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From the 9/10/2021 release of VAERS data:

Found 14,925 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

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VAERS ID: 994635 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, General physical health deterioration, 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: 2021-01-20
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:positive
CDC Split Type: DEPFIZER INC2021073647

Write-up: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; General physical health deterioration; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. A 80-years-old female patient received the first dose of bnt162b2 (COMIRNATY) vaccine , via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced positive covid-19 test with symptoms on 07Jan2021. Symptoms included: Upper respiratory tract infection General physical health deterioration and Fever, lasting for 15 days. The patient died on 20Jan2021. It was not reported if an autopsy was performed. Death cause was reported as General physical health deterioration. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: COVID 19; General physical health deterioration


VAERS ID: 994636 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021070086

Write-up: died several hours after vaccination; This is a spontaneous report from a contactable physician. An elderly female patient received the second dose of bnt162b2 (COMIRNATY, lot/batch number was not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient in one of the nursing homes died several hours after second vaccination on an unspecified date. Patient received the first dose on an unknown date. It was unknown if an autopsy was performed. Information regarding the lot/batch number has been requested.; Sender''s Comments: Based on the limited information available company does not reasonably attribute the reported event as related to vaccine. The event was likely due to subject underlying contributory factors. Case will be reevaluated based on additional information during f/u; Reported Cause(s) of Death: died several hours after vaccination


VAERS ID: 994638 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Investigation, Oxygen saturation
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: HALDOL DECANOAS; SERESTA; KEPPRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aphagia; Bedridden; Blindness; COVID-19 (discovered during a systematic test, hospitalization due to numerous risk factors.); Deglutition disorder; Depression; Feminisation acquired (XY genetic defect with artificial feminization); Fibrosis lung; Germinoma; Hemiplegia; Memory disturbance; Meningioma; Polyarthritis; Psychosis; Retardation mental; Ventriculo-peritoneal shunt
Allergies:
Diagnostic Lab Data: Test Name: constants; Result Unstructured Data: Test Result:Normal; Comments: post-vaccination; Test Name: oxygen saturation; Result Unstructured Data: Test Result:Normal; Comments: post-vaccination
CDC Split Type: FRPFIZER INC2021073668

Write-up: Death unexplained; This is a spontaneous report from a contactable physician downloaded from the WEB FR-AFSSAPS-MA20210104. This is a report received from the Regulatory Authority. A 56-year-old female patient received the first dose of bnt162b2 (COMIRNATY), Lot EM0477, intramuscular on 18Jan2021 16:00 at single dose for covid-19 immunisation. Medical history included polyarthritis, feminisation acquired (XY genetic defect with artificial feminization), blindness, hemiplegia, covid-19 in Apr2020 (discovered during a systematic test, hospitalization due to numerous risk factors), psychosis, memory disturbance, deglutition disorder, aphagia, retardation mental, ventriculo-peritoneal shunt, depression, bedridden, fibrosis lung, meningioma, germinoma. No history of drug allergy. Concomitant medication included haloperidol decanoate (HALDOL DECANOAS), oxazepam (SERESTA), levetiracetam (KEPPRA). The patient benefited from a dispensation for her care in nursing home. She was dependent for all activities of daily life. During post-vaccination surveillance, constants and oxygen saturation were normal. The night watch did not report anything abnormal. On 19Jan2021 at 08:30 AM, death was noted. The body had no edema, no bleeding, no swelling, the skin was clear, no argument for asphyxia syndrome. The patient died on 19Jan2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 994661 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-21
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0274 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, C-reactive protein, Computerised tomogram head, Death, Dehydration, EGFR status assay, Malaise, Mobility decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Tendinopathies and ligament disorders (broad), Dehydration (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; BISOPROLOL; CITALOPRAM; LERCANIDIPINE; METHYLDOPA; OMEPRAZOLE; PROCHLORPERAZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease stage 4; Dizziness; Essential hypertension; Pulmonary stenosis
Allergies:
Diagnostic Lab Data: Test Name: CT head; Result Unstructured Data: Test Result:normal; Test Name: CRP; Result Unstructured Data: Test Result:151; Test Name: eGFR; Result Unstructured Data: Test Result:11
CDC Split Type: GBPFIZER INC2021077213

Write-up: Became unwell following covid vaccine; worsening mobility; back pain; Became dehydrated; Death; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority report number GB-MHRA-WEBCOVID-202101251121428990, Safety Report Unique Identifier GB-MHRA-ADR 24641843. An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EJ0274, via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. Medical history included pulmonary valve stenosis, chronic kidney disease stage 4 (CKD 4), essential hypertension, dizziness. Patient was elderly but self-caring/independent. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medication included atorvastatin from Mar2011 to unknown date for blood cholesterol, bisoprolol from Apr2019 to unknown date for hypertension, citalopram from Aug2020 to unknown date, influenza vaccine (INFLUENZA VIRUS) in Oct2020, lercanidipine from 2018 to unknown date for hypertension, methyldopa from 2018 to 18Jan2021 for hypertension, omeprazole, prochlorperazine from 12Jan2021 to unknown date for dizziness. On unspecified date after vaccination the patient became unwell, non-specific features including worsening mobility and back pain. The patient became dehydrated. The patient was admitted via ED on 21Jan2021. Laboratory data performed on unspecified date included CRP was 151 but no obvious source of infection, eGFR was 11, Head CT was normal. The patient died on acute medical ward on 21Jan2021. 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: 994665 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Hyperventilation, Pupil fixed, Restlessness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MICARDIS; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; NORSPAN [BUPRENORPHINE]; BETULAC; BURINEX; CIRCADIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (Severe); Hypertension (The patient has from time to time had severe hypertension, has been under control lately.); Insomnia; Living in nursing home (Shielded); Obstipation; Oedema; Pain; Reflux esophagitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021069944

Write-up: fainting; fixed and dilated pupils; very restless; hyperventilated; CEREBROVASCULAR ACCIDENT (SUSPECTED CEREBRAL BLEEDING); CEREBROVASCULAR ACCIDENT (SUSPECTED CEREBRAL BLEEDING); This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Uqgwp, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013994. A 84-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot#EJ6795), intramuscular on 06Jan2021 13:15 at single dose (left arm) for COVID-19 immunization. Medical history included Hypertension (The patient has from time to time had severe hypertension, blood pressure has been under control lately), Living in nursing home (Shielded), Dementia (Severe), Reflux esophagitis, pain, Obstipation, Oedema, Insomnia. Concomitant medication included telmisartan (MICARDIS) from 15Dec2018 for Hypertension, esomeprazole magnesium (NEXIUM) from 22Dec2020 for Reflux esophagitis, buprenorphine (NORSPAN) from 03Dec2018 for pain, lactulose (BETULAC) from 21Jul2020 for Obstipation, bumetanide (BURINEX) from 04Oct2016 for Oedema, melatonin (CIRCADIN) from 13Jun2017 for Insomnia. The patient experienced cerebrovascular accident (suspected cerebral bleeding) on 14Jan2021, which was reported as fatal. It was reported that patient had cerebrovascular accident (suspected cerebral bleeding) eight days after vaccination with covid-19 vaccine. The event started with sudden loss of conciousness. After fainting she was very restless and hyperventilated. Neurological outcome in the form of fixed and dilated pupils before the patient died. Everything happened within 20-30 minutes. Cerebrovascular accident (suspected cerebral bleeding) was reported as fatal, while outcome of other events was unknown. The patient died on 14Jan2021. It was not reported if an autopsy was performed. Sender Comment translated to English: This vaccine is marked with a black triangle because it is a new vaccine. This means that the vaccine is subject to special monitoring in order to detect new safety information as quickly as possible. Healthcare professionals are encouraged to report suspected adverse reactions. It is especially important that serious and / or unusual side effects are reported. Your message is important to increase knowledge about side effects that have not been discovered in the studies. The current event is not a known side effect of this vaccine. When vaccinating marginal, elderly patients who are ill with many underlying diseases, some serious events 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 incident is due to the vaccine, the patient''s underlying disease or other incidental, concurrent cause that has nothing to do with the vaccination in question. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: CEREBROVASCULAR ACCIDENT (SUSPECTED CEREBRAL BLEEDING); CEREBROVASCULAR ACCIDENT (SUSPECTED CEREBRAL BLEEDING)


VAERS ID: 994672 (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: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 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: 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: ATORVASTATIN; FUROSEMIDE; OMEPRAZOLE; NITROGLYCERIN; OXYNORM; DULOXETINE; PREGABALIN; INSULATARD [INSULIN HUMAN INJECTION, ISOPHANE]; TROMBYL; ALVEDON; NATRIUMKLORID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis; Cardiac failure; Chronic kidney disease stage 4; General physical condition decreased; Palliative care; Peripheral arteriosclerosis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021073781

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB (SE-MPA-2021-000845 and SE-MPA-1611153095194). An 85-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6795), intramuscularly, in Jan2021 at a single dose for COVID-19 immunisation. Medical history palliative care, decreased general health condition, chronic kidney disease stage 4, cardiac failure, type 2 diabetes mellitus, aortic valve stenosis, and peripheral arteriosclerosis. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), nitroglycerin (MANUFACTURER UNKNOWN), oxycodone hydrochloride (OXYNORM), duloxetine (MANUFACTURER UNKNOWN), pregabalin (MANUFACTURER UNKNOWN), insulin human injection, isophane (INSULATARD), acetylsalicylic acid (TROMBYL), paracetamol (ALVEDON), and natriumklorid (NATRIUMKLORID). The patient previously took bisoprolol (MANUFACTURER UNKNOWN) and experienced numbness of lower extremities and allopurinol (MANUFACTURER UNKNOWN) and experienced numbness of lower extremities. The patient experienced cardiac arrest in Jan2021, which was reported as fatal. The clinical course was reported as follows: The patient was very fragile and had received palliative care in the fall due to decreased general health condition. It was reported that the patient was vaccinated in the morning and during the night at 01:00, he went to the bathroom and collapsed. The patient was diagnosed with asystole. The patient died in Jan2021. The cause of death was reported as cardiac arrest. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 994673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-27
Onset:2021-01-08
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NOVOMIX; LEXAURIN; VESOMNI; XALACOM
Current Illness: Alcoholism; Benign prostatic hyperplasia; Hypertension arterial; Type II diabetes mellitus (on insulin with frequent hypoglycemia.)
Preexisting Conditions: Medical History/Concurrent Conditions: Hypoglycemia (frequent hypoglycemia); Purulent conjunctivitis
Allergies:
Diagnostic Lab Data: Test Name: autopsy; Result Unstructured Data: Test Result:Hyperthrophy and dilatation of the whole heart; Comments: Hyperthrophy and dilatation of the whole heart, moderate to severe stage (550g -heart weight). Severe atherosclerosis of descendant branch of left coronary artery (LAD), focally stenosant up to 80%. Aortic stenosis, moderate. Congestion oedema of the lungs, moderate. Chronic congestion in liver and splen. Arterioarteriolonephrosclerosis. Atherosclerosis of aorta and her brunches, mild to moderate. Enlarged prostate. Lipomatosis of pancreas. Condition after cerebovascular accident parietooccipitally on the right. Terminal oedema of the brain.; Test Date: 20201215; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:blank; Comments: The result was not marked in the provided document, but it was not stated in the report that the patient had a previosuly confirmed SARS-CoV-2 infection.
CDC Split Type: SIPFIZER INC2021074011

Write-up: sudden death; This is a spontaneous report from two contactable physicians via Regulatory Authority, downloaded from Regulatory Authority-WEB (SI-JAZMP-NCPHV-2021SI0048_0048). A 79-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot number EJ6796) intramuscular on 27Dec2020 at single dose for COVID-19 immunisation. Relevant medical history included ongoing alcoholism, ongoing hypertension arterial, ongoing type 2 diabetes mellitus on insulin with frequent hypoglycemia, hypoglycaemia, purulent conjunctivitis from 03Dec2020 and ongoing benign prostatic hyperplasia. Concomitant medications included insulin aspart/insulin aspart protamine (crystalline) (NOVOMIX) subcutaneous at 10x5 unit, 60UE+60UE+60UE fort type 2 diabetes mellitus, bromazepam (LEXAURIN) at 3 mg twice daily, solifenacin succinate/tamsulosin hydrochloride (VESOMNI) at 1 DF (6mg/0.4mg), 1x/day (1x1) for benign prostatic hyperplasia and latanoprost/timolol maleate (XALACOM) at 1 DF (0.05mg/5mg/ml), 1x/day (1x1 gtt/in the eye) for purulent conjunctivitis. The patient previously took tobramycin (TOBREX) at 1mg/3mg/ml for purulent conjunctivitis. On 08Jan2021, the patient was found without signs of life at the toilet at 20:15 PM, which was defined as sudden death as the patient was feeling good until then. The reporting physician (the one who identified death) stated that in the medical history of the patient no data on previous adverse drug reactions could be found. Autopsy was performed on 11Jan2021 - final report was still awaited, but preliminary report was nevertheless gained along with further information from the patient''s GP. The patient was independent with regard to taking medications (insulin) and all daily activities, although he moved with difficulties and used the wheelchair. The patient also took care of blood glucose tests and as stated insulin administration. On the day the patient died smell of alcohol was sensed in his room. During Dec2020 the patient had a few medical checks: on 03Dec2020 due to mucopurulent conjunctivitis (two prescriptions were issued: TOBREX 1mg/3mg/ml eye drops, XALACOM 0.05mg/5mg/ml eye drops), on 18Dec2020 (at that time VESOMNI 6mg/0.4mg tbl. prescription was issued for benign prostatic hyperplasia), on 21Dec2020 the patient received prescription for NOVOMIX 30 FlexPen 100 IU/ml with a sheme (10x5 units, 60UE+60UE+60UE), on 27Dec2020 the patient was vaccinated against COVID-19 and no adverse reaction was seen. On 31Dec2020 the patient was prescribed LEXAURIN 3 mg tbl. (it was evident from the documentation that this was a part of his regular therapy, indication was not specified). On 15Dec2020 COVID-19 PRC test was performed, the result was not marked in the provided document, but it was not stated in the report that the patient had a previously confirmed SARS-CoV-2 infection. Preliminary autopsy results: Cause of death a) Cardiorespiratory failure c) Diabetes mellitus. Hyperthrophy and dilatation of the whole heart, moderate to severe stage (550g -heart weight). Severe atherosclerosis of descendant branch of left coronary artery (LAD), focally stenosant up to 80%. Aortic stenosis, moderate. Congestion oedema of the lungs, moderate. Chronic congestion in liver and splen. Arterioarteriolonephrosclerosis. Atherosclerosis of aorta and her brunches, mild to moderate. Enlarged prostate. Lipomatosis of pancreas. Condition after cerebovascular accident parietooccipitally on the right. Terminal oedema of the brain. Sender Comment: Serious (fatal) and unexpected ADR, assessment of the case is still ongoing, confounders such as age and concurrent diseases are noted. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiorespiratory failure; Cardiorespiratory failure


VAERS ID: 994856 (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: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Agitation, Amnesia, Barre test, Blood bicarbonate, Blood creatinine, Blood lactic acid, Blood pH, Blood potassium, Blood pressure measurement, Body temperature, C-reactive protein, Cardiovascular disorder, Chest X-ray, Confusional state, Disorientation, Electrocardiogram, Electroencephalogram, Fibrin D dimer, Gastrointestinal examination, General physical health deterioration, Heart rate, Hypovolaemic shock, Intestinal ischaemia, Investigation, Liver function test, Liver function test abnormal, Malaise, Metabolic acidosis, Nervous system disorder, Neuropsychological test, Oxygen saturation, PCO2, PO2, Patient elopement, Physical examination, Presyncope, Renal disorder, Septic shock, Staring, Tachypnoea, Troponin, White blood cell count
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ischaemic colitis (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ARIPIPRAZOLE; D-CURE; PANTOPRAZOLE; FEROGRAD; ZOLPIDEM; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; KEPPRA; ASAFLOW; DUSPATALIN [MEBEVERINE HYDROCHLORIDE]; QUETIAPINE; PARACETAMOL; TRIBVIT; SIMVASTATINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Arterial hypertension; Cognitive disorders (Start Tavonin); Cognitive impairment; Epilepsy (diagnosis of epilepsia after EEG after sleep deprivation for which start Depakine); Gait disorder (Admission to geriatric due to pain left leg with gait disorder); Hemiparesis (left) (TIA with left hemiparesis); Hypercholesterolemia; Pain in leg (Admission to geriatric due to pain left leg with gait disorder); Sigmoid volvulus (sigmoid resection at recidive sigmoidvolvulus); Sigmoidectomy (sigmoid resection at recidive sigmoidvolvulus); Sleep deprivation (diagnosis of epilepsia after EEG after sleep deprivation for which start Depakine); Tendon rupture (Supraspinatus tendon rupture); TIA (TIA with left hemiparesis)
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: ECG; Result Unstructured Data: Test Result:sinus arrhythmia, AV conduction, , narrow QRS, kno; Comments: sinus arrhythmia, AV conduction, , narrow QRS, known ST depression in DII, DIII, aVF, V4-6; Test Date: 200606; Test Name: EEG; Result Unstructured Data: Test Result:diagnosis of epilepsy; Comments: diagnosis of epilepsy after EEG after sleep deprivation for which start Depakine; Test Date: 20210115; Test Name: D-dimer; Result Unstructured Data: Test Result:2.4; Test Date: 20210115; Test Name: Abdomen exam; Result Unstructured Data: Test Result:Flexible, compressible, pain free. Normal peristal; Comments: Flexible, compressible, pain free. Normal peristaltism. No HSM, no mass palpated; Test Date: 20210115; Test Name: Heart rate; Result Unstructured Data: Test Result:88 beats per minute; Test Date: 20210115; Test Name: Heart and lungs exam; Result Unstructured Data: Test Result:S1S2 RR, systolic murmur over aortic valve. Bilate; Comments: S1S2 RR, systolic murmur over aortic valve. Bilateral vesicular breathing, slight crepitation bibasal; Test Date: 20210115; Test Name: Limbs exam; Result Unstructured Data: Test Result:No edemas, flexible calves.; Test Date: 20210115; Test Name: liver tests; Result Unstructured Data: Test Result:Disturbed; Test Date: 201211; Test Name: neuropsychological test research; Result Unstructured Data: Test Result:Mild cognitive impairment (MCI); Test Date: 20210115; Test Name: sPO2; Test Result: 90 %; Test Date: 20210115; Test Name: pCO2; Result Unstructured Data: Test Result:14.2; Test Date: 20210115; Test Name: Physical examination; Result Unstructured Data: Test Result:Eupnea, normocolor, normohydration. Somewhat abse; Comments: Eupnea, normocolor, normohydration. Somewhat absent, no focused attention, disoriented. Performs commands well, force symmetrical no sign of lateralisation; Test Date: 20210115; Test Name: pO2; Result Unstructured Data: Test Result:94.7; Test Date: 20210115; Test Name: Troponin; Result Unstructured Data: Test Result:213; Test Date: 20210115; Test Name: Troponin; Result Unstructured Data: Test Result:249 (control); Test Date: 20210115; Test Name: WBC; Result Unstructured Data: Test Result:12.6; Test Date: 20210115; Test Name: Barre; Test Result: Negative ; Test Date: 20210115; Test Name: Bicarbonate; Result Unstructured Data: Test Result:12.3; Test Date: 20210115; Test Name: Bicarbonate; Result Unstructured Data: Test Result:10.5; Comments: arterial blood gas; Test Date: 20210115; Test Name: Creatinin; Result Unstructured Data: Test Result:1.4; Test Date: 20210115; Test Name: Lactate; Result Unstructured Data: Test Result:7; Test Date: 20210115; Test Name: pH; Result Unstructured Data: Test Result:7.48; Test Date: 20210115; Test Name: K; Result Unstructured Data: Test Result:4.5; Test Date: 20210115; Test Name: blood pressure; Result Unstructured Data: Test Result:110/45 mmHg; Test Date: 20210115; Test Name: Temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Test Date: 20210115; Test Name: RX thorax; Result Unstructured Data: Test Result:Enlarged cardiac shadow.; Comments: enlarged cardiac shadow/vascularly widened mediastinum with atheroma/global slightly reticularly enhanced lung signature in both lower midfields/Enlarged right lung hilus with right basal infiltrate: pneumonic infiltrate, possibly retro-obstructive/No pneumothorax/No pleural effusion; Test Date: 20210115; Test Name: CPR; Result Unstructured Data: Test Result:18
CDC Split Type: BEPFIZER INC2021069155

Write-up: Acute respiratory decrease with increase of tachypnea; Acute respiratory decrease with increase of tachypnea; Malaise; Renal disorder; Hypovolemic / Septic shock; Hypovolemic / Septic shock; General physical health deterioration; Metabolic acidosis; Anamnesis contributes very little he did not remember what happened today; Anamnesis contributes very little he did not remember what happened today; Liver function test abnormal; Intestinal ischaemia; Cardiovascular disorder; important agitation; Neurological disorder NOS; Presyncope; Wandering; At dinner, he would stare out for a whlie; disoriented in time and space; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory authority report number was BE-FAMHP-DHH-N2021-75615. An 87-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EM0477), via an unspecified route of administration on 15Jan2021 as a single dose for COVID-19 vaccination. Medical history included arterial hypertension from an unknown date and unknown if ongoing, hypercholesterolaemia from an unknown date and unknown if ongoing, transient ischaemic attack with left hemiparesis in 1985, supraspinatus tendon rupture from 1995 to an unknown date, diagnosis of epilepsy after EEG after sleep deprivation from Jun2006 to an unknown date, light cognitive disorder from Mar2008 to an unknown date, mild cognitive impairment (based on extensive neuropsychological test research) from Nov2012 to an unknown date, pain in left leg with gait disorder in Oct2013; Alzheimer''s disease in 2018 to an unknown date; and sigmoid resection at recidive sigmoid volvulus on 05Aug2018. Concomitant medications included aripiprazole (MANUFACTURER UNKNOWN), colecalciferol (D-CURE), pantoprazole (MANUFACTURER UNKNOWN), ascorbic acid/ferrous sulfate (FEROGRAD), zolpidem (MANUFACTURER UNKNOWN) , macrogol 3350/potassium chloride/sodium bicarbonate/sodium chloride (MOVICOL), levetiracetam (KEPPRA), acetylsalicylic acid (ASAFLOW), mebeverine hydrochloride (DUSPATALIN), quetiapine (MANUFACTURER UNKNOWN), paracetamol (MANUFACTURER UNKNOWN), cyanocobalamin/folic acid/pyridoxine hydrochloride (TRIBVIT), and simvastatine (MANUFACTURER UNKNOWN). The patient previously took valproic acid (DEPAKINE) for epilepsy from Jun2006 to an unknown date; ginkgo biloba extract (TAVONIN) for light cognitive disorders from Mar2008 to an unknown date; and ginkgo biloba extract (TAVONIN) for mild cognitive impairment from Nov2012 to an unknown date. At dinner, the patient would stare out for a while, was disoriented in time and space, and experienced acute respiratory decrease with increase of tachypnea, malaise, renal disorder, hypovolemic / septic shock, general physical health deterioration, metabolic acidosis, anamnesis contributed very little he did not remember what happened today, liver function test abnormal, intestinal ischaemia, cardiovascular disorder, important agitation, neurological disorder nos, presyncope, and wandering; all on 15Jan2021 with a fatal outcome. The clinical course was as follows: the patient was already weak before vaccination (for more than a week already deterioration of general condition with reduced intake, spontaneous loss of stool). On 15Jan2021, the patient was admitted to emergency department (around 17:00) a few hours after administration of vaccination, because of presyncope (and staring for a while) after vaccination. The patient had acute confusion, agitation in emergency room and wandering (did not remember what happened + disoriented in time and space). Physical examination included: eupnea, normocolor, normohydration/somewhat absent, no focused attention, disoriented; Heart and lungs exam: S1S2 RR, systolic murmur over aortic valve/Bilateral vesicular breathing, slight crepitation bibasal; Abdomen exam: flexible, compressible, pain free/normal peristaltism/no HSM, no mass palpated; limb exam: no edemas, flexible calves; performs commands well; force symmetrical no sign of lateralization; and Barre negative. On 15Jan2021, the patient underwent lab tests and procedures which included body temperature: 35.7 degrees Centigrade; blood pressure: 110/45 mmHg, heart rate: 88 beats per minute: SpO2: 90%; electrocardiogram: sinus arrhythmia/AV conduction/narrow QRS/known ST depression in DII, DIII, aVF, V4-6; arterial blood gas: pH: 7.48, pCO2: 14.2, pO2: 94.7, HCO3: 10.5; lactate: 7, white blood cell count: 12.6; C-reactive protein: 18; D-dimer: 2.4; potassium: 4.5; bicarbonate: 12.3; creatinine: 1.4; Troponin 213 (Control 249); liver tests: disturbed; and x-ray of thorax: enlarged cardiac shadow/vascularly widened mediastinum with atheroma/global slightly reticularly enhanced lung signature in both lower midfields/Enlarged right lung hilus with right basal infiltrate: pneumonic infiltrate, possibly retro-obstructive/No pneumothorax/No pleural effusion. The labs showed discrete inflammatory picture (CRP low (18), WBC 12) on admission to emergency department and disturbed liver tests; but no fever. He went into hypovolemic/septic shock with metabolic acidosis and intestinal ischaemia. There was suspicion of acute renal insufficiency (possible underlying chronic component) + suspicion of bilateral pneumonia for which amoxicillin/clavulanic acid (AUGMENTIN) was started + suspicion of subendocardial myocardial infarction (elevated troponins). The patient also received 0.9 % sodium chloride (MANUFACTURER UNKNOWN) 100 ml and 1000 ml intravenous (IV), midazolam (MANUFACTURER UNKNOWN) 5 mg, morphine (MORFINE) 10 mg subcutaneous (SC), atropine (MANUFACTURER UNKNOWN) 0.25 mg SC and haloperidol (MANUFACTURER UNKNOWN) 5 mg intramuscular as treatment for the events. At 20:45, the patient had acute respiratory deterioration with increase in tachypnoea. The patient died on 16Jan2021. The cause of death was not reported. An autopsy was not performed. The regulatory authority assessed the causality of the events to BNT162B2 as unclassifiable.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 994857 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; AV block second degree; Carcinoma prostatic; Dementia; Hypertension arterial; Renal cell carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021073632

Write-up: Death; This is a spontaneous report from a non-contactable physician via Regulatory Authority, downloaded from the Medicines Agency (EMA) EudraVigilance-WEB (DE-PEI-PEI2021001255). A 92-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot number EM0477) intramuscular on 11Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included prostate cancer, renal cell carcinoma, hypertension arterial, dementia, acute myocardial infarction and atrioventricular block second degree, all from unknown dates and unknown if ongoing. Concomitant medications were not reported. On 14Jan2021, the patient died. It was not reported if an autopsy was performed. Result of Assessment: C. Inconsistent causal association. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 994858 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, General physical health deterioration
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: 2021-01-19
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021073654

Write-up: Coronavirus infection; Coronavirus infection; General physical health deterioration; This is a spontaneous report from a non-contactable physician via Regulatory Authority, downloaded from the Regulatory Authority-WEB (DE-PEI-PEI2021001369). An 87-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 07Jan2021, the patient experienced coronavirus infection and general physical health deterioration and died due to coronavirus infection on 19Jan2021. Death cause was reported as coronavirus infection. It was not reported if an autopsy was performed. The information on the batch number has been requested.; Reported Cause(s) of Death: Coronavirus infection


VAERS ID: 994859 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   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: FLUOXETINE; DOLIPRANE; DEXERYL [GLYCEROL;PARAFFIN, LIQUID;WHITE SOFT PARAFFIN]; MOVICOL PLAIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Anorexia (episodes of food/drink refusal.); Anxiety depression; Bedridden; Chondrocalcinosis; Kidney failure chronic; Pulmonary embolism
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021073670

Write-up: Death Unknown cause; Stroke; This is a spontaneous report from a contactable physician from the Regulatory Authority-WEB FR-AFSSAPS-MA20210112. A 89-years-old female patient received bnt162b2 (COMIRNATY; Lot # EM0477) vaccine , intramuscular on 09Jan2021 at single dose for Covid-19 immunisation . Medical history included bedridden , dementia Alzheimer''s type, chronic kidney disease, depression, pulmonary embolism from 2010, chondrocalcinosis, decreased appetite (episodes of food/drink refusal). Concomitant medication included fluoxetine (FLUOXETINE), paracetamol (DOLIPRANE), glycerol, paraffin, liquid, white soft paraffin (DEXERYL), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL PLAIN). The patient experienced stroke on 16Jan2021. The patient was found dead on 17Jan2021 It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 994861 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-01
Onset:2020-12-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal adhesions, Biopsy, COVID-19, Chest X-ray, Drug ineffective, Pneumonia aspiration, Postoperative ileus, SARS-CoV-2 test, Small intestinal obstruction, Vomiting
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-31
   Days after onset: 30
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: TIMOPTOL; SYSTANE; VITAMIN B12 [VITAMIN B12 NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Duodenal ulcer; Glaucoma; Hemochromatosis; Spinal stenosis; Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: laparotomy samples; Result Unstructured Data: Test Result:unknown results; Test Date: 202012; Test Name: Chest X-ray; Result Unstructured Data: Test Result:features of COVID-19 infection; Test Date: 20201229; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021079256

Write-up: Pneumonia aspiration; uncertain if drug related reaction but presented to hospital with small bowel obstruction and also covid positive; uncertain if drug related reaction but presented to hospital with small bowel obstruction and also covid positive; uncertain if drug related reaction but presented to hospital with small bowel obstruction and also covid positive; Abdominal adhesions; Vomiting; Postoperative ileus; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Authority. The regulatory authority report number is GB-MHRA-EYC 00236716 and GB-MHRA-ADR 24549472. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly, in Dec2020 (reported as 2 to 3 weeks prior to event) at a single dose for COVID-19 vaccination. Medical history included glaucoma, spinal stenosis, vitamin V12 deficiency, duodenal ulcer, and haemochromatosis. Concomitant medications included timolol maleate (TIMOPTOL), macrogol 400, propylene glycol (SYSTANE), and vitamin B12 (MANUFACTURER UNKNOWN). The patient experienced pneumonia aspiration in Dec2020, which caused hospitalization and was reported as fatal. In Dec2020, it was uncertain if drug related reaction but presented to hospital with small bowel obstruction and also COVID positive and experienced abdominal adhesions, vomiting, and postoperative ileus; all of which caused hospitalization. The clinical course was reported as follows: It was uncertain if drug related reaction but presented to hospital with small bowel obstruction and also COVID positive. Retrospectively, it was ascertained that the patient had recently received coronavirus vaccination in the community hub. The patient presented to the hospital with features of small bowel obstruction, which did not settle with conservative management so taken to theatre. At laparotomy, adhesion was found requiring excision and anastomosis. The samples were sent to pathology with unknown results in Dec2020. The patient did not have an admission swab for COVID-19 as patient refused and then, post-operatively, the patient had a COVID-19 virus test, which was found to be positive on 29Dec2020. It was reported that the time frame suggested community acquired. The patient was reported to have likely developed ileus and vomited, and cause of death was reported as probably aspiration pneumonia. There were some features of COVID-19 infection on chest X-ray in Dec2020, but no large oxygen requirement immediately prior to death. In the hospital, the patient received ondansetron (MANUFACTURER UNKNOWN), paracetamol (MANUFACTURER UNKNOWN), remdesivir (MANUFACTURER UNKNOWN), dexamethasone (MANUFACTURER UNKNOWN), enoxaparin (MANUFACTURER UNKNOWN), benzylpenicillin (MANUFACTURER UNKNOWN), carbocysteine (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), and general anesthetic. No post mortem was performed, however the patient did undergo a laparotomy prior to death. Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of pneumonia aspiration was fatal and of uncertain if drug related reaction but presented to hospital with small bowel obstruction and also COVID positive, abdominal adhesions, vomiting, and postoperative ileus was unknown. The patient died on 31Dec2020. The cause of death was reported as pneumonia aspiration. An autopsy was not performed. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Pneumonia aspiration


VAERS ID: 994883 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0739 / UNK - / -

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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Bronchomalacia; Sleep apnea; Steroid therapy (Taking regular steroid treatment); Comments: patient had Asthma, sleep apnea and also tracheo- bronchomalacia Unsure if patient has 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 INC2021071622

Write-up: Death/died; 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-202101221340303000 with Safety Report Unique Identifier GB-MHRA-ADR 24632549. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0739 and expiration date not provided), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. Medical history included Steroid therapy (Taking regular steroid treatment), asthma, sleep apnea, and tracheo- bronchomalacia. It was unsure if patient has had symptoms associated with COVID-19 as she has not had a COVID-19 test. The patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient was vaccinated on 16Jan2020 and died on 19Jan2020. The patient has not tested positive for COVID-19 since having the vaccine. It was unknown if an autopsy was performed and cause of death was not reported. No follow-up is possible. No further information is expected.; Reported Cause(s) of Death: Death/died


VAERS ID: 994884 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:no - negative covid-19 test
CDC Split Type: GBPFIZER INC2021071272

Write-up: Death; This is a spontaneous report from a contactable physician received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202101221818571740; Safety report unique identifier: GB-MHRA-ADR 24634372. A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death (death, medically significant) on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. The patient died on an unspecified date due to unknown cause of death. It was unknown if an autopsy was performed. It was unknown if the patient has had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 994885 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4243 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Drug ineffective, Pain in extremity, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Tendinopathies and ligament disorders (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: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 2nd degree heart block; Cardiac disorder; Dilatation atrial; Left bundle branch block (Cardiac- LBBB, dilated left ventricle, dilated atrium, dyskinesia septum, 2nd degree heart block); Left ventricular dilatation; Left ventricular hypertrophy; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped); Comments: Cardiac- LBBB, dilated left ventricle, dilated atrium, dyskinesia septum, 2nd degree heart block Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021072091

Write-up: Yes- Positive COVID-19 test; Yes- Positive COVID-19 test; Death; sore arm; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. The Regulatory authority report number is GB-MHRA-WEBCOVID-202101222143440710, Safety Report Unique Identifier GB-MHRA-ADR 24635342. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:EK4243, expiry date unspecified), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunisation. Medical history included suspected covid-19 (unsure when symptoms started, unsure when symptoms stopped), cardiac LBBB (left bundle branch block), dilated left ventricle, dilated atrium, dyskinesia septum, 2nd degree heart block, and left ventricular hypertrophy. Patient was not enrolled in clinical trial. Concomitant medication included ramipril on unspecified date for left ventricular hypertrophy. In the evening of 19Jan2021, the patient volunteered and received the vaccine. Sore arm reported only afterwards on unspecified date in Jan2021. On 20Jan2021, the patient was found dead in bed (death). The patient underwent lab test which included COVID-19 virus test: Yes- positive COVID-19 test on unspecified date. Cause of death was unknown. It was unknown if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 994886 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Loss of consciousness, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Cardiac failure congestive (CCF); Comments: Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial.
Allergies:
Diagnostic Lab Data: Test Date: 20210106; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021077364

Write-up: Unconscious; positive COVID-19 virus test; SARS-CoV-2 infection; This is a spontaneous report received from a contactable healthcare professional from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202101241937221860 and GB-MHRA-ADR 24639419. A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 06Jan2021 at a single dose for COVID-19 vaccination. Medical history included dementia Alzheimer''s type and cardiac failure congestive (CCF). The patient did not have symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. The patient''s concomitant medications were not reported. The patient experienced SARS-CoV-2 infection on 06Jan2021, which was reported as fatal. The patient experienced positive COVID-19 virus test on 06Jan2021 and unconscious on 07Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive COVID-19 test on 06Jan2021. The clinical outcome of positive COVID-19 virus test and SARS-CoV-2 infection was fatal and of unconscious was not recovered. The patient died on 09Jan2021. The cause of death was reported as SARS-CoV-2 infection. 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: SARS-CoV-2 infection


VAERS ID: 994887 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Lower respiratory tract infection, SARS-CoV-2 test, SARS-CoV-2 test positive
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: 2021-01-21
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Progressive supranuclear palsy; Comments: PSP Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210106; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021070951

Write-up: Chest infection; COVID-19 virus test: yes - positive; COVID-19 virus test: yes - positive; This is a spontaneous report received from a contactable healthcare professional by Pfizer from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202101242001444320, Safety Report Unique Identifier GB-MHRA-ADR 24639440. A 69-year-old male patient received BNT162B2 (Lot/Batch number and expiration date not known), via an unspecified route of administration from 06Jan2021 at single dose for COVID-19 immunization. Medical history included progressive supranuclear palsy (PSP) from an unknown date. 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 chest infection on 16Jan2021. The patient died on 21Jan2021 due to chest infection. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive covid-19 test on 06Jan2021. The outcome of the event "COVID-19 virus test: yes - positive" was unknown. No follow-up attempts possible; information regardin batch/lot cannot be obtained.; Reported Cause(s) of Death: chest infection


VAERS ID: 994891 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Decreased appetite, Hypersomnia
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Living in nursing home; Reduced general condition (before the vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021069227

Write-up: death; eat less; slept more and more; This is a spontaneous report downloaded from the Medicines Agency (EMA) EudraVigilance-WEB NO-NOMAADVRE-FHI-2021-Umm2a, safety report unique identifier NO-NOMAADVRE-E2B_00014029. A contactable physician reported that a 96-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number EJ6795 and expiry date unknown, batch number NDC59267-1000-1/EJ6795) intramuscular at the left arm on 06Jan2021 12:30 at single dose for Covid-19 immunization. Medical history included living in nursing home and dementia. The patient had declining health before the vaccination. The patient''s concomitant medications were not reported. The patient experienced death on 13Jan2021. The patient has no symptoms/reactions after vaccination with covid-19 vaccine (Comirnaty) on 06Jan2021 (12:30) and died six days after the vaccination. After the vaccination (Jan2021) the patient continued to eat less and slept more and more, until she died 13Jan2021. In the morning 12Jan2021, a change in her health condition was noticed and she was treated as being in her last days of life. It was not reported if an autopsy was performed. The reporter informed that no suspicion that the vaccine has played a role in this. The patient''s death was reported due to short time (less than a week) between vaccination and the death. The reporter (physician) asked leaders of the nursing home service in the municipality whether long-term residents, not terminal, should be vaccinated or not. The reporter got an answer that all patients that is not in their last days of life should be vaccinated. The vaccination took place before NIPH had come up with the proposal to assess to what extent the most frail patients should have a covid-19 vaccine. Sender Comment: A 96-year-old woman without symptoms / reactions after vaccination with covid-19 vaccine (Comirnaty) died six days after vaccination. She had declining health before the vaccination, and after the vaccination she continued to eat less and slept more, until she died. 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 incidental, concurrent cause that has nothing to do with the vaccination in question. Based on the information in the report, only the reporter''s causality assessment is registered. The reporter has stated that there is no suspicion of a connection with vaccination, and therefore a causal connection with vaccination is considered unlikely. Since the patient died, the report is classified as serious. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information, this patient''s death, decreased appetite and hypersomnia are attributed to patient''s advanced age (96 year-old) and underlying dementia and assessed Unrelated to BNT162B2 (COMIRNATY) vaccine.; Reported Cause(s) of Death: DEATH


VAERS ID: 994892 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Cold sweat, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypoglycaemia (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: TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE HYDROCHLORIDE]; DUROFERON; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; ELIQUIS; SELO-ZOK; PANODIL; SPIOLTO RESPIMAT; PANTOPRAZOL PENSA; VISCOTEARS; VENTOLINE [S
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid dyspepsia; Arm fracture; Asthma; Atrial fibrillation; Constipation; Dementia; Dry eye; Iron deficiency; Pain; Vitamin deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021069935

Write-up: DYSPNEA; COLD SWEAT; anxious; This is a spontaneous report from a contactable physician downloaded from the regulatory authority [regulatory authority NO-NOMAADVRE-FHI-2021-Upjwz ], Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013932. A 97-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection; lot number ej6795, expiry date not reported) intramuscular, on 06Jan2021, single dose for COVID-19 immunization. Medical history included dementia, recent fracture of upper arm which was conservatively treated (did not get to her feet after a recent fracture of upper arm, but returned to her normal self), cardiac disease (atrial fibrillation), pulmonar disease (asthma), vitamin deficiency, Iron deficiency, constipation, pain, acid dyspepsia, and dry eye. Concomitant medication included cyanocobalamin, folic acid, pyridoxine hydrochloride (TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE HYDROCHLORIDE]) from 31Oct2018 for vitamin deficiency, ferrous sulfate (DUROFERON) from 30Nov2018 for Iron deficiency, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]) from 18Nov2020 for constipation, apixaban (ELIQUIS) from 23Oct2019 for atrial fibrillation, metoprolol succinate (SELO-ZOK) from 27Mar2019 for atrial fibrillation, paracetamol (PANODIL) from 19Mar2018 for pain, olodaterol hydrochloride, tiotropium bromide monohydrate (SPIOLTO RESPIMAT) from 18Mar2020 for asthma, pantoprazole sodium sesquihydrate (PANTOPRAZOL PENSA) from 05Oct2017 for acid dyspepsia, carbomer (VISCOTEARS) from 05Jun2019 for dry eye, salbutamol (VENTOLINE) from 07Oct2019 for asthma , montelukast sodium (MONTELUKAST TEVA) from 17Oct2017 for asthma, and cefuroxime (FURIX [CEFUROXIME]) from 05Jun2019 for diuretic therapy. The patient previously took inuxair for asthma. On10Jan2021, at approximately 06:00 in the morning, the patient screams, patient had dyspnea described as short of breath, cold sweat and felt unwell described as anxious. Salbutamol was given, with good effect, and the situation calmed down. At approximately 15:00 the situation turned again, and emergency ward was contacted to clarify the situation. Further palliative care was given. The patient died later the same day of 10Jan2021 at 17:30 as these symptoms occurred. Outcome of the event anxiety was unknown. Causes of death were reported as dyspnea and cold sweat. It was unknown if an autopsy was performed. Sender''s Comments: A 97-year-old woman with dyspnea and cold sweat four days after vaccination with covid-19 vaccine (Comirnaty). She felt unwell and was described as anxious. The patient died later the same day that these symptoms occurred. This is a patient with, among other things, heart disease (atrial fibrillation) and lung disease (asthma) from before. Dyspnoea and cold sweats are not known side effects of the vaccine. 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 aggravation of the patient''s underlying diseases. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or another accidental, concurrent cause that has nothing to do with the vaccination in question.; Reported Cause(s) of Death: dyspnea; cold sweat


VAERS ID: 995089 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-02
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: 2021-01-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Comments: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021073430

Write-up: died very suddenly/sudden death; This is a spontaneous report from contactable consumer downloaded from the Regulatory authority BE-FAMHP-DHH-N2021-75563. An 84-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number EM0477 and expiry date unknown) via unspecified route of administration on 15Jan2021 at single dose for Covid-19 immunization. Medical history included dementia. The patient''s concomitant medications were not reported. On 17Jan2021 Sunday, the patient died very suddenly; the patient suffered from sudden death during treatment with Comirnaty. The patient died on 17Jan2021. It was not reported if an autopsy was performed. The event was considered serious with fatal outcome.; Reported Cause(s) of Death: died very suddenly/sudden death


VAERS ID: 995091 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-03
Onset:2021-01-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hyperpyrexia, Respiratory distress, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bedridden; Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021068488

Write-up: shortness of breath (respiratory distress)/ breathing remained strong; hyperpyrexia/a very high fever at 39.5; patient was no longer responsive; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB. Regulatory authority report number is DE-PEI-CADRPEI-2021012552. A 76-year-old male patient received BNT162B2 (COMIRNATY; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 03Jan2021 at a single dose for COVID-19 immunization. Medical history included parkinson''s disease and bedridden, both ongoing. The patient''s concomitant medications were not reported. Without the reporter''s knowledge, the patient (father) was vaccinated in the nursing home on the weekend of 02-03Jan2021 (also reported as 03Jan2021). Four days after the vaccination (07Jan2021), the patient was lying in bed in the morning with shortness of breath (respiratory distress) and hyperpyrexia/a very high fever at 39.5 and the reporter received the call that the patient is very badly. The fever went down 2 days later, the breathing remained strong and the patient was no longer responsive (verbal stimuli). The patient died on Sunday, 10Jan2021. The patient already had advanced Parkinson''s and was bedridden. The reporter still cannot understand why the patient was vaccinated in this condition. Per reporter, the patient would not have died in such a short time even if the patient was physically ill. The patient was conscious beforehand, he could be spoken to and, with help, he was still sitting on the edge of the bed a few days earlier and was able to run a few steps with the help of it. His condition developed within a few hours. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: shortness of breath (respiratory distress)/ breathing remained strong; hyperpyrexia/a very high fever at 39.5; patient was no longer responsive


VAERS ID: 995093 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical condition abnormal
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: Atrial fibrillation; Chronic renal insufficiency; Coronary heart disease; Dementia; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021073651

Write-up: Sudden deterioration in general condition; This is a spontaneous report from physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB DE-PEI-PEI2021001310. A 90-years-old male patient received the first dose of bnt162b2 (COMIRNATY; Lot # EJ6795) vaccine , via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation . Medical history included dementia , chronic kidney disease , atrial fibrillation , coronary artery disease , hypertension . The patient''s concomitant medications were not reported. The patient experienced sudden deterioration in general condition leading to the patient death on an unspecified date. It was not reported if an autopsy was performed. Comirnaty/ Death/ PEI/ D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 995094 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Body temperature, Cardiac failure, Pyrexia
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   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: Anticoagulant therapy; Colon carcinoma; Coronary heart disease; Dementia; Hypertension; Mitral insufficiency; Phlebothrombosis; Renal insufficiency; Wound infection
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:up to 40 degree Centigrade
CDC Split Type: DEPFIZER INC2021073650

Write-up: Fever up to 40?C; Decompensation cardiac; Atrial fibrillation; This is a spontaneous report from non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021001346 An 86-year-old male patient received his first dose of first dose of intramuscular BNT162B2 (COMIRNATY) on 20Jan2021 at single dose for COVID-19 immunisation at the age of 86-year-old. Lot number was EM0477. Medical history included phlebothrombosis, dementia, renal insufficiency, mitral insufficiency, coronary heart disease, colon carcinoma, anticoagulant therapy, hypertension, infection of the wound in the hand. Concomitant medication was not reported. On 20Jan2021, the patient developed hyperpyrexia (up to 40 degree Celsius) and atrial fibrillation and decompensation cardiac. The events were considered life-threatening. The patient died on 21Jan2021 due to hyperpyrexia, atrial fibrillation and decompensation cardiac, death cause was reported as Cardiac insufficiency (as reported). It was unknown if an autopsy was performed. Reporter''s comments: In my opinion, patient died of a vaccine reaction to the Covid-19 vaccination. However, I stated heart failure as the cause of death on the death certificate. No follow-up attempts possible. No further information expected.; Reporter''s Comments: In my opinion, patient died of a vaccine reaction to the Covid-19 vaccination. However, I stated heart failure as the cause of death on the death certificate.; Reported Cause(s) of Death: hyperpyrexia; atrial fibrillation; Cardiac insufficiency


VAERS ID: 995095 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-08
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Infective exacerbation of chronic obstructive airways disease, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   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: Chronic obstructive airways disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021073643

Write-up: Acute infection exacerbation a chronic ventilatory insufficiency with a need for oxygen; Oxygen saturation decreased.; This is a spontaneous report from physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021001365. A 59-years-old female patient received the first dose of bnt162b2 (COMIRNATY) vaccine, via an unspecified route of administration on 31Dec2020 at single dose for Covid-19 immunisation. The patient medical history included chronic obstructive airways disease. The patient''s concomitant medications were not reported. The patient experienced acute infection exacerbation of chronic obstructive airways disease and a chronic ventilatory insufficiency with a need for oxygen on 08Jan202 leading to patient death. The patient died on 13Jan2021. It was not reported if an autopsy was performed. 9 day(s) after vaccination the patient developed Infective exacerbation of chronic obstructive airways disease and Fever and Cough and Oxygen saturation decreased, lasting for unknown. Death cause was reported as Oxygen saturation decreased. Comirnaty/ all events. Unclassifiable Information about Lot number has been requested.; Reported Cause(s) of Death: Oxygen saturation decreased.; Infective exacerbation of chronic obstructive airways disease


VAERS ID: 995131 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-10
Onset:2021-01-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 - / 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: 2021-01-10
   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: RIVOTRIL; AMLODIPINE; LANTUS; VENLAFAXINE; LASIX [FUROSEMIDE]; VESSEL [SULODEXIDE]; HUMALOG; SIMVASTATIN; VANTUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiomyopathy; COVID-19; Diabetes mellitus (Insulin Dependent)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021068465

Write-up: Acute myocardial infarction; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-652799, Safety report unique identifier IT-MINISAL02-652799. A 90-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EL1484), intramuscular on 10Jan2021 11:00 to 10Jan2021 11:00 at 0.3 mL, single for COVID-19 immunization. Medical history included diabetes mellitus from 01Jan2016 (Insulin Dependent), cardiomyopathy from 01Jan2016, and was an asymptomatic ex COVID patient. It was reported that the patient was an elderly but in good compensation. Concomitant medication included clonazepam (RIVOTRIL), amlodipine (AMLODIPINE), insulin glargine (LANTUS), venlafaxine (VENLAFAXINE), furosemide (LASIX [FUROSEMIDE]) , sulodexide (VESSEL [SULODEXIDE]), insulin lispro (HUMALOG), simvastatin (SIMVASTATIN), atorvastatin calcium (VANTUS). The patient experienced death in the structure for Acute myocardial infarction on 10Jan2021 18:00. Therapeutic measures were taken as a result of acute myocardial infarction (acute myocardial infarction). ; Reported Cause(s) of Death: cardiocirculatory arrest


VAERS ID: 995134 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-12
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6796 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Vascular dementia (Alcolhol-induced.)
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Epilepsy; Hemiparesis (left) (Contracture of left hand and left foot. Sequelae after stroke.); Living in nursing home; Stroke; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021069132

Write-up: FOUND DEAD; This is a spontaneous report from contactable physician downloaded from the regulatory authority-WEB regulatory authority NO-NOMAADVRE-E2B_00013940 and NO-NOMAADVRE-FHI-2021-U42wx. An 83-year-old male patient received first dose of bnt162b2 (COMIRNATY; lot number EJ 6796, expiry date not reported) intramuscular right arm, on 07Jan2021 12:30, single dose for covid-19 immunisation. Medical history included cerebrovascular accident, living in residential institution, hemiparesis (left) described as contracture of left hand and left foot, sequelae after stroke, type 2 diabetes mellitus, angina pectoris, ongoing vascular dementia (Alcolhol-induced), epilepsy. The patient''s concomitant medications were not reported. The patient was found dead on 12Jan2021. The patient had not experienced any respiratory symptoms after vaccination and had been in his usual general condition few hours before death occurred. The patient died on 12Jan2021. It was unknown if an autopsy was performed. The reporter stated that they are unsure of an association of the patient being found dead and the recent vaccination. Sender Comment: The report is regarding a patient in his 80''s who was found dead in his bed a few days after the first dose with the Covid-19 vaccine Comirnaty. The patient had no symptoms after vaccination and was in his/her usual condition few hours before the death occurred. The patient had multiple, serious, underlying diseases. The reporter states that they are uncertain on whether the death is related to the vaccine. The median time from hospitalization to death for patients on long-term stays in nursing homes is 2.2 years, estimated from a sample of nursing home patients (n = 690) over a three-year period. High levels of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International retrospective studies have similar findings and find, among other things, that the risk of death has increased in the first four months after admittance to the nursing home, and that patients who have recently been hospitalized have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. It is stated in the report that the patient has underlying diseases before vaccination. As the incident is described, it is more likely that these diseases are behind the incident. 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 incidental occurrence which has nothing to do with the vaccination in question. Data from use in frail patients with co-morbidity (eg diabetes, cardiovascular disease) are nevertheless limited, and such lack of information will be obtained in post-marketing studies, among others. Your message is important to increase knowledge about side effects that have not been discovered in the studies. This vaccine is marked with a black triangle because it is a new vaccine. This means that the vaccine is subject to special monitoring in order to detect new safety information as quickly as possible. Healthcare professionals are encouraged to report suspected adverse reactions. It is especially important that serious and / or unusual side effects are reported. The Agency and the Public Health have recently updated their advice on Covid-19 vaccination of elderly and frail patients. 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: Death


VAERS ID: 995135 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   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: Cardiac failure aggravated; Cardiac valve disease; Hospitalisation; Infection; Living in nursing home; Non STEMI
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021069128

Write-up: FOUND DEAD; HEART FAILURE; VACCINATION SITE TENDERNESS; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-U9n1z, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013909. A contactable physician reported that a 79-year-old female patient received first dose of bnt162b2 (COMIRNATY; lot number: EJ6795) intramuscularly into the left arm on 07Jan2021 13:00 at a single dose for covid-19 immunisation. Medical history included infection from 30Nov2020 to 30Dec2020, living in nursing home from an unknown date, hospitalisation from Sep2020 to 30Dec2020, Non-ST-elevation myocardial infarction (non-STEMI) from Nov2020 to Nov2020, cardiac failure aggravated from 30Nov2020 to 30Dec2020 and cardiac valve disease from an unknown date. The patient''s concomitant medications were not reported. On 07Jan2021, the patient experienced vaccination site tenderness. On 12Jan2021, patient was found dead in her bed. It was reported that up until this point, the patient had been in good physical condition, had been eating and drinking as per usual and had no clinical signs of acute illness. The reporting physician stated that despite the death being sudden, it was not unexpected due to the patient''s underlying diseases. The probable cause of death was considered by the reporting physician to be heart failure and that it is very unlikely that the death is related to the vaccine. It was not reported if an autopsy was performed. Outcome of the event "vaccination site tenderness" was unknown. Sender''s Comments (Health Authority comments): The report concerns a 79-year-old patient, who was found dead in bed a few days after the first dose of the Covid-19 vaccine Comirnaty. With the exception of tenderness at the injection site, the patient did not experience any symptoms after vaccination, was in good general condition and had no signs of acute illness before the death. The patient was not considered terminal, but had several serious, underlying illnesses, and recent hospitalizations. The reporter further states that the probable cause of death is heart failure and that it is very unlikely that the death is related to the vaccine. The median time from admission to death for patients on long-term stays in nursing homes is 2.2 years, estimated from a sample of nursing home patients (n = 690) over a three-year period. High levels of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International, retrospective studies have similar findings and find, among other things, that the risk of death is increased in the first four months after admission, and that patients who have recently been hospitalized have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. It is stated in the report that the patient had underlying diseases before vaccination. According to the incident description, it is more likely that these diseases are behind the incident. 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 other incidental, 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 link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died afterwards, the report is also classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information the events Death and Cardiac failure are attributed to patient''s underlying medical conditions including Non-ST-elevation myocardial infarction, cardiac failure aggravated and cardiac valve disease and assessed unrelated to COMIRNATY vaccine. 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: FOUND DEAD; HEART FAILURE


VAERS ID: 995195 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH AM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Arrhythmia, Chest X-ray, Oxygen saturation, Pneumonia aspiration, pH body fluid
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   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: BISOPROLOL; GLICLAZIDE; METFORMIN; OXYGEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia cardiac (NOS); Gastroesophageal reflux; Living in nursing home; Respiratory disorder; Steinert disease (frequently requiring oxygen therapy); Swallowing disorder; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210116; Test Name: Chest X-ray; Result Unstructured Data: Test Result:unknown; Test Date: 20210116; Test Name: desaturation; Result Unstructured Data: Test Result:<70% %; Test Date: 20210116; Test Name: pH; Result Unstructured Data: Test Result:7.17
CDC Split Type: FRPFIZER INC2021078851

Write-up: Acute respiratory failure; rhythm disturbance; Pneumonia aspiration; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB FR-AFSSAPS-MP20210083. A 51-year-old male patient received first dose of bnt162b2 (COMIRNATY, Lot # AM0477), intramuscular on 09Jan2021 10:00 at single dose for covid-19 immunisation. Steinert myopathy with swallowing disorders and respiratory disorders (frequently requiring oxygen therapy), Type 2 diabetes, notions of heart rhythm disturbances (unspecified), gastroesophageal reflux. His medical condition requires hospital treatment. Despite his age, the patient is taken care of in a nursing home. Concomitant medication included bisoprolol, proton pump inhibitors, gliclazide, metformin, oxygen. On 15Jan2021 (5 p.m.) patient appearance of asthenia and resolving dyspnea on oxygen (2L / min); on 16Jan2021 (1 p.m.) patient had Acute respiratory failure with desaturation (<70%) under oxygen 1L / min, tachycardia, hyperthermia, Intensified oxygen therapy (<6L / min) and Transfer to emergency. On 16Jan2021 (evening and night): patient was Hospitalized (emergency then pneumology department), Oxygen dependent (<6L / mon), Cardiologist''s opinion who objectivies tachyarrhythmia treated with digoxin and anticoagulation, Inflammatory syndrome without fever, Metabolic acidosis (ph: 7.17), Chest X-ray performed, The patient refused ventilation, Bedridden state. On 17Jan2021 (3 p.m.): death of the patient. The pulmonologist indicates that the death was due to aspiration pneumonia and a rhythm disturbance. Outcome of other events was unknown.; Reported Cause(s) of Death: Arrhythmia NOS; Pneumonia aspiration


VAERS ID: 995210 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0739 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; BISOPROLOL; CLOPIDOGREL; LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Comments: Unsure if patient has 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 INC2021080284

Write-up: Died in sleep; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Authority. The Sender''s (Case) Safety Report Unique Identifier is: GB-MHRA-ADR 24648368, and the Regulatory authority''s case report number is: GB-MHRA-WEBCOVID-202101261211331460. A 92-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0739 and expiration date unknown), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), bisoprolol (BISOPROLOL), clopidogrel (CLOPIDOGREL), lansoprazole (LANSOPRAZOLE). The daughter found patient dead on sofa in nightclothes on 26Jan2021. The patient died on 26Jan2021. It was unknown if an autopsy was performed. Patient has not tested positive for COVID-19 since having the vaccine. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 995214 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Angiogram cerebral, Asthenia, Carotid artery dissection, Coma scale, Cranial nerve disorder, Headache, Hemiplegia, Nausea, Sopor
SMQs:, Acute pancreatitis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: CT angiography; Result Unstructured Data: Test Result:unknown results; Test Name: Angio CT intracranial vessels; Result Unstructured Data: Test Result:unknown results; Test Name: GCS; Result Unstructured Data: Test Result:13
CDC Split Type: ITPFIZER INC2021079665

Write-up: Left hemisoma hyposthenia; diagnosis of right arteria carotide dissection; left-side hemiplegia; headache; nausea; soporous; central deficit of the 7th cranial nerve left; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB IT-MINISAL02-657133. A 49-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY, Batch/lot number: EJ6797, expiry date: 30Apr2021), intramuscular on 14Jan2021 12:08 at 0.3 mL, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced 15Jan2021 20:13 in the emergency room red code, left hemisoma hyposthenia and deviation of the oral rhyme. parameters in the standard, closing 15Jan2021 21:19, admission to neurology. diagnosis of right arteria carotide dissection on 15Jan2021. Hospitalization in Neurology Department. Angio CT (computerised tomogram) intracranial vessels and CT skull neck vessels for thrombolysis. Transported to emergency service, the patient presents worsening of the clinical picture: EON: soporous, awakened, GCS (glasgow coma scale): 13, left-side hemiplegia central deficit of the 7th cranial nerve left. NIHSS (national institutes of health stroke scale): 14. He reports headache, nausea. Subjected to total venous TL 73, 8 m. Interventional neuroradiology is contacted and after viewing the images he recommends centralization for possible thrombectomy. Transportation to the hospital is organized. The patient underwent lab tests and procedures which included angiogram: unknown on 15Jan2021. The outcome of events for left-side hemiplegia central deficit of the 7th cranial nerve left, soporous, headache, nausea were unknown, for left hemisoma hyposthenia and arteria carotide dissection was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter''s comment: Summary from the patient''s folder, which is attached 15Jan2021: Transported to emergency service, the patient presents worsening of the clinical picture: EON: soporous, awakened, GCS: 13, left-side hemiplegia central deficit of the 7th cranial nerve left. NIHSS: 14. He reports headache, nausea. Subjected to total venous TL 73, 8 m. Body weight 82 Kg Interventional neuroradiology is contacted and after viewing the images he recommends centralization for possible thrombectomy. Transportation to the hospital is organized.; Reporter''s Comments: Summary from the patient''s folder, which is attached 15Jan2021: Transported to emergency service, the patient presents worsening of the clinical picture: EON: soporous, awakened, GCS: 13, left-side hemiplegia central deficit of the 7th cranial nerve left. NIHSS: 14. He reports headache, nausea. Subjected to total venous TL 73, 8 m.; Reported Cause(s) of Death: left hemisoma hyposthenia; Carotid artery dissection


VAERS ID: 996610 (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: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Rales, Respiratory depression, SARS-CoV-2 test
SMQs:, Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Respiratory failure (narrow), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; LASIX [FUROSEMIDE]; SIMVASTATIN; THYREX; SEROQUEL; ESOMEPRAZOL [ESOMEPRAZOLE]
Current Illness: Aortic valve insufficiency; Chronic renal insufficiency; Dementia; Organic psychosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201107; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Comments: TGT2 (Ct) 19.85; Test Date: 20201214; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Negative; Comments: CT value of 36
CDC Split Type: ATPFIZER INC2021073910

Write-up: Respiratory depression; Rales; General debility; This is a spontaneous report downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-00448. A contactable Health Care Professional reported that a 94 years old female patient (weight 51.5 kg, and height 158 cm) received BNT162B2 (COMIRNATY, lot. EJ6796) intramuscularly, at single dose, on 08Jan2021, for COVID-19 immunisation. Relevant medical history included organic psychosis, dementia, aortic valve insufficiency and chronic renal insufficiency, all from an unspecified date and ongoing. Concomitant medications included oral apixaban (ELIQUIS, Film-coated tablet) 2.5 mg, once daily, oral furosemide (LASIX) 20 mg, oral simvastatin 40 mg, once daily, oral levothyroxine sodium (THYREX) 75 ug, once daily, oral quetiapine fumarate (SEROQUEL, Film-coated tablet) 125 mg, once daily, for organic psychosis and oral esomeprazol (esomeprazole) 20 mg, once daily. On 09Jan2021, the patient experienced respiratory depression, rales and general debility. Relevant laboratory test included COVID-19 PCR test: it was positive on 07Nov2020 (TGT2 (Ct) 19.85) and negative on 14Dec2020 (CT value of 36 on 14Dec2020.The segregation was lifted on 14Dec2020). The patient died due to the events on 09Jan2021. No autopsy was done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Respiratory depression; Rales; General debility


VAERS ID: 996619 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute respiratory distress syndrome, Alanine aminotransferase, Basophil count, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood chloride, Blood creatinine, Blood fibrinogen, Blood sodium, Blood urea, Carbon dioxide, Fibrin D dimer, Gamma-glutamyltransferase, Lymphocyte count, Monocyte count, Oxygen saturation, PCO2, PO2, Prothrombin time ratio, SARS-CoV-2 test, Troponin T, White blood cell count, pH body fluid
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Amlor; Tahor; KARDEGIC; TRIATEC; ZYMAD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Arterial hypertension (hypertension); Asymptomatic COVID-19; Dyslipidaemia; Malignant palate neoplasm (neoplasia of the palate); Mitral incompetence (mitral insufficiency); Stroke; TIA
Allergies:
Diagnostic Lab Data: Test Date: 20210117; Test Name: partial thromboplastin time ratio; Result Unstructured Data: Test Result:1.06; Test Date: 20210117; Test Name: ALAT; Result Unstructured Data: Test Result:34 IU/l; Test Date: 20210117; Test Name: basophils; Result Unstructured Data: Test Result:0.01 g/l; Test Date: 20210117; Test Name: albumin; Result Unstructured Data: Test Result:40 g/l; Test Date: 20210117; Test Name: PAL; Result Unstructured Data: Test Result:109 IU/l; Test Date: 20210117; Test Name: bilirubin; Result Unstructured Data: Test Result:10 umol/l; Test Date: 20210117; Test Name: calcemia; Result Unstructured Data: Test Result:2.23 mmol/L; Comments: corrected; Test Date: 20210117; Test Name: Cl; Result Unstructured Data: Test Result:98 mmol/L; Test Date: 20210117; Test Name: creatinine; Result Unstructured Data: Test Result:103 umol/l; Test Date: 20210117; Test Name: fibrinogen; Result Unstructured Data: Test Result:2.95 g/l; Test Date: 20210117; Test Name: Na; Result Unstructured Data: Test Result:134 mmol/L; Test Date: 20210117; Test Name: urea; Result Unstructured Data: Test Result:23.6 mmol/L; Test Date: 20210117; Test Name: CO2; Result Unstructured Data: Test Result:20.7 mmol/L; Test Date: 20210117; Test Name: Dimers; Result Unstructured Data: Test Result:6560 ng/ml; Comments: (N$g 500); Test Date: 20210117; Test Name: GGT; Result Unstructured Data: Test Result:62 IU/l; Test Date: 20210117; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.45 g/l; Test Date: 20210117; Test Name: monocytes; Result Unstructured Data: Test Result:0.9 g/l; Test Date: 20210117; Test Name: saO2; Test Result: 63.1 %; Test Date: 20210117; Test Name: saO2; Test Result: 62 %; Test Date: 20210117; Test Name: PCO2; Result Unstructured Data: Test Result:34 mmHg; Test Date: 20210117; Test Name: pH; Result Unstructured Data: Test Result:7.3; Test Date: 20210117; Test Name: PO2; Result Unstructured Data: Test Result:35.2 mmHg; Test Date: 20210117; Test Name: Prothrombin Ratio; Test Result: 76 %; Comments: activated; Test Date: 20201215; Test Name: PCR for Covid-19; Test Result: Positive ; Test Date: 20210117; Test Name: PCR for Covid-19; Test Result: Positive ; Test Date: 20210117; Test Name: troponin T ultra sensitive; Result Unstructured Data: Test Result:40.16 ng/L; Test Date: 20210117; Test Name: polynuclear eosinophils; Result Unstructured Data: Test Result:0 g/l; Test Date: 20210117; Test Name: polynuclear neutrophils; Result Unstructured Data: Test Result:13.09 g/l; Test Date: 20210117; Test Name: White blood cells; Result Unstructured Data: Test Result:14.45 g/l
CDC Split Type: FRPFIZER INC2021078801

Write-up: Acute respiratory distress syndrome; This is a spontaneous report received from a contactable physician, downloaded from the regulatory authority FR-AFSSAPS-AN20210116. An 89-year-old female patient received bnt162b2 (COMIRNATY, lot# EM0477), intramuscularly in right arm on 12Jan2021 at single dose for COVID-19 vaccination, amlodipine besilate (AMLOR, 5 mg), oral from an unspecified date to 16Jan2021 at 1 DF (dosage form), 1x/day for Arterial hypertension, atorvastatin calcium (TAHOR, 10 mg), oral from an unspecified date to 16Jan2021 at 1 DF, 1x/day for dyslipidaemia, acetylsalicylate lysine (KARDEGIC), oral from an unspecified date to 16Jan2021 at 1 DF, 1x/day for cardiovascular event prophylaxis, triatec (RAMIPRIL, 2.5 mg), oral from an unspecified date to 16Jan2021 at 1 DF, 1x/day for Arterial hypertension, colecalciferol (ZYMAD), oral from an unspecified date to an unspecified date for Prophylactic. Medical history included Mitral incompetence from an unknown date and unknown if ongoing (mitral insufficiency), Malignant palate neoplasm from an unknown date and unknown if ongoing (neoplasia of the palate), Dyslipidaemia from an unknown date and unknown if ongoing, Asymptomatic Covid-19 in December 2020 (PCR positive on 15Dec2020) with anti-thrombotic prophylaxis at that time without specifying the duration and treatment modalities , Stroke from an unknown date and unknown if ongoing, Alzheimer''s disease from an unknown date and unknown if ongoing, Arterial hypertension from an unknown date and unknown if ongoing (hypertension), TIA (Transient ischaemic attack). Patient living in nursing home. No respiratory Past History reported. The patient''s concomitant medications were not reported. The patient experienced acute respiratory distress syndrome on 17Jan2021. The patient underwent lab tests and procedures which included biology on 17Jan2021 on admission to the emergency room: White blood cells 14.45 G / L with 13.09 G / L polynuclear neutrophils, 0.45 G / L lymphocytes, 0 G / L polynuclear eosinophils, 0.01 G / L basophils; 0.9 G / L of monocytes, Prothrombin Ratio 76% (activated) partial thromboplastin time ratio 1.06, fibrinogen 2.95 g / l, Dimers 6560 ng / ml (N$g 500), troponin T ultra sensitive to 40.16 ng / l, Na 134 mmol / l, Cl 98 mmol / l, K hemolyzed, calcemia corrected 2.23 mmol / l, urea 23.6 mmol / l, creatinine 103 ?mol / l, albumin 40 g / l, bilirubin 10 umol / l, ALAT 34 IU / l, PAL 109 IU / L (N 35-105), GGT 62 IU / L (N <40), Arterial gas measurement: pH 7.3; PCO2 34 mm Hg, PO2 35.2 mm Hg; CO2 t 20.7 mmol / l, saO2 63.1%, PCR covid positive. Vaccination on 12Jan with no particular effect afterwards. No symptoms the following days. On 17Jan in the morning during the nursing visit at 5 a.m. the patient was found dyspneic with 62% saturation. Immediately put on O2, arrival of the ambulance at 7am and transfer to the emergency room. No clinical call point, isolated sudden respiratory distress. Bilateral diffuse interstitial radio-pulmonary syndrome ("white lungs" according to the doctor). Biology must be transmitted to us: notion of high Dimers. Treatment and evolution: Admission to the emergency room then transfer to palliative care. Conclusion: Sudden respiratory distress leading to death in an 89-year-old patient vaccinated a few days earlier against covid-19. Summary: Fatal respiratory failure in an 89 years woman vaccinated with Comirnaty 5 days ago. No sign of acute cor pulmonale suggesting massive acute pulmonary embolism. Curative anticoagulation was implemented in principle as well as antibiotic therapy without mprovement of the clinical picture. Diagnosis made by emergency physicians: severe SARS CoV 2 pneumonia because PCR positive but according to the reporter the PCR can remain positive at 1 month of a covid infection. CR palliative care: on arrival, patient drowsy but awakened and dyspneic on O2 with diffuse ronchi and crackles on auscultation with slight congestion. Initiation of comfort care with morphine and midazolam. The patient died on 21Jan2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute respiratory distress syndrome


VAERS ID: 996674 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ05536450 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Drug ineffective, Dysstasia, Feeling abnormal, Pyrexia, SARS-CoV-2 test, Skin discolouration, Tremor
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: 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: Medical History/Concurrent Conditions: Dementia with Lewy bodies; Non-smoker (Never smoked.)
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: temperature; Result Unstructured Data: Test Result:High; Test Date: 20210120; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021077136

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; High temperature; Dysstasia; Skin discolouration; Tremor; Feeling abnormal; This is a spontaneous report received from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202101241732075000, Safety Report Unique Identifier GB-MHRA-ADR 24639306. An 86-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EJ05536450, via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. The patient previously received the firs dose of BNT162B2 on unspecified date with no adverse events. Medical history included non-tobacco user (Never smoked), dementia with Lewy bodies. The patient''s concomitant medications were not reported. No physical illnesses. Unsure if patient has had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. On 08Jan2021 the patient experienced high temperature, dysstasia, skin discolouration, tremor, feeling abnormal: the patient could not stand up from his bed, he was grey in skin colour, shaking and he said he felt terrible. The patient did not go to hospital and was stabilized with oxygen mask. The events were non serious with outcome of not recovered. On 08Jan2021 the patient experienced SARS-CoV-2 infection. The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive covid-19 test on 20Jan2021. The event SARS-CoV-2 infection was fatal, and the patient died for SARS-CoV-2 infection on 20Jan2021 at 7.05am. 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: SARS-CoV-2 infection


VAERS ID: 996675 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-22
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   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: ACETYLSALICYLIC ACID; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial ischaemia; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021077086

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician received from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202101251244272730, Safety Report Unique Identifier GB-MHRA-ADR 24642540. A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK1768) via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included myocardial ischaemia. Concomitant medications included acetylsalicylic acid for myocardial ischaemia (a stop date was reported as 02Apr1997) and clopidogrel from 26Apr2019 for myocardial ischaemia. On 22Jan2021, the patient experienced cardiac arrest and died on the same day due to cardiac arrest. It was not reported if an autopsy was performed. The patient has not had symptoms associated with COVID-19 and he had not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 996676 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EE8492 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-CODAMOL; TRELEGY; VENTOLINE [SALBUTAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchiectasis; COPD; Coronary heart disease; Heavy smoker ((40 cpd)); Paroxysmal atrial fibrillation; Comments: COPD, bronchiectasis, CHD, paroxysmal AF, heavy smoker (40cpd) 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: Test Date: 202101; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Not tested positive for COVID-19; Comments: Patient has not tested positive for COVID-19 since having the vaccine
CDC Split Type: GBPFIZER INC2021077445

Write-up: Death; Nausea; Cough; This is a spontaneous report from a contactable physician by Pfizer from the Regulatory Authority. The regulatory authority report number GB-MHRA-WEBCOVID-202101251308456930. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 24642613. A 78 years old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EE8492) at single dose, on 21Jan2021, for COVID-19 immunisation. Relevant medical history included chronic obstructive pulmonary disease (COPD), bronchiectasis, coronary heart disease (CHD), paroxysmal atrial fibrillation and heavy smoker (40 cpd), all from an unspecified date. Concomitant medications included codeine phosphate, paracetamol (CO-CODAMOL) from an unspecified date, at an unknown dose, for pain; fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY) from an unspecified date, at an unknown dose, for chronic obstructive pulmonary disease and salbutamol (VENTOLINE) from an unspecified date, at an unknown dose, for chronic obstructive pulmonary disease. Patient has not had symptoms associated with COVID-19 (not had a COVID-19 test). Patient was not enrolled in clinical trial. Family reported some nausea and slight increase in cough for the 2 days following vaccination. Woke early on morning of 24Jan2021, alert, not distressed. Husband went to make cup of coffee and returned to find patient unresponsive in bed. Ambulance crew pronounced life extinct. The patient died on 24Jan2021. It was unknown if autopsy was done. Patient has not tested positive for COVID-19 since having the vaccine. Clinical outcome of nausea and cough was unknown at time of the patient''s death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 996682 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CONTROLOC [PANTOPRAZOLE]; CLEXANE
Current Illness: Heartburn; Liver metastases; Metastases to lung; Ovarian cancer (3.5 years before); Peritoneal metastases
Preexisting Conditions: Medical History/Concurrent Conditions: Ascites drainage; Cannula placement; Discharge (it did not even drain therefore it was removed); Palliative care
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021084079

Write-up: Death within 1 month after vaccination/an end-stage tumor died from the underlying disease; Vomiting; This is a spontaneous report received from a contactable physician. A 52-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number: EJ6796), via intramuscular on 06Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing heartburn and at the time of the diagnosis of ovarium tumor 3.5 years before 27Jan2021, the patient already had peritoneal metastases. She received TAX (paclitaxel)+ CBP (carboplatin), GEM (gemcitabine) + CBP (carboplatin), then + BEVAC (bevacizumab), later mono BEVAC treatments. When lung- and liver metastases appeared TAX + CBP was reinduced, then she received mono TAX, finally pegylated liposomal doxorubicin hydrochloride (CAELYX) therapy. Due to peritoneal fluid ascites puncture was required on several occasions. Currently she was transferred from the department of hematology of reporter''s institution to hospice department for further palliative treatment. During the short period of treatment next to the right subclavian central cannula abundant discharge was observed, it did not even drain therefore it was removed. With the help of the Intensive Care Unit another subclavian cannula was placed to the left side. Simultaneously fever was not observed. Piperacillin sodium, tazobactam sodium (TAZOCIN) was stopped. Concomitant medication included pantoprazole (CONTROLOC) from an unspecified date to 27Jan2021 for heartburn and enoxaparin sodium (CLEXANE) from an unspecified date to 27Jan2021 for thrombosis prophylaxis. The patient had quite frequent vomiting dominated the picture which was not really affected by palonosteron administered so far or chlorpromazine. At the time indicated above the patient died quietly without an acute event. It was reported that patient died within 1 month after vaccination on 27Jan2021 02:25 am, patient with an end-stage tumor died from the underlying disease. The outcome of the event frequent vomiting was unknown. The patient died on 27Jan2021. It was unknown if an autopsy was performed.; Sender''s Comments: The patient death is unrelated to the vaccine use but due to the progression of the underlying malignancy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death within 1 month after vaccination


VAERS ID: 996691 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210118; Test Name: Oximetry; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC2021079313

Write-up: Acute respiratory failure; This is a spontaneous report downloaded from the Regulatory Authority (MINISAL02) number IT-MINISAL02-657508] from a contactable physician. An 86-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular, on 16Jan2021, at single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced acute respiratory failure on 18Jan2021 with fatal outcome the same day. The event evolved within a few hours with tachypnea and patient was medically examined. The patient underwent lab tests and procedures which included oximetry: unknown results on 18Jan2021. Therapeutic measures were taken as a result of the event and included treatment with oxygen. , patient died on arrival of the ambulance. It was not reported if an autopsy was performed. Reporter''s comment: vaccination performed two days before the event (first dose) by company personnel. The information on the lot/batch number has been requested.; Reporter''s Comments: Vaccination performed two days before the event (first dose) by company personnel.; Reported Cause(s) of Death: Acute respiratory failure


VAERS ID: 996755 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENORUTON [TROXERUTIN]; METAGELAN; RINGER LACTATO FRESENIUS; LOVENOX [LEVOFLOXACIN]; OLEOVIT D3; FOLSAN; FURON [FUROSEMIDE]; VENOBENE; QUETIAPIN; IBEROGAST; MICROLAX [MACROGOL;SODIUM CITRATE;SODIUM LAURYL SULFATE;SORBIC ACID]; CANDESARTAN;
Current Illness: Atrial fibrillation; Dementia; Hypertension arterial; Restless; Sleep disorder; Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201107; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Comments: TGT2 (Ct) 31.22
CDC Split Type: ATPFIZER INC2021073918

Write-up: General weakness, died 2 days after the 1st vaccination; This is a spontaneous report downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-00447. A contactable Health Care Professional reported that a 95 years old female patient (weight 57 kg, and height 162 cm) received the first dose of BNT162B2 (COMIRNATY, lot. EJ6796) at single dose, on 08Jan2021, for COVID-19 immunisation. Relevant medical history included hypertension arterial, restless, type II diabetes mellitus, sleep disorder, dementia, and atrial fibrillation, all from an unspecified date and ongoing. Concomitant medications included troxerutin (VENORUTON) 1 DF, daily; oral metamizole sodium monohydrate (METAGELAN) 30 drop, thrice daily; calcium chloride dihydrate, potassium chloride, sodium chloride, sodium lactate (RINGER LACTATO FRESENIUS) 500 ml, as needed; levofloxacin (LOVENOX) 1 DF, daily; colecalciferol (OLEOVIT D3) 35 drop; oral folic acid (FOLSAN, Tablet) 5 mg, daily; oral furosemide (FURON) 20 mg, alternate day; dexpanthenol, heparin sodium (VENOBENE); oral quetiapine fumarate (QUETIAPIN) 25 mg, twice daily; oral angelica archangelica root, carum carvi fruit, chelidonium majus herb, glycyrrhiza glabra root, iberis amara, matricaria recutita flower, melissa officinalis leaf, mentha x piperita leaf, silybum marianum fruit (IBEROGAST) 15 drop; macrogol, sodium citrate, sodium lauryl sulfate, sorbic acid (MICROLAX) as needed; oral candesartan tablet 8 mg, daily; morphine sulfate (VENDAL) 0.5 DF, twice daily, for strong verbal restlessness and oral pantoprazole, tablet 20 mg, daily. On 10Jan2021, the patient experienced general weakness, died 2 days after the 1st vaccination (general debility death). Relevant laboratory test included COVID-19 PCR test: it was positive on 07Nov2020 (TGT2 (Ct) 31.22). No further PCR testing took place. The segregation was lifted on 26Nov2020 because it was symptom-free for 48 hours. The patient died due to general debility on 10Jan2021. No autopsy was done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: General debility


VAERS ID: 996814 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hemoglobin decreased (After rectal bleeding); Macular degeneration; Rectal bleeding; Tiredness; Weakness of limbs
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021083775

Write-up: passed away; This is a spontaneous report from a contactable consumer reporting on her mother. A 97-year-old female patient received bnt162b2 (COMIRNATY), lot number EJ6795, via an unspecified route of administration at single dose on 30Dec2020 for COVID-19 immunisation. Medical history included rectal bleeding for a year ago, in 2020 and since then low values of haemoglobin, slight dementia, macular degeneration, often tired and weak legs, all from an unknown date. The patient''s concomitant medications were not reported. After the vaccination the patient felt well, experienced no common adverse events. The patient passed away on 02Jan2021. It was not reported if an autopsy was performed.; Sender''s Comments: Based on temporal relationship, the association between the event passed away with COMIRNATY use can not be completely excluded. Advanced age and multiple comorbid conditions may have contributory as well. 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: passed away


VAERS ID: 996818 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure, Pyrexia
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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: Cardiac insufficiency (NYHA 4)
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: fever up to 39 ? c; Result Unstructured Data: Test Result:39 Centigrade; Comments: up to 39 ? c of unknown origin
CDC Split Type: DEPFIZER INC2021083039

Write-up: Fever up to 39 ? C of unknown origin; Cardiac decompensation; This is a spontaneous report from a non-contactable physician from the Medicines Agency (MA) Regulatory authority-WEB DE-PEI-PEI2021001470. A 91-year-old male patient received his second dose of bnt162b2 (COMIRNATY, lot number EJ6795), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included cardiac insufficiency NYHA 4. The patient''s concomitant medications were not reported. The patient''s past drug therapy: Comirnaty on 30Dec2020 for COVID-19 immunisation had been tolerated. The patient experienced fever up to 39 ?c of unknown origin and cardiac decompensation on 21Jan2021, lasting for 3 day, the patient letal death on 23Jan2021. Events were reported as fatal. The patient died on 23Jan2021. It was unknown if an autopsy was performed. All events/ PEI / Unclassifiable Follow-up information has been requested.; Reported Cause(s) of Death: fever up to 39 ? c of unknown origin; Decompensation cardiac


VAERS ID: 996826 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Incorrect route of product administration
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), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   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: LOXAPAC [LOXAPINE]; XARELTO; CLOZAPINE; VALIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebellar syndrome; Cognitive disturbance; Embolism pulmonary; Psychosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021088300

Write-up: Sudden death by cardio respiratory arrest without any symptoms since the injection; BNT162B2 was administered Intravenously; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-GR20210116 This is a report received from the Regulatory Authority. A 64-year-old female patient received the first dose of BNT162B2 (COMIRNATY) (Batch/Lot number and expiration date unknown), intravenous on 12Jan2021 at single dose for COVID-19 vaccination. The patient''s medical history included Embolism pulmonary, Cognitive disturbance, Psychosis and Cerebellar syndrome, all unknown if ongoing. Concomitant medication (reported as usual treatment) included loxapine (LOXAPAC) at 25 drop, 3x/day, rivaroxaban (XARELTO) at 10 mg, daily, clozapine at 187.5 mg, daily, and diazepam (VALIUM) at 10 mg, 2x/day. The patient was living in an institution for 19 years for cognitive and psychotic disorders. On 13Jan2021, the patient experienced sudden death by cardio respiratory arrest without any symptoms since the injection, patient was found at 21:00 in her room. The patient died on 13Jan2021. It was unknown if an autopsy was performed. The cause of death was "sudden death by cardio respiratory arrest". Differential diagnostic: No known arrhythmia. No acute intercurrent pathology. Treatments managed by pharmacy and state registered nurse. No fever, no gastrointestinal disturbances, no erythroderma, no hematoma, no edema. Information on Lot/Batch has been requested.; Reported Cause(s) of Death: Sudden death by cardio respiratory arrest without any symptoms since the injection


VAERS ID: 996827 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Hypotension, Increased bronchial secretion, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: FUROSEMIDE; KARDEGIC; LERCANIDIPINE HCL; ESOMEPRAZOLE; DIFFU K; PIRACETAM; LAMOTRIGINE; TIAPRIDAL; PRAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden (but well aware); Dementia Alzheimer''s type; Epilepsy; Hypercholesterolemia; Hypertension arterial; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210116; Test Name: BP; Result Unstructured Data: Test Result:80/40 mmHg; Test Date: 20210116; Test Name: BP; Result Unstructured Data: Test Result:90/50 mmHg; Comments: At 6:45 p.m.; Test Date: 20210116; Test Name: TA; Result Unstructured Data: Test Result:120/60 mmHg; Test Date: 20210116; Test Name: Temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210116; Test Name: HR; Result Unstructured Data: Test Result:56; Comments: bpm; Test Date: 20210116; Test Name: pulse; Result Unstructured Data: Test Result:50; Comments: bpm; Test Date: 20210116; Test Name: pulse; Result Unstructured Data: Test Result:56; Comments: At 6:45 p.m.. bpm; Test Date: 20210116; Test Name: saturation; Test Result: 93 %; Test Date: 20210116; Test Name: saturation; Test Result: 73 %; Test Date: 20210116; Test Name: saturation; Test Result: 63 %; Comments: At 6:45 p.m. under 6L / min of O2
CDC Split Type: FRPFIZER INC2021078842

Write-up: Arterial oxygen saturation decreased; Increased bronchial secretion; Hypotension; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority FR-AFSSAPS-NY20210090. A 91-year-old female patient received BNT162B2 (COMIRNATY) (lot #: EJ6788) via intramuscular on 16Jan2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included epilepsy, dementia alzheimer''s type, bedridden but well aware, hypertension arterial, hypercholesterolemia, and stroke, all from an unknown date and unknown if ongoing. Concomitant medication included furosemide taken for hypertension arterial, acetylsalicylate lysine (KARDEGIC), lercanidipine HCL taken for hypertension arterial, esomeprazole, potassium chloride (DIFFU K), piracetam taken for epilepsy, lamotrigine, tiapride hydrochloride (TIAPRIDAL), prazepam. The patient experienced arterial oxygen saturation decreased, increased bronchial secretion and hypotension, all on 16Jan2021, seriousness of the events reported as death. Treatment was received for the events. The patient died on 16Jan2021. An autopsy was not performed. Clinical course: On 16Jan2020, at 10:15 a.m., the attending physician came to administer the BNT162B2 vaccine. At noon, the resident had a good lunch. She was then installed on a relax chair. At 2 p.m., she was found sweating with bronchial congestion. She was then installed in her bed in a semi-seated position. The constants were then not measurable because the resident was very agitated. Oxygen and suction device taken in the chamber. Call 15 at the same time. Medical opinion: in view of the residents age and her history, it was decided not to transport her to the hospital. The regulator instructed to put the patient under 2L / min of O2 and to perform a tracheal aspiration, which was done. Constants: Blood pressure (TA) 120/60 mm Hg, heart rate (HR) 56 bpm, saturation 93%. A doctor present on the site asks for an injection of adrenaline according to the protocol transmitted by the ARS (post vaccination). The resident weighing 38kg, an intramuscular injection of 0.38 mg of adrenaline was made and the oxygen was increased to 6L / min. At this time, saturation was 73%, pulse at 50 bpm, Temperature (T) at 36.2 Centigrade and Blood pressure (BP) at 80/40 mm Hg. Several tracheal aspirations are performed during the afternoon but without improvement. At 6:45 p.m., 63% saturation under 6L / min of O2, pulse at 56 bpm, BP at 90/50 mmHg. The resident had her eyes closed and no longer reacts to stimuli. The doctor present on site recommended monitoring at night. The night nurse was called by the resident''s daughter at around 10:30 p.m. because she was vomiting. The resident passed away at 11 p.m. Opinion of the attending physician: not in favor of a suspicion of pulmonary embolism, may be acute lung edema but no evidence to confirm it. Note the absence of abnormal pulmonary secretions before vaccination. Conclusion: 91-year-old woman, 38 kg, vaccinated by COMIRNATY who presents approximately 3 to 4 hours later with sweating, bronchial congestion, arterial desaturation and hypotension. Management by oxygen therapy and injection of adrenaline. No hospitalization. Unfavorable development with death in the evening.; Reported Cause(s) of Death: Arterial oxygen saturation decreased; Increased bronchial secretion; Hypotension


VAERS ID: 996874 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-05
   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: ALLOPURINOL; ACETYLSALICYLIC ACID; ATENOLOL; CO-CODAMOL; FENOFIBRATE; LOSARTAN; PROMETHAZINE HYDROCHLORIDE; ROSUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain; Dresslers syndrome; Hyperlipidaemia; Hypertension; IHD; Myocardial infarction; Myocardial ischaemia; Orthopaedic procedure; Poor quality sleep; Sciatica; Spinal decompression; Comments: PMH IHD from 2000 when he had MI + Dresslers syndrome BUT HAD BEEN STABLE FOR YEARS. No chest pain or breathlessness. Not needed to use GTN spray Main medical problem in past few months had been intractable back pain sciatica- was under orthopaedics - previous L4/5 decompression-awaiting result of recent EMG. He died suddenly on the evening of 5th January after finishing his evening meal The post mortem report stated the cause of death as : 1a : pulmonary oedema b : Ischaemic & Hypertensive Heart Disease 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: Test Name: EMG; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC2021080551

Write-up: heart failure; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202101261304036870, Safety Report Unique Identifier GB-MHRA-ADR 24648978. A 79-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EL0141), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunization. Medical history included IHD (ischemic heart disease) from 2000 when he had MI (myocardial infarction) and dresslers syndrome but they had been stable for years. Patient had no chest pain or breathlessness and did not need to use GTN spray. Main medical problem in past few months in 2020 included patient had intractable back pain, sciatica and was under orthopaedics. The patient previously had L4/5 decompression and was waiting result of recent EMG (electromyogram). Other medical history included myocardial ischaemia, hypertension, poor quality sleep and hyperlipidaemia. Concomitant medication included allopurinol, acetylsalicylic acid for prophylaxis, atenolol for myocardial ischaemia, codeine phosphate, paracetamol (CO-CODAMOL) for spinal decompression, fenofibrate for prophylaxis, losartan for hypertension, promethazine hydrochloride for poor quality sleep, rosuvastatin for hyperlipidaemia. The patient previously took the first dose of BNT162B2 on 14Dec2020 for COVID-19 immunization. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced heart failure on Jan2021 and died on 05Jan2021. Clinical information: reporter was reporting this as the vaccines were black triangle drugs, and patient died within 24 hours of his 2nd vaccine. He had no signs or symptoms suggestive of heart failure in the weeks before he died. The patient underwent lab tests and procedures which included EMG: unknown results on an unspecified date. The patient had not had a COVID-19 test. He died suddenly on the evening of 05Jan2021 after finishing his evening meal. Autopsy had been done. The post mortem report stated the cause of death as pulmonary oedema, ischaemic and hypertensive heart disease. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: heart failure; Autopsy-determined Cause(s) of Death: pulmonary oedema; Hypertensive Heart Disease; Ischaemic


VAERS ID: 996875 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-01-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0739 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; CODEINE; ASPIRIN [ACETYLSALICYLIC ACID]; SPIRONOLACTONE; EZETIMIBE; FLUOXETINE; ISMN; MORPHINE; OMEPRAZOLE; RAMIPRIL; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker user; IHD; Myocardial infarction; Percutaneous coronary intervention (following MI); Comments: Patient had known IHD - coronary PCI in 2016 following MI. Had a pacemaker, and was being considered by the cardiology team for implantable cardiac defibrillator. On multiple medications: bisoprolol, codiene, aspirin, spironolactone, ezetimibe, fluoxetine, ISMN, levo, morphine, omeprazole, ramipril, tamsulosin. 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 INC2021084750

Write-up: sounds like a fatal MI; sounds like a fatal MI; This is a spontaneous report from a contactable physician. This is a report received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202101271751159800, and reference number: GB-MHRA-ADR 24656397. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0739), via an unspecified route of administration on 24Jan2021 at single dose for covid-19 immunization. Medical history included known IHD, coronary PCI in 2016 following MI (Myocardial infarction). The patient had a pacemaker, and was being considered by the cardiology team for implantable cardiac defibrillator. 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 bisoprolol; codeine; (acetylsalicylic acid) ASPIRIN; spironolactone; ezetimibe; fluoxetine; isosorbide mononitrate (ISMN); levo; morphine, omeprazole, ramipril, tamsulosin. The patient had what sounds like a fatal MI on 26Jan2021 (2 days after his covid vaccine). Given his history of IHD, this is likely NOT due to the vaccine, but given the time frame, the reporter felt it prudent to report. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: sounds like a fatal MI


VAERS ID: 996892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-03
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: 2021-01-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021079740

Write-up: She passed away; This is a spontaneous report downloaded from the Medicines Agency (MA) WEB number IT-MINISAL02-655718] from a contactable physician. An 83-year-old female patient received bnt162b2 (COMIRNATY) (lot# EJ6797, exp date 30Apr2021), intramuscular, on 15Jan2021 at 12:00, at 0.3 ml single, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient passed away on 15Jan2021 at 14:50. 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: She passed away


VAERS ID: 996893 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-19
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-03
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Basal cell epithelioma; Dementia; Hypertension arterial; Postictal state; Renal anaemia; Renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021079653

Write-up: multiple chronic disease patient died 8 days post vaccination, no adverse reactions between vaccination and death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, Regulatory Authority number: IT-MINISAL02-656776. An 88-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number: EL1484, expiration date: 30Apr2021) Intramuscular at left arm (left shoulder) on 11Jan2021 at single dose for COVID-19 vaccination. Medical history included hypertension arterial, basal cell epithelioma, dementia, renal failure, AFib, postictal state and renal anaemia, all from unspecified date and unknown if ongoing. Concomitant medications were not reported. It was reported multiple chronic disease patient died 8 days post vaccination (19Jan2021), no adverse reactions between vaccination and death. It was unknown if autopsy was done. Reporter''s comments: I report this case only for scruple. No follow-up attempts possible. No further information expected.; Reporter''s Comments: I report this case only for scruple.; Reported Cause(s) of Death: multiple chronic disease patient died 8 days post vaccination


VAERS ID: 996986 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ELO141 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Chills, Diarrhoea, Dyspnoea, Dysuria, Electrocardiogram, Pyrexia, Rash, Rash macular, Retching, Vascular dementia
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
   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 FUMARATE; CLOPIDOGREL; LEVOTHYROXINE SODIUM; ASPIRIN [ACETYLSALICYLIC ACID]; RAMIPRIL; VITAMIN D NOS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Aortic bypass; Aortic valve disease; Bronchiectasis (unconscious in itu for 5 months in 2009 following vascular surgery with some bronchiectasis); Chronic kidney disease; Coronary stent user; Dementia; Gout; Myxoedema; Peripheral arterial disease; Ulcers of extremities (dry toe ulcers); Ureteral stent insertion
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: Body temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Test Date: 20210107; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Nil acute
CDC Split Type: GBPFIZER INC2021020101

Write-up: Rash macular; vascular dementia; Fever; Acute dyspnoea; Altered state of consciousness; possible dysuria; transient facial rash; retching; prolonged rigors; acute diarrhoea; This is a spontaneous report from two contactable physicians. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-EYC 00237097, Safety Report Unique Identifier GB-MHRA-ADR 24560862, GB-MHRA-TPD-00238125, GB-MHRA-ADR 24612966. A 94-years-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # ELO141) , intramuscular on 05Jan2021 at single dose for covid-19 immunisation. He received the first dose bnt162b2 on 11Dec2020 17:30 for covid-19 immunisation. Medical history included allergic, chronic kidney disease, Ureteric stent, Coronary stent, Aortic graft, Myxoedema, gout, Early dementia, Peripheral arterial disease, Ulcers of extremities, Aortic valve disease. Concomitant medication included bisoprolol fumarate, clopidogrel, levothyroxine sodium, aspirin (ASPIRIN), ramipril, vitamin d nos. The patient experienced vascular dementia on 09Jan2021 , acute diarrhea on 05Jan2021, prolonged rigors on 05Jan2021 19:00, fever, acute dyspnea, altered state of consciousness, possible dysuria on 07Jan2021, retching on 05Jan2021 20:00, transient facial rash on 05Jan2021 20:45 , rash macular on an unspecified date. The patient received paracetamol for acute diarrhoea, prolonged rigors. Given Fosfomycin for acute dyspnoea, possible dysuria, slight alteration conscious level. The patient underwent lab tests and procedures which included body temperature: 38.8 centigrade on 07Jan2021, electrocardiogram: nil acute on 07Jan2021. The patient died on 09Jan2021 in his sleep. Cause of death given as frailty of old age, vascular dementia. It was not reported if an autopsy was performed. The outcome of event Vascular dementia was fatal; outcome of event acute diarrhoea was recovered on 06Jan2021; outcome of event acute Chills, retching, Facial rash was recovered on 05Jan2021; outcome of event Fever, Altered state of consciousness, possible dysuria was recovered. outcome of event Acute dyspnea was recovered on 07Jan2021; outcome of other events was unknown. No follow-up attempts are possible. No further information is expected. Follow-up (27Jan2021): This is a follow-up report combining information from duplicate reports 2021020101 and 2021055874. The current and all subsequent follow-up information will be reported under manufacturer report number 2021020101. The new information reported from two contactable physicians includes: medical history, lab data, concomitant drug added, event Fever, Acute dyspnea, Altered state of consciousness, Dysuria added. the case upgraded to serious. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vascular dementia


VAERS ID: 997256 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Facial paralysis, Haemorrhagic stroke, Hemiparesis, Pneumonia aspiration, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: CT head; Result Unstructured Data: Test Result:confirmed R Thalamic bleed; Test Date: 202101; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative
CDC Split Type: GBPFIZER INC2021076965

Write-up: aspiration pneumonia; L sided facial droop and weakness; L sided facial droop and weakness; Haemorrhagic stroke; This is a spontaneous report from a contactable physician by Pfizer from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202101251108186060, safety report unique identifier GB-MHRA-ADR 24641370. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number not reported), via an unspecified route of administration at single dose on 13Jan2021 15:15 for Covid-19 immunisation. The patient medical history was not reported. Concomitant medication included metformin for diabetes mellitus. The patient experienced haemorrhagic stroke on 13Jan2021, aspiration pneumonia on an unspecified date, L sided facial droop and weakness on 13Jan2021 at 15:25with outcome of unknown. The patient underwent lab tests and procedures which included in Jan2021: sars-cov-2 test: negative; CT head confirmed R Thalamic bleed. The patient died on 21Jan2021 from aspiration pneumonia caused by the stroke. It was not reported if an autopsy was performed. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. No follow up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: aspiration pneumonia caused by the stroke; aspiration pneumonia caused by the stroke


VAERS ID: 999464 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
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 EJ6797 / 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: BLOPRESS; CLOPIDOGREL GENERICON; CETIRIZINE; NOVOMIX; GENTEAL HA; VITA POS; TEEBAUM OEL; AMLODIPIN GENERICON; DIPROGENTA; URBASON [METHYLPREDNISOLONE]; ADENURIC; BALNEUM HERMAL; ATARAX [HYDROXYZINE HYDROCHLORIDE]; PANTOLOC [PANTOPRAZOLE]
Current Illness: Adipositas (Adipositas); Arterial hypertension (essential (primary) hypertension); Carotid artery stenosis (stenosis of the carotid artery near the outlet); Cholecystitis chronic (chron. Cholecystitis and Pericholecystitis); Hypercholesteraemia (Hypercholesterinaemia); Hyperuricaemia; Type II diabetes mellitus (DM Typ II)
Preexisting Conditions: Medical History/Concurrent Conditions: Below knee amputation (status post. lower leg Amputation left); Cholecystolithiasis; Chronic eczema; Esophageal varices; Hypothyreosis (latent hypothyroidism); Iron deficiency anaemia (Iron deficiency anemia); Osteomyelitis of the foot (status post Osteomyelitis cakcaneus right); Percutaneous transluminal coronary angioplasty; Peripheral arterial occlusive disease Fontaine stage III (Peripheral artery disease right with popliteal stenosis right); Peripheral arterial occlusive disease Fontaine stage IV (Peripheral artery disease IV left of the US type); Popliteal stenosis; Renal insufficiency (status post acute renal insufficiency under NSAIDs, ACE inhibitors, oral antidiabetic drugs); Ulcus cruris (Ulcus cruris calcanei dx rez Ulcera heel right and amputation stump left)
Allergies:
Diagnostic Lab Data: Test Date: 20201230; Test Name: COVID-19 antigen test; Result Unstructured Data: Test Result:Negative; Comments: Reason for test: was on 25Dec2020 with relatives; Test Date: 20201104; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:Negative; Comments: On 04Nov2020, a PCR test was carried out in the house for everyone because one of the residents was ill
CDC Split Type: ATPFIZER INC2021083549

Write-up: Found dead a few days later; This is a spontaneous report from a contactable physician downloaded from the (MA) Agency-WEB AT-BASGAGES-2021-00453. A 73-year-old male patient received bnt162b2 (COMIRNATY; Lot # EJ6797) vaccine, via an unspecified route of administration on 13Jan2021 12:00 at single dose for Covid-19 immunisation. Medical history included Type II diabetes mellitus (continuing), Chronic eczema, Hyperuricaemia (continuing), Ulcus cruris (2019), Peripheral arterial occlusive disease Fontaine stage IV, Peripheral arterial occlusive disease Fontaine stage III, Popliteal stenosis, Percutaneous transluminal coronary angioplasty in Jun20008 and Jan2009, Below knee amputation (1999), Osteomyelitis of the foot(2008), Cholecystitis chronic Cholecystolithiasis, Esophageal varices, Hypothyreosis, Iron deficiency anaemia, Adipositas, Hypercholesteraemia, Carotid artery stenosis Arterial hypertension, Renal insufficiency. Concomitant medication included candesartan cilexetil (BLOPRESS), clopidogrel besylate (CLOPIDOGREL GENERICON), cetirizine (CETIRIZINE), insulin aspart, insulin aspart protamine (crystalline) (NOVOMIX), hyaluronate sodium (GENTEAL HA) , retinol palmitate (VITA POS), melaleuca alternifolia oil (TEEBAUM OEL), amlodipine mesilate (AMLODIPIN GENERICON), betamethasone dipropionate, gentamicin sulfate (DIPROGENTA), methylprednisolone (URBASON [METHYLPREDNISOLONE]) , febuxostat (ADENURIC), glycine max seed oil (BALNEUM HERMAL), hydroxyzine hydrochloride (ATARAX [HYDROXYZINE HYDROCHLORIDE]), pantoprazole (PANTOLOC [PANTOPRAZOLE]). The patient found dead on Jan2021 a few days after receiving the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 30Dec2020, Sars-cov-2 test: negative on 04Nov2020. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cause of death not specified


VAERS ID: 999465 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-21
   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 EL1491 / 1 - / OT

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

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: SEROQUEL; CANDEBLO
Current Illness: Depression (Depression); Hiatus hernia (Hiatal hernia); Hypovitaminosis D (AD hypovitaminosis); Sleep disorder; Vitamin A deficiency (AD hypovitaminosis)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021089019

Write-up: Letal death; This is a spontaneous report from a contactable healthcare professional downloaded from the database AT-BASGAGES-2021-00612. An 85-year-old female patient started to receive the first dose of BNT162B2 (COMIRNATY, lot: EL1491), intramuscularly on 19Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing depression, hypovitaminosis D, vitamin A deficiency, sleep disorder, and hiatus hernia. Concomitant medications included quetiapine fumarate (SEROQUEL), and candesartan cilexetil (CANDEBLO). On 21Jan2021, the patient experienced Death NOS (letal death). Outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Letal death


VAERS ID: 999467 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-17
   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 EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, 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) (narrow), Acute central respiratory depression (broad), Respiratory failure (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VENLAFAXINE; CALCIUM CARBONATE; ASAFLOW; DILTIAZEM; PANTOPRAZOLE; MEDROL [METHYLPREDNISOLONE ACETATE]; OLMESARTAN; AMLOR; ZOCOR
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021083303

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the database. Regulatory Authority number BE-FAMHP-DHH-N2021-75590. A 72-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY) (lot# EM0477), via an unspecified route of administration, on 16Jan2021, at single dose, for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included venlafaxine (unknown manufacturer), calcium carbonate (unknown manufacturer), acetylsalicylic acid (ASAFLOW), diltiazem (unknown manufacturer), pantoprazole (unknown manufacturer), methylprednisolone acetate (MEDROL), olmesartan (unknown manufacturer), amlodipine besilate (AMLOR), simvastatin (ZOCOR). The patient experienced cardio-respiratory arrest on 17Jan2021 with fatal outcome the same day. Patient had cardiopulmonary respiratory arrest at home at the end of 17Jan2021 evening and died at the hospital at 11:40 PM. Therapeutic measures were taken as a result the event and included cardiopulmonary resuscitation. It was not reported if an autopsy was performed. Patient''s notes: pulmonary fibrosis and severe deterioration of general condition. Reporter''s comment: patient had cardiopulmonary respiratory arrest on 17Jan2021 at home at the end of the evening, died at the hospital at 11:40 p.m. (i.e.$g 30 hours after vaccination) No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Patient had cardiopulmonary respiratory arrest on 17Jan2021 at home at the end of the evening, died at the hospital at 11:40 p.m. (i.e.$g 30 hours after vaccination). ADR treatment: Yes: Cardiopulmonary resuscitation.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 999468 (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: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Death, Restlessness
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   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: Atrial fibrillation; Dementia; Pulmonary embolism; Venous ulceration
Allergies:
Diagnostic Lab Data: Test Name: Body mass index; Result Unstructured Data: Test Result:around 30
CDC Split Type: BEPFIZER INC2021083307

Write-up: Agitation; restlessness; This is as spontaneous report from a contactable physician received from the Regulatory Authority, downloaded from the database (regulatory authority report number BE-FAMHP-DHH-N2021-75638). A 92-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included venous ulcer, pulmonary embolism, atrial fibrillation and dementia. The patient had a BMI around 30. Concomitant medications were not reported. On 16Jan2021, the patient experienced restlessness with outcome of unknown and agitation and on 18Jan2021 she died. The reporter specified that her son died of COVID a few months earlier and since then she has shown a let-down and a will not to live anymore. She was vaccinated on 15Jan2021 and started showing signs of restlessness on 16Jan2021 evening. No fever or diarrhea. The outcome of the event agitation was reported as fatal. An autopsy was not performed. Reporter''s comment: 92-year-old patient. BMI +/- 30. Important medical history: Venous ulcer, pulmonary embolism, atrial fibrillation, dementia. Her son died of covid a few months earlier and since then she has shown a let-down and a will not to live anymore. She was vaccinated on Friday and started showing signs of restlessness on Saturday evening. No fever or diarrhea. No follow-up attempts are possible, information about batch number cannot be obtained.; Reporter''s Comments: 92-year-old patient. BMI +/- 30. Important medical history: Venous ulcer, pulmonary embolism, atrial fibrillation, dementia. Her son died of covid a few months earlier and since then she has shown a let-down and a will not to live anymore. She was vaccinated on Friday and started showing signs of restlessness on Saturday evening. No fever or diarrhea.; Reported Cause(s) of Death: Agitation


VAERS ID: 999469 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Death, Diabetic complication, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (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), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency; Diabetic complication; Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021083309

Write-up: Diabetic complication; Renal insufficiency; Cardiac insufficiency; This is a spontaneous report from a contactable other HCP received via Regulatory Authority downloaded from the database (EMA) BE-FAMHP-DHH-N2021-75648. A 60-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number EM0477) via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 vaccination. The patient''s medical history included cardiac insufficiency, renal insufficiency and diabetic complication. The patient suffered from cardiac insufficiency, renal insufficiency and diabetic complication during treatment with BNT162B2. The patient died on 14Jan2021. It was not reported if an autopsy was performed. The outcome of the events cardiac insufficiency, renal insufficiency and diabetic complication was fatal. Reporter''s comment: The problems were also there before the vaccination, so probably not linked. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: The problems were also there before the vaccination, so probably not linked.; Reported Cause(s) of Death: cardiac insufficiency; renal insufficiency; diabetic complication


VAERS ID: 999480 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-18
   Days after vaccination:18
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: Arrhythmia, Death, Multimorbidity, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure chronic; Chronic renal insufficiency; Dementia; Parkinson''s disease
Preexisting Conditions: Medical History/Concurrent Conditions: Bundle branch block left; Hypertensive crisis; Infarct myocardial; Stethalgia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021088220

Write-up: Ventricular fibrillation; This is a spontaneous report from a non-contactable physician downloaded from the database [Regulatory Authority number DE-DCGMA-21187603]. An 85-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular, on 31Dec2020, at single dose, for COVID-19 immunisation. Medical history included ongoing Parkinson''s disease, hypertensive crisis (unknown if ongoing), ongoing cardiac failure chronic, infarct myocardial (not ongoing), stethalgia (unknown if ongoing), ongoing dementia, ongoing chronic renal insufficiency, bundle branch block left (unknown if ongoing). Concomitant medications were not reported. The patient experienced ventricular fibrillation on 18Jan2021. Shocking and cardiopulmonary resuscitation (CPR) were performed. The patient was hospitalized due to the event in Jan2021. The patient died on 19Jan2021 due to multimorbidity, cardiac arrhythmia and ventricular fibrillation. It was not reported if an autopsy was performed. Reporter comment: Measures: Initial restoration of the circulation after shocking and CPR on 18Jan2021. No resuscitation measures, no artificial ventilation and no intensive medical therapy desired on the part of the family. Thus regular ward. Development of aspiration pneumonia. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Ventricular fibrillation; Multimorbidity; Cardiac arrhythmia


VAERS ID: 999484 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-01
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Death, Dyspnoea, General physical health deterioration, Pain, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blind (almost); Dementia (mild)
Allergies:
Diagnostic Lab Data: Test Name: coronavirus test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021082733

Write-up: corona test was positive; corona test was positive; Weakness; Pain (morphine administration); Shortness of breath; Unresponsive; Deterioration in general condition; This is a spontaneous report from a non-contactable consumer downloaded from the database. The regulatory authority report number is DE-PEI-CADRPEI-2021012826. A 91-year-old female patient received BNT162B2 (COMIRNATY; Lot number unknown), via an unspecified route of administration on 30Dec2020 as single dose for covid-19 immunization. Medical history included being almost blind and mild dementia from an unknown date. The patient''s concomitant medications were not reported. On an unspecified date, corona test was positive. On 01Jan2021, the patient experienced fatal events weakness, pain, shortness of breath, death after corona vaccination, unresponsive and deterioration in general condition. The patient underwent lab tests and procedures which included coronavirus test: positive an unspecified date. Detailed event description were as follows: Patient was vaccinated on 30Dec2020. On 01Jan2021, she became ill, was weak and had shortness of breath, was given oxygen, was on a drip, and was hardly responsive. The corona test was positive, date unspecified . After a few days she felt a little better; patient was even able to speak on the phone. Her condition deteriorated rapidly, she was now also in severe pain, and the doctor administered morphine. The patient passed away on the morning of 17Jan2021. Therapeutic measures were taken as a result of weakness, pain and shortness of breath as aforementioned. The patient died on 17Jan2021. It was not reported if an autopsy was performed. Senders comment: Almost blind, mild dementia, otherwise healthy and still mobile. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 999488 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-20
   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 - / -

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: 2021-01-20
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021082665

Write-up: Sudden death, unknown cause; This is a spontaneous report from a non-contactable physician downloaded from the database. This is a report received from the Regulatory Authority. Regulatory authority report number was DE-PEI-PEI2021001410. An 82-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EM0477), via an unspecified route of administration on 17Jan2021 (at the age of 82-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 20Jan2021, the patient experienced sudden death due to an unknown cause. It was not reported if an autopsy was performed. The regulatory authority assessed the causality between the sudden death and vaccine as unclassifiable. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 999489 (history)  
Form: Version 2.0  
Age: 94.0  
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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Death
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? 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: Adipositas
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021083029

Write-up: Collapse on the edge of the bed before going to the toilet; This is a spontaneous report from a non-contactable physician downloaded from the database regulatory authority, DE-PEI-PEI2021001427. A 94-year-old female patient received the second dose of bnt162b2 (COMIRNATY, batch no. was not reported), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included adipositas from an unknown date and unknown if ongoing. The concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY, batch no. was not reported) on 27Dec2020 for COVID-19 immunisation. The patient experienced collapse on the edge of the bed before going to the toilet in Jan2021. Death cause was reported as circulatory collapse. The patient died in Jan2021. It was not reported if an autopsy was performed. Reporter''s comments: Pulmonary embolism conceivable in obese patients. Event/ Unclassifiable. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Collapse on the edge of the bed before going to the toilet


VAERS ID: 999490 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-22
   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 - / UNK - / -

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

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:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021083037

Write-up: Asystolia; Collapse circulatory; This is a spontaneous report from a non-contactable physician downloaded from the database DE-PEI-PEI2021001474. An 84-year-old female received bnt162b2 (COMIRNATY, batch/lot number and expiration date not provided), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation. Medical history included dementia and atrial fibrillation, both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 22Jan2021 after vaccination the patient developed Death and Collapse circulatory and Asystolia, lasting for unknown. The patient is dead. The outcome of the events was fatal. The patient died on 22Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Collapse; Asystolia


VAERS ID: 999491 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
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 EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021083035

Write-up: Arteriosclerosis; This is a spontaneous report from a non-contactable physician downloaded from the database DE-PEI-PEI2021001475. A 90-year-old female patient received bnt162b2 (COMIRNATY) (batch/lot number: EM0477) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included Arteriosclerosis and Dementia, both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. 60 minute(s) after vaccination the patient developed death. It was reported that patient fall in front of the bed, patient dead on an unspecified date. Death cause was reported as Arteriosclerosis. It was not reported if an autopsy was performed. The outcome of the event was fatal. Relatedness of drug to reaction(s)/event(s): Source of assessment: regulatory authority. Result of Assessment: D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Arteriosclerosis


VAERS ID: 999494 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2021-01-21
   Days after vaccination:23
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: Asthenia, Death, Dyspnoea, Hypotension, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021082664

Write-up: Death; Fever; Weakness; Dyspnoea; Hypotension; This is a spontaneous report from a non-contactable physician downloaded from the database [DE-PEI-PEI2021001479]. An 80-year-old female patient received BNT162B2 (COMIRNATY) at single dose on 29Dec2020 for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 21Jan2021, 23 days after vaccination, the patient developed fever, weakness, dyspnea, hypotension and unknown cause of death (as reported), lasting for unknown. The patient was dead on 21Jan2021. Death cause was reported as unknown cause of death. It was unknown if an autopsy was performed or not. The outcome of events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Dyspnoea; Hypotension; Fever; Weakness; Unknown cause of death


VAERS ID: 999495 (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: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Nausea, Personality change, Renal failure, Unresponsive to stimuli, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   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: Atrial fibrillation; Chronic renal insufficiency; Femoral neck fracture; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021088234

Write-up: Death; Blood pressure cannot be measured; Renal failure/Medical history included chronic renal insufficiency; Vomiting; unresponsive; Personality change; Nausea; This is a spontaneous report from a non-contactable downloaded from the Agency Regulatory Authority-WEB. Regulatory authority report number IS DE-PEI-PEI2021001511. A female patient of an unspecified age received BNT162B2 (COMIRNATY; Lot number EM0477), via an unspecified route of administration on 19Jan2021 as single dose for covid-19 immunization. Medical history included chronic renal insufficiency, osteoporosis, femoral neck fracture from and atrial fibrillation from unknown dates and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced the following events, which were serious as they lead to death: vomiting on 20Jan2021; unresponsive on 20Jan2021; personality change on 20Jan2021; nausea on 20Jan2021; death on 21Jan2021; blood pressure cannot be measured on 21Jan2021; renal failure on 21Jan2021. Details were as follows: On 20Jan2021, after vaccination, the patient developed nausea, vomiting, personality change, unresponsive to verbal stimuli and blood pressure immeasurable, renal failure and unknown cause of death, lasting for unknown duration. The patient died on 21Jan2021. It was not reported if an autopsy was performed. Death cause was reported as renal failure. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Renal failure


VAERS ID: 999496 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-23
Onset:2021-01-20
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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: 2021-01-20
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aggression; Arteriosclerosis; Atrial fibrillation; Depression; Disorientation (Gerontopsychological abnormalities); Fall; Myocardial infarction; Osteomyelitis; Recurrent urinary tract infection; Stroke; Transient ischemic attack
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:negative; Comments: negative; Test Date: 20210120; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:positive; Comments: positive
CDC Split Type: DEPFIZER INC2021088245

Write-up: Death; SARS-CoV-2 test with positive result; SARS-CoV-2 test with positive result; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-PEI2021001558 and received via Regulatory Authority. An 84-year(s)-old male patient was vaccinated with the first dose of BNT162B2 (COMIRNATY, Lot number: not reported) at single dose for COVID-19 immunisation on 23Dec2020. Relevant history included Osteomyelitis, Arteriosclerosis, Myocardial infarction, Depression, Aggression, Recurrent urinary tract infection, Transient ischemic attack, Atrial fibrillation, Fall, Stroke, Disorientation. Relevant concomitant was not reported. The patient was dead on 20Jan2021, 29 day(s) after the vaccination. The cause of death was unknown. It was unknown if the autopsy was performed or not. Relevant lab tests included SARS-CoV-2 test with negative result on unknown date; SARS-CoV-2 test with positive result on 20Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 999504 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-28
Onset:2021-01-11
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J6796 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 13
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: Cardiovascular disorder (excluding hypertension); Living in nursing home; Comments: Enfermedad cardiovascular (excluida la HTA)
Allergies:
Diagnostic Lab Data: Test Date: 20210112; Test Name: temperature; Result Unstructured Data: Test Result:37.5 degrees; Test Date: 20210112; Test Name: heart rate (Fc); Result Unstructured Data: Test Result:bpm; Test Date: 20210112; Test Name: oxygen saturation (SaO2); Result Unstructured Data: Test Result:88-89 %; Test Date: 20210111; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: ESPFIZER INC2021088765

Write-up: cardiorespiratory arrest; COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report a contactable pharmacist downloaded from the Agency Agency-WEB (ES-AEMPS-726724). An 82-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot number: J6796), intramuscularly in the right arm, on 28Dec2020 at a single dose for COVID-19 immunisation. Medical history included cardiovascular disorder (excluding hypertension) and nursing home resident. The patient''s concomitant medications were not reported. The patient experienced COVID-19 pneumonia on 11Jan2021 and cardiorespiratory arrest on 24Jan2021, which caused hospitalization and was reported as fatal. The clinical course was reported as follows: The patient was in a nursing home with no previous diagnosis or suspicion of COVID-19 and was vaccinated on 28Dec2020. On 11Jan2021, an COVID-19 antigen test was performed with a positive result. On 12Jan2021, the patient started to have symptoms of dyspnea, fatigue, oxygen saturation (SaO2): 88-89% without oxygen, heart rate (Fc): 90 beats per minute (bpm), temperature: 37.5 degrees, and vesicular murmur with crackling, for which he was referred to the hospital. After initial improvement and maintenance of stable SaO2 with oxygen, the patient died on 24Jan2021 due to cardiorespiratory arrest due to COVID-19 pneumonia. The patient died on 24Jan2021. The cause of death was reported as COVID-19 pneumonia and cardiorespiratory arrest. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia; cardiorespiratory arrest


VAERS ID: 999507 (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: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, Dyspnoea, General physical health deterioration, Pyrexia, Rash macular
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE; RISPERDAL; ENTOCORT; OPAMOX; SOMAC; HIDRASEC; THYROXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Anemia; Biliary pancreatitis (In 2016 hospitalization due to suspected biliary pancreatitis.); Cholecystitis; Dementia (Due to dementia in a nursing home from 7/15.); Diarrhea; Diverticulosis; Hypothyroidism; Inguinal hernia; Intestinal bleeding; Pneumonia; Subdural hematoma (In 2011 chronic subdural hematomas were treated x3.); Thrombus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021083336

Write-up: Pyrexia; Skin blotches; Dyspnoea; General physical health deterioration; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB FI-FIMEA-20210194. A 93-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 08Jan2021 at single dose for covid-19 immunisation. The patient medical history included Alzheimer''s disease (2014). Hypothyroidism, diverticulosis, large inguinal hernia on the right. In 2011 chronic subdural hematomas were treated x3. 2013 cholecystitis. In 2016 hospitalization due to suspected biliary pancreatitis. In 2017 anemia, intestinal bleeding. In 2019 pneumonia and lower limb thrombus. Due to dementia in a nursing home from 7/15. Diarrhea symptom for years with drug trials. Diarrhea worsened in the fall and since then varied with occasional severe diarrhea that worsened general well-being. Eating and drinking have become bad and food has not been absorbed. Started with Entocort 9 mg and hidrasec 5.1.2021, by the end of the week diarrhea clearly decreased. Concomitant medication included sertraline, risperidone (RISPERDAL), budesonide (ENTOCORT), oxazepam (OPAMOX), pantoprazole sodium sesquihydrate (SOMAC), racecadotril (HIDRASEC), levothyroxine sodium (THYROXIN). The patient experienced pyrexia (death) on 09Jan2021, skin blotches (death) on 09Jan2021, dyspnoea (death) on 09Jan2021, general physical health deterioration (death) on 09Jan2021. Received the COVID vaccine on 8.1, after a couple of hours later there was shortness of breath and spotted areas in the legs. General condition stabilized, breathing calmed down, and an ambulance checked the situation. Quick-crp 5, no fever. Fallen asleep. The next day 9.1. in the morning refreshed, came back to be a former self and ate normal lunch in the dayroom sitting in a G-chair. In the afternoon fever ad 37.9, general condition worsened, breathing became difficult again, stayed in bed, and has no longer taken anything orally. The patient died on 12Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 999508 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-22
   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, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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: Hypertension arterial; Hyperthyroidism; Supraventricular tachyarrhythmia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: oxygen saturation; Result Unstructured Data: Test Result:usually around 91-92 %; Test Date: 20210122; Test Name: oxygen saturation; Test Result: 88 %; Comments: decreased; Test Date: 20210122; Test Name: oxygen saturation; Test Result: 80 %
CDC Split Type: FRPFIZER INC2021088291

Write-up: Oxygen saturation decreased; This is a spontaneous report from a contactable physician downloaded from the Agency. The regulatory authority report number is FR-AFSSAPS-CF20210094. A 93-years-old female patient received the first dose of bnt162b2 (COMIRNATY, batch/lot number EJ6796) , intramuscular at left arm on 21Jan2021 2pm at 0.3 mL, single for covid-19 immunization. Medical history included ongoing hyperthyroidism, ongoing supraventricular tachyarrhythmia, ongoing hypertension arterial. No history of Covid-19. The patient''s concomitant medications were not reported. The patient experienced oxygen saturation decreased on 22Jan2021 with outcome of fatal. Lab data included within 24 hours after the injection, on 22Jan2021 an oxygen desaturation occured at level 88% (usually around 91-92%), demanding oxygen in the evening, saturation at level 80%. The patient died on 23Jan2021 in the morning. It was not reported if an autopsy was performed. The cause of death was oxygen saturation decreased. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Oxygen saturation decreased


VAERS ID: 999509 (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: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EF6795 / 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: 2021-01-21
   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: Compression of fractured vertebra; Endobrachyoesophagus; Essential hypertension (primary); Failure respiratory; Progressive fibrosing interstitial lung disease (under NIV and O2); Stroke (not specified as being hemorrhagic or by infarction); Syndrome sicca
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: vital signs; Result Unstructured Data: Test Result:normal; Test Date: 20210121; Test Name: vital signs; Result Unstructured Data: Test Result:cardio-respiratory arrest
CDC Split Type: FRPFIZER INC2021088218

Write-up: Death unexplained/sudden death; This is a spontaneous report from a contactable physician downloaded from the AGENCY -WEB FR-AFSSAPS-PA20210105. A 70-year-old female patient received bnt162b2 (COMIRNATY) (lot number EF6795), intramuscular on 20Jan2021 15:05 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Medical history included syndrome sicca; endobrachyoesophagus; respiratory failure with fibrosing interstitial lung diseases under NIV and O2, essential hypertension (primary); stroke, not specified as being hemorrhagic or by infarction; vertebral compression; all from an unknown date and unknown if ongoing. The patient''s concomitant medications included unspecified medication. On 21Jan2021, sudden death of the resident in the morning at 10:10 a.m. Normal checking vital signs before and after vaccination, patient on 2.5L of O2 started on the day before vaccination (patient was regularly on O2). Patient in her usual state in the morning after getting up, took her medication in the morning. Nurse put her aerosol on and a few minutes later when another nurse was checking vital signs, a resident found in cardio-respiratory arrest, sitting leaning on her bed. The patient died on 21Jan2021. 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/sudden death


VAERS ID: 999514 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
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 EK4243 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dilatation atrial; Left ventricular hypertrophy; Palpitations
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac MRI (results awaited, specialist informed); SARS-CoV-2 test positive
Allergies:
Diagnostic Lab Data: Test Name: Muscle biopsy; Result Unstructured Data: Test Result:heart muscle biopsies awaited; Test Date: 20210120; Test Name: Heart rate; Result Unstructured Data: Test Result:29
CDC Split Type: GBPFIZER INC2021084552

Write-up: Cardiac arrest; a sore arm; tired; Bradycardia; This is a spontaneous report from a contactable physician received from the RA. Regulatory authority report number GB-MHRA-ADR 24646306. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EK4243), via an unspecified route of administration at single dose on 19Jan2021 at 16:35 for Covid-19 immunisation. Medical history included ongoing left ventricular hypertrophy, ongoing atrial dilation, palpitations from Dec2020 and ongoing , sars-cov-2 test positive in Dec2020, magnetic resonance imaging heart (results awaited, specialist informed). Concomitant medications were not reported. The patient experienced bradycardia on an unspecified date in Jan2021 with outcome of not recovered, pain in extremity on 19Jan2021 with outcome of not recovered, fatigue on 19Jan2021 with outcome of not recovered, cardiac arrest (death) on 20Jan2021. The patient underwent lab tests and procedures which included biopsy muscle: heart muscle biopsies awaited on unknwn date, heart rate: 29 on 20Jan2021. Therapeutic measures were taken as a result of fatigue. The patient died on 20Jan2021. An autopsy was performed and results were not provided. The patient was extremely fit, ultra marathon runner who was complaining only of a sore arm of day of vaccination (19Jan2021) although tired so slept in separate room to wife. ''Garmin'' notes profound bradycardia 29 with heart stopping 03:10 i.e. no signs anaphylaxis. Impression: Presumption is cardiac cause, probably unrelated to Covid vaccination. Post Mortem results to follow: Post Mortem result on Friday 22nd January 2021: inconclusive. Cardiologist has suggested that an inflammatory response to vaccine may be a cause. He is now liaising with pathologist and heart muscle biopsies awaited 6/52. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 999520 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
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 - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anal incontinence, Cardiac arrest, Chest pain, Death, Dyspnoea, Muscular weakness, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Noninfectious diarrhoea (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; DOSULEPIN; DULOXETINE; PREDNISOLONE; PROMETHAZINE HYDROCHLORIDE
Current Illness: Caregiver (Has a carer); Chronic obstructive pulmonary disease; Dementia; Depressive disorder; Dyspnea; Ear wax removal; Ex-smoker; Gout; Heart failure; Hepatic steatosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200818; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Basophil count; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Blood albumin; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Blood alkaline phosphatase; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Blood bilirubin; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Blood creatinine; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Blood electrolytes; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Blood folate; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Blood potassium; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200729; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200821; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Blood sodium; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Blood test; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Blood thyroid stimulating hormone; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Blood urea; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200305; Test Name: Computerised tomogram abdomen; Result Unstructured Data: Test Result:unknwn results; Test Date: 20210111; Test Name: Creatinine renal clearance; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Eosinophil count; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Full blood count; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Glomerular filtration rate; Result Unstructured Data: Test Result:Estimated; Test Date: 20200818; Test Name: Glycosylated haemoglobin; Result Unstructured Data: Test Result:unknwn results; Comments: Haemoglobin A1c level; Test Date: 20200818; Test Name: Haematocrit; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Haemoglobin; Result Unstructured Data: Test Result:Estimation; Test Date: 20200818; Test Name: Heart rate; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Liver function test; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Lymphocyte count; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Mean cell haemoglobin; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Mean cell volume; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Mean platelet volume; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Monocyte count; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Neutrophil count; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: , Serum N-terminal pro B-type natriuretic peptide concentration; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200729; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Platelet count; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Platelet distribution width; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Plateletcrit; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: Red blood cell count; Result Unstructured Data: Test Result:unknwn results; Test Date: 20200818; Test Name: White blood cell count; Result Unstructured Data: Test Result:unknwn results
CDC Split Type: GBPFIZER INC2021096242

Write-up: Cardiac arrest; Weakness of leg; Chest pain; Anal incontinence/faecal/ urinary incontinence; Urinary incontinence; Dyspnoea/breathlessness; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-EMIS-418-7f3e7af1-1ad3-4f0d-a96f-732929335a69 and GB-MHRA-ADR 24654897. A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included gout from 11Jan2021 and ongoing, gout from 23Dec2020 and ongoing, ongoing dementia, ongoing cardiac failure, ongoing depression, caregiver from 28Oct2020 and ongoing (Has a carer), dyspnoea from 01Sep2020 and ongoing, dyspnoea from 21Aug2020 and ongoing, dyspnoea from 13Aug2020 and ongoing, Dyspnoea from 29Jul2020 and ongoing, ongoing Chronic obstructive pulmonary disease, Ex-tobacco user from 22Jul2020 and ongoing, Hepatic steatosis from 13May2020 and ongoing, Cerumen removal from 09Mar2020 and ongoing. Concomitant medication included allopurinol from 23Dec2020 for Gout, dosulepin from 11Nov2020 to 24Dec2020, duloxetine from 18Dec2020 for Depression, prednisolone from 23Dec2020, promethazine hydrochloride from 11Nov2020. The patient previously took ANGIOTENSIN II ANTAGONIST NOS and experienced drug intolerance. The patient has some chest pain after the vaccination in Jan2021. Then developed bilateral weakness of legs on 22Jan2021 with faecal/ urinary incontinence. Didn''t seek medical advice until 26Jan2021 when concerned about his breathlessness in Jan2021. Called ambulance but arrested and died. The patient experienced Anal incontinence/ faecal/ urinary incontinence in Jan2021. The patient died due to Cardiac arrest on 26Jan2021. An autopsy was not performed. The outcome of Weakness of leg was not recovered, of other events were unknown. Lab data included blood pressure measurement on 21Aug2020, Blood test, blood pressure measurement, Heart rate, Full blood count, White blood cell count , Red blood cell count (red blood cell distibution width measured), Haemoglobin (Estimation), Mean cell haemoglobin, Haematocrit, Mean cell volume, Platelet count, Plateletcrit, Mean platelet volume, Platelet distribution width, Neutrophil count, Lymphocyte count, Monocyte count, Eosinophil count, Basophil count, Liver function test, Blood albumin, Blood bilirubin, Blood alkaline phosphatase, Alanine aminotransferase, Blood urea, Blood electrolytes, Blood sodium, Blood potassium, Blood creatinine, Glomerular filtration rate (Estimated), Blood thyroid stimulating hormone, Blood folate, Serum N-terminal pro B-type natriuretic peptide concentration, Glycosylated haemoglobin (Haemoglobin A1c level) on 18Aug2020, Blood pressure measurement, Oxygen saturation (Peripheral oxygen saturation) on 29Jul2020, Computerised tomogram abdomen on 05Mar2020. No follow up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 999777 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALENDRONIC ACID; FLUOXETINE; LAXIDO; ZOPICLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Communication disorder; Haemorrhagic stroke; Movement disorder (Using wheelchair); Transient ischaemic attack; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021077035

Write-up: Died in sleep/passed away; 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-202101251422035050, Safety Report Unique Identifier GB-MHRA-ADR 24643393. A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not known), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunization. Medical history included previous large haemorrhagic stroke in 2011. Subsequent vascular dementia. Recent transient ischaemic attack (TIA''s). Poor functional ability. Using wheelchair and very limited verbal communication. Concomitant medication included alendronic acid, fluoxetine, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXIDO), zopiclone for poor quality sleep. The patient had the Pfizer vaccine on the morning of the 06Jan2021. She was well throughout the day with no immediate reactions and no side effects. She was in bed in the evening and was found to have passed away. The reporter thought this lady had another large stoke. This would fit with her previous history and frailty. The patient died on 06Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Died in sleep/passed away


VAERS ID: 999779 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-25
   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 EL0739 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CVA; Comments: small CVA 6/1/21, COVID imm 20/1/21, found dead by wife in morning 25/1/21. Awaiting Coroners PM 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 INC2021084419

Write-up: dead; This is a spontaneous report from a contactable physician received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202101271121343780, Safety Report Unique Identifier GB-MHRA-ADR 24653881. A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0739) via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Medical history included small cerebrovascular accident (CVA) from 06Jan2021 which had recovered. The patient''s concomitant medications were not reported. The patient was found dead by wife in morning on 25Jan2021. Awaiting Coroners PM. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. It was not reported if an autopsy was performed. The outcome of the event was fatal. The reporter considered the suspect product had an unknown relationship with cause of death. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: dead


VAERS ID: 999780 (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: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EE8493 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 5
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: Coronary artery stenosis; Comments: Patient was independently active and mobile. Has had previous surgery for coronary artery stenosis Had first covid injection 28th Dec 2020 without problems. Had second vaccine, 19th Jan 2021 but after vaccine tired, not eating and went steadily downhill, leading to death on 25th Jan 2021 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 INC2021084141

Write-up: after vaccine tired, not eating and went steadily downhill, leading to death; after vaccine tired, not eating and went steadily downhill, leading to death; This is a spontaneous report from a contactable physician (patient''s daughter). This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202101271354304610, Safety Report Unique Identifier GB-MHRA-ADR 24654845. A 99-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EE8493), via an unspecified route of administration at single dose on 19Jan2021 for Covid-19 immunisation. Medical history included previous surgery for coronary artery stenosis. Patient was independently active and mobile. Concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on 28Dec2020 for Covid-19 immunisation without problems. The patient experienced after vaccine, on 20Jan2021 tired, not eating and went steadily downhill, leading to death. The patient died on 25Jan2021. It was not reported if an autopsy was performed. The events were assessed by the reporter as fatal and life threatening. The patient had not been tested for COVID-19 since the vaccination. The patient had not been tested positive for COVID-19 since the vaccination. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. The daughter notes steady decline in health after second vaccine. Managed by being nursed at home. However as clearly dying, moved to ED where she passed away. No investigations conducted: clinical diagnosis. Daughter is a consultant respiratory physician. No follow-up attempts possible; information regarding batch/lot for first dose cannot be obtained; No further information expected.; Reported Cause(s) of Death: Appetite absent; TIREDNESS


VAERS ID: 999799 (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: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dysphoria, Dyspnoea, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Respiratory failure (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:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021074570

Write-up: Death sudden; cardiac arrest; Dyspnea; Dysphoria; This is a spontaneous report from a non-contactable consumer via local legal and a contactable pharmacist downloaded from the Medicines Agency (MA) -WEB (GR-GREOF-20210423). An 87-year-old female patient received BNT162B2 (COMIRNATY; Lot number: EJ6795), intramuscularly, on 20Jan2021 at 15:00 at a single dose for COVID-19 vaccination. The patient had no medical history. It was reported that the medical history was free of any chronic cardiac, pulmonary, renal, or other metabolic disease. The patient had no history of anaphylactic medical events. The patient''s concomitant medications were not reported. The patient was not taking long-term anticoagulant therapy or aspirin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccinations 15 days prior to the vaccine. The patient experienced death sudden, cardiac arrest, dyspnea, and dysphoria on 21Jan2021, which were reported as medically significant and fatal. She was not admitted to the hospital but got in contact with her private medical doctor. The clinical outcome of all of the events was fatal. The patient died on 21Jan2021. The causes of death were reported as death sudden, cardiac arrest, dyspnea, and dysphoria. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Follow-up (28Jan2021): The initial case was missing the following minimum criteria: reporter with first-hand knowledge (initially: non-contactable consumer via local legal). Upon receipt of follow-up information on 28Jan2021, this case now contains all required information to be considered valid. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cardiac arrest; dyspnea; sudden death; dysphoria


VAERS ID: 999864 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-10
   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 EJ 6795 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Multiple organ dysfunction syndrome
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (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: 2021-01-13
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Chronic renal failure; Living in nursing home; Malnutrition; Multimorbidity; Peritoneal dialysis; Reduced general condition; Syncope
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021089314

Write-up: MULTIORGAN FAILURE; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB [NO-NOMAADVRE-FHI-2021-Uedy8], Sender''s (Case) Safety Report Unique Identifier is NO-NOMAADVRE-E2B_00014172. A 75-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot#: EJ 6795) at single dose in arm left on 08Jan2021 at 10:15 for COVID-19 immunisation. Medical history included patient was multimorbid nursing home resident in the 70s (living in nursing home); with chronic renal failure stage 5; well-functioning peritoneal dialysis last couple of years and spontaneous residual diuresis until recently; gradually declining general condition (reduced general condition); malnutrition for several weeks prior to vaccination with the covid-19 vaccine; multiple episodes with near-syncope and syncope, ECOG score 3; multimorbidity; bedridden. Concomitant medication was not reported. Patient experienced multiorgan failure on 10Jan2021 that resulting death on 13Jan2021. Two days after vaccination, the patient had greatly reduced general condition, bedridden, no food intake and did not take his medication, no diuresis, somnolent, confused, no fever. ECOG score 4. Assessed as irreversible condition and preterminal status. Dialysis was terminated in consultation with a renal physician. Transition to palliative care phase. The man died on day 5 after vaccination. It was not reported if an autopsy was performed or not. The outcome of event was fatal. Reporting physician and attending nephrologist and infectious disease specialist at hospital saw no connection with the current incident and vaccination with the covid-19 vaccine. Reporter''s causality assessment: COMIRNATY/Multiorgan failure: Unlikely Sender''s Comments: Based on the information in the report, only the reporter''s causality assessment is registered. Reporter has stated that there is no suspicion of a connection with vaccination, and therefore a causal connection with vaccination is considered unlikely. Based on the information in the report, we agree that another cause, other than the vaccine, must be considered a cause of multi-organ failure. Since the patient died, the report is classified as serious. No follow-up attempts are possible. No further information expected.; Sender''s Comments: There is not a reasonable possibility that event multiorgan failure is related to BNT162B2. The patient had multiple underlying diseases, which predisposed the elderly patient to developing the event.; Reported Cause(s) of Death: MULTIORGAN FAILURE


VAERS ID: 999870 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden (in Nursing Home); Living in nursing home (bedridden)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021082844

Write-up: Death; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority. The regulatory authority report number is PT-INFARMED-E202101-1056. An elderly male patient received BNT162B2 (COMIRNATY; Lot number unknown), intramuscular on 06Jan2021 at 0.3 mL, single for covid-19 immunization. The patient''s medical history was noted as previous history of a patient with multimorbidity, bedridden in a nursing home since an unspecified date. The patient''s concomitant medications were not reported. The patient experienced death on 07Jan2021. Details were as follows: the case refers to an elderly patient who died associated with the use of BNT162B2 , as a first dose. The adverse reaction (ADR) appeared one day after the single administration of the suspected drug. The patient died on 07Jan2021. It was not reported if an autopsy was performed. The cause of death was reported as cardiorespiratory arrest. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Cardiopulmonary arrest


VAERS ID: 1000247 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-25
   Days after vaccination:24
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
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Ataxia (Ataxia); Dementia (Dementia); Struma nodosa (Struma nodos)
Preexisting Conditions: Medical History/Concurrent Conditions: TIA (Status post TIA)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021089054

Write-up: died; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB [AT-BASGAGES-2021-00572]. A 86-year-old female patient received BNT162B2 (COMIRNATY) on Jan2021 Intramuscular at single dose for COVID-19 immunisation. The patient''s medical history included: Dementia (continuing), Ataxia (continuing), Transient ischaemic attack (TIA), Struma nodosa (continuing). Concomitant medication was not reported. The patient died a few days after receiving the Covid vaccination on 25Jan2021. It was unknown if autopsy was done. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 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


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