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

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



Case Details

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VAERS ID: 1202872 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP6775 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Respiratory arrest, Respiratory distress
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 (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021386392

Write-up: the following day at 8 am she stopped breathing; Cardiorespiratory arrest; refers lack of air the day after the Covid-19 vaccine application; This is a spontaneous report from a non-contactable healthcare professional. This is a report received from a regulatory authority via email. Regulatory authority report number is 12213-4. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in left arm on 17Mar2021 (Batch/Lot Number: EP6775; Expiration Date: 01Jun2021) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was healthy before vaccination. The patient experienced cardiorespiratory arrest on 18Mar2021. The patient referred lack of air the day after the Covid-19 vaccine application (18Mar2021). The vaccine was applied around 10-11 am and the following day at 8 am she stopped breathing. Treatment received before receiving medical attention which included Ketorolac. The patient died on 18Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiorespiratory arrest; refers lack of air the day after the Covid-19 vaccine application; the following day at 8 am she stopped breathing


VAERS ID: 1202873 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN1198 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Asthenia, Body temperature, Cardio-respiratory arrest, Chills, Erythema, Fatigue, Headache, Irritability, Nausea, Pain, Pyrexia, Sensitive skin, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (from 7 or 8 years of evolution); Cardiac disorder; Edema lower limb; Hyperuricemia (in treatment)
Allergies:
Diagnostic Lab Data: Test Date: 20210323; Test Name: Body temperature; Result Unstructured Data: Test Result:upper or equal than 38 Centigrade; Comments: Fever
CDC Split Type: MXPFIZER INC2021386393

Write-up: it was an acute infarction of the myocardium; irreversible cardiorespiratory arrest to resuscitation maneuvers; Fever upper or equal than 38 centigrade; Headache; Asthenia/Fatigue, Adynamia; Asthenia/Fatigue, Adynamia; Irritability; Chills; Pain; Sensitivity; Erythema/Redness; Nausea; Vomiting; This is a Spontaneous report from a non-contactable other health professional. This is a report received from the regulatory authority via email. Regulatory authority report number is 12650-4. An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 intramuscular, administered in left arm on 22Mar2021 (Lot Number: EN1198; Expiration Date: 01Jun2021) as single dose for covid-19 immunization (age at vaccination: 83 years old). Medical history included cardiopathy and arterial hypertension from 7 or 8 years of evolution, hyperuricemia in treatment, and lower limbs edema, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took telmisartan, hydrochlorothiazide, atorvastatin +pharma, alopurinol. On 23Mar2021, the patient experienced fever upper or equal than 38 centigrade, headache, asthenia/fatigue, adynamia, irritability, chills, pain/sensitivity, erythema/redness, nausea, vomiting, dyspnea/respiratory distress, intense precordial pain, dyspnea and anguish. Clinical course was reported as follows. The covid-19 vaccine was applied, on 22Mar2021, the next day he started with intense precordial pain at 02:00 am, with minimum effort dyspnea, anguish and anxiety. They called a particular physician, who already found him in irreversible cardiorespiratory arrest to resuscitation maneuvers, so the physician refers that it was an acute infarction of the myocardium. Timeframe between vaccination and starting of symptoms: 11 hours. The events acute infarction of the myocardium and irreversible cardiorespiratory arrest to resuscitation maneuvers were fatal; while outcome of the rest of the events was unknown. The patient died on 23Mar2021. 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: acute infarction of the myocardium


VAERS ID: 1202880 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-21
Onset:2021-02-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood alkaline phosphatase, Blood lactate dehydrogenase, Blood magnesium, Blood phosphorus, Blood potassium, Blood sodium, C-reactive protein, Cardiac failure, Chest scan, Computerised tomogram, Delirium, Dysphagia, Dyspnoea, Echocardiogram, Fatigue, Fibrin D dimer, Glomerular filtration rate, Incontinence, Malaise, Nausea, Paralysis, Pneumonia aspiration, Red blood cell count, SARS-CoV-2 test, Speech disorder, Troponin I
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PLAVIX; ATORVASTATIN; GINKGO BILOBA; CRANBERRY; MOVICOLON; CALCI CHEW D3; PANTOPRAZOLE
Current Illness: Hypercholesterolemia; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Ischaemia cerebral; Leg paresis; Paralysis arm; Sudden deafness; Torticollis; Zenker diverticulum (2008 Swallowing complaints due to Zenker''s diverticulum)
Allergies:
Diagnostic Lab Data: Test Date: 20210228; Test Name: CT scan; Result Unstructured Data: Test Result:no intracranial bleeding; Comments: CT scan of brain: showed no intracranial bleeding, showed an old infarction in thalamus and brain stem. Showed white matter injury conform.; Test Date: 20210224; Test Name: CRP; Result Unstructured Data: Test Result:19; Test Date: 20210224; Test Name: ECG; Result Unstructured Data: Test Result:SR, no ischaemia.; Comments: SR, no ischaemia, normal cardiac axis and conduction times; Test Date: 20210224; Test Name: D-dimer test; Result Unstructured Data: Test Result:4.312; Test Date: 20210224; Test Name: eGFR CKD-EPI; Result Unstructured Data: Test Result:56; Test Date: 20210301; Test Name: eGFR CKD-EPI; Result Unstructured Data: Test Result:58; Test Date: 20210224; Test Name: erythocytes; Result Unstructured Data: Test Result:5.17; Test Date: 20210225; Test Name: Corona PCR neg; Result Unstructured Data: Test Result:Negative; Test Date: 20210301; Test Name: Corona PCR neg; Result Unstructured Data: Test Result:Negative; Test Date: 20210224; Test Name: HS Troponine I; Result Unstructured Data: Test Result:7; Test Date: 20210224; Test Name: Alkaline Phosphatase; Result Unstructured Data: Test Result:130; Test Date: 20210224; Test Name: LD; Result Unstructured Data: Test Result:260; Test Date: 20210301; Test Name: magnesium; Result Unstructured Data: Test Result:1.07; Test Date: 20210302; Test Name: magnesium; Result Unstructured Data: Test Result:1.10; Test Date: 20210228; Test Name: Phosphate; Result Unstructured Data: Test Result:0.83; Test Date: 20210301; Test Name: Phosphate; Result Unstructured Data: Test Result:0.75; Test Date: 20210228; Test Name: potassium; Result Unstructured Data: Test Result:3.2; Test Date: 20210301; Test Name: potassium; Result Unstructured Data: Test Result:3.0; Test Date: 20210302; Test Name: potassium; Result Unstructured Data: Test Result:2.8; Test Date: 20210228; Test Name: sodium; Result Unstructured Data: Test Result:148; Test Date: 20210301; Test Name: sodium; Result Unstructured Data: Test Result:151; Test Date: 20210302; Test Name: sodium; Result Unstructured Data: Test Result:158; Test Date: 20210224; Test Name: X thorax; Result Unstructured Data: Test Result:No signs of pneumonia; Comments: No signs of pneumonia, no signs of decompensatio cordis. Possibly some volume loss left.
CDC Split Type: NLPFIZER INC2021370973

Write-up: with worsening cordial decompensation; aspiration pneumonia was suspected; Dyspnoea; Delirium; Nausea; more difficulty speaking; paralysis symptoms; Fatigue; Not feeling well; more difficulty swallowing; Incontinence; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority report number is NL-LRB-00490328. An 85-year-old female patient received bnt162b2 (COMIRNATY) lot number and expiration date not provided, via an unspecified route of administration on 21Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included torticollis from 1990, asthma, leg paresis from 2011, Zenker diverticulum from 2008, paralysis arm from 2011, ischaemia cerebral from 2011, ongoing hypertension, sudden deafness from 2012 and ongoing hypercholesterolaemia. Concomitant medications included clopidogrel bisulfate (PLAVIX), atorvastatin, ginkgo biloba (GINKGO BILOBA), cranberry, macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON) taken for an unspecified indication, start and stop date were not reported; calcium carbonate, colecalciferol (CALCI CHEW D3), pantoprazole. On 21Feb2021, the patient experienced delirium, nausea, more difficulty speaking, paralysis, fatigue, not feeling well, more difficulty swallowing and incontinence. The patient was hospitalized due to a suspected COVID-19 infection with dyspnoea and decline of her general health condition since vaccination. However, the patient tested negative twice. During hospitalization, the patient health deteriorated. It was the intention to start tube feeding due to dysphagia, but placement of the tube failed. The patient health condition further deterioraated and an aspiration pneumonia was suspected with aggravation of cardiac decompensation. Patient was adequately treated (not further specified) during 48 hours without improvement after with a palliative policy was agreed. The patient underwent lab tests and procedures which included on 04Feb2021 alkaline phosphatase: 130, lactate dehydrogenase: 260 and chest scan: no signs of pneumonia. No signs of pneumonia, no signs of decompensatio cordis. Possibly some volume loss left, CRP: 19, ECG: SR, no ischaemia normal cardiac axis and conduction times, D-dimer test: 4.312, erythrocytes: 5.17 and HS Troponine I 7. On 25Feb2021, Corona PCR negative. On 28Feb2021, lab test showed phosphorus: 0.83, potassium: 3.2, sodium: 148 and computerised tomogram: no intracranial bleeding. On 01Mar2021, magnesium: 1.07, phosphorus: 0.75, potassium: 3.0, sodium: 151, eGFR CKD-EPI: 58, Corona PCR negative. On 02Mar2021, magnesium: 1.10, potassium: 2.8, sodium: 151. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no paralysis symptoms, incontinence, delirium, increased difficulty swallowing and speaking ---------------------- Additional information ADR: The side effect occurs half a day after being vaccinated. These side effects increased over time. Nausea Hospitalization information: Delirium eci, suspected covid COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: see photo / attachment below; Reported Cause(s) of Death: Delirium; Nausea; Speech disorder; Paralysis; Fatigue; Malaise; Swallowing difficult; Incontinence; Dyspnoea; with worsening cordial decompensation; aspiration pneumonia was suspected


VAERS ID: 1202897 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   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: Alcohol addiction; Arterial hypertension; Cerebral infarction; Chronic ischaemic heart disease, unspecified (Chronic ischaemic heart disease); Encephalopathy (multiorgan encephalopathy); Epilepsy; Myocardial infarction; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021380218

Write-up: death during sleep; Swelling of the limb; This is a spontaneous report received from a contactable physician reporting for a patient downloaded from the Regulatory Authority-WEB. The regulatory authority report number is PL-URPL-3-471-2021. A 60-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 25Mar2021 13:08 (Batch/Lot Number: ER9480; Expiration Date: 28Mar2021) as 0.3 mL, single for covid-19 immunisation, at 60 years old. Medical history included epilepsy, Alcohol addiction, Arterial hypertension, cerebral infarction, Chronic ischaemic heart disease, unspecified, encephalopathy (multiorgan encephalopathy), type 2 diabetes mellitus, and myocardial infarction from an unknown date. The patient''s concomitant medications were not reported. The patient experienced swelling of the limb on 25Mar2021 and death during sleep on 26Mar2021 03:20. The patient died on 26Mar2021. Case narrative was reported as follows: The PL-URPL-3-471-2021 notification was sent to the Regulatory Authority on 26Mar2021. Patient: male; was administered on 25Mar2021 at 1308, Comirnaty vaccine, 0.3ml, first dose, left arm, i.m., lot ER9480, exp.28Mar2021, Pfizer. Date of occurrence of the reaction 26Mar2021 at 03.20. In the submitted report of an adverse reaction after vaccination, the following symptoms were listed: swelling of the left limb. Description of the reaction: death. Additional data: condition after cerebral infarction, heart attack, type II diabetes, alcohol addiction, epilepsy, multiple cause encephalopathy, arterial hypertension, chronic ischemic heart disease. He was vaccinated at around 1:15 pm (also reported as 13:08), left limb edema was observed during the evening toilet, elevations were applied (treatment), and at 03:20 death during sleep was confirmed. Health result: death. The data contained in the electronic report are all available to the Regulatory Authority - in the case of obtaining additional information, another version will be sent. Outcome of the events was fatal. It was not reported if an autopsy was performed. Sender comment: Name of the vaccine Comirnaty- COVID-19 vaccine (mRNA). The report mentioned the side effect of limb edema without specifying the exact location of the reaction. It is not known whether the edema was related to the grafted limb or the lower limb. There is a time relationship between the administration of the vaccine and the occurrence of a side effect. The immediate cause of death is unknown, and based on the patient''s medical history, it cannot be determined whether the vaccine contributed to the patient''s death. The person reporting Adverse Events Following Immunization qualified it as severe. The Regulatory Authority assessed the AEFI as severe. Swelling of limb: Source of assessment, Method of assessment WHO scale, Result of Assessment Possible No follow-up attempts possible. No further information expected. Lot number has been obtained.; Reported Cause(s) of Death: death during sleep; Swelling of the limb


VAERS ID: 1202898 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   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: PLPFIZER INC2021380208

Write-up: Dizziness; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number PL-URPL-3-473-2021. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 25Mar2021 11:50 (Batch/Lot Number: ET3674) as 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 28Mar2021 20:30, the Emergency Medical Team was called due to dizziness. On arrival, the patient deteriorated, resuscitation was started and a doctor was called to declare death. The patient died on 28Mar2021. It was not reported if an autopsy was performed. Sender Comment: Comirnaty- COVID-19 vaccine (mRNA). Dizziness is an unexpected adverse reaction for this vaccine. It is not possible to address the cause of death without knowing the patient''s medical history. Regulatory Authority has requested supplementary information. There is a temporal relationship between vaccination and the occurrence of adverse reactions and death. The reporter classified the ADR as severe. Regulatory Authority assessed the ADR as severe. Relatedness of drug to reaction(s)/event Source of assessment Method of assessment WHO scale Result of Assessment Conditional No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: dizziness


VAERS ID: 1202899 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-03-05
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Oxygen saturation, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Diabetes (diabetes treated with oral hypoglycaemic drugs)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: Oxygen saturation; Test Result: 93 %; Test Date: 20210305; Test Name: COVID-19 antigen test; Result Unstructured Data: Test Result:Positive
CDC Split Type: PLPFIZER INC2021363342

Write-up: Oxygen saturation decreased; COVID-19 antigen test positive/positive COVID-19 test with symptoms; COVID-19 antigen test positive/positive COVID-19 test with symptoms; High fever; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, Regulatory Authority report number is PL-URPL-DML-MLP.4401.2.156.2021. A 71-year-old male patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY), (Batch/Lot Number: EP9598) intramuscular on 19Feb2021 (at the age of 70 years-old) as single dose for covid-19 immunisation. The second dose was scheduled for 12Mar2021. Medical history included ongoing diabetes treated with oral hypoglycaemic drugs, ongoing hypertension. The patient''s concomitant medications were not reported. On 05Mar2021, SARS-COVID 2 test by ABBOTT was performed with a positive result. The patient also had a high fever for several days, the primary care physician did not start any treatment. On 05Mar2021, patient''s cardiovascular and respiratory were efficient, in full contact, sat. Without oxygen 93%. Patient was prescribed with Levoxa 500 mg, Pyralgina, Berodual N, Pabi-Dexamethason, Neoparin. Patient was then referred home. On 07Mar2021, in the morning, the patient''s condition worsened, and he was taken by ambulance to the hospital at the Emergency Room, and then placed in the Department of Infectious Disease. Oxygen was administered. On 09Mar2021, the patient''s condition worsened, and was connected to a ventilator. On 13Mar2021, at 18:20, patient was pronounced dead. Oxygen saturation decreased, COVID-19 antigen test positive and High fever all from 05Mar2021 were reported as the cause of death of the patient on 13Mar2021. An autopsy was not performed. Sender''s comment: Pyrexia is an expected adverse reaction as described in the SmPC following the administration of Comirnaty. Reduced saturation and a positive COVID-19 test result are unexpected symptoms. As of 19Mar2021, 197 cases of SARS-Cov-2 test positive and 231 cases of oxygen saturation decreased were reported in the database. The patient suffered from hypertension and diabetes. Due to the lack of medical information on the cause of death (no autopsy was also performed), the influence of other factors on the patient''s death cannot be ruled out. There is a time relationship between vaccination and the occurrence of adverse reactions. A regulatory authority due to the health result: death assessed the application as serious. No follow-up attempts are possible. No further information is expected; Reported Cause(s) of Death: high fever; COVID-19 antigen test positive/positive COVID-19 test with symptoms; COVID-19 antigen test positive/positive COVID-19 test with symptoms; Oxygen saturation decreased


VAERS ID: 1202939 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-13
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: HALDOL; METOPROLOL; FURIX [FUROSEMIDE]; ERGENYL RETARD [VALPROATE SODIUM;VALPROIC ACID]; FOLACIN [FOLIC ACID]; THERALEN; DIMOR; BETOLVIDON; ZOPICLONE; TROMBYL; OLANZAPINE; PREDNISOLONE; DENTAN; OMEPRAZOLE; AMLODIPINE; MELATONIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood disorder NOS (possibly an undiagnosed hematological disease); Renal failure; Schizoaffective disorder
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: SEPFIZER INC2021363338

Write-up: COVID-19 infection; COVID-19 infection; This is a spontaneous report from a contactable physician downloaded from a regulatory authority. Regulatory Authority Report Number : SE-MPA-2021-019700. Worldwide unique case identification number: SE-MPA-1615907429753. A 72-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as a single dose and dose 1 via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included schizoaffective disorder, renal failure and possibly an undiagnosed hematological disease. Concomitant medications included haloperidol (HALDOL), metoprolol, furosemide (FURIX), valproate sodium, valproic acid (ERGENYL RETARD), folacin [folic acid], alimemazine tartrate (THERALEN), loperamide hydrochloride (DIMOR), cyanocobalamin (BETOLVIDON), zopiclone, acetylsalicylic acid (TROMBYL), olanzapine, prednisolone, sodium fluoride (DENTAN), omeprazole, amlodipine, melatonin. The patient experienced COVID-19 infection on 13Mar2021. The patient was vaccinated with Comirnaty on 19Jan2021 and 18Feb2021. The patient fell ill with subfebrility, cough, fell, and had elevated inflammatory parameters on 13Mar2021. Patient tested positive to COVID-19 PCR test in the emergency department. The patient was cared for in hospital and had a low need for oxygen. The patient deteriorated respiratory and later died at the hospital. The reporter states that they have not received any answer as to what type of COVID-19 the patient had. Outcome: Fatal. Report assessed as serious: death, hospitalization. It was unknown if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19; COVID-19


VAERS ID: 1202940 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP 2166 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Metastatic uterine cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021380320

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number SE-MPA-2021-021283. Other case identifier number SE-MPA-1616072349251. An 83-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular in Mar2021 (Batch/Lot Number: EP 2166) as 0.3 mL, single for COVID-19 immunization. Medical history included metastatic uterine cancer with unspecified localization. There were no concomitant medications. The patient died in Mar2021 at home, seven days after her first dose of Comirnaty. It was unknown if an autopsy was performed. Outcome: Fatal. Report assessed as serious, death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1202941 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRIMPERAN; FURIX [FUROSEMIDE]; FRAGMIN; OXYCONTIN; ALVEDON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Deep vein thrombosis; Diabetes mellitus; Hypertension; Lung cancer metastatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021380341

Write-up: arterial embolism in the leg; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number SE-MPA-2021-021667. An 86-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular in Jan2021 (Batch/Lot Number: not reported) as single dose for Covid-19 immunization. Medical history included lung cancer metastatic, diabetes mellitus, hypertension, abdominal aortic aneurysm, and deep vein thrombosis; all from an unknown date and unknown if ongoing. Concomitant medications included metoclopramide hydrochloride (PRIMPERAN), furosemide (FURIX), dalteparin sodium (FRAGMIN), oxycodone hydrochloride (OXYCONTIN), and paracetamol (ALVEDON); all taken for an unspecified indication, start and stop date were not reported. The patient got an arterial embolism in the leg 12 days after dose 1 of Comirnaty, which was treated acutely and despite the ongoing high dose low molecular treatment with Fragmin (dalteparin) as treatment for deep vein thrombosis the patient had a new thrombosis shortly afterwards and had to amputate her leg. The patient got slightly better but did not recover and died 36 days after the vaccination. The cause of death was reported as "lung cancer metastatic". The patient died on an unspecified date (36 days after the vaccination). An autopsy was not performed (Autopsy will not be performed). The report was assessed as serious, death, life threatening by health authority. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Lung cancer metastatic


VAERS ID: 1202944 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood glucose increased, Cerebral thrombosis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Ehlers-Danlos syndrome; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021. This regulatory authority case was reported by an other and describes the occurrence of BLOOD GLUCOSE INCREASED and CEREBRAL THROMBOSIS in a 76-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Diabetes, Ehlers-Danlos syndrome and Hypertension. In February 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In February 2021, the patient experienced BLOOD GLUCOSE INCREASED (seriousness criterion death) and CEREBRAL THROMBOSIS (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route) was unknown. Treatment information was not provided. Concomitant medications were not reported. Very limited information regarding these events has been provided at this time. The events are probably related to the patient''s comorbidities. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient''s comorbidities; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1202954 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction (condition after acute myocardial infarction); Atherosclerosis generalized; Type II diabetes mellitus (with vascular complications)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC2021379710

Write-up: Sudden cardiac death; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number SI-JAZMP-NCPHV-2021SI0371_0371. A 78-year-old male patient received the second dose of BNT162B2 (COMIRNATY; lot number: ET3620, expiry date: 30Jun2021), intramuscular on 17Mar2021 at single dose for COVID-19 immunisation. The patient''s medical history included type II diabetes mellitus with vascular complications, atherosclerosis generalized, acute myocardial infarction (condition after acute myocardial infarction). The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY) on an unspecified date for COVID-19 immunization. On 25Mar2021, the patient experienced sudden cardiac death. The outcome of the event was fatal. It was not reported if an autopsy was performed. This case report was assessed as medically significant. No additional data arrived in the initial case report. Sender Comment: Further data on the case along with the assessment is expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1206437 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000424 60 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Heart rate, International normalised ratio, Ultrasound scan
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN CALCIUM ANHYDROUS; BILOL; DILTIAZEM HYDROCHLORIDE R; PHENPROCOUMON
Current Illness: Arterial hypertension; Atrial fibrillation paroxysmal (Paroxysmal atrial fibrillation/flutter - CHADs2 Score 1); Atrial flutter; Dyslipidemia; Hypertensive heart disease (mild concentric left ventricular hypertrophy); Prostatic hyperplasia
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm (Asymptomatic infrarenal partially thrombosed abdominal aortic aneurysm Aneurysm of left common femoral artery); Aortic dissection (History of de/rebranching of internal iliac artery and bilateral endovascular aortic prosthesis May 2008); Aortic ectasia (Ectasia of internal and common iliac arteries, right common femoral and left popliteal artery); Arterial graft (Stent graft extension of the left iliac artery); Artery dissection (Asymptomatic dissection of distal superior mesenteric artery); Colonic polyp; Polyp removal (polyp removal in 2011 and 2014); Polypectomy (of 4 polyps); Renal cyst (Two large cortical renal cysts on left (9.9 and 5.1 cm),); Total hip replacement
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: BP; Result Unstructured Data: Normal; Test Date: 20210127; Test Name: Pulse; Result Unstructured Data: Normal; Test Date: 20210112; Test Name: INR; Test Result: Inconclusive ; Result Unstructured Data: 2.8; Test Name: Abdominal sonogram; Test Result: Inconclusive ; Result Unstructured Data: Two large cortical renal cysts on left (9.9 and 5.1 cm)
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death NOS; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death NOS) in a 75-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3000424 60) for COVID-19 vaccination. The patient''s past medical history included Aneurysm (Asymptomatic infrarenal partially thrombosed abdominal aortic aneurysm Aneurysm of left common femoral artery) in May 2008, Renal cyst (Two large cortical renal cysts on left (9.9 and 5.1 cm),), Colonic polyp on 13-Mar-2018, Aortic ectasia (Ectasia of internal and common iliac arteries, right common femoral and left popliteal artery), Artery dissection (Asymptomatic dissection of distal superior mesenteric artery), Polyp removal (polyp removal in 2011 and 2014) in 2011, Polypectomy (of 4 polyps) in August 2018, Total hip replacement on 15-Oct-2020, Aortic dissection (History of de/rebranching of internal iliac artery and bilateral endovascular aortic prosthesis May 2008) in May 2008 and Arterial graft (Stent graft extension of the left iliac artery) on 13-Mar-2018. Concurrent medical conditions included Atrial fibrillation paroxysmal (Paroxysmal atrial fibrillation/flutter - CHADs2 Score 1), Arterial hypertension, Hypertensive heart disease (mild concentric left ventricular hypertrophy), Dyslipidemia, Prostatic hyperplasia since June 2020 and Atrial flutter. Concomitant products included ATORVASTATIN CALCIUM ANHYDROUS, BISOPROLOL FUMARATE (BILOL), DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE R) and PHENPROCOUMON for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 29-Jan-2021 The patient died on 29-Jan-2021. The cause of death was not reported. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, International normalised ratio: 2.8 (Inconclusive) 2.8. On 27-Jan-2021, Blood pressure measurement: 117/80 (normal) Normal. On 27-Jan-2021, Heart rate: 73 (normal) Normal. On an unknown date, Ultrasound scan: abnormal (Inconclusive) Two large cortical renal cysts on left (9.9 and 5.1 cm). For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information provided. Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. Causality is also confounded by the patient''s advanced age and medical history of Atrial fibrillation paroxysmal / atrial flutter- CHADs2 Score 1, Arterial hypertension, Hypertensive heart disease , Aneurysm and previous surgery for aortic dissection. The cause of death was not reported. Reporter did not allow further contact; Sender''s Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. Causality is also confounded by the patient''s advanced age and medical history of Atrial fibrillation paroxysmal / atrial flutter- CHADs2 Score 1, Arterial hypertension, Hypertensive heart disease , Aneurysm and previous surgery for aortic dissection. The cause of death was not reported.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1206443 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESOMEPRAZOLE; NICOBION; TRIMBOW; LEXOMIL 6 mg, double-scored tablet; OROCAL; VENLAFAXINE; VITAMINE B1 B6 BAYER; VENTOLINE
Current Illness: Cachexia
Preexisting Conditions: Medical History/Concurrent Conditions: COPD (Gold IV); Depression; Dyspnoea on effort; Reflux esophagitis (Grade 3); Smoker; Ulcer peptic
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Sudden death unexplained; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death unexplained) in a 77-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Ulcer peptic, Depression, COPD (Gold IV), Smoker, Reflux esophagitis (Grade 3) and Dyspnoea on effort. Concurrent medical conditions included Cachexia. Concomitant products included ESOMEPRAZOLE, NICOTINAMIDE (NICOBION), BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, GLYCOPYRRONIUM BROMIDE (TRIMBOW), BROMAZEPAM (LEXOMIL 6 mg, double-scored tablet), CONCENTRAT DE CHOLECALCIFEROL, FORME PULVERULENTE, CALCIUM (CARBONATE DE), CARBONATE DE CALCIUM (OROCAL), VENLAFAXINE, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMINE B1 B6 BAYER) and SALBUTAMOL (SULFATE DE), SULFATE DE SALBUTAMOL (VENTOLINE) for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 11-Mar-2021. The reported cause of death was Sudden death unexplained. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided . This case was received from a regulatory authority (FR-AFSSAPS-NY20210563). Reporter did not allow further contact; Sender''s Comments: Very limited information regarding this event has been provided at this time. Patient''s advanced age along with underlying conditions may have been contributory for the occurrence of the death. No further follow-up information is expected.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1206814 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021384544

Write-up: Sudden death; This is as spontaneous report received from a contactable consumer downloaded from the regulatory authority. The regulatory authority report number is NL-LRB-00492336. A 88-years-old male patient received dose 2 of bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. Historical vaccine 1 dose of COMIRNATY for covid-19 immunisation: no adverse reaction. The patient medical history and concomitant medications were not reported. he patient experienced sudden death on 17Mar2021. 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 suddenly


VAERS ID: 1206818 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021389686

Write-up: thrombosis; This is a spontaneous report from a contactable consumer. A 74-years-old male patient received bnt162b2 (COMIRNATY; Batch/Lot number was not reported), via an unspecified route of administration on 30Mar2021, (at the age of 74-years-old) at single dose for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient died due to thrombosis on 06Apr2021 at 09:55. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: thrombosis


VAERS ID: 1206977 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-03-11
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PERINDOPRIL ERBUMINE; LORAZEPAM; TEMAZEPAM; ISOSORBIDE MONONITRATE; BISOPROLOL; ACENOCOUMAROL
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown; Test Name: x thorax; Result Unstructured Data: Test Result:unknown; Test Name: ECG; Result Unstructured Data: Test Result:UNKNOWN; Test Date: 20210311; Test Name: positieve Covid test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021342699

Write-up: COVID-19 pneumonia; SARS-CoV-2 test positive/tested positive for COVID 19; drug ineffective/tested positive for COVID 19/Covid 19 pneumonia; Malaise; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00479488 and Safety Report Unique Identifier NL-LRB-00485119. An 86-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 08Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient has no medical history. Concomitant medications included perindopril erbumine, lorazepam, temazepam, isosorbide mononitrate, bisoprolol, and acenocoumarol. The patient experienced covid-19 pneumonia on 12Mar2021, sars-cov-2 test positive on 11Mar2021, drug ineffective on 11Mar2021, and malaise on 11Mar2021. The patient was hospitalized for covid-19 pneumonia from 16Mar2021. The patient had Covid 19 pneumonia and malaise following administration of Covid-19 vaccine. The patient tested positive for COVID 19 on 11Mar2021 and was admitted to hospital on 16Mar2021. Covid 19 pneumonia is treated with hospital admission with oxygen therapy and dexamethasone. The patient has no previous COVID-19 infection. Diagnostic procedures included ECG (electrocardiogram), blood test and x thorax. Therapeutic measures were taken as a result of covid-19 pneumonia. The outcome of the event malaise was unknown. The patient died on an unspecified date due to covid-19 pneumonia, sars-cov-2 test positive and drug ineffective. It was unknown if an autopsy was performed. Reporter''s comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no Covid Pneumonia Hospitalization information: Covid pneumonia is still unknown Additional information ADR (adverse drug reaction): 11Mar21 malaise and positive Covid test. 16Mar2021 admission for oxygen therapy and dexamethasone COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: ECG (electrocardiogram) blood test x thorax Follow up 25Mar2021 Follow-up received: 1. Patient has died 2. No. 3. Patient had no relevant history. Assessor: FU received. Did patient that on yes. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: Summary of Reporter Comment Hospitalization information: Covid pneumonia is still unknown Additional information ADR: 11Mar21 malaise and positive Covid test. 16Mar2021 admission for oxygen therapy and dexamethasone Previous COVID-19 infection: No. diagnostic procedures: ECG (electrocardiogram) blood test x thorax 25Mar2021 Follow-up received: 1. Patient has died 2. No. 3. Patient had no relevant history. Assessor: FU received. Did patient that on yes.; Reported Cause(s) of Death: COVID-19 pneumonia; SARS-CoV-2 test positive/tested positive for COVID 19; drug ineffective/tested positive for COVID 19/Covid 19 pneumonia


VAERS ID: 1208840 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021398931

Write-up: contracts covid; contracts covid; This is a spontaneous report from a contactable consumer (Pfizer colleague). A 104-year-old female patient received first dose of bnt162b2 (COMIRNATY; Lot number was not reported) in Jan2021 and second dose (Lot number was not reported) in the beginning of Feb2021 both given via an unspecified route of administration, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient contracted covid in the mid of Mar2021 with fatal outcome. The patient died on 26Mar2021 in the hospital. Cause of death was COVDI-19. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: covid; covid


VAERS ID: 1208852 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000496 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature increased, Circulatory collapse, Hypotension, Hypoxia, Oxygen saturation, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; ASPIRIN CARDIO; PERINDOPRIL
Current Illness: Aortic valve sclerosis; Dementia; Hypertensive heart disease; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210313; Test Name: temperature; Result Unstructured Data: fever 38.4 celsius; Test Date: 20210313; Test Name: oxygen saturation; Result Unstructured Data: 80
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Hypotension; Cardiovascular collapse; Hypoxemia; Fever; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (Hypotension) and CIRCULATORY COLLAPSE (Cardiovascular collapse) in an 88-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3000496) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertensive heart disease, Aortic valve sclerosis, Osteoporosis and Dementia. Concomitant products included ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN CARDIO) and PERINDOPRIL for an unknown indication. On 12-Mar-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced HYPOTENSION (Hypotension) (seriousness criterion death), CIRCULATORY COLLAPSE (Cardiovascular collapse) (seriousness criterion death), HYPOXIA (Hypoxemia) and PYREXIA (Fever). On 13-Mar-2021, HYPOXIA (Hypoxemia) and PYREXIA (Fever) had not resolved. The patient died on 13-Mar-2021. The reported cause of death was Hypotension, Cardiovascular collapse, Hypoxemia and Fever. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature increased: 38.4 celsius (High) fever 38.4 celsius. On 13-Mar-2021, Oxygen saturation: 80 (Low) 80. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter considered PYREXIA (Fever) to be possibly related and HYPOTENSION (Hypotension), CIRCULATORY COLLAPSE (Cardiovascular collapse) and HYPOXIA (Hypoxemia) to be unlikely related. Action taken with mRNA-1273 in response to the events was not Applicable. Patient experienced pyrexia (38.4? C), breathing difficulty (80% saturation; "Bioxx ca 80"), for which she was administered with oxygen and, afterwards, experienced low blood pressure with cardiovascular collapse and died (on 13/03/2021). This case concerns an 88 year old female patient, with a medical history of Hypertensive heart disease and Aortic valve sclerosis, who experienced a serious unexpected event of Death (fatal) 1 day after receiving her 1st dose of mRNA- 1273. Very limited information regarding these events has been provided at this time. However, the patient''s advance age and multiple co-morbidities may remain as risk factors. Further information is not expected. Reporter did not allow further contact; Sender''s Comments: This case concerns an 88 year old female patient, with a medical history of Hypertensive heart disease and Aortic valve sclerosis, who experienced a serious unexpected event of Death (fatal) 1 day after receiving her 1st dose of mRNA- 1273. Very limited information regarding these events has been provided at this time. However, the patient''s advance age and multiple co-morbidities may remain as risk factors. Further information is not expected.; Reported Cause(s) of Death: Hypotension; Cardiovascular collapse; Hypoxemia; Fever


VAERS ID: 1208853 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-26
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatinine, Computerised tomogram head, Death, Traumatic intracranial haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID; VALPROATE SODIUM; VALPROATE SODIUM; LITHIUM CARBONATE; LISINOPRIL; QUETIAPINE FUMARATE
Current Illness: Adiposis (WHO grade I (BMI 30.7 kg/m2)); Arterial hypertension; Bipolar affective disorder; Gonarthrosis
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal insufficiency (most likely pharmacological secondary to lithium overdose)
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: Creatinine; Result Unstructured Data: high; Test Date: 20210226; Test Name: CT of neurocranium; Result Unstructured Data: cranial calvaria and posterior fossa, native and with i.v. contrast examination. RESULT: Large, space-occupying, acute subdural hematoma in the left hemisphere with consecutive midline shift. Subfalcine, uncal, and incipient transtentorial herniation. Extensive SAH [subarachnoid hemorrhage] emphasized in the left hemisphere and frontobasal contusion hemorrhages on the left. Signs of CSF congestion and consecutive brain stem compression. Suspected left hemispheric brain edema. Non-dislocated, semi-circumferential fracture with involvement of the frontal, parietal, and occipital bones on the right and the occipital and parietal bones on the left: Large, space-occupying, acute subdural hematoma in the left hemisphere with consecutive midline shift. Subfalcine, uncal, and incipient transtentorial herniation. Extensive SAH [subarachnoid hemorrhage] emphasized in the left hemisphere and frontobasal contusion hemorrhages on the left. Signs of CSF congestion and consecutive brain stem compression.
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death NOS; Cerebral hemorrhage traumatic; This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Death NOS) and TRAUMATIC INTRACRANIAL HAEMORRHAGE (Cerebral hemorrhage traumatic) in a 76-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3000427) for COVID-19 vaccination. The patient''s past medical history included Acute renal insufficiency (most likely pharmacological secondary to lithium overdose) in January 2021, Arterial hypertension since an unknown date, Adiposis (grade I (BMI 30.7 kg/m2)) since an unknown date, Bipolar affective disorder since an unknown date and Gonarthrosis since an unknown date. Concomitant products included ACETYLSALICYLIC ACID, VALPROATE SODIUM, VALPROATE SODIUM, LITHIUM CARBONATE, LISINOPRIL and QUETIAPINE FUMARATE for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced TRAUMATIC INTRACRANIAL HAEMORRHAGE (Cerebral hemorrhage traumatic) (seriousness criterion death). The patient died on 01-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Blood creatinine: 92 (High) high. On 26-Feb-2021, Computerised tomogram head: abnormal (abnormal) cranial calvaria and posterior fossa, native and with i.v. contrast examination. RESULT: Large, space-occupying, acute subdural hematoma in the left hemisphere with consecutive midline shift. Subfalcine, uncal, and incipient transtentorial herniation. Extensive SAH [subarachnoid hemorrhage] emphasized in the left hemisphere and frontobasal contusion hemorrhages on the left. Signs of CSF congestion and consecutive brain stem compression. Suspected left hemispheric brain edema. Non-dislocated, semi-circumferential fracture with involvement of the frontal, parietal, and occipital bones on the right and the occipital and parietal bones on the left: Large, space-occupying, acute subdural hematoma in the left hemisphere with consecutive midline shift. Subfalcine, uncal, and incipient transtentorial herniation. Extensive SAH [subarachnoid hemorrhage] emphasized in the left hemisphere and frontobasal contusion hemorrhages on the left. Signs of CSF congestion and consecutive brain stem compression.. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Death NOS) and TRAUMATIC INTRACRANIAL HAEMORRHAGE (Cerebral hemorrhage traumatic) to be unlikely related. CT of neurocranium incl. cranial calvaria and posterior fossa, native and with i.v. contrast examination was performed RESULTS: Large, space-occupying, acute subdural hematoma in the left hemisphere with consecutive midline shift. Subfalcine, uncal, and incipient transtentorial herniation. Extensive SAH [subarachnoid hemorrhage] emphasized in the left hemisphere and frontobasal contusion hemorrhages on the left. Based on reporter''s causality and the patient''s advanced age along with multiple comorbidities, the event is assessed as unlikely related to mRNA-1273. Reporter did not allow further contact; Sender''s Comments: Based on reporter''s causality and the patient''s advanced age along with multiple comorbidities, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Unknown case of death


VAERS ID: 1208860 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Apnoea, Auscultation, Blood creatinine, Body temperature, C-reactive protein, C-reactive protein increased, Feeding disorder, General physical health deterioration, Loss of consciousness, Physical examination, Pyrexia, Urine analysis
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (date of diagnosis not known); Chronic obstructive airways disease (date of diagnosis not known); Chronic renal insufficiency (creatinine on 17Mar2021 181 mcmol/L); COVID-19; Decubitus ulcer (sacral deep but clean ulcer); Deep vein thrombosis (Suspicion of DVT right leg); Dementia (moderate grade); Heart failure NYHA class IV (date of diagnosis not known); Hospitalization (for surgery to clean a sacral decubitus); Ileostomy
Allergies:
Diagnostic Lab Data: Test Date: 20210322; Test Name: heart auscultation; Result Unstructured Data: Test Result:No abnormal heart and lung auscultation; Test Date: 202103; Test Name: Lung auscultation; Result Unstructured Data: Test Result:normal; Test Date: 20210322; Test Name: Lung auscultation; Result Unstructured Data: Test Result:No abnormal heart and lung auscultation; Test Date: 20210317; Test Name: Blood creatinine; Result Unstructured Data: Test Result:181 umol/l; Test Date: 20210317; Test Name: creatinine; Result Unstructured Data: Test Result:181; Comments: mcmol/L; Test Date: 20210318; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210317; Test Name: C-reactive protein; Result Unstructured Data: Test Result:37.4 mg/l; Test Date: 20210319; Test Name: C-reactive protein; Result Unstructured Data: Test Result:21.6 mg/l; Test Date: 20210322; Test Name: abdomen; Result Unstructured Data: Test Result:was hard in the lower abdomen, no sounds were dete; Comments: was hard in the lower abdomen, no sounds were detectable/no oedema/no stool or air in the stoma bag; Test Date: 202103; Test Name: urine; Result Unstructured Data: Test Result:normal
CDC Split Type: CHPFIZER INC2021381353

Write-up: Apnoea; unconscious; temperature of 38 degrees C; elevation of CRP (37.4mg/L on 17Mar2021 and 21.6mg/L on 19Mar2021); poor general condition; abdomen was indolent; difficulty feeding himself/hardly ate and drank; This is a spontaneous report received from a contactable physician via Swissmedic, the regulatory authority. Regulatory authority report number CH-SM-2021-13577. An 86-year-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, lot and expiry were not reported), intramuscular on 06Mar2021 (at the age of 86-years-old) as single dose for covid-19 immunisation. The patient''s first dose of bnt162b2 (lot not reported) was in Feb2021 (at the age of 86-years-old) IM, given during hospital stay as single dose for COVID-19 immunisation. Medical history included Heart failure NYHA class IV (date of diagnosis not known), chronic obstructive airways disease (date of diagnosis not known), deep vein thrombosis (DVT) from Aug2020 (Suspicion of DVT right leg), alcohol abuse (date of diagnosis not known), dementia (moderate grade), hospitalized on 08Feb2021 to 05Mar2021 (for surgery to clean a sacral decubitus), decubitus ulcer from Feb2021 (sacral deep but clean ulcer), chronic renal insufficiency (creatinine on 17Mar2021 181 mcmol/L), Covid-19 in Oct2020 and ileostomy wearer. Following hospitalization, he was discharged to a home for the elderly. Usual pharmacotherapy not known and not known if the patient had any allergies. Concomitant medications included unspecified peroral medications (unknown) were discontinued. On 15Mar2021, the doctor was called because of poor general condition and Biox under oxygen therapy with apneas fluctuating to below 60%. Lung auscultation was normal in Mar2021. The abdomen was indolent, he had difficulty feeding himself from Mar2021 and from 18Mar2021 a temperature of 38 degrees C and slightly above was noted. The laboratory showed an elevation of CRP (37.4mg/L on 17Mar2021 and 21.6mg/L on 19Mar2021) and normal urine in Mar2021. He was given ciprofloxacin 250mg 2x daily starting 18Mar2021 for the fever of unclear etiology. His condition did not improve and the family refused hospitalization and ventilation, including CPAP. From 21Mar2021, he hardly ate and drank and was unconscious on 22Mar2021 when he visited the doctor, his abdomen was hard in the lower abdomen, no sounds were detectable. No abnormal heart and lung auscultation, no oedema. There was no stool or air in the stoma bag. Peroral medications (unknown) were discontinued and the patient died of apnea the same evening on 22Mar2021. Swissmedic assessed this case as serious, results in death. The outcome of the events was unknown except for apnea which was fatal. The patient died due to apnea on 22Mar2021. It was unknown if an autopsy was performed. A causal relationship between Comirnaty and death (apnea) was assessed as being unlikely. Sender''s comment (Swissmedic): Death occurred 15 days after administration of the second dose of Comirnaty of very elderly and frail patient. Sudden deaths are not known according to the Swiss monograph of Comirnaty among possible adverse events. Foreign monographs also do not list sudden deaths among the ADEs of mRNA-based Covid-19 vaccines, even in the frail elderly population subgroup. The patient presented very frail in the presence of severe comorbidities, particularly NYHA IV heart failure, COPD, and renal failure. The decline in general condition, already very impaired on entry into the home for the elderly, worsened with fever 12 days after the second dose of the vaccine. Uptodate reports a time of onset of fever in correlation with Covid-19 mRNA vaccine of 1-3 days, which is therefore not compatible with the case of this patient. In conclusion, in view of the advanced age and the already very compromised state of health of the patient, further proven by a recent hospitalization for sacral decubitus cleaning, we hypothesize a progressive decline until death due to apnea on COPD, a hypothesis supported by the reporting physician. At the current state of knowledge, therefore, despite the temporal correlation of 15 days, not being able to exclude other possible pathophysiological causes in this severely compromised patient, we judge the causal correlation between the vaccine and death unlikely. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Death due to apnea in COPD in the setting of a recent Covid vaccination.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the apnea and other reported events. There is limited information provided in this report. This case will be reassessed once additional information is 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: Apnoea


VAERS ID: 1209281 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021389879

Write-up: died 4 days after vaccination, external signs appeared to resemble an asthma attack/ breathless after gasping for breath; This is a spontaneous report from a contactable consumer (patient''s relative) based on information received by Pfizer from Biontech (manufacturer control number 33034), license party for Comirnaty. A 67-year-old patient of unspecified gender received BNT162B2 (COMIRNATY, lot number not provided), on unspecified date at single dose for COVID-19 immunisation. The patient''s medical history included ongoing asthma. The patient''s concomitant medications were not reported. It was reported that the week of the present report (Apr2021) a relative of reporter (patient) with asthma died 4 days after COVID-19 vaccination by Biontech/Pfizer vaccine. The exact cause of death was unclear until autopsy was done, but external signs appeared to resemble an asthma attack. The person became breathless after gasping for breath and he/she could not be resuscitated. The patient died on unspecified date in Apr2021. It was unknown if autopsy was performed. The outcome of the event was fatal. Information about lot/batch number has been requested.; Reported Cause(s) of Death: died 4 days after vaccination, external signs appeared to resemble an asthma attack/ breathless after gasping for breath


VAERS ID: 1209396 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood alkaline phosphatase, Blood culture, Blood electrolytes, Blood glucose, Blood lactate dehydrogenase, Blood test, Body temperature, C-reactive protein, Chest X-ray, Computerised tomogram, Death, Electrocardiogram, Fungal test, General physical health deterioration, Haematology test, Pneumonia, Procalcitonin, Prostatic specific antigen, Pyrexia, SARS-CoV-2 test, Sputum test, Urine analysis, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   Days after onset: 16
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: FURIX [FUROSEMIDE]; ELIQUIS; SIMVASTATIN SANDOZ; PAMORELIN; METFORMIN ACTAVIS; CENTYL MED KALIUMKLORID; METOCAR; PAMOL; LANTUS; VOGALENE; PANTOLOC [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; KALEORID; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODI
Current Illness: Atrial fibrillation; Broken hip (CT scan showed Feb2021 that the hip had not heeled)
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Diabetes; Diuretic therapy; Heart rate irregular; Hypercholesterolaemia; Infection; Nausea; Pain; Prostate cancer
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:2140; Comments: 2140 (other organ markers normal); Test Date: 202103; Test Name: Blood culture; Test Result: Negative ; Test Date: 202103; Test Name: Blood electrolytes; Result Unstructured Data: Test Result:nothing abnormal; Test Date: 202103; Test Name: Glucose; Result Unstructured Data: Test Result:24.8; Test Date: 202103; Test Name: LDH; Result Unstructured Data: Test Result:1050; Test Date: 20210224; Test Name: Blood test; Result Unstructured Data: Test Result:infection; Test Date: 20210303; Test Name: Body temperature; Result Unstructured Data: Test Result:39.1 Centigrade; Test Date: 202103; Test Name: Thorax x-ray; Result Unstructured Data: Test Result:infiltrate right lung, confirm pneumonia no emboli; Test Date: 202102; Test Name: CT scan; Result Unstructured Data: Test Result:the hip had not heeled; Test Date: 202103; Test Name: C-reactive protein; Result Unstructured Data: Test Result:287; Test Date: 202103; Test Name: EKG; Result Unstructured Data: Test Result:Atrial fibrillation; Test Date: 202103; Test Name: Fungus culture; Result Unstructured Data: Test Result:sparse fungal growth; Test Date: 202103; Test Name: Haematology test; Result Unstructured Data: Test Result:except Leuco., incl. thrombocyte, Nothing abnormal; Test Date: 202103; Test Name: Procalcitonin; Result Unstructured Data: Test Result:0.71; Test Date: 202103; Test Name: PSA test; Result Unstructured Data: Test Result:increasing; Test Date: 202103; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:negative; Comments: on tracheal sputum: negative; Test Date: 202103; Test Name: Sputum test; Result Unstructured Data: Test Result:No results available; Test Date: 20210225; Test Name: Urine analysis; Result Unstructured Data: Test Result:No results available; Test Date: 202103; Test Name: Leucocyte count; Result Unstructured Data: Test Result:11.8
CDC Split Type: DKPFIZER INC2021301703

Write-up: pneumonia; Fever; Reduced general condition; unknown cause of death; The initial safety information received was reporting only non-serious adverse drug reactions, upon receipt of follow-up information on 30Mar2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable nurse, contactable physician and contactable consumer downloaded from the regulatory authority. Regulatory Authority number DK-DKMA-WBS-0041488, DK-DKMA-ADR 24912440 and duplicate case DK-DKMA-WBS- 0050849. An 85-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot Number: EJ6789; Expiration Date: 31May2021) as SINGLE DOSE for COVID-19 immunisation. Medical history included hip fracture from 11Sep2020 and ongoing (CT scan showed Feb2021 that the hip had not healed), ongoing atrial fibrillation, infection from an unknown date and unknown if ongoing, heart rate irregular from an unknown date and unknown if ongoing, diuretic therapy from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing, constipation from an unknown date and unknown if ongoing, hypercholesterolaemia from an unknown date and unknown if ongoing, nausea from an unknown date and unknown if ongoing and prostate cancer from an unknown date and unknown if ongoing. Concomitant medications included furosemide (FURIX) taken for diuretic therapy from 22Jan2021 to an unspecified stop date; apixaban (ELIQUIS) taken for thrombosis prophylaxis from 16Dec2020 to 03Mar2021; simvastatin (SIMVASTATIN SANDOZ) taken for hypercholesterolaemia from 23Nov2016 to 04Mar2021; triptorelin embonate (PAMORELIN) taken for prostate cancer from 14Mar2017 to an unspecified stop date; metformin hydrochloride (METFORMIN ACTAVIS) taken for type 2 diabetes mellitus from 2010 to 03Mar2021; bendroflumethiazide, potassium chloride (CENTYL MED KALIUMKLORID) taken for diuretic therapy from 22Jan2021 to an unspecified stop date; metoprolol tartrate (METOCAR) taken for heart rate irregular from 16Dec2020 to 04Mar2021; paracetamol (PAMOL) taken for pain from Sep2020 to 03Mar2021; insulin glargine (LANTUS) taken for diabetes mellitus from 25Dec2020 to 03Mar2021; metopimazine (VOGALENE) taken for nausea from 22Dec2020 to an unspecified stop date; pantoprazole sodium sesquihydrate (PANTOLOC) taken for prophylaxis against gastrointestinal ulcer from 21Dec2020 to 03Mar2021; potassium chloride (KALEORID) taken for mineral supplementation from 22Jan2021 to an unspecified stop date; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) taken for constipation from 22Jan2021 to an unspecified stop date; morphine hydrochloride (MORFIN ALTERNOVA) taken for pain from 21Jul2020 to an unspecified stop date; calcium carbonate, vitamin d nos (CALCIUM + VIT D) taken for an unspecified indication from 11Aug2020 to an unspecified stop date; cyanocobalamin-tannin complex (BETOLVEX) taken for vitamin b12 deficiency from 17Dec2020 to an unspecified stop date; dexamethasone (DEXAMETASON ABCUR) taken for prostate cancer, start and stop date were not reported; and metformin hydrochloride (METFORMIN AUROBINDO) taken for diabetes mellitus, start and stop date were not reported. On 19Feb2021 the patient experienced reduced general condition, on 20Feb2021 the patient developed Fever, on an unknown date in Mar2021, the patient experienced pneumonia. The fever started the day after vaccination and fever increased. Blood test on day 5 showed the infection. The fever increased despite treatment with antibiotics for 5 days. The patient was hospitalized for the pneumonia on 02Mar2021 and hospitalized from 03Mar2021 to 07Mar2021 for fever and reduced general condition. The patient underwent lab tests and procedures which included blood alkaline phosphatase: on Mar2021 2140 (other organ markers normal), blood culture: negative on Mar2021, blood electrolytes: nothing abnormal on Mar2021, blood glucose: 24.8 on Mar2021, blood lactate dehydrogenase: 1050 on Mar2021, blood test: infection on 24Feb2021, body temperature: 39.1 centigrade on 03Mar2021, chest x-ray: infiltrate right lung, confirm pneumonia no emboli on Mar2021, computerised tomogram: the hip had not healed on Feb2021, C-reactive protein: 287 on Mar2021, electrocardiogram: atrial fibrillation on Mar2021, fungal test: sparse fungal growth on Mar2021, haematology test: except leuco., incl. thrombocyte, nothing abnormal on Mar2021, procalcitonin: 0.71 on Mar2021, prostatic specific antigen: increasing on Mar2021, COVID-19 virus test on tracheal sputum: negative on Mar2021, Sputum test: no results available on Mar2021; urine analysis: no results available on 25Feb2021; Leucocyte count: 11.8 (no units available) on Mar2021. Therapeutic measures were taken as a result of fever and reduced general condition which included antibiotic treatment. The patient died on 07Mar2021. The cause of death was not reported. It was not reported if an autopsy was performed. The clinical outcome of the event fever and reduced general condition was not recovered, pneumonia was unknown. Causality: The Physicians do not suspect that the death is related to the vaccination, and the death has therefore not been reported to the police. They believe that Comirnaty cannot be ruled out as a contributing cause, but does not suspect any direct causality between death and vaccination with Comirnaty. No follow up attempts possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1209677 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-03-01
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardiac arrest, Chest X-ray, Contusion, Culture, Depressed level of consciousness, Haemoglobin, Haemorrhagic diathesis, International normalised ratio, Oedema peripheral, Platelet count, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   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: FURIX [FUROSEMIDE]; ELIQUIS
Current Illness: Chronic kidney disease; Chronic obstructive lung disease; Heart failure with reduced ejection fraction; Pacemaker syndrome; Pneumonia (Double side); Prostate cancer; Pulmonary hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Blood test; Result Unstructured Data: Test Result:decreasing infection count; Test Date: 202103; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:Infiltrate on both lungs; Test Date: 202103; Test Name: Culture; Test Result: Negative ; Test Date: 202103; Test Name: Haemoglobin; Result Unstructured Data: Test Result:decreasing count; Test Date: 202103; Test Name: INR; Result Unstructured Data: Test Result:Normal; Test Date: 202103; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:Normal
CDC Split Type: DKPFIZER INC2021379149

Write-up: Severe bleeding tendency on skin on arms, difficult to stopp bleeding after blood test; Oedema of arms and legs; Respiratory failure; Consciousness decreased; Cardiac arrest; Bruising on skin; This is a spontaneous report downloaded from the Regulatory Authority-WEB (Regulatory Authority report number: DK-DKMA-WBS-0060196). A contactable physician (contactable through Regulatory Authority only) reported that an 85-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: EJ6789; Expiration Date: 31May2021), intramuscular on 05Feb2021 as a single dose, for COVID-19 immunization. Medical history included ongoing pulmonary hypertension; ongoing prostate cancer; ongoing pneumonia (double side); ongoing chronic kidney disease; ongoing heart failure with reduced ejection fraction; ongoing pacemaker syndrome; ongoing chronic obstructive pulmonary disease; and atrial fibrillation. Concomitant medications included furosemide (FURIX); and apixaban (ELIQUIS) for atrial fibrillation from 08Apr2019 to an unspecified stop date. The patient had previously received the first dose of BNT162B2 (COMIRNATY, Lot number: EJ6134; Expiration date: 30Apr2021) on 13Jan2021 for COVID-19 immunization. On 25Mar2021, the patient had oedema of arms and legs; respiratory failure; consciousness decreased; severe bleeding tendency on skin on arms, difficult to stop bleeding after blood test (at 02:00); and cardiac arrest. In Mar2021, the patient had bruising on the skin. The events were reported to be life-threatening. The patient''s blood test showed decreasing infection count, thorax X-ray showed infiltrate on both lungs, culture was negative, hemoglobin was decreasing in count, international normalized ration (INR) was normal and thrombocyte count was normal; all in Mar2021.~The patient had died on 25Mar2021 due to the reported events. An autopsy was not performed. No follow-up attempts are possible. No further information is expected. Information on lot number was already obtained.; Reported Cause(s) of Death: Respiratory failure; Cardiac arrest; Oedema of arms and legs, known with heart and kidney failure; Consciousness decreased; Severe bleeding tendency on skin on arms, difficult to stopp bleeding after blood test; Bruising on skin


VAERS ID: 1210227 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-01-01
Onset:2020-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Haematoma muscle, Off label use
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   Days after onset: 377
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: Eliquis
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified; Chronic kidney disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021402001

Write-up: Hematoma muscle; Anemia; The patient received Apixaban at 2.5 mg/24h for atrial fibrillation; This is a spontaneous report from a contactable physician via regulatory authority (regulatory authority number: ES-AEMPS-798845), based on information received by Pfizer from a company (manufacturer control number: ES-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-031295) through regulatory authority, license party for apixaban (ELIQUIS). This case was received via HA (Reference number: ES-AEMPS-798845) on 29Mar2021 and was forwarded to regulatory authority on 29Mar2021. This spontaneous case was reported by a physician and describes the occurrence of HAEMATOMA MUSCLE (Hematoma muscle) and ANAEMIA (Anemia) in 86-year-old female patient who received apixaban (Eliquis) for Cerebrovascular accident prophylaxis. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19 immunization. Product or product use issues identified: OFF LABEL USE (The patient received Apixaban at 2.5 mg/24h for atrial fibrillation) on 01Jan2020. The patient''s past medical history included Cardiovascular disease, unspecified and Chronic kidney disease. On 01Jan2020, the patient started Eliquis (Oral), 2.5 milligram once a day. On 05Jan2021, the patient started Covid-19 Vaccine (Intramuscular). On 05Jan2021, the patient experienced HAEMATOMA MUSCLE (seriousness criterion hospitalization) and ANAEMIA (seriousness criterion hospitalization). Eliquis (Oral) was withdrawn on 05Jan2021. At the time of the report, HAEMATOMA MUSCLE and ANAEMIA was resolving. Therapy with COVID-19 vaccine and Apixaban was withdrawn on 05Jan2021. Causality was not provided for COVID-19 vaccine. The patient died due to cardiac failure and chronic kidney disease on 12Jan2021. For Eliquis (Oral), the reporter did not provide any causality assessments. Follow-up not performed, as case was downloaded from regulatory authority. Regulatory authority medical evaluation comment: This patient had muscle hematoma and anemia after therapy with apixaban. Based on the anticoagulant action of the suspect drug, its contributory role in these reported events are considered as possible. Causality Assessment: The events "Hematoma muscle, Anemia" were considered related to ELIQUIS by Company). The event "Off label dosing frequency" was considered unrelated to ELIQUIS by Company.; Sender''s Comments: Regulatory authority medical evaluation comment: This patient had muscle hematoma and anemia after therapy with apixaban. Based on the anticoagulant action of the suspect drug, its contributory role in these reported events are considered as possible.; Reported Cause(s) of Death: cardiac failure; chronic kidney disease


VAERS ID: 1210316 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THYROXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021389403

Write-up: Pulmonary embolism; Venous thrombosis; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority. Regulatory authority number FI-FIMEA-20211617. This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority, regulatory authority number FI-FIMEA-20211617. A 80-years-old female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 04Mar2021 (at the age of 80) (Batch/Lot Number: UNKNOWN) as single dose for covid-19 immunisation. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (THYROXIN) taken for hypothyroidism. Five days after taking the vaccine, on 09Mar2021, the patient was found dead at home. The patient experienced pulmonary embolism on 04Mar2021, venous thrombosis on 04Mar2021. The cause of death was determined in a forensic autopsy, and the cause of death was venous thrombosis and pulmonary embolism. Information about lot/batch number cannot be obtained. No further information expected.; Autopsy-determined Cause(s) of Death: Pulmonary embolism; Venous thrombosis


VAERS ID: 1210642 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 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: 2021-03-27
   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: METFORMINE [METFORMIN]; CARDENSIEL; ALPRAZOLAM; ZOLOFT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Hypertension; Overweight; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021380165

Write-up: Sudden death; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB. The Regulatory Authority report number is FR-AFSSAPS-BX20212598. An 89-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: ET3620 and expiration date not reported), intramuscular, administered in the left arm on 26Mar2021 as a single dose for COVID-19 immunisation. Medical history included Type 2 diabetes mellitus, Depression, Overweight, Hypertension; all from an unknown date and unknown if ongoing. Concomitant medications included metformin (METFORMINE), bisoprolol fumarate (CARDENSIEL), alprazolam, and sertraline hydrochloride (ZOLOFT). The patient is autonomous at home and went to bed around 8:30 pm to 9 p.m. On 27Mar2021, the patient experienced sudden death. Presence of a basin next to the bed and there was no sign of struggle. The patient died on 27Mar2021. 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: 1211031 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; BISOPROLOL; CLOPIDOGREL; KAYEXALATE; LEVOTHYROXINE; OROCAL [CALCIUM CARBONATE]; PANTOPRAZOLE; PARACETAMOL; RENVELA; SPECIAFOLDINE; TRINITRIN; UN ALFA; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic hemodialysis; Chronic kidney disease stage 5 (with hemodialysis); Coronary bypass (triple coronary bypass grafting); Ischaemic heart disease ((triple coronary bypass grafting with complications)); Peripheral arterial occlusive disease (multi-stented PAD); Valvular heart disease NOS ((calcified aortic stenosis tight))
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021380261

Write-up: sudden death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20210907. A 65-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, lot: EP2166), intramuscular on 10Mar2021 as single dose for covid-19 immunisation. Medical history included chronic kidney disease stage V (with hemodialysis), chronic hemodialysis, peripheral arterial occlusive disease (multi-stented PAD), ischaemic heart disease (triple coronary bypass grafting with complications) and valvular heart disease (calcified aortic stenosis tight). Concomitant medications included atorvastatin; bisoprolol; clopidogrel; sodium polystyrene sulfonate (KAYEXALATE); levothyroxine; calcium carbonate (OROCAL); pantoprazole; paracetamol; sevelamer carbonate (RENVELA); folic acid (SPECIAFOLDINE); glyceryl trinitrate (TRINITRIN); alfacalcidol (UN ALFA) and warfarin. The patient did not have Sars-CoV2 infection. The physician reported sudden death of the patient in a few minutes while preparing to come to his dialysis session on 24Mar2021. He was 14 days after a first dose of bnt162b2 and had a significant cardiovascular history. The patient died on 24Mar2021. It was unknown if autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1211394 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-03-01
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
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: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021384790

Write-up: stroke; This is a spontaneous repot from a contactable HCP via medical information team. A 97-year-old male patient received his second dose of bnt162b2 (COMIRNATY; Batch/Lot number not reported), via an unspecified route of administration on 17Feb2021 as single dose for covid-19 immunisation. The patient took the first dose of bnt162b2 on 27Jan2021. The patient''s concomitant medications were not reported. The patient died of a stroke in early Mar2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information currently available, the event stroke most likely represents an intercurrent medical condition and is unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided. 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: stroke


VAERS ID: 1211461 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000496 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPAKINE [VALPROATE SODIUM]; MYDOCALM [TOLPERISONE HYDROCHLORIDE]; NOVALGIN [METAMIZOLE SODIUM]; QUETIAPIN ACTAVIS; TEMESTA EXPIDET
Current Illness: Cramps of extremities; Epilepsy; Pain
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Dementia (Neurodegenerative dementia); Glaucoma (bilateral glaucoma); Metastatic breast cancer (status post metastatic breast cancer)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Acute heart failure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE ACUTE (Acute heart failure) in a 74-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3000496) for COVID-19 vaccination. The patient''s past medical history included Dementia (Neurodegenerative dementia), Arterial hypertension, Metastatic breast cancer (status post metastatic breast cancer) and Glaucoma (bilateral glaucoma). Concurrent medical conditions included Epilepsy, Cramps of extremities and Pain. Concomitant products included TOLPERISONE HYDROCHLORIDE (MYDOCALM [TOLPERISONE HYDROCHLORIDE]) from 02-Mar-2021 to 21-Mar-2021 for Cramps of extremities, VALPROATE SODIUM (DEPAKINE [VALPROATE SODIUM]) from 18-Feb-2020 to 21-Mar-2021 for Epilepsy, METAMIZOLE SODIUM (NOVALGIN [METAMIZOLE SODIUM]) from 25-Feb-2020 to 21-Mar-2021 for Pain, QUETIAPINE FUMARATE (QUETIAPIN ACTAVIS) from 30-Oct-2020 to 21-Mar-2021 and LORAZEPAM (TEMESTA EXPIDET) from 02-Mar-2021 to 21-Mar-2021 for an unknown indication. On 19-Mar-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE ACUTE (Acute heart failure) (seriousness criterion death). The patient died on 21-Mar-2021. The reported cause of death was Acute heart failure. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIAC FAILURE ACUTE (Acute heart failure) to be unlikely related. Treatment information was not provided. This is a case of death in a 74-year-old female subject with a medical history of dementia, arterial hypertension, metastatic breast cancer and glaucoma, who died 2 days after receiving a dose of vaccine. Based on the reporters comment and the information received, the cardiac failure is assessed as unlikely related to mRNA-1273. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 74-year-old female subject with a medical history of dementia, arterial hypertension, metastatic breast cancer and glaucoma, who died 2 days after receiving a dose of vaccine. Based on the reporters comment and the information received, the cardiac failure is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Acute heart failure


VAERS ID: 1211696 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WARFARIN
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 INC2021382454

Write-up: Death sudden; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104060902445850. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Not known), dose 1 via an unspecified route of administration on 01Feb2021 17:00 as single dose for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. Concomitant medication included warfarin (WARFARIN) taken for atrial fibrillation, start and stop date were not reported. The patient experienced death sudden on 02Feb2021 08:00. Additional information included: Received vaccine at 5pm, went to bed early and was found dead at 8am the following morning. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on unspecified date. The patient died on 02Feb2021. It was not reported if an autopsy was performed. Information about lot/batch number cannot be obtained. Follow-up attempts are completed. No further information is expected; Reported Cause(s) of Death: Death sudden


VAERS ID: 1211700 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-04-05
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage; Lactation decreased; Non-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021387053

Write-up: Cerebral haemorrhage; This is a spontaneous report from a contactable other hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104070824399490. A 50-years-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Mar202, at SINGLE DOSE for covid-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing, cerebral haemorrhage from an unknown date and unknown if ongoing, non-tobacco user from an unknown date and unknown if ongoing. The patient has not had symptoms associated with COVID-19, has not had a COVID-19 test, was not enrolled in a clinical trial, was not pregnant, and was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient was admitted via accident & emergency to the intensive care unit of the hospital on 04Apr2021 with cerebral haemorrhage; however, it was reported that the patient experienced cerebral haemorrhage on 05Apr2021. The seriousness criteria of cerebral haemorrhage were considered to be Results in death and Other medically important condition by the regulatory authority. Caused/prolonged hospitalization was considered as an additional seriousness criteria for cerebral haemorrhage. The reporter confirmed that this report relates to possible blood clots or low platelet counts, that it was unknown whether the platelet count was less than 150 x10e9/L, whether the D-dimer was greater than 4000, and whether the anti-PF4 antibodies were identified. The patient has not tested positive for covid-19 since having the vaccine. She was diagnosed as having cerebral haemorrhage. The patient died on 05Apr2021 due to cerebral haemorrhage. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1211717 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-02-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Anaemia, Anuria, Bronchitis, COVID-19, Cardiomegaly, Confusional state, Cough, Diarrhoea, Drug ineffective, Dyspnoea, Electrocardiogram, Emergency care examination, Endoscopy upper gastrointestinal tract, Fall, Fibrin D dimer, Fibrin D dimer increased, Gastritis erosive, Gastrointestinal haemorrhage, General physical health deterioration, Glomerular filtration rate decreased, Investigation, Melaena, Pneumonia, Renal impairment, Respiratory disorder, SARS-CoV-2 test, Syncope, Tension, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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), Pseudomembranous colitis (broad), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-06
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TAMSULOSIN; XARELTO; BISOPROLOL; FURON [FUROSEMIDE]; MILURIT; AMILOZID; KALDYUM; THEOSPIREX [THEOPHYLLINE SODIUM AMINOACETATE]; BUFOMIX EASYHALER; VENTOLINE [SALBUTAMOL]
Current Illness: Atrial fibrillation; COPD; Hypertension; Ischemic heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210220; Test Name: ECG; Result Unstructured Data: Test Result:HR: 90-130/min. Tachyarrhythmia, left axis, right; Comments: HR: 90-130/min. Tachyarrhythmia, left axis, right bundle branch block, disturbed repolarization; Test Date: 20210220; Test Name: emergency examination; Result Unstructured Data: Test Result:In the emergency department, laboratory tests conf; Comments: In the emergency department, laboratory tests confirmed impaired renal function and low GFR (glomerular filtration rate ) which presumably caused the development of erosive gastritis as a source of gastrointestinal bleeding.; Test Date: 20210220; Test Name: Gastroscopy; Result Unstructured Data: Test Result:gastric erosions; Test Date: 20210226; Test Name: Fibrin D dimer is above 12000 ng/ml; Result Unstructured Data: Test Result:is above 12000 ng/ml; Test Name: investigation; Result Unstructured Data: Test Result:During further observations, on day 5 of treatment; Comments: During further observations, on day 5 of treatment, dyspnoea, catarrhal cough occurred, and physical examination revealed pulmonary circulation decompensation and incipient bronchitis. The patient became hypotonic, anuric, so he received a pressor agent, his tension settled, and his diuresis started.; Test Date: 20210220; Test Name: COVID-19 antigen test; Result Unstructured Data: Test Result:negative; Test Date: 20210221; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative
CDC Split Type: HUPFIZER INC2021363615

Write-up: fell again twice in a row; Fibrin D dimer is above 12000 ng/ml; Fibrin D dimer on 26Feb2021 was 12011 ng/ml.; collapsed (had syncope); melaena diarrhea; gastrointestinal bleeding was suspected; developed anemia; impaired renal function; erosive gastritis; pneumonia; COVID-19 was detected; COVID-19 was detected; hypotonic, anuric; pulmonary circulation decompensation; low GFR (glomerular filtration rate); dyspnoea; catarrhal cough; incipient bronchitis; tension; he became confused; respiratory deterioration; cardiomegaly; Suspicion of urinary incontinence; his condition started to gradually worsen/patient''s condition showed a gradual and unstoppable progression; melaena diarrhea; This is a spontaneous report downloaded from the Regulatory authority-WEB. Regulatory Authority report number is HU-OGYI-158121. A contactable physician reported that an 83-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via intramuscular route, administered in the left arm on 20Feb2021 (Batch/Lot Number: EL0725) at 0.3 mL, as single dose for covid-19 immunization. Medical history included hypertension, ischemic heart disease, atrial fibrillation and COPD. Concomitant medications included tamsulosin, rivaroxaban (XARELTO), bisoprolol, furosemide (FURON), allopurinol (MILURIT) potassium chloride (KALDYUM), theophylline sodium aminoacetate (THEOSPIREX), salbutamol (VENTOLINE), budesonide, formoterol fumarate (BUFOMIX EASYHALER) and amiloride hydrochloride, hydrochlorothiazide (AMILOZID); all taken from unspecified dates (unknown if ongoing) for unspecified indications. On 21Feb2021, the patient felt unwell while standing in line before vaccination which resolved when he sat down. After the observation period, the patient collapsed (had a syncope) after 10 m long walking. The patient was taken home, where he fell again twice in a row, and had melaena diarrhea twice. Ambulance was called because gastrointestinal bleeding was suspected. In the emergency department, laboratory tests confirmed impaired renal function and low GFR (glomerular filtration rate) which presumably caused the development of erosive gastritis as a source of gastrointestinal bleeding. Due to the developed anemia, a total of 6 units of blood were transfused without complications, the patient''s blood count improved. Anticoagulant therapy was suspended and switched to low-dose LMWH corresponding to low (glomerular filtration rate). During further observations, on day 5 of treatment, dyspnoea, catarrhal cough occurred, and physical examination revealed pulmonary circulation decompensation and incipient bronchitis. The patient became hypotonic, anuric, so he received a pressor agent, his tension settled, and his diuresis started. Parenteral broad-spectrum antibiotics were initiated with further careful infusion, diureticization, and Berodual (ipratropium bromide; fenoterol)-ambroxol inhalation, supplemented with oxygen therapy. However, his condition started to gradually worsen, he became confused, so low-dose sedatives, steroids and intravenous bronchodilator was also initiated. Due to significant respiratory deterioration, the patient received mechanical ventilation for a short period of time. A chest X-ray was taken, which showed significant cardiomegaly, a congestive pattern, and no lesions suggestive to pneumonia. Suspicion of urinary incontinence also arose during a urine test, based on the results of inoculation, antibiotic therapy was switched to targeted treatment. Despite the treatment applied, the patient''s condition showed a gradual and unstoppable progression, the patient died on 06Mar2021 at 08:30 am. Autopsy was not done, COVID-19 was detected. The patient underwent lab tests and procedures on 20Feb2021 which included ECG: HR: 90-130/min. Tachyarrhythmia, left axis, right bundle branch block, disturbed repolarization and gastroscopy showed gastric erosions. COVID-19 antigen test on 21Feb2021 was negative. COVID-19 PCR test on 26Feb2021 was negative. Fibrin D dimer on 26Feb2021 was 12011 ng/ml. Senders Comment: The 83 year-old patient had syncope after Comirnaty vaccination. TTO was around 30 minutes. The patient also felt unwell right before vaccination. The patient had gastric erosions, anaemia, and impaired renal function. Fibrin D dimer was 12011 ng/ml 6 days after vaccination. The patients condition worsened, and died in hospital 14 after vaccination. Autopsy was not done, COVID-19 was detected. The causal relationship between the events and Comirnaty is considered unlikely. The case is serious due to hospitalization and fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: collapsed (had syncope); Fibrin D dimer is above 12000 ng/ml; Fibrin D dimer on 26Feb2021 was 12011 ng/ml.


VAERS ID: 1211718 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, Loss of consciousness, Myocardial ischaemia, Off label use
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   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: MIRAP [MIRTAZAPINE]; FUROSEMIDE; DONEPEZIL; ROSUVASTATIN; LACTULOSE; MEMANTINE; THORENS; PRADAXA; SEROPIA; UROREC; MOLIPAXIN; ETALOPRO; TWYNSTA; BISOP
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Atrial fibrillation; Benign prostatic hyperplasia; Constipation; Hypercholesterolemia; Hyperlipidemia; Hypertensive; Major depressive illness; Vascular dementia (Advanced Dementia and was in special unit); Vitamin D deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021370924

Write-up: DEATH; POSSIBLE CAUSE OF DEATH MYOCARDIAL ISCHEMIA; FOUND UNCONSCIOUS; first dose of Comirnaty given on 21Jan2021; 2nd dose given on 16Mar2021; first dose of Comirnaty given on 21Jan2021; 2nd dose given on 16Mar2021; This is a spontaneous report from contactable other healthcare professionals downloaded from a regulatory authority-WEB, report received regulatory authority number IE-HPRA-2021-069830. An 81-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EP9605), dose 2 via an unspecified route of administration on 16Mar2021 (at the age of 81years) as single dose for Covid-19 immunization. The patient received the first dose of bnt162b2 (lot number: EJ6134) on 21Jan2021 for Covid-19 immunization. Medical history included major depressive illness, vascular dementia (Advanced Dementia and was in special unit), atrial fibrillation, hyperlipidemia, Alzheimer''s disease, constipation, hypercholesterolemia, hypertensive, benign prostatic hyperplasia, and vitamin D deficiency; all from an unknown date and unknown if ongoing. Concomitant medications included mirtazapine (MIRAP) taken for major depressive episode from 16Sep2020 to 16Mar2021; furosemide taken for loop diuretic from 20Nov2020 to 16Mar2021; donepezil taken for dementia Alzheimer''s disease from 16Sep2020 to 16Mar2021; rosuvastatin taken for abnormal lipids from 16Sep2020 to 16Mar2021; lactulose taken for constipation from 21Dec2020 to 16Mar2021; memantine taken for Alzheimer''s disease from 16Sep2020 to 15Mar2021; colecalciferol (THORENS) taken for vitamin D deficiency from 16Sep2020 to 16Mar2021; dabigatran etexilate mesilate (PRADAXA) taken for anticoagulant from 16Sep2020 to 16Mar2021; quetiapine fumarate (SEROPIA) taken for depression from 16Sep2020 to 16Mar2021; silodosin (UROREC) taken for benign prostatic hyperplasia from 16Sep2020 to 16Mar2021; trazodone hydrochloride (MOLIPAXIN) taken for depression from 23Oct2020 to 16Mar2021; escitalopram oxalate (ETALOPRO) taken for depression from 16Sep2020 to 16Mar2021; amlodipine besilate, telmisartan (TWYNSTA) taken for blood pressure management from 16Sep2020 to 16Mar2021; and bisoprolol fumarate (BISOP) taken for hypertension from 16Sep2020 to 16Mar2021. On 16Mar2021, the patient was vaccinated with his second dose of Comirnaty. The reporter outlined that post vaccination on 16Mar2021, the patient had been really well in the recovery area. It was reported that the patient remained there for some time as it was the day room. It was reported that the patient was really well; he sang and provided entertainment. On 17Mar2021, 18 hours post vaccination, at 07:40 am, the patient was found unconscious by staff. The patient died within minutes. The patient passed away before treatment could be given. It was reported that the patient''s HCP considered the possible cause of death to be myocardial ischemia. The patient died on 17Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : IE-HPRA-2021-070148; Reported Cause(s) of Death: Myocardial ischemia; DEATH; Unconscious


VAERS ID: 1211719 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-21
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NU-SEALS; FUROSEMIDE; RANEXA; PANTOPRAZOLE; PROLIA; COVERSYL [PERINDOPRIL ERBUMINE]; LIPITOR [ATORVASTATIN CALCIUM]; CARDICOR; ZOPITAN; AVODART; NEURONTIN; XATRAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Benign prostatic hyperplasia; CABG; Congestive cardiac failure; Coronary arterial stent insertion; Coronary artery disease (cor artery disease and stents); Gastrooesophagitis; Heart failure; Hypertension; Neuropathy; Osteoarthritis; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021370907

Write-up: DIED SUDDENLY; SHIVERY; UNWELL; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB. This is a report received from Regulatory Authority (RA) Regulatory authority number IE-HPRA-2021-070237. An 89 years old male patient received second dose of BNT162B2 (COMIRNATY, Lot Number: ER7812) via an unspecified route of administration on 17Mar2021 at single dose for COVID-19 immunisation. Medical history included coronary artery disease "cor artery disease and stents", hypertension, coronary arterial stent insertion, gastrooesophagitis, osteoporosis, angina pectoris, heart failure, neuropathy, osteoarthritis, CABG, benign prostatic hyperplasia and congestive cardiac failure. Historical vaccine was reported as first dose of Comirnaty on 17Feb2021. Concomitant medications included acetylsalicylic acid (NU-SEALS) taken for coronary artery disease and stents, furosemide taken for cardiac failure, ranolazine (RANEXA) taken for angina, pantoprazole taken for gastrooesophagitis, denosumab (PROLIA) taken for osteoporosis, perindopril erbumine (COVERSYL) taken for hypertension, congestive cardiac failure, atorvastatin calcium (LIPITOR) taken for coronary artery disease, bisoprolol fumarate (CARDICOR) taken for congestive cardiac failure and angina, zopiclone (ZOPITAN) taken for hypnotic, dutasteride (AVODART) taken for benign prostatic hyperplasia (BPH), gabapentin (NEURONTIN) taken for neuropathy feet, alfuzosin hydrochloride (XATRAL) taken for benign prostatic hyperplasia (BPH), start and stop date were not reported. The patient experienced shivery and unwell on 21Mar2021 and died suddenly on 22Mar2021. The events were assessed as serious (death). It was reported that the patient was well after vaccination. On the night of 21Mar2021, the patient was unwell and shivery. On 22Mar2021, at 6 am, the patient was found dead. It was reported that the patient died suddenly. The outcome of all the events was fatal. The Coroner was informed and a post mortem was advised. The patient died on 22Mar2021. It''s unknown if an autopsy was performed. The cause of death was shivery, unwell and died suddenly. The reporter outlined it was unclear if the death was vaccine related. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SHIVERY; UNWELL; DIED SUDDENLY


VAERS ID: 1211776 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Electrocardiogram, Hypotensive crisis, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   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: LOSARTAN POTASICO HIDROCLOROTIAZIDA; PANTOPRAZOLE; AVODART; MADOPAR; TAMSULOSIN HYDROCHLORIDE; TRITTICO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Barrett''s esophagus; Benign prostatic hypertrophy; Bladder cancer; Cognitive deterioration; Extrapyramidal syndrome; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: blood sugar; Test Result: 115 mg/dl; Test Date: 20210326; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:no pathological abnormalities; Test Date: 20210326; Test Name: blood pressure; Result Unstructured Data: Test Result:improvement; Comments: after 1 hour
CDC Split Type: ITPFIZER INC2021380399

Write-up: Loss of consciousness 30 minutes after the vaccine with severe hypotensive crisis; Loss of consciousness 30 minutes after the vaccine with severe hypotensive crisis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB IT-MINISAL02-707250. An 83-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: ER9470; expiration date: 31Jul2021), intramuscular, administered in arm right on 26Mar2021 15:07 as single dose (at the age of 83-years-old) for covid-19 immunisation. Medical history included cognitive deterioration, bladder cancer, barrett''s oesophagus, extrapyramidal syndrome, benign prostatic hypertrophy and hypertension arterial; all from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN POTASICO HIDROCLOROTIAZIDA); pantoprazole; dutasteride (AVODART); benserazide hydrochloride, levodopa (MADOPAR); tamsulosin hydrochloride; trazodone hydrochloride (TRITTICO); all were taken for an unspecified indication, start and stop date were not reported. On 26Mar2021, the patient experienced loss of consciousness 30 minutes after the vaccine with severe hypotensive crisis. The patient underwent lab tests and procedures which included blood sugar: 115 mg/dl and electrocardiogram (ECG): no pathological abnormalities both on 26Mar2021. The patient was treated with physiological solution, adrenaline, betamethasone and emergency 118 intervention. After about 1 hour, the patient returned to being alert with improvement in blood pressure. The patient was stable until 10:00 PM, time of death. The patient died on 26Mar2021. Cause of death were loss of consciousness and severe hypotensive crisis. The outcome of the events was fatal. It was unknown if an autopsy was performed. Sender Comment: The Patient is a resident in a nursing home. Clinical report will follow. Update of 30Mar2021: the clinical report drawn up by the reporting doctor and the 118 intervention report are attached. It should be noted that the doctor, informed by the emergency medical service who has ascertained the death of the case, has notified the carabinieri; a post-mortem swab was requested by the Public Prosecutor''s Office. Update 01Apr2021: the autopsy examination will be performed on 02Apr2021 on the request of the Prosecutor''s Office. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Loss of consciousness 30 minutes after the vaccine with severe hypotensive crisis; Loss of consciousness 30 minutes after the vaccine with severe hypotensive crisis


VAERS ID: 1211839 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1742 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021386391

Write-up: patient who is found in his car without vital signs; This is a spontaneous report from a non-contactable healthcare professional received from Regulatory Authority (COFEPRIS) via email. Regulatory authority report number is 11810-4. A 63-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 intramuscular, administered in left arm on 12Mar2021 (Batch/Lot Number: ER1742) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was found in his car without vital signs on 13Mar2021 at around 8:30 hours. He is given CPR (cardiopulmonary resuscitation), he was transferred to a hospital arriving without signs, advanced CPR was given, he was declared dead at 9:20 hours. Treatment given was 2 ampoules of adrenaline in two time and a Bicarnat vial. Treatment received before receiving medical attention was none. The patient died on 13Mar2021 at 9:20 hours. It was not reported if an autopsy was performed. Case was reported as serious, hospitalization required. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: patient who is found in his car without vital signs


VAERS ID: 1211889 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Embolism, Pyrexia, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   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: SARS-CoV-2 infection (mild COVID-19 course)
Allergies:
Diagnostic Lab Data: Test Date: 20210227; Test Name: Body temperature; Result Unstructured Data: FATAL; Test Date: 20210302; Test Name: Body temperature; Result Unstructured Data: FATAL
CDC Split Type: PLMODERNATX, INC.MOD20210

Write-up: Sudden cardiac arrest; Seizures; Embolism; Body temperature increased to 39.7; Subfebrile body temperature; This regulatory authority case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Sudden cardiac arrest), SEIZURE (Seizures), EMBOLISM (Embolism), PYREXIA (Body temperature increased to 39.7) and PYREXIA (Subfebrile body temperature) in a 77-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination. The patient''s past medical history included SARS-CoV-2 infection (mild COVID-19 course) from October 2020 to November 2020. Previously administered products included for an unreported indication: ELIQUIS. On 25-Feb-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) at an unspecified dose. On 27-Feb-2021 at 1:00 PM, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PYREXIA (Subfebrile body temperature) (seriousness criterion death). On 02-Mar-2021, the patient experienced CARDIAC ARREST (Sudden cardiac arrest) (seriousness criterion death), SEIZURE (Seizures) (seriousness criterion death), EMBOLISM (Embolism) (seriousness criterion death) and PYREXIA (Body temperature increased to 39.7) (seriousness criterion death). The patient died on 02-Mar-2021. The reported cause of death was sudden cardiac arrest. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 37.5 degree Celsius (abnormal) Fatal. On 02-Mar-2021, Body temperature: 39.7 degree Celsius (High) Fatal. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route) was unknown. Treament was not reported/ unknown. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 77-year-old male subject with a medical history of recent SARS-CoV-2 infection but unknown other conditions, who died 5 days after receiving a dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Sudden cardiac arrest


VAERS ID: 1211906 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IMPUGAN [FUROSEMIDE]; CLOPIDOGREL; DIVISUN; SYMBICORT; ATORVASTATIN; SPIRIVA; ALLOPURINOL; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Hypertension; Late effects of cerebral stroke; Renal failure; Transient ischaemic attack (hospitalized for 2 days for suspected TIA (transient ischemic attack)); Weakness left or right side
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021380344

Write-up: unclear death in the home; she may have fallen; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB SE-MPA-2021-021308. Safety Report Unique Identifier SE-MPA-1616078200533. An 80-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as 0.3 mL, single for COVID-19 immunization. Medical history included hypertension, renal failure, hospitalized for 2 days for suspected TIA (transient ischemic attack) from 23Feb2021, weakness left or right side, cerebral stroke in 2004, and cardiac failure. Concomitant medications included furosemide (IMPUGAN), clopidogrel, colecalciferol (DIVISUN), budesonide, formoterol fumarate (SYMBICORT), atorvastatin, tiotropium bromide (SPIRIVA), allopurinol, and omeprazole. The patient experienced unclear death in the home in Mar2021. The woman had recently been hospitalized for 2 days for suspected TIA (transient ischemic attack). Almost two weeks later, the woman was vaccinated with Comirnaty. A relative tried to reach the patient on the phone eight days later, but got no answer. The next day, the home care staff find her lying dead on the bathroom floor, according to the reporter, she may have fallen. Outcome: Fatal. Report assessed as serious, death. Autopsy will not be performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: unclear death in the home; she may have fallen


VAERS ID: 1211907 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL 1484 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: TIA
Allergies:
Diagnostic Lab Data: Test Name: coronary x-ray; Result Unstructured Data: Test Result:UNKNOWN
CDC Split Type: SEPFIZER INC2021380325

Write-up: heart attack/MYOCARDIAL INFARCTION; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB. Regulatory Authority report number is SE-MPA-2021-021846. A 97-year-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in Feb2021 (Batch/Lot Number: EL 1484) as SINGLE DOSE for covid-19 immunization. Medical history included TIA (transient ischaemic attack) from 2014. The patient previously received the 1st dose of COMIRNATY (lot:EL 1484) for covid-19 immunization. The patient''s concomitant medications included blood pressure medications (not specified). The reporter stated that the patient was healthy for her age, managed to walk to the vaccinations 1.4 km both times. Four days after her 2nd vaccination (Feb2021), the patient had a heart attack/myocardial infarct and after about a week of hospitalization, the woman had another heart attack and died. The patient underwent lab tests and procedures which included coronary x-ray: with unknown results;it was decided that a pacemaker would be inserted after her second heart attack but patient died. It was reported that patient received a treatment due to the event. It was not reported if an autopsy was performed. The event was assessed as "serious, causing patient''s death". No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: heart attack/MYOCARDIAL INFARCTION


VAERS ID: 1211913 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine increased, General physical health deterioration, Hepatic enzyme increased, Infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), 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: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LOSARTAN; BRILIQUE; ALVEDON; ATORVASTATIN ACCORD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appetite lost (a few days before second dose of vaccine); Cholesterol high; Feeling unwell (a few days before second dose of vaccine); Headache (a few days before second dose of vaccine); Hypertension; Myocardial infarct; Nausea (a few days before second dose of vaccine); Pain (a few days before second dose of vaccine); Stomachache (a few days before second dose of vaccine)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021384548

Write-up: suspected severe infection; increased creatinine value; deterioration in general condition; increased liver value; This is a spontaneous report received from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is SE-MPA-2021-023979. A 94 years old female patient received second dose of BNT162B2 (Comirnaty, solution for injection) on Mar2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included Hypertension, Cholesterol high, myocardial infarct on Feb2021. The patient received first dose of vaccine on Feb2021. It was also informed that patient had for a few days before second dose of vaccine felt unwell with a little headache, body pain and stomachache, nausea and reduced appetite. Concomitant medications included losartan, ticagrelor (BRILIQUE), paracetamol (ALVEDON) and atorvastatin calcium trihydrate (ATORVASTATIN ACCORD). On Mar2021 the same day after second dose general health condition was reduced and at the evening the woman went to the hospital. Laboratory values showed creatinine increased and elevated liver enzymes. She also had a suspected severe infection. Reported suspect adverse events from the physician were creatinine increased, elevated liver enzymes, infection, reduced general condition. The patient died the day after vaccination. All reported events were assessed as fatal. It was unknown if an autopsy was perfofmed. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: creatinine increased; Hepatic enzyme increased; General physical health deterioration; suspected severe infection


VAERS ID: 1213587 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, Pyrexia, SARS-CoV-2 antibody test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (with an antibody level of 145)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 antibody; Result Unstructured Data: Test Result:145
CDC Split Type: BEPFIZER INC2021400096

Write-up: she had diarrhea and fever before dying; diarrhea; fever; This is a spontaneous report from a contactable physician via Medical Information. An 80-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. Medical history included COVID-19 infection from an unknown date and unknown if ongoing with an antibody level of 145. The patient''s concomitant medications were not reported. The patient experienced she had diarrhea and fever before dying on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 test: 145 on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of diarrhea and fever was unknown. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: she had diarrhea and fever before dying


VAERS ID: 1213603 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-21
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Gas gangrene
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRITTICO; ATORVASTATINE [ATORVASTATIN]; QUETIAPINE; PANTOPRAZOLUM; ASPIRIN CARDIO; MADOPAR DR; CALCIMAGON [CALCIUM]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021403563

Write-up: Gas gangrene on foot; This is a spontaneous report received from a contactable consumer via a regulatory authority. Regulatory authority report number CH-SM-2021-12813. A 94-year-old female received second dose of intramuscular BNT162B2 (COMIRNATY) on 12Feb2021 at single dose for Covid-19 immunisation at the age of 94-year-old. Medical history was unknown. Concomitant medications included trazodone hydrochloride (TRITTICO), atorvastatine, quetiapine, pantoprazolum, acetylsalicylic acid (ASPIRIN CARDIO), benserazide hydrochloride, levodopa (MADOPAR), calcium (CALCIMAGON). Vaccination history included first dose of intramuscular BNT162B2 (COMIRNATY) on 13Jan2021 for Covid-19 immunisation. On 12Feb2021, reported gaseous gangrene in the foot, then spread to the body. On 22Feb2021, death due to gas gangrene. Not known therapy received, not known if hospitalization or further course. It was unknown if an autopsy was performed. A causal relationship between Comirnaty and death and gas gangrene was assessed as being unlikely. A regulatory authority assessed this case as serious, results in death. Reporter comment: Report of death after 2nd Corona vaccination. Inquiry: Dear Sir or Madam, on behalf of my mother-in-law I unfortunately have to report a death 10 days after the 2nd Corona Biotech vaccination. Patient died very unexpectedly of gas gangrene 10 days after the 2nd vaccination. She was otherwise in generally good health. Sender''s comment: Elderly 94-year-old female. No known personal history. Weight 48 kg, height 160 cm. Chronic therapy with: Trittico, Atorvastatin, Quetiapine, Pantoprazol, Aspirin cardio, Madopar no parkinson, Calcimagon. Second dose of Comirnaty on 12Feb2021. On 21Feb2021 reported Gas Gangrene to the foot, then spread to the body. On 22Feb2021, death. Further information requested from reporter, not received. Gas Gangrene, death are adverse events not noted in the country monograph for Comirnaty. They are not reported in two different countries monographs. In resource, they do not appear as adverse events for covid-19 mRNA vaccines. In resource, we do not find any cases of Gas Gangrene following Covid-19 vaccination. The adverse events described, without knowledge of possible concomitant causes (multi-medicated patient), without data in the literature, with a delayed timing (9 and 10 days after vaccination) are judged unlikely. The event resulted in death (serious). No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reporter''s Comments: Report of death after 2nd Corona vaccination. Inquiry: Dear Sir or Madam, on behalf of my mother-in-law I unfortunately have to report a death 10 days after the 2nd Corona Biotech vaccination. Patient died very unexpectedly of gas gangrene 10 days after the 2nd vaccination. She was otherwise in generally good health.; Sender''s Comments: Fatal event gaseous gangrene represents an intercurrent medical condition and unrelated to BNT162B2 .; Reported Cause(s) of Death: Gas gangrene


VAERS ID: 1213609 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Death
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hemithyroidectomy; Neck surgery (about 15 years ago); Neurofibromatosis, type 1 (von Recklinghausen''s disease) (surgery several times about 15 y ago in the neck/cervical spine region (C3-D1 stabilization in 2001)); Spinal operation (about 15 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021402504

Write-up: Death; Asphyxiation; This is a spontaneous report received from a contactable physician via regulatory authority. Regulatory authority report number CH-SM-2021- 14151. A 34-years-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 27Mar2021 (Batch/Lot Number: unknown) as single dose (at the age of 34) for covid-19 immunisation. Medical history included neurofibromatosis, type 1 (von Recklinghausen''s disease) (surgery several times about 15 years ago in the neck and cervical spine region (C3-D1 stabilization in 2001)), hemithyroidectomy from 2008 to an unknown date. She had no known allergies. The patient''s concomitant medications were not reported. On 27Mar2021 she received the first administration of COMIRNATY without any problems. On 29Mar2021 (the day of her death) she first accused severe pain in her left arm, later she declared that she felt her neck swelling on the left. Her parents noticed a swelling that grew "visibly", to the point of compromising the airways. After alarming the emergency sercice they started a heart massage. Upon arrival of the rescuers, an asystole and a complete obstruction of the upper respiratory tract was found. An intubation was attempted which was not feasible, followed by a successful cricotomy, but despite the resuscitation with 100% oxygen for 15'' there was no sign of recovery (always in asystole). The parents specifically asked not to extend the resuscitation maneuvers any longer. Given the rapid evolution of the swelling, the hypothesis is that of an arterial hemorrhage. The doctors explained to the parents the need to perform an autopsy to know the exact cause of death but they were against it and therefore it was not performed. The patient''s illness in Jul2020 was defined as stable. The patient experienced death on 29Mar2021, fatal asphyxiation on 29Mar2021. An autopsy was not performed. This case was reported as serious with seriousness criterion Results in death. A causal relationship between COMIRNATY and the events death and Asphyxiation was assessed as being unlikely. Sender''s comment: Sudden death of a young patient known for neurofibromatosis two days after administration of Comirnaty. Death occurred from asphyxia due to an obstruction of the airways. Sudden arm pain, latency time (2 days) and unilateral swelling speak against a possible anaphylactic allergic cause due to the vaccine. In the first hypothesis there is a possible arterial dissection with bleeding that has obstructed the soft parts with consequent asphyxiation. Neurofibromatosis as a risk factor for arterial dissection: Update (1): "Other manifestations - .... Other vascular lesions may cause stenosis of major vessels, including the internal carotid, resulting in moyamoya disease. In rare instances, arterial dissection can occur, sometimes leading to life-threatening hemorrhage. " Therefore, despite the absence of an autopsy to support the hypothesis of haemorrhage, given the patient''s disease (neurofibromatosis) and the elements that speak against edema on anaphylaxis, we judged the causal correlation with the vaccine as unlikely. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender''s Comments: In concurring with the reported physician, the reported fatal event of Asphyxiation represents an intercurrent medical condition and unrelated to bnt162b2 .; Reported Cause(s) of Death: Asphyxiation


VAERS ID: 1213610 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: COPFIZER INC2021390509

Write-up: was found dead at her home; This is a spontaneous report from a contactable physician. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On the day of reporting (09Apr2021), patient was found dead at her home in the early morning. The patient died on 09Apr2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: The causal relationship between BNT162B2 and 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: was found dead at her home


VAERS ID: 1213633 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Angina pectoris, Asthenia, Back pain, Cardiac disorder, Death, Electrocardiogram, Electrocardiogram abnormal, Gallbladder disorder, Gastric ulcer, Gastrointestinal disorder, Gastrointestinal examination, Joint swelling, Myocardial infarction, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal ulceration (narrow), Gallbladder related disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 22
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: Heart disease, unspecified ((ECG finding stable for long time)); Nonsmoker
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: ECG; Result Unstructured Data: Test Result:weak heart with respect to age; Comments: weak heart with respect to age; Test Date: 20210323; Test Name: ECG; Result Unstructured Data: Test Result:disarranged; Test Date: 202103; Test Name: Gastrointestinal examination; Result Unstructured Data: Test Result:gastro possibly normal
CDC Split Type: CZPFIZER INC2021389799

Write-up: weak heart; "disarranged" ECG; stomach ulcer; Death; Pain from abdominal to heart and back/stomach pain radiating to the heart and back; suspicion of heart attack or irritated gallbladder; Nausea; Pain from abdominal to heart and back/stomach pain radiating to the heart and back; Weakness; Swollen ankles; Pain from abdominal to heart and back/stomach pain radiating to the heart and back; suspicion of heart attack or irritated gallbladder; suspected of gastrointestinal problems; paler than usual; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority- CZ-CZSUKL-21003462. A 90-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included heart disease, unspecified (ECG finding stable for long time), nonsmoker and has no obesity with above average health condition. The patient''s concomitant medications were not reported. The patient experienced nausea, pain from abdominal to heart and back, weakness, and swollen ankles on Mar2021. The patient died on 24Mar2021. It was reported that the patient experienced sudden weakness, nausea, stomach pain radiating to the heart and back (patient had a suspicion of heart attack or irritated gallbladder after meal) 3 weeks after the vaccination with Comirnaty vaccine (Mar2021). The pain was not severe, rather unpleasant, suspected of gastrointestinal problems. The patient took Famosan for stomach ulcer (unspecified date), took commonly on prescription - pain subsided. He was happier but sicker and paler than usual and his ankles were swollen according to his daughter. The same problems were repeated the next day, Wednesday 23Mar2021, again in the afternoon. In the evening, at 6 PM, an ambulance was called just for affirmation. Ambulance finding was weak heart and "disarranged" ECG; he was transferred to intensive care unit. Gastrointestinal examination and ECG were performed, according to the physician he had a weak heart with respect to age, gastro possibly normal. The patient died on 24Mar2021. Therapeutic measures were taken as a result of nausea, and pain from abdominal to heart and back. The outcome of the events was unknown. The patient died on 24Mar2021 due to an unknown cause. An autopsy was not performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1213634 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Arthralgia, Headache, Influenza like illness, Nausea, Oropharyngeal pain
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   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: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021389788

Write-up: Infarct; nausea; headache; joint pain; Flu-like symptoms; Sore throat; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority- CZ-CZSUKL-21003489. An 85-year-old male patient received first dose of BNT162B2 (COMIRNATY; lot number and expiry date were unknown), intramuscular on 12Mar2021 at a single dose for COVID-19 immunization. Medical history included COVID-19 in early Dec2020, no difficult course, no hospitalization, infection detected by accident after admission to the spa, no health consequences and no health problems. Concomitant medications were not reported. On 18Mar2021, the patient began to experience symptoms of nausea, headache and joint pain reported as flu-like symptoms and sore throat. On 22Mar2021, the medical condition was resolved with a district physician who started antibiotic treatment. Outcome of the events nausea, headache, joint pain, flu-like symptoms and sore throat was recovered on 22Mar2021. The patient died on 30Mar2021 and the doctor stated a heart attack resulting in death, also reported as infarct/acute myocardial infarction. An autopsy was not performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1213640 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-30
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Heart failure; Nausea; Vomiting
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:high
CDC Split Type: DEPFIZER INC2021389404

Write-up: Acute myocardial infarction/Infarct myocardial; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021042553. A 80-year-old male patient received BNT162B2 (COMIRNATY, mRNA TOZINAMERAN), intramuscular on 22Mar2021 (Batch/Lot Number: ER2659) as 0.3 mL, single dose for COVID-19 immunisation. Medical history included ongoing hypertension, high blood pressure, nausea with vomiting and heart failure factors or previous illnesses from unspecified dates. There were no concomitant medications. The patient experienced acute myocardial infarction/infarct myocardial on 30Mar2021. The patient died on 30Mar2021. The patient''s outcome was fatal for acute myocardial infarction. It was not reported if an autopsy was performed. This report is serious - death. Sender Comment (verbatim): Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses High blood pressure / nausea with vomiting, heart failure No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction/Infarct myocardial


VAERS ID: 1213641 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Dizziness, Incorrect route of product administration, Laryngeal oedema, Leukaemia
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Medication errors (narrow), Haematological malignant tumours (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 36
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Adenocarcinoma of the prostate stage I; Arterial hypertension; Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Conjunctivitis; Erectile dysfunction
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: Arterial pressure NOS decreased; Result Unstructured Data: Test Result:decreased
CDC Split Type: DEPFIZER INC2021389412

Write-up: Malignant pleural effusion on the right side./edema of the larynx; Leukaemia; low blood pressure, dizziness and weakness/arterial blood pressure decreased; low blood pressure, dizziness and weakness; low blood pressure, dizziness and weakness; Comirnaty via intravenous; This is as spontaneous report received from a non-contactable consumer downloaded from a regulatory authority-WEB. The regulatory authority report number is DE-PEI-CADR2021043445, Safety report unique identifier DE-PEI-202100031181. A 91-year-old male patient received the second dose of bnt162b2 (COMIRNATY, lot number and expiration date were not reported), intravenous on 06Feb2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included ongoing diabetes, ongoing arterial hypertension, adenocarcinoma of the prostate stage I from 2004 and ongoing, erectile dysfunction from 2004, and right conjunctivitis. The patient''s concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (COMIRNATY) on 15Jan2021 for COVID-19 immunisation. On 06Feb2021, the patient experienced low blood pressure, dizziness and weakness. On 26Feb2021, the patient experienced leukaemia. On 04Mar2021, the patient experienced malignant pleural effusion on the right side. It was further reported that patient experienced asthenia and not specified arterial blood pressure decreased both on 06Feb2021, and edema of the larynx on 04Mar2021. The patient underwent lab tests and procedures which included arterial pressure NOS decreased: decreased on 06Feb2021. The patient died on 14Mar2021. It was not reported if an autopsy was performed. The patient had not yet recovered from low blood pressure, dizziness and weakness while events malignant pleural effusion on the right side and leukaemia both resulted in fatal outcome. Sender Comment: Are you or the person concerned aware of any allergies? If yes, which ones? no Information. On risk factors or previous illnesses Diabetes, arterial hypertension, prostate carcinoma ED (erectile dysfunction) 2004, right conjunctivitis. Relatedness of drug to reaction(s)/event(s): Laryngeal oedema, Lightheadedness, Asthenia, Arterial pressure NOS decreased, Source of assessment: PEI, Result of Assessment: D. Unclassifiable.; Reported Cause(s) of Death: Leukaemia; Malignant pleural effusion on the right side


VAERS ID: 1213645 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-30
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021389408

Write-up: Unknown cause of death; increasing deterioration; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-PEI2021003965. A 95-year-old female patient received first dose bnt162b2 (COMIRNATY; Lot Number: not reported) intramuscular, on Jan2021, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 30Jan2021, after vaccination, the patient developed Reduced general condition and Unknown cause of death. The patient died on 30Jan2021. The events were considered as serious (medically significant). Outcome of Reduced general condition was fatal. Causes of death was reported as unknown cause of death and Reduced general condition. It was unknown if an autopsy was performed. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death; Reduced general condition


VAERS ID: 1213646 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-14
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021389406

Write-up: Unknown cause of death; especially vaccination reaction; especially vaccination reaction; This is as spontaneous report received from a non-contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is DE-PEI-PEI2021003966. A 97-year-old female patient received BNT162B2 (COMIRNATY; lot number and expiry date were not reported), intramuscular on Jan2021 (at the age of 97-years-old) at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that after vaccination, the patient developed "especially vaccination reaction" also reported as reduced general condition on 14Feb2021. Outcome of the events vaccination reaction and reduced general condition was unknown. The patient died on 14Feb2021. It was not reported if an autopsy was performed. Death cause was reported as unknown cause of death. The company assessment of the event with the drug was unclassifiable. No follow-up attempts are; information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1213649 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-03-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Death, Dyspnoea, Restlessness
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: blood pressure; Result Unstructured Data: Test Result:decrease
CDC Split Type: DEPFIZER INC2021400138

Write-up: dyspnea; decrease of blood pressure; restlessness; death after second vaccination; This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech, license party for Comirnaty (reference no.: 33877). An elderly female patient received bnt162b2 (COMIRNATY), first dose (Lot Number: EP2163) on 07Mar2021 and second dose (Lot Number: ER7812) on 28Mar2021; both were via an unspecified route of administration as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The physician wanted to report that a female patient died after second dose of bnt162b2. She was vaccinated on 07Mar2021 with first dose with lot EP2163 and on 28Mar2021 with second dose with lot ER7812. Since 29Mar2021, the patient experienced dyspnea, blood pressure decrease, restlessness; on 30Mar2021 admission to hospital via ambulance; on 01Apr2021 at 11:30 a.m. the patient died in hospital. the physician thinks the interval between first and second vaccination was too small. It is too strenuous for the organism, especially for elderly people. Cause of death was unknown. It was unknown if an autopsy was performed. The outcome of the events dyspnea, blood pressure decrease, restlessness was unknown.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. A causal association between the reported dyspnea, blood pressure decrease and restlessness cannot be completely excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1215191 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-21
Onset:2020-12-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Computerised tomogram, Fibrin D dimer, Platelet count, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   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: DIGOXIN; FINASTERIDE; FUROSEMIDE; SALBUTAMOL; SOLIFENACIN; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: GI bleed
Allergies:
Diagnostic Lab Data: Test Date: 20201228; Test Name: CT scan; Result Unstructured Data: Test Result:showed possible clot in middle cerebral artery ter; Comments: showed possible clot in middle cerebral artery territory; Test Date: 20201228; Test Name: D-dimer; Result Unstructured Data: Test Result:Unknown if greater than 4000; Test Date: 20201228; Test Name: Platelet count; Result Unstructured Data: Test Result:less than 150 x10 9/l
CDC Split Type: GBPFIZER INC2021391870

Write-up: middle cerebral artery CVA; platelet count that was less than 150 x10 9/l; This is a spontaneous report from a contactable other healthcare professional received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104080848015550; Safety Report Unique Identifier GB-MHRA-ADR 25101411. An 85-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE, Batch/Lot Number: EJ0553) dose: 1, via an unspecified route of administration on 21Dec2020, as a single dose for covid-19 immunization. Medical history included gastrointestinal bleed. The patient denied having any previous reactions to medications, especially heparin or anticoagulants, and it was unknown if any anti-PF4 antibodies were identified. The patient has not had symptoms associated with COVID-19, has not had a COVID-19 test, and is not enrolled in a clinical trial. Concomitant medications included digoxin taken for atrial fibrillation from 21May2020, finasteride, furosemide, salbutamol, solifenacin, and tamsulosin. The patient previously took the direct oral anticoagulant rivaroxaban for atrial fibrillation and experienced GI bleed. It was reported that one month prior to this report, the patient was admitted to the hospital with a gastrointestinal bleed when the rivaroxoaban was stopped. On 28Dec2020, the patient experienced middle cerebral artery cerebrovascular accident. The patient was admitted to the hospital with right-sided weakness and a middle cerebral artery cerebrovascular accident on 28Dec2020. The patient underwent lab tests and procedures, which included a CT scan that showed a possible clot in the middle cerebral artery territory on 28Dec2020, a platelet count that was less than 150 x10 9/l on 28Dec2020, and a fibrin d dimer that was unknown if it was greater than 4000 on 28Dec2020. The patient has not tested positive for covid-19 since having the vaccine. The outcome of the middle cerebral artery cerebrovascular accident was fatal, for event platelet count that was less than 150 x10 9/l was unknown. The patient died on 04Jan2021. It was not reported if an autopsy was performed and the reported cause of death was middle cerebral artery cerebrovascular accident. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: middle cerebral artery CVA


VAERS ID: 1215192 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-23
Onset:2021-01-04
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688/V0007 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Haemorrhagic stroke, Hypertension
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple sclerosis (Taking medicines for multiple sclerosis); Thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021391930

Write-up: Hypertension.; coma; Haemorrhagic stroke; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number: GB-MHRA-WEBCOVID-202104080925179560, Safety Report Unique Identifier: GB-MHRA-ADR 25101425. An 80-years-old male patient received first dose of BNT162B2, lot no. EJ1688/V0007, via an unspecified route of administration on 23Dec2020 as single dose for COVID-19 immunisation. Medical history included multiple sclerosis (taking medicines for multiple sclerosis) and thrombosis. He has not had symptoms associated with COVID-19, not had a COVID-19 test, and not enrolled in clinical trial. Concomitant medications included warfarin taken for thrombosis and unspecified medicines for multiple sclerosis. The patient experienced haemorrhagic stroke on 04Jan2021 (fatal per HA assessment). Case narrative: Taken to hospital and went into coma. Passed away from incebral haemorage and hypertension. Not unwell before vaccine. No relevant investigations or tests conducted. The patient died on 04Jan2021 due to haemorrhagic stroke and hypertension. The outcome of coma was unknown. It was not reported if an autopsy was performed. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Haemorrhagic stroke; Hypertension


VAERS ID: 1215280 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-04-08
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210325; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021398357

Write-up: Ventricular fibrillation; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21101289.?? A 51-year-old (reported as 51-year and 4-month-old) male patient received bnt162b2 (COMIRNATY, Lot Number: EP9605; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration on 25Mar2021 11:39 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient''s family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Body temperature before vaccination was 36.6 degrees Centigrade. On 08Apr2021 at after 0:00, just after midnight (14 days after the vaccination), the patient experienced ventricular fibrillation and was admitted to the hospital. The course of the event was as follows: On 08Apr2021, after 0:00, just after midnight (14 days after the vaccination), the patient was found in respiratory arrest in his sleep. Cardiopulmonary resuscitation (CPR) was initiated, and the patient was transferred to a hospital. CPR was continued, but the patient died. The reporting physician was told by the patient''s family that the cause of death was ventricular fibrillation. The reporting physician noted the details of the clinical course were unknown because it was hearsay. The reporting physician classified the event as serious (death) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was not reported. The patient underwent lab tests and procedures which included body temperature: 36.6 centigrade on 25Mar2021 before vaccination. The patient died on 08Apr2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Ventricular fibrillation


VAERS ID: 1215381 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Malaise, 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 (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HALOPERIDOL; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified; COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210404; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever: 38 to 40.5 degrees Celsius Centigrade; Test Date: 20201228; Test Name: SARS-CoV-2 test positive; Test Result: Positive
CDC Split Type: NLPFIZER INC2021399242

Write-up: Sudden breathlessness, followed by death; not feeling well/malaise; Fever: 38 to 40.5 degrees Celsius; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB regulatory authority NL-LRB-00497586. A 75-years-old female patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on 01Apr2021 (Lot Number: ET3674) as single dose for COVID-19 immunisation. Medical history included COVID-19 from 28Dec2020 without disease symptoms and cardiovascular disease. Concomitant medication(s) included haloperidol and clopidogrel. On 04Apr2021, the patient experienced sudden shortness of breath and not feeling well/malaise, after which death. Adverse event came about suddenly. The patient also experienced fever: 38 to 40.5 degrees Celsius on 04Apr2021. There were no diagnostic procedures. The patient underwent SARS-COV-2 test positive on 28Dec2020. The patient died on an unspecified date. It was not reported if an autopsy was performed. The event outcome for events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden breathlessness, followed by death; Malaise; Fever: 38 to 40.5 degrees Celsius


VAERS ID: 1215590 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Staphylococcal sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALENDRONATE SANDOZ; ACETYLSALISYLSYRE ACTAVIS; AMLODIPINE ACCORD; COAPROVEL; CALCIGRAN FORTE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021389409

Write-up: Sepsis with yellow staphylococci; This is a spontaneous report from a contactable consumer or other non hcp downloaded from a regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-PASRAPP-2021-U7jppw, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00024234. An 88-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 05Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ongoing alendronate sodium (ALENDRONAT SANDOZ); acetylsalicylic acid (ACETYLSALISYLSYRE ACTAVIS); amlodipine besilate (AMLODIPIN ACCORD); all taken for unspecified indications; ongoing hydrochlorothiazide, irbesartan (COAPROVEL) taken for hypertension and ongoing calcium carbonate, colecalciferol (CALCIGRAN FORTE) taken for an unspecified indication. The patient experienced sepsis with yellow staphylococci (staphylococcal sepsis) on 12Feb2021. The patient died on 26Feb2021 due to staphylococcal sepsis. It was not reported if an autopsy was performed. The outcome of the event was fatal. It was also reported that the event stop date was on 27Feb2021. Reporter''s comment: Contact with healthcare professionals: Physician. Daughter-in-law reported that patient died due to SEPSIS with YELLOW STAPHYLOCOCCUS , one week after VACCINATION. Patient was described as healthy before the ADR, without any other signs of infections, Autopsy was not mentioned by reporter. Sender Comment: Daughter-in-law signed up on behalf of her mother-in-law. Patient info was changed to Mother-in-law''s patient data. No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained.; Reporter''s Comments: Contact with healthcare professionals: Physician. Daughter-in-law reported that patient died due to SEPSIS with YELLOW STAPHYLOCOCCUS , one week after VACCINATION. Patient was described as healthy before the ADR, without any other signs of infections, Autopsy was not mentioned by reporter.; Reported Cause(s) of Death: STAPHYLOCOCCAL SEPSIS


VAERS ID: 1215596 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anal incontinence, Asthenia, Cardiac arrest, Chills, Feeling cold, Stupor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Noninfectious diarrhoea (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   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: Blood pressure high
Preexisting Conditions: Medical History/Concurrent Conditions: Blood cholesterol abnormal
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021389413

Write-up: Contact loss; Feeling cold; weakness (lack of strength, lack of energy); Chills; Circulatory arrest; Uncontrolled stools; This is a spontaneous report from a contactable consumer (patient daughter) downloaded from a regulatory authority-WEB, regulatory authority number PL-URPL-DML-MLP.4401.2.189.2021. A 94-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot Number: ER2659), intramuscular on 04Mar2021 (at the age of 94-year-old) as single dose for COVID-19 immunization. Medical history included ongoing high blood pressure and cholesterol (disorder). The patient was taking medications for high blood pressure and cholesterol. On 05Mar2021, the patient experienced feeling cold, chills, weakness, lack of strength, lack of energy, circulatory arrest (cardiac arrest), uncontrolled stools, loss of contact/contact loss. The patient died on 08Mar2021 due to the reported events. The outcome of the events was fatal. An autopsy was not performed. Sender comments: Chills, weakness (lack of strength, lack of energy) are expected side effects for the vaccine. Feeling cold, uncontrolled stools, loss of contact, cardiac arrest are unexpected side effects for the vaccine. The feeling of coldness and diarrhea after using the Comirnaty vaccine have already been reported in the database. Death occurred in an elderly person with a history of hypertensive disease, a coincidence cannot be ruled out. The temporal relationship speaks for a cause-and-effect relationship. A regulatory authority assessed the application as severe (death). Comirnaty/ all events/ Neurocirculatory Asthenia, Possible No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Circulatory arrest; contact loss; feeling cold; chills; weakness (lack of strength, lack of energy); uncontrolled stools


VAERS ID: 1215599 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   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: LANSOPRAZOLE; ATORVASTATIN; VIGANTOL [COLECALCIFEROL]; TRAJENTA; QUETIAPINE
Current Illness: Chronic renal failure (stage 4 chronic renal failure)
Preexisting Conditions: Medical History/Concurrent Conditions: Atheromatosis (aorta and coronary); Emphysematous cystitis (hospitalization in February 2021); Glucose increased (high glucose since the above hospitalization.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021389483

Write-up: cause of death is unknown; sudden malaise; This is a spontaneous report from a contactable physician from a regulatory authority-WEB, regulatory authority is PT-INFARMED-G202103-2995. An 81-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 1, intramuscular on 18Mar2021 (Batch/Lot Number: ET3620) as 0.3 mL, single for COVID-19 immunisation. Medical history included atheromatosis of aorta and coronary, ongoing chronic renal failure (stage 4 chronic renal failure), emphysematous cystitis from 17Feb2021 (hospitalization in February 2021) and high glucose since the above hospitalization. Concomitant medications included lansoprazole, atorvastatin, colecalciferol (VIGANTOL [COLECALCIFEROL]), linagliptin (TRAJENTA) and quetiapine, all taken for an unspecified indication, start and stop date were not reported. The patient had sudden malaise 2 days after administration of the 1st dose of the vaccine. Date of death was 20Mar2021. The cause of death is unknown. It is unknown if an autopsy was performed. The cause of death is unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cause of death is unknown; sudden malaise


VAERS ID: 1215613 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac 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), Cardiomyopathy (broad), Respiratory failure (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CPAP; Hypothyreosis; Ischemic heart disease; Percutaneous coronary intervention; Pulmonary embolism; Sleep apnea
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021389516

Write-up: Cardiac arrest; comirnaty administered via subcutaneous; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The Regulatory Authority report number is SE-MPA-2021-023470, other case identifier number SE-MPA-1616707176996. A 78-year-old male patient received BNT162B2 (COMIRNATY, lot number and expiration date not reported), subcutaneous on 25Mar2021 as a single dose for COVID-19 immunisation. Medical history included ischemic heart disease, Hypothyreosis, sleep apnea uses CPAP (continuous positive airway pressure) at night, pulmonary embolism and previous percutaneous coronary intervention in 2005. The patient''s concomitant medications were not reported. According to a relative, the patient has been feeling well lately. On the same day that the patient was vaccinated with Comirnaty, on 25Mar2021, the patient experienced cardiac arrest in the evening. The patient died the same day despite CPR (cardiopulmonary resuscitation) for nearly 60 minutes. The patient died on 25Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1215614 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram, Electrocardiogram ST segment elevation
SMQs:, Myocardial infarction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Essential hypertension; Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:ST-T segment elevation
CDC Split Type: SEPFIZER INC2021389525

Write-up: Chest pain; ST-T segment elevation; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority report number: SE-MPA-2021-024468). A contactable physician (contactable through Regulatory Authority only) reported that an 84-year-old female patient received BNT162B2 (COMIRNATY, Lot number: EP2166; Expiration date was not reported), intramuscular in Mar2021 as a single dose for COVID-19 immunization. Medical history included essential hypertension and hypothyroidism; both were unknown if ongoing. The patient''s concomitant medications were not reported. In Mar2021, 8 days after the vaccination, the patient had chest pain. The patient did not seek medical attention, then called the health center a week later, and was referred to the emergency room. The patient''s electrocardiogram (ECG) in Mar2021 ST-T segment elevation. The patient had underwent percutaneous coronary intervention for the reported events. The patient had died on an unspecified date in 2021 after two days of hospitalization. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Chest pain; ST-T segment elevation


VAERS ID: 1215618 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Death, Dyspnoea, Myocardial infarction, Pallor
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN; CHOLESTEROL TABLET
Current Illness: High cholesterol
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SGPFIZER INC2021393107

Write-up: On the same day 9pm he suddenly out of breath, cold sweat, turn pale; On the same day 9pm he suddenly out of breath, cold sweat, turn pale; On the same day 9pm he suddenly out of breath, cold sweat, turn pale; died after he had his 1dose of COVID 19 vacation; Doctor immediately attend to him, after half an hour doc came out and said he had heart attack n heart beat has stopped; This is a spontaneous report from a contactable consumer received via a sales representative. An 81-year-old male patient received bnt162b2 (BNT162B2), dose 1 via intramuscular route of administration on 06Apr2021 08:30 (Batch/Lot number was not reported) as an unspecified dose (at the age of 81-year-old) for covid-19 immunisation. The patient medical history included ongoing bit high cholesterol. The patient was healthy and strong. No major sickness before. The patient''s concomitant medications included ongoing vitamins and on cholesterol tablets (drug names not reported). Prior vaccination (within 4 weeks) were none. On 06Apr2021 the patient cycled to and fro to nearby clinic and took his 1st dose of vaccine at 08:30 am. The patient reached home and had his regular meals as per normal. On the same day 9 pm he was suddenly out of breath, cold sweat, turned pale. Immediately, family members called ambulance and rushed him to hospital. The patient was still conscious when he left the house and when reached hospital. Doctor immediately attended to the patient, after half an hour doctor came out and said he had heart attack and heart beat stopped. They cannot retrieve him and the patient died on 06Apr2021. Autopsy was performed and cause of death was ischaemic heart disease. No follow-up attempts are needed, information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: ischaemic heart disease


VAERS ID: 1217122 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 4
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Carcinoma bladder (in treatment)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: CZMODERNATX, INC.MOD20210

Write-up: Massive pulmonary embolism; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Massive pulmonary embolism) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 in January 2021 and Carcinoma bladder (in treatment) since an unknown date. On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PULMONARY EMBOLISM (Massive pulmonary embolism) (seriousness criterion death). The patient died on 17-Mar-2021. The reported cause of death was Pulmonary embolism. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: Positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1217164 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   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: No adverse event (No reported medical history.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Cardio-respiratory arrest; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001413) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history.). On 20-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criterion death). The patient died on 22-Mar-2021. The reported cause of death was Cardio-respiratory arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was reported. Reporter did not allow further contact; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1217281 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PLAVIX; BELOC ZOK; COMILORID; FELODIPIN; CELECOXIB; DUODART; OMEZOL LYO
Current Illness: Diabetes mellitus; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarct; Renal failure; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death) in an 86-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Myocardial infarct, Stroke and Renal failure. Concurrent medical conditions included Diabetes mellitus and Hypertension. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), METOPROLOL SUCCINATE (BELOC ZOK), AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE (COMILORID), FELODIPIN, CELECOXIB, DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE (DUODART) and OMEPRAZOLE SODIUM (OMEZOL LYO) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 23-Mar-2021 The patient died on 23-Mar-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (death) to be unlikely related. Treatment was not provided. On 22-Mar, he was visited by the attending physician for non-specific symptoms (fluctuating vertigo, mild chest tightness, arterial hypotension), partly known but aggravated symptoms. Clinical examination and ECG without pathological findings, D-Dimer negative, Troponin-T non-pathological in view of age and concomitant chronic renal failure.; Sender''s Comments: This is a case of death in a 86-year-old male subject with a medical history of Diabetes mellitus, Hypertension. Myocardial infarct, Stroke and Renal failure, who died 5 days after receiving the first dose of vaccine. Based on reporter''s causality that patient''s age and clinical condition with several known pathologies, the death is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1217331 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history provided.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1616410261153

Write-up: Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in a 75-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No medical history provided.). On 18-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on March 2021 The patient died in March 2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact; Sender''s Comments: Concomitant Product use was not provided. Treatment information was not provided. This case refers to a 75-year-old elderly female patient who died after receiving the second dose of mRNA-1273 vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1218470 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20210

Write-up: Death NOS; This case was received via another Manufacturer (Reference number: QTS-210413-110) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death NOS) in a 63-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history). On 20-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 23-Mar-2021 The patient died on 23-Mar-2021. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 63-year-old male subject with unknown medical history of, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.


VAERS ID: 1218478 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 70068 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Crohn''s disease; Paranoid schizophrenia; Renal insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse; Nicotine abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Exitus letalis; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Exitus letalis) in a 68-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 70068) for COVID-19 vaccination. The patient''s past medical history included Nicotine abuse and Alcohol abuse. Concurrent medical conditions included Crohn''s disease, Paranoid schizophrenia and Renal insufficiency. On 26-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 29-Mar-2021 The patient died on 29-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Action taken with the mRNA-1273 was not applicable Very limited information regarding the event of death has been provided at this time. No further information has been requested. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding the event of death has been provided at this time. No further information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1218479 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-03-10
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722; 3000 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Alanine aminotransferase, Angiogram, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood creatinine, Blood gases, Blood glucose, Blood lactate dehydrogenase, Blood lactic acid, Blood potassium, Blood sodium, Blood urea, C-reactive protein, Cerebrovascular accident, Echocardiogram, Electrocardiogram, Fibrin D dimer, Gamma-glutamyltransferase, Haemoglobin, International normalised ratio, Loss of consciousness, Neutrophil count, Platelet count, Troponin T, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   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: ELTROXIN; KALEORID; LERCATIO; HEART MAGNIL; SPIRIVA; LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Atherosclerosis
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: Alanine aminotransferase; Test Result: Inconclusive ; Result Unstructured Data: 248 Unit not specified; Test Date: 20210310; Test Name: CT angiography; Test Result: Inconclusive ; Result Unstructured Data: occlusion of the left ICA; Test Date: 20210310; Test Name: CT angiography; Test Result: Inconclusive ; Result Unstructured Data: thrombus in the left a. Cerebri media; Test Date: 20210310; Test Name: CT angiography; Test Result: Inconclusive ; Result Unstructured Data: stenosis of the left a. Carotis interna; Test Date: 20210310; Test Name: Albumin; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Alkaline phosphatase; Test Result: Inconclusive ; Result Unstructured Data: 145 Unit not specified; Test Date: 20210310; Test Name: Bilirubin; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Creatinine; Test Result: Inconclusive ; Result Unstructured Data: 187 Unit not specified; Test Date: 20210310; Test Name: Arterial blood gases; Test Result: Inconclusive ; Result Unstructured Data: Metabolic acidosis Unit not specified; Test Date: 20210310; Test Name: Glucose; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: LDH; Test Result: Inconclusive ; Result Unstructured Data: 1080 Unit not specified; Test Date: 20210310; Test Name: Lactate; Test Result: Inconclusive ; Result Unstructured Data: 11 to 14 Unit not specified; Test Date: 20210310; Test Name: Potassium; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Sodium; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Urea; Test Result: Inconclusive ; Result Unstructured Data: 10.5 Unit not specified; Test Date: 20210310; Test Name: C-reactive protein; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Echocardiography; Test Result: Inconclusive ; Result Unstructured Data: thrombus in coronary artery; Test Date: 20210310; Test Name: EKG; Test Result: Inconclusive ; Result Unstructured Data: Inferior STEMI; Test Date: 20210310; Test Name: Fibrin D dimer; Test Result: Inconclusive ; Result Unstructured Data: $g35, too high to measure Unit not specified; Test Date: 20210310; Test Name: GGT; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Hemoglobin; Test Result: Inconclusive ; Result Unstructured Data: 6.8 Unit not specified; Test Date: 20210310; Test Name: INR; Test Result: Inconclusive ; Result Unstructured Data: 1.11 Unit not specified; Test Date: 20210310; Test Name: Neutrophil count; Test Result: Inconclusive ; Result Unstructured Data: 19.3 Unit not specified; Test Date: 20210310; Test Name: Thrombocyte count; Test Result: Inconclusive ; Result Unstructured Data: 303 Unit not specified; Test Date: 20210310; Test Name: Troponin T; Test Result: Inconclusive ; Result Unstructured Data: 3130 Unit not specified; Test Date: 20210310; Test Name: Leukocyte count; Test Result: Inconclusive ; Result Unstructured Data: 22 Unit not specified
CDC Split Type: DKMODERNATX, INC.MOD20210

Write-up: Apoplexy; Brought to the hospital unconscious; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Apoplexy) and LOSS OF CONSCIOUSNESS (Brought to the hospital unconscious) in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 300042722; 3000489 and 300042722; 3000489) for COVID-19 vaccination. The patient''s past medical history included Atherosclerosis since an unknown date. Previously administered products included for an unreported indication: VESICARE in 2016. Concurrent medical conditions included Apoplexy. Concomitant products included ACETYLSALICYLSYRE (HEART MANGIL) from 23-Jun-2014 to an unknown date for Anticoagulant therapy, TIOTROPIUM BROMIDE (SPIRIVA) from 23-Jun-2014 to an unknown date for Chronic obstructive pulmonary disease, LERCANIDIPINE HYDROCHLORIDE (LERCATIO) from 24-Mar-2014 to an unknown date and LOSARTAN POTASSIUM (LOSARSTAD) from 19-Feb-2014 to an unknown date for Hypertension, LEVOTHYROXINE SODIUM (ELTROXIN) from 24-Apr-2014 to an unknown date for Hypometabolism, POTASSIUM CHLORIDE (KALEORID) for Potassium supplementation. On 09-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Apoplexy) (seriousness criterion death) and LOSS OF CONSCIOUSNESS (Brought to the hospital unconscious) (seriousness criterion death). The patient died on 10-Mar-2021. The reported cause of death was Apoplexy and Unconscious. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Alanine aminotransferase: 248 248 Unit not specified. On 10-Mar-2021, Angiogram: occlusion of the left ICA, thrombus in the left a. Middle Cerebral and stenosis of the left artery Carotid On 10-Mar-2021, Blood albumin: (normal) Normal. On 10-Mar-2021, Blood alkaline phosphatase: 145 145 Unit not specified. On 10-Mar-2021, Blood bilirubin: (normal) Normal. On 10-Mar-2021, Blood creatinine: 187 187 Unit not specified. On 10-Mar-2021, Blood gases: Metabolic acidosis Unit not specified. On 10-Mar-2021, Blood glucose: mg/dl (normal) Normal. On 10-Mar-2021, Blood lactate dehydrogenase: 1080 1080 Unit not specified. On 10-Mar-2021, Blood lactic acid: 11-14 11 to 14 Unit not specified. On 10-Mar-2021, Blood potassium: (normal) Normal. On 10-Mar-2021, Blood sodium: (normal) Normal. On 10-Mar-2021, Blood urea: 10.5 10.5 Unit not specified. On 10-Mar-2021, C-reactive protein: (normal) Normal. On 10-Mar-2021, Echocardiogram: thrombus in coronary artery. See Sender comments. On 10-Mar-2021, Electrocardiogram: inferior stemi Inferior STEMI. On 10-Mar-2021, Fibrin D dimer: $g35 $g35, too high to measure Unit not specified. On 10-Mar-2021, Gamma-glutamyltransferase: (normal) Normal. On 10-Mar-2021, Haemoglobin: 6.8 6.8 Unit not specified. On 10-Mar-2021, International normalised ratio: 1.11 1.11 Unit not specified. On 10-Mar-2021, Neutrophil count: 19.3 19.3 Unit not specified. On 10-Mar-2021, Platelet count: 303 303 Unit not specified. On 10-Mar-2021, Troponin T: 3130 3130 Unit not specified. On 10-Mar-2021, White blood cell count: 22 22 Unit not specified. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Echocardiography, 10 Mar2021: Thrombus in coronary artery. Confirmed by elevated troponin T and high D dimer. Severe aortic stenosis, initial localised inferior hypokinesia, later takotsubo like heart failure, likely due to the apoplexies. Action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided. Reporter did not allow further contact.; Sender''s Comments: Very limited information regarding the reported fatal events has been provided at this time. However, patient''s advanced age and underlying cardiovascular comorbidities may have been contributory. No further information has been requested.; Reported Cause(s) of Death: Apoplexy; Unconscious


VAERS ID: 1218495 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic ischemic heart disease, unspecified; COVID-19; Dementia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1616333419620

Write-up: fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever) in an 86-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 30-Dec-2020, Chronic ischemic heart disease, unspecified, Dementia and Hypertension. In March 2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1. In March 2021, the patient experienced PYREXIA (fever) (seriousness criterion death). The patient died in March 2021. The reported cause of death was Fever. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable. Reporter did not allow further contact; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Fever


VAERS ID: 1225005 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 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: 2021-03-26
   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: ASAFLOW; INEGY; LISINOPRIL; SINTROM; TARDYFERON; TENORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioplasty (angioplasty stenting); Ischemic heart disease; Myocardial necrosis (patient with a history of antero-septal myocardial necrosis); Thrombocytopenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021398715

Write-up: Sudden death during an effortless walk this 26mar2021 after the vaccine no adverse effects before, no complaints before the walk; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number BE-FAMHP-DHH-N2021-86449. A 72-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: EP9605), via an unspecified route of administration on 23Mar2021 13:30 as single dose for COVID-19 immunization. Medical history included ischemic heart disease, antero-septal myocardial necrosis, angioplasty stenting, and stable isolated thrombocytopenia, all from an unknown date. Concomitant medications included acetylsalicylic acid (ASAFLOW), ezetimibe, simvastatin (INEGY), lisinopril, acenocoumarol (SINTROM), ferrous sulfate (TARDYFERON), and atenolol (TENORMIN) all taken for an unspecified indication, start and stop date were not reported. The patient experienced sudden death during an effortless walk this 26Mar2021 after the vaccine no adverse effects before, no complaints before the walk. The patient died on 26Mar2021. It was not reported if an autopsy was performed. Reporter comment: Treatment - Evolution of the ADR - Death. Relatedness of drug to reaction(s)/event(s): Source of assessment: Health Agency. Method of assessment: WHO. Result of Assessment : unclassifiable. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - Evolution of the ADR - Death. Relatedness of drug to reaction(s)/event(s): Source of assessment: Health Agency. Method of assessment: WHO. Result of Assessment : unclassifiable.; Reported Cause(s) of Death: sudden death


VAERS ID: 1225006 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Cardiac arrest, Chills, Constipation, Faecal vomiting, Gastric dilatation, Intestinal obstruction, Investigation, Nausea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   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: ATORVASTATIN; ALLOPURINOL; LYSANXIA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Investigation; Result Unstructured Data: Test Result:Per-resuscitation ultrasound: Fluid content of the; Comments: Per-resuscitation ultrasound: Fluid content of the digestive loops.
CDC Split Type: BEPFIZER INC2021398719

Write-up: cardiac arrest around 30h post-vaccination; fecaloid vomiting; abdominal dilation; Bowel obstruction; no bowel movements; Abdominal pain; shivering; Vomiting; Asthenia; Nausea; This is a spontaneous report from a contactable physician downloaded from a regulatory authority. Regulatory Authority Report Number: BE-FAMHP-DHH-N2021-86590. A 73-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Mar2021 (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was stated as: the patient''s general condition was good, no significant history. Concomitant medications included atorvastatin; allopurinol; prazepam (LYSANXIA), all were taken for an unspecified indication, start and stop date were not reported. On 26Mar2021, the patient experienced shivering, nausea, asthenia, abdominal pain, vomiting, no bowel movements, bowel obstruction, stomach dilatation, fecal vomiting. On 27Mar2021, the patient experienced cardiac arrest around 30h post-vaccination. The events were assessed as serious, lead to death. Examinations - Per-resuscitation ultrasound: Fluid content of the digestive loops. ADR description - Within a few hours of vaccination, asthenia, chills. A few hours later, abdominal pain and vomiting. Persistence of abdominal pain with absence of stool and false need. EMS support for cardiac arrest approximately 30 hours after vaccination. Table of intestinal obstruction with abdominal dilation +++, per-resuscitation fecaloid vomiting, fluid content of the digestive loops on per-resuscitation ultrasound. Death of the patient. The patient died on 28Mar2021. It was not reported if an autopsy was performed. Treatment of events includes Buscopan, Ibuprofen. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: Treatment - Buscopan, Ibuprofen; Evolution of the ADR - Death; Examinations - Per-resuscitation ultrasound: Fluid content of the digestive loops. ADR description - Within a few hours of vaccination, asthenia, chills. A few hours later, abdominal pain and vomiting. Persistence of abdominal pain with absence of stool and false need. EMS support for cardiac arrest approximately 30 hours after vaccination. Table of intestinal obstruction with abdominal dilation +++, per-resuscitation fecaloid vomiting, fluid content of the digestive loops on per-resuscitation ultrasound. Death of the patient.; Reported Cause(s) of Death: cardiac arrest; fecaloid vomiting; abdominal dilation; Bowel obstruction; no bowel movements; Abdominal pain; shivering; Vomiting; Asthenia; Nausea


VAERS ID: 1225007 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Pyrexia, Septic shock
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bacterial infection NOS (Bacterial problems); Bed sore (Bed sores); General physical condition decreased (my dad was paralyzed and not in the best health shape); Iodine allergy (allergy to iodine); Paralyzed (Paralyzed for 23 years); Sepsis (multiple blood infections, chronic blood infections)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021405803

Write-up: Bacterial infection/Sepsis shock; Fever; not feeling well; This is a spontaneous report from a contactable consumer. A 60-year-old male patient (father of the reporter) received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration in the left arm on 05Mar2021 at 13:00 (at the age of 60-year-old) (Lot Number: EP2166) as single dose for COVID-19 immunisation. Relevant medical history included multiple blood infections and chronic blood infections, paralysis from 1997 (paralyzed for 23 years), bed sores, bacterial problems, general physical health deterioration (the patient was paralyzed and not in the best health shape) and iodine allergy. Concomitant medications were not reported. The patient died 3 days after receiving the vaccine. He had a blood infection and the doctor decided that it was ok to give him the vaccine. He had a fever and was not feeling well on 05Mar2021. The patient was hospitalized for the events. The patient died on 08Mar2021. An autopsy was not performed. The patient did not receive corrective treatments. The reporter commented that his dad was paralyzed and not in the best health shape and he was not sure why was he given the vaccine. The doctor told the reporter that he died from bacterial infection and the cause of death was septic shock (onset date 05Mar2021).; Reported Cause(s) of Death: Sepsis Shock


VAERS ID: 1225011 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carcinoma; Lung nodule (Unknown if patient was born with one lung or if a pneumonectomy took place); Pneumonectomy (Unknown if patient was born with one lung or if a pneumonectomy took place)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021404159

Write-up: My father died 15Mar2021, 50 minutes after receiving the vaccine/Patient collapsed and died after 30min of resuscitation/sudden death; This is a spontaneous report received from a contactable consumer (patient''s child) via a regulatory authority. Regulatory authority report number CH-SM-2021-14212. A 73-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EP2163), intramuscular on 15Mar2021 as a single dose (at the age of 73-years-old) for covid-19 immunisation. The patient medical history included carcinoma; one lung and a new nodule on the remaining lung and it was unknown if patient was born with one lung or if a pneumonectomy took place. The patient''s concomitant medications were not reported. The consumer reported that his/her father (patient) died 50 minutes after receiving the vaccine on 15Mar2021. Clinical course details: He was at the parking, he was going to his car to get his ticket when he collapsed on his 2 knees while holding his chest or belly (these are the surveillance cameras) which was filmed. He had 30 minutes of resuscitation in vain on the spot. The patient died on 15Mar2021. Cause of death reported as "Patient collapsed and died after 30min of resuscitation". An autopsy was performed and results were not provided. A causal relationship between Comirnaty and Death was assessed as being conditional/unclassified. This case was reported as serious (fatal outcome). Sender''s comment: Sudden death 50 minutes after vaccination in an oncology patient with a single lung who had been diagnosed with a nodule. The autopsy is in progress that will explain the death and that we will integrate in the report as soon as it is received. At the moment, we don''t have other details, we judged the causal correlation with the vaccine as conditional/unclassified. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Patient collapsed and died after 30min of resuscitation


VAERS ID: 1225015 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute respiratory failure; Adipositas; Arterial hypertension; Autoimmune thyroiditis; Bipolar affective disorder; Bronchial pneumonia; COPD; Hashimoto''s encephalopathy; Sleep apnoea syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398796

Write-up: The body was found on 26Mar2021 at around 8 a.m.; This is a spontaneous report from a non-contactable other healthcare professional (HCP) downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100032180. A 57-years-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: ER7812, expiry date not reported), via an unspecified route of administration on 25Mar2021 18:25 at 0.3 mL, single for covid-19 immunisation. Medical history included Hashimoto''s encephalopathy, acute respiratory failure, and bronchial pneumonia, all on unknown dates (not ongoing); and COPD, bipolar affective disorder, sleep apnoea syndrome, adipositas, autoimmune thyroiditis, arterial hypertension, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient had the first dose of Comirnaty for COVID-19 immunisation at 0.3ml on 09Feb2021. The patient''s body was found on 26Mar2021 at around 8 a.m. The patient died on 26Mar2021 with unknown cause of death. It was unknown if an autopsy was performed. Sender comments: 2nd vaccination Comirnaty on 25Mar21 at 6:25 pm. After that, well-being. The corpse was found on March 26Mar21 at around 8 h. Comirnaty/ death/ Regulatory Authority, D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225016 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Electrocardiogram
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? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:unknown result
CDC Split Type: DEPFIZER INC2021398798

Write-up: The lethal outcome with asystole 20:20h; This is a spontaneous report received from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB. The Regulatory Authority report number is DE-PEI-202100031681. A 78-year-old male patient received BNT162B2 (COMIRNATY, lot number: ER9480 and expiration date not reported), via an unspecified route of administration on 06Apr2021 as 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 06Apr2021 20:20 the patient experienced lethal outcome with asystole. ECG (Electrocardiography), Cardiopulmonary Resuscitation through Ramus diagonalis. The patient died on 06Apr2021. It was not reported if an autopsy was performed. The event was assessed as serious (death, life threatening). Relatedness of drug to reaction/event by Regulatory Authority was D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: The lethal outcome with asystole


VAERS ID: 1225018 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Pulmonary embolism
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   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: CLOTRIMAZOL; PANTOZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; ACTILYSE; QUETIAPIN; NOVALGIN [METAMIZOLE SODIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis; Dementia; Diabetes; Lung embolism; Renal insufficiency; Right ventricular failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398803

Write-up: Lung embolism; Cerebral infarction; This is a spontaneous report from a non-contactable healthcare professional downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-202100031683. A 79-year-old male received BNT162B2 (COMIRNATY), second dose via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: Unknown) as 0.3 mL, single dose for COVID-19 immunisation. Medical history included arteriosclerosis, renal insufficiency, lung embolism, right ventricular failure, dementia and diabetes; all unknown if ongoing. Concomitant medications included clotrimazol; pantoprazole sodium sesquihydrate (PANTOZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]); alteplase (ACTILYSE); quetiapine fumarate (QUETIAPIN); and metamizole sodium (NOVALGIN [METAMIZOLE SODIUM]); and "HCT 12" and "Torein" (unspecified, pending clarification); all taken for an unspecified indication, start and stop date were not reported. The patient took the first dose of BNT162B2 on 05Feb2021 for COVID-19 immunisation. On 03Mar2021, the patient experienced cerebral infarction. On 07Mar2021, the patient experienced a lung embolism. The patient has not recovered from cerebral infarction. The regulatory authority assessed lung embolism as serious, death, hospitalization and life-threatening; while cerebral infarction as serious requiring hospitalization and life-threatening. The patient died on 07Mar2021. It was unknown if an autopsy was performed. Sender Comment: He was suddenly found dead in the hospital bed. It is unclear whether he died in connection with the vaccination. Previous illness: Vascular damage to the legs, already several operations. Relatedness of drug to reaction(s)/event(s) for all events Result of Assessment D. Unclassifiable Comirnaty batch/lot number: unknown; Reported Cause(s) of Death: Pulmonary embolus


VAERS ID: 1225021 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-03-13
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398820

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100032174. A 94-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously receive first dose of COMIRNATY for Prophylactic vaccination on 27Jan2021. On 13Mar2021, it was reported that the patient died. The cause of death was unknown. An autopsy was not performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225022 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-28
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   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 INC2021398822

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100032176. A 97-year-old female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 22Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had the first dose of bnt162b2 (COMIRNATY) on 31Dec2020 at 0.3 ml for Covid-19 immunisation. On 28Feb2021, the patient died of an unknown cause. An autopsy was not performed. Comirnaty and death was assessed by Regulatory Authority as unclassifiable. No follow-up attempts possible. No further information expected. Batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225023 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-12
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer
Allergies:
Diagnostic Lab Data: Test Name: echocardiogram; Result Unstructured Data: Test Result:no results; Test Name: Transesophageal echocardiography; Result Unstructured Data: Test Result:no results
CDC Split Type: DEPFIZER INC2021398829

Write-up: Unknown cause of death; Lung embolism; This is a spontaneous report from a non-contactable physician reporting for a patient downloaded from the regulatory authority, company number DE-PEI-202100032178. An 82-year-old female patient received bnt162b2 (COMIRNATY) reported as "mRNA TOZINAMERAN", via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: Unknown) as 0.3 mL, single for covid-19 immunisation, at 82 years old. Medical history included breast cancer from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took COMIRNATY on 07Jan2021 for Prophylactic vaccination. The patient experienced unknown cause of death on an unspecified date and lung embolism on 12Feb2021. The patient underwent lab tests and procedures which included echocardiogram: no results, and Transesophageal echocardiography: no results on unspecified dates. Seriousness criteria was provided as death, hospitalization (unspecified date), and life threatening. The patient died on an unspecified date. It was not reported if an autopsy was performed. Causality was provided as Unclassifiable. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225024 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-24
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398831

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-202100032179. A 90-year-old female patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 05Mar2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of COMIRNATY on 12Feb2021 at 0.3 ml for COVID-19 immunization. The patient experienced unknown cause of death on 24Mar2021. The patient died on 24Mar2021. An autopsy was not performed. Relatedness of drug to reaction/event: Unclassifiable Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225025 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-11
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-18
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: 2021-03-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398825

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB with regulatory authority number DE-PEI-202100032180. An 86-year-old female patient received bnt162b2 (COMIRNATY also reported as mRNA TOZINAMERAN), at vaccination age of 86-year-old via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as 0.3 mL single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 11Mar2021, the patient experienced cause of death unknown. The outcome of the event was fatal. The patient died on 11Mar2021. An autopsy was not performed. Comirnaty/ death/ Regulatory Authority , D. Unclassifiable No follow-up attempts possible. Batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225026 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-12
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-04-18
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: 2021-02-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398833

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority -WEB, regulatory authority number DE-PEI-202100032181. A 90-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 22Jan2021 (Lot number was not reported) as 0.3 mL, single for covid-19 immunization at age 90 years old. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of COMIRNATY on 31Dec2020 as 0.3 mL, single for COVID-19 immunization at age 90 years old The patient experienced unknown cause of death on 12Feb2021. The patient died on 12Feb2021. An autopsy was not performed. The relatedness of Comirnaty to death was unclassifiable as per PEI. No follow-up attempts are possible. No further information is expected. Batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225027 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-03-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pacemaker insertion (cardiac)
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm; Arterial hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398811

Write-up: lethal outcome 18h after Comirnaty; This is a spontaneous report from a non-contactable other health care professional downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-202100032187. A 92-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 29Mar2021 (Batch/Lot Number: Unknown) at the age of 92-years-old as single dose for covid-19 immunisation. Medical history included arterial hypertension, aneurysm from an unknown date and unknown if ongoing, ongoing pacemaker. The patient''s concomitant medications were not reported. The patient experienced lethal outcome 18h after comirnaty (death) on 30Mar2021. The patient died on 30Mar2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Sender Comment: Pacemaker Comirmaty/ Death/ PEI/ Unclassifiable No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225028 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398819

Write-up: Cerebral haemorrhage; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB DE-PEI-202100032189. A 90-year-old male patient received bnt162b2 (COMIRNATY; lot number and expiration date unspecified), via an unspecified route of administration on 26Feb2021 as 0.3 mL, single for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. On 03Mar2021, the patient experienced cerebral haemorrhage. The patient died on 25Mar2021 due to the event. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s) Source of assessment PEI Result of Assessment D. Unclassifiable No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1225034 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021400068

Write-up: death; shortness of breath; This is a spontaneous report from a contactable physician. This is a report based on information received by Pfizer from a regulatory authority. An 80-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 08Apr2021 as single dose for covid-19 immunisation. Medical history included heart insufficiency from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient was vaccinated on 08Apr2021 with the 1st dose of BioNtech corona vaccine. The patient has been doing well so far. Shortness of breath began around 24 hours late (09Apr2021). Then patient died on 10Apr2021 due to an unknown cause of death. It was not reported if an autopsy was performed. Outcome of shortness of breath was unknown. Follow-up (12Apr2021): New information received by Pfizer from a contactable physician via BioNTech (license number: 36038), license party for COMIRNATY. Batch/lot number: EW8904.; Sender''s Comments: Lacking any details on the circumstances and cause of patient''s demise, the reported death is considered as related to BNT162B2 as a cautionary measure only. 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: unknown cause of death


VAERS ID: 1225055 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood fibrinogen, Blood glucose, Blood potassium, Blood sodium, Cerebral haemorrhage, Coagulation test, Computerised tomogram head, Haemoglobin, Mean cell haemoglobin, Mean cell volume, Neutrophil count, Platelet count, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Dyslipidemia; Fall; Glaucoma; Hip injury; Ischaemic stroke; Transurethral resection of bladder tumor
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: creatinine; Result Unstructured Data: Test Result:normal; Test Date: 202103; Test Name: fibrinogen; Result Unstructured Data: Test Result:79.75; Test Date: 202103; Test Name: glucose; Test Result: 160 mg/dl; Test Date: 202103; Test Name: potassium; Result Unstructured Data: Test Result:3.7 mEq/l; Test Date: 202103; Test Name: sodium; Result Unstructured Data: Test Result:153 mEq/l; Test Date: 202103; Test Name: coagulation; Result Unstructured Data: Test Result:normal; Test Date: 20210329; Test Name: CT skull; Result Unstructured Data: Test Result:corresponding to hematoma; Comments: corresponding to hematoma in acute evolutionary phase with associated vasogenic edema; Test Date: 202103; Test Name: hemoglobin; Result Unstructured Data: Test Result:98 g/l; Test Date: 202103; Test Name: MCH; Result Unstructured Data: Test Result:normal; Test Date: 202103; Test Name: MCV; Result Unstructured Data: Test Result:normal; Test Date: 202103; Test Name: neutrophils; Result Unstructured Data: Test Result:neutrophilia 8650; Test Date: 202103; Test Name: platelets; Result Unstructured Data: Test Result:normal; Test Date: 202103; Test Name: leukocytes; Result Unstructured Data: Test Result:leukocytosis 12100
CDC Split Type: ESPFIZER INC2021398873

Write-up: Cerebral haemorrhage; This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority-WEB ES-AEMPS-816333. An 89-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 as 0.3 mL, single for COVID-19 immunisation. Medical history included ischaemic stroke from 2013 to an unknown date, arterial hypertension, glaucoma, dyslipidaemia from an unknown date and unknown if ongoing, transurethral bladder resection from 2007 to an unknown date, fall from 15Mar2021 and joint injury from 15Mar2021 to an unknown date. Concomitant medication included acetylsalicylic acid taken for an unspecified indication, start and stop dates were not reported. The patient experienced cerebral haemorrhage on 29Mar2021. Clinical course was as follows: Patient''s background: stroke in 2013; Hypertension; Glaucoma; Dyslipidemia; Transurethral resection of bladder tumor in 2007; Fall on 15Mar2021 without head trauma. Hip contusion, so the dose of ASA is reduced from 300 to 100 mg. Complementary examinations on admission: Patient in coma, with closed eyes without verbal response to the stimuli. To the pain stimulus, no eye opening, no verbal response and with decerebrate movements in both arms. Dysphoric right pupil due to history of surgical intervention, middle left pupil with slow photomotor. Focused gaze. Absence of oculocephalic movements. Left facial asymmetry to the Marie-Foix maneuver. Bilateral extensor plantar reflex. No abnormal movements. General analysis: Hb 98 g / L, MCV and normal MCH. Leukocytes 12100 with neutrophilia 8650. Normal platelets. Normal coagulation. Glucose 160mg / dl. Creatinine normal, Fibrinogen 79.75. Na 153mEq / L, K 3.7 mEq / L. CT 29Mar2021: Cranial CT: hyperdense intraparenchymal lesion of 60x30 mm with maximum axial diameters, located in the right midsemioval center with ipsilateral capsulo-lenticular caudal extension, with peripheral hypodense area, suggestive of corresponding to hematoma in acute evolutionary phase with associated vasogenic edema. It determines a compressive effect on the adjacent structures, altering the morphology of the ipsilateral ventral lateral nucleus, with displacement of midline structures (approximately 8mm). Free base and peritroncular cisterns. Ventricular system of conserved size and asymmetric morphology in relation to what was previously described. No images of fracture in the bone structures studied. CONCLUSION: Hematoma in acute evolutionary phase located in the right semioval center with ipsilateral capsulo-lenticular extension, which determines a compressive effect on the ipsilateral ventral lateral nucleus and displacement of midline structures (approximately 8mm). To assess probable hypertensive origin. Exitus 01Apr2021: Torpid evolution in the first 24 hours, remaining in a comatose state, without responding to stimuli, decerebrate movement to the painful stimulus, absence of oculocephalic reflex, weak corneal and middle pupil reflex with little photoreactivity. Given neurological deterioration without being a candidate for aggressive measures due to age, multiple pathologies and torpid evolution in less than 24 hours with signs of possible uncal herniation, together with the family they decided to prioritize comfort measures. The outcome of the events was fatal. The patient died on 01Apr2021. An autopsy was performed that revealed decerebration. No follow-up attempts are possible, information on batch numbers cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage; Autopsy-determined Cause(s) of Death: Decerebration


VAERS ID: 1225056 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-10
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia megaloblastic; Aortic stenosis; Arteriosclerotic cardiovascular disease; COPD; External carotid artery stenosis; Fibrillation atrial; Hypertension arterial; Sigmoid diverticulosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021398884

Write-up: Decompensation cardiac; COPD exacerbation; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number [ES-AEMPS-816748]. A 91-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Lot Number: ep2163), intramuscular on 04Mar2021 as single dose for COVID-19 vaccination. Medical history included anaemia megaloblastic, hypertension arterial, aortic stenosis, fibrillation atrial, external carotid artery stenosis, arteriosclerotic cardiovascular disease, sigmoid diverticulosis, COPD (chronic obstructive pulmonary disease). The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 11Feb2021 for COVID-19 vaccination. The patient experienced COPD exacerbation on 10Mar2021 (6 days after the second vaccination) and decompensation cardiac on 20Mar2021 (16 days after the second vaccination). The patient died on an unspecified date. Cause of death were COPD exacerbation and decompensation cardiac. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: COPD exacerbation; decompensation cardiac


VAERS ID: 1225058 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HIDROFEROL; SINTROM; DEPRAX [FLUOXETINE HYDROCHLORIDE]; DUODART; RAMIPRIL CINFA; METFORMIN [METFORMIN]; ROSUVASTATIN CINFA; BISOPROLOL CINFA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Benign prostatic hyperplasia; DVT; Fibrillation paroxysmal atrial; Hepatic cyst; Hypertension arterial; Hypertensive heart disease; Obstructive sleep apnea hypopnea syndrome; Pulmonary thromboembolism; Sigmoid diverticulitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021398620

Write-up: Ventricular fibrillation; asystole; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB manufacturer report number ES-AEMPS-818055. An 83-year-old male patient received bnt162b2 (COMIRNATY, lot number and expiry date were unknown), intramuscular on 24Mar2021 as single dose for COVID-19 immunization. Medical history included hypertensive heart disease, hepatic cyst, abdominal aortic aneurysm, sigmoid diverticulitis, pulmonary thromboembolism in 2014, obstructive sleep apnea hypopnea syndrome, hypertension arterial, fibrillation paroxysmal atrial, DVT and benign prostatic hyperplasia. Concomitant medications included calcifediol (HIDROFEROL); acenocoumarol (SINTROM); fluoxetine hydrochloride (DEPRAX); dutasteride, tamsulosin hydrochloride (DUODART); ramipril (RAMIPRIL CINFA); metformin (METFORMINA); rosuvastatin calcium (ROSUVASTATINA CINFA); bisoprolol fumarate (BISOPROLOL CINFA). Four (4) days after vaccination on 28Mar2021, the patient experienced ventricular fibrillation and asystole. Course of events were as follows: when starting dinner, being previously well, he shouted and falled unconscious. He was treated urgently and found ventricular fibrillation, which progressed to asystole in 20 minutes. The patient died on an unspecified date. Cause of death was ventricular fibrillation and asystole. It was unknown if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: ventricular fibrillation; asystole


VAERS ID: 1225064 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-02-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dizziness, General physical health deterioration, Mobility decreased, Nausea, Poor quality sleep
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LINATIL; ELIQUIS; HUMIDOSE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy; Cardiac pacemaker insertion (insertion of a permanent VV1 pacemaker); Gallstones removal (gallstone removal, monitored from 2002 onwards); Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021398633

Write-up: Unknown cause of death; Mobility decreased; Sleep restless; Nausea; Dizziness; General physical health deterioration; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number FI-FIMEA-20211659. An 88-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 22Feb2021 (Batch/Lot Number: EJ6790) as single dose for COVID-19 immunisation. Medical history included VV1 pacemaker (cardiac pacemaker insertion) on 31Jan2020: insertion of a permanent VV1 pacemaker, gallstone removal from the beginning of 2020: "monitored from 2002 onwards", hypertension and anticoagulant therapy. Concomitant medications included enalapril maleate (LINATIL) taken for hypertension, start and stop date were not reported; apixaban (ELIQUIS) taken for anticoagulant therapy, start and stop date were not reported; calcium chloride dihydrate, potassium chloride, sodium chloride (HUMIDOSE) taken for an unspecified indication, start and stop date were not reported. On 23Feb2021, the patient experienced mobility decreased, sleep restless, nausea, dizziness and general physical health deterioration. The day after the vaccination there was difficulty moving due to dizziness, he had to take support from the walls while walking and had nausea and restless sleep. On 09Mar2021, he had difficulty getting out of bed. His overall condition deteriorated after vaccination. The patient died (unknown cause of death) on 09Mar2021. The results of the forensic autopsy research were not yet available. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225069 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-03-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   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: Auricular fibrillation; Gout; Hypothyroidism; Infarct myocardial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021398740

Write-up: Tachycardia, death; This is a spontaneous report from a contactable Consumer downloaded from a regulatory authority-WEB FR-AFSSAPS-BR20211119 and received via a pharmaceutical company. A 85-years-old female patient received first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), intramuscular on 14Mar2021 as single dose for COVID-19 immunization. Medical history included Gout, Hypothyroidism, Auricular fibrillation from Aug2017, Infarct myocardial from Jan2017. The patient''s concomitant medications were not reported. The patient experienced tachycardia, death (fatal tachycardia) on 17Mar2021. The patient died on 17Mar2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Tachycardia, death


VAERS ID: 1225084 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-03-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-18
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: 2021-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021398759

Write-up: Death NOS; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LY20212736. An 86-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 29Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing. The patient had no history of COVID. The patient''s concomitant medications were not reported. The patient experienced death nos (no further information) on 31Mar2021. The patient died on 31Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information on lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1225102 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dyspnoea, Heart rate, Hypertension, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breathing difficult; Carotid artery dissection; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210309; Test Name: blood pressure; Result Unstructured Data: Test Result:140/80; Test Date: 20210309; Test Name: heart rate; Result Unstructured Data: Test Result:120; Comments: 120 bpm
CDC Split Type: FRPFIZER INC2021363175

Write-up: Hypertension arterial; Tachycardia; Dyspnoea; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PO20211393. An 85-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EP9605), dose 1 intramuscular, administered in Arm Left on 09Mar2021 14:30 (at the age of 85years) as single dose for Covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing; and breathing difficult on 07Mar2021. The patient''s concomitant medications were not reported. History: treatment with blood pressure medication (name of medication not given); mention of old carotid dissection according to the medical examiner; the doctor does not want to communicate about the patient''s history. According to the attending physician, he came on Sunday 07Mar2021 at 1 pm to check the patient''s blood pressure, she had breathing difficulties during the weekend. Declaration by a forensic doctor of the death of a patient who received the Comirnaty vaccine the same day: the physician transferred the information because of the ongoing forensic investigation autopsy in progress. On 09Mar2021, the patient was vaccinated with Comirnaty vaccine, lot number: EP9605, left arm, first injection on 09Mar2021 at 2:30 pm. During the pre-vaccination consultation, nothing to report; on 09Mar2021: around 7:50 pm, BP at 140/80 but dyspnea stage II (as since Sunday according to the attending physician) and especially tachycardia at 120 bpm and the attending physician specifies "in this context, there is every reason to look for a latent coronary insufficiency". The doctor writes his letter to the emergency room and contacts a cab to take her to the emergency room; the cab driver discovers the patient face down on the ground, he informed the attending physician who contacts the Emergency medical services; the Emergency medical services takes charge of the patient: he notices traces of blood in the mouth, blood on the internal face of the surgical mask resuscitation gestures carried out: external cardiac massage, intubation, ventilatory maneuvers, infusion of adrenaline 6 mg, thrombolysis 7 ml were given; death noted on 09Mar2021 at 9:13 pm by the doctor of the Emergency medical services. Conclusion: unexplained death within 24 hours after the vaccination, not attributable to the only effects presented on 09Mar2021 and described by the attending physician without precise information on the patient''s medical history. The patient died on 09Mar2021. An autopsy was performed, and results were not available.; Reported Cause(s) of Death: Hypertension arterial; Tachycardia; Dyspnoea


VAERS ID: 1226499 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Lung neoplasm malignant, Pulmonary embolism, SARS-CoV-2 test, X-ray
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer; Lung operation
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210113; Test Name: X-ray; Result Unstructured Data: Test Result:all clear
CDC Split Type: GBPFIZER INC2021394552

Write-up: Pulmonary embolism; lung cancer; Breath shortness; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202104021551278950. A 81-year-old male patient received second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH) unspecified route of administration, on 06Jan2021, as single dose for COVID-19 immunisation. Medical history included lung neoplasm malignant and lung operation from Sep2020. 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 pulmonary embolism and lung cancer on an unspecified date; and breath shortness on 08Jan2021. The patient had negative COVID-19 test on unspecified date. The reported outcome for the events lung cancer and breath shortness was not recovered. The patient died on 15Jan2021. The cause of death was pulmonary embolism. It was not reported if an autopsy was performed. The clinical course was reported as follows: patient began complaining of a shortness of breath two days later and described it as felt as though the oxygen wasn''t getting to the bottom of his legs. On the 13Jan2021, patient went to the hospital appointment for an X-ray of his lungs as a check up following a lung cancer operation in Sep2020 and received an all clear results. On 15Jan2021, Friday morning between 9 and 10 am patient collapsed at home and passed away. The coroners report stated cause of death as bilateral pulmonary emboli. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: bilateral pulmonary emboli


VAERS ID: 1226526 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-02-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN3924 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal behaviour, Back pain, Blood pressure decreased, Blood pressure measurement, Body temperature, Chest pain, Cold sweat, Communication disorder, Confusional state, Decreased appetite, Illness, Malaise, Musculoskeletal chest pain, Myocardial infarction, Sepsis, Unresponsive to stimuli, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   Days after onset: 54
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: General physical health deterioration (He was in a poor state of health.); Parkinson''s disease (He has had Parkinson''s disease for 30 years.); Recurrent urinary tract infection; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally).)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210328; Test Name: Blood pressure; Result Unstructured Data: Test Result:No results provided; Test Date: 20210328; Test Name: Blood pressure; Result Unstructured Data: Test Result:Dropping rapidly; Test Date: 20210328; Test Name: temperature; Result Unstructured Data: Test Result:No results provided
CDC Split Type: GBPFIZER INC2021393710

Write-up: sickness/a bit sick; RIb pain; Chest pain; abnormal behaviour/acting strange; back pain/having terrible pains in his back; Communication disorder/inability to be understood; Blood pressure decreased; only ate a small amount of his dinner; Unresponsive to stimuli; feeling unwell; clammy/clammy to touch; Confusion; sepsis; Urinary tract infection/urine infection; heart attack; This is a spontaneous report from a contactable consumer or other non healthcare professional received from a Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104030643017380. Safety Report Unique Identifier GB-MHRA-ADR 25075357. A male patient of an unspecified age received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH; batch/lot number: EN3924; expiration date not provided), via an unspecified route of administration on 31Jan2021 as single dose for COVID-19 immunisation. Patient''s medical history included ongoing steroid therapy [reported as ''Taking regular steroid treatment (e.g. orally or rectally)], ongoing Parkinson''s disease (reported as ''He has had Parkinson''s disease for 30 years''), ongoing general physical health deterioration (reported as ''He was in a poor state of health''), and ongoing recurrent urinary tract infection (also reported as ''recurring water infections''). This was further reported as Patient has had Parkinson''s disease for 30 years and was in a poor state of health with recurring water infections. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced sepsis, ''urinary tract infection/urine infection'', and heart attack on 29Mar2021; feeling unwell, ''clammy/clammy to touch'', ''sickness/a bit sick'', rib pain, chest pain, ''abnormal behaviour/acting strange'', ''back pain/having terrible pains in his back'', ''Communication disorder/inability to be understood'', blood pressure decreased, unresponsive to stimuli, and ''only ate a small amount of his dinner'' on 28Mar2021; confusion on 02Feb2021. Patient''s clinical course is as follows: ''Confusion'', it was reported that patient had a bad reaction 2 days after receiving the vaccine. The first time the patient had the reaction, he was confused and didn''t seem to know what he was doing, and he was more or less out of it all day. Patient''s wife thought she would leave the patient until the next day to see if the patient was any better. Patient did seem better but looked awful in his face. Then 2 days later, he had the same reaction but not so severe. Patient seemed to be ok for a while then on Sunday 28th March, he woke up feeling unwell but didn''t mentioned it to his wife. As the day wore one, patient was a bit sick at lunch time and said he was hurt across his chest, under his ribs. It was reported that patient only ate a small amount of his dinner, then watched the football in the kitchen in his wheelchair, then patient''s wife pushed the patient in the lounge with her and turned on the television. After 30 minutes, patient was acting strangely and wife asked if the patient was ok, then patient started having terrible pains in his back, so wife prayed for the patient and called an ambulance. They couldn''t get a lot of sense from him as to where the pain was, so they took the patient to hospital where wife met them and was allowed to go in because of patient''s inability to be understood. Patient was put on a drip et cetera, took his temperature, and blood pressure, then took him to another ward and put him in a cubicle. They didn''t check the patient, then the nurse came and said they were moving him to another ward and putting him in a more comfortable bed. They moved the patient up the trolley as his feet were sticking out. Then wife said to the nurse that patient was clammy to touch. So, she moved the drip up higher, and the other nurse did check the patient''s blood pressure again, and it was dropping rapidly. So, the patient became unresponsive and died. They gave the cause of death as urine infection and sepsis set in causing a heart attack, but wife would like to know how they could tell that without a postmortem. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included blood pressure with no result provided on 28Mar2021 and with result of ''Dropping rapidly'' on 28Mar2021; and temperature with no result provided on 28Mar2021. The outcome of the events ''sepsis'', ''urinary tract infection/urine infection'', and ''heart attack'' was fatal; outcome of the events ''feeling unwell'', ''clammy/clammy to touch'', and confusion was not recovered; outcome of the remaining events was unknown. The patient died on 29Mar2021. It was reported that an autopsy was not performed. The reported causes of death were ''sepsis'', ''urinary tract infection/urine infection'', and ''heart attack''. Follow-up attempts are completed. No further information is expected; Reported Cause(s) of Death: Urinary tract infection/urine infection; Sepsis; Heart attack


VAERS ID: 1226606 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-03
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Embolism, Sudden death, Thrombocytopenia
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESTRADOT; FLUOXETINE; FOSTAIR; MIRENA; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Dyspepsia; Hormone replacement therapy; Low mood
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021393940

Write-up: Death; died suddenly and unexpectedly/sudden death; Thromboembolic event/thrombocytopenia; Thromboembolic event/thrombocytopenia; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104071207356460. Safety Report Unique Identifier GB-MHRA-ADR 25094370. A 58-year-old female patient received second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH; batch/lot number: ER1741; expiration date not provided), via an unspecified route of administration on 26Mar2021 as SINGLE DOSE for COVID-19 immunisation. Patient''s medical history included low mood, asthma, hormone replacement therapy, and dyspepsia all from unspecified dates and unknown if ongoing. It was unsure if patient has had symptoms associated with COVID-19. Patient has not had a COVID-19 test. It was unsure if patient is enrolled in clinical trial. Concomitant medications included estradiol (ESTRADOT) for hormone replacement therapy, fluoxetine for low mood, beclometasone dipropionate, formoterol fumarate (FOSTAIR) for asthma, levonorgestrel (MIRENA) for an unspecified indication, and omeprazole for dyspepsia. All concomitant medications from unspecified dates and unknown if ongoing. The patient experienced ''death'', ''died suddenly and unexpectedly/sudden death'', and Thromboembolic event/thrombocytopenia'' on 03Apr2021 (as reported). Patient''s clinical course is as follows: It was reported that the patient died suddenly and unexpectedly 9 days after receiving second dose of Pfizer vaccine. It was reported that a post mortem is planned on 07Arp2021 but at present, there was no indication of the cause of death. Reporter mentioned that this report is being submitted now due to the recent vaccination but has no indication that the vaccine caused sudden death until a post mortem report is available. When probed if the report relates to possible blood clots or low platelet counts, reported responded "Yes" thromboembolic event/thrombocytopenia. It was also stated that "Not known if it was as post mortem pending". It was unknown if the platelet count was <150 A-109/L, if was D-dimer $g4000, and if anti-PF4 antibodies were identified. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events was fatal. It was unknown if an autopsy was performed. The reported causes of death were ''death'', ''died suddenly and unexpectedly/sudden death'', and Thromboembolic event/thrombocytopenia''. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: died suddenly and unexpectedly/sudden death; Thromboembolic event/thrombocytopenia; Thromboembolic event/thrombocytopenia; death


VAERS ID: 1226608 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021393990

Write-up: Dyspnoea; This is a spontaneous report from a contactable physician. This report is received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104081152037820. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial.The patient experienced dyspnoea on 31Mar2021. The patient died on an unspecified date. The cause of death was dyspnea. An autopsy was not performed. Clinical course was reported as follows: patient received vaccine with no acute side effects on 31Mar2021. Observed for at least 90 minutes at the hub by staff including GP (prolonged wait as waiting for transport), during which time was alert and not in extremis. Reported to be breathless at home over 4 hours after vaccine administration (reported to her family who were unable to respond at the time). Found unresponsive at home the following morning 01Apr2021. CPR through paramedics unsuccessful. Currently awaiting post mortem report to detail cause of death.; Reported Cause(s) of Death: dyspnoea


VAERS ID: 1226613 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1749 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   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: ASPIRIN [ACETYLSALICYLIC ACID]; BISOPROLOL; IRBESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Motor neurone disease
Allergies:
Diagnostic Lab Data: Test Name: Investigation; Result Unstructured Data: Test Result:unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021394244

Write-up: Death/ Unexpected death; This is a spontaneous report from a contactable healthcare professional. This report was received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104091148082320. Safety Report Unique Identifier GB-MHRA-ADR 25111212. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: ER1749) as single dose for COVID-19 immunisation. The patient medical history included motor neurone disease. It was unsure if patient has had symptoms associated with COVID-19, unsure if patient was enrolled in clinical trial. Concomitant medications included aspirin [acetylsalicylic acid] from 13May2016, bisoprolol from 08Nov2007, and Irbesartan from 08Nov2007; all taken for unspecified indications and with unspecified stop dates. The patient experienced death/unexpected death on 05Apr2021. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on unspecified date and unspecified investigations and tests conducted (results unknown) were in the hands of the coroner. The patient died on 05Apr2021. Cause of death was unknown. It was not reported if an autopsy was performed. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Death/ Unexpected death


VAERS ID: 1226662 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PERINDOPRIL; DELORAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Sleep disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021398771

Write-up: Vomiting/vomiting episode with traces of blood; Cardiac arrest; This is a spontaneous report downloaded from the regulatory authority-WEB [Regulatory authority number IT-MINISAL02-710856]. A contactable physician reported an 82-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular administered on arm left on 01Apr2021 10:35 (Batch/Lot Number: ER9470; Expiration Date: 31Jul2021) as SINGLE DOSE for COVID-19 immunization. Medical history included arterial hypertension and sleep disorder (reported as sleeping). Concomitant medications included perindopril (PERINDOPRIL) taken for arterial hypertension and delorazepam (DELORAZEPAM) taken for sleep disorder (sleeping disorder) both taken since unknown therapy dates. On 02Apr2021 (reported as 24 hours after administration), the patient had vomiting episode with traces of blood. After access to the patient, she was transferred to perform esophago-gastro-duodenoscopy but died of the patient due to cardiac arrest on that same day of 02Apr2021. It was not reported if an autopsy was performed. The patient died due to vomiting and cardiac arrest. Sender''s comments: On 06Apr2021 request for a clinical report and if an autopsy examination was carried out. Reporter''s comment: death of the patient 24 hours after the administration of the vaccine. No follow-up attempts are possible. No further information is expected. ; Reporter''s Comments: death of the patient 24 hours after the administration of the vaccine.; Reported Cause(s) of Death: Vomiting/ vomiting episode with traces of blood; cardiac arrest


VAERS ID: 1226663 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 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: 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: ITPFIZER INC2021398757

Write-up: The person was vaccinated at home and found in asystole, the 118 was called and the person died.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, manufacturer report number IT-MINISAL02-710964. A 55 years male patient received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, lot number: ER9470), via an unspecified route of administration on 03Apr2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. On 04Apr2021, the patient was vaccinated at home and found in asystole, the 118 was called. On 06Apr2021 request for a clinical report and whether an autopsy was carried out. It was unknown whether the autopsy was performed or not. The patient died due to asystole. ; Reported Cause(s) of Death: he person was vaccinated at home and found in asystole, the 118 was called and the person died.


VAERS ID: 1226665 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-18
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Gait disturbance, Motor dysfunction
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021398828

Write-up: Difficulty coordinating movements and speech difficulties; Difficulty coordinating movements and speech difficulties; Difficulty coordinating movements and speech difficulties; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-711634. An 84-year-old male patient received second dose of BNT162B2 (COMIRNATY; Solution for injection; Lot number: unknown) via intramuscular route of administration on arm right on 26Feb2021 at 0.3 ug dose as SINGLE DOSE for COVID-19 immunization. The patient medical history included cardiac pacemaker insertion from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 18Mar2021, the patient had difficulty in coordinating movements and speech difficulties (aphasia, gait disturbance and motor dysfunction) (death). The patient died on an unknown date and the outcome of all events reported as fatal. It was not reported/unknown if an autopsy was performed or not. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: My father wore a pacemaker in his heart.


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