMZUUR), sotalol, citalopram and furosemide. The patient experienced sudden death on 29Jan2021. The patient underwent lab tests and procedures which included eGFR (glomerular filtration rate): 55 on unknown date. The patient was found deceased on the toilet the day after vaccination. Reported other possible cause was suspicion of colon malignity. The patient died on 29Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death; suspicion of colon malignity


VAERS ID: 1045461 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Blood glucose, Blood pressure measurement, Body temperature, C-reactive protein, Cough, Heart rate, Oxygen saturation, Pyrexia, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   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: OLANZAPINE TEVA; LAXOBERAL; WELLBUTRIN Retard; LACTULOSE MIP; DUROGESIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure; Atrial fibrillation (ATRIAL FIBRILLATION AND FLUTTER); Cardiac failure; Depression; Hypertension; Living in nursing home; Reduced general condition (Reduced general condition for some time but had been up and around. The symptoms that started the day after vaccination (2nd dose) were new.)
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: Blood glucose; Result Unstructured Data: Test Result:6,5; Test Date: 20210128; Test Name: Blood pressure; Result Unstructured Data: Test Result:121/83; Test Date: 20210128; Test Name: Body temperature; Result Unstructured Data: Test Result:36,9; Test Date: 20210130; Test Name: Body temperature; Result Unstructured Data: Test Result:39,4; Test Date: 202101; Test Name: C-reactive protein; Result Unstructured Data: Test Result:22; Test Date: 20210128; Test Name: Pulse rate; Result Unstructured Data: Test Result:85; Test Date: 20210128; Test Name: Oxygen saturation; Test Result: 88 %; Test Date: 20210128; Test Name: Respiratory rate; Result Unstructured Data: Test Result:12
CDC Split Type: NOPFIZER INC2021158452

Write-up: FEVER; ACUTE COUGH; APNOEA; This is a spontaneous report from a contactable health Professional downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is NO-NOMAADVRE-FHI-2021-Uj5xz. Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014817. An 85-year-old male patient received BNT162B2 (COMIRNATY; Lot number EM0477), intramuscular on 27Jan2021 as single dose for covid-19 immunisation. Medical history included Living in nursing home, cardiac failure, hypertension, acute renal failure, reduced general condition (reduced general condition for some time but had been up and around. The symptoms that started the day after vaccination (2nd dose) were new), depression and atrial fibrillation (atrial fibrillation and flutter), from unknown dates. Concomitant medication included olanzapine (OLANZAPINE TEVA), sodium picosulfate (LAXOBERAL), bupropion hydrochloride (WELLBUTRIN RETARD), lactulose (LACTULOSE MIP), fentanyl (DUROGESIC). The patient experienced apnoea on 28Jan2021, acute cough on 28Jan2021, fever on 30Jan2021. The patient underwent lab tests and procedures which included blood glucose: 6,5 on 28Jan2021, blood pressure measurement: 121/83 on 28Jan2021, body temperature: 36,9 on 28Jan2021, body temperature: 39,4 on 30Jan2021, c-reactive protein: 22 on Jan2021, heart rate: 85 on 28Jan2021, oxygen saturation: 88 % on 28Jan2021, respiratory rate: 12 on 28Jan2021. The patient died on 31Jan2021. It was not reported if an autopsy was performed. Details were as follows: the day after being administered the second dose of BNT162B2, the patient developed acute cough/mucus production and short episodes of apnea with slight twitches. The body temperature was normal, but he became increasingly febrile two days later. He then also stopped eating, got breathing problems, became less conscious and died in the evening on day 4 after the vaccination. The patient was multimorbid and living in a nursing home. He had reduced general condition for some time, but had been up and around. The symptoms that started on the day after the second vaccination were new. Vascular disease has been stated as the cause of death. An ADR report has been submitted since the symptoms started the day after the vaccination. Sender''s Comments: Fever is a known side effect after vaccination. It cannot be ruled out that the vaccine has contributed to any of the symptoms the patient experienced the day after the patient had received the second dose. Causal connection with the further course is more difficult to assess. When vaccinating marginal patients with underlying diseases and risk factors for disease, some serious events, including acute illness and / or death, may occur relatively shortly after vaccination, without any connection to vaccination. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed 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. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: VASCULAR DISORDER


VAERS ID: 1045462 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BNT03 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Nausea, Pallor, Restlessness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Frailty; Living in care (DNR code)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021158454

Write-up: They were not a visible side effect. The patient received vaccine 28Jan2021 second dose of vaccine. Deaths 03Feb2021. Just suspected possible side effect. Not sure .; slightly nauseous; unease/restless; acute breathing difficulties; pale; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (NO-NOMAADVRE-FHI-2021-Uny5z and NO-NOMAADVRE-E2B_00014868). A 92-year-old female patient received the second dose of BNT162B2 (COMIRNATY; Lot number: BNT03), intramuscularly in the right arm, on 28Jan2021 at a single dose for COVID-19 vaccination. Medical history included living in care (do not resuscitation (DNR) code) and frail. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY) in Jan2021 for COVID-19 immunization; the patient had no complications after the first dose of Comirnaty three weeks before, but it is stated in the report that she was frail (DNR code). The patient experienced acute breathing difficulties and pale in 2021 and felt slightly nauseous and unease/restless on 02Feb2021. It was reported that on 03Feb2021: they were not a visible side effect. The patient received vaccine 28Jan2021 second dose of vaccine. Deaths 03Feb2021. Just suspected possible side effect. Not sure. The event was reported as fatal. The clinical course was reported as follows: The patient developed acute breathing difficulties, got pale and died six days after being administered the second dose. On the day before death, she had been slightly nauseous and unease, but any possible adverse reactions had not been observed. The patient had no complications after the first dose of three weeks before, but it is stated in the report that she was frail (DNR code). The clinical outcome of acute breathing difficulties, pale, slightly nauseous, and unease/restless was unknown. The patient died on 03Feb2021. The cause of death was not reported. It was not reported if an autopsy was performed. The reporter suspects causality between the vaccine and the death but was not certain. Sender''s Comment: Background: Several cases have been reported in which elderly, frail patients have died after vaccination against Covid-19. When vaccinating marginal patients with underlying diseases and risk factors for disease, some serious events, including acute illness and / or death, may occur relatively soon after vaccination, without any connection to vaccination. It is difficult to imagine how this vaccine will cause sudden difficulty breathing six days after vaccination, and without other concomitant symptoms, as in the present case. This suggests that the symptoms had another cause. The report contains relatively little information, but according to international criteria, the causal link with vaccination is still considered 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 message is classified as serious. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: DEATH


VAERS ID: 1045465 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: Cognitive impairment; Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210131; Test Name: C-reactive protein; Result Unstructured Data: Test Result:About 90-94
CDC Split Type: NOPFIZER INC2021158458

Write-up: CRP was about 90-94; GENERAL PHYSICAL CONDITION DECREASED; This is a spontaneous report from a contactable nurse downloaded from the Medicines Agency (MA) Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Uq7ng, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014862. A 103-years-old female patient received the second dose of bnt162b2 (COMIRNATY, lot# EM0477), intramuscular at left arm on 28Jan2021 11:35 at single dose for covid-19 immunization. Medical history included living in nursing home and cognitive failure. The patient''s concomitant medications were not reported. The patient experienced general physical condition decreased on 29Jan2021 with outcome of fatal. The clinical course was reported as follow: patient was reduced on 29Jan2021, denied food and drink, on 31Jan2021 she was no longer contactable and was put on palliative care, died 01Feb2021 at 22:35. The nurse was asked by the doctor to report the event due to strong time relation to the vaccine. After vaccine the patient had no nausea or fever. No infection sign before 31Jan2021, then CRP was about 90-94 with outcome of unknown. The patient underwent lab tests included c-reactive protein: about 90-94 on 31Jan2021. The patient died on 01Feb2021. It was not reported if an autopsy was performed. Sender''s Comment: When vaccinating patients with frailty who are ill with 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. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or something else incidental, at the same time a cause that has nothing to do with the vaccination in question. On the basis of the information in the report and in accordance with international criteria, the causal relationship with vaccination is assessed 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 also classified as serious, even though a causal link between the vaccine and the death has not been established. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: GENERAL PHYSICAL CONDITION DECREASED


VAERS ID: 1045495 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood sodium, Fatigue, General physical health deterioration, Hypernatraemia
SMQs:, Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Cognitive impairment; Fibrillation cardiac NOS; Multimorbidity
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: blood sodium; Result Unstructured Data: Test Result:153
CDC Split Type: SEPFIZER INC2021158459

Write-up: Hypernatremia; Reduced general condition; more tired; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, Regulatory Authority number SE-MPA-2021-002838. Other case identifier number SE-MPA-1612528958083. A 91-year-old female patient received second dose of bnt162b2 (COMIRNATY, lot# EJ6795) via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunisation. Medical history included multimorbidity, fibrillation cardiac NOS, cardiac failure, cognitive impairment. The patient had been walking shorter distances with a walker. Concomitant medication included apixaban (ELIQUIS). No previous drug reactions. The day after the patient received dose 2 of the vaccination, she became more tired and was bedridden. Ate and drank were ok. Vital parameters were stable. Nine days after vaccination, lab of Na was 153, otherwise essentially were ok. The patient developed reduced general condition and hypernatremia in Jan2021. The patient became increasingly tired and died quietly about 2 weeks after the vaccination with bnt162b2. Cause of death was reduced general condition and hypernatremia. It was not reported if an autopsy was performed. The outcome of event fatigue was unknown, outcome of events reduced general condition and hypernatremia was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Reduced general condition; Hypernatremia


VAERS ID: 1045496 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute left ventricular failure, Arrhythmia, Myocardial infarction, Pulmonary artery thrombosis, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Pulmonary embolism; Type 2 diabetes mellitus; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021151993

Write-up: Pulmonary artery thrombosis; acute left ventricular failure; pulmonary edema; arrhythmia; myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-003041. Other case identifier number SE-MPA-1612771616648. A 78-years-old female patient received bnt162b2 (COMIRNATY, Batch/lot number: EJ6134), intramuscular on an unspecified date in Jan2021 at 0.3 mL single dose for covid-19 immunisation. Medical history included vascular dementia, type 2 diabetes mellitus, hypertension, pulmonary embolism, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. According to the reporter the woman died of cardiac stress (left ventricular failure with pulmonary edema, arrhythmia or myocardial infarction can not be ruled out, according to the reporter) secondary to thrombosis in the pulmonary artery, three days after the vaccination with bnt162b2 in Jan2021. Indicated cause of death: acute left ventricular failure. The events outcome was fatal. It was not reported if an autopsy was performed. The report was assessed as serious, death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: myocardial infarction; arrhythmia; Acute left ventricular failure; thrombosis in the pulmonary artery; pulmonary edema


VAERS ID: 1045497 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Coma scale, Depressed level of consciousness, Head injury, Heart rate, Heart rate decreased, Hypothermia, Investigation
SMQs:, 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), Accidents and injuries (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (severe)
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: body temperature; Result Unstructured Data: Test Result:34 Centigrade; Comments: four days later; Test Date: 202101; Test Name: RLS; Result Unstructured Data: Test Result:lowered RLS; Test Date: 202101; Test Name: heart rate; Result Unstructured Data: Test Result:low; Test Date: 202101; Test Name: head examination; Result Unstructured Data: Test Result:superficial head injury
CDC Split Type: SEPFIZER INC2021151994

Write-up: Hypothermia/the temperature was 34 degrees; lowered RLS; low heart rate; superficial head injury; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-003055. Other case identifier number SE-MPA-1612780626657. An 82-year-old female patient received second dose of bnt162b2 (COMIRNATY, lot number EJ6134) intramuscular in Jan2021 at single dose for COVID-19 immunisation. Medical history included severe dementia and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY, lot number EJ6795) in Dec2020 and dose two 21 days later in Jan2021. Two days after dose two was given in Jan2021, the patient collapsed and was then examined in the emergency room with a low heart rate and a superficial head injury. Four days later the temperature was 34 degrees (hypothermia) with lowered RLS in Jan2021. The patient died due to hypothermia 17 days after vaccination two was given in 2021. The outcome of event hypothermia was fatal; of other events was unknown. Event hypothermia was assessed as serious, Death by the reporter. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hypothermia


VAERS ID: 1045498 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Fatigue, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: ADHD; Asperger''s disorder; Chronic obstructive pulmonary disease; Congenital oesophageal anomaly; Hepatitis C; Pulmonary fibrosis; Respiratory congenital anomaly; Right ventricular failure
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:38 degrees
CDC Split Type: SEPFIZER INC2021158460

Write-up: Breathing difficult; Fever; tiredness; This is a spontaneous report from a contactable nurse downloaded from the Regulatory Authority, Regulatory Authority number SE-MPA-2021-003068. Other case identifier number SE-MPA-1612791403816. A 47-year-old female patient received the first dose of bnt162b2 (COMIRNATY) (Batch/lot number: EJ6134) intramuscularly in Jan2021 at 0.3ml single for COVID-19 immunisation. Medical history included congenital oesophageal anomaly, respiratory congenital anomaly, chronic obstructive pulmonary disease, pulmonary fibrosis, attention deficit hyperactivity disorder (ADHD), Asperger''s disorder, hepatitis C, right ventricular failure, all unknown if ongoing. Concomitant medications were not reported (Current medication list was missing). Patient developed fever and breathing difficult in Feb2021. According to the reporting nurse the woman (patient), five days after the vaccination with Comirnaty, developed tiredness, fever (38 degrees) and difficulty breathing in Feb2021. The woman herself called an ambulance, she was given Alvedon and Ventoline and booked an appointment at the health center the following day. The next morning, the woman was found dead on the floor of her home (Feb2021). It was not reported if an autopsy was performed. Report assessed the events as serious, Death.; Reported Cause(s) of Death: Breathing difficult; Fever; tiredness


VAERS ID: 1045499 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, 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)

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: Dementia
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: SEPFIZER INC2021158469

Write-up: Fever; Oxygen saturation decreased; Cough; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-003137. Other case identifier number SE-MPA-1612828705321. An 85-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation. Medical history included dementia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient developed fever, oxygen saturation decreased, cough in Jan2021. The reaction occurred the day after the first vaccination with bnt162b2. Other possible causes of the side effect, according to the consumer: "COVID-19, but there was a visit stop at the special home care living, and no infection in residents/staff". The time relationship between the date of the vaccination with bnt162b2 and the death was not stated in the report. There was no further information about the death in the report. Therapeutic measures were taken as a result of all events. The patient died in 2021. It was not reported if an autopsy was performed. Outcome of events were fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Fever; Oxygen saturation decreased; Cough


VAERS ID: 1045500 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Death, Peripheral swelling, Seizure
SMQs:, Cardiac failure (narrow), Angioedema (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic subdural hematoma; Fibrillation cardiac NOS; Hypertension; Myocardial infarct; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021158466

Write-up: Died after vaccination; repeated absence attacks that turned into seizures; Heart failure; Swollen legs; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-003164. Other case identifier number SE-MPA-1612855306187. A 79-year-old male patient received bnt162b2 (COMIRNATY) (Batch/lot number: EJ6796) intramuscularly in Jan2021 at 0.3 ml single for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, cardiac fibrillation, hypertension, chronic subdural hematoma and a previous myocardial infarction. Concomitant medications were not reported. The reported adverse reaction is died in Jan2021 after vaccination. The patient began to have repeated absence attacks that turned into seizures, became uncontactable. Swollen legs. Heart failure was suspected. Treatment with Furix given. They deduced this to previous myocardial infarction and cardiac fibrillation. As well as the absence attacks to his subdural hematoma. However, it is unclear whether any of the above may have been exacerbated by vaccination, the reporter states. The outcome of events repeated absence attacks that turned into seizures, Swollen legs, Heart failure was unknown. The patient died 16 days after Comirnaty. It was unknown if an autopsy was performed or not. Report assessed event died after vaccination as serious, death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1045502 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Crepitations, Death, Decreased appetite, Diarrhoea, Dyspnoea, Fatigue, Pyrexia, Urine output decreased
SMQs:, Acute renal failure (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRTAZAPINE; MEMANTINE; RISPERDAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021158461

Write-up: Death for unknown reason; Slight fever; Decreased appetite; Loose stools; urine volume decreased (she also had a decreased fluide intake); more tired; slight dyspnoea; crackles; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-003234. Other case identifier number SE-MPA-1612867407348. An 80-year-old female received bnt162b2 (COMIRNATY, Expiration Date unknown) second dose in Feb2021 (Lot Number EJ6136) and first dose in Jan2021 (Lot Number EL1484), both via Intramuscular at 0.3ml single dose for COVID-19 immunisation. The patient''s medical history included dementia Alzheimer''s type and unknown if was ongoing. The concomitant medications included mirtazapine from 28Jan2019 to Feb2021; memantine from 06Aug2019 to Feb2021; risperidone (RISPERDAL) from 12Oct2019 to Feb2021. Patient developed decreased appetite, slight fever and loose stools the day after first dose in Jan2021. She got better but a few days before the second dose Comirnaty (21 days after 1st dose) patient got worsened with decreased appetite, stopped eating, urine volume decreased (she also had a decreased fluide intake) that continued after the second dose. The woman got more tired, had a slight dyspnoea and crackles the last days. Dies calmly four days after the second dose Comirnaty. During her last days patient also received single dose of morphine and Robinul. The MPA will request further information. The outcome of events was fatal. Unknown if autopsy had been done. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: decreased appetite; fever; loose stools; urine volume decreased; tiredness; dyspnoea; crackles; unknown cause of death


VAERS ID: 1045506 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood sodium, Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: Alzheimer''s disease; Diabetes; Hypertension; Parkinson''s disease; Renal failure; Rheumatic disorder
Allergies:
Diagnostic Lab Data: Test Name: Creatinine value; Result Unstructured Data: Test Result:worsened; Test Name: Sodium value; Result Unstructured Data: Test Result:worsened
CDC Split Type: SEPFIZER INC2021158468

Write-up: Diarrhoea; Vomiting; This is a spontaneous report from a contactable nurse downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-003489. Other case identifier number SE-MPA-1613029319186. An 80-year-old male patient started to receive bnt162b2 (COMIRNATY) Batch/lot number: EJ6134, intramuscular in Jan2021 at single dose for covid-19 immunisation. Medical history included Alzheimer''s disease from an unknown date and unknown if ongoing, Renal failure from an unknown date and unknown if ongoing , diabetes from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, parkinson''s disease from an unknown date and unknown if ongoing, rheumatic disorder from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced diarrhoea and vomiting in Jan2021. Man with gradually deteriorating general condition due to severe kidney failure and dementia. Expected palliative care. Blood samples was taken before vaccination. The test results arrived after vaccination and showed worsened Creatinine value and a high Sodium value. The patient was tired and exhausted, did not receive food and drink. The man died four days after the vaccination was given. The patient underwent lab tests and procedures which included blood creatinine: worsened, blood sodium: worsened. The patient died in 2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Diarrhoea; Vomiting


VAERS ID: 1048218 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure diastolic, Blood pressure systolic, Body temperature, Fatigue, Gait disturbance, Heart rate, Hypophagia, Hypotonia, Marasmus, Oxygen saturation, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (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: 2021-02-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XARELTO; MOLAXOLE
Current Illness: Alzheimer''s disease; Aortic valve stenosis; Atrial flutter; Bee sting hypersensitivity (Bee sting allergy); Chronic atrial fibrillation (chronic atrial fibrillation arrhythmia); Conduct behaviour disorder (other organ. Personality and behavioral disorders since 04Jul2017); Delusion (delusional disorder since 04Jul2017); Dysphagia; Hearing loss; Osteoporosis; Personality disorder (other organ. Personality and behavioral disorders since 04Jul2017)
Preexisting Conditions: Medical History/Concurrent Conditions: Fall (Fall on 31Oct2019); Joint arthroplasty; Subarachnoid haemorrhage (Smallest subarachnoid hemorrhage on the left frontal)
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: Diastolic blood pressure; Result Unstructured Data: Test Result:60 mmHg; Test Date: 20210206; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:110 mmHg; Test Date: 20210206; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Test Date: 20210206; Test Name: Heart rate; Result Unstructured Data: Test Result:99; Comments: CPM; Test Date: 20210206; Test Name: Oxygen saturation; Test Result: 93 %; Test Date: 20210206; Test Name: COVID-19 antigen test; Test Result: Negative
CDC Split Type: ATPFIZER INC2021159812

Write-up: patient died on 07Feb2021 from Marasmus; powerless; Fatigue; limp; Floppy; reduced oral intake; This is a spontaneous report from other healthcare professional downloaded from the Medicines Agency (MA) Regulatory Authority-WEB AT-BASGAGES-2021-01701 and received via Regulatory Authority. A 91-year-old female patient received the second dose of BNT162B2 (COMIRNATY, batch/lot number: EJ6136), Intramuscular at single dose on 04Feb2021 for COVID-19 immunisation. The patient''s medical history and concurrent conditions included ongoing other organ. Personality and behavioral disorders since 04Jul2017, ongoing delusional disorder since 04Jul2017, ongoing Alzheimer''s disease since 04Jul2017, ongoing Hearing loss since 04Jul2017, Atrial flutter and atrial fibrillation since 04Jul2017, Smallest subarachnoid hemorrhage on the left frontal since 20Feb2019 and unknown if ongoing, ongoing chronic atrial fibrillation arrhythmia since 07May2019, ongoing Aortic valve stenosis since 07May2019, ongoing Osteoporosis since 07May2019, Fall on 31Oct2019, ongoing Dysphagia since 06May2020 and ongoing Bee sting allergy. Above all, paradoxical moderate to high-grade aortic valve stenosis with a BSA of 1 cm since 05May2019; Mainly right occipital hemorrhage since 20Feb2019; VLC frontalis right and VLC occipitalis since 20Feb2019; VLC reg frontal since 31Oct2019; VLC min intranasal dext, fract dent 1., 1.2, 1.3 since 12Aug2020; VLC reg periorb dext since 31Oct2019; Presence of orthopedic. Joint implants since 04Jul2017. Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOLAXOLE) for obstipation from 22Aug2019, rivaroxaban (XARELTO) from 04Mar2019 to 03Feb2021 and then from 05Feb2021 for Atrial fibrillation. The patient previously received the first dose of BNT162B2 (COMIRNATY) for COVID-19 immunisation on 14Jan2021. At the time of vaccination there were no signs of infection. A rapid antigen test was carried out on 06Feb2021, but it was negative. On 06Feb2021 12:00, the patient experienced tiredness, floppy, weakness. On 06Feb2021 at 12 o''clock the patient felt tired, limp, powerless. Due to reduced oral intake, 500 ml NaCl 0.9% infusion was administered sc. Vital signs included RR (Systolic blood pressure /Diastolic blood pressure) 110/60 mmHg, pulse 99 CPM, temperature 36.9 ? C, Oxygen saturation 93% on 06Feb2021. On 07Feb2021 08:45 the patient experienced Death NOS death. The patient''s outcome was not recovered/not resolved. The patient died on 07Feb2021 from Marasmus. No autopsy was arranged according to the medical officer. Cause of death according to the death certificate was senile marasmus. Other essential Disease conditions that contributed to death (according to death certificate): SDAT (Senile dementia of Alzheimer''s type), VHFL, aortic valve stenosis. Health Authority Comment: Confounding factors: elderly age, underlying disease (atrial fibrillation) Temporal relationship: 3 days The causal relationship between the product/substance COMIRNATY / TOZINAMERAN and tiredness, weakness and floppy is assessed as Possible. The causal relationship between the product/substance COMIRNATY / TOZINAMERAN and Death NOS is assessed as possible. The information provided in this individual case does not warrant a change in the product information or other measures. The case will be closed at this time. The topic will be monitored closely. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: senile marasmus


VAERS ID: 1048219 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   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: THROMBO ASS
Current Illness: Aortic stenosis; Aortic valve stenosis (aortic valve stenosis); Arteriosclerosis; Atrial fibrillation (atrial fibrillation); Geromarasmus (Marasmus seni); Hypertension arterial (art. hypertension)
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction (Status post cerebral insult); Coronary disease (coronary heart disease); Myocardial infarct (status post myocardial infarction)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021164867

Write-up: died on 20Jan2021, vaccination on 19Jan2021; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority- WEB [AT-BASGAGES-2021-02012] received via Regulatory Authority. A 89-year-old male patient received bnt162b2 (COMIRNATY, lot# EJ6797), intramuscular on 19Jan2021 at single dose for vaccination. Medical history included cerebral infarction (status post cerebral insult) from an unknown date and not ongoing, ongoing hypertension arterial, ongoing arteriosclerosis, ongoing geromarasmus (marasmus seni), myocardial infarct (status post myocardial infarction) from an unknown date and not ongoing, ongoing atrial fibrillation, ongoing aortic valve stenosis, coronary disease from an unknown date and unknown if ongoing, ongoing aortic stenosis. Concomitant medication included acetylsalicylic acid (THROMBO ASS) and unspecified antihypertensive drug. The patient experienced died on 20Jan2021, vaccination on 19Jan2021 (Decompensation cardiac) on 20Jan2021 10:00. There were no allergies or intolerances. He had no signs of infection. According to the daughter - a doctor herself (she does not attribute the death to the vaccination) - there were no symptoms after the vaccination. His wife helped him use the toilet at night, and in the morning he was found dead in bed. The patient never tested positive for SARS-CoV2. The disease leading immediately to death (not the mode of death): cardiac decompensation. Previous causes: decompensated aortic valve stenosis, coronary heart disease. Other major disease states that contributed to death: arterial hypertension, Marasmus seni. The patient died on 20Jan2021. An autopsy was not performed. Sender Comment: BASGAGES-comment: Follow-up information has been requested. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: decompensated aortic valve stenosis; coronary heart disease; arterial hypertension; Marasmus seni; cardiac decompensation


VAERS ID: 1048221 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood lactic acid, Inflammatory marker test, Multiple organ dysfunction syndrome, Myocarditis, Septic shock
SMQs:, 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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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: COVID-19 (not hospitalized)
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Lactate values; Result Unstructured Data: Test Result:increased; Test Date: 202101; Test Name: Inflammation values; Result Unstructured Data: Test Result:increased
CDC Split Type: ATPFIZER INC2021164871

Write-up: Septic shock; extensive myo- and pericarditis; Multiple organ failure despite hemofiltration; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB AT-BASGAGES-2021-02122. An 81-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. Medical history included covid-19 not ongoing not hospitalized. The patient''s concomitant medications were not reported. The patient experienced septic shock, extensive myo- and pericarditis, multiple organ failure despite hemofiltration on 14Jan2021. The events were fatal. The patient underwent lab tests and procedures which included Lactate values and Inflammation values: increased in Jan2021. The patient died on 16Jan2021. An autopsy was performed that revealed carditis pericardium myocardium. Comirnaty/ all events/ Primary source/ Certain. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Septic shock; extensive myo- and pericarditis; Multiple organ failure despite hemofiltration; Autopsy-determined Cause(s) of Death: Carditis pericardium myocardium


VAERS ID: 1048230 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, General physical health deterioration, Malaise, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Hypoglycaemia (broad)

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: ATORVASTATIN; METFORMIN; DONEPEZIL; ASAFLOW; LORMETAZEPAM; TAMSULOSINE [TAMSULOSIN]; SOTALOL; ALLOPURINOL; PROLOPA; PARACETAMOL; DIPIPERON; BURINEX; DUROGESIC; INSUMAN BASAL; OZEMPIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronavirus infection; Dementia (clinical frailty score of 7); Diabetes; Hyperlipidemia; Hypertension; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021158451

Write-up: suspected myocardial infarction (not further specified); 2 days after vaccination unwell at night, clammy and very rapid deterioration; 2 days after vaccination unwell at night, clammy and very rapid deterioration; 2 days after vaccination unwell at night, clammy and very rapid deterioration; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. This is a report received from the Regulatory Authority. Regulatory authority report number was BE-FAMHP-DHH-N2021-76257. An 80-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EM0477), via an unspecified route of administration on 28Jan2021 as a single dose for COVID-19 vaccination. Medical history included diabetes, dementia (severe dementia with clinical frailty score of 7), hypertension, obesity, and hyperlipidaemia; all from unknown dates and coronavirus infection in Apr2020 to an unknown date. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), donepezil (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASAFLOW), lormetazepam (MANUFACTURER UNKNOWN), tamsulosin (TAMSULOSINE), sotalol (MANUFACTURER UNKNOWN), allopurinol (MANUFACTURER UNKNOWN), benserazide hydrochloride/levodopa (PROLOPA), paracetamol (MANUFACTURER UNKNOWN), pipamperone hydrochloride (DIPIPERON), bumetanide (BURINEX), fentanyl (DUROGESIC), insulin human injection, isophane (INSUMAN BASAL), and semaglutide (OZEMPIC); all taken for unknown indications from unknown dates and unknown if ongoing. On 30Jan2021, 2 days after vaccination, the patient was unwell at night, clammy and had a very rapid deterioration. The clinical outcomes of unwell, clammy, and rapid deterioration were fatal. The patient died on 30Jan2021. It was not reported if an autopsy was performed. The physician comments included suspected myocardial infarction (not further specified). No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Suspected myocardial infarction; Reported Cause(s) of Death: very rapid deterioration; unwell; clammy


VAERS ID: 1048234 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Coma, Death, Disturbance in attention, Peripheral vascular disorder
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   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: CITALOPRAM; ENTRESTO; SPIRICORT; TORASEMIDE; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure
Allergies:
Diagnostic Lab Data: Test Date: 20210117; Test Name: blood glucose; Result Unstructured Data: Test Result:22 mmol/L
CDC Split Type: CHPFIZER INC2021172023

Write-up: Death; Coma; Circulatory disorder peripheral; Vigilance decreased; This is a spontaneous report received from a contactable physician via the regulatory authority. Regulatory authority report number CH-SM-2021-10507. A 95-year-old female patient received first dose of BNT162B2 (COMIRNATY), intramuscular at arm right on 15Jan2021 (at the age of 95 years) at single dose for COVID-19 immunization. The patient medical history included severe terminal heart failure from an unknown date and unknown if ongoing. The patient''s concomitant medication included citalopram, sacubitril valsartan sodium hydrate (ENTRESTO), prednisolone (SPIRICORT), torasemide, clopidogrel. The patient experienced vigilance decreased on 17Jan2021, coma and circulatory disorder peripheral, both on 21Jan2021. The patient underwent lab tests and procedures which included blood glucose: 22 mmol/l on 17Jan2021. The patient outcome of the events was fatal. The patient died on 22Jan2021. An autopsy was not performed. A causal relationship between COMIRNATY and death, vigilance decreased, coma and circulatory disorder peripheral was assessed as being unlikely. Sender''s comment: elderly patient with terminal cardiac failure, general state of decay since one month (before receiving the vaccine) who died in temporal correlation to the COMIRNATY vaccine (in particular there was a worsening of vigilance and high glycemia (non-diabetic patient) detected two days after vaccination).Unfortunately no other blood samples were taken and there was no sugar value on 21Jan2021, a value that could have confirmed hyperglycemia with possible hyperglycemic coma that could then lead to death. Autoimmune problems related to vaccines are discussed, so in the overall evaluation of this case could be considered also an autoimmune type I diabetes. However, there is no supporting data and so we leave this as a hypothesis/speculation. The lack of perfusion in the arm of the vaccination could be due to a venous thrombosis of the arm favored also by severe cardiac insufficiency (we do not know if there was a prothrombotic state) and unfortunately has not been made any assessment (Duplex, other Imaging) that can confirm this hypothesis. A possible immobilization of the arm due to pain of the vaccine (so indirect cause, not the vaccine itself but the vaccination procedure) could have favored a thrombosis in the arm, but here it is only speculation as the data to confirm have been requested but are not available (because not performed). That said, in the absence of reliable data and given the very advanced age, the severe terminal failure and the general state of decay that began well before the vaccine, we have judged the causal correlation between death and the vaccine as improbable, improbable also the disturbance of circulation in the arm (because in the absence of data for WHO we must go down a step possible-$gunlikely).; Reported Cause(s) of Death: deterioration of the general condition


VAERS ID: 1048236 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, C-reactive protein, COVID-19, Chest X-ray, Computerised tomogram, Diarrhoea, Lymphocyte count, Respiratory distress, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 4
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; Dyslipidemia; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: Chest X-ray; Test Result: Positive ; Comments: Parenchymal thickening in the left mid-basal and right supradiaphragmatic sites; Test Date: 20210119; Test Name: CT angiogram; Test Result: Positive ; Comments: Picture compatible with SARS-CoV-2 disease; Test Date: 20210119; Test Name: C-reactive protein; Result Unstructured Data: Test Result:92 mg/l; Test Date: 20210119; Test Name: Lymphocyte count; Result Unstructured Data: Test Result:0.60 x10 9/l; Test Date: 20210119; Test Name: SARS-CoV-2 swab; Test Result: Positive
CDC Split Type: CHPFIZER INC2021168874

Write-up: COVID-19/CT angiogram confirming a picture compatible with SARS-CoV-2 disease; Diarrhea; Asthenia; Respiratory distress; This is a spontaneous report received from a contactable pharmacist via agency, the regulatory authority. Regulatory authority report number CH-SM-2021-11420. An 89-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 17Jan2021 at single dose for COVID-19 immunisation. Medical history included arterial hypertension, dyslipidemia and type 2 diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced covid-19 on 19Jan2021, diarrhea on 18Jan2021, asthenia on 18Jan2021, respiratory distress on 18Jan2021. The patient was hospitalized for the event from 19Jan2021 to an unknown date. The events were also fatal. Clinical course: On 17Jan2021 she received the administration of the first dose of Comirnaty. The next day (18Jan2021) she began to manifest diarrhea, asthenia and respiratory distress because of which, on 19Jan2021, she presented at the emergency room. Laboratory tests showed an inflammatory syndrome with C Reactive Protein at 92 mg/L (normal range less than 5 mg/L) and lymphocyte count at 0.6x10E9/L (on 19Jan2021) (normal range 1.50-4.00x10 9/l). On the same day, a SARS-CoV-2 swab is performed, which is positive, a chest X-ray showing parenchymal thickening in the left mid-basal and right supradiaphragmatic areas, and a CT angiogram confirming a picture compatible with SARS-CoV-2 disease. The woman was hospitalized on 19Jan2021 and treated pharmacologically with dexamethasone (6mg for 7-10 days). On 20Jan2021, respiratory distress worsens so high-flow oxygen therapy is required. The subsequent course was unfavorable with progressive deterioration of general conditions and worsening of the respiratory picture. The woman died of COVID-19 on 22Jan2021. An autopsy was not done. A causal relationship between Comirnaty and all events was assessed as being unlikely. Agency assessed this case as serious, results in death. Sender''s comment: COVID-19 infection (confirmed by swab on 19Jan2021), with diarrhea, asthenia and respiratory distress in a polymorbid elderly woman (89 years old) on 18Jan2021, the day after vaccination with the first dose of Comirnaty (17Jan2021). At the hospital, laboratory and imaging investigations show a picture compatible with SARS-CoV-2 disease. The woman dies from the viral infection due to progressive worsening of her general condition. In the Swiss monograph of Comirnaty it is reported that the duration of protection offered by the vaccine is not known, since it is still being determined in ongoing clinical trials, and, as with any vaccine, vaccination with Comirnaty may not protect all recipients. In particular, it is reported that subjects may not be fully protected until 7 days after the second dose of the vaccine. Although the woman did not present with any symptoms at the time of the first vaccination, the fact that she was not swabbed for COVID-19 before vaccination does not allow us to exclude that the infection was already ongoing before vaccination. In addition, the timing of the onset of the symptomatology described here, one day after the first vaccination, speaks against a causal role of Comirnaty, in agreement with what has been reported in the monograph, namely the possibility that vaccinated subjects are not fully protected until 7 days after the second dose (which the woman did not receive) and are therefore susceptible to COVID-19 infection in the period between the first and second dose of vaccine. On the basis of these considerations, in the current state of knowledge, the Comirnaty-COVID-19 causal link is judged unlikely. Note the rapidity of the lethal event for COVID-19 from the time of onset of symptoms (only 5 days).; Reported Cause(s) of Death: Diarrhea; Asthenia; Respiratory distress; COVID-19


VAERS ID: 1048245 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
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 decreased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021164541

Write-up: General physical condition deterioration; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, Regulatory Authority number DE-DCGMA-21187965. A 95-year-old female patient was vaccinated with bnt162b2 (COMIRNATY, lot# unknown), the first dose on an unspecified date and the second dose on 22Jan2021, both via an unspecified route of administration at single dose for prophylactic vaccination. Medical history included general physical condition decreased since 01Jan2021 and ongoing. Concomitant medication was not reported. The patient experienced general physical condition deterioration after 1st on an unspecified date with outcome of unknown. 13 days after the second dose of vaccination the patient developed general physical condition decreased on 03Feb2021 with outcome of fatal. The patient was dead on 03Feb2021 due to general physical condition decreased. It was not reported if an autopsy was performed. Causal relationship between the event and the administration of bnt162b2 was assessed as "C. Inconsistent causal association" by the Regulatory Authority. Reporter comment: General physical condition deterioration after 1st and 2nd vaccination, but also fragile before that. The causal relationship cannot be clearly established, the general physical condition was also fragile beforehand, but significantly reduced after the two vaccinations. Temporal Connection exited (03Feb2021) after 2nd vaccination (22Jan2021). No follow-up attempts are possible, information on lot/batch number cannot be obtained.; Reporter''s Comments: General physical condition deterioration after 1st and 2nd vaccination, but also fragile before that. The causal relationship cannot be clearly established, the general physical condition was also fragile beforehand, but significantly reduced after the two vaccinations. Temporal Connection exited (03Feb2021) after 2nd vaccination (22Jan2021).; Reported Cause(s) of Death: General physical condition deterioration


VAERS ID: 1048251 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pyrexia, Renal failure, Urosepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
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: Mental disability
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021160565

Write-up: Fever; Kidney failure; Urosepsis; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB DE-PEI-PEI2021002337. A 64-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation. Medical history included mental disability from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced Fever and Renal failure and Urosepsis on an unspecified date, lasting for unknown. The patient died on 04Feb2021. An autopsy was not performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Fever; Urosepsis; Renal failure


VAERS ID: 1048252 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2020-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Multi-organ disorder, SARS-CoV-2 test
SMQs:, 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: 2021-01-02
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201229; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: qualitative
CDC Split Type: DEPFIZER INC2021164676

Write-up: Multi-organ disorder; SARS-CoV-2 PCR test: positive; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory authority- WEB [DE-PEI-PEI2021002546] received via Regulatory Authority. An 87-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 29Dec2020 at single dose for prophylactic vaccination. The patient''s medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included SARS-CoV-2 PCR test: positive, qualitative on 29Dec2020 4 h after vaccination. 5 days after vaccination the patient developed multi-organ disorder, lasting for unknown. Outcome of event SARS-CoV-2 PCR test: positive was unknown. The patient was dead on 02Jan2021. Reported cause of death was multi-organ disorder. It was unknown if an autopsy was performed. Reporter''s comments: 4 h after vaccination: SARS-CoV-2 PCR positive. Sender Comment: Multi-morbid full-time nursing home resident died on 02Jan2021 of her many illnesses. No symptoms developed after vaccination. Causality assessment by RA for Comirnaty / Multi-organ disorder: D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: 4 h after vaccination: SARS-CoV-2 PCR positive; Reported Cause(s) of Death: Multi-organ disorder


VAERS ID: 1048253 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-02-05
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 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: 2021-02-10
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:positive NA
CDC Split Type: DEPFIZER INC2021164677

Write-up: vaccinated with two doses of Comirnaty/ COVID-19 virus test positive; Diagnosis was confirmed by COVID-19 virus test (result: positiv/positive, unit: NA); This is a spontaneous report from non-contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-PEI2021002548. A 69-year-old male patient received two doses of bnt162b2 (COMIRNATY), via an unspecified route of administration on 31Dec2020 (lot number: EJ6796, first dose) and on 26Jan2021 (second dose, lot number: EK9788) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After vaccination the patient experienced COVID-19 virus test positive on 05Feb2021 and developed Death on 10Feb2021, lasting for unknown. The patient was dead and was hospitalized. Diagnosis was confirmed by COVID-19 virus test (result: positiv/positive, unit: NA) on 05Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Lethal outcome/Death; Diagnosis was confirmed by COVID-19 virus test (result: positiv/positive, unit: NA); vaccinated with two doses of Comirnaty/ COVID-19 virus test positive


VAERS ID: 1048254 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-01-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

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

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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Diabetes mellitus; Hematoma subdural; Palliative care
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021164728

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number DE-PEI-PEI2021002560. An 86-year-old male patient was vaccinated with BNT162B2 (COMIRNATY), (lot number: EM0477) intramuscularly on 23Jan2021 at a single dose for COVID-19 immunization. The patient medical history included: palliative care, hematoma subdural, dementia, diabetes mellitus. Concomitant medication was not reported. 4 days after vaccination on 27Jan2021, the patient developed death, lasting for unknown. The patient was dead. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1048255 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021164500

Write-up: General physical health deterioration; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number DE-PEI-PEI2021002561. A 98-year-old male patient received the second dose bnt162b2 (COMIRNATY), intramuscular on 03Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose bnt162b2 (COMIRNATY) in Jan2021 for covid-19 immunization, and had been tolerated. On 05Feb2021 after vaccination the patient developed general physical health deterioration, lasting for 5 days. No treatment, no hospitalization. The patient died in Feb2021. It was not reported if an autopsy was performed. The outcome of event general physical health deterioration was fatal. Event Assessment: For both events / RA / D. Unclassifiable. No follow-up attempts possible, batch/lot number cannot be obtained.; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1048258 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dehydration, Hypotension, Infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Arrhythmia related investigations, signs and symptoms (broad), 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), Cardiomyopathy (broad), Respiratory failure (broad), Dehydration (narrow), Hypokalaemia (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: ATORVASTATIN; L-THYROXIN [LEVOTHYROXINE]; METOPROLOL; ACETYLSALICYLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Dementia; Hyperuricaemia; Hypotensive; Hypothyroidism; Renal insufficiency; Syncope (Hospitalized for hypotonic circulatory dysregulation)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021164727

Write-up: Multi-infarction syndrome; Exsiccosis; Asystolia; Hypotension; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB Regulatory Authority number DE-PEI-PEI2021002567. An 85-year-old female patient received bnt162b2 (COMIRNATY, batch/lot number: EK9788), intramuscularly on 11Feb2021 at single dose for covid-19 immunization. Medical history included hyperuricaemia, hypothyroidism, syncope from Sep2020 to an unknown date (Hospitalized for hypotonic circulatory dysregulation), renal failure, aortic valve incompetence, dementia. Concomitant medication included atorvastatin, levothyroxine] (L-THYROXIN), metoprolol, acetylsalicylic acid. The patient died from multi-infarction syndrome, exsiccosis, asystolia and hypotension on 11Feb2021, lasting for unknown. It was not reported if an autopsy was performed. The causality for Comirnaty with events infarction, exsiccosis, asystolia, hypotension per Regulatory Authority/ C. was inconsistent causal association. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Multi-infarction syndrome; Exsiccosis; Hypotension; Asystolia


VAERS ID: 1048259 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-10
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Diet refusal, General physical health deterioration, Restlessness, SARS-CoV-2 test, SARS-CoV-2 test positive, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 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: Basal cell carcinoma; Coxarthrosis; Dementia Alzheimer''s type; Prostatic adenoma; Squamous cell carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210111; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positiv/positive NA; Test Date: 20210110; Test Name: COVID-19 rapid POC test; Result Unstructured Data: Test Result:positiv/positive NA
CDC Split Type: DEPFIZER INC2021164542

Write-up: Sudden death; Refusal to eat; Deterioration in general condition; Restlessness; cough; COVID-19 PCR test/COVID-19 rapid POC test : positiv/positive NA; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB DE-PEI-PEI2021002569. An 83-years-old male patient received first dose of bnt162b2 (COMIRNATY, Lot# no.: EM0477), via an unspecified route of administration on 01Jan2021 at single dose for covid-19 immunisation. Medical history included Dementia Alzheimer''s type, Coxarthrosis, Basal cell carcinoma, Squamous cell carcinoma, Prostatic adenoma. The patient''s concomitant medications were not reported. The patient experienced refusal to eat on 15Jan2021, cough on 12Jan2021, deterioration in general condition on 15Jan2021, restlessness on 12Jan2021. Clinical course reported as: 11 day(s) after vaccination the patient developed Cough and Restlessness and General physical health deterioration and Diet refusal, lasting for 12 day(s). The patient underwent lab tests and procedures which included COVID-19 PCR test: positiv/positive NA on 11Jan2021, COVID-19 rapid POC test: positiv/positive NA on 10Jan2021. The patient died on 23Jan2021. It was not reported if an autopsy was performed. Events refusal to eat, cough, deterioration in general condition, restlessness were reported as serious with seriousness criterion death. Cause of death was reported as sudden death. No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Restlessness; General physical health deterioration; cough; Refusal to eat; Sudden death


VAERS ID: 1048262 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-12
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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: 2021-01-22
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210112; Test Name: coronavirus rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021164941

Write-up: patient contracted Coronavirus/coronavirus rapid test: positive on 12Jan2021/symptoms were reported as loss of appetite and weakened; patient contracted Coronavirus/coronavirus rapid test: positive on 12Jan2021/symptoms were reported as loss of appetite and weakened; This is a spontaneous report from a non-contactable consumer based on information received by Pfizer from Biontech [manufacturer control number: 15873], license party for Comirnaty.This consumer reported similar events for 39 reports. This is the second of the 39 reports. A 78-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY) lot# EM0477, via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced patient contracted coronavirus on 12Jan2021,symptoms were reported as loss of appetite and weakened. The patient underwent lab tests and procedures which included coronavirus rapid test: positive on 12Jan2021. The patient died on 22Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021164939 same reporter, same drug, different patients, similar events; Reported Cause(s) of Death: patient contracted Coronavirus/coronavirus rapid test: positive on 12Jan2021/symptoms were reported as loss of appetite and weakened; patient contracted Coronavirus/coronavirus rapid test: positive on 12Jan2021/symptoms were reported as loss of appet


VAERS ID: 1048263 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
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: 20210105; Test Name: Coronavirus rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021164984

Write-up: patient contractred Coronavirus; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Biontech [manufacturer control number: 15873], license party for Comirnaty. The reporter reported similar events for 39 patients, this is the 15th of 39 reports. A 91-year-old patient of an unspecified gender received 1st dose of bnt162b2 (COMIRNATY, lot number EM0477), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient contractred coronavirus (covid-19) (death) on an unspecified date. The patient underwent lab tests and procedures which included coronavirus rapid test: positive on 05Jan2021. The patient died on 09Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021164939 same reporter/drug, similar events, different patient; Reported Cause(s) of Death: patient contractred Coronavirus


VAERS ID: 1048264 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: COVId-19 rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021165007

Write-up: swallowing difficult; COVId-19 rapid test: positive; Coronavirus infection detected via quick test; This is a spontaneous report received from a contactable employee of a nursing home based on information received by Pfizer from Biontech [manufacturer control number: 15873], license party for Comirnaty. The reporter reported similar events for 39 patients, this is the 21th of 39 reports. An approximately 90 years old patient of an unspecified gender received 1st dose of bnt162b2 (COMIRNATY, lot# EM0477), via an unspecified route of administration at single dose on 31Dec2020 for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced coronavirus infection detected via quick test (death) on 05Jan2021, swallowing difficult (non-serious) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVId-19 rapid test: positive on 05Jan2021. The patient died on 16Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021164939 same reporter/drug, similar events, different patients.; Reported Cause(s) of Death: Coronavirus infection detected via quick test


VAERS ID: 1048265 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: COVID-19 Quick test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021165011

Write-up: Coronavirus infection; Swallowing disorder; COVID-19 quick test positive; This is a spontaneous report received from a contactable employee of a nursing home based on information received by Pfizer from Biontech [manufacturer control number: 15873], license party for Comirnaty. The reporter reported similar events for 39 patients, this is the 23th of 39 reports. A 90-year-old (at time of vaccination) patient of an unspecified gender received first dose of bnt162b2 (COMIRNATY, Lot number: EM0477) via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced coronavirus infection and swallowing disorder on an unspecified date. Patient had COVID-19 quick test positive on 07Jan2021. Outcome of "Coronavirus infection" was fatal, of other events was unknown. The patient died on 15Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021164939 same reporter/drug, similar events, different patients; Reported Cause(s) of Death: Coronavirus infection


VAERS ID: 1048266 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210101; Test Name: Covid-19 rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021165026

Write-up: Coronavirus infection; swallowing difficulty; Covid-19 rapid test positive; This is a spontaneous report received from a contactable employee of a nursing home based on information received by Pfizer from Biontech [manufacturer control number: 15873], license party for Comirnaty. The reporter reported similar events for 39 patients, this is the 30th of 39 reports. A 101-year-old patient of an unspecified gender received first dose of bnt162b2 (COMIRNATY, Lot number: EM0477) via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced coronavirus infection and swallowing difficulty on an unspecified date. Patient had Covid-19 rapid test positive on 01Jan2021. Outcome of "Coronavirus infection" was fatal, of other events was unknown. The patient died on 11Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021164939 same reporter/drug, similar events, different patients; Reported Cause(s) of Death: Coronavirus infection


VAERS ID: 1048267 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epilepsy, Obstructive airways disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021168762

Write-up: died of vomit in his airways; died of vomit in his airways; epileptic attack; This is a spontaneous report from a contactable consumer or other non-healthcare professional and two other healthcare professionals, based on information received by Pfizer from Biontech [manufacturer control number: 16401], license party for bnt162b2 (COMIRNATY). A 32-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 12Feb2021 at single dose for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient in good health condition, was vaccinated on 12Feb2021. Patient died on 13Feb2021 due to vomit in his airways after an epileptic attack, signs of hashish consumption (joint). It was not reported if an autopsy was performed. The outcome of event ''epileptic attack'' was unknown. Lot/batch number has been requested.; Reported Cause(s) of Death: vomit in his airways; vomit in his airways


VAERS ID: 1048268 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / 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: 2021-01-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALCIUM & VITAMIN D3; DURAPHAT; KALIUMKLORID ORIFARM; FUROSEMID ORIFARM; BETMIGA; PAMOL; XARELTO; TOILAX; ALNOK; PANTOPRAZOLE TEVA; GANGIDEN; METOPROLOLSUCCINAT HEXAL
Current Illness: COVID-19; General physical health deterioration; Living in nursing home (there was a covid-19 outbreak among several residents and staff.)
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Constipation; Esophageal acid reflux; Heart rate irregular; Hyperactive bladder; Pain
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158654

Write-up: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB and received via Regulatory Authority DK-DKMA-WBS-0032128. Safety Report Unique Identifier (DK-DKMA-ADR 24692697). An 86-year-old male patient received first dose bnt162b2 (COMIRNATY) Lot # EJ6797, intramuscular on 31Dec2020 at single dose for covid-19 immunisation. Medical history included Esophageal acid reflux, Allergy, Hyperactive bladder, Constipation, Heart rate irregular, pain,ongoing Living in nursing home (there was a covid-19 outbreak among several residents and staff), ongoing general physical health deterioration and ongoing COVID-19. Concomitant medication included calcium carbonate, colecalciferol (CALCIUM & VITAMIN D3) from 07Feb2019 as Calcium supplementation, sodium fluoride (DURAPHAT)from 20Nov2019 as Dental disorder prophylaxis, potassium chloride (KALIUMKLORID ORIFARM) from 14Jan2019 as Potassium supplementation, furosemide (FUROSEMID ORIFARM) from 14Jan2019 as diuretic therapy, mirabegron (BETMIGA) from 02Jun2020 for Hyperactive bladder, paracetamol (PAMOL) from 09Sep2019 for pain, rivaroxaban (XARELTO) from 05Dec2019 as Thrombosis prophylaxis, bisacodyl (TOILAX) from 13Mar2019 for Constipation, cetirizine hydrochloride (ALNOK) from 06Feb2019 for Allergy, pantoprazole sodium sesquihydrate (PANTOPRAZOLE TEVA) from 25-Sep2019 for Esophageal acid reflux, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (GANGIDEN) from 19Feb2019 for Constipation, metoprolol succinate (METOPROLOLSUCCINAT HEXAL) from 28Feb2019 for Heart rate irregular. The patient experienced death on 05Jan2021. it was not inconceivable that the total liability of covid-19 disease and the vaccination has been fatal for the patient. The patient underwent lab tests and procedures which included COVID-19 virus test: positive in Jan2021. The patient died on 05Jan2021. An autopsy was not performed. The ADRs were by the physician reported as Fatal. Reported cause of death: Death and of/with COVID-19. Only usual confirmation of death was performed post mortem. No findings were reported. If the Medicines Agency receives supplemental significant information regarding this case the case will be re-submitted. Sender Comment: COMMENT from MA: Version 001 has not been submitted to RA. Agency should therefore consider version 2 as the initial report. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient


VAERS ID: 1048269 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-13
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Pyrexia, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), 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), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: CALCIUM AND VIT D; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; CENTYL MED KALIUMKLORID; OLANZAPIN STADA; ELOCOM; MAGNESIA [MAGNESIUM HYDROXIDE]; PANTOPRAZOL KRKA; IBUMETIN; PARACETAMOL ORIFARM; SERTRALIN A
Current Illness: COVID-19; General physical health deterioration; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (for many years before he came to the nursery home); Cerebral haemorrhage (with sequelae (psychosis, burns with ulcer, fungal infec, vomiting blood, haemorrhage, immobility)); Constipation; Depression; Eczema; Edema; Esophageal acid reflux; Mental disorder; Pain; Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210103; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210104; Test Name: COVID-19 virus test; Test Result: Inconclusive ; Test Date: 20210106; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210113; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158652

Write-up: COVID-19; Respiratory failure; Fever; COVID-19 test 13Jan2021: Positive; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB [DK-DKMA-WBS-0032130]. The case was received from a contactable physician via The Agency. A 70-years-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6797, Expiration Date: 30Apr2021), intramuscular on 31Dec2020 at single dose for covid-19 immunisation. Medical history included Living in nursing home from 2018 and ongoing, alcohol abuse for many years before he came to the nursery home not ongoing, ongoing covid-19, ongoing general physical health deterioration, cerebral haemorrhage from 2010 not ongoing with sequelae (psychosis, burns with ulcer, fungal infec, vomiting blood, haemorrhage, immobility), vitamin D deficiency, edema, eczema, constipation, mental disorder, esophageal acid reflux, depression, pain. The patient lived in a nursery home and there were a covid-19 outbreak among several residents and staff. Concomitant medication included calcium, colecalciferol (CALCIUM AND VIT D) from 05Mar2017 for Vitamin D deficiency, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) from 08Aug2017 for Constipation, bendroflumethiazide, potassium chloride (CENTYL MED KALIUMKLORID) from 23Apr2020 for Edema, olanzapine (OLANZAPIN STADA) from 16Feb2017 for mental disorder, mometasone furoate (ELOCOM) from 02Apr2020 for Eczema, magnesium hydroxide (MAGNESIA) from 04Aug2017 for constipation, pantoprazole sodium sesquihydrate (PANTOPRAZOL KRKA) from 10Sep2020 for Esophageal acid reflux, ibuprofen (IBUMETIN) from 10Sep2020 for pain, paracetamol (PARACETAMOL ORIFARM) from 21Nov2019 for pain, sertraline hydrochloride (SERTRALIN ACCORD) from 06Mar2019 for Depression. Past vaccines included Pneumovax (Pneumococcal vaccine, 23-valent) on 11May2020 and Influenza (Influenza Type A and Influenza Type B vaccine, 4-valent) on 20Oct2020. On 18Jan2021 the patient developed fever and respiratory insufficiency and died on 19Jan2021. The ADRs were by the reporter reported as fatal. Reported cause(es) of death was respiratory insufficiency and COVID 19. The reporter was in doubt about how long the vaccine affected the immune system, the reporter thought that the patient may have a worsening course of the disease with covid due to the vaccine, even though the patient did first become ill 2 weeks after the vaccine. The patient underwent lab tests and procedures which included COVID-19 test 03Jan2021: Negative, 04Jan2021: Inconclusive, 06Jan2021: Negative, 13Jan2021: Positive. The patient died on 19Jan2021. An autopsy was not performed. Only ordinary confirmation of death was performed post-mortem. The reporter stated that it was not inconceivable that the total liability of Covid-19 disease and the vaccination had been fatal for the patient. Senders comment: COMMENT from Agency: Version 001 has not been submitted to Regulatory Authority. Health Authority should therefore consider version 2 as the initial report. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 test 13Jan2021: Positive; COVID-19; Respiration failure; Fever


VAERS ID: 1048270 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: General physical health deterioration; Living in nursing home (There was a covid-19 outbreak among several residents and staff)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158644

Write-up: Death with COVID-19/COVID-19 virus test, Jan2021, positive; Death with COVID-19/COVID-19 virus test, Jan2021, positive; This is a spontaneous report from a contactable physician received from the Medicines Agency. Regulatory authority report number DK-DKMA-WBS-0032136. A 91-year-old female patient received the first dose bnt162b2 (COMIRNATY, Batch number/lot number: EJ6797), intramuscular on 31Dec2020 at single dose for covid-19 immunization. The patient''s concurrent conditions included general physical health deterioration, the patient was living in nursing home, where there was a covid-19 outbreak among several residents and staff. The patient''s concomitant medications were not reported. The patient experienced covid-19 in Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive in Jan2021. The patient died on 16Jan2021. An autopsy was not performed. Reported cause of death was death with COVID-19. The outcome was fatal.; Reported Cause(s) of Death: Death with COVID-19/COVID-19 virus test, Jan2021, positive; Death with COVID-19/COVID-19 virus test, Jan2021, positive


VAERS ID: 1048271 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, 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: 2021-01-06
   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: ALENDRONAT SANDOZ; ARICEPT; BETOLVEX [CYANOCOBALAMIN-TANNIN COMPLEX]; METFORMIN ACTAVIS; VISCOTEARS; VITAMIN D [COLECALCIFEROL]
Current Illness: COVID-19; Feverish; General physical health deterioration; Hyperthyroidism; Living in nursing home (there was a covid-19 outbreak among several residents and staff.); Renal impairment (One functional kidney); Urinary infection
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Dry eyes; Osteoporosis; Type 2 diabetes mellitus; Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210103; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158642

Write-up: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient .; COVID-19 virus test positive; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [DK-DKMA-WBS-0032137]. Safety Report Unique Identifier DK-DKMA-ADR 24693268. The case was received from a contactable physician via The Medicines Agency (MA). An 87-year-old female patient received first dose of bnt162b2 (COMIRNATY, Batch number: EJ6797, Expiration Date: 30Apr2021) intramuscular on 31Dec2020 at single dose for covid-19 immunization. Medical history included Osteoporosis, Dementia Alzheimer''s type, Vitamin B12 deficiency, Type 2 diabetes mellitus, Dry eyes, General physical health deterioration, COVID-19, Feverish, Urinary infection, Hyperthyroidism, Renal impairment (One functional kidney) and the patient was living in nursing home (there was a covid-19 outbreak among several residents and staff). Concomitant medications include alendronate sodium (ALENDRONAT SANDOZ) for Osteoporosis from 24Apr2020, donepezil hydrochloride (ARICEPT) from 17Jun2019 for dementia Alzheimer''s type, cyanocobalamin-tannin complex (BETOLVEX) since 20Oct2014 for Vitamin B12 deficiency, metformin hydrochloride (METFORMIN ACTAVIS) from 11Mar2020 for Type 2 diabetes mellitus, carbomer (VISCOTEARS) from 28Aug2019 for dry eyes, colecalciferol (VITAMIN D) from 30Apr2020 for Osteoporosis. Past vaccinations included PNEUMOVAX (Pneumococcal vaccine, 23-valent) (batch number: S014391) and FLUZONE (Influenza Type A and Influenza Type B vaccine, 3-valent) (batch number: UJ459AB). Past drug included OXYGEN in Apr2020. On 31Dec2020, the patient was vaccinated with COMIRNATY first dose (Batch number: EJ6797) dosed 1 DF for COVID-19 immunization. The patient got unwell on 02Jan2021 and had COVID-19 virus test positive on 03Jan2021. The patient did not need respirator but quickly gets very unwell. Receives palliative treatment with oxygen and Imacilin (AMOXICILLIN) due to mucus accumulation. Patient death occurred on 06Jan2021. Reported cause(es) of death: Death and of/with COVID-19. Only normal confirmation of death was performed. No findings were reported. Causality: It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient .


VAERS ID: 1048272 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TAMSULOSIN TEVA; PAMOL; GABAPENTIN ORIFARM; AMLODIPIN KRKA; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; COLECALCIFEROL; LAXOBERAL; NITROFURANTOIN "DAK"; MORFIN ABCUR; DURAPHAT; SERTRALIN ORION
Current Illness: Anxiety; Constipation; Dementia; General physical health deterioration; Hypertension; Living in nursing home; Neuropathic pain; Pain; Type II diabetes mellitus; Urination difficulty
Preexisting Conditions: Medical History/Concurrent Conditions: Dental caries; Prophylaxis urinary tract infection; Vitamin D3 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210112; Test Name: Oxygen saturation; Test Result: 94 %; Test Date: 20210103; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210106; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158638

Write-up: diarrhea but his fluid intake was fine; body temperature: 37.7 centigrade; Respiratory insufficiency; COVID-19; This is a spontaneous report from contactable physician downloaded from the Agency Regulatory-WEB DK-DKMA-ADR 24693280. An 86-years-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6797), intramuscular on 31Dec2020 at single dose for covid-19 immunisation. Medical history included dementia from 2016 and ongoing, living in nursing home from 2016 and ongoing, ongoing general physical health deterioration, ongoing Type II diabetes mellitus, ongoing hypertension, ongoing neuropathic pain, ongoing anxiety, ongoing difficulty in urination, ongoing pain, ongoing constipation, Vitamin D3 deficiency, Prophylaxis urinary tract infection and Dental caries. Past vaccines included Pneumovax (Pneumococcal vaccine, 23-valent) on 11May2020 and Fluzone (Influenza Type A and Influenza Type B vaccine, 3-valent) on 20Oct2020. Concomitant medication included tamsulosin hydrochloride (TAMSULOSIN TEVA) from 06Apr2016 for urination difficulty, paracetamol (PAMOL) from 02Jun2014 for pain, gabapentin (GABAPENTIN ORIFARM) from 07Nov2019 for Neuropathic pain, amlodipine besilate (AMLODIPIN KRKA) from 11Sep2020 for hypertension, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) from 02Jul2015 for constipation, colecalciferol from 11Jan2016 for Vitamin D3 deficiency, sodium picosulfate (LAXOBERAL) from 06Jun2019 for Constipation, nitrofurantoin (NITROFURANTOIN "DAK") from 09Jan2017 for Prophylaxis urinary tract infection, morphine hydrochloride (MORFIN ABCUR) from 18Jan2021 for pain, sodium fluoride (DURAPHAT) from 15Dec2017 for Dental caries, sertraline hydrochloride (SERTRALIN ORION) from 25Jul2016 for Anxiety. On 06Jan2021 the patient was tested positive for COVID-19 and on 07Jan2021 he developed symptoms with weakened respiration treated with oxygen. On 12Jan2021 the patients general conditions was worsened but stabil. He had diarrhea but his fluid intake was fine. The patient was treated with morfine subcutaneously to reduce oxygen consumption. On 20Jan2021 the patient developed respiratory insufficiency and died. Respiratory insufficiency was by the reporter reported as fatal. Reported cause(es) of death was Respiratory insufficiency and of/with COVID 19. The patient underwent lab tests and procedures which included body temperature: 37.7 centigrade on 08Jan2021, oxygen saturation: 94 % on 12Jan2021, COVID-19 virus test: negative on 03Jan2021, positive on 06Jan2021. The patient died on 20Jan2021. An autopsy was not performed. Only ordinary inquest was performed post-mortem on 21Jan2021. The outcome for body temperature: 37.7 centigrade and diarrhea but his fluid intake was fine was unknown. The reporter stated that it was not inconceivable that the total liability of Covid-19 disease and the vaccination had been fatal for the patient. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19; Respiratory insufficiency


VAERS ID: 1048273 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   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: General physical health deterioration; Living in nursing home (there was a covid-19 outbreak among several residents and staff)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158633

Write-up: Death; COVID-19/COVID-19 disease; COVID-19/COVID-19 disease; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [DK-DKMA-WBS-0032141]. The case was received from a contactable physician via The Medicines Agency (MA). An 88-year-old female patient received first dose of BNT162B2 (COMIRNATY, batch/lot number: EJ6797, expiration date: 30Apr2021) intramuscular on 31Dec2020 at single dose for COVID-19 immunisation. Medical history included general physical health deterioration, was living in nursing home (there was a COVID-19 outbreak among several residents and staff), both ongoing. Concomitant medications were not reported. On 14Jan2021 the patient developed death. Reported cause(es) of death: Death and of/with COVID-19. Only normal confirmation of death was performed post mortem. It was reported that it is not inconceivable that the total liability of COVID-19 disease and the vaccination has been fatal for the patient. Lab data included: in Jan2021, COVID-19 virus test was positive. Autopsy was not done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19/COVID-19 disease; Death; COVID-19/COVID-19 disease


VAERS ID: 1048274 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-15
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Heart rate, Oxygen saturation, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XARELTO; KLORAMFENIKOL VISKOES DAK; BETOLVEX [CYANOCOBALAMIN-TANNIN COMPLEX]; RISPERDAL; IMOZOP; ARAX; LAXOBERAL; SAPIMOL; ESOMEPRAZOL KRKA
Current Illness: Atrial fibrillation; Cerebral infarct; Chronic renal insufficiency; General physical health deterioration; Living in nursing home (there was a covid-19 outbreak among several residents and staff.); Renal cysts; Type 2 diabetes mellitus; Vascular dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchospasm; Bypass surgery; Constipation; Esophageal acid reflux; Eye infection; Insomnia; Mania; Pain; Prostate cancer (Possibly Prostate cancer. Not diagnosed due to comorbidity); Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Pulse rate; Result Unstructured Data: Test Result:76; Comments: 76 Unit not specified; Test Date: 202101; Test Name: Oxygen saturation; Test Result: 88 %; Test Date: 20210115; Test Name: Oxygen saturation; Test Result: 92 %; Test Date: 20210106; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210113; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:unknown results; Comments: Test lost; Test Date: 20210118; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158632

Write-up: COVID-19/ COVID-19 virus test, positive; COVID-19/ COVID-19 virus test, positive; Respiratory insufficiency. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient.; This is as spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is DK-DKMA-WBS-0032145. Safety Report Unique Identifier DK-DKMA-ADR 24693311. An 84-year-old male patient received first dose of bnt162b2 (COMIRNATY, Lot number: EJ6797, expiration date: 30Apr2021) intramuscular on 31Dec2020 at single dose for covid-19 immunisation. Medical history included bypass surgery from 2008 and not ongoing, conditions included pain, vitamin b12 deficiency, esophageal acid reflux, insomnia, eye infection, constipation, mania, bronchospasm, ongoing general physical health deterioration, ongoing type 2 diabetes mellitus, ongoing chronic renal insufficiency, renal cysts from 2014 and ongoing, vascular dementia from 2015 and ongoing, atrial fibrillation from 2018 and ongoing, cerebral infarct from 2019 and ongoing, undiagnosed prostate cancer and unknown if ongoing, possibly prostate cancer, not diagnosed due to comorbidity, the patient was ongoing living in nursing home, there was a covid-19 outbreak among several residents and staff. Concomitant medication included hydroxyzine hydrochloride (ARAX) from 14Dec2020 for pain, cyanocobalamin-tannin complex (BETOLVEX) from 25Jan2016 for vitamin B12 deficiency, esomeprazole magnesium (ESOMEPRAZOL KRKA) from 23Dec2020 for esophageal acid reflux, zopiclone (IMOZOP) from 15Sep2020 for insomnia, chloramphenicol (KLORAMFENIKOL VISKOES DAK) from 08Dec2020 for eye infection, sodium picosulfate (LAXOBERAL) from 15Sep2020 for constipation, risperidone (RISPERDAL) from 17Sep2020 for mania, ipratropium bromide, salbutamol sulfate (SAPIMOL) from 13Sep2020 for bronchospasm and xarelto (rivaroxaban) from 12Apr2018 as thrombosis prophylaxis. The patient previously received Influvectra (Influenza Type A and Influenza Type B vaccine, 4-valent) on 22Dec2020 for immunisation, pneumococcal vaccine polysacch 23v (PNEUMOVAX) on 19May2020 for immunisation. The patient experienced respiratory insufficiency, it is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient, in an 84 year old male patient vaccinated with bnt162b2. On 15Jan2021 the patient developed respiratory insufficiency, the patient was sweaty, did not react to voice or touch, the patient had apnoea, pain, increased fever and secretion and was treated palliatively with subcutaneous morphine. Spacer pressurised inhalation, prednisolone and furosemide (FURIX), but not with oxygen. On 18Jan2021 the patient was tested positive with COVID-19 and on 19Jan2021 the patient died. Respiratory insufficiency was reported by the physician as fatal. Reported causes of death: Death and of/with COVID-19. The patient underwent lab tests and procedures, which included test results COVID-19 virus test on 06Jan2021 as negative, COVID-19 virus test on 13Jan2021 as unknown result, test lost, COVID-19 virus test on 18Jan2021 as positive; Oxygen saturation on 15Jan2021 as 92%, Oxygen saturation on Jan2021, 88%, Pulse rate on Jan2021 as 76, unit not specified. Only ordinary inquest was performed post-mortem. No findings were reported. The patient died on 19Jan2021.An autopsy was not performed and the reported cause of death was Respiratory insufficiency and COVID-19. Causality from the reporter: it is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient.; Reported Cause(s) of Death: COVID-19/ COVID-19 virus test, positive; COVID-19/ COVID-19 virus test, positive; Respiratory insufficiency


VAERS ID: 1048275 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   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:
Current Illness: Exposure to COVID-19; General physical health deterioration; Living in nursing home
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158626

Write-up: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient; COVID-19; This is a spontaneous report from a contactable physician. This is a report received from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory authority number DK-DKMA-WBS-0032146. Safety Report Unique Identifier DK-DKMA-ADR 24693314. An 86-year-old male patient received the first dose of bnt162b2 (COMIRNATY), batch/lot number: ej6797, intramuscularly on 31Dec2020 at single dose for covid-19 immunisation. Medical history included ongoing general physical health deterioration, and the patient was living in nursing home where there was a covid-19 outbreak among several residents and staff (concurrent condition). There was no information regarding concomitant medication and past medication. On 10Jan2021 the patient died. Reported cause of death was death and of/with COVID-19. Only normal confirmation of death was performed post mortem. No findings were reported. An autopsy was not performed. The adverse drug reactions (ADRs) were by the physician reported as fatal. No treatment due to the ADRs was reported. The patient underwent lab tests which included Covid-19 virus test in Jan2021, positive. About causality, the physician stated that It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient; COVID-19


VAERS ID: 1048276 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-13
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COVID-19; General physical health deterioration; Living in nursing home (there was a covid-19 outbreak among several residents and staff)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158625

Write-up: Covid-19; Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient.; This is a spontaneous report downloaded from the Regulatory Authority-WEB DK-DKMA-ADR 24693323. The case was received from a contactable physician via The Agency. A 92-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot number: ej6797, expiration date: 30Apr2021) intramuscular on 31Dec2020 at single dose for covid-19 immunisation. Medical history included patient concurrent conditions included Covid-19 and general physical health deterioration and Living in nursing home in which there was a covid-19 outbreak among several residents and staff. Concomitant medications were not provided. The patient was death on 13Jan2021, which the reporting physician described the occurrence of death, it is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient, in a 92 years old female patient vaccinated with bnt162b2. Reported cause(es) of death: Death and of/with COVID-19. Only normal confirmation of death was performed post mortem. The patient underwent lab tests and procedures, which included Covid-19 test on Jan2021 as positive. The patient died on 13Jan2021. An autopsy was not performed and the reported cause of death was death and COVID-19. Causality from the reporter: it was not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19; Death


VAERS ID: 1048277 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-02-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Atrial fibrillation, Blood pressure measurement, Body temperature, Chest X-ray, Chest pain, Dyspnoea, Hypoxia, Pneumonia, Pulmonary oedema, Respiratory acidosis, Respiratory failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: OCULAC [POVIDONE]; BETOLVEX [CYANOCOBALAMIN]; PROPRANOLOL HYDROCHLORIDE; BETASERC; HJERDYL; KALEORID; CITALOPRAM STADA; TRADOLAN; GABAPENTIN STADA; PANTOPRAZOLE TEVA; MAGNESIUMHYDROXIDE; NITROLINGUAL; GANGIDEN; ALLOPURINOL; KALEORID; DIURAL
Current Illness: Cardiac insufficiency (Terminal cardiac insufficiency)
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis gouty; Cardiac disorder; Constipation; Depression; Dry eyes; Dyspnoea (Sees physician due to dyspnoea two days before second vaccination, afebrile and normal bp); Esophageal acid reflux; Meniere''s disease; Neuropathic pain; Pain; Tremor; Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: Blood pressure; Result Unstructured Data: Test Result:Normal; Comments: Normal; Test Date: 20210129; Test Name: Body temperature; Result Unstructured Data: Test Result:Afebrile; Test Date: 20210201; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:Possible pneumonia or pulmonary edema
CDC Split Type: DKPFIZER INC2021163659

Write-up: New case of atrial fibrillation; Acute respiratory decompensation; Respiratory insufficiency; pneumonia; pulmonary edema; Hospitalised due to sudden onset of central chest pain; Hospitalised due to sudden onset of dyspneoea; Increasing hypoxia during hospitalisation; increasing respiratory acidosis during hospitalisation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (DK-DKMA-WBS-0032508). A 92-year-old female patient received the second dose of BNT162B2 (COMIRNATY; Lot number: EK9788; Expiration date: 31May2021), via an unspecified route of administration, on 31Jan2021 at a single dose for COVID-19 immunisation. Medical history included ongoing cardiac insufficiency (terminal cardiac insufficiency), non-ongoing dyspnoea from 29Jan2021 to an unspecified date (sees physician due to dyspnoea two days before second vaccination, afebrile and normal blood pressure (BP)), arthritis gouty, Meniere''s disease, depression, neuropathic pain, neuropathic pain, constipation, cardiac disorder, dry eyes, esophageal acid reflux, tremor, vitamin B12 deficiency, and pain. Concomitant medications included povidone (OCULAC) taken for dry eyes from 17Mar2020, cyanocobalamin (BETOLVEX) taken for vitamin B12 deficiency from 12Jun2020, propranolol hydrochloride (MANUFACTURER UNKNOWN) taken for tremor from 21Feb2020, betahistine hydrochloride (BETASERC) taken for Meniere''s disease from 17May2017, acetylsalicylic acid (HJERDYL) taken for anticoagulant therapy from 16Aug2007, potassium chloride (KALEORID) taken for potassium supplementation from 11Aug2020, citalopram hydrobromide (MANUFACTURED BY: STADA) taken for depression from 03Aug2017, tramadol hydrochloride (TRADOLAN) taken for pain from 10Nov2020, gabapentin (MANUFACTURED BY: STADA) taken for neuropathic pain from 25Apr2017, pantoprazole sodium sesquihydrate (MANUFACTURED BY: TEVA) taken for esophageal acid reflux from 28Mar2017, magnesium hydroxide (MANUFACTURER UNKNOWN) taken for constipation from 18Aug2020, glyceryl trinitrate (NITROLINGUAL) taken for cardiac disorder from 31Oct2020, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (GANGIDEN) taken for constipation from 19Jan2020, allopurinol (MANUFACTURER UNKNOWN) taken for arthritis gouty from 10Jun2020, potassium chloride (KALEORID) taken for potassium supplementation from 11Aug2020, furosemide (DIURAL) taken for diuretic therapy from 04Oct2019, lidocaine hydrochloride (XYLOCAIN) taken for itch from 20Nov2020, diphenhydramine hydrochloride (reported as: acrivastine; BENADRYL) taken for itch from 21Dec2020, oxazepam (OXAPAX) taken for sedative therapy from 11Nov2020, furosemide (FURIX) taken for diuretic therapy from 31Oct2020, and paracetamol (PINEX) taken for pain from 23May2016. The patient previously received the first dose of BNT162B2 (COMIRNATY; Lot number: EM0477) on 07Jan2021 for COVID-19 immunisation and experienced possible dyspnea. The patient experienced new case of atrial fibrillation, acute respiratory decompensation, and respiratory insufficiency on 01Feb2021, which were reported as fatal. The patient was also hospitalised due to sudden onset of central chest pain, hospitalised due to sudden onset of dyspneoea, increasing hypoxia during hospitalisation, and increasing respiratory acidosis during hospitalisation on 01Feb2021. It was also reported that the patient experienced pneumonia and pulmonary edema on 01Feb2021 as reported that: possible as seen on x-ray when hospitalized and possible cause of death. All of the events caused hospitalization. The patient underwent lab tests and procedures which included blood pressure: normal on 29Jan2021, body temperature: afebrile on 29Jan2021, and thorax x-ray: possible pneumonia or pulmonary edema on 01Feb2021. No treatment due to the events was reported. The clinical outcome of new case of atrial fibrillation, acute respiratory decompensation, respiratory insufficiency, pneumonia, and pulmonary edema was fatal; hospitalised due to sudden onset of central chest pain and hospitalised due to sudden onset of dyspneoea were unknown; and of increasing hypoxia during hospitalisation and increasing respiratory acidosis during hospitalization was not recovered. The patient died on 02Feb2021. The cause of death was reported as respiratory insufficiency, pneumonia, atrial fibrillation, acute respiratory decompensation, and pulmonary edema. An autopsy was not performed. The causality was reported as: the physician states that due to the timing, they are reporting the adverse drug reactions on the Comirnaty vaccine. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: pulmonary edema; Respiratory insufficiency; Pneumonia; Atrial fibrillation; Acute respiratory decompensation


VAERS ID: 1048279 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021158473

Write-up: Oxygen saturation decreased; This is a spontaneous report from a contactable consumer reporting different events for the same patient, downloaded from the Medicines Agency (MA) -WEB and received via Regulatory Authority ES-AEMPS-735202. An elderly male patient received 2nd dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 29Dec2020 for covid-19 immunisation, days later he was positive for COVID-19. The patient was administered the second dose on 19Jan2021, after four days oxygen desaturation was detected and he was transferred to the hospital. He dies two days later (25Jan2021). The patient''s doctor does not associate the vaccine with the fatal outcome. The patient died on 25Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain; Reported Cause(s) of Death: Oxygen saturation decreased


VAERS ID: 1048282 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-19
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: 2021-02-09
   Days after onset: 21
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; Dementia Alzheimer''s type
Preexisting Conditions: Medical History/Concurrent Conditions: Fibrillation atrial
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:positive
CDC Split Type: ESPFIZER INC2021169112

Write-up: COVID-19; COVID-19; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority-Web [Regulatory Authority number ES-AEMPS-746451] from a contactable consumer. A 99-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in the arm, on 05Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing chronic kidney disease, ongoing dementia Alzheimer''s type and atrial fibrillation. Concomitant medications were not reported. The patient experienced COVID-19 on 19Jan2021. The patient presented symptoms and was hospitalized due to the event from 01Feb2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 19Jan2021. The patient died on 09Feb2021 due to the event. 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: 1048283 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Blood immunoglobulin G, Body temperature, 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), Hypersensitivity (broad), Respiratory failure (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Very recent and recovering Covid-19); Comments: Ha pasado la COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: Immunoglobulin G; Result Unstructured Data: Test Result:positive; Test Date: 202102; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210108; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive
CDC Split Type: ESPFIZER INC2021169108

Write-up: Acute respiratory failure; This is a spontaneous report downloaded from the Regulatory Authority-WEB [Regulatory Authority number ES-AEMPS-749279] from a contactable physician. An 86-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY, lot# EL8723), via an unspecified route of administration, on 04Feb2021, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from Jan2021 to an unknown date (very recent and recovering Covid-19) and ongoing dementia Alzheimer''s type. She was vaccinated in the COVID-19 convalescent period. Concomitant medications were not reported. The patient experienced acute respiratory failure on 05Feb2021 with fatal outcome the same day. Therapeutic measures were taken as a result of the event and included sedation. The patient underwent lab tests and procedures which included blood immunoglobulin G: positive on 28Jan2021, body temperature: 39 C in Feb2021 (at dawn from the 4th to the 5th), COVID-19 PCR test: positive on 08Jan2021. An autopsy was not performed. The reporting physician stated that the AUP just before death, right hemithorax MVC, the left crackles of liquid. The reporting physician suspected that patient''s state of high fragility due to age, associated pathologies, Alzheimer''s and due to a state of greater deterioration due to being recent and convalescing from COVID-19, have been able to contribute to the outcome by giving her the vaccine so early that it could precipitate her death given her high fragility. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute respiratory failure


VAERS ID: 1048290 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1419 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Dysphagia, Hypotonia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), 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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANADOL FORTE [PARACETAMOL]; OXYNORM; NORSPAN [BUPRENORPHINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (for years)
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: fever; Result Unstructured Data: Test Result:fever
CDC Split Type: FIPFIZER INC2021159022

Write-up: Death; mild fever; swallowing worsened; muscle tone decreasead; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB FI-FIMEA-20210506. An 87-year-old female patient received first dose bnt162b2 (COMIRNATY, Solution for injection, lot number: EL1419), intramuscular on 20Jan2021 at single dose for COVID-19 vaccination. Medical history included sufferring from Alzheimer''s disease for years. Concomitant medications included paracetamol (PANADOL FORTE), oxycodone hydrochloride (OXYNORM), buprenorphine (NORSPAN). The patient experienced death on 31Jan2021. Since the beginning of Jan2021, mild fever, swallowing worsened and muscle tone decreasead. Transferred to hospice care on 29Jan2021, only painkillers were used then in the treatment. Exitus on 31Jan2021. Therapeutic measures were taken as a result of mild fever, swallowing worsened, muscle tone decreasead. The patient died on 31Jan2021. It was not reported if an autopsy was performed. The outcome of the event death was fatal. The outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1048291 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   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: OXANEST; FURESIS; MEMANTIN ORION; KALEORID; OXYNORM; THEOFOL; CARDACE [RAMIPRIL]; LUMIGAN; SOMAC; SPIRIVA RESPIMAT; MAREVAN; VENTOLINE [SALBUTAMOL SULFATE]; SERETIDE EVOHALER; PRIMPERAN; LEVOLAC; ZOFRAN [ONDANSETRON]; SIMVASTATIN ACTAVIS; P
Current Illness: Chronic atrial fibrillation; Chronic obstructive pulmonary disease
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Arteriosclerosis obliterans; Atrial enlargement; Cerebellar infarction; Coronary artery disease; Glaucoma; Heart valve incompetence; Hyperparathyroidism; Lung cancer NOS (In 2013 received radiotherapy for that); Meningioma; Myocardial infarction; Osteoporosis; Radiotherapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021159023

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB FI-FIMEA-20210510. An 84-year-old female patient received the first dose of bnt162b2 (COMIRNATY) via Intramuscular on 14Jan2021 at single dose (Lot # EJ6795) for covid-19 immunisation. Medical history included Alzheimer disease, ongoing chronic atrial fibrillation, Coronary artery disease, experienced myocardial infarction, ongoing Chronic obstructive pulmonary disease, difficult Arteriosclerosis obliterans, glaucoma, osteoporosis, Hyperparathyroidism and enlarged left atrium as well as leaking in mitral, tricuspid and aortic valves diagnosed by heart ultrasound. In 2011 experienced cerebellum infarction. Earlier cerebellum meningioma treated with radiotherapy. In 2010 in the left lung tumor was diagnosed. In 2013 received radiotherapy for that and declined further investigations. From time to time abundant mucosity and in January again more mucosity. No allergies. Concomitant medications included oxycodone hydrochloride (OXANEST) via intravenous as needed, furosemide (FURESIS) orally at 40 mg, daily, memantine hydrochloride (MEMANTIN ORION) orally at 10 mg, daily, potassium chloride (KALEORID) orally at 2 g, daily, oxycodone hydrochloride (OXYNORM) orally as needed, theophylline (THEOFOL) orally as needed, ramipril (CARDACE) orally at 10 mg, daily, bimatoprost (LUMIGAN) Ophthalmic at 1 drop, daily, pantoprazole sodium sesquihydrate (SOMAC) at 40 mg, daily, tiotropium bromide (SPIRIVA RESPIMAT) Resp Inhalation at 5 ug, daily, warfarin sodium (MAREVAN) orally, salbutamol sulfate (VENTOLINE) Resp Inhalation as needed, fluticasone propionate, salmeterol (SERETIDE EVOHALER) Resp Inhalation at 4 DF, daily, metoclopramide hydrochloride (PRIMPERAN) orally as needed, lactulose (LEVOLAC) orally as needed, ondansetron (ZOFRAN) orally as needed, simvastatin (SIMVASTATIN ACTAVIS) orally ay 20 mg, daily, paracetamol (PANADOL FORTE) orally as needed, zopiclone (IMOVANE) orally as needed, carbomer (OFTAGEL) Ophthalmic at 6 drop, daily, buprenorphine (NORSPAN) Transdermal, denosumab (PROLIA) 12 mg, cyclic (yearly), macrogol 4000 (PEGORION) orally 36 g, weekly. She was death on 15Jan2021. It is unknown if autopsy was done. Outcome of the event was fatal. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1048293 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Fatigue, General physical health deterioration, Heart rate increased, Hyperventilation, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: Body temperature; Result Unstructured Data: Test Result:37.3 Centigrade
CDC Split Type: FIPFIZER INC2021165834

Write-up: Heart rate increased; Fatigue; Dyspnoea; Respiratory arrest; General physical health deterioration; Pyrexia; heavy breathing; This is a spontaneous report from a non-contactable nurse downloaded from the Agency Regulatory Authority-WEB FI-FIMEA-20210566. A 79-year-old male patient received bnt162b2 (COMIRNATY, lot number: EJ6134), intramuscular on 26Jan2021 at single dose for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. The patient experienced heart rate increased, fatigue, dyspnoea, respiratory arrest, general physical health deterioration, and pyrexia on 27Jan2021. The events were reported as serious, serious criteria was fatal. The day after vaccination (27Jan2021), mild fever (37.3), fatigue, heavy breathing, occasionally high heart rate. Symptoms were being followed, as they did not seem severe. The next day (28Jan2021), in the evening, severe shortness of breath and a decrease in general condition, paramedics were called. Died when paramedics were moving him on a stretcher to the hospital, breathing stopped. The patient underwent lab tests and procedures which included body temperature: 37.3 centigrade on 27Jan2021. The patient died on 28Jan2021. 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: Heart rate increased; Fatigue; Dyspnoea; Respiratory arrest; General physical health deterioration; Pyrexia


VAERS ID: 1048297 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Gaze palsy, Opisthotonus
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dystonia (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow)

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; PAMOL; MEMANTINE; MAREVAN; BISOPROLOL; NEXIUM MUPS [ESOMEPRAZOLE MAGNESIUM]; ISMOX; RISPERIDON ORION; MELATONIN; MIRTAZAPIN ORION; CALCICHEW D3 FORTE; EXELON [RIVASTIGMINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Atrial fibrillation; Behaviour disorder; Cerebral infarction; Gastrointestinal disorder prophylaxis; Hypertension; Insomnia; Pain; Sleep disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021165949

Write-up: Death; Back arched backward/stiffened back; Laboured breathing/to breathe heavily; Upward deviation of eyes; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB FI-FIMEA-20210629. A 91-year-old female patient receives the first dose of BNT162B2 (COMIRNATY, lot number: EJ6134), intramuscularly from 26Jan2021 10:26 in left upper arm, at single dose for covid-19 vaccination. Medical history included dementia Alzheimer disease, hypertension, atrial fibrillation, cerebral infarction in 2019, pain, gastrointestinal disorder prophylaxis, behaviour disorder, sleep disorder, insomnia. Concomitant medication included amlodipine from 21Jul2020 for hypertension, paracetamol (PAMOL) from 02Jun2020 for pain, memantine from 21Jul2020 for Alzheimer''s disease, warfarin sodium (MAREVAN) from 23Aug2019 for Atrial fibrillation, bisoprolol from 21Jul2020 for hypertension, esomeprazole magnesium (NEXIUM MUPS) from 29Nov2013 for gastrointestinal disorder prophylaxis, isosorbide mononitrate (ISMOX) from 21Jul2020 for hypertension, risperidone (RISPERIDON ORION) from 19Sep2019 for Behaviour disorder, melatonin from 24Oct2019 for Sleep disorder, mirtazapine (MIRTAZAPIN ORION) from 19Dec2019 for Insomnia, calcium carbonate, colecalciferol (CALCICHEW D3 FORTE) from 21Jul2020, rivastigmine (EXELON) from 21Jul2020 for Alzheimer''s disease. The patient received the vaccine at about 10:26 in the left upper arm. Vaccinated, according to the nurse supervisor and was monitored until about 12 noon, during that time, according to the records, there were no abnormalities in the health condition. According to the patient records, at about 4 p.m., during the meal, the patient began to breathe heavily/ laboured breathing, stiffened back/ back arched backward, and the gaze deviated upwards/ upward deviation of eyes. Staff took the patient to the corridor where an attempt was made to make her cough. This was not successful, an attempt was made to manually remove food or other obstacles from the mouth, but the patient teeth remained firmly closed. An ambulance was called, however, the patient went lifeless before the ambulance arrival. The patient diagnosed as dead at 4.15 pm by the first aid. A colleague also certified the patient at 19.25 as dead. The patient died on 26Jan2021. 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: Upward deviation of eyes; Death; Back arched backward/stiffened back; Laboured breathing/to breathe heavily


VAERS ID: 1048298 (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: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, General physical health deterioration, Pneumonia aspiration
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021165950

Write-up: confusion; Pneumonia aspiration; General physical health deterioration; This is a spontaneous report from a non-contactable nurse downloaded from the Medicines Agency (MA) Regulatory authority-WEB FI-FIMEA-20210630. An 84-years-old male patient received 2nd dose of bnt162b2 (COMIRNATY), intramuscular on 25Jan2021 at single dose for COVID-19 vaccination. Medical history included Alzheimer disease from Aug2018 and no allergies. The patient''s concomitant medications were not reported. The historical vaccine included 1st dose of bnt162b2 on 04Jan2021 for COVID-19 vaccination. After the boost dose vaccination on 25Jan2021 the general health condition of patient worsened rapidly (26Jan2021) and on 05Feb2021 at 3 am. in the night the patient died. The patient experienced confusion, general health condition worsening. He had to come to emergency room, there aspiration pneumonia diagnosed on 02Feb2021. It was not reported if an autopsy was performed. The events aspiration pneumonia, general health condition worsening outcome was fatal, of the other was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: general health condition worsening; Pneumonia aspiration


VAERS ID: 1048299 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal carcinoma, Pneumonia, Pneumoperitoneum, Tumour perforation
SMQs:, Malignancy related conditions (narrow), Gastrointestinal perforation (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibrosis lung; Neurodegenerative disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021164862

Write-up: pneumoperitoneum; tumor digestive perforation; tumor digestive perforation; Infectious pneumonitis/infectious lung disease; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, FR-AFSSAPS-BR20210146. This is a report received from the Regulatory Authority. An 83-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number EK0477 (as reported, also "EM0477" was provided)), via intramuscular on 20Jan2021 at single dose (reported as "1 DF") in left arm for COVID-19 vaccination. Medical history included fibrosis lung, neurodegenerative disorder, both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced infectious pneumonitis (infectious lung disease) on 27Jan2021. The event was reported as serious due to death and life threatening. Transfer to Emergency. Discovery of a pneumoperitoneum probably linked to a tumor digestive perforation. Urgent medical intervention. The patient died on an unspecified date for infectious pneumonitis (infectious lung disease). It was unknown if an autopsy was performed. The outcome of the rest events was unknown. No follow-up attempts possible. No further information expected. Information on lot and batch numbers already obtained. ; Reported Cause(s) of Death: Infectious pneumonitis (infectious lung disease)


VAERS ID: 1048300 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiogenic shock, Myocardial infarction, SARS-CoV-2 test negative, Troponin
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Diabetes mellitus insulin-dependent; Hypertension arterial (arterial); Pseudopolyarthritis; Senile macular degeneration
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: blood pressure; Result Unstructured Data: Test Result:suspected low; Test Date: 202102; Test Name: SARS CoV-2; Test Result: Negative ; Test Date: 202102; Test Name: troponin; Result Unstructured Data: Test Result:very high
CDC Split Type: FRPFIZER INC2021169036

Write-up: Infarct myocardial; Cardiogenic shock; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, Regulatory Authority number FR-AFSSAPS-BR20210213. A 91-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY, Lot/batch n EJ6788) intramuscular on 04Feb2021 at single dose for covid-19 immunisation. Medical history included pseudopolyarthritis, hypertension arterial, asthma, Diabetes mellitus insulin-dependent, Senile macular degeneration. he patient''s concomitant medications were not reported. On 08Feb2021 she was admitted to the emergency room for suspicion of low blood pressure and deterioration of her general condition. The patient experienced infarct myocardial on 06Feb2021. The patient underwent lab tests and procedures which included blood pressure measurement: suspected low in Feb2021, Sars-cov-2 PCR test: negative in Feb2021, troponin: very high in Feb2021. Conclusion: acute coronary syndrome seen late because of digestive symptomatology, cardiogenic shock. Unfavorable evolution towards rapid death. The patient died on 08Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiogenic shock; Infarct myocardial


VAERS ID: 1048303 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   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: COTAREG
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioedema (over 40 years ago when she ate asparagus); Giant hives; Head injury (hit her head on a door (not serious) in the days before vaccination); Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021160039

Write-up: Death unexplained; Asthenia; very marked headaches; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory Authority number was FR-AFSSAPS-BX20210504. A 77-year-old female patient received her 1st dose of BNT162B2 (COMIRNATY, lot number EJ6789) at single dose on 06Feb20021 around noon intramuscular in left arm for COVID-19 immunization. Medical history included giant hives, hypertension treated with hydrochlorothiazide, valsartan (COTAREG), hit her head on a door (not serious) in the days before vaccination. Patient lived at home with her daughter with very good general condition. Patient had history of angioedema over 40 years ago (as of 15Feb2021) when she ate asparagus. Concomitant drug included hydrochlorothiazide, valsartan (COTAREG) for high blood pressure. On 06Feb2021, patient experienced very marked headaches and asthenia in the afternoon. On 07Feb2021 around 8 am, patient found dead in bed. Intervention included transportable services for emergency response. Resuscitation attempt including intubation, unsuccessful. No visible lesions on the body. No edema seen during intubation. No autopsy performed. The family does not want medical-scientific expertise. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Asthenia; very marked headaches; Death unexplained


VAERS ID: 1048305 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathy; Atrial fibrillation (episode); Dyslipidaemia; Eschar (stage 4 multiple); Hospitalization; Hypertension; Obstructive sleep apnea syndrome; Peripheral arterial occlusive disease; Pseudomonal sepsis (P. aeruginosa); Spastic paraplegia (in spinal cord compression treated by laminectomy); Total knee replacement; Type II diabetes mellitus; Urinary catheter insertion
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021164513

Write-up: dead; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MA20210345. An 89-year-old male patient received received the first dose of bnt162b2 (COMIRNATY, lot number: EM0477), intramuscularly at the site of right deltoid on 19Jan2021 at single dose for COVID-19 immunization. Medical history included peripheral arterial occlusive disease, pseudomonal sepsis (P. aeruginosa), dyslipidaemia, obstructive sleep apnea syndrome, spastic paraplegia (in spinal cord compression treated by laminectomy), eschar (stage 4 multiple), atrial fibrillation (episode), hypertension, type II diabetes, total knee replacement, arteriopathy obliterating of the lower limbs, indwelling urinary catheter and hospitalizations from 30Mar2020, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Clinical course: The patient was entry into nursing home on 03Jan2021 after leaving follow-up and rehabilitation care after several emergency room stays and hospitalizations from 30Mar2020. After first dose of vaccination, the patient presents no adverse effects during post-vaccination monitoring. On 23Jan2021 at 5:55 p.m., the patient was found dead without problem either the day before or the same day (as reported). The patient died on 23Jan2021. An autopsy was not performed. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: dead


VAERS ID: 1048306 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Blood creatine phosphokinase, Blood test, Body temperature, Computerised tomogram, Disorientation, Fall, Gamma-glutamyltransferase, Influenza virus test, Neutrophil count, Pyrexia, Restlessness, SARS-CoV-2 test, Sleep talking, Sudden death, Urinary tract infection bacterial, Urine analysis
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   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: CANDESARTAN; DAFALGAN; HALDOL; MACROGOL; SERESTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Aortic stenosis; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: creatine phosphokinase; Result Unstructured Data: Test Result:normal; Test Date: 20210126; Test Name: creatine phosphokinase; Result Unstructured Data: Test Result:246; Test Date: 20210125; Test Name: Blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210124; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Test Date: 20210125; Test Name: computed tomography scan; Result Unstructured Data: Test Result:nothing in particular; Comments: in particular no intracerebral bleeding; Test Date: 20210125; Test Name: Gamma-glutamyltransferase; Result Unstructured Data: Test Result:41; Test Date: 20210125; Test Name: influenza serology; Test Result: Negative ; Test Date: 20210125; Test Name: Neutrophils; Result Unstructured Data: Test Result:4000; Test Date: 20210126; Test Name: Neutrophils; Result Unstructured Data: Test Result:2930; Comments: remained unremarkable; Test Date: 20210125; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210126; Test Name: Urine examination (cytobacteriological examination of urine); Test Result: Positive
CDC Split Type: FRPFIZER INC2021169150

Write-up: Sudden death; disorientation and agitation a little increased compared to usual; disorientation and agitation a little increased compared to usual; positive cytobacteriological examination of urine; The patient fell 3 times; more restless; talked in sleep; Febricule / low fever at 37.8 Celsius degrees; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority number FR-AFSSAPS-MP20210171). A 92 years old female patient received the first single dose of BNT162B2 (COMIRNATY; lot EJ6788) intramuscular, in right arm, on 21Jan2021 at 14:42, for COVID-19 vaccination. The patient was considered to be at risk of developing a severe form of the disease COVID-19. The patient had no history of COVID-19. Medical history included aortic stenosis, hypertension arterial, Alzheimer''s disease, all from an unknown date and unknown if ongoing. Concomitant medications included candesartan 8 mg, paracetamol (DAFALGAN) 3 g, haloperidol (HALDOL) 2 mg, macrogol, oxazepam (SERESTA) 10 mg. Normal immediate monitoring. On 24Jan2021 more restless patient, talked in sleep, low fever at 37.8 Celsius degrees. On 25Jan2021 the patient underwent blood test and COVID-19 PCR test which was negative, normal creatine phosphokinase (CPK), neutrophils 4000, Gamma-glutamyltransferase 41, influenza serology negative. The patient fell 3 times during the day and a computed tomography scan was performed showing nothing in particular (in particular no intracerebral bleeding). On 26Jan2021 creatine phosphokinase (CPK) 246, neutrophils 2930, remained unremarkable. Urine examination positive cytobacteriological examination of urine: prescription of a sachet of fosfomycin (FOSFOCIN). On 27Jan2021 disorientation and agitation a little increased compared to usual with Haldol 2 mg per day for a long time. Evolution: on 29Jan2021 the patient was found deceased in her bed in the early morning holding a glass in her hand. It was unknown if an autopsy was done. Sudden death and febricula were reported as fatal events. The outcome of the other events was unknown. Accountability made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Official bulletin of the Ministry of Health No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death; Febricule / low fever at 37.8 Celsius degrees


VAERS ID: 1048308 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Diabetes; Hypertension arterial; Obesity; Obstructive sleep apnea syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021169163

Write-up: Infarct myocardial; Chest pain; This is a spontaneous report from a contactable physician, received from the Medicines Agency (MA) Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MP20210177. An 91-year-old male patient received the first dose of BNT162B2 (COMIRNATY), from lot EJ6788, via intramuscular route in the left arm on 25Jan2021 at single dose for covid-19 immunisation. Medical history included hypertension arterial, chronic obstructive pulmonary disease, obesity, diabetes, obstructive sleep apnea syndrome, all from an unknown date and unknown if ongoing. No COVID prior vaccination. Concomitant medications were not reported. On 30Jan2021 the patient experienced Chest pain and pain in the left arm and onset of sweating, nausea, vomiting, after physical exertion (wanted to move his chair). The patient experienced an infarct myocardial. The patient died due to infarct myocardial on the same date. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1048309 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / 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: 2021-02-06
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Living in nursing home
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021169148

Write-up: COVID-19 aggravated; This is a spontaneous report from a contactable consumer reporting on behalf of the father and downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority number FR-AFSSAPS-NC20210377). A 94 years old male patient received the first single dose of BNT162B2 (COMIRNATY; lot EJ6788) intramuscular, on 29Jan2021, for COVID-19 immunisation. The patient was resident at the nursing home. Other medical history and concomitant medications were not reported. The anti-COVID vaccine was administered to the patient at the nursing home on 29Jan2021. Following 1 positive case of COVID detected in the nursing home, the residents were confined to their rooms from 30Jan2021. The patient tested positive for COVID on 03Feb2021, as well as 2 other residents of the residence. His state of health quickly deteriorated and he died on 06Feb2021 in the nursing home due to COVID-19 aggravated. It was unknown if an autopsy was done. 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 follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: COVID-19 aggravated


VAERS ID: 1048310 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Anal fistula, General physical health deterioration
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Dementia; Dyslipidaemia; Osteoporosis; Psoriasis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021160109

Write-up: General physical health deterioration; Rectum to skin fistula; Abdomen enlarged; This is a spontaneous report from a contactable physician from the Regulatory Authority-WEB FR-AFSSAPS-NY20210243. An 89-year-old patient female patient received the first dose of bnt162b2 (COMIRNATY) via Intramuscular on 04Feb2021 Arm Left at single dose (Lot # EJ6788) for covid-19 immunisation. Medical history included bedridden, dementia, severe psoriasis, osteoporosis, dyslipidemia all unknown if ongoing. 24 hours after the injection (05Feb2021), deterioration of the general condition with abdominal distension in the context of a wound in the buttock, deterioration of the general condition a few days earlier in a communicating patient. No general infectious symptoms, nor skin. Following the discovery of stool in the wound of internal origin with the presence of a commensal germ of digestive origin on the wound, suspicion of an anorecto-cutaneous fistula. Abdominal enlarged, general physical health deterioration and suspicion of rectum to skin fistula in the patient after a vaccination on 05Feb2021. 06Feb2021, death of the patient. Unfavorable evolution with death of the patient. All events were death and Life-threatening. It is unknown if autopsy was done. Outcome of the events was fatal. No accountability in the absence of direct causation according to the declarant. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the information currently available, there was not a reasonable possibility that the events "General physical health deterioration, Rectum to skin fistula and Abdomen enlarged" were related to bnt162b2. The patient''s advance age with multiple underlying disease provide plausible alternative explanation.; Reported Cause(s) of Death: General physical health deterioration; Rectum to skin fistula; Abdomen enlarged


VAERS ID: 1048311 (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: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 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: Bronchiectasis; Lung lobectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021164521

Write-up: Embolism pulmonary/pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-NY20210244 received from the Regulatory Authority. A 77-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EM0477), intramuscular in left arm on 21Jan2021 at single dose for covid-19 immunisation. The patient''s medical history included bronchiectasis and lobectomy in 1972. Concomitant medications were not reported. On 23Jan2021, The patient experienced an evidence of pulmonary embolism. The patient died on an unknown date. It was not reported if an autopsy was performed. The cause of death was embolism pulmonary/pulmonary embolism. The event was considered as fatal and life-threatening. Conclusion: pulmonary embolism demonstrated 2 days after vaccination with COMIRNATY (lot EM0477). Urgent medical intervention, involving the vital prognosis. Death of the patient. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Embolism pulmonary/pulmonary embolism


VAERS ID: 1048312 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Lower respiratory tract congestion, Lung abscess, Pleural effusion, Pyrexia
SMQs:, Cardiac failure (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Disease Parkinson''s (stabilized with appropriate treatment)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: temperature; Result Unstructured Data: Test Result:up to 39.7 Centigrade; Comments: fever
CDC Split Type: FRPFIZER INC2021164519

Write-up: Bronchial congestion; Abscess of lung; Fever; Pleural effusion; This is a spontaneous report from a contactable consumer (patient''s daughter) downloaded from the Regulatory Authority-WEB FR-AFSSAPS-NY20210245. This is a report received from the Regulatory Authority. An 81-year-old male patient in care home received the first dose of BNT162B2 (COMIRNATY) (Batch/Lot number and expiration date unknown), intramuscular in the right arm on 19Jan2021 at single dose for COVID-19 vaccination. The patient''s medical history included ongoing Parkinson''s disease (stabilized with appropriate treatment). Concomitant medications were not reported. On 20Jan2021, the onset of fever (up to 39.7 Celsius degrees) followed by congestion of the bronchi then an abscess in the lung (requiring maximum respiratory assistance at 15L) and pleural effusion. The patient was hospitalized due to the above mentioned events. On 27Jan2021, death of the patient. The outcome of the events was reported as death one week later. The patient died on 27Jan2021. It was not reported if an autopsy was performed. Conclusion (as reported): Fever, bronchial congestion, lung abscess and pleural effusion in an 81-year-old patient the day after a first injection of the vaccine COMIRNATY (lot not documented). Unfavorable evolution: death of the patient one week later. No accountability in the absence of medical evidence. Fever, bronchial congestion, abscess of lung, pleural effusion in a 81 year-old man one day after a COVID-19 vaccination with COMIRNATY (batch unknown). Accountability without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Therapy. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Bronchial congestion; Abscess of lung; Fever; Pleural effusion


VAERS ID: 1048315 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-04
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   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: EUTHYROX; SEROPLEX; EDUCTYL; SPECIAFOLDINE; COSOPT; FORTIMEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer (Former breast cancer (2004). in remission); COVID-19; Dementia; Meningioma (partially calcified frontal anterior right); Psychosis; Thyroid cancer; Thyroidectomy (Thyroidectomy for thyroid cancer in 2011, Dysthyroidism)
Allergies:
Diagnostic Lab Data: Test Date: 20200407; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021169146

Write-up: Sudden death; This is a spontaneous report from a physician. This is a report received from the Regulatory Authority. Regulatory authority report number {enter regulatory authority number}. A 88-years-old female patient started to receive bnt162b2 (COMIRNATY) , intramuscular from 27Jan2021 to 27Jan2021 at 0.3 mL, single for covid-19 immunisation . Medical history included meningioma from 2019 to an unknown date partially calcified frontal anterior right , dementia from an unknown date and unknown if ongoing , covid-19 from 07Apr2020 to an unknown date , psychotic disorder from an unknown date and unknown if ongoing , breast cancer from 2004 to an unknown date Former breast cancer (2004). in remission , thyroidectomy from 2011 to an unknown date Thyroidectomy for thyroid cancer in 2011, Dysthyroidism , thyroid cancer from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (EUTHYROX), escitalopram oxalate (SEROPLEX), potassium bitartrate, sodium bicarbonate (EDUCTYL), folic acid (SPECIAFOLDINE), dorzolamide hydrochloride, timolol maleate (COSOPT) , nutrients nos (FORTIMEL). The patient experienced sudden death (sudden death) (death) on 04Feb2021 05:00. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Apr2020 . The action taken in response to the event(s) for bnt162b2 was not applicable. The patient died on 04Feb2021. An autopsy was not performed.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1048316 (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: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
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: Atrial fibrillation; Conduction disorder; Diabetes; End stage renal failure; Ischaemic heart disease; Permanent cardiac pacemaker insertion; Renal dialysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021164518

Write-up: patient was found at her deceased home on the scheduled day of her dialysis.; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB with regulatory authority number FR-AFSSAPS-PB20210265. A 73-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number: EJ6788), intramuscularly on 28Jan2021 at single dose for covid-19 immunization. Medical history included diabetes, permanent cardiac pacemaker insertion, atrial fibrillation, renal dialysis, Ischaemic heart disease, end stage renal failure and conduction disorder, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The circumstances are unknown and unexplained. She was found at her deceased home on the scheduled day of her dialysis. The patient died on 31Jan2021. 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: patient was found at her deceased home on the scheduled day of her dialysis.


VAERS ID: 1048317 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK 9788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, C-reactive protein, Death, Investigation, Physical examination, Pyrexia, SARS-CoV-2 test, Subileus, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   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: ENOXAPARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of colon stage II (T2N0M0); Colectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: blood test; Result Unstructured Data: Test Result:not showing any ionic disturbances; Test Date: 20210205; Test Name: body temperature; Result Unstructured Data: Test Result:38; Test Date: 20210204; Test Name: CRP; Result Unstructured Data: Test Result:13; Test Date: 20210206; Test Name: CRP; Result Unstructured Data: Test Result:200; Test Date: 20210204; Test Name: imaging test; Result Unstructured Data: Test Result:not showing any ionic disturbances; Test Date: 20210206; Test Name: clinical examination; Result Unstructured Data: Test Result:without particularities, flexible calves; Test Date: 20210205; Test Name: COVID PCR test; Result Unstructured Data: Test Result:negative; Test Date: 20210206; Test Name: leukocytes; Result Unstructured Data: Test Result:3000
CDC Split Type: FRPFIZER INC2021169133

Write-up: Death NOS; fever at 38; Subocclusive syndrome; This is a spontaneous report from a contactable physician via The National Agency for Medicines and Health Products Safety downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-PB20210301. An 81-years-old female patient received the first dose of bnt162b2 (COMIRNATY, lot/batch EK 9788), intramuscular on 03Feb2021 at single dose for covid-19 immunisation. Medical history included very recent discovery of early stage colon cancer (T2N0M0) in Jan2021 for which the patient had a right colectomy on 20Jan2021, hospitalization for a few days, simple consequences, return home, with preventive anticoagulant treatment. The patient had no particular ACTD, lived at home with her husband, who was totally independent. The patient''s concomitant medications included enoxaparin. The patient experienced subocclusive syndrome on 04Feb2021. It was reported onset the next day of vaccination of digestive disorders such as vomiting, leading her to consult on 04Feb2021: diagnosis of subocclusive syndrome, carrying out of tests (blood, imaging) not showing any ionic disturbances, CRP at 13, patient on an empty stomach and insertion of a gastric tube. Favorable evolution over the following days, from 05Feb2021 gastric probe not very productive, supple stomach, in the evening fever at 38, carrying out a negative COVID PCR test. Saturday 06Feb2021 was better on the digestive plan, was refueling, clinical examination without particularities, flexible calves. On biology, CRP raised to 200 and in parallel, leukocytes to 3000. The patient died on 07Feb2021. It was not reported if an autopsy was performed. Patient found dead at 5:30 a.m. On Sunday 07Feb2021 morning, during the 3 a.m. tour, the nurse noted that the patient was asleep. Conclusion: unexplained death, in an 81-year-old female patient, with no specific ATCD, in a context of sub-occlusive syndrome occurring hours after vaccination. No physical complaint overnight. No signs suggesting venous thrombosis or pulmonary embolism in this patient treated with preventive enoxaparin for 3 weeks. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unexplained death


VAERS ID: 1048319 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EF6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Aspartate aminotransferase, Atrial fibrillation, Blood bicarbonate, Blood creatinine, Blood lactic acid, Brain natriuretic peptide, Electrocardiogram, Fibrin D dimer, Laboratory test, Myocardial infarction, PCO2, PO2, Respiratory distress, SARS-CoV-2 test, Troponin, Venous oxygen saturation, Venous oxygen saturation decreased, Vomiting, pH body fluid
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Myocardial infarction (narrow), Supraventricular tachyarrhythmias (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Hypertensive heart disease NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:35 times above normal; Test Date: 20210128; Test Name: Bicarbonates; Result Unstructured Data: Test Result:17; Comments: Blood gases: Bicarbonates at 17; Test Date: 20210128; Test Name: creatinine; Result Unstructured Data: Test Result:140; Comments: creatinine at 140 (versus 90 baseline); Test Date: 20210128; Test Name: Lactates; Result Unstructured Data: Test Result:4.2; Comments: Blood gases: Lactates at 4.2; Test Date: 20210129; Test Name: Brain natriuretic peptide; Result Unstructured Data: Test Result:2800; Test Date: 20210128; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm with LBBB; Comments: ECG in sinus rhythm with left bundle branch block at 8:50 p.m.; Test Date: 20210128; Test Name: DDimer; Result Unstructured Data: Test Result:3980 /mm3; Comments: D-Dimer to 3980 / mm3; Test Date: 20210128; Test Name: laboratory test; Result Unstructured Data: Test Result:inflammatory syndrome; Comments: inflammatory syndrome with polynuclear neutrophils at 21000; Test Date: 20210128; Test Name: pCO2; Result Unstructured Data: Test Result:28; Comments: Blood gases: pCO2 = 28; Test Date: 20210128; Test Name: pH; Result Unstructured Data: Test Result:7.4; Comments: Blood gases: pH 7.4; Test Date: 20210128; Test Name: pO2; Result Unstructured Data: Test Result:51; Comments: Blood gases: pO2 = 51; Test Date: 20210128; Test Name: PCR Covid test; Test Result: Negative ; Test Date: 20210129; Test Name: PCR Covid test; Test Result: Negative ; Test Date: 20210129; Test Name: Troponin; Result Unstructured Data: Test Result:above 25.000; Test Date: 20210128; Test Name: venous oxygen saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: FRPFIZER INC2021164520

Write-up: Distress respiratory; Atrial fibrillation aggravated; Infarct myocardial; Venous oxygen saturation decreased; Emesis; Acute coronary syndrome; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-PC20210191. A 91-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number EF6795), intramuscular on 28Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included hypertensive heart disease NOS and arterial hypertension both unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced infarct myocardial on 28Jan2021, distress respiratory on 31Jan2021, venous oxygen saturation decreased on 28Jan2021, emesis on 28Jan2021, acute coronary syndrome on 28Jan2021, atrial fibrillation aggravated on 31Jan2021. Clinical course: After dinner, episode of vomiting with 78% desaturation in ambient air - Call to the firefighters who brought the patient to the emergency department. At the emergency room: ECG in sinus rhythm with left bundle branch block at 8:50 p.m. Respiratory distress - Biological assessment which finds an inflammatory syndrome with polynuclear neutrophils at 21000. - renal failure with creatinine at 140 (versus 90 baseline). aspartate aminotransferase at 35 times above normal. DDimer to 3980 / mm3. Blood gases: pH 7.4 - pO2 = 51 - pCO2 = 28 - Bicarbonates at 17 - Lactates at 4.2. PCR Covid negative. Scanner suggestive of Covid19. In UGA on 29Jan2021: Troponin above 25.000. Brain natriuretic peptide (BNP) at 2800. negative COVID control PCR, Cardiac advice request: Acute Coronary Syndrome Complicated IV Left + global hypokinesia + 20% visual ejection fraction. Initiation of medical treatment: aspirin 250mg IV + plavix 75 + heparin calcium at an effective dose. 31Jan2021: Clinical degradation with progression to rapid atrial fibrillation without resolution following the administration of 3 Cordarone tablets. Faced with the deterioration of the state of vigilance and the persistence of a picture of acute respiratory distress, referral to exclusive palliative care with the introduction of morphine and hypnovel. Evolution: Death 03Feb2021. The patient died on 03Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Distress respiratory; Venous oxygen saturation decreased; Emesis; Acute coronary syndrome; Atrial fibrillation aggravated; Infarct myocardial


VAERS ID: 1048321 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-02-04
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Death, Pneumonia aspiration
SMQs:, Cardiac failure (narrow), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (Dysrhythmic heart disease in atrial fibrillation); Chronic obstructive airways disease; Parotid tumor (untreated); Prostatic cancer (under hormone therapy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021165956

Write-up: inhalation pneumonitis; heart failure; Sudden death/natural death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-RE20210275. A 93-year-old male patient received bnt162b2 (COMIRNATY) (lot: EM0477) intramuscularly on the left arm on 13Jan2021 at a single dose for COVID-19 immunisation. Medical history included progressive tumor of the parotid, untreated, prostate cancer under hormone therapy, dysrhythmic heart disease in atrial fibrillation, chronic obstructive pulmonary disease. Concomitant medications were not reported. HISTORY OF THE DISEASE: Patient considered to be at risk of developing a severe form of the COVID-19 disease: ''comorbidities, uncontrolled cancer'', not having contracted COVID-19 and not having been tested. Patient experienced sudden death/natural death on 04Feb2021. Event was considered serious due to hospitalization and death. 04Feb2021: Death of the patient: ''natural death, inhalation pneumonitis and heart failure probable''. "No resuscitation measures given the advanced stage of the parotid tumor and the comorbidities". The outcome of inhalation pneumonitis and heart failure was unknown. It was not reported if an autopsy was performed. Sender''s Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code) (Sudden death, cause unknown). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death/natural death


VAERS ID: 1048322 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-07
Onset:2021-02-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, C-reactive protein, Haemoglobin, Heart rate, Hyperleukocytosis, Lung disorder, Neutrophil count, Oxygen saturation, Physical examination, Polymerase chain reaction, Renal function test, Respiratory distress, Respiratory rate, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Malignancy related conditions (narrow), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: TEMESTA [LORAZEPAM]; MICROPAKINE; AMLODIPINE; TIAPRIDAL; PANTOPRAZOL [PANTOPRAZOLE]; PARACETAMOL; SPECIAFOLDINE; PHOSPHONEUROS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hypertension arterial; Malnutrition; Starvation (malnutrition); Transient ischaemic attack
Allergies:
Diagnostic Lab Data: Test Date: 20210208; Test Name: blood pressure; Result Unstructured Data: Test Result:130/82 mmHg; Comments: On arrival; Test Date: 20210208; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: On arrival; Test Date: 20210208; Test Name: CRP; Result Unstructured Data: Test Result:141 mg/l; Test Date: 20210208; Test Name: Hb; Result Unstructured Data: Test Result:14.9 g/dl; Test Date: 20210208; Test Name: Heart rate; Result Unstructured Data: Test Result:91 bpm; Comments: On arrival; Test Date: 20210208; Test Name: hyperleukocytosis; Result Unstructured Data: Test Result:17.9 g/l; Test Date: 20210208; Test Name: Neutrophils; Result Unstructured Data: Test Result:16.5 g/l; Test Date: 20210208; Test Name: saturation; Test Result: 96 %; Comments: On arrival: SaO2 at 96% under 3l / min O2; Test Date: 20210208; Test Name: saturation; Result Unstructured Data: Test Result:<80 %; Comments: Rapid deterioration of the respiratory state with desaturation <80%, high concentration mask put on; Test Date: 20210208; Test Name: saturation; Test Result: 76 %; Comments: 76% desaturation in ambient air; Test Date: 20210208; Test Name: saturation; Test Result: 96 %; Comments: Put under oxygen with glasses, saturation at 96% under 3l / min of O2.; Test Date: 20210208; Test Name: saturation; Test Result: 88 %; Comments: Worsening of dyspnea on 08Feb21 at the end of the day, with 88% desaturation under 3l / min of O2, requiring emergency transfer for treatment.; Test Date: 20210208; Test Name: clinical examination; Result Unstructured Data: Test Result:found signs of dehydration (skin fold, roasted ton; Comments: pulmonary auscultation with bilateral bronchial rales of stasis, ineffective cough, trouble swallowing, normal abdominal examination.; Test Date: 20210208; Test Name: PCR on nasal swab; Test Result: Negative ; Comments: PCR on nasal swab: negative influenza; Test Date: 20210208; Test Name: renal function; Result Unstructured Data: Test Result:normal; Test Date: 20210208; Test Name: respiratory rate; Result Unstructured Data: Test Result:16/min; Comments: On arrival; Test Date: 20210208; Test Name: PCR on nasal swab; Test Result: Negative ; Comments: PCR on nasal swab: Covid-19
CDC Split Type: FRPFIZER INC2021164860

Write-up: Distress respiratory; Pneumopathy; This is a spontaneous report from a contactable physician from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-RN20210395. An 82-years-old male patient received second dose of bnt162b2 (COMIRNATY, lot: EJ6789), intramuscular on 07Feb2021 at SINGLE DOSE on Arm Left for covid-19 immunisation. Medical history included starvation, malnutrition, transient ischaemic attack, dementia, Hypertension arterial all from an unknown date and unknown if ongoing. No known allergy. Concomitant medication included lorazepam (TEMESTA [LORAZEPAM]), valproate sodium, valproic acid (MICROPAKINE), amlodipine (AMLODIPINE), tiapride hydrochloride (TIAPRIDAL), pantoprazol [pantoprazole] (PANTOPRAZOL [PANTOPRAZOLE]) , paracetamol (PARACETAMOL), folic acid (SPECIAFOLDINE), calcium phosphate monobasic, magnesium glycerophosphate, phosphoric acid, sodium phosphate dibasic (PHOSPHONEUROS). Historical Vaccine included comirnaty, 1st dose for Covid-19 immunisation, single dose No noticeable reaction during the 1st injection. No noticeable reaction during the 1st injection. No sign of current infection at the time of injection, including apyrexia. The patient experienced distress respiratory and pneumopathy on 08Feb2021. It was reported that the patient presented on 08Feb21 acute respiratory distress in the morning, with 76% desaturation in ambient air. Put under oxygen, saturation at 96% under 3l / min of O2. Introduction of antibiotic therapy with Ceftriaxone for a suspicion of infectious pneumopathy in front of a fever. Worsening of dyspnea on 08Feb21 at the end of the day, with 88% desaturation under 3l / min of O2, requiring emergency transfer for treatment. On arrival on 08Feb2021 of the patient: T 37.5 c, SaO2 at 96% under 3l / min O2, respiratory rate.(fr FR) 16 / min, Heart rate (fr FC) 91bpm, Blood pressure 130 / 82mmHg. The clinical examination found signs of dehydration (skin fold, roasted tongue), pulmonary auscultation with bilateral bronchial rales of stasis, ineffective cough, trouble swallowing, normal abdominal examination. The biology found hyperleukocytosis at 17.9 g/l with Neutrophils (fr PNN) 16.5G / L, Hb 14.9 g/dl, CRP 141mg / l, ionogram and normal renal function. PCR on nasal swab: negative influenza and Covid-19. Rapid deterioration of the respiratory state with desaturation <80%, high concentration mask put on. No resuscitation measure given the very limited autonomy and also after a call from the wife, who does not want therapeutic persistence. Death at 10:24 p.m. on 08Feb2021. It was not reported if an autopsy was performed. Subject to other elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Official bulletin of the Ministry in charge of health n ? 84/50, 24Jan1985 Published in: Therapy 1985; 40: 111-8 No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumopathy; Distress respiratory


VAERS ID: 1048323 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Asymptomatic COVID-19, Auscultation, Blood pressure measurement, COVID-19, Cardiopulmonary failure, Culture urine, Death, Disorientation, Electrocardiogram, Heart rate, Hypotension, Oedema peripheral, Oxygen saturation, Oxygen saturation decreased, Pallor, Physical examination, Respiratory distress, SARS-CoV-2 test, Sinus tachycardia, Tachycardia, Tachypnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemic (treated by a transfusion of 2 red blood cells bags); Cognitive disturbance (Moderate); Diabetes mellitus insulin-dependent; Escherichia coli infection; Hospitalization (due to deterioration of general condition and vomiting revealing cardiac decompensation); Hypertension arterial (HTA treated and balanced)
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: pulmonary auscultation; Result Unstructured Data: Test Result:Clear and symmetrical; Comments: No right or left cardiac insufficiency sign; Test Date: 20210202; Test Name: Blood pressure; Result Unstructured Data: Test Result:still low at 9/5; Test Date: 20210204; Test Name: Blood pressure; Result Unstructured Data: Test Result:140/80; Test Date: 20210112; Test Name: cytobacteriological urine exam; Result Unstructured Data: Test Result:positive to E. coli; Comments: sensitive to Amoxicillin; Test Date: 20210204; Test Name: ECG; Result Unstructured Data: Test Result:sinus tachycardia; Comments: sinus tachycardia with a shift in particular in V5-V6; Test Date: 20210201; Test Name: Heart rate; Result Unstructured Data: Test Result:100; Comments: Tachycardia around 100 bpm; Test Date: 20210202; Test Name: Heart rate; Result Unstructured Data: Test Result:115; Comments: tachycardia at 115 bpm; Test Date: 20210204; Test Name: Heart rate; Result Unstructured Data: Test Result:145 bpm; Test Date: 20210204; Test Name: saturation; Test Result: 80 %; Test Date: 20210201; Test Name: physical examination; Result Unstructured Data: Test Result:Soft, painless calves. Hydroaeric noises ok; Comments: abdomen soft, no guarding, no tenderness. No urinary symptoms. No externalized bleeding observed.; Test Date: 20210202; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021164911

Write-up: sudden death / Death unexplained; acute respiratory distress; 80% desaturation; agitation without disturbance of consciousness; Polypnea, thoraco-abdominal rocking, pursed lip; slight edema of the lower limbs; a sinus tachycardia with a shift in particular in V5-V6; a sinus tachycardia with a shift in particular in V5-V6; cardio-respiratory failure; Blood pressure still low at 9/5; Positive COVID test; Positive COVID test (screening as part of a cluster in the service; disoriented in time and space; Tachycardia around 100 bpm; slight pallor; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-RS20210171. An 83-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot/batch number: EJ6788), intramuscularly on 01Feb2021 at single dose for COVID-19 immunization. Medical history included hypertension arterial (HTA treated and balanced), cognitive disturbance (moderate), diabetes mellitus insulin-dependent, hospitalized due to deterioration of general condition and vomiting revealing cardiac decompensation, anemic syndrome associated with melena treated by a transfusion of 2 red blood cells bags and E. coli infection, all from an unknown date and unknown if ongoing. Concomitant medication included amoxicillin from 12Jan2021 to 18Jan2021 for E. coli infection. Clinical course: On 12Jan2021, the patient was hospitalized due to deterioration of general condition and vomiting revealing cardiac decompensation. The selected decompensation factors are an infection with a cytobacterioligical urine exam positive to E. coli sensitive to Amoxicillin, treated with amoxicillin 1 g x 3 for 7 days as well as an anemic syndrome associated with melena, treated by a transfusion of 2 red blood cells bags. Progressive resolution of the cardiological symptoms and progressive regression of the inflammatory syndrome during hospitalization. After vaccination, medical observation of 01Feb2021: rather coherent remarks, but patient disoriented in time and space. No somatic complaint. Tachycardia around 100 bpm, slight pallor. Clear and symmetrical pulmonary auscultation. No right or left cardiac insufficiency sign. Physical examination: Soft, painless calves. Hydroaeric noises ok, abdomen soft, no guarding, no tenderness. No urinary symptoms. No externalized bleeding observed. 02Feb2021: Patient partially oriented in time. Blood pressure still low at 9/5, tachycardia at 115 bpm. Stable clinical condition. Cardio-pulmonary auscultation: aortic stenosis, abdomen soft, no guarding, no tenderness. Positive COVID test (screening as part of a cluster in the service). Asymptomatic patient. 03Feb2021: good constants, patient "as usual". 04Feb2021: without an established cause according to the declarant. Call for acute respiratory distress with 80% desaturation and with agitation without disturbance of consciousness. BP 140/80, 145bpm. Polypnea, thoraco-abdominal rocking, pursed lip. No cyanosis observed. Patient placed under O2 in a high concentration mask between 10 and 15L allowing correct saturation$g 90%. Crackling in the 2 fields, frothy sputum in a second step, slight edema of the lower limbs. ECG made finding a sinus tachycardia with a shift in particular in V5-V6 already present on the previous ECG. Rapid degradation, no improvement after 40mg of furosemide (LASILIX) IV. Then cardio-respiratory failure, start of an external heart massage, no flow <1min. Initial notice to the resuscitator on call, resuscitation continued. Non-shockable rhythm, administration of 2x1mg of adrenaline. Decision not to continue resuscitation after review of the file, after 20min of CPR. Sudden death occurred; death noted at 3:05 am. Coded as "unexplained death" (because death without an established cause according to the declarant) pending the final hospitalization report for update of the file. The patient died at 3:05 am on 04Feb2021. It was not reported if an autopsy was performed. The outcome of events was not recovered. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death / Death unexplained


VAERS ID: 1048324 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-03
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, COVID-19, Drug ineffective, Haemoglobin, Heart rate, International normalised ratio, Oxygen saturation, Platelet count, SARS-CoV-2 test, Spinal X-ray, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COUMADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathic disease; Atrial fibrillation; Cardiac arrhythmia; Chronic cor pulmonale; COPD; Dementia aggravated; Dementia with Lewy bodies; Hernia hiatal; Hyperthermia (hyperthermia and sudden desaturation); Oxygen saturation decreased (hyperthermia and sudden desaturation); Thromboendarterectomy (Bilateral pulmonary thromboendarterectomy); Thyroidectomy; Ulcer
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: BP; Result Unstructured Data: Test Result:retained; Test Date: 20210121; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210203; Test Name: body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Test Date: 20210126; Test Name: haemoglobin; Result Unstructured Data: Test Result:16.4 g/dl; Test Date: 20210203; Test Name: pulse; Result Unstructured Data: Test Result:Rapid pulse +++; Test Date: 20210123; Test Name: international normalized ratio; Result Unstructured Data: Test Result:2.9; Test Date: 20210126; Test Name: international normalized ratio; Result Unstructured Data: Test Result:New rise in INR; Comments: New rise in INR despite reduction in dose of COUMADINE.; Test Date: 20210129; Test Name: international normalized ratio; Result Unstructured Data: Test Result:1.7; Test Date: 20210202; Test Name: international normalized ratio; Result Unstructured Data: Test Result:1.7; Test Date: 20210203; Test Name: oxygen saturation; Result Unstructured Data: Test Result:below 70 %; Test Date: 20210126; Test Name: platelets; Result Unstructured Data: Test Result:277 x10 9/l; Test Date: 20201231; Test Name: PCR COVID-19 test; Test Result: Negative ; Test Date: 20210203; Test Name: PCR COVID-19 test; Test Result: Positive ; Test Date: 20210126; Test Name: sacro-coccygeal abscess; Result Unstructured Data: Test Result:sacro-coccygeal abscess; Test Date: 20210126; Test Name: leucocyte; Result Unstructured Data: Test Result:8.7 x10 9/l
CDC Split Type: FRPFIZER INC2021164512

Write-up: COVID-19 infection; COVID-19 infection; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB regulatory authority FR-AFSSAPS-RS20210172. A 73-year-old female patient received the first dose bnt162b2 (COMIRNATY, lot number: EJ6788), intramuscular on 21Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Cardiac arrhythmia, Dementia with Lewy bodies, Atrial fibrillation, COPD, Ulcer, Chronic cor pulmonale, Thyroidectomy, Arteriopathic disease, Hernia hiatal, all from unknown date and unknown of ongoing, Bilateral pulmonary thromboendarterectomy in 2000, severe dementia from Oct2020, hyperthermia and sudden desaturation from 31Dec2020. Concomitant medication included warfarin sodium (COUMADINE). The patient previously received clozapine (LEPONEX) for dementia, ceftriaxone sodium (ROCEPHINE), amoxicillin clavulanic acid (AUGMENTIN), and ofloxacin. The patient experienced COVID-19 infection on 03Feb2021 with outcome of fatal. Clinical course: In Oct2020, the patient presented psychotic symptoms of severe dementia. Introduction of clozapine. 31Dec2020: episode of hyperthermia and sudden desaturation. PCR COVID negative. Treatment with ceftriaxone sodium in probabilistic mode. Switch ceftriaxone sodium to amoxicillin clavulanic acid + ofloxacin for cutaneous + urinary tract. 14Jan2021: seat lesion on the way to healing but widening of the orifice of the lesion which is flush with the anus. 21Jan2021: vaccination with bnt162b2. Apyretic patient at 36.5 deg C before injection. No reaction 15 minutes after injection. Patient under warfarin sodium (COUMADINE) (not administered on 20Jan2021 in the evening). Long compression at the injection site, no hematoma. Medical observations following vaccination: 23Jan2021: INR 2.9 check. 26Jan2021: biologically: Hb 16, 4 g / dL; Leuco 8.7 G / L; platelets 277 G / L. New rise in INR despite reduction in dose of warfarin sodium, new warfarin sodium treatment regimen. Hemoconcentration, it is recommended that the patient drink well. 29Jan2021 and 02Feb2021: INR 1.7. 03Feb2021: occurrence of acute asphyxial febrile respiratory distress on massive PAO, call from the IDE for acute dyspnea with desaturation below 70 percent. Fever at 38.7 deg C. Stage IV dyspnea. Rales diffuse in the 2 pulmonary fields. No edema of the MIG. Rapid pulse +++ BP retained. 03Feb2021: SARS-Cov2 RT-PCR positive. COVID 19 infection GD. Poor short-term prognosis. Part of cardiac decompensation on AC / AF rapid. The patient died on 03Feb2021 at 5:15 p.m. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: COVID-19 infection; COVID-19 infection


VAERS ID: 1048325 (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: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

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: Alzheimer''s disease; Bedridden; Hypertension arterial; Hypertensive heart disease
Allergies:
Diagnostic Lab Data: Test Name: COVID test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC2021169144

Write-up: acute pulmonary edema; This is a spontaneous report from a contactable physician, received from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RS20210184. A 97-year-old female patient, living in care home, received the first dose of BNT162B2 (COMIRNATY), from lot #EM0477, via intramuscular route in the left arm on 15Jan2021 at single dose for covid-19 immunisation. Medical history included Bedridden, Hypertension arterial, Severe stage Alzheimer''s disease, Hypertensive heart disease, all from an unknown date and unknown if ongoing. No sign of allergy or reactogenicity since vaccination. Concomitant medications were not reported. On 29Jan2021, she presented with food vomiting with inhalation overnight and then left cardiac decompensation. On the morning of the 29Jan2021 she was in acute pulmonary edema and given the age and context, clinicians quickly turned to symptomatic treatment. The evolution was then unfavorable with death on 05Feb2021, despite diuretic treatment. It was unknown if an autopsy was performed. Lab data included a SARS-CoV-2 test with negative result on unknown date. The coincidence vaccine death seems rather fortuitous. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available, the event acute pulmonary edema is attributed to an intercurrent medical condition and assessed unrelated to BNT162B2 (COMIRNATY) vaccine.; Reported Cause(s) of Death: acute pulmonary edema


VAERS ID: 1048327 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-11
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiac failure, Disease recurrence, Drug ineffective, Dyspnoea, Haemodynamic instability, Hypoxia, Lung disorder, Pneumonia, Respiratory distress, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Anxiety; Cardiomyopathy; Chronic renal failure; Cognitive disturbance; Decompensation cardiac; Depression; Hyperthyroidism; Insulin-requiring type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210117; Test Name: antigenic Covid test; Test Result: Negative ; Test Date: 20210121; Test Name: antigenic Covid test; Test Result: Negative ; Test Date: 20210121; Test Name: Covid PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021159197

Write-up: 2019 novel coronavirus infection; Covid PCR test: positive; Pneumopathy; Dyspnoea; Hypoxia; worsening of the respiratory state, respiratory distress; hemodynamic instability; appearance of signs of cardiac decompensation; appearance of signs of cardiac decompensation; left basal pneumonia treated with antibiotics; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-ST20210155. A 90-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot/batch number and expiry date unknown), intramuscular on 05Jan2021 at unknown age at 0.3 mL single dose for covid-19 immunization. Medical history included atrial fibrillation, Cognitive disturbance, insulin-requiring type 2 diabetes mellitus, hyperthyroidism, anxiety, Chronic renal failure, Decompensation cardiac, depression, and cardiomyopathy, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced pneumopathy on 15Jan2021. On 11Jan2021, the patient had evidence of dyspnea with moderate hypoxia. On 15Jan2021, the patient had evidence of left basal pneumonia treated with antibiotics. On 17Jan2021, the patient performed an antigenic covid test with negative result. On 20Jan2021, the patient had worsening of the respiratory state with appearance of signs of cardiac decompensation. On 21Jan2021, the patient carried out of a new antigenic Covid test with negative result and Covid PCR test with positive test. On 22Jan2021, the patient was worsening of the respiratory state, respiratory distress and hemodynamic instability. The patient had comfort care in the service. The patient died on 23Jan2021. Seriousness criteria provided for hypoxia, pneumopathy, dyspnea, 2019 novel coronavirus infection and Covid PCR test with positive test was hospitalization and death. The reporter considered the picture of concomitant COVID-19 infection to be worsened by vaccination. The patient died for hypoxia, pneumopathy, dyspnea, 2019 novel coronavirus infection and Covid PCR test with positive test on 23Jan2021. An autopsy was not performed. Outcome of other events were unknown. No follow-up attempts are possible. No further information expected. Information on batch/lot number can not be obtained.; Reported Cause(s) of Death: dyspnea; hypoxia; Pneumopathy; 2019 novel coronavirus infection; covid pcr test: positive


VAERS ID: 1048386 (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: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

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: APIXABAN; METROGEL; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Gout; Malignant melanoma; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021166588

Write-up: atrial fibrillation; myocardial infarction; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102121200406190, Safety Report Unique Identifier GB-MHRA-ADR 24748777. A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 vaccination. Medical history included gout from Feb2020, malignant melanoma from Oct2019, atrial fibrillation from Oct2019, all unknown if ongoing. Concomitant medications included apixaban, metronidazole (METROGEL), tamsulosin. The patient experienced myocardial infarction on 04Feb2021 and patient died on 04Feb2021. Cause of death reported as myocardial infarction and atrial fibrillation. An autopsy was performed and results were not available. It was reported that there''s no known causal link to the vaccine, but death occurred in a very close proximity to the vaccine date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: atrial fibrillation; Myocardial infarction


VAERS ID: 1048387 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-23
Onset:2020-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 45
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: 20210202; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20201215; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021170192

Write-up: Viral pneumonia; SARS-CoV-2 infection; SARS-CoV-2 infection; Sepsis; This is a spontaneous report from a contactable consumer, received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102121609242860, Safety Report Unique Identifier GB-MHRA-ADR 24750893. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunisation, on release from hospital. The patient medical history and the patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient felt at home on 24Dec2020 and was hospitalized. She was discovered to have sepsis, occurred on 23Dec2020. She improved and was released to a care home on 06Jan2021. She had a COVID-19 PCR test performed with a positive result on 02Feb2021 and shortly after was rushed to hospital. She was diagnosed with viral pneumonia and died on 06Feb2021 of viral pneumonia. It was not reported if an autopsy was performed. The patient underwent lab test included a sars-cov-2 test: negative on 15Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Viral pneumonia


VAERS ID: 1048388 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-02
Onset:2021-02-02
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4243 / 1 - / -

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? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021159508

Write-up: Sudden death; This is a spontaneous report from a contactable consumer. This is a report received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202102141035416710, Safety Report Unique Identifier GB-MHRA-ADR 24759210. A 77-years-old male patient received first dose of BNT162B2 (lot number: ek4243), via an unspecified route of administration, on 02Jan2021 at single dose for COVID-19 immunisation. The patient medical history included high blood pressure (BP) and pacemaker. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient previously received warfarin. The patient''s concomitant medications were not reported. The patient experienced sudden death on 02Feb2021. Had vaccine and dead in morning. The seriousness criteria of the event was reported as life threatening. The patient underwent lab tests and procedures which included COVID-19 virus test: negative covid-19 test on an unknown date. Patient had not tested positive for COVID-19 since having the vaccine. The details of any relevant investigations or tests conducted: "Post-mortem said natural causes due to a fib condition but had pacemaker". The outcome of the event was fatal. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: sudden death; Autopsy-determined Cause(s) of Death: a fib condition


VAERS ID: 1048389 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-24
Onset:2020-12-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-29
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201226; Test Name: BP; Result Unstructured Data: Test Result:Low
CDC Split Type: GBPFIZER INC2021170308

Write-up: Vomit aspiration; Diarrhea; Low BP; This is a spontaneous report from a contactable consumer received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102141939491930, Safety Report Unique Identifier GB-MHRA-ADR 24760587. An 83-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 24Dec2020 at single dose for covid-19 immunisation. The patient medical history and the patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. On 26Dec2020 the patient experienced vomit aspiration, diarrhea and low bp. The outcome of the events diarrhea and low BP was reported as not recovered. The outcome of the event vomit aspiration was reported as fatal. The patient died on 29Dec2020. 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: Vomit aspiration


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