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From the 1/7/2022 release of VAERS data:

Found 21,745 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1260577 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: Aortic stenosis; Heart disease pulmonary; Heart failure NYHA class III
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021441483

Write-up: The patient died on 12Apr2021; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB IT-MINISAL02-717031. A 92-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly at left arm on 10Apr2021 12:00 (Lot Number: EW2246; Expiration Date: 31Jul2021) at 0.3 mL, single dose for COVID-19 immunization. Medical history included pulmonary heart disease and tight aortic stenosis NYHA class 3, all ongoing. The patient''s concomitant medications were not reported. The patient died on 12Apr2021. It was unknown if an autopsy was performed. Reporter Comment: as of 16Apr cause of death is unknown. No follow-up attempts are possible. No furthermore information is expected.; Reported Cause(s) of Death: died


VAERS ID: 1260588 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 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: 2021-04-17
   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: TICLOPIDINA [TICLOPIDINE]; CARDIOASPIRIN; QUETIAPINE FUMARATE; OMNIC
Current Illness: Dementia; Paraplegia
Preexisting Conditions: Medical History/Concurrent Conditions: Ischaemia (Reported by family members previous unspecified ischemic episodes); Prostatic hypertrophy (benign)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021441454

Write-up: First dose of given at 12.40. After vaccination and an appropriate monitoring period, the daughter led the father in the car. Shortly after the departure, he collapsed on the seat; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Database-WEB, regulatory authority number IT-MINISAL02-717045. A 96-year-old male patient received the first dose of bnt162b2 (Vaccine), intramuscular on 17Apr2021 12:40 (Lot Number: EX0893) as single dose for covid-19 immunisation. Medical history included benign prostatic hyperplasia, ongoing dementia, ischaemia, ongoing paraplegia. Concomitant medications included ticlopidina (ticlopidine); acetylsalicylic acid (CARDIOASPIRIN); quetiapine fumarate; tamsulosin hydrochloride (OMNIC). First dose of given at 12:40. After vaccination and an appropriate monitoring period, the daughter led the patient in the car. Shortly after the departure, patient collapsed on the seat. Sudden death occurred on 17Apr2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: First dose of given at 12.40. After vaccination and an appropriate monitoring period, the daughter led the father in the car. Shortly after the departure, he collapsed on the seat.


VAERS ID: 1260672 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021450256

Write-up: Death; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number and expiration date not reported) at a single dose for COVID-19 immunisation. The reporting pharmacist heard of death after the second dose of BNT162b2 in a patient (hospital staff). On an unspecified date after the second vaccination, the patient died. The cause of death was not reported. It was not reported if an autopsy was performed. Information about lot/batch number has been requested.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1260673 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anal incontinence, Axillary pain, Body temperature, Cardiac failure acute, Loss of consciousness, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   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: BAYASPIRIN; RISEDRONATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic dissection; Atrial fibrillation; Cerebral infarction; Heart disease, unspecified; Hypertension; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021450583

Write-up: Cardiac failure acute; Rubbing around the axilla, she complained that the region ached; loss of consciousness; faecal incontinence; vomiting; This is a spontaneous report from a contactable physician (inoculator) received from the regulatory authority. Regulatory authority report number is v21102891. A 90-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: ET3674, expiration date: 31Jul2021), via an unspecified route of administration on 20Apr2021 10:00 (at 90-year-old) at single dose for COVID-19 immunisation. The patient had a medical history of heart disease, hypertension, aortic dissection from 2012, atrial fibrillation from 2021, cerebral infarction, and osteoporosis. Body temperature before vaccination was 36.7 degrees Centigrade on 20Apr2021. There were no points to be considered on the vaccine screening questionnaire (no allergies, no vaccinations and illnesses within the last one month, no convulsion). Concomitant medications included acetylsalicylic acid (BAYASPIRIN) and risedronate sodium (RISEDRONATE). On the morning of 21Apr2021 (1 day after the vaccination), she had faecal incontinence and loss of consciousness. In the morning and afternoon, two physicians consulted her. Vital signs were stable. Speech could be clearly heard. She experienced vomiting at dinner. On 22Apr2021 at 00:40 (1 day, 14 hours and 40 minutes after the vaccination), the patient experienced cardiac failure acute. About 36 hours after the vaccination (as reported), On 22Apr2021 around 00:40, the sensor was operating. When visiting the room, the patient sat on the bed, saying "I don''t know what''s happening." Rubbing around the axilla, she complained that the region ached. Immediately after lying down on the bed, she rolled her eyes back. It looked like that breathing had stopped. Therefore, this was reported quickly. Cardiopulmonary resuscitation (CPR) and oxygen administration were initiated. That was mandibular breathing and breathing became shallow little by little. Emergency response team arrived. Performing designated procedures, they took the patient to a hospital, not a reporting hospital because other patients (cardiopulmonary arrest (CPA) and pyrexia) had already been transported and under treatment in the reporting hospital. Although intubated and administered adrenaline, the patient did not respond. At 2:32, the patient''s death was confirmed. It was confirmed by phone that death certificate described that the patient died from cardiac failure acute 2 hours after the onset. Myocardial infarction and other cardiac disease were suspected. Blood collection and imaging were not performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was described above. The reporting physician commented as follows: Causal relationship was unknown. The elderly patient had a history of cardiac disease and more than 24 hours passed after the vaccination. Causal relation between the death and BNT162b2 could not be determined, but they report this case because of fatal case.; Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1260675 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Cardiac tamponade, Cardio-respiratory arrest, Computerised tomogram, Electrocardiogram, Investigation
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: 2021-03-20
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210319; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210320; Test Name: CT; Result Unstructured Data: Test Result:acute aortic dissection and cardiac tamponade; Test Date: 20210320; Test Name: ECG; Result Unstructured Data: Test Result:PEA; Test Date: 20210320; Test Name: Ai imaging; Result Unstructured Data: Test Result:Stanford Type A aortic dissection; Comments: Stanford Type A aortic dissection with a cardiac tamponade
CDC Split Type: JPPFIZER INC2021450827

Write-up: cardio-respiratory arrest; cardiac tamponade; Type A aortic dissection; This is a spontaneous report from a contactable physician via regulatory authority. Regulatory authority report number is v21103103. The 46-year-old and 9-month-old male patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EP2163, Expiration date 31May2021) via an intramuscular route in the arm left on 19Mar2021 at 16:00, as a single dose for COVID-19 immunization. The patient had no medical history or allergies to medications, food, or other products. The patient had no family history. Concomitant medication was not reported. Body temperature before vaccination was 36.3 degrees Centigrade. The patient had back pain since the morning of the day after vaccination. The patient visited the orthopedic department of his local physician. The patient was instructed that it was not an orthopedic problem and was advised to see an internist if he was concerned. After returning home, while eating bread, the patient suddenly started snore-like breathing and was unresponsive, so emergency service was called. On 20Mar2021 at 15:35 (1 day after the vaccination), the patient experienced cardio-respiratory arrest. When the paramedics contacted the patient, the ECG showed PEA (Pulseless Electrical Activity). The patient was still the same on arrival at the hospital and was immediately intubated and adrenaline was used for a total of 3 ampules. However, there was no change from cardiac arrest, and death was confirmed at 16:27. AI imaging showed a Stanford Type A aortic dissection with a cardiac tamponade. The patient''s family was informed that the direct cause of death was acute aortic dissection. An autopsy was not performed as of the reporting date, and the reported cause of death was acute aortic dissection and cardiac tamponade on CT. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was fatal on 20Mar2021 with treatment including cardiopulmonary resuscitation. The reporting physician commented the causality between the event and BNT162b2 was unassessable, and other possible cause of the event such as any other diseases was acute aortic dissection. The direct cause of death was acute aortic dissection. The age of onset of the event was somewhat young, and it could not be concluded that there was no causal relationship with the vaccine at all. ; Reported Cause(s) of Death: Cardiac tamponade; Acute aortic dissection


VAERS ID: 1260706 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-19
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Loss of consciousness, Malaise, Nausea, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), 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: Transient ischaemic attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death), SEIZURE and LOSS OF CONSCIOUSNESS in an 84-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ACENOCOUMAROL tablet for TIA. The patient''s past medical history included Transient ischaemic attack. In 2011, the patient started ACENOCOUMAROL (unknown route) 1 mg. On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DEATH (Death) (seriousness criterion death), SEIZURE (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (seriousness criterion medically significant), MALAISE and NAUSEA. The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, SEIZURE, LOSS OF CONSCIOUSNESS, MALAISE and NAUSEA outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Cause of death was not specifically reported so event of death added Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Cause of death was not specifically reported so event of death added; Reported Cause(s) of Death: Death


VAERS ID: 1260715 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-10-13
Onset:2021-03-30
   Days after vaccination:1995
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Hyperammonaemia
SMQs:, Liver related investigations, signs and symptoms (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INSULATARD HUMAN; CARVEDILOL; PANTOPRAZOL [PANTOPRAZOLE]; NOVORAPID; METFORMINE [METFORMIN]; IRBESARTAN; PREDNISON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Death; idiopathische hyperammoniaemie; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) and HYPERAMMONAEMIA (idiopathische hyperammoniaemie) in a 69-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Co-suspect product included non-company product TACROLIMUS MONOHYDRATE (TACROLIMUS [TACROLIMUS MONOHYDRATE]) capsule for an unknown indication. The patient''s past medical history included No adverse event (No reported medical history). Concomitant products included INSULIN HUMAN INJECTION, ISOPHANE (INSULATARD HUMAN), CARVEDILOL, PANTOPRAZOL [PANTOPRAZOLE], INSULIN ASPART (NOVORAPID), METFORMINE [METFORMIN], IRBESARTAN and PREDNISONE (PREDNISON) for an unknown indication. On 13-Oct-2015, the patient started TACROLIMUS MONOHYDRATE (TACROLIMUS [TACROLIMUS MONOHYDRATE]) (unknown route) 2d1. On 25-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced HYPERAMMONAEMIA (idiopathische hyperammoniaemie) (seriousness criteria death and medically significant). The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. On 14-Oct-2014 the patient started additional Co-suspect non company product PREDNISON TABLET (brand name not specified) for an unknown indication, action taken dose increased. Additional concomitant medications included Gliclazide and Irbesartan for an unknown indication. Company comment: This is a case of death in a 69-year-old male subject with a medical history of HTN and DM, who died 5 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. This is a case of death in a 69-year-old male subject with a medical history of HTN and DM, who died 5 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No specific follow-up information recorded.; Sender''s Comments: This is a case of death in a 69-year-old male subject with a medical history of HTN and DM, who died 5 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1260717 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-14
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: 2021-04-14
   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: LEVOTHYROXINE; SPIRONOLACTONE; FUROSEMIDE; NOVORAPID; LISINOPRIL; IMBRUVICA; METOPROLOL SUCCINATE
Current Illness: Leukaemia lymphocytic chronic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021435852

Write-up: acute death, possibly cardiac; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB NL-LRB-00509644, received from Regulatory Authority. An 80-year-old female patient received the 1st dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 26Mar2021 at 0.3 ml single for COVID-19 immunisation. Medical history included ongoing leukaemia lymphocytic chronic. The patient had no previous COVID-19 infection. Concomitant medications included levothyroxine, spironolactone, furosemide, insulin aspart (NOVORAPID), lisinopril, ibrutinib (IMBRUVICA), metoprolol succinate. The patient experienced acute death, possibly cardiac on 14Apr2021 following administration of covid-19 vaccine pfizer Injectable solution. The outcome of sudden cardiac death was fatal. It was unknown if autopsy was performed. Reporter comment: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no - acute death Additional information ADR: unexpected death Citizen service number available: yes confounding factors: chronic leukemia Chronic Lymphocytic Leukemia COVID-19 Previous COVID-19 infection: No. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no - acute death Additional information ADR: unexpected death Citizen service number available: yes confounding factors: chronic leukemia Chronic Lymphocytic Leukemia COVID-19 Previous COVID-19 infection: No.; Reported Cause(s) of Death: acute death, possibly cardiac


VAERS ID: 1260721 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-01-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood pressure diastolic, Blood pressure systolic, Blood sodium, Body temperature, Coma scale, Computerised tomogram head, Depressed level of consciousness, Electroencephalogram, Glomerular filtration rate, Haemoglobin, Heart rate, Intraventricular haemorrhage, Lumbar puncture, Mini mental status examination, Neutrophil count, Oxygen saturation, Platelet count, Red blood cell sedimentation rate increased, Respiratory rate, SARS-CoV-2 test, Troponin, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: LOSARTAN KRKA [LOSARTAN]; SERETIDE DISKUS [FLUTICASONE PROPIONATE;SALMETEROL]; ELIQUIS; METOPROLOL; SOMAC
Current Illness: Atrial fibrillation; Bronchiectasis; COPD; Esophagitis (Esophagitis/gastritis. Negative H.pylori test.); Hypertension; Liver cirrhosis; Palliative care; Pancreatic calcification; Psoriasis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210226; Test Name: Creatinine; Result Unstructured Data: 105 umol/L; Test Date: 20210226; Test Name: Potassium; Result Unstructured Data: 3.9 mmol/L; Test Date: 20210226; Test Name: Diastolic blood pressure; Test Result: 78 {DF}; Result Unstructured Data: 78 mmHg; Test Date: 20210226; Test Name: systolic blood pressure; Test Result: 166 {DF}; Result Unstructured Data: 166 mmHg; Test Date: 20210226; Test Name: Sodium; Result Unstructured Data: 141 mmol/L; Test Date: 20210226; Test Name: Body temperature; Result Unstructured Data: 37 degrees Celsius; Test Date: 20210226; Test Name: Glasgow coma scale; Test Result: Inconclusive ; Result Unstructured Data: 12-10; Test Date: 20210226; Test Name: Head CT; Test Result: Inconclusive ; Result Unstructured Data: Intraventricular hemorrhage with small hematoma in posterior horn of lateral ventricles, mostly left side. Somewhat reduced discrepancy between gray and white matter frontally left side. Age-corresponding surface relief and ventricular caliber. Open basal cisterns.; Test Date: 20210226; Test Name: EEG; Result Unstructured Data: Slow activity, not epileptiform activity.; Test Date: 20210226; Test Name: GFR; Test Result: Inconclusive ; Result Unstructured Data: 41 mL/min/1.73m^2; Test Date: 20210226; Test Name: Hemoglobin; Result Unstructured Data: 12.2 g/dL; Test Date: 20210226; Test Name: Pulse rate; Test Result: Inconclusive ; Result Unstructured Data: 83 /min; Test Date: 20210226; Test Name: Spinal tap; Test Result: Inconclusive ; Result Unstructured Data: Leukocytes: 79 (primarily mononuclear cells). Some blood in the ventricular system.; Test Date: 20210226; Test Name: MMSE; Test Result: Inconclusive ; Result Unstructured Data: 25 out of a total of 30; Test Date: 20210226; Test Name: Neutrophils; Test Result: Inconclusive ; Result Unstructured Data: 8 x 10^9/L; Test Date: 20210226; Test Name: Oxygen saturation; Result Unstructured Data: 98%; Test Date: 20210226; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: 263 x 10^9/L; Test Date: 20210226; Test Name: Raised ESR; Test Result: Inconclusive ; Result Unstructured Data: 30 mm/hr; Test Date: 20210226; Test Name: Respiratory rate; Test Result: Inconclusive ; Result Unstructured Data: 20 /min; Test Date: 20210226; Test Name: sars-cov-2 test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210226; Test Name: Cardiac troponin; Test Result: Inconclusive ; Result Unstructured Data: 26 ng/L; Test Date: 20210226; Test Name: White blood cells; Test Result: Inconclusive ; Result Unstructured Data: 12.5 x 10^9
CDC Split Type: NOMODERNATX, INC.MOD20210

Write-up: Intraventricular hemorrhage; Depressed level of consciousness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INTRAVENTRICULAR HAEMORRHAGE (Intraventricular hemorrhage) and DEPRESSED LEVEL OF CONSCIOUSNESS (Depressed level of consciousness) in an 87-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Psoriasis, Palliative care, Esophagitis (Esophagitis/gastritis. Negative H.pylori test.) since 2008, Liver cirrhosis since January 2020, Pancreatic calcification since January 2020, Atrial fibrillation, COPD, Hypertension and Bronchiectasis. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, LOSARTAN (LOSARTAN KRKA [LOSARTAN]), FLUTICASONE PROPIONATE, SALMETEROL (SERETIDE DISKUS [FLUTICASONE PROPIONATE;SALMETEROL]) and METOPROLOL for an unknown indication, PANTOPRAZOLE SODIUM SESQUIHYDRATE (SOMAC). On 24-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (Depressed level of consciousness) (seriousness criteria death, hospitalization and medically significant). On 26-Feb-2021, the patient experienced INTRAVENTRICULAR HAEMORRHAGE (Intraventricular hemorrhage) (seriousness criteria death, hospitalization and medically significant). DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood creatinine: 105 (abnormal) 105 umol/L. On 26-Feb-2021, Blood potassium: 3.9 (abnormal) 3.9 mmol/L. On 26-Feb-2021, Blood pressure diastolic: 78 mmHg (abnormal) 78 mmHg. On 26-Feb-2021, Blood pressure systolic: 166 mmHg (abnormal) 166 mmHg. On 26-Feb-2021, Blood sodium: 141 (abnormal) 141 mmol/L. On 26-Feb-2021, Body temperature: 37 (abnormal) 37 degrees Celsius. On 26-Feb-2021, Coma scale: 12-10 (Inconclusive) 12-10. On 26-Feb-2021, Computerised tomogram head: intraventricular hemorrhage (Inconclusive) Intraventricular hemorrhage with small hematoma in posterior horn of lateral ventricles, mostly left side. Somewhat reduced discrepancy between gray and white matter frontally left side. Age-corresponding surface relief and ventricular caliber. Open basal cisterns.. On 26-Feb-2021, Electroencephalogram: slow activity, not epileptiform activity (abnormal) Slow activity, not epileptiform activity.. On 26-Feb-2021, Glomerular filtration rate: 41 (Inconclusive) 41 mL/min/1.73m^2. On 26-Feb-2021, Haemoglobin: 12.2 g/dL (normal) 12.2 g/dL. On 26-Feb-2021, Heart rate: 83 /min (Inconclusive) 83 /min. On 26-Feb-2021, Lumbar puncture: leukocytes: 79 (Inconclusive) Leukocytes: 79 (primarily mononuclear cells). Some blood in the ventricular system.. On 26-Feb-2021, Mini mental status examination: 25 (Inconclusive) 25 out of a total of 30. On 26-Feb-2021, Neutrophil count: 8 10^9/L (Inconclusive) 8 x 10^9/L. On 26-Feb-2021, Oxygen saturation: 98 % (normal) 98%. On 26-Feb-2021, Platelet count: 263 10^9/L (Inconclusive) 263 x 10^9/L. On 26-Feb-2021, Red blood cell sedimentation rate increased: 30 mm/hr (Inconclusive) 30 mm/hr. On 26-Feb-2021, Respiratory rate: 20 /min (Inconclusive) 20 /min. On 26-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. On 26-Feb-2021, Troponin: 26 ng/L (Inconclusive) 26 ng/L. On 26-Feb-2021, White blood cell count: 12.5 10^9/L (Inconclusive) 12.5 x 10^9. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Very limited information regarding these events has been provided at this time. . Patient''s advanced age along with the presence of multiple comorbidities may have been contributory for the occurrence of the death. No further follow-up information is expected. Reporter did not allow further contact; Reporter''s Comments: NIPH will request additional information from hospital. 25 / Mar / 2021 NIPH: Additional information received from hospital, the report is updated (posted under "Person" and "Disease", "Product" and "Lab"). Background: A woman in her late 80s was vaccinated with COVID-19 vaccine Moderna in January and February 2021. According to the report, she has subsequently had several admissions due to impaired consciousness, GCS 9-10. Thoroughly investigated. Spinal fluid with leukocytes of 79, primarily mononuclear cells, but some blood in the gastric system for unexplained reason. Proven less deep cerebral infarction right side. No explanation the patient''s condition based on the report. Sign up for inflammation of the spinal fluid, without the agent becoming proven after thorough investigation. Possible immunological reaction to the vaccine? Transition to palliative care treatment. Comment: The current event is per now no known side effect of this vaccine, but your message is important to increase knowledge about side effects which may not have been discovered in the studies. Unexpected and serious incidents after vaccination are monitored and assessed, both continuously and collectively, as a acquires further experience from completed vaccination. In this case, it is difficult to know whether the symptoms can be attributed to the vaccine or another, random simultaneous cause that has nothing to do with it current vaccine to do. If the reporter has more information that may be relevant for the assessment of causal connection, then these can be communicated to us. Information that is of interest is details about the course of events, onset of symptoms in relation to vaccination time, any relevant comorbidity and drugs in use. It can be said to be a temporal connection between the current medical history and time for vaccination, and on that basis we have therefore considered it to be a possible causal relationship. According to international criteria, a possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in temporal relation to the use of a drug, but which may also be due to underlying disease, other drugs or chemicals (1). References: Adverse reactions: definitions, diagnosis and management. Lancet 2000; 356: 1255-59.; Sender''s Comments: Very limited information regarding these events has been provided at this time. . Patient''s advanced age along with the presence of multiple comorbidities may have been contributory for the occurrence of the death. No further follow-up information is expected.


VAERS ID: 1260723 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30001176 / 1 - / OT

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

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: Dementia; Frailty; Life expectancy shortened; Ovarian cancer metastatic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, 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 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION and DEATH in an 81-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 30001176) for COVID-19 vaccination. Concurrent medical conditions included Ovarian cancer metastatic, Life expectancy shortened, Frailty and Dementia. On 30-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) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION(seriousness criterion death). The patient died in April 2021. The reported cause of death was Reduced general condition. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered GENERAL PHYSICAL HEALTH DETERIORATION and DEATH to be possibly related. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable. Company comment:This is a case of death in a 81year-old female subject with a medical history of Ovarian cancer metastatic, who died next day after receiving the vaccine. Based on patient''s age and comorbid conditions the death and other events are assessed as unlikely related to mRNA-1273.; Sender''s Comments: This is a case of death in a 81year-old female subject with a medical history of Ovarian cancer metastatic, who died next day after receiving the vaccine. Based on patient''s age and comorbid conditions the death and other events are assessed as unlikely related to mRNA-1273; Reported Cause(s) of Death: unknown cause of death; Reduced general condition


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