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

Found 15,386 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

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VAERS ID: 1000250 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

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: TRIBVIT; CARVEDILOL; D VITAL FORTE; HALDOL; SERTRALINE; L-THYROXINE [LEVOTHYROXINE]; FRAXIPARINE; RIVOTRIL; PANTOPRAZOLE; DOMINAL [ACETYLSALICYLIC ACID]; ALGOSTASE; DUROGESIC; LAXIDO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hip fracture; Mental deterioration (requiring care); Parkinson''s disease; Wheelchair user
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021088925

Write-up: Sudden death; Vomit was found near the body.; This is a spontaneous report from contactable physician downloaded from the Agency (EMA) Agency-WEB BE-FAMHP-DHH-N2021-75651. A 80-year-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunisation. The patient medical history included wheelchair-bound (Parkinson''s, Parkinson''s dementia), hip fracture in Oct2020 and mentally deteriorating so requiring care. Concomitant medication included cyanocobalamin, folic acid, pyridoxine hydrochloride (TRIBVIT), carvedilol (CARVEDILOL), calcium carbonate, colecalciferol (D VITAL FORTE), haloperidol (HALDOL), sertraline (SERTRALINE), l-thyroxine [levothyroxine] (L-THYROXINE [LEVOTHYROXINE]), nadroparin calcium (FRAXIPARINE), clonazepam (RIVOTRIL), pantoprazole (PANTOPRAZOLE), acetylsalicylic acid (DOMINAL [ACETYLSALICYLIC ACID]), caffeine, paracetamol (ALGOSTASE), fentanyl (DUROGESIC), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXIDO). The patient experienced sudden death on 19Jan2021. The patient died on 19Jan2021. An autopsy was not performed. Outcome of the event was fatal. Reporter''s comment: Reporter does not know if death is due to vaccination, but rather thinks not because of ''time to onset'' of 11 days. Cause of death is unknown, however. Vomit was found near the body. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1000251 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-20
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Cardiovascular disorder, Death, General physical health deterioration, 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: 2021-01-20
   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: LIXIANA; BURINEX; ESCITALOPRAM; AMLOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Osteoporosis; Comments: Hypertension, Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021088938

Write-up: General physical health deterioration; Cardiac failure; Lung edema; Cardiovascular disorder; This is a spontaneous report downloaded from the Medicines Agency (MA) WEB BE-FAMHP-DHH-N2021-75687. A contactable physician reported that a 85 years old female patient received first dose BNT162B2 (COMIRNATY), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 vaccination. The medical history included hypertension, osteoporosis. Concomitant drugs were escitalopram (strength 10 mg), bumetanide (BURINEX, strength 1 mg), edoxaban tosilate (LIXIANA, strength 60 mg) and amlodipine besilate(AMLOR, strength 10 mg).On 20Jan2021 the patient suffered from cardiovascular disorder, lung edema, cardiac failure and general physical health deterioration during treatment with BNT162B2. The patient died on 20Jan2021. It''s unknown if an autopsy was performed. The cause of death was cardiovascular disorder, lung edema, cardiac failure and general physical health deterioration. The outcome of events was fatal. Reporter Comment: no really obvious side effects after vaccination. earlier further deterioration (so this already deteriorated before vaccination) No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: no really obvious side effects after vaccination. earlier further deterioration (so this already deteriorated before vaccination); Reported Cause(s) of Death: General physical health deterioration; Cardiac failure; Lung edema; Cardiovascular disorder


VAERS ID: 1000256 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood calcium normal, Blood creatinine increased, Blood parathyroid hormone decreased, Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal, Death, Disturbance in attention, Epilepsy, Fall, General physical health deterioration, Hypercalcaemia, Seizure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Systemic lupus erythematosus (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), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   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: LEFAX [DIMETICONE;SILICON DIOXIDE, COLLOIDAL]; CALCIUM-SANDOZ [CALCIUM GLUBIONATE]; DEKRISTOL; TORASEMIDE; CANDESARTAN; PREDNISOLONE; PALEXIA; LAXOFALK; PANTOZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; DULCOLAX [BISACODYL]; METAMIZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Esophageal disorder (CT Throrax-Abdomen noted thickened esophagus)
Allergies:
Diagnostic Lab Data: Test Name: Calcium; Result Unstructured Data: Test Result:2.4 mmol/L; Test Name: Blood creatinine; Test Result: 2.8 mg/dl; Test Name: Parathyroid hormone; Result Unstructured Data: Test Result:9.0 ng/ml; Test Name: CT Throrax-Abdomen; Result Unstructured Data: Test Result:Thickened Esophagus
CDC Split Type: DEPFIZER INC2021088230

Write-up: Deterioration in general condition; Vigilance reduction; Acute kidney failure; Fall; Epilepsy; Hypercalcemic crisis; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) WEB. The regulatory authority report number is DE-DCGMA-21187620. A female patient of an unspecified age received BNT162B2 (COMIRNATY), intramuscular on 09Jan2021 as first 0.3 mL, single for immunization. The patient''s medical history noted, CT Throrax-Abdomen noted thickened esophagus on an unspecified date. Concomitant medication included dimeticone, silicon dioxide, colloidal (LEFAX [DIMETICONE;SILICON DIOXIDE, COLLOIDAL]), calcium glubionate (CALCIUM-SANDOZ [CALCIUM GLUBIONATE]), colecalciferol (DEKRISTOL), torasemide (MANUFACTURER UNKNOWN), candesartan (MANUFACTURER UNKNOWN), prednisolone (MANUFACTURER UNKNOWN), tapentadol hydrochloride (PALEXIA), macrogol (LAXOFALK), pantoprazole sodium sesquihydrate (MANUFACTURER UNKNOWN), bisacodyl (DULCOLAX) , metamizole (MANUFACTURER UNKNOWN). The patient experienced vigilance reduction, acute kidney failure, fall, epilepsy, hypercalcemic crisis on 13Jan2021; the patient also experienced deterioration in general condition on 14Jan2021. The events were serious as they involved hospitalization and lead to death. The patient underwent lab tests and procedures on an unspecified date, which included blood calcium: 2.4 mmol/l; blood creatinine: 2.8 mg/dl; Computerised tomogram (CT) Throrax-Abdomen: thickened esophagus; parathyroid hormone: 9.0 ng/ml. Details were as follows: after vaccination, the patient developed general physical condition abnormal and fall and acute renal failure and hypercalcaemia and vigilance decreased and epilepsy, lasting for eight days. The patient is dead. A diagnosis was confirmed by blood creatinine result: (2.8, unit: mg/dl), calcium (result: 2.4, unit: mmol/l). The death cause was reported as acute renal failure. After vaccination, the patient also developed vigilance decreased and hypercalcaemia and seizure cerebral and acute renal failure, lasting for unknown. The patient was hospitalized, and was dead. CT-Thorax-Abdomen without contrast medium noted possible esophageal carcinoma. Notes in the patient history noted CT Throrax-Abdomen noted thickened esophagus. Disturbance in attention, acute kidney injury, epilepsy, and hypercalcaemia were reported with stop date 20Jan2021 (also reported as with fatal outcome). The causality information for BNT162B2 for all the events per attending physician/ was reported as D. Unclassifiable. Referenced "dekristol 1000 palexia 50". The reporter''s commented that measures: infusion therapy to lower calcium, prednisone IV. (50mg / d), calcitonin 100 IU 2x subcutaneous. A sufficiently reliable, alternative cause for the above entities could not be found. The patient died on 20Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Acute renal failure


VAERS ID: 1000261 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021088236

Write-up: Unclear death; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) WEB DE-PEI-PEI2021001514. A 46-year-old female patient received bnt162b2 (COMIRNATY) (batch no.: EM0477) on 20Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. 12 hours after vaccination the patient developed unclear death (unknown cause of death) (Jan2021), lasting for unknown. The patient is dead. It was not reported if an autopsy was performed. Reporter''s comments: Connection unlikely. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Connection unlikely; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1000263 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021090238

Write-up: died a few days after vaccination; This is a spontaneous report from a contactable physician based on information received by Pfizer from BioNTech medical information, license party for BNT162B2. An elderly male patient of an unknown age received initial dose of BNT162B2 (COMIRNATY) at single dose on 13Jan2021 via an unknown route for Covid-19 immunization. Medical history and concomitant drug were not provided. The physician stated that he vaccinated (initial dose) an elderly male patient with COMIRNATY (on13Jan2021) and the patient died a few days later. It was unknown if an autopsy was performed. Information about lot/batch number was requested.; Sender''s Comments: The causal relationship between BNT162B2and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: died a few days after vaccination


VAERS ID: 1000268 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-12
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Myocardial infarction, Vomiting
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRAZODONE; QUETIAPINE; LORAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular disorder; COPD; Dementia with Lewy bodies; Infarction; Lacunar stroke; Mixed dementia; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20201221; Test Name: covid-19 antigen test; Test Result: Negative ; Test Date: 20201215; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: ESPFIZER INC2021088677

Write-up: Vomiting/food vomit; suspected heart attack; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA) WEB ES-AEMPS-726097. An 80-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 04Jan2021 at 0.3 mL, single for covid-19 immunisation. Medical history included Mixed vascular and Lewy body dementia, with severe and rapidly progressive cognitive deterioration and with behavioral and psychological symptoms of dementia in treatment with trazodone, quetiapine, and lorazepam. Rivastigmine was not tolerated in July 2019. Cerebral vascular disease. Multiinfarction. Lacunar stroke Aug2019. Chronic obstructive pulmonary disease (COPD). Diabetes Mellitus II. Negative PCR 15Dec2020. Rapid Antigen Test screening 21Dec2020 negative. Concomitant medication included trazodone, quetiapine, lorazepam, all for dementia. Since the day of the vaccination, he has not presented new symptoms to his usual one. On the night of 12Jan2021, he developed food vomit and died 10 minutes later. They report suspected heart attack. It was unknown whether an autopsy has been performed. No follow-up attempts are possible, information on batch numbers cannot be obtained.; Reported Cause(s) of Death: Vomiting/food vomit; suspected heart attack


VAERS ID: 1000269 (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: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANTUS; GALVUS; HYDROCHLOROTHIAZIDE; ARANESP; LUMINAL [FLUOXETINE HYDROCHLORIDE]; FUROSEMIDE; HIDROFEROL; RESINCALCIO; SPIROLACTONE; ATORVASTATIN; TARDYFERON; ALOPURINOL; OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic (Cardiovascular disease (excluding hypertension)); Chronic anaemia; Chronic kidney disease; Fibrillation atrial; Hypertension (HTA); Hyperuricaemia; Subdural hematoma; Thromboembolic stroke; Type II diabetes mellitus (Type II diabetes)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021088719

Write-up: Death sudden; This is a spontaneous report received from a contactable physician, downloaded from the Medicines Agency (MA) ES-AEMPS-727019. A 86-year-old male patient received first dose of BNT162B2 (COMIRNATY, Lot number EJ6796) Intramuscular in left arm on 19Jan2021 at single dose for COVID-19 vaccination. Medical history included Hypertension, Hyperuricaemia, Cardiac failure chronic, Chronic kidney disease, Thromboembolic stroke, Fibrillation atrial, Subdural hematoma, Chronic anaemia and Type II diabetes mellitus. Concomitant medications included insulin glargine (LANTUS) for Diabetes mellitus, vildagliptin (GALVUS) for Diabetes mellitus, hydrochlorothiazide for Hypertension, darbepoetin alfa (ARANESP) for Chronic anaemia, fluoxetine hydrochloride (LUMINAL), furosemide for Cardiac failure, calcifediol (HIDROFEROL), calcium polystyrene sulfonate (RESINCALCIO), spironolactone (SPIROLACTONE), atorvastatin, ferrous sulfate (TARDYFERON), alopurinol and omeprazole (OMEPRAZOL). The patient received the first dose of the COVID 19 vaccine and the following morning deceased in his room. Given the patient''s medical history, it seemed that it was most likely a sudden death of cardiac origin, given his history, and that it has coincided temporarily with the COVID vaccine. He had no local or general reaction on the day he got the vaccine. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1000270 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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: 2021-01-05
   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: ESCITALOPRAM; PARACETAMOL; TARDYFERON; DIAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer metastatic (IN PALIATIVE CARE)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021098104

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Agency Agency-WEB. The regulatory authority report number is ES-AEMPS-728224. An 89-year-old female patient received BNT162B2 (COMIRNATY; Lot number EM0477), via an unspecified route of administration on 05Jan2021 as single dose for covid-19 immunization. Medical history included cancer (CA) breast with metastasis, in palliative care (final situation), from an unspecified date. Concomitant medication included escitalopram (MANUFACTURER UNKNOWN), paracetamol (MANUFACTURER UNKNOWN), ferrous sulfate (TARDYFERON), diazepam (MANUFACTURER UNKNOWN). The patient experienced sudden death on 05Jan2021. Details were as follows: patient with basic pathology that justifies the death; CA breast in palliative care (final situation) was noted. But since the death occurred at 30 minutes after the vaccine administration, it was decided to declare it. The patient died on 05Jan2021. 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: Sudden death


VAERS ID: 1000275 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Balance disorder, COVID-19, Cardiac arrest, Computerised tomogram abnormal, Cough, Death, Echocardiogram, Ejection fraction decreased, Gait disturbance, Intracardiac thrombus, Loss of consciousness, Productive cough, Rhinorrhoea, SARS-CoV-2 test positive, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   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: SERESTA; ATORVASTATINE ARROW; INNOHEP; ENALAPRIL EG; PHOSPHONEUROS; BISOPROLOL SANDOZ; PANTOPRAZOLE MYLAN; DEXAMETHASONE; JANUVIA [SITAGLIPTIN]; AUGMENTIN [AMOXICILLIN;CLAVULANATE POTASSIUM]; MIMPARA; ELIQUIS; LERCAPRESS [ENALAPRIL MALEATE;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acoustic neuroma (Right acoustic neuroma operated on in 2014 with sequelae facial palsy); Adenocarcinoma of colon stage III (Stage IIIB colon adenocarcinoma treated with simplified LV5FU2); AFib (ACFA (complete arrhythmia by atrial fibrillation)); Cerebral thrombosis (hospitalized on 17Dec2020 left hemicorporeal deficit and dysarthria); Dyslipidaemia; Facial palsy (Right acoustic neuroma operated on in 2014 with sequelae facial palsy); Fall (was hospitalized on 17Dec2020); Hospitalisation (improved neurologically,partial regression,total regression-visual impairment,dysarthria); Hospitalization (G1 asthenia throughout the intercure, improvement in BP, better general condition.); Hospitalization; Hypercalcemia (prompting the administration of Pamidronate); Hypertension arterial (HTA (arterial hypertension)); Hypothyroidism; Ileostomy; Iodine allergy; Non-insulin-dependent diabetes mellitus; Obstructive pyelonephritis (Obstructive pyelonephritis in renal colic); Recto-sigmoidectomy; Stroke (hospitalized on 17Dec2020 left hemicorporeal deficit and dysarthria); Surgery (Right acoustic neuroma operated on in 2014 with sequelae facial palsy)
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: cardio level/Auscultation; Result Unstructured Data: Test Result:no palpitation, no sign of HF, or sign of DVT, reg; Comments: no palpitation, no sign of HF, or sign of DVT, regular auscultation without noticeable breath.; Test Date: 20210120; Test Name: cardio level/Auscultation; Result Unstructured Data: Test Result:Auscultation with the same anomalies as yesterday; Comments: Auscultation with the same anomalies as yesterday (clear drop in MV in left base) therefore monitoring.; Test Date: 20201214; Test Name: BP; Result Unstructured Data: Test Result:117/70 mmHg; Test Date: 20210118; Test Name: BP; Result Unstructured Data: Test Result:106/67 mmHg; Test Date: 20210119; Test Name: BP; Result Unstructured Data: Test Result:140/70 mmHg; Test Date: 20210112; Test Name: orthostatic hypotension test; Test Result: Positive ; Test Date: 20201214; Test Name: afebrile; Result Unstructured Data: Test Result:afebrile; Test Date: 20210118; Test Name: afebrile; Result Unstructured Data: Test Result:afebrile; Test Date: 20210119; Test Name: CT scan; Result Unstructured Data: Test Result:compatible with covid 19 infection (minimal degree; Comments: compatible with covid 19 infection (minimal degree of involvement <10%).; Test Date: 20201214; Test Name: HR; Result Unstructured Data: Test Result:102; Comments: 102 bpm; Test Date: 20210118; Test Name: HR; Result Unstructured Data: Test Result:89; Comments: 89 bpm; Test Date: 20210119; Test Name: pulse; Result Unstructured Data: Test Result:60; Comments: 60 / min; Test Date: 20210114; Test Name: Bubble test; Result Unstructured Data: Test Result:No patent foramen ovale found; Test Date: 20201217; Test Name: MRI; Result Unstructured Data: Test Result:reveals an ischemic stroke of the posterior arm of; Comments: reveals an ischemic stroke of the posterior arm of the right internal capsule and of the diffusing right internal and occipital temporal cortex. On the TOF, we find an occlusion of the posterior cerebral artery from the beginning and an occlusion of the right internal carotid artery with slow cerebral artery and permeable middle cerebral artery.; Test Date: 20201221; Test Name: MRI; Result Unstructured Data: Test Result:Ischemic stroke made up of the right posterior sup; Comments: Ischemic stroke made up of the right posterior superficial Sylvian territory and the superficial and deep territories of the right posterior cerebral artery. Recanalization of the right internal carotid artery and the right posterior cerebral artery of fetal origin.; Test Date: 20201230; Test Name: on the control hepatic MRI; Result Unstructured Data: Test Result:Exploration of an adrenal adenoma accidentally dis; Comments: Exploration of an adrenal adenoma accidentally discovered.; Test Date: 20201224; Test Name: NIHSS score; Result Unstructured Data: Test Result:2; Comments: NIHSS score of 2, with a slight drop in her left upper limb before 10 seconds, and sensitive extinction. There persist ataxia of the lower limbs and facial paralysis which were sequelae respectively of an old cerebellar lesion and a neuroma.; Test Date: 20201214; Test Name: AA saturation; Test Result: 97 %; Test Date: 20210118; Test Name: AA saturation; Test Result: 97 %; Test Date: 20201214; Test Name: clinical examination; Result Unstructured Data: Test Result:normal; Test Date: 20210118; Test Name: clinical examination; Result Unstructured Data: Test Result:Consciousness normal, higher functions a little sl; Comments: Consciousness normal, higher functions a little slowed down and tendency to drowsiness. Staggering walk with loss of balance, must hold on to furniture.; Test Date: 20210119; Test Name: digestive level; Result Unstructured Data: Test Result:no diarrhea, no nausea or vomiting, no abdominal p; Comments: no diarrhea, no nausea or vomiting, no abdominal pain, palpation within the standards; Test Date: 20201214; Test Name: WHO; Result Unstructured Data: Test Result:1-2; Test Date: 20210118; Test Name: WHO; Result Unstructured Data: Test Result:3; Comments: 3 with above all significant loss of autonomy; Test Date: 20210119; Test Name: respiratory level; Result Unstructured Data: Test Result:FR at 15 / min; Comments: respiratory level: FR at 15 / min, Rhinorrhea, expectorating cough, no dyspnea, no chest pain, no anosmia or ageusia, asthenia, no headache auscultation with clear reduction of MV on the left base, elimination of vibrations and dullness; Test Date: 20210120; Test Name: respiratory level; Result Unstructured Data: Test Result:FR at 22 / min, no anosmia or ageusia, no diarrhea; Comments: FR at 22 / min, no anosmia or ageusia, no diarrhea, no dyspnea, no chest pain, no sign of cardiac insufficiency no sign of DVT or VTE.; Test Date: 20210118; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20201218; Test Name: EDTSA; Result Unstructured Data: Test Result:with an obliteration of the right internal carotid; Comments: with an obliteration of the right internal carotid artery downstream of the portion visualized (which is difficult to assert because on indirect arguments), with good replacement of the cerebral arteries via the anterior communicating artery or with a stenosis of the right siphon without occlusion of the internal carotid artery explaining the velocities preserved in right MCA.; Test Date: 20210114; Test Name: transthoracic ultrasound; Result Unstructured Data: Test Result:LVEF conserved at 50% in SB on an enlarged LV (SIV; Comments: LVEF conserved at 50% in SB on an enlarged LV (SIV and PP 11mm) not dilated. Bi-atrial expansion with left atrium 86 ml / m? and right atrium 21 cm?. No increase in left ventricle filling pressures. Central minimal mitral insuffisiency. Tricuspid aortic valve, mean gradient 2 mmHg. Moderately impaired RV function, no PH with PAPS estimated at 30-35 mmHg. Breathable dilated IVC. Free pericardium. Transesophageal echocardiography: Left auricle not free with impaired emptying rate, no thrombus directly visualized but significant spontaneous contrast.; Test Date: 20201214; Test Name: Weight; Test Result: 62 kg; Test Date: 20210118; Test Name: Weight; Test Result: 60 kg
CDC Split Type: FRPFIZER INC2021088311

Write-up: Death unexplained/massive pulmonary embolism in the context of neoplastic COVID +; Massive stroke related to intracardiac thrombus; massive pulmonary embolism in the context of neoplastic COVID +/Covid19 PCR performed: positive/CT scan compatible with covid 19 infection; massive pulmonary embolism in the context of neoplastic COVID +/Covid19 PCR performed: positive/CT scan compatible with covid 19 infection; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, FR-AFSSAPS-DJ20210104. A 75-year-old female patient received bnt162b2 (COMIRNATY, lot number: EM0477), via intramuscular on 14Jan2021 at single dose for COVID-19 vaccination. Medical history included stage IIIB colon adenocarcinoma- (pT3N1aM0) from Aug2020 and unknown if it was ongoing with rectosigmoid resection on 27Aug2020 and ileostomy closure on 09Oct2020. HTA (arterial hypertension), ACFA (complete arrhythmia by atrial fibrillation), Non-insulin-dependant diabetes, Dyslipidemia, Obstructive pyelonephritis in renal colic, Hypothyroidism, right acoustic neuroma (operated on in 2014 with sequelae facial palsy), and all unknown if they were ongoing and notion of allergy to iodine. The patient followed in particular for an adenocarcinoma of the colon treated with simplified LV5FU2 (cisplatin, 5-fluorouracil, leucovorin) as an adjuvant with a 4th treatment carried out in a day hospital on 14Dec2020. The patient is non-DPD deficient. The patient lives at home with her husband, a household helper, a nurse who comes several times a week. Autonomous for toilet and meals. The report of the day hospitalization of 14Dec2020 mentioned: INTERCURE: G1 asthenia throughout the intercure, improvement in BP, better general condition. CLINICAL REVIEW: WHO 1-2, BP 117/70 mmHg, HR 102 bpm, afebrile, 97% AA saturation. Weight 62 kg stable. Normal clinical examination. She received her cure of LV5FU2. She was hospitalized on 17Dec2020 for a stroke in the territory of the right posterior cerebral artery, with thrombus in P1, not revascularized (fall from her bed at 6 a.m., her husband noting a left hemicorporeal deficit and dysarthria). An MRI is immediately performed which reveals an ischemic stroke of the posterior arm of the right internal capsule and of the diffusing right internal and occipital temporal cortex. On the TOF, we find an occlusion of the posterior cerebral artery from the beginning and an occlusion of the right internal carotid artery with slow cerebral artery and permeable middle cerebral artery. EDTSA carried out on 18Dec2020: "The echo-Doppler anomalies presented can be compatible either: with an obliteration of the right internal carotid artery downstream of the portion visualized by echo-Doppler (which is difficult to assert because on indirect arguments), if this is the case, it looks old since ''''with good replacement of the cerebral arteries via the anterior communicating artery or with a stenosis of the right siphon without occlusion of the internal carotid artery explaining the velocities preserved in right MCA". Cerebral MRI of 21Dec2020: Ischemic stroke made up of the right posterior superficial Sylvian territory and the superficial and deep territories of the right posterior cerebral artery. Recanalization of the right internal carotid artery and the right posterior cerebral artery of fetal origin. During the stay, she improved neurologically, with partial regression of motor impairment, total regression of visual impairment and dysarthria. Upon discharge, she presented a NIHSS score of 2, with a slight drop in her left upper limb before 10 seconds, and sensitive extinction. There persist ataxia of the lower limbs and facial paralysis which were sequelae respectively of an old cerebellar lesion and a neuroma. The patient is anticoagulated by LMWH tinzaparin sodium (INNOHEP), due to the occurrence of a stroke under ELIQUIS, her known AF, and the neoplastic context. INNOHEP will be continued in the long term. She was leaving for her home on 24Dec2020. Patient finally admitted to Follow-up and Rehabilitation Care on 30Dec2020. Decision with the patient not to resume adjuvant chemotherapy given the loss of autonomy and an unfavorable benefit-risk balance. Similarly contraindication to any colonoscopy. Exploration of an adrenal adenoma accidentally discovered on the control hepatic MRI. Hypercalcemia on 31Dec2020 prompting the administration of Pamidronate. On 12Jan2021: Positive orthostatic hypotension test. Concomitant medications included oxazepam (SERESTA) from Dec2020, atorvastatin calcium (ATORVASTATINE ARROW), tinzaparin sodium (INNOHEP) from 22Dec2020 for Atrial fibrillation, enalapril maleate (ENALAPRIL EG), calcium phosphate monobasic, magnesium glycerophosphate, phosphoric acid, sodium phosphate dibasic (PHOSPHONEUROS) from 19Jan2021, bisoprolol fumarate (BISOPROLOL SANDOZ), pantoprazole sodium sesquihydrate (PANTOPRAZOLE MYLAN) from Dec2020, dexamethasone from 19Jan2021, sitagliptin (JANUVIA), amoxicillin, clavulanate potassium (AUGMENTIN) from 19Jan2021, cinacalcet hydrochloride (MIMPARA) from 12Jan2021, apixaban (ELIQUIS), enalapril maleate, lercanidipine hydrochloride (LERCAPRESS), esomeprazole, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL), alprazolam. Notification from a hospital specialist concerning this patient who died as a result of vaccination with COMIRNATY. Vaccination by COMIRNATY on 14Jan2021 with good immediate tolerance. The same day realization of a transthoracic ultrasound which was programmed: LVEF conserved at 50% in SB on an enlarged LV (SIV and PP 11mm) not dilated. Bi-atrial expansion with left atrium 86 ml / m? and right atrium 21 cm?. No increase in left ventricle filling pressures. Central minimal mitral insuffisiency. Tricuspid aortic valve, mean gradient 2 mmHg. Moderately impaired RV function, no PH with PAPS estimated at 30-35 mmHg. Breathable dilated IVC. Free pericardium. Transesophageal echocardiography: Left auricle not free with impaired emptying rate, no thrombus directly visualized but significant spontaneous contrast. Bubble test: No patent foramen ovale found. On 15Jan2021: Well clinically. No headache, no cough, no transit disorder following the Covid vaccination. Good constants, afebrile. On 16Jan2021: Appearance of a cough. She was reviewed in hospitalization oncology day on 18Jan2021 for reassessment. CLINICAL EXAMINATION: WHO 3 with above all significant loss of autonomy. Consciousness normal, higher functions a little slowed down and tendency to drowsiness. BP 106/67 mmHg, HR 89 bpm, afebrile, 97% AA saturation. Weight 60 kg (-2 kg). Staggering walk with loss of balance, must hold on to furniture. On 18Jan2021: No fever, no diarrhea, no other symptom found apart from the cough. Covid19 PCR performed: positive. On 19Jan2021: blood pressure 140/70 mmHg, pulse 60 / min, respiratory level: FR at 15 / min, Rhinorrhea, expectorating cough, no dyspnea, no chest pain, no anosmia or ageusia, asthenia, no headache auscultation with clear reduction of MV on the left base, elimination of vibrations and dullness therefore: possible pleural effusion. At the cardio level: no palpitation, no sign of HF, or sign of DVT, regular auscultation without noticeable breath. At the digestive level: no diarrhea, no nausea or vomiting, no abdominal pain, palpation within the standards. Note that the patient does not want to go to intensive care in the event of deterioration, she does not want intubation. At the end of the morning, episode of loss of contact with return to full consciousness for several minutes, it is possible that she was suffering from epilepsy after his stroke with lowering of the epileptogenic threshold on COVID / fever. No brain imaging. On the other hand, in view of the saturation: initiation of dexamethasone and AUGMENTIN + realization of an emergency chest scanner today (on 19Jan2021). CT scan compatible with covid 19 infection (minimal degree of involvement <10%). On 20Jan2021 at 11:30 am the consultation word mentions: better today, FR at 22 / min, no anosmia or ageusia, no diarrhea, no dyspnea, no chest pain, no sign of cardiac insufficiency no sign of DVT or VTE. Auscultation with the same anomalies as yesterday (clear drop in MV in left base) therefore monitoring. The same day on 20Jan2021, call from a licensed nurse around 2:35 p.m. for a patient found on the ground, not reactive. Arrival of the doctor in the room: patient in a state of clinical death, facial cyanosis, no pulse, no breathing, no heart rate. Total asystole. Time of death recorded 14:45. Most likely in no flow for 15 minutes. Patient who had refused resuscitation care yesterday in the event of degradation (refusal of CPR and intubation) so in this context no resuscitation procedure started. Opinion of the doctor in charge of the patient since entry into Follow-up and Rehabilitation Care: presence of an intracardiac thrombus with great certainty according to cardiologists. Possible cause of death: massive pulmonary embolism in the context of neoplastic COVID +, Massive stroke related to intracardiac thrombus. Exclusive role of COVID (see respiratory distress) very unlikely because no major respiratory damage in this patient, correct respiratory rate and saturation. AF was fairly stable (no recent ECG either). Unexplained death notified because the participatory role of the vaccine cannot be completely excluded. The patient died on 20Jan2021. An autopsy was not performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: massive pulmonary embolism in the context of neoplastic COVID +; Massive stroke related to intracardiac thrombus; Massive stroke related to intracardiac thrombus; massive pulmonary embolism in the context of neoplastic COVID +; massive pulmonary embo


VAERS ID: 1000276 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, International normalised ratio increased, SARS-CoV-2 test positive
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   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: PREVISCAN [FLUINDIONE]; FUROSEMIDE; SERETIDE; NORMACOL BISMUTH; SERESTA; MONOPROST; ACTISKENAN; BISOPROLOL; AMIODARONE; DOLIPRANE; NITROUS OXIDE;OXYGEN; OXYGEN; MACROGOL
Current Illness: Hospitalization
Preexisting Conditions: Medical History/Concurrent Conditions: Bed sore; Bedridden; Chronic respiratory failure (with oxygen); Dyslipidaemia; Heart disease, unspecified; Hospitalization (most recent of numerous stays); Hypertension arterial; Oxygen therapy; Permanent cardiac pacemaker insertion; Prostatectomy; Pulmonary arterial hypertension; Renal failure chronic (severe)
Allergies:
Diagnostic Lab Data: Test Date: 20210104; Test Name: INR; Result Unstructured Data: Test Result:2.61; Test Date: 20210109; Test Name: INR; Result Unstructured Data: Test Result:2.42; Test Date: 20210118; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021097911

Write-up: Death unexplained; asymptomatic COVID-19 (with postivie PCR test); asymptomatic COVID-19 (with postivie PCR test); This is a spontaneous report from a contactable pharmacist downloaded from the database. This is a report received from the Regulatory Authority. Regulatory authority report number was FR-AFSSAPS-DJ20210108. An 87-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EM0477), intramuscular on 14Jan2021 as a single dose for COVID-19 vaccination. Medical history included severe chronic renal failure, arterial hypertension, pulmonary arterial hypertension, dyslipidemia, heart disease, permanent cardiac pacemaker insertion, prostatectomy, and chronic respiratory failure with oxygen; all from unknown dates and unknown if ongoing. Concomitant medications included fluindione (PREVISCAN), furosemide (MANUFACTURER UNKNOWN), fluticasone propionate/salmeterol xinafoate (SERETIDE), bismuth subnitrate/sterculia urens (NORMACOL BISMUTH), oxazepam (SERESTA), latanoprost (MONOPROST), morphine sulfate (ACTISKENAN), bisoprolol (MANUFACTURER UNKNOWN), amiodarone (MANUFACTURER UNKNOWN), paracetamol (DOLIPRANE), nitrous oxide/oxygen (MANUFACTURER UNKNOWN), oxygen (MANUFACTURER UNKNOWN), and macrogol (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. On 20Jan2021, the patient experienced unexplained death. The clinical course was as follows: the patient had been hospitalized since 02Dec2020 due to difficult home care (patient confined to bed) with bedsores in the heels and especially a very important sacral bedsore. It was reported that the patient had made numerous stays in this service for some time, in particular a stay from 28Aug2020 to 22Oct2020. In the afternoon of 14Jan2021, the patient was vaccinated and no signs of reactogenicity were observed after vaccination. On 18Jan2021, the COVID-19 PCR test came back positive (test carried out because other patients were positive) but the patient was not symptomatic. On 19Jan2021, he presented with a cough. On 20Jan2021 around midnight, when the nurse took her turn, the patient was sleeping, there was nothing in particular to report. When she returned to see the patient at 5:30 a.m. taking her turn, the nurse noticed that the patient was dead. The cause of death was unexplained and it was not reported if an autopsy was performed. The clinical outcome of asymptomatic COVID-19 was unknown at the time of death. Chronologically, the patient died 6 days after the COVID-19 vaccination. According to the information provided, no therapeutic modification had been made in the days preceding the occurrence of the patient''s death. On the semi logical level, the COVID-19 test was positive on 18Jan2021. The other etiologies discussed with the doctor were a massive pulmonary embolism (but INR at 2.61 on 04Jan2021 and 2.42 on 09Jan2021) or septic shock on a sacral pressure ulcer with bone involvement. It should be noted that the patient did not present any particular sign of reactogenicity such as fever following the vaccination. No follow-up attempts are possible. No information is expected.; Reported Cause(s) of Death: unexplained death


VAERS ID: 1000277 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM 0477 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   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: Basedow''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021088328

Write-up: Death unexplained; tired; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB regulatory authority FR-AFSSAPS-LY20210170. A 92-years-old female patient received her first dose bnt162b2 (COMIRNATY), lot number: EM0477, intramuscular on 15Jan2021 at single dose for covid-19 immunisation. Medical history included basedow''s disease from an unknown date and unknown if ongoing. Usual treatment was L Throxine. The patient''s concomitant medications were not reported. On 15Jan2021, the patient received a first dose of bnt162b2 vaccine, her neighbors saw her in the evening and she reported being tired. On 17Jan2021 the neighbors heard a falling noise and found the deceased patient. The patient died unexplained on 17Jan2021. The outcome of event tired was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1000280 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER EJ6795 / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Bronchitis, Decreased appetite, Fall, Pyrexia, Sudden death, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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: ACETYLSALICYLIC ACID; LANSOPRAZOLE; ATORVASTATINE [ATORVASTATIN]; PARACETAMOL; NOVORAPID; IMOVANE; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; LANTUS; RISPERDAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioplasty (angioplasty on the IVA + stent); Cognitive disorder (Last MMS 23/30 in Oct2019); COVID-19 (a documented COVID infection, non-serious form of COVID); Diabetes mellitus insulin-dependent; Dissociative identity disorder (Dissociative identity disorder (DID)); Dyslipidemia; Effort angina (stress angina for more than 20 years); Enterococcal bacteremia (diverticular sigmoiditis with enterococcal bacteremia, necrotic esophagitis and shock treated in ICU); Fall (Repeated falls 27Jan20 to 28Apr2020, on 11Dec2021: SSR admission for treatment. CT:no brain bleeding); Finger amputation (Amputation 1st and 2nd phalanx 5th finger right hand); Gastritis; Hip prosthesis insertion (Bilateral hip prosthesis); Hypotension orthostatic (low compression refusal); Infective sigmoiditis (Diverticular sigmoiditis with enterococcal bacteremia, necrotic esophagitis and shock treated in ICU); Intervertebral disc compression (Vertebral compression); Necrotizing esophagitis (diverticular sigmoiditis with enterococcal bacteremia, necrotic esophagitis and shock treated in ICU); Shock (diverticular sigmoiditis with enterococcal bacteremia. necrotic esophagitis and shock treated in ICU); Stent placement (angioplasty on the IVA + stent); Swallowing disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210113; Test Name: Albuminemia; Result Unstructured Data: Test Result:36 g/l; Test Date: 20210113; Test Name: Creatinemia; Result Unstructured Data: Test Result:67 umol/l; Test Date: 20210113; Test Name: Kalaemia; Result Unstructured Data: Test Result:4 mmol/L; Test Date: 20210116; Test Name: Blood pressure; Result Unstructured Data: Test Result:118/70; Comments: At 8:00 a.m; Test Date: 20210116; Test Name: Blood pressure; Result Unstructured Data: Test Result:100/55; Comments: at 6:00 p.m; Test Date: 20200430; Test Name: Systolic PAP; Result Unstructured Data: Test Result:60 / min; Test Date: 20210113; Test Name: Natremia; Result Unstructured Data: Test Result:145; Test Date: 20210114; Test Name: body temperature; Result Unstructured Data: Test Result:maximum 38 Centigrade; Test Date: 20210116; Test Name: body temperature; Result Unstructured Data: Test Result:afebrile all day Centigrade; Test Date: 2020; Test Name: CT scan; Result Unstructured Data: Test Result:No brain bleeding; Test Date: 20200505; Test Name: documented COVID infection; Result Unstructured Data: Test Result:COVID infection; Test Date: 20210113; Test Name: CRP; Result Unstructured Data: Test Result:18; Test Date: 20200420; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:Moderately tight aortic stenosis (SA = 1.4 cm?) an; Comments: Moderately tight aortic stenosis (SA = 1.4 cm?) and calcified. LV of normal size with slightly hypertrophied walls in a concentric way. Global systolic function of LV normal (EF = 61%). Normal LV filling pressures. Discreetly dilated OG. Normal straight cavities. Systolic PAP = 34 mmHg. Normal pericardium.; Test Date: 20200430; Test Name: ECG; Result Unstructured Data: Test Result:RSR at 60 / min, full BBG already known; Test Date: 20210113; Test Name: HB; Result Unstructured Data: Test Result:13.4 g/dl; Test Date: 20210115; Test Name: pulse; Result Unstructured Data: Test Result:103/min; Test Date: 20210116; Test Name: pulse; Result Unstructured Data: Test Result:103/min; Comments: At 8:00 a.m; Test Date: 20210116; Test Name: pulse; Result Unstructured Data: Test Result:106/min; Comments: at 6:00 p.m; Test Date: 20210115; Test Name: Sa O2; Test Result: 91 %; Test Date: 20210113; Test Name: platelet; Result Unstructured Data: Test Result:220 000; Test Date: 20201214; Test Name: COVID PCR test; Result Unstructured Data: Test Result:negative; Test Date: 20210113; Test Name: Leukocytes; Result Unstructured Data: Test Result:10,300
CDC Split Type: FRPFIZER INC2021088231

Write-up: Agitation; Tachycardia; Sudden death; Fall; This is a spontaneous report from contactable physician downloaded from the Medicines Agency (MA) WEB regulatory authority FR-AFSSAPS-PC20210066. An 82-year-old male patient received bnt162b2 (COMIRNATY, lot/batch EJ6795) intramuscular at single dose on 15Jan2021 for covid-19 immunisation, prednisolone (SOLUPRED) oral from 15Jan2021 to 15Jan2021 at 40 mg for bronchitis, amoxicillin, clavulanic acid (AUGMENTIN) oral from 14Jan2021 to 16Jan2021 at 2 g for bronchitis. Medical history included effort angina (stress angina for more than 20 years), angioplasty on the IVA + stent in 1997, diabetes mellitus insulin-dependent, orthostatic hypotension (low compression refusal), dyslipidemia, stent placement, fall, cognitive disorder, dissociative identity disorder (DID), gastritis, diverticular sigmoiditis in May2018 with enterococcal bacteremia complicated by necrotic esophagitis and shock treated in intensive care, amputation 1st and 2nd phalanx 5th finger right hand, bilateral hip prosthesis, vertebral compression, swallowing disorders. Between 27Jan20 to 28Apr2020: admitted to SSR for treatment of repeated falls (also on 11Dec2021). No brain bleeding on the CT scan. On 20Apr2020 Cardiac ultrasound: Moderately tight aortic stenosis (SA = 1.4 cm?) and calcified. LV of normal size with slightly hypertrophied walls in a concentric way. Global systolic function of LV normal (EF = 61%). Normal LV filling pressures. Discreetly dilated OG. Normal straight cavities. Systolic PAP = 34 mmHg. Normal pericardium. On 30Apr2020 ECG: RSR at 60 / min, full BBG already known. On 05May2020: a documented COVID infection, non-serious form of COVID. Last COVID PCR test 14Dec2020: negative. The last blood test was carried out on 13Jan2021: Kalaemia at 4 mmol/l, Natremia at 145 mmol/l, Creatinemia at 67 micromol/l, CRP at 18, Leukocytes at 10,300 and HB at 13.4 g/dl, platelet at 220 000, Albuminemia at 36 g/l. The patient''s concomitant medications included as usual treatments: acetylsalicylic acid (manufacturer unknown) 75 mg 1 sachet in the morning, for 1 month, every day, lansoprazole (manufacturer unknown) 15 mg mg: 1 tab in the morning, for 1 month, every day, atorvastatine (manufacturer unknown) 10 mg tablet: 1 tab in the morning, for 1 month, every day, paracetamol (manufacturer unknown) 500 mg: 1 morning sachet, 1 midday sachet, 1 evening sachet, for 1 month, every day if moderate to light pain, insulin aspart (NOVORAPID) 100 IU/ml: Subcutaneous, 8:00, 12:00, 18:00, according to protocol, for 1 month, every day, zopiclone (IMOVANE) 3.75 mg: 1 tab in the evening, macrogol (MOVICOL) 13.8 g: 2 sachets in the morning, insulin glargine (LANTUS) 100 IU/ml slow-acting solution for injection: Subcutaneous, 20 IU in the morning, for 1 month, every day, risperidone (RISPERDAL) 0.5 mg/d (date of introduction not specified). The patient experienced fall on 15Jan2021, agitation on 16Jan2021, tachycardia on 16Jan2021, sudden death on 16Jan2021. On an unknown date the patient did not eat a lot because they are dissatisfied with the mixed meals set up due to swallowing disorders. Course of events: Due to repeated falls, the patient cannot return home. He was hospitalized in Long Term Care while waiting for a place in Home for Senior and Dependent Persons. On 14Jan2021, due to bronchitis with a fever (maximum 38?C), the patient initiated treatment with AUGMENTIN 1g x2/day and BRICANYL aerosol. On 15Jan2021: 10:30 am administration of the COMIRNATY vaccine. Before vaccination the patient did not appear to be feverish, pulse at 103 / min. At meals, as at breakfast, the patient did not eat a lot because they are dissatisfied with the mixed meals set up due to swallowing disorders. At 1:00 p.m. after the meal, the patient falls from her chair. He rocked back. A priori no notion of head trauma. The Sa O2 was then 91%. At 4 p.m., as part of his bronchitis, the patient received 40 mg of SOLUPRED. During the night of 15Jan2021 to 16Jan2021 the patient was agitated. He "spoke until 2 am". He was also agitated on the morning of 16Jan2021 during his toilet and then in the afternoon. He pulled out his IV. At 8:00 a.m. pulse at 103, BP 118/70 then at 6:00 p.m. pulse at 106/min and BP at 100/55. A BRICANYL aerosol was applied at 7 p.m., lasting 15 minutes. When removing the aerosol, the patient was fine but has just eaten little with his evening meal (a small compote). Patient remained afebrile all day. DEXTRO at 23 mmol/l . At 8:25 p.m.: during his shift, the nurse notices the patient''s death in his bed. The action taken in response to the events for bnt162b2 was not applicable, for amoxicillin, clavulanic acid was unknown. It was not reported if an autopsy was performed. The outcome of patient did not eat a lot was unknown, of all other events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden death; tachycardia; agitation; fall


VAERS ID: 1000285 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood albumin decreased, Blood creatinine increased, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein increased, Death, Haemoglobin decreased, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: CIMETIDINE; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; FUMAFER; FUROSEMIDE; BISOPROLOL; PARACETAMOL; ZOPICLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decompensation cardiac (hospitalized on 18Dec2020 for global cardiac decompensation on mitral insufficiency and left ventricular ejection fraction); Fall; Functional renal failure; General discomfort (then on 14Jan2021); Haemorrhage of digestive tract; Hyponatremia; Left ventricular dysfunction (moderate); Left ventricular ejection fraction; Mitral insufficiency; Neurocognitive deficit; Pneumopathy; Tachyarrhythmia absoluta; Ulcerative gastritis
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: Albumin; Result Unstructured Data: Test Result:29 g/l; Test Date: 20210115; Test Name: creatinine; Result Unstructured Data: Test Result:129 ?M; Test Date: 20210115; Test Name: K; Result Unstructured Data: Test Result:4.6 mM; Test Date: 20210115; Test Name: Na; Result Unstructured Data: Test Result:136 mM; Test Date: 20210115; Test Name: Urea; Result Unstructured Data: Test Result:15 mM; Test Date: 20210115; Test Name: CRP; Result Unstructured Data: Test Result:64 mg/l; Test Date: 20210108; Test Name: electrocardiogram; Result Unstructured Data: Test Result:unchanged; Test Date: 20210115; Test Name: Hb; Result Unstructured Data: Test Result:10.6 g/dl; Test Date: 20210115; Test Name: Leukocytes; Result Unstructured Data: Test Result:6.9
CDC Split Type: FRPFIZER INC2021088340

Write-up: Death unexplained; This is a spontaneous report from a contactable Pharmacist downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-RN20210166 This is a report received from the Regulatory Authority. A 93-year-old male patient received first dose bnt162b2 (COMIRNATY, lot/batch: EM0477) , intramuscular on 15Jan2021 at single dose for covid-19 vaccination. Medical history included complete tachyarrhythmia by atrial fibrillation and mitral insufficiency with a large leak which were treated with cimetidine, movicol, fumafer, furosemide, bisoprolol, paracetamol if needed and zopiclone, He was hospitalized on 18Dec2020 for global cardiac decompensation on mitral insufficiency and left ventricular ejection fraction at 40 percent with moderate left ventricular dysfunction (NT pro Brain Natriuretic Peptide: 17 965pg / ml) on arrhythmia complete by atrial fibrillation + pneumopathy and functional renal failure under furosemide (LASILIX), severe hyponatremia, digestive haemorrhage due to probable ulcerative erosive gastritis, severe neurocognitive troubles and difficult home maintenance, repeated falls in the service. Sensation of discomfort without loss of consciousness on 08Jan2021 then on 14Jan2021. Cardiac decompensation table since 12Jan2021 with an increase in diuretics. Cardiac stabilized although fragile. Concomitant medication included cimetidine, macrogol 3350/ potassium chloride/ sodium bicarbonate/ sodium chloride (MOVICOL), ferrous fumarate (FUMAFER), furosemide, bisoprolol , paracetamol, zopiclone. The patient previously took furosemide (LASILIX) for functional renal failure. The patient experienced death unexplained on 19Jan2021, it was reported that he suddenly dead on 19Jan2021 in the evening, he was found dead reactive around 10 p.m(19Jan2021 22:00). An autopsy was not performed. The relaunched clinicians do not put forward any hypothesis on the cause of death. Lab data included an electrocardiogram was performed on 08Jan2021, it was unchanged. Lonogram on 15Jan2021 in the morning, stable: Na 136 mM, K 4.6 mM, Urea 15 mM, creatinine 129 uM, Albumin 29 g / l, Haemoglobin 10.6 g / dl Leukocytes at 6.9 and C-reactive protein (CRP) 64 mg / L. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1000286 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Death, Gastric volvulus, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiomyopathy; Hypertension arterial; Renal failure chronic
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021088336

Write-up: emesis/vomiting of food; Gastric volvulus; abdominal pain; This is a spontaneous report from a contactable physician from the regulatory authority FR-AFSSAPS-RN20210173 . A 90-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY, lot number: EM0477) via intramuscular in the left arm on 13Jan2021 at single dose for COVID-19 vaccination. Medical history included hypertension arterial, cardiomyopathy and renal failure chronic, no known allergy, no history of infection with Covid-19. Long-term treatment not specified. Concomitant medications were unknown. From 16Jan2021, the patient presented with abdominal pain with emesis/vomiting of food, prompting hospital transfer. A gastric volvulus was highlighted, operated urgently. The patient died despite the surgery on 21Jan2021. It was unknown if autopsy performed. Clinicians did not hypothesize the causes of death. Outcome of all events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: emesis/vomiting of food; Gastric volvulus; abdominal pain


VAERS ID: 1000287 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-18
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Ulcer skin (Biology normal on 15Jan20201)
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: biology; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021088344

Write-up: Death unexplained; Pyrexia; This is a spontaneous report from a contactable physician downloaded from the Agency-WEB. This is a report received from the Regulatory Authority. Regulatory authority report number was FR-AFSSAPS-RN20210174. A 93-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EM0477), intramuscular in the left arm on 13Jan2021 as a single dose for COVID-19 vaccination. Medical history included ongoing nursing home resident and cutaneous ulcer in Jan2021 (biology performed on 15Jan2021 was normal). The patient''s medical history and concomitant medications were not reported. On 18Jan2021, the patient presented with a fever without a starting point of clinical infection, apart from a cutaneous ulcer treated at the beginning of Jan2021 without sign of recurrence. On 19Jan2021, the patient died, and the cause was unexplained. The clinicians did not hypothesize the causes of death. It was not reported if an autopsy was performed. The clinical outcome of the fever was not recovered at the time of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1000288 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-17
Onset:2021-01-08
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   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: Test Date: 20210108; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210113; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021095822

Write-up: positive COVID-19 virus test; COVID-19; Back pain; This is a spontaneous report received from a contactable healthcare professional by Pfizer from the products Regulatory Agency. The regulatory authority report number is GB-MHRA-ADR 24648457. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 17Dec2020 at a single dose for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. The patient experienced COVID-19 on 13Jan2021, which was reported as fatal. The patient also experienced positive COVID-19 virus test on 13Jan2021 and back pain on 08Jan2021. The clinical course was reported as follows: The patient was admitted with back pain and multiple co-morbidities and COVID-19 virus test was negative on admission on 08Jan2021. On 13Jan2021, the COVID-19 virus test was positive (reported as 3 weeks and 6 days after his first vaccination on 17Dec2020). The clinical outcome of positive COVID-19 virus test and COVID-19 was fatal and of back pain was unknown. The patient died on 20Jan2021. The cause of death was reported as positive COVID-19 virus test and COVID-19. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1000375 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; ATORVASTATIN; HYDRALAZINE; LANSOPRAZOL; MONOMIL XL; RIVAROXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Atrial fibrillation; Cardiac pacemaker insertion (cardiac pace maker in situ); Chronic lymphocytic leukaemia; DVT; Heart failure; Hypertension; Prostate cancer; Type 2 diabetes mellitus; Comments: Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210117; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021095923

Write-up: COVID-19 pneumonia/sars-cov-2 infection/dyspnoea, cough and pyrexia; COVID-19 pneumonia; SARS-CoV-2 infection; pyrexia; cough; Dyspnoea; This is a spontaneous report received from a contactable physician by Pfizer from the products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202101261732199850. Safety Report Unique Identifier GB-MHRA-ADR 24651485. A 92-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK1768), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. Medical history included cardiac pacemaker insertion, hypertension, chronic lymphocytic leukaemia, atrial fibrillation, type 2 diabetes mellitus, angina pectoris, prostate cancer, deep vein thrombosis, cardiac failure. Concomitant medication included allopurinol, atorvastatin, hydralazine, lansoprazol, isosorbide mononitrate (MONOMIL XL), rivaroxaban for atrial fibrillation. On 17Jan2021, patient was admitted with shortness of breath/ dyspnoea, cough and pyrexia, he was suspected covid-19 then confirmed having sars-cov-2 infection and covid-19 pneumonia. The patient underwent lab tests included COVID-19 virus test: positive on 17Jan2021. It was not sure if he was carrying the virus at the time of vaccination. He said he didn''t have any temperature at the time of the vaccination. Outcome of event covid-19 pneumonia was fatal, sars-cov-2 infection was not recovered, and the events pyrexia, cough, dyspnoea was unknown. The patient died on 21Jan2021. It was not reported if an autopsy was performed. The cause of death was covid-19 pneumonia/drug ineffective. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19 pneumonia


VAERS ID: 1000376 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-24
Onset:2020-12-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-03
   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: Chronic kidney disease; Dementia; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20201228; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:COVID/SARS-CoV-2 infection
CDC Split Type: GBPFIZER INC2021096190

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202101261748200590, Safety Report Unique Identifier GB-MHRA-ADR 24651574. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. Medical history included dementia from an unknown date and unknown if ongoing, chronic kidney disease from an unknown date and unknown if ongoing. Text for relevant medical history and concurrent conditions: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced SARS-COV-2 infection (death) on 28Dec2020. Reported that patient developed COVID on 28Dec2020, died on 03Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: COVID/SARS-CoV-2 infection (Positive) on 28Dec2020, COVID-19 virus test: NO - Negative covid-19 test on an unknown date. The patient died on 03Jan2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1000377 (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: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal tenderness, C-reactive protein increased, Chest X-ray, Computerised tomogram abnormal, Confusional state, Death, Diverticulitis, Fibrin D dimer increased, Hypotension, Hypothermia, Intestinal perforation, Large intestine perforation, SARS-CoV-2 test negative, Slow response to stimuli, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal perforation (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: CRP; Result Unstructured Data: Test Result:199; Comments: elevated; Test Date: 20210115; Test Name: D dimer; Result Unstructured Data: Test Result:elevated; Test Date: 20210115; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210115; Test Name: wcc; Result Unstructured Data: Test Result:5.8
CDC Split Type: GBPFIZER INC2021095725

Write-up: Intestinal perforation; This is a spontaneous report from a contactable physician. This is a report received from the products Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202101272220168460 and Safety Report Unique Identifier of GB-MHRA-ADR 24657435. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Jan2021 as single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, and was not enrolled in a clinical trial. The patient experienced intestinal perforation on 15Jan2021, which was serious as it was life threatening, and lead to death. Details were as follows: patient was taken to emergency (A&E) by ambulance in afternoon of 15Jan2021, after being found at home poorly responsive, confused and hypotensive. The patient had been seen in the evening previously, by her son. Covid vaccine was reported as likely not relevant. In A&E, noted hypothermic, hypotensive, elevated D dimer, elevated -reactive protein (CRP) 199, AKI, WCC 5.8, diffusely tender abdomen. CXR L basal consolidation. Air under diaphragm bilaterally seen clinically not reported. CT TAP free fluid and free intraperitoneal air indicating perforated viscus. Likely sigmoid colon perforation and signs of diverticulitis. Patient had not tested positive for COVID-19 since the vaccination. COVID-19 virus test, was negative on 15Jan2021. The patient died on 16Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender''s Comments: The 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 14Jan2021, and didnot have symptoms associated with COVID-19. On 15Jan2021, she experienced intestinal perforation, with clinical and lab findings supporting sigmoid colon perforation and signs of diverticulitis. The fatal event was more likely an intercurrent disease, and unlikely causally related to BNT162B2.; Reported Cause(s) of Death: Death


VAERS ID: 1000378 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-21
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abdominal tenderness, Blood creatinine increased, Blood lactic acid increased, Blood sodium decreased, Blood urea increased, Confusional state, Haemoglobin normal, Hyponatraemia, Hypotension, Intestinal perforation, Lethargy, Memory impairment, Mobility decreased, SARS-CoV-2 test negative, Scan abdomen abnormal, Unresponsive to stimuli, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Gastrointestinal perforation (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 4
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: Brain tumour (acoustic neuroma, 20 years ago); Breast cancer (mastectomy, 20 years ago); Mastectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210123; Test Name: creatinine; Result Unstructured Data: Test Result:increasing; Test Date: 20210121; Test Name: lactate; Result Unstructured Data: Test Result:slightly elevated on admission but lactate elevate; Comments: slightly elevated on admission but lactate elevated 3.5; Test Date: 20210123; Test Name: BP; Result Unstructured Data: Test Result:hypotensive; Test Name: sodium; Result Unstructured Data: Test Result:hyponatraemic; Comments: previously hyponatraemic; Test Date: 20210121; Test Name: sodium; Result Unstructured Data: Test Result:117; Test Date: 20210123; Test Name: urea; Result Unstructured Data: Test Result:increasing; Test Name: CT scan; Result Unstructured Data: Test Result:reported as unclear as to source of perforation; Test Date: 20210123; Test Name: CT scan; Result Unstructured Data: Test Result:showed intestinal perforation; Test Date: 20210121; Test Name: CRP; Result Unstructured Data: Test Result:18; Test Name: Haemoglobin; Result Unstructured Data: Test Result:remains normal throughout; Test Date: 20210121; Test Name: NEWS; Result Unstructured Data: Test Result:zero on admission; Test Date: 20210121; Test Name: MMT; Result Unstructured Data: Test Result:1/7 right; Test Date: 20210121; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021095661

Write-up: lethargy; abdominal pain; vomiting; hyponatraemic; very confused; mobility issues; memory problems; urea and creatinine increasing; urea and creatinine increasing; hypotensive and unresponsive; abdominal tenderness; Intestinal perforation; This is a spontaneous report received from a contactable physician by Pfizer from the products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202101272230124630. Safety Report Unique Identifier GB-MHRA-ADR 24657446. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 13Jan2021 at single dose for COVID-19 Immunization. The relevant medical history included brain tumour (acoustic neuroma, 20 years ago) and breast cancer (mastectomy, 20 years ago). Concomitant medications were not reported. The patient experienced Intestinal perforation on 21Jan2021. It was also reported as admitted on 21Jan2021, GP admit with abdominal pain, off food, vomiting and lethargy, previous brain tumour (acoustic neuroma) and breast cancer (mastectomy) 20 years ago, also noted to be very confused, mild lower abdominal pain, also mobility issues and memory problems, CRP=18; 1/7 right in brief MMT, sodium 117 (previously hyponatraemic) very dry AKI plan is to rehydrate, consultant review replace electrolytes, slight RIF tenderness, AXR reported as NAD, 23Jan2021. 23Jan2021 (12.43) asked to see sodium increasing but urea and creatinine increasing, became unresponsive later that day (16.35) hypotensive and unresponsive, diffuse abdominal tenderness, plan is for CTTAP, hydrocortisone, pip/taz, also sees later in the day, CT abdomen showed intestinal perforation, spoke to surgical team at CIC accepted patient, tube, 22.10, further deterioration 23.57 decision to keep comfortable, family updated on a regular basis. Following day palliative care involved and dies early hours of 25Jan2021 at 00:25. Haemoglobin remains normal throughout, CT scan reported as unclear as to source of perforation, lactate was slightly elevated on admission but lactate elevated 3.5; NEWS = zero on admission, acute collapse probably reflects perforation but there was a delay in identifying cause of intra-abdominal pathology. Patient died on 25Jan2021. It was not reported if an autopsy was performed. The patient had COVID-19 virus test on 21Jan2021 showed No - Negative COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of the event intestinal perforation was fatal, while other events were unknown. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: intestinal perforation


VAERS ID: 1000379 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure
Allergies:
Diagnostic Lab Data: Test Date: 20210106; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021091335

Write-up: Chest infection; positive COVID-19 virus test/suspected COVID-19; positive COVID-19 virus test/suspected COVID-19; This is a spontaneous report received from a contactable other healthcare professional by Pfizer from the products Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202101280002382610, Safety Report Unique Identifier GB-MHRA-ADR 24657514. A 100 years old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history heart failure. Patient is not enrolled in clinical trial. The concomitant medications was not reported. Patient had suspected COVID-19 from 15Jan2021. Onset of chest infection on 15Jan2021, revived the course of antibiotics. But the course not completed as became too poorly moved to the stage of end of life. Patient died on 27Jan2021. Lab test included positive COVID-19 virus test on 06Jan2021. The outcome of events was fatal. Unknown if autopsy was done. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: chest infection; positive COVID-19 virus test/suspected COVID-19; positive COVID-19 virus test/suspected COVID-19


VAERS ID: 1000380 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-27
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   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: ATORVASTATIN; IBUPROFEN; OMEPRAZOLE; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker user; Heart block; Hypertension; Osteoarthritis; Prediabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021091648

Write-up: 27.1; Death of unknown cause; This is a spontaneous report from a contactable physician. This is a report received from the HA. Regulatory authority report number GB-MHRA-WEBCOVID-202101280855444210, Safety Report Unique Identifier GB-MHRA-ADR 24657685. A 79-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history included Hypertension, OA, Prediabetes, Pacemaker for heart block. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication included atorvastatin for hypertension from 09Jan2015, ibuprofen for Arthritis from 07Jul2016, omeprazole from 17Dec2019, Ramipril for hypertension from 17Oct2014. The patient experienced death of unknown cause on 27Jan2021, 27.1 (pruritus) on an unspecified date. The patient died on 27Jan2021. An autopsy was not performed. Referred to coroner and for post mortem examination. It would be likely that this death is cardiovascular )MI/CVA etc) but given the recent vaccination we thought it prudent to report it. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event death was fatal, of the event pruritus was unknown. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: Death of unknown cause


VAERS ID: 1000387 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH AB002 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia due to Parkinson''s disease; Parkinson''s disease; Comments: Parkinsons Dementia Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210121; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021090893

Write-up: Death; UTIs; vomiting; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202101281914030060, Safety Report Unique Identifier GB-MHRA-ADR 24663167. A 82-year-old male patient received BNT162B2 (PFIZER COVID-19 VACCINE, lot: Ab002), via an unspecified route of administration on 17Jan2021 at single dose for COVID-19 immunization. Medical history included Parkinsons and dementia. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The concomitant medications were not reported. The patient vaccinated on 17Jan2021. On 18Jan2021, the patient had unresponsive vomiting. On 19Jan2021, the doctor prescribed antibiotics as known to have frequent urinary tract infection(UTIs). On 21Jan2021, Antibiotics and all meds stopped as no swallow reflex and COVID test was negative. On 23Jan2021, the patient passed away/death. The lab tests included COVID-19 virus test with results as no - negative covid-19 test on 15Jan2021. The patient died on 23Jan2021. It was not reported if an autopsy was performed. The outcome of other events was unknown. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1000389 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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: AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Haemorrhage; Intervertebral discitis; Osteoporosis; Urinary tract infection; Comments: 5 years previous had urinary tract infection which led to discitis, followed by severe osteoporosis and blood clot. 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 INC2021091590

Write-up: Stroke; bleed to brain; This is a spontaneous report from a contactable consumer. This is a report received from the HA. Regulatory authority report number GB-MHRA-WEBCOVID-202101282143521990, Safety Report Unique Identifier GB-MHRA-ADR 24663909. An 85-year-old female patient received BNT162B2, via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. Medical history included 5 years previous had urinary tract infection which led to discitis, followed by severe osteoporosis and blood clot. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medication included amlodipine. The patient experienced stroke, and bleed to brain on 16Jan2021. Patient had vaccine on the 12Jan2021 and was prior to this very fit and well. Then patient died suddenly and unexpectedly with no prior illness in the proceeding days. Post mortum stated bleed to brain. Patient had not tested positive for COVID-19 since having the vaccine. Post mortum: No signs of anaphylaxis. Outcome of the events was fatal. The patient died on 16Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: stroke; bleed to brain


VAERS ID: 1000401 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Death, Pancreatitis
SMQs:, Acute pancreatitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VENLAFAXINE; FOLIC ACID; ELIQUIS; PRAVASTATIN; OMESAR [OLMESARTAN MEDOXOMIL]; FRUSEMIDE [FUROSEMIDE]; PANTOPRAZOLE SODIUM; VITAMIN D NOS; LAMICTAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker user; Atrial fibrillation; COVID-19; CVA; Dementia; Pancreatitis; Comments: Previous CVA ; AF + Pacemenker Dementia Previous pancreatitis 2014 ? cause Covid 19 04/2020
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021103209

Write-up: PANCREATITIS; This is a spontaneous report from a contactable physician downloaded from the regulatory authority (IE-HPRA-2021-063633). A 91-year-old female patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation. Medical history included cerebrovascular accident (CVA), atrial fibrillation, artificial cardiac pacemaker user, dementia, pancreatitis in 2014 and COVID-19 from Apr2020. Concomitant medication included olmesartan medoxomil (OMESAR), lamotrigine (LAMICTAL), Vitamin D, folic acid, apixaban (ELIQUIS), frusemide (FRUSEMIDE), pravastatin, pantoprazole sodium and venlafaxine. The patient experienced pancreatitis on 20Jan2021. The patient had experienced a previous episode of pancreatitis six years prior, in 2014, the cause of which was unknown. The reporter outlined it was unclear if the pancreatitis was related to COMIRNATY. The seriousness for the event was fatal and hospitalization. The patient died in Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: PANCREATITIS


VAERS ID: 1000403 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: CALOGEN [FATS NOS]; RENALIN; GALFER; FOLIC ACID; MEMANTINE; SENOKOT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker user; Chronic kidney disease; Fainting (Faints while sitting out at commode but nil in recent months); Road traffic accident; Vascular dementia; Comments: 1) pacemaker 2013, 2) RTA June 2016, 3) vascular dementia 4) Chronic Kidney Disease 2018 5) history of faints while sitting out at commode but nil in recent months.
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021103092

Write-up: MYOCARDIAL INFARCTION; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (IE-HPRA-2021-063720). A 97-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: EM0477) intramuscularly on 22Jan2021 at 0.3 ml single in left deltoid for COVID-19 immunization. The patient''s medical history included pacemaker from 2013, Road traffic accident (RTA) from Jun2016, vascular dementia, chronic kidney disease from 2018, history of faints while sitting out at commode but nil in recent months. It was reported that the patient was very unwell one year ago (2020) and had been receiving end of life care for a period but improved. In the three months prior to reporting (Oct2020), the patient tended to be in bed more often but this fluctuated. The patient had taken her meals in her bedroom in the past three months. It was outlined that the patient had been recently bright/alert and eating well. The patient''s concomitant medications included ferrous fumarate (GALFER); blumea balsamifera, curcuma longa, lagerstroemia speciosa, orthosiphon aristatus (RENALIN); fats nos (CALOGEN); sennoside A+B (SENOKOT); folic acid; and memantine for dementia. The patient previously received quadrivalent influenza vaccine (split virion, inactivated), suspension for injection in pre-filled syringe. The patient experienced myocardial infarction on 25Jan2021. On 22Jan2021, the patient was well post vaccination and no side effects to vaccination had been noted. On 25Jan2021 at 7.30 am, the patient was noted to be asleep in bed when checked. At 8.15 am, the patient was found dead. The patient was not for resuscitation. It was reported that the General Practitioner (GP) certified the cause of death as myocardial infarction. The patient died on 25Jan2021. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: MYOCARDIAL INFARCTION


VAERS ID: 1000473 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, Fluid intake reduced, Hypophagia, 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: 2021-01-01
   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: BUSCOPAN; AFIPRAN; PARACET [PARACETAMOL]; PINEX; SELO-ZOK; FENTANYL SANDOZ; LANTUS; MORPHINE ORION; SOBRIL; COZAAR; HALDOL; MIDAZOLAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Cognitive impairment; Decreased appetite; Diabetes mellitus; Gastrointestinal spasm; Hypertension; Living in nursing home; Nausea; Unrest
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021089362

Write-up: DIARRHEA; VOMITING; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority with Regulatory authority report number NO-NOMAADVRE-FHI-2021-U4eqa, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014144. An 89-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, lot number: EJ6795), intramuscularly on 06Jan2021 09:00 at single dose in Left arm for Covid-19 vaccination. Medical history included diabetes mellitus, angina pectoris, decreased appetite (Reduced food intake two weeks before vaccination) cognitive impairment, gastrointestinal spasm, nausea, hypertension, unrest, all from an unknown date and unknown if ongoing. The patient was Living in nursing home. Concomitant medication included hyoscine butylbromide (BUSCOPAN) from 12Jan2021 to 17Jan2021 for gastrointestinal spasm, metoclopramide hydrochloride (AFIPRAN) from 12Jan2021 to 17Jan2021 for nausea, paracetamol (PARACET) from an unknown date to 13Jan2021 for pain, paracetamol (PINEX) from an unknown date to 11Jan2021 for pain, metoprolol succinate (SELO-ZOK) from an unknown date to 12Jan2021 for hypertension, fentanyl (FENTANYL SANDOZ) from 11Jan2021 to 17Jan2021 for pain, insulin glargine (LANTUS) from an unknown date to 13Jan2021 for diabetes mellitus, morphine hydrochloride (MORPHINE ORION) from 12Jan2021 to 17Jan2021 for pain, oxazepam (SOBRIL) from an unknown date to 13Jan2021 for unrest, losartan potassium (COZAAR) from an unknown date to 12Jan2021 for hypertension, haloperidol (HALDOL) from 12Jan2021 to 17Jan2021 for unrest, midazolam from 12Jan2021 to 17Jan2021 for unrest. The patient experienced vomiting on 06Jan2021 and diarrhea on 08Jan2021, reported as serious with serious criteria death. The patient experienced vomiting once on the same day as vaccination on 06Jan2021. Two days after vaccination on 08Jan2021, he developed diarrhea, gradually continuous running stools, no food/fluid intake. Reporter states that it is not certain that the symptoms are due to a side effect of the vaccine as the man had reduced appetite a few weeks before vaccination, as well as comorbidity. In the time before vaccination, the man also did not want to take his medication, including long-acting insulin. The patient died on an unspecified date in Jan2021. It was not reported if an autopsy was performed. The outcome of events vomiting and diarrhea was fatal. Sender Comment: Nausea is reported as a side effect of the vaccine Comirnaty, while diarrhea is not listed as a known side effect. In some people, reactions such as short-term / transient nausea and loose stomach can be linked to being vaccinated, but then as a form of physiological stress response to the event / vaccination. In this case, there is a relatively close temporal relationship between vomiting, diarrhea and vaccination. It is stated that the patient had reduced food intake in the period before vaccination, and it can therefore not be ruled out that vomiting and diarrhea may have been symptoms of an underlying condition that was present in before vaccination. On the basis of the information in the report and in accordance with 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 relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient''s death, the message 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: Vomiting; diarrhea


VAERS ID: 1000474 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Death, Dyspnoea, Fluid intake reduced, General physical health deterioration, Hypophagia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   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: MORFIN [MORPHINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Confused; Disorientated; Drowsiness; Dyspnea; Pain (Started morfine (subcutanous) 01Jan2021 for generalised pain); Reduced general condition; Respiratory arrest; Urinary tract infection (Per oral antibiotics 30Dec2020 - 06Jan2021 for possible urinary tract infection); Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: C-reactive protein; Result Unstructured Data: Test Result:20; Test Date: 20210115; Test Name: C-reactive protein; Result Unstructured Data: Test Result:30
CDC Split Type: NOPFIZER INC2021089310

Write-up: RESPIRATORY ARREST; REDUCED GENERAL CONDITION; DYSPNEA; health condition was already reduced (reduced general condition and possible dyspnea) from before, and it got worse the same day as the vaccination; This is a spontaneous report from a contactable Other Health Professional downloaded from the Agency Agency-WEB NO-NOMAADVRE-FHI-2021-Uedw5, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014102. A 94-years-old male patient received his first dose bnt162b2 (COMIRNATY), lot number: EM0477, intramuscular on left arm on 14Jan2021 12:25 at single dose for covid-19 immunisation. Medical history included wheelchair user, respiratory arrest, reduced general condition, possible dyspnea, generalised pain and started morfine (subcutanous) 01Jan2021 for generalised pain, he was not completely clear and oriented afterwards and was more drowsy/confused; urinary tract infection (Per oral antibiotics 30Dec2020 to 06Jan2021 for possible urinary tract infection), all from an unknown date. Concomitant medication included morfin [morphine] subcutaneous from 01Jan2021 for generalised aching. The patient experienced dyspnea and reduced general condition the same day as vaccination with covid-19 vaccine bnt162b2 on 14Jan2021, and experienced respiratory arrest and death the day after on 15Jan2021. His health condition was already reduced (reduced general condition and possible dyspnea) from before, and it got worse the same day as the vaccination on 14Jan2021. He could not either eat/drink or take his medicines and was bedridden to the day after the vaccination when he died (15Jan2021). It was reported "Start-up with oxygen 0.5-1 L on spectacle catheters after clearly reduced breathing pattern." He was independent in meal situations from an unspecified date. The patient underwent lab tests and procedures which included c-reactive protein: 20 on 07Jan2021, c-reactive protein: 30 on 15Jan2021. The patient died on 15Jan2021. It was not reported if an autopsy was performed. Sender Comment: A 94-year-old man with dyspnoea and reduced general condition same day as vaccination with covid-19 vaccine (Comirnaty). Respiratory arrest and death the next day. His health was already reduced from before the vaccination, but the situation worsened after the vaccination. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. 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 some other random incident, happening at the same time but 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 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 relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the message is classified as serious, even though no causal link between the vaccine and the death has been established. Reporter''s comment: 21Jan2021: Received additional information from reporter (phone call): date of death, date of adverse events, other details. No follow-up attempts possible. No further information expected.; Reporter''s Comments: 21Jan2021: Received additional information from reporter (phonecall): date of death, date of adverse events, other details; Reported Cause(s) of Death: reduced general condition; RESPIRATORY ARREST; His health condition was already reduced (reduced general condition and possible dyspnea) from before, and it got worse the same day as the vaccination; dyspnea


VAERS ID: 1000476 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose decreased, Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow)

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: BISOPROLOL; DUROFERON; PANTOLOC [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; CLOPIDOGREL; AMLODIPINE; CANDEXETIL; ATORVASTATIN; METFORMIN; TRAJENTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021089170

Write-up: Dead; FEVER; Blood sugar decreased; This is a spontaneous report from a contactable nurse received from Regulatory Authority, downloaded from the Regulatory Authority-WEB (SE-MPA-2021-000794, other case identifier: SE-MPA-1611147230356). An 88-year-old female patient received BNT162B2 (COMIRNATY; Lot number EL1484) intramuscular in Jan2021 at 0.3 mL single for COVID-19 immunisation. Relevant medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medications included candesartan cilexetil (CANDEXETIL) from 08Sep2020, ferrous sulfate (DUROFERON) from 10Mar2020, pantoprazole sodium sesquihydrate (PANTOLOC) from 10Mar2020, linagliptin (TRAJENTA) from 01Dec2020, amlodipine from 08Sep2020, atorvastatin from 10Mar2020, bisoprolol from 21Nov2020, clopidogrel from 10Mar2020 and metformin from 21Nov2020. In Jan2021, the patient experienced fever, decreased blood sugar and died. According to the rapporteur, the female developed fever in the afternoon the same day as she got vaccinated with BNT162B2, during the night her blood sugar decreased. She was sent to hospital and died two days after vaccination with BNT162B2. The patient died in Jan2021. 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: 1000477 (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: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Death, Depressed level of consciousness, Hemiplegia, SARS-CoV-2 test positive
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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: COVID-19 (during Christmas weekend 2020 and tested positive for Covid); Hypertension; Infection; Progression of Alzheimer''s disease; Tiredness (more tired than usual after the covid infection)
Allergies:
Diagnostic Lab Data: Test Date: 20201230; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: SEPFIZER INC2021089283

Write-up: STROKE/decreased consciousness and right-side paresis; This is a spontaneous report from a contactable physician downloaded from the Agency (EMA) Agency-WEB SE-MPA-2021-000972, other case identifier: SE-MPA-1611224017780, received from Regulatory Authority. A 72-year-old female patient received bnt162b2 (COMIRNATY, Batch/lot number: EL1484), via an unspecified route of administration on Jan2021 at unknown age at single dose for covid-19 immunisation. Medical history included progression of Alzheimer''s disease and hypertension. The female was living in a special care home and got infected with Covid during Christmas weekend 2020 and a few days later on 30Dec2020 she tested positive for Covid. The female had sparse infection symptoms, no fever, but felt more tired than usual after the covid infection. The patient''s concomitant medications were not reported. The female experienced a stroke on Jan2021. The reporter stated that according to guidelines the female was vaccinated with Comirnaty in mid-Jan2021 and fell ill 5 days later, decreased consciousness and right-side paresis. The reporter stated it was similar to a clinical picture in the event of a stroke, unknown if it was an ischemic stroke or caused by a bleeding. The female calmly died shortly thereafter. The patient underwent lab tests and procedures which included COVID19 test: positive on 30Dec2020. The patient died on Jan2021. Outcome of the event stroke was fatal. An autopsy was not performed. The reporter stated that the probability of death caused by Comirnaty is low. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: stroke


VAERS ID: 1000478 (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: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein increased, Cough, Death, Pneumonia, Pyrexia, SARS-CoV-2 test negative, White blood cell disorder
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MEMANTINE; MIRTAZAPINE; LASIX [FUROSEMIDE] RETARD; TROMBYL; APROVEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder catheterisation; Cerebellar stroke; Polymyalgia rheumatica; Polyneuropathy; Reduced general condition; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: CRP; Result Unstructured Data: Test Result:42; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:negative; Test Date: 202101; Test Name: leukocytes in the urine; Result Unstructured Data: Test Result:leukocytes in the urine
CDC Split Type: SEPFIZER INC2021089014

Write-up: Pneumonia; cough; fever; CRP 42; had leukocytes in the urine; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB SE-MPA-1611238512515 Safety Report Unique Identifier SE-MPA-2021-001019 and received via Regulatory Authority. An 85-years-old male patient received the first dose of BNT162B2 (COMIRNATY) (lot: EJ6795) intramuscular on Jan2021 at single dose for COVID-19 immunisation. Medical history included polyneuropathy from an unknown date and unknown if ongoing, cerebellar stroke from 2006 and unknown if ongoing, reduced general condition from an unknown date and unknown if ongoing, bladder catheterisation from an unknown date and unknown if ongoing, vascular dementia from an unknown date and unknown if ongoing, polymyalgia rheumatica from an unknown date and unknown if ongoing. Concomitant medication included memantine from 2017 to 21Jan2021, mirtazapine from 2017 to 21Jan2021, furosemide (LASIX RETARD) from 2006 to 21Jan2021, acetylsalicylic acid (TROMBYL) from 2006 to 21Jan2021, irbesartan (APROVEL) from 2006 to 21Jan2021. The patient experienced pneumonia on Jan2021. The patient lived in a service home and was vaccinated with Comirnaty in early Jan2021, 12 days after the vaccination with Comirnaty he got a cough and one day later he got fever, CRP 42 and got treated with ciprofloxacin. He had a negative COVID test. Next day he was out of fever and he ate breakfast, but dies later that day (Jan2021). No reaction close to vaccine 2, before death the patient had periods of a reduced general condition and at the time of death the patient had leukocytes in the urine, but he also carried a catheter. The reporter states that the pneumonia is the cause of death and that the probability of death caused by Comirnaty is low. The reaction started 13 days after the vaccination with Comirnaty. It is unknown if the man has had any previous drug reactions. Event outcome for pneumonia was fatal, for fever was recovered on Jan2021, while for others was unknown. The patient died on Jan2021. An autopsy will not be performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1000479 (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: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Condition aggravated, Continuous positive airway pressure, Death, Dyspnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021097900

Write-up: Cardiac failure aggravated; breathing difficulties; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is SE-MPA-2021-001654 and other case identifier number SE-MPA-1611657205772. An 89-year-old female patient received BNT162B2 (COMIRNATY; Lot number EL1484), intramuscular in Jan2021 as single dose for covid-19 immunization. Medical history included cardiac failure from an unknown date and unknown if ongoing and atrial fibrillation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced cardiac failure aggravated in Jan2021, which was serious as it lead to death. The patient also experienced breathing difficulties in Jan2021, with unknown outcome. Details were as follows: patient had palliative care prescriptions since Apr2020, but was sent to hospital with breathing difficulties three days after the vaccination and died the same day. The patient was treated with CPAP (continuous positive airway pressure) and intravenous diuretic at the hospital. The patient died on an unspecified date. 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: Cardiac failure aggravated


VAERS ID: 1003806 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood potassium, Glomerular filtration rate, Haemoglobin, 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: 2021-01-20
   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: PARACETAMOL; MIANSERIN; ALPRAZOLAM; ZYMAD; SOTALOL; TERCIAN [CYAMEMAZINE]; DIFFU-K; NACL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Anemia (need to be transfused for anemia at 7.6g/l with no cause found); Bedridden; Dyslipidaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: potassium; Result Unstructured Data: Test Result:4.52 mmol/L; Test Date: 20210108; Test Name: GFR; Result Unstructured Data: Test Result:96.6 ml/min; Test Date: 20210108; Test Name: Hemoglobin; Result Unstructured Data: Test Result:9.2 g/dl
CDC Split Type: FRPFIZER INC2021088235

Write-up: sudden death; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MP20210082. A 87-years-old female patient received first dose of bnt162b2 (COMIRNATY, Lot number: EM0477), via intramuscular on 20Jan2021 15:00 at single dose on the left arm for COVID-19 vaccination. Medical history included Alzheimer''s disease, bedridden, dyslipidaemia and altered state for a few weeks in December, needed to be transfused for anemia at 7.6g/l with no cause found. Concomitant medication included paracetamol, mianserin, alprazolam, colecalciferol (ZYMAD), sotalol, cyamemazine (TERCIAN), potassium chloride (DIFFU-K) and nacl. The patient experienced sudden death on 20Jan2021 23:00. Last assessment carried out on this patient 08Jan2021: Hemoglobin 9.2 g/dl, potassium 4.52 mmol/l, GFR 96 .9 ml/min. Regarding the follow-up after vaccination at the center: Evolution: refused the snack and at 7:00 p.m. took half a dessert. Patient found dead 8 hours after the vaccination on 20Jan2021 at 11 pm. It was unknown if an autopsy was performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1004188 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-01
Onset:2021-01-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA156571-EJ679 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Dementia; Osteoporosis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Name: temperature; Result Unstructured Data: Test Result:elevated; Test Name: heart rate; Result Unstructured Data: Test Result:fast; Test Name: X-ray; Result Unstructured Data: Test Result:bilateral pneumonia
CDC Split Type: SEPFIZER INC2021095267

Write-up: Sepsis; Pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. Regulatory Authority report number is SE-MPA-2021-001251. Other case identifier number SE-MPA-1611326316846. An 87-year-old male patient received BNT162B2 (COMIRNATY; Lot number Lot number: PAA156571-EJ6795), intramuscular in Dec2020 as single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, osteoporosis and dementia from unknown dates and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced sepsis and pneumonia in Jan2021, which were serious as it lead to death; patient was admitted to the hospital on an unspecified date. Details were as follows: The man had a scenario compatible with pneumonia and sepsis. 16 days after the vaccination with BNT162B2 the patient was wheezy in the morning and there was a suspicion of aspiration. He suddenly got worse with elevated temperature, low blood pressure and fast heart rate. The patient was admitted to a hospital on an unspecified date, and a chest X-ray was performed where they saw bilateral pneumonia. The patient died a few days later. The patient died on an unspecified date. 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: Pneumonia; Sepsis


VAERS ID: 1010236 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Fatigue, Hypertension, Pain, Rales, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

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:
Current Illness: Aortic aneurysm; Dementia vascular; Marasmus; Ulcus cruris
Preexisting Conditions: Medical History/Concurrent Conditions: Ischemia cerebral
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021097455

Write-up: death; somnolence; Pain; rale; hypertensive emergency; fatigue aggravated; This is a spontaneous report received from a contactable physician by Pfizer from the database. The regulatory authority report number is AT-BASGAGES-2021-00487. An 83-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing ulcus cruris, ongoing marasmus, ongoing dementia vascular, Ischemia cerebral from an unknown date and unknown if ongoing, ongoing aortic aneurysm. The patient''s concomitant medications were not reported. On 13Jan2021 the patient experienced fatigue aggravated. On 14Jan2021 the patient experienced hypertensive emergency. On 18Jan2021 the patient experienced somnolence, hypertensive emergency, pain, rale. On 19Jan2021 the patient experienced death. It was not reported if an autopsy was performed. Medication from 14Jan2021: Ringer''s solution 500 ml sc because of decreased fluid absorption on 14Jan; nitrospray on 14. and 18Jan because of RR$g200; 0.5 Vendal ampoules on 18. and 19Jan because of pain; 0.5 Buscopan ampoules on 18. and 19Jan because of mucus rattling. The outcome of events Pain, Hypertensive emergency and rale was unknown, while the outcome of the other events was fatal. Sender Comment: Confounding factors: elderly age, underlying weakness. Temporal relationship: 7 days between vaccination and death. The causal relationship between the product/substance COMIRNATY / TOZINAMERAN and fatigue aggravated and somnolence is assessed as unclassifiable. 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. Follow-up information has been requested. No follow-up attempts possible. No further information expected.


VAERS ID: 1010237 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Left ventricular dysfunction
SMQs:, Cardiac failure (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension (arterial hypertension); Atrial fibrillation (tachicardia, atrial fibrillation); Cerebral atrophy (cortical atrophy); Diabetes mellitus (diabetes mellitus); Extrasystoles (SVES and VES (triples and couplets)); Lumbago (lumbago by the spine); Normal pressure hydrocephalus (Normal pressure cephalus- condition after lumbar puncture 2011); Steatosis hepatic (Inhomogeneous Steatosis hepatis); Vitamin D deficiency (Vit D deficiency)
Preexisting Conditions: Medical History/Concurrent Conditions: Acute appendicitis (acute appendicitis with localized peritonitis, open appendectomy); Appendectomy (open appendectomy); Atrial tachycardia (unstable atrial tachycardia due to exsiccosis); Commotio cerebri (condition after a fall with commotio cerebri); Coxarthrosis (Left hip joint, increased sclerosis in acetabular roof with bony extensions, narrowing hip joint gap); Diastolic dysfunction (severely impaired QTc prolongation, severely impaired LVEF, severely diastolic dysfunction); Ejection fraction low (severely impaired QTc prolongation, severely impaired LVEF, severely diastolic dysfunction); Electrical cardioversion (condition after electric cardioversion); Electrocardiogram QTc interval prolonged (severely impaired QTc prolongation, severely impaired LVEF, severely diastolic dysfunction); Exsiccosis; Generalised convulsion (SEC generalized cerebral seizure, DD TIA with resulting epileptic seizure); Haematuria microscopic (microhematuria); Hypergammaglobulinaemia; Hypoproteinaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021097977

Write-up: Pre-collapse symptoms; left ventricular failure; This is a spontaneous report from a contactable physician downloaded from the database [AT-BASGAGES-2021-00632] received via Regulatory Authority. An 86-year-old male patient received the first dose of BNT162B2 (COMIRNATY) (Lot number EJ6796, expiration date unknown), intramuscular on 18Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concurrent conditions included: Acute appendicitis (from 12Aug2014, unknown if ongoing, acute appendicitis with localized peritonitis, open appendectomy), Appendectomy (from 15Jul2014, not ongoing, open appendectomy), Commotio cerebri (not ongoing, condition after a fall with commotio cerebri), Extrasystoles (continuing, SVES and VES (triples and couplets)), Arterial hypertension (continuing), Diabetes mellitus (continuing), Normal pressure hydrocephalus (continuing, Normal pressure cephalus- condition after lumbar puncture 2011), Cerebral atrophy (continuing, cortical atrophy), Haematuria microscopic (unknown if ongoing, microhematuria), Hypergammaglobulinaemia (unknown if ongoing), Lumbago (continuing, lumbago by the spine), Hypoproteinaemia, Vitamin D deficiency (continuing), Steatosis hepatic (continuing, Inhomogeneous Steatosis hepatis), Coxarthrosis (unknown if ongoing, Left hip joint, increased sclerosis in the acetabular roof with bony extensions, narrowing of the hip joint gap, this almost completely eliminated, bony extensions on the femoral head), Atrial fibrillation (continuing, tachicardia, atrial fibrillation), Electrical cardioversion (not ongoing, condition after electric cardioversion), Generalised convulsion (unknown if ongoing, SEC generalized cerebral seizure, DD TIA with resulting epileptic seizure), Atrial tachycardia (unknown if ongoing, unstable atrial tachycardia due to exsiccosis), Exsiccosis (unknown if ongoing), Electrocardiogram QTc interval prolonged (unknown if ongoing, severely impaired QTc prolongation, severely impaired LVEF, severely diastolic dysfunction), Ejection fraction low (unknown if ongoing, severely impaired QTc prolongation, severely impaired LVEF, severely diastolic dysfunction), Diastolic dysfunction (unknown if ongoing, severely impaired QTc prolongation, severely impaired LVEF, severely diastolic dysfunction). The patient''s weight and height was not reported. There''s no known allergies. Concomitant medications were not reported. On 19Jan2021 19:00, the patient experienced pre-collapse symptoms which was reported as serious due to required hospitalization. On 23Jan2021, the patient experienced left ventricular failure which resulting in death. The outcome of the event pre-collapse symptoms was unknown, for the event left ventricular failure was fatal. The patient died in Jan2021. Autopsy was performed. The cause of death was left heart failure according to autopsy findings from 25Jan2021, findings are not transmitted to BASG. No evidence of adverse drug reaction from vaccination. Causality assessment by BASGAGES: the causality of the event left heart failure with COMIRNATY was unlikely, for the event pre-collapse symptoms with COMIRNATY was possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: left ventricular failure


VAERS ID: 1010238 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Death, Malaise, Oxygen saturation decreased, Pneumonia, Respiratory disorder, Sedation, White blood cell count
SMQs:, Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BISOPROLOL EG; PANTOMED [DEXPANTHENOL]; QUETIAPINE EG; ELIQUIS; BEFACT [CYANOCOBALAMIN;PYRIDOXINE;THIAMINE]; PARACETAMOL EG; AMIODARONE; ALDACTONE [SPIRONOLACTONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Overactive bladder
Allergies:
Diagnostic Lab Data: Test Name: C-reactive protein; Result Unstructured Data: Test Result:180; Test Name: Leukocyte count; Result Unstructured Data: Test Result:15.000; Test Name: investigation; Result Unstructured Data: Test Result:yeasts from HC
CDC Split Type: BEPFIZER INC2021098152

Write-up: Respiratory disorder; Unwell; Bilateral pneumonia; Dopiness; Oxygen saturation decreased; This is a spontaneous report from a contactable consumer downloaded from the database and received via Regulatory Authority BE-FAMHP-DHH-N2021-75690 . A 90-year-old female patient received first dose of BNT162B2 (COMIRNATY) on 13Jan2021 at single dose for COVID-19 vaccination. Medical history included atrial fibrillation and overactive bladder. Concomitant medications included bisoprolol fumarate (BISOPROLOL EG), dexpanthenol (PANTOMED), quetiapine fumarate (QUETIAPINE EG), apixaban (ELIQUIS), cyanocobalamin, pyridoxine, thiamine (BEFACT), paracetamol (PARACETAMOL EG), amiodarone, and spironolactone (ALDACTONE). The patient experienced Unwell, Respiratory disorder, Bilateral disorder, Oxygen saturation decreased, Dopiness on 14Jan2021. The patient was admission to hospital on 14Jan2021 and death on 16Jan2021, probably not related to covid vaccination the day before. Treatment received included antibiotherapy, oxygen Evolution. Lab data included blood analysis: CRP 180; leucocytes 15,000 (left shift), yeasts from HC. Reporter Comment : admission to hospital on 14Jan and death on 16Jan, probably not related to covid vaccination the day before Treatment - Yes antibiotherapy, oxygen Evolution of the ADR - Died Examinations - blood analysis: CRP 180; leucocytes 15,000 (left shift); yeasts from HC. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain; Sender''s Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: Oxygen saturation decreased; Unwell; Bilateral pneumonia; Dopiness; Oxygen saturation decreased


VAERS ID: 1010239 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Acute respiratory failure, Death, General physical health deterioration, Oxygen saturation decreased, Pneumonia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), 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), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   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: AMLOR; SERTRALINE; LOSFERRON; ASAFLOW; ISOTEN; MOXONIDINE; VIMPAT; COVERSYL [PERINDOPRIL ARGININE]; OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis (Mild); Bronchopneumonia (Recurrent, favored by broncho-inhalations); Chronic renal failure (with probable nephroangiosclerosis, Stage IV); Depression; Emphysema pulmonary; Gastroduodenal ulcer; Hemangioma of liver; Hepatic cyst (Multiple); Hiatus hernia (with beginner Schatzky ring); Hypoxaemia (nocturnal, with probable sleep apnea syndrome); Hypoxemia; Malnutrition (Severe); Mitral insufficiency (moderate); Nephroangiosclerosis (probable); Pulmonary arterial hypertension (57 mmHg + PVC with hypoxemia, Severe); Rotator cuff syndrome (right, without surgical sanction); Schatzki''s ring (beginner); Sleep apnea syndrome; Tricuspid insufficiency (moderate)
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: BEPFIZER INC2021098049

Write-up: Hypoxemia; Bilateral bronchopneumonia; General physical health deterioration; Acute respiratory failure; Oxygen saturation decreased; Acute renal insufficiency; This is a spontaneous report from a contactable physician from the database, Regulatory authority report number is BE-FAMHP-DHH-N2021-75743. A 95-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number: EM0477), via an unspecified route of administration on 15Jan2021at single dose for Covid-19 vaccination. Medical history included Stage IV chronic renal failure with probable nephroangiosclerosis, Multiple hepatic cysts and hepatic angioma. Gastro-duodenal ulcers in 2017. Hiatus hernia with beginner Schatzky ring. Mild aortic stenosis, moderate mitral insufficiency, moderate tricuspid insufficiency, Severe pulmonary arterial hypertension (57 mmHg + PVC) with hypoxemia in 2017. depression, Involvement of the right rotator cuff without surgical sanction. Recurrent right basal bronchopneumonia favored by broncho-inhalations in 2017. Severe undernutrition in 2017. Pulmonary emphysema, nocturnal hypoxemia with probable sleep apnea syndrome in 2017. Concomitant medications included amlodipine besilate (AMLOR), sertraline, ferrous gluconate (LOSFERRON), acetylsalicylic acid (ASAFLOW), bisoprolol fumarate (ISOTEN), moxonidine, lacosamide (VIMPAT), perindopril arginine (COVERSYL), omeprazole. The patient experienced oxygen saturation decreased on 19Jan2021, acute renal insufficiency on 19Jan2021, hypoxemia on 21Jan2021, bilateral bronchopneumonia on 19Jan2021, general physical health deterioration on 19Jan2021, acute respiratory failure on 19Jan2021. Seriousness Criteria for all events was reported as death. The outcome of the events oxygen saturation decreased, acute renal insufficiency, hypoxemia, bilateral bronchopneumonia, general physical health deterioration, acute respiratory failure was fatal. The patient died on 21Jan2021. It was unknown if an autopsy was performed. Casual relationship between bnt162b2 (COMIRNATY) and all events per FAMHP, WHO: unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: oxygen saturation decreased; acute renal insufficiency; Hypoxemia; Bilateral bronchopneumonia; General physical health deterioration; Acute respiratory failure


VAERS ID: 1010240 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrioventricular block complete, Blood lactate dehydrogenase, Body temperature, C-reactive protein, COVID-19, COVID-19 pneumonia, Drug ineffective, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test, Serum ferritin
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Conduction defects (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: LDH; Result Unstructured Data: Test Result:unknown results; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Comments: fever 39 Celsius degree; Test Name: crp; Result Unstructured Data: Test Result:unknown results; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Name: Ferritin; Result Unstructured Data: Test Result:unknown results
CDC Split Type: BEPFIZER INC2021098156

Write-up: COVID-19 pneumonitis; fever 39 Celsius degree; Atrioventricular block third degree; Oxygen saturation decreased; drug ineffective; Radiographic Image of Covid Pneumonitis + Positive PCR Test; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) Regulatory Authority-WEB BE-FAMHP-DHH-N2021-75795. An 84-year-old male patient received bnt162b2 (COMIRNATY), via unknown route of administration on 11Jan2021 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient experienced drug ineffective and covid-19 on an unspecified date with outcome of unknown, oxygen saturation decreased on 13Jan2021, covid-19 pneumonitis on 13Jan2021, fever on 13Jan2021, atrioventricular block third degree on 13Jan2021. On 13Jan2021 symptom onset. On 15Jan2021 admission with covid pneumonitis (desaturation, fever 39 Celsius degree) and 3rd degree AV block. The patient died on 19Jan2021. The outcome of the other events was fatal.Treatment was unknown. The patient underwent lab tests and procedures which included blood lactate dehydrogenase: unknown results, c-reactive protein: unknown results, serum ferritin: unknown results on unknown date and Radiographic Image of Covid Pneumonitis + Positive PCR Test. It was not reported if an autopsy was performed. Reporter''s comment: 11/1 covid vaccine in RVT 13/1 symptom onset 15/1 admission with covid pneumonitis (desaturation, fever 39 Celsius degree) and 3rd degree AV block. Treatment -Unknown. Evolution of the ADR - Died. Examinations - Clinical, Biochemical (CRP, Ferritin, LDH) and Radiographic Image of Covid Pneumonitis + Positive PCR Test. Event assessment: FAMHP/to all events/unlikely. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: 11/1 covid vaccine in RVT 13/1 symptom onset 15/1 admission with covid pneumonitis (desaturation, fever 39 Celsius degree) and 3rd degree AV block Treatment - Unknown Evolution of the ADR - Died Examinations - Clinical, Biochemical (CRP, Ferritin, LDH) and Radiographic Image of Covid Pneumonitis + Positive PCR Test; Reported Cause(s) of Death: COVID-19 pneumonitis; Oxygen saturation decreased; Atrioventricular block third degree; fever 39 Celsius degree


VAERS ID: 1010246 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, No reaction on previous exposure to drug, Oxygen saturation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HALOPERIDOL; CLOMETHIAZOLE; ACETYLSALICYLIC ACID; DONEPEZIL; DIAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Expressive aphasia; Mental deterioration
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: Blood pressure; Result Unstructured Data: Test Result:reported as unknown and decreased; Test Date: 20210125; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:reported as unknown and decreased
CDC Split Type: CYPFIZER INC2021098045

Write-up: No reaction on previous exposure to vaccine; 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 (PVPR). The regulatory authority report number is CY-CYPPVPR-270121KK9. A 90-year-old female patient received the first and second doses of the bnt162b2 (COMIRNATY), on 28Dec2020 (Lot Number: EJ6796) and 18Jan2021 (Lot Number: EJ6796); both via intramuscularly at 0.3 mL, single for COVID-19 immunization. Medical history included mental deterioration from an unknown date and unknown if ongoing, expressive aphasia from an unknown date and unknown if ongoing, bedridden from an unknown date and unknown if ongoing. Concomitant medications included haloperidol (MANUFACTURER UNKNOWN), clomethiazole (MANUFACTURER UNKNOWN), acetylsalicylic acid (MANUFACTURER UNKNOWN), donepezil (MANUFACTURER UNKNOWN), diazepam (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unspecified date to an unspecified date. On 26Jan2021, the patient experienced: "death not related to vaccine" (also medically significant). On an unspecified date, the patient experienced: "no reaction on previous exposure to vaccine" (death; as reported). The patient underwent lab tests and procedures which included blood pressure: reported as unknown and decreased, oxygen saturation: reported as unknown and decreased; both on 25Jan2021. The clinical outcome of the events was reported as fatal. The patient died on 26Jan2021 due to being bedridden and mental deterioration. An autopsy was performed and results were not provided. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The reported event "no reaction on previous exposure to vaccine" is considered not related to BNT162B2, but due to underlying disease.; Reported Cause(s) of Death: Bedridden; Mental deterioration


VAERS ID: 1010251 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-16
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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: Hypertension; Multimorbidity; Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021097557

Write-up: Death, as a possible consequence of covid vaccination; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-DCGMA-21187688. A 86-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Medical history included multimorbidity, pneumonia, hypertension. The patient''s concomitant medications were not reported. The patient experienced death, as a possible consequence of covid vaccination on 16Jan2021 with outcome of fatal. It was not reported if an autopsy was performed. The cause of death was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death, as a possible consequence of covid vaccination


VAERS ID: 1010255 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   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: Hydrocephalus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021098302

Write-up: Influenza like illness; This is a spontaneous report from a non-contactable consumer downloaded from the Medicines Agency (EMA) Regulatory Authorithy-WEB DE-PEI-CADRPEI-2021013344. An 80-year-old male patient was vaccinated with the first dose of BNT162B2 (COMIRNATY, lot number not known) via an unspecified route of administration on 08Jan2021 at a single dose for prophylaxis. Medical history included Hydrocephalus. Concomitant medication was not reported. The patient developed influenza like illness on 09Jan2021 and died on 15Jan2021 due to the event. It was not reported if an autopsy was performed. Causality between the event and product was unclassifiable.; Reported Cause(s) of Death: Influenza like illness


VAERS ID: 1010256 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-02
Onset:2021-01-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: General physical condition abnormal, Incorrect route of product administration, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Drug abuse and dependence (broad), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   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: Breast cancer metastatic (bone metastases); Palliative care
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Chemotherapy; Mastectomy bilateral
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021097581

Write-up: Rapid deterioration in general condition 3 days after vaccination. Died 14 days after vaccination but had end-stage breast cancer, with palliative treatment; Deterioration in general condition; patient received BNT162B2 subcutaneously; This is a spontaneous report from a non-contactable consumer downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. This is a report received from the Regulatory Authority. Regulatory authority report number was DE-PEI-CADRPEI-2021013746. An 80-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: UNKNOWN), subcutaneous on 02Jan2021 as a single dose for COVID-19 immunisation. Medical history included breast cancer from 2018 with surgical removal of both breasts on an unknown date, ongoing metastatic breast cancer (bone metastases) from 2020, cancer therapy from an unknown date to Nov2020, and ongoing palliative care from an unknown date. The patient''s concomitant medications were not reported. On 05Jan2021 (also reported as 04Jan2021), the patient experienced deterioration in general condition. She had a rapid deterioration in general condition 3 days after vaccination and died 14 days after vaccination but had end-stage breast cancer, with palliative treatment. The patient died on 15Jan2021 and cause of death was reported as sudden death. It was not reported if an autopsy was performed. The Regulatory Authority assessed the causality between the events and the vaccine as indeterminate. No follow-up attempts are possible; information about lot number cannot be obtained.; Reporter''s Comments: First corona vaccination on 2Jan2021; 4Jan2021 General condition deterioration; 15Jan2021 Died; Reported Cause(s) of Death: Sudden death NOS.


VAERS ID: 1010258 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-10
Onset:2021-01-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   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: Allergy; Inflammation (Dec-2020 an operation of the hip joint (artificial) because of inflammation); Surgery (Dec-2020 an operation of the hip joint (artificial) because of inflammation); Weight loss (lost a lot of weight)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021097583

Write-up: respiratory distress; This is a spontaneous report from consumer or other non hcp downloaded from the Regulatory Authority-WEB DE-PEI-CADRPEI-2021013776. A 83-years-old female patient received bnt162b2 (COMIRNATY; batch no.: was not reported), intramuscular on 10Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included had allergies, since September 2020 she has lost a lot of weight. In December2020 an operation of the hip joint (artificial) because of an inflammation. The patient''s concomitant medications were not reported. The patient experienced respiratory distress on 17Jan2021. 8 days after vaccination the patient developed Respiratory distress, lasting for 9 days. The patient died in hospital. Death cause was reported as Respiratory distress. Reported respiratory distress with stop date 25Jan2021. The patient died on 27Jan2021. It was not reported if an autopsy was performed. Reporter''s comments: From 17Jan patient got worse and worse until reporter could hear a slight simmer on 22Jan. On 23Jan the noises were very loud and patient had severe shortness of breath! She was admitted to hospital PRIVACY, where she died on 27Jan.; Reported Cause(s) of Death: Respiratory distress


VAERS ID: 1010262 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Respiratory failure, SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Glioblastoma
Allergies:
Diagnostic Lab Data: Test Date: 20210111; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210117; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: DEPFIZER INC2021098046

Write-up: Lethal death with unclear cause of death; Respiratory failure; Lethal death with unclear cause of death; This is a spontaneous report from a non-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 DE-PEI-PEI2021001614. A 64-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: UNKNOWN), via an unspecified route of administration on 14Jan2021 as a single dose for COVID-19 immunisation. Medical history included glioblastoma from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 11Jan2021, the patient had a negative SARS-CoV-2 test. On 14Jan2021, the patient received the vaccination. On 17Jan2021, patient had another negative SARS-CoV-2 test. On 19Jan2021, the patient experienced respiratory failure and death with unclear cause of death. The patient died on 19Jan2021 and the reported cause of death was sudden death, cause unknown. An autopsy was not performed. The clinical outcome of the respiratory failure was also reported as fatal. The Regulatory Authority assessed the causality between the respiratory failure and sudden death and suspect vaccine as indeterminate.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1010263 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, General physical condition abnormal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   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 INC2021098048

Write-up: Died/ dead/ Unknown cause of death; Deterioration of the general condition; This is a spontaneous report from a non-contactable physician from the Regulatory Authority. An 84 years old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, batch/lot number: EM0477), intramuscular on 18Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was reported that 4 day(s) after vaccination the patient developed General physical condition abnormal (21Jan2021) and Unknown cause of death (25Jan2021), lasting for 5 day(s). The patient was dead. The patient died on 25Jan2021. Death cause was reported as unknown cause of death. It was unknown if an autopsy was performed. The outcome of "Died/ dead/ Unknown cause of death" was fatal, of the other event was unknown. Comirnaty/Unknown cause of death, General physical condition abnormal. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Died/ dead/ Unknown cause of death


VAERS ID: 1010264 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOHEXAL; FENTANYL; NOVAMINSULFON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency; Coronary heart disease; Hypertension arterial; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021098157

Write-up: Sudden death chronologically related to vaccination; Another stroke was suspected to be the cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021001650. A 95-year-old female patient was vaccinated with the first dose of BNT162B2 (COMIRNATY, lot number was not reported) via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunisation. Medical history included Stroke with hemiparesis, Cardiac insufficiency, Coronary heart disease, Hypertension arterial. Concomitant medications included bisoprolol fumarate (BISOHEXAL), novaminsulfon and fentanyl. The patient developed Death sudden and Accident cerebrovascular after 4 days vaccination. Death cause was reported as Accident cerebrovascular. It was reported an autopsy was not performed. Causality between the event and product was indeterminate. No follow-up attempts possible; information regarding batch/lot cannot be obtained.; Reported Cause(s) of Death: Accident cerebrovascular


VAERS ID: 1010265 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-10
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RISPERIDON; ENALAPRIL; NITRENDIPINE; ASS; SIMVASTATIN; MIRTAZAPINE; PANTOPRAZOLE; TORASEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic pain; COPD; Coronary heart disease; Dementia; Dizziness; Hypercholesteraemia; Hypertension arterial; Myocardial infarction; Renal insufficiency; Sleep disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021098154

Write-up: The presumed cause of death is a renewed heart attack; Sudden death in chronologicall connection with vaccination; This is a spontaneous report from physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB DE-PEI-PEI2021001651 A non-contactable physician reported for an 89-year-old male patient received first dose of bnt162b2 (COMIRNATY, Batch and lot tested and found within specifications), intramuscular on 05Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Coronary heart disease, Hypertension arterial, Renal insufficiency, Dementia, Sleep disorder, Hypercholesteraemia, COPD, Myocardial infarction, Dizziness, Chronic pain, all from an unknown date and unknown if ongoing. Concomitant medication included risperidone (RISPERIDON), enalapril (ENALAPRIL), nitrendipine (NITRENDIPINE), acetylsalicylic acid (ASS), simvastatin (SIMVASTATIN), mirtazapine (MIRTAZAPINE), pantoprazole (PANTOPRAZOLE), torasemide (TORASEMIDE). 5 days after vaccination the patient developed Sudden death in chronologicall connection with vaccination and Myocardial re infarction (The presumed cause of death is a renewed heart attack) on 10Jan2021. The patient died on 10Jan2021. No autopsy was performed. No follow-up attempts possible. Information about lot/batch# cannot be obtained.; Reported Cause(s) of Death: Sudden death in chronologicall connection with vaccination; Myocardial reinfarction


VAERS ID: 1010266 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-17
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021098158

Write-up: Sudden death, cause unknown; This is a spontaneous report from a non-contactable physician. This is a report received from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory authority number DE-PEI-PEI2021001652. A 96-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot: EJ6796), intramuscular on 30Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 17Jan2021, the patient developed Sudden death, cause unknown. The patient is dead. The outcome of the event was fatal. The patient died on 17Jan2021. 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: Sudden death, cause unknown


VAERS ID: 1010269 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Peripheral vascular disorder, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency; Coronary heart disease; Gastrointestinal haemorrhage
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021097692

Write-up: Vomiting; Circulatory collapse; hypotonic circulatory failure; This is a spontaneous report from a non-contactable physician downloaded from the Medicines (MA) Regulatory Authority-WEB Regulatory Authority number DE-PEI-PEI2021001758. A 91-year-old female patient received her second dose of bnt162b2 (COMIRNATY, batch/lot no.: EK9788), intramuscular on 20Jan2021 at single dose for COVID-19 immunization. Medical history included gastrointestinal haemorrhage from 2020, coronary artery disease, Cardiac insufficiency. The patient''s concomitant medications were not reported. The patient previously took her first dose of Comirnaty on 28Dec2020 for COVID-19 immunization and experienced no adverse reaction. 1 day after vaccination on 21Jan2021, the patient developed vomiting and circulatory disorder peripheral and hypotonic circulatory failure, lasting for 4 hour(s). The patient was dead. Death cause was reported as Circulatory failure. The patient died on 21Jan2021. It was unknown if an autopsy was performed. Comirnaty/Vomiting, Circulatory disorder peripheral, Circulatory failure/Regulatory Authority/D. Unclassifiable.; Reported Cause(s) of Death: Circulatory failure; Vomiting; Circulatory disorder peripheral


VAERS ID: 1010282 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Renal failure, Respiratory failure, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ARAX; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; MULTI-TABS [ASCORBIC ACID;COLECALCIFEROL;RETINOL]; CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; ELIQUIS; VENLAFAXIN; ELTROXIN
Current Illness: Dementia; Epistaxis; General physical condition decreased; Renal impairment
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210109; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021095781

Write-up: Respiratory failure due to severe course of COVID19 infection; COVID-19 aggravated / infected with COVID19; COVID-19 aggravated / infected with COVID19; renal failure; This is a spontaneous report downloaded from Regulatory Authority-WEB [DK-DKMA-WBS-0029669]. The case was received from a contactable physician via Agency . A 82-years-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot/Batch number: EJ6797), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunisation. Ongoing medical history included renal impairment, dementia, decreased general physical condition and epistaxis. Concomitant medication included hydroxyzine hydrochloride (ARAX) from 24Mar2017 for pain, macrogol 3350 / potassium chloride / sodium bicarbonate / sodium chloride (MOVICOL) from 19May2017 for constipation, ascorbic acid / colecalciferol / retinol (MULTI-TABS) from 10Apr2016 00 for vitamin supplementation, calcium carbonate / colecalciferol (CALCIUM + VITAMIN D) from 07Oct2020 for vitamin D deficiency, apixaban (ELIQUIS) from 05Apr2019 for thrombosis prophylaxis, venlafaxine from 20Aug2013 for depression, levothyroxine sodium (ELTROXIN) from 27May2013 for hypometabolism. The patient previously received Past drug included pneumococcal vaccine polysacch 23v (PNEUMOVAX) on 28Apr2020 and influenza vaccine inact sag 4v (INFLUVACTETRA) on 08Oct2020, both for immunization. The patient was at the hospital on 07Jan2021 with nosebleeds and physician suspected she got infected with covid19 here. 9 days after vaccine on 09Jan2021 the patient infected with COVID19 and develops symptoms of this: fever, breathing difficult, pain and later renal failure (Jan2021). The patient received treatment at the hospital, where the patient then experiences renal failure. It is then assessed to stop the treatment afterwards, as it will not help further and the patient was discharged on the 18Jan2021. On 10Jan2021, 10 days after vaccination, the patient developed respiratory failure and COVID-19 aggravated which reported as fatal on 19Jan2021. Cause of death was respiratory failure due to severe course of COVID19 infection. It was unknown if autopsy was performed. COVID-19 virus test on 31Dec2020 was negative. COVID-19 virus test on 09Jan2021 was positive. The outcome of COVID-19 aggravated and respiratory failure was fatal (died on 19Jan2021). The outcome of other events was unknown. Causality: The physician reports on suspicion that the COVID-19 vaccine may aggravate a COVID-19 disease course if you become infected in close relation to having received the vaccine. Therefore, she is too much in doubt not to report it as an adverse reaction. The physician believes that the patient has died of COVID-19 and that the vaccine has only worsened the course and is therefore not directly responsible for the death.; Reported Cause(s) of Death: COVID-19 aggravated / infected with COVID19; COVID-19 aggravated / infected with COVID19; Respiratory failure


VAERS ID: 1010288 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Electrocardiogram, Heart rate, Sudden death, Troponin
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: 2021-01-01
   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: Cardiovascular disease, unspecified (Cardiovascular disease (excluding HT).); Chest pain (oppressive chest pain); Pain in arm; Comments: Enfermedad cardiovascular (excluida la HTA).
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: Blood pressure; Result Unstructured Data: Test Result:167/76; Test Date: 20210120; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:EKG: sinus rhythm at 71 bpm; Comments: EKG: sinus rhythm at 71 bpm, normal axis and PR, QRS without blockage signs, possible LVH, no significant alterations in repolarization.; Test Date: 20210120; Test Name: Heart rate; Result Unstructured Data: Test Result:75; Test Date: 20210120; Test Name: Troponin; Result Unstructured Data: Test Result:1? troponin 91, 2? troponin 92
CDC Split Type: ESPFIZER INC2021098106

Write-up: Sudden death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA) Regulatory Authority-WEB and received via Regulatory Authority ES-AEMPS-728115. A 61-year-old male patient received the first dose of bnt162b2 (COMIRNATY) on 21Jan2021 at single dose (Lot # EM0477) for covid-19 immunisation. Medical History included Cardiovascular disease (excluding HT). Cardiopathic patient under study who attended the hospital emergency department on 20Jan2021 for chest pain. The patient went to the hospital emergency room on 20Jan2021 and in the CH data it appears as a current disease: "he has had intermittent episodes of a few minutes duration of oppressive chest pain together with pain in right upper limb. Today (20Jan2021) a new episode lasting minutes that disappears with walking, not accompanied by vegetative courtship. No dyspnea or other symptoms. 1? troponin 91, 2? troponin 92. EKG: sinus rhythm at 71 bpm, axis and PR normal, QRS without signs of blockade, possible LVH, no significant alterations in repolarization. Blood pressure 167/76, HR 75. ". Discharged at home with a diagnosis of chest pain and a proposal for follow-up by cardiology. On 21Jan2021 the first dose of the vaccine was administered. On the morning of 23Jan2021, the family found him on the sofa, already passed away. The emergency services certify the death that would have occurred in the early morning of January 22-23. A judicial procedure for autopsy is being processed. No autopsy results available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1010300 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Atrial fibrillation; Cardiac ablation; Coronary artery disease; Diabetic diet (diabetes diet alone since Jan2019); Stent placement (stent in the circumflex and intraventricular artery); Ulcer (epoxy bleed out); Ulcer bleeding (epoxy bleed out)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021095018

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-LL20210225. An 81-year-old male patient received BNT162B2 (COMIRNATY; Lot number EJ6788), intramuscular in left arm on 20Jan2021 as first single dose for covid-19 immunization. Medical history includes history of bleeding from an ulcer from 2019; reported as epoxy bleed out, coronary artery disease and stent in the circumflex and intraventricular artery since unknown dates, diabetes diet alone since Jan2019 and atrial fibrillation catheter ablation on an unspecified date. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest on 22Jan2021, which was serious as it lead to death. Details were as follows: On 22Jan2021, there was sudden death, reported as possible massive infarction or severe arrhythmia. No chest pain that could have alerted the patient, and no complaint were noted. He was found dead in the morning in his bathroom, razor in hand. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1010305 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac failure, Glomerular filtration rate, Heart rate, Malaise, Oxygen saturation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast neoplasm female (untreated); Carotid artery stenosis; Chronic respiratory failure (requiring oxygen therapy by nasal probe: 3 L / min); Emphysema; Hematoma subdural; Hypertension arterial; Living in residential institution (reported as EHPAD); Mediastinal lymphadenopathy; Pulmonary fibrosis
Preexisting Conditions: Medical History/Concurrent Conditions: Melanoma (of the left knee)
Allergies:
Diagnostic Lab Data: Test Date: 20210118; Test Name: blood pressure; Result Unstructured Data: Test Result:138/76 mmHg; Comments: t 0; Test Date: 20210118; Test Name: blood pressure; Result Unstructured Data: Test Result:125/72 mmHg; Comments: t + 5 minutes; Test Date: 20210118; Test Name: blood pressure; Result Unstructured Data: Test Result:124/75 mmHg; Comments: t + 15 minutes; Test Date: 20210118; Test Name: temperature; Result Unstructured Data: Test Result:36.6 degrees Centigrade; Comments: post-vaccination surveillance; Test Name: GFR; Result Unstructured Data: Test Result:59.7 ml/min/1.73M2; Test Date: 20210118; Test Name: pulse; Result Unstructured Data: Test Result:101 bpm; Comments: t 0; Test Date: 20210118; Test Name: pulse; Result Unstructured Data: Test Result:93 bpm; Comments: t + 5 minutes; Test Date: 20210118; Test Name: pulse; Result Unstructured Data: Test Result:88 bpm; Comments: t + 15 minutes; Test Date: 20210118; Test Name: pulsed O2 saturation; Test Result: 82 %; Comments: t 0; Test Date: 20210118; Test Name: pulsed O2 saturation; Result Unstructured Data: Test Result:78% %; Comments: t + 5 minutes; without oxygen therapy; Test Date: 20210118; Test Name: pulsed O2 saturation; Test Result: 92 %; Comments: t + 15 minutes; under oxygen therapy 3L/min
CDC Split Type: FRPFIZER INC2021095027

Write-up: Sudden death; Decompensation cardiac; MALAISE; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (FR-AFSSAPS-MP20210116). A 94-year-old female patient started to receive BNT162B2 (COMIRNATY; Lot number: EM0477), intramuscularly, on 18Jan2021 11:07 at a single dose for COVID-19 vaccination. It was reported that the vaccine was prepared at 10:10. Medical history included ongoing mediastinal lymphadenopathy, ongoing cancerous tumor of the right breast (untreated), melanoma (of the left knee) from 2013, ongoing chronic respiratory failure (requiring oxygen therapy by nasal probe: 3 L/min), ongoing emphysema, ongoing appearance of pulmonary fibrosis, ongoing hematoma subdural, ongoing hypertension arterial, ongoing carotid artery stenosis, and ongoing residing in a retirement home . Concomitant medications included clopidogrel bisulfate (PLAVIX), paracetamol (DOLIPRANE), haloperidol (HALDOL; reported as HALDOL FORT), and colecaliciferol (ZYMAD). The patient experienced sudden death, decompensation cardiac, and malaise on 21Jan2021. All of the events were reported to be fatal. The clinical course was reported as follows: It is reported that the patient was desaturating more and more frequently. His biological assessment was slightly disturbed with a slight albuminemia, moderate renal insufficiency (glomerular filtration rate (GFR) 59.7 ml/min/1.73M2 on an unspecified date) and slight anemia. On 15Jan2021, there was no specific pre-vaccination consultation. On 18Jan2021, the patient received the vaccine and post-vaccination surveillance showed temperature of 36.6 degrees Centigrade on 18Jan2021. At time (t) 0 (as reported) on 18Jan2021: blood pressure was 138/76 mmHg; pulse at 101 beats per minute (bpm); pulsed oxygen (O2) saturation: 82%. At t + 5 minutes on 18Jan2021: blood pressure was 125/72 mmHg; pulse at 93 bpm; pulsed O2 saturation: 78% without oxygen therapy. And at t + 15 minutes on 18Jan2021: blood pressure was 124/75 mmHg; pulse at 88 bpm; O2 saturation was 92% under oxygen therapy 3L/min. On 21Jan2021, around 09:15, the patient experienced sudden cardiovascular decompensation with malaise, reported as rapidly fatal. The patient died on 21Jan2021. The causes of death were reported as sudden death, decompensation cardiac, and malaise. 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: MALAISE; Sudden death; Decompensation cardiac


VAERS ID: 1010309 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EF6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, SARS-CoV-2 test
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive disturbance
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021095014

Write-up: Infarct myocardial; 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 FR-AFSSAPS-PC20210079. A 100-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EF6795), intramuscular on 21Jan2021 (at the age of 100-years-old) as a single dose for COVID-19 vaccination. Medical history included cognitive disturbances from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 24Jan2021, the patient experienced myocardial infarction, which was fatal. The patient had a COVID-19 PCR test on 24Jan2021, which was negative. The patient died on 24Jan2021 and the occurrence of the myocardial infarction was responsible for the death. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1010318 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Body temperature, Death, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOCE; LASILIX [FUROSEMIDE]; PLAVIX; PRAVASTATIN; FUMAFER; ROCALTROL; SYMBICORT; OMEPRAZOLE; ESCITALOPRAM; LEVOTHYROX; CETIRIZINE; DOLIPRANE; FUROSEMIDE; CLOPIDOGREL; PRAVASTATIN; CALCITRIOL; LEVOTHYROX; CETIRIZINE; ESCITALOPRAM; PARACETAM
Current Illness: Arterial hypertension; Cardiac failure chronic; Cardiac insufficiency; Chronic kidney disease stage 4 (rejected on dialysis); COPD; Dilated cardiomyopathy ((ischemic, chronic alcohol, hypertension)); General physical health deterioration; Hypertension; Renal failure chronic
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Asiderotic anemia; Autonomic dysfunction; Hospitalization; Iron deficiency anemia; Laparotomy (occlusive syndrome); Myocardial infarction; Pain; Sleep apnea syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210117; Test Name: fever; Result Unstructured Data: Test Result:no fever; Test Date: 20201223; Test Name: tested for COVID-19; Result Unstructured Data: Test Result:didn''t have COVID-19
CDC Split Type: FRPFIZER INC2021095038

Write-up: was at the end of his life/ death; abdominal pain; asthenia; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) FR-AFSSAPS-SE20210116 and received via Regulatory Authority. A 79-year-old male patient received bnt162b2 (COMINARTY, Solution for injection, batch/lot number: EM0477) intramuscularly on 12Jan2021 at single dose (1 dose form) in the left arm for COVID-19 vaccination, during hospitalization during a geriatric stay for deterioration of general condition with difficult home maintenance. The patient''s medical history included triple chamber defibrillator for severe multifactorial dilated cardiomyopathy (ischemic, chronic alcohol, hypertension), Renal failure chronic, Arterial hypertension, Chronic obstructive pulmonary disease (COPD), Cardiac insufficiency, Hypertention; Chronic kidney disease (IRC) stage IV rejected on dialysis, end-stage heart failure, deterioration of general condition, all ongoing; Asiderotic anemia from an unknow date and unknow if ongoing; paired sleep apnea syndrome from an unknow date and unknow if ongoing; Laparotomy for occlusive syndrome in 2018; Iron deficiency anemia; Myocardial infarction (IDM) in 2000; Autonomy loss; pain; anxiety; hospitalization. The patient''s concomitant medications included bisoprolol fumarate (BISOCE); furosemide (LASILIX [FUROSEMIDE]); clopidogrel bisulfate (PLAVIX); pravastatin; ferrous fumarate (FUMAFER); calcitriol (ROCALTROL); budesonide formoterol fumarate (SYMBICORT) (400/12 ?g); omeprazole; escitalopram; levothyroxine sodium (LEVOTHYROX); cetirizine; paracetamol (DOLIPRANE); furosemide; clopidogrel; pravastatin; calcitriol; levothyroxine sodium (LEVOTHYROX); cetirizine; escitalopram; paracetamol; tramadol for pain; ferrous fumarate (FUMAFER); macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]); sodium bicarbonate; oxazepam for anxiety; formoterol fumarate (FORMOAIR); fluticasone propionate (FLIXOTIDE); lansoprazole; bisoprolol; delical boisson fruitee (NUTRIENTS NOS) (delical fruity multifruit drink). The day after the vaccination, he returned home, as planned (no adverse effects within 24 hours of vaccination). On 17Jan2021, he presented (according to his wife), abdominal pain with asthenia, no fever, no vomiting, supple stomach, no disturbance of consciousness. The Emergency medical services was called, with advice to continue the analgesics and to reassess. No medical intervention on site. The patient was multi-pathologic, and the wife said she knew her husband was at the end of his life. She did not wish to have him hospitalized again. No real symptom of discomfort according to her, with a more peaceful patient at the end of the day. The death occured at the beginning of the night (17Jan2021). No more details on the specific causes. No autopsy was performed. According to the doctor who took care of the patient during his hospitalization: No obvious causal link with the vaccination in view of the patient''s very severe polypathology. The patient didn''t have COVID-19. The patient had been tested for COVID-19 on 23Dec2020. The outcome of the event "was at the end of his life/ death" was fatal, of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: was at the end of his life/ death


VAERS ID: 1010322 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-16
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, General physical health deterioration, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   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: BISOPROLOL HEMIFUMARATE; CORDARONE; DIFFU K; ELIQUIS; LEVOTHYROX; PANTOPRAZOLE; RAMIPRIL; LASILIX SPECIAL [FUROSEMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Pulmonary arterial hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210116; Test Name: blood pressure; Result Unstructured Data: Test Result:88/60; Comments: (dropped); Test Date: 20210117; Test Name: blood pressure; Result Unstructured Data: Test Result:90/60; Test Date: 20210119; Test Name: blood pressure; Result Unstructured Data: Test Result:10/60
CDC Split Type: FRPFIZER INC2021095043

Write-up: Reduced general condition; Hypotension; This is a spontaneous report from a contactable physician downloaded from the regulatory a. This is a report received from the regulatory authority. Regulatory authority report number was FR-AFSSAPS-TO20210224. A 94-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EM0477), intramuscular in the right deltoid on 08Jan2021 as a single dose for COVID-19 vaccination and furosemide (LASILIX SPECIAL), oral from an unspecified date at 1 dosage form once a day for arterial hypertension. Medical history included pulmonary arterial hypertension and heart failure; both from unknown dates and unknown if ongoing. Concomitant medications included bisoprolol hemifumarate (MANUFACTURER UNKNOWN), amiodarone hydrochloride (CORDARONE), potassium chloride (DIFFU K), apixaban (ELIQUIS), levothyroxine sodium (LEVOTHYROX), pantoprazole (MANUFACTURER UNKNOWN), and ramipril (MANUFACTURER UNKNOWN); all taken for unspecified indications from unknown dates and unknown if ongoing. On 16Jan2021, the patient experienced reduced general condition and hypotension; both serious for being fatal. The clinical course was as follows: The patient had onset of drop in blood pressure (88/60) on 16Jan2021. On 17Jan2021, blood pressure was 90/60. On 18Jan2021, the physician decreased the dose of furosemide (unspecified if the last dose of original regimen was on 17Jan2021 or 18Jan2021). On 19Jan2021, the patient presented a feeling of discomfort and an increase in edema of the lower limbs and blood pressure was 10/60 (as reported). On 20Jan2021, the patient died, and the cause of death was reported as reduced general condition. An autopsy was not performed.; Reported Cause(s) of Death: Reduced general condition


VAERS ID: 1010379 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4243 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Cardiac arrest, Decreased appetite, Fatigue, Lethargy, Nausea, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma lung (treated); Diffuse large B-cell lymphoma (ON CHEMOTHERAPY r-GCVP started this Nov2020 5th cycle given 13Jan2020); Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy))
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: temperature; Result Unstructured Data: Test Result:developed
CDC Split Type: GBPFIZER INC2021100281

Write-up: developed temperature; tired; Sudden death; cardiac arrest; lethargic; nauseous; off fluids/food; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202101290801165170, Safety Report Unique Identifier GB-MHRA-ADR 24664184. An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4243), via an unspecified route of administration on 19Jan2021 in morning at single dose for Covid-19 immunisation. Medical history included neoplasm (recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)), adenocarcinoma lung from 2019 and been treated, diffuse large B cell lymphoma from Oct2020 (on chemotherapy r-GCVP started this Nov2020 5th cycle given 13Jan2020). Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced sudden death on 19Jan2021, serious due to fatal. It was reported that patient been c/o tired and lethargic / nauseous ? presumed post chemotherapy side effect- also off food / fluids in afternoon on 19Jan2021, at around 18:00 developed temperature, cardiac arrest following this. Suspect Reactions. None details of any relevant investigations or tests conducted could be provided. The patient died on 19Jan2021. The outcome of the other events was unknown. It was unknown whether an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1010382 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH D4V3B / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Diarrhoea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 26
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: Comments: Pt had COVID vaccine on 17th Jan and died on 27th Jan 2021 Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021101243

Write-up: D&V; D&V; frail; Death; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202101291229313620, Safety Report Unique Identifier GB-MHRA-ADR 24666545. A 90-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: D4V3B, via an unspecified route of administration on 17Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient had COVID vaccine on 17Jan and died on 27Jan2021. Patient was very frail. He had diarrhea and vomiting after the vaccine was administered in Jan2021. He was admitted to hospital and died there. The cause of death was not reported. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 25Jan2021. The outcome of events diarrhea, vomiting and frail was unknown. It was not reported if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: DEATH


VAERS ID: 1010384 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ELO739 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Fatigue, Nausea, SARS-CoV-2 test, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 6
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: GATALIN XL; LEVOTHYROXINE
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Chest infection; Curvature of spine; Dementia; Frailty; Hyperthyroidism; Pneumonia (5 years earlier); Recurrent urinary tract infection; Comments: Mum had dementia, repeated UTIs and occasional chest infections. She had 5 years esrlier suffered from pneumonia. She had curavture of the spine and was very frail. She recently had the flu jab. A few weeks later the covid vaccine. She in the days after started to complain of nausea and increased fatigue. A longer term cough became a bit more persistent. She had a UTI and had received a single dose antibiotic. Shehpassed away at 515pm on the 30th January. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:no - negative covid-19 test
CDC Split Type: GBPFIZER INC2021100610

Write-up: fatigue; Nausea; longer term cough became a bit more persistent; UTI; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202101311214445570, Safety Report Unique Identifier GB-MHRA-ADR 24673468. An 86-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ELO739), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. The patient has not tested positive for COVID-19 since having the vaccine. Medical history included suspected COVID-19 from 01Feb2020 and ongoing, dementia from an unknown date and unknown if ongoing, repeated urinary tract infections (UTIs) from an unknown date and unknown if ongoing, pneumonia in 2016 (5 years earlier), curvature of spine from an unknown date and unknown if ongoing, frail from an unknown date and unknown if ongoing, occasional chest infections from an unknown date and unknown if ongoing, hyperthyroidism from an unknown date and unknown if ongoing. Concomitant medications included galantamine hydrobromide (GATALIN XL) taken for dementia from 05Aug2018 to an unknown date, levothyroxine (MANUFACTURER UNKNOWN) taken for Hyperthyroidism 05May2010 to an unknown date. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) for immunization on an unknown date. On 24Jan2021, the patient experienced nausea; which required hospitalization, and was assessed for disability, and being medically significant, life threatening, and resulted in death. On an unspecified date, the patient experienced fatigue; which required hospitalization, and was assessed for disability, and being medically significant, life threatening; longer term cough became a bit more persistent (non-serious); and UTI (non-serious). The clinical course was reported as follows: The patient had dementia, repeated UTIs and occasional chest infections. Five years earlier, the patient suffered from pneumonia. The patient also had curvature of the spine and was very frail. The patient recently had the flu vaccine (also reported as "jab"); and then a few weeks later the COVID vaccine. The patient in the days after, started to report of nausea and increased fatigue. A longer-term cough became a bit more persistent. The patient also had a UTI and had received a single dose antibiotic. The patient had passed away at 17:15 on 30Jan2021. When asked to provide details of any relevant investigations or tests conducted, the reporter responded: "As the patient died at home it is with the coroner." The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. Therapeutic measures were taken as a result of UTI. The clinical outcome of the event, nausea, was fatal. The clinical outcome of the event, fatigue, cough, and UTI was unknown. The patient died on 30Jan2021 at 17:15 due to nausea (as reported). It was unknown if an autopsy was performed. The patient was not enrolled in a clinical trial. It was reported that: "nausea, increased fatigue and potential underlying infections. It appeared as if the vaccine may have been a bit too much for her." No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Nausea


VAERS ID: 1010415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 LA / OT

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

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: FUROSEMIDE; ROSUTEC; NEO FERRO FOLGAMMA; SPIRON [SPIRONOLACTONE]; CLEXANE; VITAMIN D3; PANTOPRAZOLE; FENTANYL; ACETYLSALICYLIC ACID; CITROKALCIUM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021098468

Write-up: Death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA) Regulatory Authority-WEB HU-OGYI-020821. A 90-year-old female patient received first dose of bnt162b2 (COMIRNATY, batch/lot number: EL1484), intramuscularly in the left upper arm on 09Jan2021 at 0.3 mL, single for COVID-19 vaccination. The patient medical history was not reported. Concomitant medication included furosemide, rosuvastatin calcium (ROSUTEC), ferrous sulfate, folic acid (NEO FERRO FOLGAMMA), spironolactone (SPIRON), enoxaparin sodium (CLEXANE), colecalciferol (VITAMIN D3), pantoprazole, fentanyl, acetylsalicylic acid, calcium citrate (CITROKALCIUM). The patient was in a fair general condition for the vaccination. On 19Jan2021 ten days after the vaccination at 5 pm, the patient had silently fallen asleep. The nurses found her dead. The patient died on 19Jan2021. It was unknown if an autopsy was performed. Sender Comment: An elderly vaccinated patient died 10 days after the vaccination. The patient was in a fair general condition for the vaccination. After the vaccination, no abnormalities were detected during the observation period. Based on above there is an unlikely the causal relationship between the suspect vaccine and the death of the patient. The case is serious due to the patient''s death as reported. Further information is expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1010460 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   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: SOBRIL; ZOPICLONE; SINEMET; PARACET [PARACETAMOL]; TOILAX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Constipation; Living in nursing home; Parkinson''s disease; Vitamin D deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021095256

Write-up: ALTERED STATE OF CONSCIOUSNESS; DECREASED APPETITE; TIREDNESS; This is a spontaneous report from a contactable other health professional downloaded from the Medicines Agency (MA) Regulatory Authority NO-NOMAADVRE-FHI-2021-U4eaa, Safety Unique Identifier NO-NOMAADVRE-E2B_00014164. An 88-year-old female patient received first dose of BNT162B2 (COMIRNATY, Lot#EJ6795) via intramuscular on 08Jan2021 at single dose for COVID-19 vaccination. The medical history included living in nursing home, parkinson''s disease, alzheimer''s disease, vitamin d deficiency, constipation. Concomitant medication included oxazepam (SOBRIL), zopiclone, carbidopa/ levodopa (SINEMET), paracetamol (PARACET), bisacodyl (TOILAX). On 09Jan2021, the patient developed tiredness and decreased appetite. From 16Jan2021 the patient became bedridden and had altered state of consciousness. The patient died on 18Jan2021. t was not reported if an autopsy was performed. The outcome of events was fatal. The case was considered to be Serious. Sender Comment: The report concerns a patient in her 80s, who became increasingly tired and fatigued and had a reduced appetite from the day after the first dose of the Covid-19 vaccine Comirnaty. One week later, the patient became bedridden and uncontactable, and died a few days later. The patient was a resident of a nursing home and had underlying diseases. The most common adverse reactions with Comirnaty in study participants were injection site pain ($g 80%), fatigue ($g 60%), headache ($g 50%), myalgia and chills ($g 30%), arthralgia ($g 20%), fever and swelling at the injection site ($g 10%). They occurred within 1-2 days after vaccination, were usually of mild or moderate intensity and passed after a few days. However, we cannot rule out that such relatively mild side effects may lead to a more serious course in severely debilitated patients. When vaccinating vulnerable / frail, multi-diseased elderly patients, some serious events, including death, may occur shortly after vaccination. In the individual case, however, it is difficult to know whether the symptoms are due to a vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. 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 relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient later died, the message is also classified as serious, even though no causal link between the vaccine and the death has been established. Relatedness of drug to reactions/events: Source of assessment was Pharmacovigilance Center, Result of Assessment was Possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Decreased appetite; Tiredness; Altered state of consciousness


VAERS ID: 1010461 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Cerebral haemorrhage, Death, Heart rate increased, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   Days after onset: 4
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; Dementia; Hypertension; Living in residential institution
Allergies:
Diagnostic Lab Data: Test Date: 20210113; Test Name: Blood pressure; Result Unstructured Data: Test Result:156/100 mmHg; Test Date: 20210113; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210113; Test Name: Computerised tomogram head; Result Unstructured Data: Test Result:Confirms major haemorrhage.; Test Date: 20210113; Test Name: C-reactive protein; Result Unstructured Data: Test Result:51 mg/l; Test Date: 20210113; Test Name: Heart rate; Result Unstructured Data: Test Result:136; Comments: Units:{beats}/min; Test Date: 202101; Test Name: Heart rate; Result Unstructured Data: Test Result:Stable around 100 bpm.; Test Date: 20210113; Test Name: Respiratory rate; Result Unstructured Data: Test Result:34; Comments: Units:{breaths}/min
CDC Split Type: NOPFIZER INC2021095239

Write-up: Fever, high pulse - further large cerebral haemorrhage the same day.; Fever, high pulse - further large cerebral haemorrhage the same day.; Fever, high pulse - further large cerebral haemorrhage the same day.; consciousness became altered; started vomiting; unknown cause of death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB [NO-NOMAADVRE-FHI-2021-U5ea5]. A 90-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6795), via intramuscular on left arm on 06Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unknown date, living in residential institution from an unknown date, atrial fibrillation from an unknown date, dementia from an unknown date. The patient''s concomitant medications were not reported. The patient experienced fever, high pulse - further large cerebral haemorrhage the same day on 13Jan2021. The events were reported as serious due to hospitalization. Narrative was reported as on 13Jan2021, the patient developed fever, high pulse rate. After a while, the patient''s consciousness became altered and she started vomiting. Cerebral haemorrhage was suspected and confirmed by computerised tomomgram. The patient underwent lab tests and procedures which included blood pressure measurement: 156/100 mmHg on 13Jan2021; body temperature: 38 centigrade on 13Jan2021; computerised tomogram head: confirms major haemorrhage on 13Jan2021; c-reactive protein: 51 mg/l on 13Jan2021; heart rate: 136 (Units:{beats}/min) on 13Jan2021, heart rate: stable around 100 bpm in Jan2021; respiratory rate: 34 (Units:{breaths}/min) on 13Jan2021. The patient died on 17Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. The outcome of the event unknown cause of death was fatal, while other events were unknown. Sender''s comment: The report concerns a patient in his 90s, who developed a fever, high heart rate and cerebral haemorrhage a few days after the first dose of the Covid-19 vaccine Comirnaty. The patient died a few days after the event. The patient had known dementia, hypertension and atrial fibrillation. With the exception of fever, the reported symptoms are not among the adverse reactions reported in the participants in the clinical trials at Comirnaty. Data from use in frail, multi-sick elderly patients are nevertheless limited. When vaccinating vulnerable / frail, multi-diseased elderly patients, some serious events may occur shortly after vaccination. In each case, it is difficult to know whether the events are due to the vaccine, the patient''s underlying disease or other random, concurrent cause that has nothing to do with the vaccination in question. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. Nor can we rule out rare side effects. There should be a low threshold for reporting rare or unexpected side effects that occur after vaccination. Since the vaccine is new, it is subject to special surveillance in order to detect new safety information as quickly as possible. It is especially important that serious and / or unusual side effects are reported. Your message is therefore important to increase knowledge about side effects that have not been discovered in the studies. 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: unknown cause of death


VAERS ID: 1010462 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 2021-01-01
   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: Living in nursing home; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: C-reactive protein; Result Unstructured Data: Test Result:increased
CDC Split Type: NOPFIZER INC2021095232

Write-up: REDUCED GENERAL CONDITION; C-REACTIVE PROTEIN INCREASED; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB regulatory authority NO-NOMAADVRE-FHI-2021-Uggnm. A 97-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 vaccination. Medical history included and urinary tract infection. The concomitant medications were not reported. The patient experienced reduced general condition and C-reactive protein increased in Jan2021 and died a week after vaccination in Jan2021. The events were fatal. The patient died in Jan2021. It was not reported if an autopsy was performed. Senders Comment: A woman in her 90s, a nursing home patient, was vaccinated with the covid-19 vaccine Comirnaty. Rising CRP and declining general condition, and she died a week after vaccination. In the time from vaccination to the patients death, she was simultaneously treated for urinary tract infection. The doctor indicates little suspicion of a causal link between the Corminaty vaccine and the patients death. Comment: The most common adverse reactions in participants in the vaccine studies were injection site pain (Less than 80percent ), fatigue (greater than 60percent ), headache (greater than 50percent ), myalgia and chills (greater than 30percent ), arthralgia (greater than 20percent ), fever and swelling at the injection site (greater than 10percent ). They occurred within 1-2 days after vaccination, were usually of mild or moderate intensity and passed after a few days. It is stated in the report that the patient had a concomitant urinary tract infection during the time of vaccination. This can also be the cause of rising CRP and declining general condition. However, it cannot be ruled out that the vaccine may have contributed to some of the symptoms in the course of the disease to the already established infection. 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 are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: REDUCED GENERAL CONDITION; C-REACTIVE PROTEIN INCREASED


VAERS ID: 1010465 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Cardiac failure, Conjunctivitis, Death, Electrocardiogram, Fatigue, General physical health deterioration, Heart rate, Heart rate increased, Hyperkalaemia, Hypertension, Hyperventilation, Infection, Leukocytosis, Pain in extremity, Paralysis, Urinary tract infection, Urine analysis
SMQs:, Cardiac failure (narrow), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Conjunctival disorders (narrow), Ocular infections (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   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: Aphasia (some aphasia); Chronic pulmonary heart disease; Dementia; Dysarthria; Heart failure; Kidney failure; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210110; Test Name: Blood test; Result Unstructured Data: Test Result:almost unchanged severe renal failure, mild hyperk; Comments: samples that showed almost unchanged severe renal failure, mild hyperkalaemia, increased heart failure and leukocytosis.; Test Date: 20210109; Test Name: ECG; Result Unstructured Data: Test Result:No acute pathology; Test Date: 20210110; Test Name: Urine strip test; Result Unstructured Data: Test Result:UTI; Test Date: 202101; Test Name: blood pressure; Result Unstructured Data: Test Result:hypertension; Test Date: 202101; Test Name: heart rate; Result Unstructured Data: Test Result:high
CDC Split Type: NOPFIZER INC2021095235

Write-up: FOUND DEAD; mild hyperkalemia; UTI; leukocytosis; concomitant bilateral conjunctivitis; a bit tired; reduced general condition; increasing infection paralyzed shortly after vaccination; increasing infection paralyzed shortly after vaccination; increased heart failure; severe pain in both arms; hyperventilated; hypertension; high heart rate; This is a spontaneous report from contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Uzjg2. Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014154. A 97-year-old male patient received bnt162b2 (COMIRNATY) (Batch/lot number EJ6796), intramuscular on 06Jan2021 14:30 at SINGLE DOSE for covid-19 immunization. Vaccine location was right arm. Medical history included living in nursing home, dementia, stroke in 2009 with sequelae such as dysarthria / some aphasia, pulmonary heart disease, heart failure, kidney failure. The medical history all ongoing except for stroke. The patient was functioning well. He used to be up, eating and drinking well. The patient''s concomitant medications were not reported. After about 3 days after vaccination against COVID - he complained of severe pain in both arms, he was hyperventilated, had hypertension and high heart rate. The ambulance was called. ECG showed no acute pathology. Patient received Nitroglycerin - with effect. Patient was better the next day but was somewhat confused. With suspicion of UTI, u-Stix was taken which showed UTI. In addition, it was taken among others. samples that showed almost unchanged severe renal failure, mild hyperkalaemia, increased heart failure and leukocytosis. Patient was rapidly habitual after starting AB treatment with Selexid 200 mg x 3. In addition, the patient developed concomitant bilateral conjunctivitis and started treatment with Chloramphenicol eye ointment. One day after starting with AB, the patient was better clinically. He was up, eating and drinking well. He was still a bit tired and needed more help with care. 1 week after vaccination he was out in the corridor. Ate well and went to his room to watch TV. About 20 min. after that he was found dead sitting in the chair of his room on 13Jan2021. Due to the rapidly declining AT, increasing infection paralyzed shortly after vaccination, it is suspected that if coronary vaccine was the cause of this. Relatives were informed and they denied an autopsy. It was also reported that UTI (09Jan2021), hyperkalemia (09Jan2021), conjunctivitis (Jan2021), death. On Jan2021, the patient developed reduced general condition. Relevant laboratory findings and investigations included in the report (ECG, 09Jan2021) (urine strip test, 10Jan2021)(blood test, 10Jan2021). One week after vaccination the patient was found dead. The patient''s outcome was Fatal, at the time of the report. The outcome of events "severe pain in both arms, he was hyperventilated, had hypertension and high heart rate" was recovering, the outcome of other events was unknown. The case was considered to be Serious. Reporter''s comment: Patient who was 97 years old man. Known from before with dementia, stroke in 2009 with sequelae such as dysarthria / some aphasia, pulmonary heart disease, heart failure, kidney failure. The patient was functioning well. He used to be up, eating and drinking well. After about 3 days after vaccination against COVID - he complained of severe pain in both arms, he was hyperventilated, had hypertension and high heart rate. The ambulance was called. ECG showed no acute pathology. Patient received Nitroglycerin - with effect. Patient was better the next day but was somewhat confused. With suspicion of UTI, u-stix was taken which showed UTI. In addition, it was taken among others. samples that showed almost unchanged severe renal failure, mild hyperkalaemia, increased heart failure and leukocytosis. Patient was rapidly habitual after starting AB treatment with Selexid 200 mg x 3. In addition, the patient developed concomitant bilateral conjunctivitis and started treatment with Chloramphenicol eye ointment. One day after starting with AB, the patient was better clinically. He was up, eating and drinking well. He was still a bit tired and needed more help with care. 1 week after vaccination he was out in the corridor. Ate well and went to his room to watch TV. About 20 min. after that he was found dead sitting in the chair of his room. Due to the rapidly declining AT, increasing infection paralyzed shortly after vaccination, it is suspected that coronary vaccine was the cause of this? Relatives were informed and they denied an autopsy. EMA Comment: Local reaction with swelling, redness, heat and pain at the injection site may occur after all vaccines, and is a known side effect of this vaccine. Local reaction. Local reactions usually begin during the first 2 days, and can last for many days. Nonspecific symptoms such as fever, malaise, headache, dizziness and general malaise occur in the first days after vaccination. The symptoms described may thus suit a reaction to the vaccine. However, the report also describes that the patient had an acute infection with UTI and bilateral conjunctivitis. This can also be the cause of the patient''s ailments. An improvement in symptoms before the patient was suddenly found dead is further described. It is difficult to imagine how the vaccine will cause sudden death seven days after vaccination in a patient who was otherwise recovering. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur in the period after vaccination without any connection to vaccination. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or other accidental, concurrent cause that has nothing to do with the vaccination in question. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur in the period after vaccination without any connection to vaccination. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or other random, concurrent 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 are possible. No further information is expected.; Reported Cause(s) of Death: FOUND DEAD


VAERS ID: 1010472 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse; Depression; Epilepsy; Hypokalaemia; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021098056

Write-up: SUDDEN DEATH; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB SE-MPA-1611755997275, Safety Report Unique Identifier SE-MPA-2021-001827. An 81-year-old male patient received bnt162b2 (COMIRNATY, lot number EJ6795) , intramuscular in Jan2021 at single dose for COVID-19 vaccination. Medical history included hypokalaemia, stroke, alcohol abuse, epilepsy, depression, all of which were from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The reported adverse reaction is sudden death in Jan2021. The patient dies unexpectedly and not witnessed the night after the vaccination without prior deterioration. Report assessed as serious, death. The patient died on an unspecified date in Jan2021. An autopsy cannot determine the cause of death according to the reporter.; Reported Cause(s) of Death: sudden death


VAERS ID: 1010476 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Dyspnoea, General physical health deterioration, Infection, Oxygen saturation, Oxygen saturation abnormal, Pulse abnormal, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: LOSARTAN / HIDROCLOROTIAZIDA; PREDNISOLON [PREDNISOLONE]; MOXALOLE; PARACETAMOL; BUPREMYL; MIRTAZAPIN; KAJOS; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypereosinophilic syndrome; Hypertension; Nightmares (betablocker gave nightmares.); Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 202101; Test Name: pulse oximetry; Result Unstructured Data: Test Result:severely impaired
CDC Split Type: SEPFIZER INC2021095262

Write-up: Infection NOS; impaired general condition; fever; affected breathing with severely impaired pulse oximetry; affected breathing with severely impaired pulse oximetry; affected breathing with severely impaired pulse oximetry; decreased blood pressure; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB, Regulatory Authority number SE-MPA-2021-000479. Other case identifier number SE-MPA-1610717478720. An 85-year-old female patient received bnt162b2 (COMIRNATY, lot number: EJ6795), via intramuscular on unspecified date in Jan2021 at single dose for COVID-19 immunization. The relevant medical history included nightmares (betablocker gave nightmares), vascular dementia, hypertension, hypereosinophilic syndrome, all from unspecified dates and unknown if ongoing. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN / HIDROCLOROTIAZIDA), prednisolone, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOXALOLE), paracetamol, buprenorphine (BUPREMYL), mirtazapine (MIRTAZAPIN), potassium citrate (KAJOS), bisoprolol. Reported suspected adverse event was infection nos, the day after vaccination in Jan2021. Treated with Penomax. According to rapporteur "Suddenly impaired general condition, fever, affected breathing with severely impaired pulse oximetry and decreased blood pressure". The patient died five days after vaccination on an unspecified date in 2021. Report assessed as serious, death. No autopsy performed, cause of death was infection nos. The outcome of the event infection nos was fatal, while other events were unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infection NOS


VAERS ID: 1010478 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL 1484 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; RAMIPRIL; ATORBIR; WARAN; SOBRIL; LEVAXIN; HYDROCHLOROTHIAZIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Atrial fibrillation; Hyperlipidaemia; Hypertension; Hypothyroidism; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021095518

Write-up: death; This is a spontaneous report from a contactable consumer or other non hcp and an other HCP downloaded from the Medicines Agency (MA) Regulatory Authority-WEB SE-MPA-2021-000677, Other case identifier number SE-MPA-1611061284120. An 88-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot EL 1484), intramuscularly on Jan2021 at 0.3 mL, single dose for COVID-19 vaccination. Medical history included hypothyroidism, anxiety, stroke from 1992, atrial fibrillation, hypertension, hyperlipidaemia. Concomitant medication included bisoprolol, ramipril, atorvastatin calcium (ATORBIR), warfarin sodium (WARAN), oxazepam (SOBRIL) , levothyroxine sodium (LEVAXIN), hydrochlorothiazide. The woman was found dead in the morning two days after vaccination in Jan2021. According to consumer reporter, the patient was healthy but sensitive to medicines before vaccination. Consumer reporter also write that according to doctor cause of death was unknown. The woman was not autopsied. Report assessed as serious, death. The outcome of event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1010479 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / OT

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

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: Hypertension; Renal failure; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021095408

Write-up: acute myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA)R Regulatory Authority -WEB, Regulatory Authority number SE-MPA-2021-001016. Other case identifier number SE-MPA-1611233695800. An 83-year-old female patient received (COMIRNATY, lot number: EL1484) intramuscular on Jan2021 at 0.3 ml single for COVID-19 immunisation. Medical history included diabetes type 2, kidney failure and hypertension. Concomitant medications were unknown. The patient was vaccinated in the morning, in the evening she felt well but was found dead the next day in the morning, died during the night on Jan2021. Cause of death was acute myocardial infarction. The patient was not autopsied. Report assessed as serious, death. Outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1010480 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: QUETIAPINE; ZOPICLONE; HEMINEVRIN [CLOMETHIAZOLE EDISILATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Frontotemporal dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021096129

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (EMA) EudraVigilance-WEB SE-MPA-2021-001018, Other case identifier number SE-MPA-1611233985028. A 70-year-old male patient received bnt162b2 (COMIRNATY), via intramuscular on Jan2021 at single dose for covid-19 immunisation. Medical history included frontotemporal dementia from an unknown date and unknown if ongoing. Concomitant medication included quetiapine, zopiclone and clomethiazole edisilate (HEMINEVRIN [CLOMETHIAZOLE EDISILATE]), all from unknown date for unknown indication. The patient died unexpected 8 days after vaccination. The patient was autopsied. The Medical Products Agency have requested for autopsy report. Outcome of the event was fatal. No follow-up attempts are possible, information on batch numbers cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1010481 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Hypothyreosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021095397

Write-up: Death; Tiredness; This is a spontaneous report from a contactable healthcare professional downloaded from the Agency Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-001257. Other case identifier number SE-MPA-1611395632614. A 90-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: EL1484), intramuscularly in Jan2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included dementia Alzheimer''s type and hypothyroidism. No previous known drug reactions. The patient''s concomitant medications were none. The patient experienced death, and tiredness in Jan2021. The day after the vaccination, the woman developed increasing tiredness and stopped eating and drinking (orally). Apart from that, her health condition was entirely without remarks according to the reporter. The woman died 5 days after the vaccination. The patient died on an unspecified date. Outcome of event tiredness was unknown. 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: 1010482 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Palliative care; TIA
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021095409

Write-up: Cardiopulmonary failure; general physical health deterioration; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB SE-MPA-2021-001508. A 98-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot number: EL1484) Intramuscular at single dose in Jan2021 for COVID-19 vaccination. Medical history included angina pectoris and status post TIA (transient ischaemic attack). The woman had been in palliative care in 2019 and a renewed decision was made in May2020. No concomitant medication. The patient was vaccinated with the first dose of Comirnaty in Jan2021. A renewed decision regarding palliative care was made three days after the vaccination. Six days after the vaccination, the patient died. Causes of death were cardiopulmonary failure and general physical health deterioration. Report assessed as serious, death. The MPA has requested further information. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Cardiopulmonary failure; General physical health deterioration


VAERS ID: 1010483 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 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: 2021-01-14
   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: OXASCAND; MEMANTINE; ACETYLSALICYLIC ACID; SIMVASTATIN; BETOLVEX [CYANOCOBALAMIN]; FOLVIDON; MIRTAZAPINE; LEVAXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive lung disease; Dementia Alzheimer''s type (late onset)
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: SEPFIZER INC2021095406

Write-up: Death in COVID 19, VIRUS positive; Death in COVID 19, VIRUS positive; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB (SE-MPA-2021-001581 and SE-MPA-1611603955343). An 86-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6795), intramuscularly, on 05Jan2021 at a single dose for COVID-19 immunisation. Medical history included chronic obstructive lung disease and dementia Alzheimer''s type (late onset). Concomitant medications included oxazepam (OXASCAND) from 2012, memantine (MANUFACTURER UNKNOWN) from 2016, acetylsalicylic acid (MANUFACTURER UNKNOWN) from 2009, simvastatin (MANUFACTURER UNKNOWN) from 2009, cyanocobalamin (BETOLVEX) from 2009, folic acid (FOLVIDON) from 2009, mirtazapine (MANUFACTURER UNKNOWN) from 2012, and levothyroxine sodium (LEVAXIN) from 2009. The patient had no previous drug reactions. The patient experienced death in COVID 19, virus positive on 07Jan2021, which was reported as fatal. The clinical course was reported as follows: Two days after the vaccination, the patient suddenly desaturated and was sent to a hospital, where a COVID-19 virus test was taken, which came back positive on 07Jan2021. The man was treated with high levels of oxygen and parenteral fluid and nutrition, but his consciousness decreased, and he died after a week in the hospital, reported as 9 days after the vaccination. The physician reported that the patient was probably already infected, both health care providers and residents had verified ongoing COVID-19 during that time and the man tested positive 2 days after the first dose of vaccination. The patient died on 14Jan2021. The cause of death was reported as COVID-19. It was not reported if an autopsy was performed. The physician reported that the vaccination in itself is not suspected to have caused the death and does not suspect aggravated COVID-19 infection due to vaccination.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1010484 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Circulatory collapse
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (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: Chronic obstructive pulmonary disease; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021095412

Write-up: Circulatory failure/circulatory arrest; chest pain; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB and received via Regulatory Authority SE-MPA-2021-001718. Other case identifier number SE-MPA-1611673292424. A 61-years-old female patient received bnt162b2 (COMIRNATY), lot number: EL1484, intramuscular in Jan2021 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was reported three days after vaccination in 2021, the patient suddenly experienced chest pain. Fell down and Circulatory failure/circulatory arrest. The patient died after one hour with cardiopulmonary rescue. Reporter wrote no clinical suspicion of correlation with vaccination. The report was reported as serious with death. Autopsy was ordered by reporter. The Medical Products Agency had requested for autopsy protocols and epicrisis. The patient died of Circulatory failure/circulatory arrest on an unspecified date in 2021. The outcome of events chest pain and fell down was unknown. It was not reported if an autopsy was performed at the time of report.; Sender''s Comments: Based on temporal association, the causal relationship between bnt162b2 and the events circulatory collapse and chest pain cannot be excluded. The contributory role of the pre-existing COPD and hypertension cannot be excluded as well. It is noted that an autopsy has been requested. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Circulatory failure/circulatory arrest


VAERS ID: 1014882 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Death, General physical health deterioration
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: FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL FUMARATE]; NOVALGIN [CAFFEINE;PARACETAMOL;PROPYPHENAZONE]; PARACETAMOL; CONCOR
Current Illness: Bronchial neoplasm (N. Bronchi suspicion); Schizophrenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20190702; Test Name: CT Thorax; Result Unstructured Data: Test Result:Results NOS
CDC Split Type: ATPFIZER INC2021104335

Write-up: reduced general condition in the context of advanced tumor disease; Death NOS death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB , Regulatory Authority number: AT-BASGAGES-2021-00605. A 65-year-old male patient received second dose of bnt162b2 (COMIRNATY, lot: EJ6796), intramuscularly at deltoid left on 22Jan2021 at 0.3 mL (2nd dose) single for COVID19 mRNA vaccination. Medical history included Bronchial neoplasm N. Bronchi suspicion from Mar2020 and ongoing, schizophrenia from 01Dec1991 and ongoing. Concomitant medication included beclometasone dipropionate, formoterol fumarate (FOSTER) from 2020, caffeine, paracetamol, propyphenazone (NOVALGIN) from 2020, paracetamol from 2020, bisoprolol fumarate (CONCOR). The patient previously took CISORDINOL (reported as CISCORDINOL) from 1991 to Mar2020, first dose of bnt162b2 (COMIRNATY) on 29Dec2020. Patient found dead in the room. The day before, 2nd gift of Comirnaty. Given at the express request of the patient. Clinically mucous, reduced general condition in the context of advanced tumor disease. On 23Jan2021 the patient experienced Death NOS death. The patient experienced also General physical condition decreased. The patient''s outcome was fatal for General physical condition decreased, fatal for Death NOS. The patient died on 23Jan2021 from Vaccination adverse reaction, Embolism, Bronchial neoplasm. Relatedness of drug to events was assessed by reporter as possible for both events (Death NOS and General physical condition decreased). The patient underwent lab tests and procedures which included computerised tomogram: results nos on 02Jul2019. The patient died on 23Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Mainly side effect Comirnaty (2nd dose) DD: Embolism as a result of the tumor disease; Mainly side effect Comirnaty (2nd dose) DD: Embolism as a result of the tumor disease; Mainly side effect Comirnaty (2nd dose) DD: Embolism as a result of the tumo


VAERS ID: 1014883 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-22
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Autopsy, Electrocardiogram
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

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:
Current Illness: Arrhythmia (Cardiac arrhythmia including unconsciousness as a result several times, but ECG examinations were unremarkable.); Unconsciousness (Cardiac arrhythmia including unconsciousness as a result several times, but ECG examinations were unremarkable.)
Preexisting Conditions: Medical History/Concurrent Conditions: Colitis ulcerative (Ulcerative colitis earlier, no longer acute)
Allergies:
Diagnostic Lab Data: Test Name: post-mortem examination; Result Unstructured Data: Test Result:the definite cause of death as "death due to cardi; Comments: "death due to cardiac arrhythmia"; Test Name: ECG examinations; Result Unstructured Data: Test Result:unremarkable
CDC Split Type: ATPFIZER INC2021104337

Write-up: Death due to cardiac arrhythmia according to autopsy; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, number AT-BASGAGES-2021-00720. An 80-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 13Jan2021 at single dose for Vaccination against Sars-Cov-2. The patient''s medical history and concurrent conditions included: Arrhythmia (continuing), Cardiac arrhythmia including unconsciousness (contiue) as a result several times, but ECG examinations were unremarkable, Colitis ulcerative earlier, no linger acute. The patient''s concomitant medications were not reported. The patient previously took bisphosphonates. Nine days after the Pfizer-Biontec SarsCoV-2 vaccination "Comirnaty", the patient (care level 3) was found lying dead in the bathroom on 22Jan2021. Until then, the patient was still in good health. A post-mortem examination revealed the definite cause of death as "death due to cardiac arrhythmia" (Cardiac arrhythmia according to autopsy). On 22Jan2021 the patient experienced Arrhythmia death. An autopsy was performed and results were not provided. Sender Comment: Confounding factors: underlying arrhythmia,elderly age The available information was considered inadequate to fully assess the case. No follow-up attempts are possible. Batch/Lot# and expiry date not provided and not possible to obtain.; Reported Cause(s) of Death: Cardiac arrhythmia according to autopsy


VAERS ID: 1014886 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-29
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / OT

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

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:
Current Illness: Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Atrioventricular block third degree (Condition after AV block 3 with pacemaker implantation 2014); Cerebral infarction (Condition after cerebral insult with left paresis in 2015); Pacemaker insertion (cardiac) (Condition after AV block 3 with pacemaker implantation 2014); Paresis (Condition after cerebral insult with left paresis in 2015)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021109645

Write-up: Death NOS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-00813 and received via Regulatory Authority. A 78-years-old female patient received bnt162b2 (COMIRNATY) , Lot# EJ6797 intramuscular on unspecified date in Jan2021 at single dose for covid-19 immunisation . The patient''s medical history and concurrent conditions included: Hypertension arterial (continuing), Cerebral infarction (Condition after cerebral insult with left paresis in 2015) not ongoing , Paresis (Condition after cerebral insult with left paresis in 2015) unknown if ongoing, Atrioventricular block third degree (Condition after AV block 3 with pacemaker implantation 2014) not ongoing, Pacemaker insertion (cardiac) (Condition after AV block 3 with pacemaker implantation 2014) not ongoing .The patient''s concomitant medications were not reported. The patient experienced death nos on 29Jan2021.It was not reported if an autopsy was performed. The patient''s outcome was: fatal for Death NOS. Sender Comment: BASGAGES-comment: Follow-up information has been requested. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death NOS


VAERS ID: 1014887 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Blood pressure measurement, Cardiac arrest, Heart rate, Malaise, Nausea, Oxygen saturation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Deep vein thrombosis; Hypertension; Ischemic cardiomyopathy; Mitral insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210113; Test Name: Blood pressure; Result Unstructured Data: Test Result:160/70 mmHg; Test Date: 20210113; Test Name: Pulse rate; Result Unstructured Data: Test Result:59 beats per minute; Test Date: 20210113; Test Name: Oxygen saturation; Test Result: 90 %
CDC Split Type: BEPFIZER INC2021097913

Write-up: In cardiac arrest and resuscitation fails; the patient feels unwell; Nausea; Anxiety; 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-N2021-75817. A 98-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EM0477), via an unspecified route of administration on 13Jan2021 (at the age of 98-year-old) as a single dose for COVID-19 vaccination and domperidone (MANUFACTURER UNKNOWN), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. Medical history included hypertension, ischaemic cardiomyopathy, mitral valve insufficiency, aortic insufficiency, and deep vein thrombosis; all from unknown dates and unknown if ongoing. The patient''s concomitant medications were not reported. On 13Jan2021 at 23:00, the patient experienced nausea and anxiety. On 13Jan2021, the patient underwent lab tests and procedures which included blood pressure measurement: 160/70 mmhg, pulse rate: 59 beats per minute, and oxygen saturation: 90 %. On 14Jan2021, the patient experienced feeling unwell. On 14Jan2021, the patient had cardiac arrest and cardiopulmonary resuscitation failed. It was decided that an acute heart attack was the cause. The physician did not see any relationship with the vaccine. The action taken in response to the events for domperidone was unknown. The clinical outcomes of the cardiac arrest, nausea, anxiety, and feeling unwell were fatal. The patient died on 14Jan2021. It was not reported if an autopsy was performed. The regulatory authority assessed the causality between the vaccine and cardiac arrest, nausea, anxiety, and feeling unwell as unclassifiable. The regulatory authority assessed the causality of the domperidone to cardiac arrest and feeling unwell as unclassifiable and that to nausea and anxiety as unlikely. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Nearly 99 years old (born PRIVACY ), history of Hypertension, ischemic cardiomyopathy, mitral insufficiency, aortic insufficiency, deep vein thrombosis. I don''t see any relationship with the vaccine. Patient in cardiac arrest and CPR fails. It is decided that an acute heart attack is the cause.; Sender''s Comments: There is not a reasonable possibility that the reported event was related to the suspect product event most likely due to patient underlying contributory factors The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.; Reported Cause(s) of Death: cardiac arrest; feeling unwell; nausea; anxiety


VAERS ID: 1014895 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Peripheral vascular disorder, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; METOCLOPRAMIDE; ACETYLSALICYLIC ACID; TORASEMIDE; AMLODIPINE; SIMVASTATINE
Current Illness: Cardiac insufficiency; Coronary heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure; Arterial hypertension; Arteriosclerosis; Cardiac failure; Cerebral ischaemia; Chronic gastritis; COVID-19 respiratory infection; Multi-infarct dementia; Pneumonia; Upper gastrointestinal haemorrhage; Vomiting
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021103840

Write-up: hypotonic circulatory failure; Circulatory collapse; Vomiting; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB other manufacturer number DE-DCGMA-21187686. A female 91-year-old patient, born on PRIVACY, was vaccinated with the second dose of BNT162B2 (COMIRNATY, batch no.: EK9788) for COVID-19 immunisation, Intramuscular on 20Jan2021. Concomitant medications included: pantoprazol, metoclopramide, acetylsalicylic acid, torasemid, amlodipin, simvastatin Patient past drug therapy: Comirnaty (start date: 28Dec2020, No adverse reaction). Medical history included: Pneumonia, Acute renal failure, Upper gastrointestinal haemorrhage, Multi-infarct dementia, COVID-19 respiratory infection, Arterial hypertension, Cerebral ischaemia, Arteriosclerosis, Chronic gastritis, Cardiac failure, Vomiting, Coronary heart disease, Cardiac insufficiency. 1 day after vaccination the patient developed Vomiting and Circulatory disorder peripheral and Circulatory failure, lasting for 4 hour(s). The patient is dead. Death cause was reported as Circulatory failure. ADDITIONAL INFORMATION ON DRUG PROVIDED IN PRODUCT NOTES: Second vaccination Adverse events: increasing hypotensive circulatory failure in the following hours, no response to infusion therapy, bradycardic arrhythmia, asystole/death at 11.15 am. 1st Covid-19 vaccination on 28Dec2020 was well tolerated; pat was in good, stable until 20Jan21, 2nd Covid-19 vaccination on 1/20Jan2021; sudden onset of symptoms described above starting at approximately 7 am on 21Jan2021. Measures: Considering the patient''s age and general condition with infusion therapy. Supplement for Reporter''s comments: Ringer''s lactate, 1 MCP 10 mg ampoule IV, later Akrinor IV from the emergency doctor; no stat. Instruction or resuscitation (living will was available) No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Adverse events: increasing hypotensive circulatory failure in the following hours, no response to infusion therapy, bradycardic arrhythmia, asystole/death at 11.15 am. 1st Covid-19 vaccination on 28Dec2020 was well tolerated; pat was in good, stable until 20Jan21, 2nd Covid-19 vaccination on 1/20Jan2021; sudden onset of symptoms described above starting at approximately 7 am on 21Jan2021. Measures: Considering the patient''s age and general condition with infusion therapy; Reported Cause(s) of Death: Circulatory failure


VAERS ID: 1014897 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNK / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram thorax, Cyanosis, Death, General physical health deterioration, Pneumonia, Respiratory failure, Syncope, Urinary tract infection
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) (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), Cardiomyopathy (broad), 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 (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Arterial stent insertion (Stent-PTA of the popliteal artery and the right tibiofibular trunk in 2011); Atrial fibrillation (Permanent atrial fibrillation - NOAC with Pradaxa); Cholecystolithiasis; Chronic gastritis; Chronic renal insufficiency (stage II); Depressive disorder; Hepatomegaly; Hyperlipidaemia; Hypertensive heart disease; Hyperuricemia; Liver fatty (Grade II); Peripheral arterial occlusive disease Fontaine stage I; Triple vessel disease; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: CT chest; Result Unstructured Data: Test Result:pronounced pneumonia
CDC Split Type: DEPFIZER INC2021103905

Write-up: Respiratory failure; Syncope; Pneumonia; Cyanosis; General physical condition decreased; Unknown cause of death; urinary tract infection; This is a spontaneous report from a non-contactable consumer downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [DE-PEI-CADRPEI-2021013072]. An 85-year-old male patient received the first dose of bnt162b2 (COMIRNATY), intramuscularly on 14Jan2021 at single dose for prophylactic vaccination. Medical history included Peripheral arterial occlusive disease Fontaine stage I, Arterial stent insertion (Stent-PTA of the popliteal artery and the right tibiofibular trunk in 2011), Atrial fibrillation (Permanent atrial fibrillation - NOAC with Pradaxa), Triple vessel disease, Type 2 diabetes mellitus, Arterial hypertension, Hypertensive heart disease, Chronic renal insufficiency stage II, Hyperlipidaemia, Chronic gastritis, Cholecystolithiasis, Grade II Liver fatty, Hepatomegaly, Depressive disorder, Hyperuricemia, all were ongoing. The patient''s concomitant medications were not reported. 8 days after vaccination (as reported), on 21Jan2021 the patient developed Respiratory failure and Syncope and Cyanosis and General physical condition decreased and Pneumonia, lasting for unknown. Patient in the PFH syncopated and fallen out of bed, dyspnoic, resp. partial insufficiency, with oxygen requirement -$g hospital admission -$g oxygen demand 8l/min, antibiotics for urinary tract infection, pronounced pneumonia in the CT chest. The patient was dead on 21Jan2021. The patient had not recovered from the events Respiratory failure and Syncope and Cyanosis and General physical condition decreased and Pneumonia at the date of reporting, and outcome of urinary tract infection was unknown. Death cause was reported as Unknown cause of death. It was not reported if an autopsy was performed. Senders comment: Peripheral arterial occlusive disease stage I; Stent-PTA of the popliteal artery and the right tibiofibular trunk in 2011; Permanent atrial fibrillation - NOAC with Pradaxa; Three vessel coronary disease; Type 2 diabetes mellitus; Arterial hypertension with hypertensive heart disease; Chronic renal insufficiency St. II; Hyperlipidemia; Chronic gastritis; Cholecystolithiasis; Grade II fatty liver with hepatomegaly; Depressive disorder; Hyperuricemia. Patient in the PFH syncopated and fallen out of bed, dyspnoic, resp. partial insufficiency. with oxygen requirement -$g hospital admission -$g oxygen demand 8l/min, antibiotics for urinary tract infection, pronounced pneumonia in the CT chest, both, anamnestic vaccination COVID 19 on 14Jan2021. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1014898 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, General physical health deterioration, Incorrect route of product administration
SMQs:, Anaphylactic reaction (broad), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (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: Adrenal insufficiency; Atrial fibrillation; Dementia; Diabetes; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021103902

Write-up: Reduced general condition; Dyspnea; Inappropriate route of administration/intravenously; This is a spontaneous report from a non-contactable other health care professional (Other HCP). This is a report received from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory authority or other manufacturer number DE-PEI-CADRPEI-2021013125. An elderly male patient received bnt162b2 (COMIRNATY) (batch/lot: EJ6797) intravenously (Inappropriate route of administration) on 15Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing adrenal insufficiency, ongoing dementia, ongoing diabetes, ongoing atrial fibrillation, ongoing hypertension. Concomitant medications were not reported. 7 days after vaccination, the patient developed dyspnea and reduced general condition on 21Jan2021, lasting for unknown. Events dyspnea and reduced general condition were considered serious as fatal. The patient is dead on an unspecified date. It was not reported if an autopsy was performed. Sender Comment: Atrial fibrillation, renal insufficiency, Hypertension, dementia, diabetes. AZ reduced on 21Jan2021, got hard to breathe.; Reported Cause(s) of Death: Reduced general condition; dyspnea


VAERS ID: 1014899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Multiple organ dysfunction syndrome, Pyrexia
SMQs:, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: Chronic obstructive pulmonary disease; General physical condition decreased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021103903

Write-up: Death due to non-receding fever after vaccination, multi-organ failure; Death due to non-receding fever after vaccination, multi-organ failure; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority, number DE-PEI-CADRPEI-2021013126. A 71-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing General physical condition decreased, ongoing chronic obstructive pulmonary disease. The patient''s concomitant medications were not reported. The patient experienced Death due to non-receding fever after vaccination, multi-organ failure since 14Jan2021. Detail clinical course was reported as on the same day after vaccination the patient developed Fever and Multiorgan failure, lasting for unknown, fever did not go down; antibiotics or Novalgin etc. did not help. The patient died on Jan2021. An autopsy was performed that revealed multiorgan failure. Death cause was reported as Multiorgan failure. The event outcome was fatal. Sender Comment: COPD, poor general condition, fever did not go down; antibiotics or Novalgin etc. did not help. Comirnaty/Fever/PEI/A. Consistent causal association to Comirnaty/Multiorgan failure/PEI/D. Unclassifiable No follow-up attempts are possible. Batch/Lot# and expiry date not provided and not possible to obtain.; Reported Cause(s) of Death: Multiorgan failure; Fever; Autopsy-determined Cause(s) of Death: Multiorgan failure


VAERS ID: 1014900 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021114082

Write-up: Died 3 days after vaccination; This is a spontaneous report from a non-contactable consumer downloaded from the Medicines Agency (MA) Regulatory Authority-WEB (DE-PEI-CADRPEI-2021013143). A 90-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, on 07Jan2021 at a single dose for COVID-19 immunisation. Medical history included ongoing dementia and ongoing hypertension. The patient''s concomitant medications were not reported. The patient died 3 days after vaccination on 10Jan2021. The cause of death was unknown and not reported. An autopsy was not performed. The causality assessment of the event was reported as unclassifiable by Paul-Ehrlich-Institut (PEI). No follow-up attempts are possible; information on batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1014901 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Dementia (condition after apoplexy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021110103

Write-up: death; General physical health deterioration; General physical health deterioration and progressive breakdown until death within a few days; This is a spontaneous report from consumer or other non hcp downloaded from the Medicines Agency (MA) Regulatory Authority-WEB DE-PEI-CADRPEI-2021013996 and received via Regulatory Authority. A 97-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY) intramuscular at single dose at arm on 15Jan2021 for covid-19 immunisation Medical history included dementia, condition after apoplexy. The patient''s concomitant medications were not reported. On 16Jan2021 (also reported as 2 days after vaccination) the patient developed Influenza like illness and general physical health deterioration and progressive breakdown until death within a few days lasting for 5 days (considered fatal). The patient died on 20Jan2021. It was not reported if an autopsy was performed. Cause of death was unknown. Reporter''s comments: It is unclear whether the general physical health deterioration is related to the vaccination; there has been no similar short-term deterioration in the general physical health deterioration in the past 2 years Batch/Lot# and expiry date not provided and not possible to obtain. No follow-up attempts possible. No further information expected.; Reporter''s Comments: It is unclear whether the general physical health deterioration is related to the vaccination; there has been no similar short-term deterioration in the general physical health deterioration in the past 2 years; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1014902 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-06
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 22
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: Apoplexy; COVID-19; Crohn''s disease; Hypertension; Ileocecal resection; Renal artery aneurysm; Vascular encephalopathy; Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: post-stroke condition
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021110102

Write-up: Exitus letalis; On 06Jan2021 first vaccination against Covid-19 with feverish reaction.; This is a spontaneous report from a consumer or other non hcp downloaded from the regulatory authority-WEB DE-PEI-CADRPEI-2021014030. A 78-year-old male patient received bnt162b2 (COMIRNATY) intramuscular at single dose 1st dose on 06Jan2021, and 2nd on 27Jan2021 for covid-19 immunisation. Medical history included apoplexy, vascular encephalopathy, post-stroke condition, renal artery aneurysm, Crohn''s disease with ileo resection, hypertension, Covid 19 disease in Apr2020. The patient''s concomitant medications were not reported. The patient experienced feverish reaction on 06Jan2021 after the 1st dose, fever of 39 on 27Jan2021 after the 2nd dose, exitus letalis (death) on 28Jan2021. On 28Jan2021, the patient was still asleep, 15 minutes later the nurse found him dead in bed. The nurse did the inquest and called the police on suspicion of unnatural death. It was not reported if an autopsy was performed. Sender''s comments: Hypertension, post-stroke condition, vascular encephalopathy, renal artery aneurysm, post-ileum resection due to Crohn''s disease. - All old diagnoses. Causality for fever / regulatory authority /Consistent causal association to Causality for death/ regulatory authority / Unclassifiable No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: in April 2020 Covid 19 disease. On 06Jan2021 first vaccination against Covid-19 with feverish reaction. On 27Jan2021 second vaccination with a fever of 39, death on 28Jan2021.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1014905 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-25
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH M0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decompensation cardiac
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021097562

Write-up: Pneumonia; Lung oedema; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB [DE-PEI-PEI2021001761]. A 95 years old female patient received first dose of bnt162b2 (COMIRNATY, Lot Number M0477 and Expiration Date unknown) via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history included decompensation cardiac from Nov2020 and unknown if it was ongoing. The concomitant medications was not reported. After 5 days of vaccination (25Jan2021), the patient developed lung oedema and pneumonia, lasting for unknown and patient dead in 2021. Unknown if autopsy was done. Outcome of events was fatal. Reporters comment: A precise connection between death and vaccination cannot be established. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: lung oedema; pneumonia


VAERS ID: 1014906 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Death, Malaise, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 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: Apoplexy; Cardiac insufficiency; Dementia; Renal insufficiency; Vascular encephalopathy
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Body temperature; Result Unstructured Data: Test Result:increased after first shot Centigrade; Test Date: 20210127; Test Name: Body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Comments: increased
CDC Split Type: DEPFIZER INC2021103849

Write-up: Found lifeless; tremble; Elevated temperature 38.7C; malaise; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) DE-PEI-PEI2021001818 and received via Regulatory Authority (PEI). This is the first of two reports. An unknown 77-year-old patient, born on PRIVACY, was vaccinated with the second dose of BNT162B2 (COMIRNATY, lot/batch no.: EM0477) for COVID-19 immunisation, Intramuscular on 27Jan2021. Concomitant medication included: concomitant medication was not reported. Patient past drug therapy: Comirnaty (start date: 06Jan2021, reaction: Body temperature increased). Medical history included: Dementia, Vascular encephalopathy, Apoplexy, Renal insufficiency, Cardiac insufficiency. 1 day(s) after vaccination the patient developed Unknown cause of death. On 27Jan2021, patient developed Body temperature increased 38.7C and Malaise and Trembling, lasting for unknown. The patient is dead. Death cause was reported as Unknown cause of death. Follow-up information has been requested. Patient''s notes: Anamnestic: fever episodes during interventions, patient multimorbid. Assesment for all the events were reported by PEI Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1014907 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-01-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021103800

Write-up: Death; This is a spontaneous report from a non-contactable physician via Regulatory Authority-WEB DE-PEI-PEI2021001836. An 89 years old female patient received the first dose of bnt162b2 (COMIRNATY, lot/batch no: EK9788), intramuscular on 24Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on 27Jan2021. It was not reported if an autopsy was performed. Death cause was reported as Unknown cause of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1014908 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Haemoglobin, Ileus paralytic, Microcytic anaemia, Pneumonia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (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), Gastrointestinal obstruction (narrow), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: Haemoglobin; Result Unstructured Data: Test Result:6.9 g/dl
CDC Split Type: DEPFIZER INC2021103811

Write-up: Ileus paralytic; Pneumonia; Microcytic anemia; Acute renal failure; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB [DE-PEI-PEI2021001837]. A 97-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. Medical history included Hypertension arterial from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 06Jan2021 the patient developed Ileus paralytic and Microcytic anemia and Pneumonia and Death and Acute renal failure, lasting for unknown. The patient is dead and was hospitalized. The patient underwent lab tests and procedures which included haemoglobin: 6.9 g/dl. The patient died on 08Jan2021. Death cause was Ileus paralytic, Pneumonia, Microcytic anemia, Acute renal failure. It was unknown if an autopsy was performed. No follow-up attempts possible, batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Pneumonia; Microcytic anemia; Acute renal failure; Ileus paralytic


VAERS ID: 1014909 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-24
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Cardiac insufficiency; Chronic pain; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021103804

Write-up: Sudden death; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (EMA) EudraVigilance-WEB [DE-PEI-PEI2021001842]. A 87-year-old female patient received first dose of BNT162B2 (COMIRNATY) Lot number EM0477, on 12Jan2021 at single dose for COVID-19 immunisation. Medical history included: Parkinson''s disease, Aortic valve insufficiency, Cardiac insufficiency, Chronic pain, all unknown if ongoing. Concomitant medication was not reported. 12 day(s) after vaccination (24Jan2021) the patient developed Death sudden. The patient was dead. Death cause was reported as Sudden death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1014910 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021103820

Write-up: Death; This is a spontaneous report from a non-contactable physician via Regulatory Authority downloaded from the Agency Regulatory Authority-WEB Regulatory Authority number DE-PEI-PEI2021001843. An 88 years old female patient received the first dose of bnt162b2 (COMIRNATY, lot/batch no: EJ6796), intramuscular on 30Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died (sudden death) on an unspecified date. It was not reported if an autopsy was performed. Death cause was reported as Unknown cause of death. Reporter Comment: During the follow-up period, no abnormalities were observed. I do not think that the death can be related to the vaccination. No follow-up attempts possible. No further information expected.; Reporter''s Comments: During the follow-up period, no abnormalities were observed. I do not think that the death can be related to the vaccination.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1014928 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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: ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021098081

Write-up: Aortic dissection; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authoity-WEB. The regulatory authority report number is ES-AEMPS-723023. A 64-year-old female patient receive BNT162B2 (COMIRNATY; Lot number EL1491), via an unspecified route of administration on 15Jan2021 as single dose for COVID-19 immunization. Medical history included hypercholesterolaemia from an unknown date. Concomitant medication included ongoing atorvastatin (MANUFACTURER UNKNOWN) for hypercholesterolaemia from 2012. There was no known hypertension, aneurysms, or any type of heart disease. The patient experienced aortic dissection on 15Jan2021, which was serious as it lead to death. The vaccine was administered in the morning of 15Jan2021, and the event occurred in the night of the same day, being intervened and ending in a fatal outcome the next day. 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.; Reported Cause(s) of Death: Aortic dissection


VAERS ID: 1014938 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, C-reactive protein increased, Chest X-ray, Dyspnoea, Loss of consciousness, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   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: LOSARTAN KRKA [LOSARTAN POTASSIUM]; FURESIS; SERETIDE EVOHALER; LIXIANA; MEMANTINE RATIOPHARM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abnormal chest sound; Asthma; Benign renal neoplasm; Cognitive deterioration; Heart failure; Hydronephrosis; Hypertension; Lung neoplasm; Memory impairment; Pneumonia (On 08Jan2021, prescribed Avelox due to cough, decreased general condition, and increased crp ad 68.); Pneumonia (Oct2020 was a hospitalization period due to a heart failure and pneumonia); Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210122; Test Name: Temperature; Result Unstructured Data: Test Result:37.7; Test Name: lung x-ray; Result Unstructured Data: Test Result:suspected malignant tumor; Test Name: CRP; Result Unstructured Data: Test Result:increased crp ad 68; Test Date: 20210122; Test Name: CRP; Result Unstructured Data: Test Result:just over 80
CDC Split Type: FIPFIZER INC2021104360

Write-up: Pyrexia; C-reactive protein increased; Loss of consciousness; Dyspnoea/shortness of breath; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FI-FIMEA-20210274. A 93-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly on 21Jan2021 10:00 am at single dose for covid-19 vaccination. Concomitant medication included losartan potassium (LOSARTAN KRKA) for Hypertension, furosemide (FURESIS), fluticasone propionate, salmeterol (SERETIDE EVOHALER) for Asthma, edoxaban tosilate (LIXIANA) for Cerebrovascular accident prophylaxis, memantine hydrochloride (MEMANTINE RATIOPHARM) for Memory impairment. The patient''s medical history included Hypertension, Memory impairment, vascular cognitive decline diagnosed 2011, asthma, heart failure, hydronephrosis 2014 with suspected benign renal tumor in the background, RTG in autumn 2019 with suspected lung tumor. The patient refused the difficult investigations and treatments related to possible lung tumor, symptomatic treatment line. Transferred to a nursing home Jul2020. The condition was slowly declining. Oct2020 was a hospitalization period due to a heart failure and pneumonia. On lung x-ray suspected malignant tumor. During the hospitalization, a treatment plan was adviced in which hospital transfers would be avoided in the future, focus on effective symptomatic treatment, and, if necessary, consultation with the home-hospital from the nursing home. From the hospitalization period the patient remained permanently with harsh breath, a wheelchair patient. On 08Jan2021, the patient was prescribed Avelox antibiotic therapy orally due to cough, decreased general condition, and increased crp ad 68. Pneumonia was suspected. The issue was resolved. CRP monitoring was not considered indispensable since the patient had lung disease, it was speculated that crp may fluctuate due to lung disease. Last steps for the patient: On 21Jan2021, at about 10 a.m., the patient received bnt162b2 to prevent coronavirus infection. The same evening complained to shortness of breath (Dyspnoea) which relieved spontaneously. The next morning, 22Jan, shortness of breath was severe, thus the patient was administered Atrovent comp and oxynorm medications according to the treatment plan. Initially there was a response to these products, but after lunch, patient''s shortness of breath was strongly provoked. Temperature was measured it was 37.7 (Pyrexia), crp was measured and was just over 80 (C-reactive protein increased). The patient quickly went into an unconscious state (Loss of consciousness). Symptomatic treatment line according to a proactive treatment plan. The patient died in the presence of staff at 4.45 pm on 22Jan2021. Lung cancer has been identified as the primary cause of death, as it was the reason for the palliative treatment line and the proactive treatment plan. With regard to the underlying diseases, there may have been a prognosis for perhaps a few months; temporary association with bnt162b2 raised suspicions of adverse drug reaction, which was predisposed by lung cancer, asthma and heart failure. When writing a death certificate, a forensic doctor was consulted over the phone. No forensic autopsy considered necessary. The relative also did not want further clarifications. In the death certificate a vaccine adverse event was reported as a contributing factor to death. The outcome of the events was fatal. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Lung cancer; Dyspnoea/shortness of breath; Pyrexia; C-reactive protein increased; Loss of consciousness


VAERS ID: 1014939 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, General physical health deterioration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Heartburn; Pain; Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: fever; Result Unstructured Data: Test Result:fever
CDC Split Type: FIPFIZER INC2021104363

Write-up: slowly declining condition deteriorated further; fever; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB FI-FIMEA-20210275. An 88-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, lot/batch number and expiration date unknown), intramuscularly on 20Jan2021 at single dose (1 dose form) for COVID-19 vaccination. The patient''s medical history included Parkinson''s disease, atrial fibrillation, pain, heartburn. The patient had concomitant treatments and necessary medications for parkinson''s disease, atrial fibrillation, pain, heartburn. The patient received the vaccine on 20Jan2021, started with fever the next day on 21Jan2021, and the already slowly declining condition deteriorated further, there was no longer contact with the patient, a convalescent care decision was made. The patient died at the end of the a short convalescence treatment in the evening on 25Jan2021. It was unknown if an autopsy was performed. The general condition had been constantly fading before, it was speculated that the rise in fever seemed to that broke the camel''s back and burdened to such an extent that the well-being deteriorated further. The outcome of the events was fatal. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: fever; slowly declining condition deteriorated further


VAERS ID: 1014940 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Dementia Alzheimer's type, Dyspnoea, General physical health deterioration, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXIN; OXYNORM
Current Illness: Dementia (treated in a care home)
Preexisting Conditions: Medical History/Concurrent Conditions: Pain (from 10Jan swallowing difficulties); Reduced general condition; Shortness of breath (from 10Jan swallowing difficulties); Swallowing difficult (more than a year); Tooth infection
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: CRP; Result Unstructured Data: Test Result:52
CDC Split Type: FIPFIZER INC2021104518

Write-up: Alzheimer''s disease; General physical health deterioration; Pyrexia; Breathing difficult; Pneumonia; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB FI-FIMEA-20210280. A 92-year-old male patient received bnt162b2 (COMIRNATY, Lot/batch number and Expiration date were not provided), intramuscular on 12Jan2021 at single dose for covid-19 immunization. Medical history included ongoing end-stage dementia (treated in a care home), difficulty swallowing for more than a year, shortness of breath/pain from 10Jan2021 (from 10Jan swallowing difficulties), dental inflammation, General health condition declined. Concomitant medication included amoxicillin trihydrate (AMOXIN) for tooth infection, oxycodone hydrochloride (OXYNORM) from 10Jan2021 for Dyspnoea and pain. The patient experienced general physical health deterioration and pyrexia on 15Jan2021, breathing difficult and pneumonia on 14Jan2021, Alzheimer''s disease on unspecified date. The patient died from the events. A man with end-stage dementia living in a nursing home, treated in a care home according to a preventive treatment plan without intravenous medication, for symptomatic treatment in case of an emergency Oxynorm prescription written Jan2019. General health condition declined, was occasionally raised to sit by a crane. Difficulty swallowing for more than a year, from 10Jan swallowing difficulties, suspected shortness of breath/pain, therefore Oxynorm given as an emergency medicine 3mg 0-3 times a day. Physician went to evaluate the patient 12Jan2021 in the morning of the COVID vaccination day, then physician suspected dental inflammation as an aggravating factor in eating difficulties and started an antibiotic for that, no pneumonia. Physician had not made a convalescent treatment decision, as the patient at that time was able to eat and the convalescent treatment decision would have been inconsistent with the initiation of the antibiotic. And because the patient did not have a convalescent treatment decision, a COVID vaccine was given. CRP 52 on Jan2021. On 14Jan2021 the sounds of breathing were quiet and now even on a visit to the doctor the breathing was heavy, so physician suspected that the patient had pneumonia, however, the patient still ate. On 15Jan2021 the patient''s general condition collapsed, the fever rose and a convalescent treatment decision was made, the patient died the same evening. The patient died after receiving the COVID vaccine. Physician had no doubt about the patient dying due to COVID vaccine, physician had written Alzheimer''s disease on the death certificate. Under current guidelines, physician would not have given the COVID vaccine, but on 12Jan2021 the guideline was to not administer the COVID vaccine only in the absence of a convalescent treatment decision or if the patient refuses. The outcome of the events was fatal. The patient died on 15Jan2021. 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: Alzheimer''s disease; General physical health deterioration; Breathing difficult; Pneumonia; Pyrexia


VAERS ID: 1014941 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Increased upper airway secretion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: ELIQUIS; FLIXOTIDE; CALCICHEW D3 EXTRA APPELSIINI; HEINIX; FURESIS; BISOPROLOL
Current Illness: Dementia; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthma; Atrial fibrillation; Cardiac insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021114235

Write-up: Increased upper airway secretion; Pyrexia; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB (FI-FIMEA-20210308). A 91-year-old female patient received BNT162B2 (COMIRNATY; Lot number: EL1491), intramuscularly, on 19Jan2021 at a single dose for COVID-19 vaccination. Medical history included atrial fibrillation, asthma, allergy, cardiac insufficiency, ongoing nursing home patient, and ongoing severe dementia. Concomitant medications included apixaban (ELIQUIS) taken for atrial fibrillation from 22Jun2020, fluticasone propionate (FLIXOTIDE) taken for asthma from 07Apr2020, calcium carbonate, colecalciferol (CALCICHEW D3 EXTRA APPELSIINI) from 07Jun2017, cetirizine hydrochloride (HEINIX) taken for allergy from 14Mar2018, furosemide (FURESIS) taken for cardiac insufficiency from 21Sep2010, and bisoprolol (MANUFACTURER UNKNOWN) from 03Oct2011. The patient experienced increased upper airway secretion and pyrexia on 20Jan2021, which was reported as fatal. It was reported that the patient felt feverish and had mucous the next day after vaccination. The patient died on 20Jan2021. The cause of death was assessed as increased upper airway secretion and pyrexia. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Increased upper airway secretion; pyrexia


VAERS ID: 1014942 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / 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: 2021-01-23
   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: Alzheimer''s disease; Aortic valve disease mixed; Arterial hypertension; Cancer of prostate; COVID-19 (in March 2020); Diabetes; Disease coronary artery
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021103893

Write-up: SUDDEN DEATH; This is a spontaneous report from a contactable Physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB FR-AFSSAPS-AM20210092. This is a report received from the Regulatory Authority. A 78-years-old male patient with multiple pathologies received first dose of bnt162b2 (COMIRNATY) (lot EM0477), intramuscular on 22Jan2021 at single dose in the left deltoid for covid-19 immunisation. Medical history included aortic valve disease mixed, Alzheimer''s disease, Disease coronary artery, covid-19 in Mar2020, Diabetes, Arterial hypertension, Cancer of prostate, all unknown if ongoing. The patient''s concomitant medications were not reported. On 23Jan2021, at 6 a.m., the patient was found dead in his bed. The patient experienced SUDDEN DEATH on 23Jan2021 06:00. It was not reported if an autopsy was performed. No significant event (no variation in blood pressure, fever, etc.) between the day of vaccination and the day of death. The patient was walking around and was independent before the vaccination. No worsening of his state of health reported before vaccination. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SUDDEN DEATH


VAERS ID: 1014943 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESOMEPRAZOLE; HALDOL; ESCITALOPRAM; DOLIPRANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210111; Test Name: Covid-19 test: PCR; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC2021109778

Write-up: Reduced general condition; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-AN20210151 and received via Regulatory Authority (AFSSAPS). A 85-year-old female patient received bnt162b2 (COMIRNATY, lot number EM0477) via intramuscular in arm left on 15Jan2021 at single dose for COVID-19 vaccination. Medical history included Alzheimer''s disease unknown if ongoing. Concomitant medication included esomeprazole, haloperidol (HALDOL), escitalopram and paracetamol (DOLIPRANE). Clinical course: patient with advanced dementia, deterioration of general condition, false routes and swallowing disorders presenting clinical deterioration since late December - early January with thymic decline at the end of December signs of bronchial congestion motivating the introduction of the aerosol vaccination on the 15Jan2021, no signs of infection that day thereafter further deterioration of the general condition without marked worsening immediately after vaccination on the 21Jan2021 marked clinical deterioration, discontinuation of oral feeding. patient found deceased on 23Jan2021.Covid-19 test: PCR: carried out on 11Jan2021, result not specified on the declaration. CONCLUSION death 8 days after vaccination by comirnaty in an elderly patient with dementia, death seeming more related to the course of the disease of the patient whose condition had been declining for several weeks. usual treatment esomeprazole, haldol, escitalopram, doliprane, laxatives. The patient experienced reduced general condition in Jan2021 and death unexplained on 23Jan2021. The patient died of reduced general condition on 23Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Reduced general condition


VAERS ID: 1014944 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood culture, Blood pressure measurement, Body temperature, C-reactive protein, Cardiac monitoring, Culture stool, Electrocardiogram, Heart rate, Investigation, Laboratory test, Microbiology test, Oxygen saturation, Pneumonia, SARS-CoV-2 test, Scan, Troponin, Urine analysis, Weight
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Artificial cardiac pacemaker wearer; Cognitive disorders; Coronary arterial stent insertion; Deafness unilateral; Decreased appetite; Dementia Alzheimer''s type; General physical health deterioration (for a few months); Gonarthrosis; Inguinal hernia repair (2004); Major neurocognitive disorder; Malnutrition; Mixed dementia; Myocardial infarction; Osteoporosis with fracture (L1 settlement in 2015); Osteoporosis with fracture; Peripheral arterial occlusive disease; Stent placement; Tibial artery occlusion; Weight loss
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: Auscultation; Result Unstructured Data: Test Result:congestion but no clear appearance of OAP.; Comments: Always oligo-anuric; Test Date: 20210119; Test Name: cardiopulmonary auscultation; Result Unstructured Data: Test Result:Normal cardiopulmonary auscultation,no focus found; Test Date: 20210120; Test Name: pulmonary auscultation; Result Unstructured Data: Test Result:indrawing, crackles of the 2 bases; Test Date: 20210119; Test Name: Blood cultures; Result Unstructured Data: Test Result:unknown results; Test Date: 20210120; Test Name: BP; Result Unstructured Data: Test Result:64/40 mm Hg; Test Date: 20210120; Test Name: BP; Result Unstructured Data: Test Result:69/40; Test Date: 20210120; Test Name: BP; Result Unstructured Data: Test Result:70/40 mm Hg; Comments: 7h; Test Date: 20210119; Test Name: fever; Result Unstructured Data: Test Result:39.1 Centigrade; Test Date: 20210119; Test Name: fever; Result Unstructured Data: Test Result:38.1 Centigrade; Test Date: 20210120; Test Name: fever; Result Unstructured Data: Test Result:39.2 Centigrade; Test Date: 20210120; Test Name: fever; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20210120; Test Name: cardiac auscultation; Result Unstructured Data: Test Result:BDC irregular; Test Date: 20210119; Test Name: CRP; Result Unstructured Data: Test Result:95; Test Date: 20210119; Test Name: fecaloma; Result Unstructured Data: Test Result:fecaloma +++; Test Date: 20210119; Test Name: ECG; Result Unstructured Data: Test Result:possible AC / FA 117 / min with disturbance; Comments: possible AC / FA 117 / min with disturbance of repolarization; Test Date: 20210120; Test Name: HR; Result Unstructured Data: Test Result:96 bpm; Test Date: 20210119; Test Name: pulse; Result Unstructured Data: Test Result:180 then 110 / min; Test Date: 20210120; Test Name: desaturation; Test Result: 65 %; Comments: in AA; Test Date: 20210119; Test Name: ECBU; Result Unstructured Data: Test Result:unknown results; Test Date: 20210120; Test Name: FR; Result Unstructured Data: Test Result:24; Test Date: 20210119; Test Name: MT; Result Unstructured Data: Test Result:MT 06/13; Test Date: 20210120; Test Name: FC; Result Unstructured Data: Test Result:128 bpm; Test Date: 20210119; Test Name: Biology; Result Unstructured Data: Test Result:CRP 95; Test Date: 20210119; Test Name: saturation; Test Result: 92 %; Comments: in AA; Test Date: 20210120; Test Name: saturation; Test Result: 96 %; Comments: under mask at high concentration 6 l / min; Test Date: 20210120; Test Name: saturation; Test Result: 93 %; Test Date: 20210119; Test Name: COVID + 19 sample; Test Result: Negative ; Test Date: 20210119; Test Name: scanner; Result Unstructured Data: Test Result:right base pneumonia, urinary globe ++, fecaloma +; Test Date: 20210119; Test Name: troponins; Test Result: Negative ; Test Date: 20210119; Test Name: urinary; Result Unstructured Data: Test Result:globe ++; Test Name: weight; Result Unstructured Data: Test Result:loss of 11 kg
CDC Split Type: FRPFIZER INC2021095013

Write-up: Pneumonia; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (EMA) FR-AFSSAPS-BR20210077 and received via Regulatory Authority (AFSSAPS). An 89-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, batch/lot number: EJ6795), intramuscular in the left arm on 18Jan2021 at single dose for COVID-19 vaccination. Medical history included osteoporosis with fracture from 1962, anxiodepressive syndrome from Jun2017, major neurocognitive disorder, coronary arterial stent insertion, myocardial infarction with stenting, artificial cardiac pacemaker wearer from May2017, secondary right deafness from 1962, inguinal hernias operated from 2003 (and 2004), fracture osteoporosis from 2015 (L1 settlement in 2015), gonarthrosis, obliterating arterial disease of the lower limbs, occlusion of the middle third of the left anterior tibial artery, neuro-cognitive disorders, probable Alzheimer''s dementia, mixed dementia, undernutrition, context of deterioration of the general condition for a few months, weight with loss of 11 kg in less than a year (small appetite). Patient at risk of developing a severe form of COVID-19 because of his age. Has not had COVID-19, has not been tested. The patient''s concomitant medications were not reported. The patient previously took mirtazapine (NORSET) from Jun2017 for anxio-depressive syndrome. The patient experienced pneumonia (death, life threatening) on 19Jan2021. Reported as follows: No adverse effects during monitoring for 15 minutes.19Jan2021 at 8 AM: fever at 38.1 C then 39.1 C, chills. Diffuse very sensitive abdomen. Normal cardiopulmonary auscultation, no focus found. 12:30 p.m .: contact with the emergency doctor who advises an emergency scan. Biology: CRP 95. Implementation of antibiotic therapy with ROCEPHINE 1 g / day in SC. 1 p.m .: negative troponins. 5:40 p.m .: MT 06/13, 92% saturation in AA, pulse 180 then 110 / min. ECG: possible AC / FA 117 / min with disturbance of repolarization. Opinion of the radiology intern on the scanner: right base pneumonia, urinary globe ++, fecaloma +++. To behave : COVID + 19 sample (negative sample). Blood cultures (unknown results), ECBU (unknown results). Normacol, continuation of antibiotic therapy with ROCEPHINE, LOVENOX 0.4 morning and evening. 20Jan2021 at 12:45 a.m .: call from the resident on call for 65% desaturation in AA, BP 64/40 mm Hg FC 128 bpm, fever at 39.2 C. Patient reactive. On arrival of the intern: hypovigilant patient, who cannot be woken up even to pain, G5 Y1V1M3, saturation 96% under mask at high concentration 6 l / min, BP 69/40, HR 96 bpm, cold knees not marbled, FR 24, indrawing, crackles of the 2 bases on pulmonary auscultation, BDC irregular on cardiac auscultation. The patient does not appear to be in pain. Addition of FLAGYL 500 mg 3 times / day + new 500 ml NaCl (free flow). If no improvement in the constants and if the patient seems uncomfortable, possibility of introducing morphine + HYPNOVEL. Family informed of the situation. 7h: patient still hypovigilant, BP 70/40 mm Hg, saturation 93% under high concentration mask, temperature at 36.8 C. New bag of NaCl 500 ml. 11:30 am: desaturation, congestion, disturbances in vigilance. Auscultation: congestion but no clear appearance of OAP. Always oligo-anuric. No hospitalization. Comfort care. 20Jan2021 at 4 p.m .: death. Overall: right basal pneumonia complicated by septic shock. Suspicion of salivary inhalation: frequent false routes to liquids. Therapeutic measures were taken as a result of pneumonia. AE result in Emergency Room Visit. The patient died on 20Jan2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1014946 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-23
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, SARS-CoV-2 test
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Embolism pulmonary; Hypertension arterial; Ischaemic heart disease; Stroke; Unspecified hypertensive heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20201022; Test Name: Covid-19 test; Result Unstructured Data: Test Result:did not have Covid-19
CDC Split Type: FRPFIZER INC2021103853

Write-up: Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, FR-AFSSAPS-BX20210244. An 83-year-old female patient received 1st injection of bnt162b2 (COMIRNATY, Lot#: EJ6134), intramuscular at right arm on 15Jan2021 at single dose for covid-19 immunization. Medical history included arterial hypertension, unspecified hypertensive heart disease, ischemic heart disease, stroke, pulmonary embolism, dementia Alzheimer''s type. Patient who did not have Covid-19: test carried out on 22Oct2020. Person considered to be at risk of developing a severe form of Covid-19. Risk factors: deterioration of the general condition, heart disease. The patient''s concomitant medications were not reported. The patient experienced infarct myocardial on 23Jan2021 with fatal outcome. Description of the event: On Day 8 of the vaccination, 23Jan2021: Chest pain accompanied by a brief convulsion, then cardiac arrest. External cardiac massage, emergency services call, resuscitation measures put in place, unspecified anticoagulant taken, and death noted 1 hour later. It was not reported if an autopsy was done.; Reported Cause(s) of Death: Infarct myocardial


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