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From the 1/14/2022 release of VAERS data:

Found 22,193 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

Government Disclaimer on use of this data



Case Details

This is page 1293 out of 2,220

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VAERS ID: 1240330 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-04-05
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-22
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: 2021-04-05
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disorder (Confounding factors)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021414326

Write-up: My mother passed away; This is as spontaneous report received from a contactable consumer downloaded from the Medicine Agency (MA) -WEB NL-LRB-00505367. An 89-year-old female patient received the second dose of BNT162b2 (COMIRNATY; lot number: ER7812), on 25Mar2021 at single dose for COVID-19 immunisation. Medical history included confounding factors: with cardiological burden. Concomitant medications were not reported. The patient previously took the first dose of BNT162b2 injection fluid 0,3ml on 16Feb2021 for covid-19 immunisation and experienced no ADRs. The patient passed away on 05Apr2021, 11 days after start. The patient died on 05Apr2021. Diagnostic procedures: no, but the reporter did pass it on to the General practitioner, who said that it was unrelated. Reporter thought it was worth mentioning because it was 10 days after the vaccination (as reported) that the mother died. There was no proof that it was not related to the vaccination. The outcome of the event was fatal. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: My mother passed away


VAERS ID: 1240331 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Dyspnoea, Inappropriate schedule of product administration, Malaise, Off label use, SARS-CoV-2 test, Swelling face
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Medication errors (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: METOPROLOL TARTRATE; NORTRIPTYLINE HYDROCHLORIDE; EUTHYROX; OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (disease symptoms: quite)
Allergies:
Diagnostic Lab Data: Test Date: 20200430; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021414344

Write-up: Heart failure; Dyspnoea; Swelling face; Not feeling well; 1st dose on 09Feb2021, 2nd dose on 23Feb2021; 1st dose on 09Feb2021, 2nd dose on 23Feb2021; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00505445. This is first of two reports. An 82-year-old female patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 23Feb2021 (Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included covid-19 from 30Apr2020 (disease symptoms: quite). Concomitant medications included metoprolol tartrate; nortriptyline hydrochloride; levothyroxine sodium (EUTHYROX); omeprazole (OMEPRAZOL). The patient previously received the first dose of bnt162b2 on 09Feb2021 at 0.3ml single for COVID-19 immunization, and experienced dyspnoea and swollen. The patient experienced heart failure (death) on 01Mar2021, dyspnoea (death) on 01Mar2021, swelling face (death) on 01Mar2021, not feeling well (death) on 01Mar2021. The patient underwent lab tests and procedures which included corona, confirmed with test: positive on 30Apr2020. Therapeutic measures were taken as a result of heart failure, dyspnoea, swelling face, which included treatment with Furosemide. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021420247 same patient, different dose; Reported Cause(s) of Death: Heart failure; Dyspnoea; Swelling face; Not feeling well


VAERS ID: 1240334 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-30
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis, Depressed level of consciousness, Hemiplegia, Platelet count, Pneumonia, Respiratory failure, SARS-CoV-2 test, Thrombocytopenia
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LIPITOR [ATORVASTATIN]; ESBRIET; PROSCAR; ACETYLSALISYLSYRE ACTAVIS; NEXIUM [ESOMEPRAZOLE MAGNESIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal); Fibrosis lung; Hypercholesterolaemia; Hyperplasia of prostate; Platelet abnormalities
Allergies:
Diagnostic Lab Data: Test Date: 20210330; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:120 x10 9/l; Test Date: 20210401; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:60 x10 9/l; Test Date: 20210330; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: NOPFIZER INC2021414237

Write-up: Admission with severe pneumonia 3 weeks after the last vaccine dose.; dies of respiratory failure; After 2 days of ongoing antibiotics, there is a decrease in consciousness and half-sided paralysis; After 2 days of ongoing antibiotics, there is a decrease in consciousness and half-sided paralysis; thrombocytopenia, intracerebral thrombosis; thrombocytopenia, intracerebral thrombosis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority NO-NOMAADVRE-FHI-2021-Ug4wdy Safety Report Unique Identifier NO-NOMAADVRE-E2B_00025961. A 75-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 10Mar2021 12:00 (Batch/Lot Number: EP9605) as SINGLE DOSE for covid-19 immunization, at the age of vaccination of 75 years old. Medical history included FIBROSIS LUNG from 2019 to an unknown date, hypercholesterolaemia, HYPERPLASIA OF PROSTATE , antiplatelet and ACID REFLUX (ESOPHAGEAL). Historical vaccine included first dose of comirnaty for covid-19 immunisation. Concomitant medications included atorvastatin (LIPITOR) taken for hypercholesterolaemia; pirfenidone (ESBRIET) taken for FIBROSIS LUNG from 2019 to 31Mar2021; finasteride (PROSCAR) taken for HYPERPLASIA OF PROSTATE; acetylsalicylic acid (ACETYLSALISYLSYRE ACTAVIS) taken for antiplatelet therapy; esomeprazole magnesium (NEXIUM) taken for ACID REFLUX (ESOPHAGEAL). The patient experienced admission with severe pneumonia 3 weeks after the last vaccine dose on 30Mar2021, thrombocytopenia, intracerebral thrombosis on 30Mar2021, died of respiratory failure on 01Apr2021, after 2 days of ongoing antibiotics, there was a decrease in consciousness and half-sided paralysis on 01Apr2021, thrombocytopenia, intracerebral thrombosis on 01Apr2021. The patient underwent lab tests which included platelet count: 120 x10 9/l on 30Mar2021, platelet count: 60 x10 9/l on 01Apr2021, COVID-19 PCR TEST: negative on 30Mar2021. Therapeutic measures were taken as a result of admission with severe pneumonia 3 weeks after the last vaccine dose. The patient died on 01Apr2021. It was not reported if an autopsy was performed. Reported on 30Mar2021 the patient developed severe PNEUMONIA and was admitted to the hospital. The thrombocyte count was 120 x 10 9/L. On 01Apr2021, after two days with antibiotic therapy, the patient developed DEPRESSED LEVEL OF CONSCIOUSNESS, PARALYSIS ONE SIDE OF BODY, THROMBOCYTOPENIA, CEREBRAL THROMBOSIS. The patient was not susceptible for thrombectomy due to widespread infarction changes at the time of diagnosis. Terminated intensive care therapy due to poor prospects for survival. The patient died of RESPIRATORY FAILURE. The patient''s outcome was Fatal, at the time of the report. The case was considered to be Serious. This case was received from a Physician. The reporting physician states that the event was reported due to pronounced thrombosis with low platelet count. Relatedness of drug to reactions:Source of assessment: Regional Pharmacovigilance Center. COMIRNATY the Result of Assessment was Possible for ALL EVENTS. Sender Comment: Since the vaccine is new, it is subject to special surveillance to detect new safety information as quickly as possible. It is especially important that serious and / or unusual side effects are reported. Your message is therefore important to increase knowledge about side effects that have not been discovered in the studies, and is an important contribution to international cooperation to maintain safe vaccination worldwide. Reports after coronary vaccination in the adverse reaction register are processed by the agency in collaboration with the information service. The agency publishes weekly summaries of reports of suspected side effects after vaccination. As additional information about the incident has been requested, the adverse reaction message is currently being processed. When new information is received, we will update the message. Reporter comment: 08Apr2021 agency/information service: requested additional information. If new medical information is received, report will be updated.Information in product tab:Dose no. in series: 2 Vaccination site: LeftArm. 10Mar2021:12:00. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: RESPIRATION FAILURE


VAERS ID: 1240342 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
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: Hospice care; Idiopathic pulmonary fibrosis
Preexisting Conditions: Medical History/Concurrent Conditions: Oxygen therapy (home oxygen therapy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021414229

Write-up: Death; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is PL-URPL-3-511-2021. A 71-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 01Apr2021 16:47 (Batch/Lot Number: EW8904; Expiration Date: 04Apr2021) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hospice care , ongoing idiopathic pulmonary fibrosis , oxygen therapy with home oxygen therapy. The patient''s concomitant medications were not reported. A patient with multimorbidity, including spontaneous pulmonary fibrosis, under home hospice care on home oxygen therapy, died after returning home from vaccination, which the family informed the management of the clinic today and presented a certificate from the doctor stating the death. The patient died on 01Apr2021 at 18:00. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1240344 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Essential hypertension, Type 2 diabetes mellitus, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021414226

Write-up: Vomiting; - non-insulin dependent diabetes mellitus; - essential hypertension; This is as spontaneous report received from a contactable Physician downloaded from a regulatory authority-WEB. The regulatory authority report number is PL-URPL-DML-MLP.4401.1.210.2021. An 83-years-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 25Mar2021 09:57 (Lot Number: ET3674; Expiration Date: 28Mar2021) as 0.3 mL, single for covid-19 immunisation. The patient was not Pregnant at Time of Vaccination. The patient medical history and the concomitant medications were not reported. On 26Mar2021, the patient died on the first day after vaccination. Cause of death: - non-insulin dependent diabetes mellitus; - essential hypertension. The patient was accompanied by vomiting on 26Mar2021. An autopsy was not performed. The reporting physician assessed the side effects as serious. URPL classified the application as heavy. URPL''s comments: Vomiting is an unexpected adverse reaction. The temporal relationship speaks for a cause-and-effect relationship. The reporting physician assessed the side effects as serious. URPL classified the application as heavy. Relatedness of drug to reaction(s)/event(s) by a regulatory authority; Reported Cause(s) of Death: Vomiting; Essential (primary) hypertension; Type 2 diabetes mellitus


VAERS ID: 1240345 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Epigastric discomfort, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021414232

Write-up: Sudden death; Epigastric discomfort; This is as spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) -WEB. The regulatory authority report number is PL-URPL-DML-MLP.4401.1.53.2021. A 60-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 intramuscular on 10Feb2021 (Batch/Lot number was not reported) as 0.3 mL, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of COMIRNATY intramuscular at 0.3 ml on 20Jan2021 for COVID-19 IMMUNISATION. The patient''s brother died suddenly probably several years earlier. The patient was not pregnant during the period of use of the drug. On 11Feb2021, the patient experienced epigastric discomfort (death), Sudden death (death). The patient died on 11Feb2021. It was unknown if an autopsy was performed. It was reported that the patient received Comirnaty vaccine (0.3ml, intramuscular, dosing - interval 3 weeks) from 20Jan2021 to 10Feb2021. The drug was not used in the past. Sudden death. The patient, a (polish nursing home) worker, was vaccinated in the presence of the reporting physician with the 2nd dose of Comirnaty, 0.3ml. No side effects on the day of administration. On the following day at work she reported epigastric discomfort, which she associated with a heavy meal. She returned home on her own power. She probably did not report her complaints to her physician (the reporting person was not her family physician). She was found by her family at home on the floor with no signs of life. The reporting person did not know if the patient was treated for chronic conditions and what medications she used. Family history - brother died suddenly probably several years earlier. Result: death. The reporting physician assessed the adverse reaction as serious (death). polish HA classified the report as serious. The outcome of the events was fatal. Health Authority Comment: Epigastric pain is an unexpected adverse reaction not reported in section 4.8 of the summary of product characteristics of Comirnaty. Reported by a physician who was at the time of vaccination of the patient, does not have information on possible chronic medical conditions and medication used, does not know if an autopsy was performed, and does not provide the lot number and expiry date of the vaccine. The description provided includes the occurrence of an adverse reaction, but this cannot be confirmed due to insufficient information - data cannot be completed or verified. Association not assessable /not classifiable. The reporting physician assessed the side effect as serious (death). Polish HA classified the report as serious. No follow-up attempts are possible. Information on lot/batch numbers cannot be obtained. ; Reported Cause(s) of Death: Epigastric discomfort; Sudden death


VAERS ID: 1240346 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Body temperature increased, COVID-19, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (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: 2021-03-12
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes (from 30 years ago)
Allergies:
Diagnostic Lab Data: Test Date: 20210308; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 20210306; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: PLPFIZER INC2021414332

Write-up: COVID-19 virus test positive; Weakness; Body temperature increased/ 38 centigrade; This is a spontaneous report received from a contactable consumer (patient''s son) downloaded from the Regulatory Authority (RA). The regulatory authority report number is PL-URPL-DML-MLP.4401.2.190.2021. A 73-years-old female patient received BNT162B2 (COMIRNATY), intramuscular on 03Mar2021 (Batch/Lot Number: ER2659) as single dose for covid-19 immunisation. Medical history included diabetes from 30 years ago. The patient''s concomitant medications were not reported. Patient was not pregnant during the period of taking the drug. From 06Mar2021 there was a weakening, increased body temperature 38 centigrade. On 08Mar2021, a medical rescue team performed the COVID-19 virus test (positive), did not take the patient to the hospital. On 12Mar2021 21:00 (9 days from the administration) patient died. An autopsy was not performed. The reporting person did not classified seriousness of the adverse reactions. The event outcome for events was fatal. Sender comment: On 26Mar2021, additional information was obtained during a telephone conversation (it was added to the notification) and the statistical number of the death was sent by e-mail. Until 29Mar2021 no response was received. Pyrexia is an expected adverse reaction listed in section 4.8 of COMIRNATY Summary of Product Characteristics. Asthenia is an unexpected side effect not included in the Summary of the Suspected Drug. There is a time relationship between drug administration and the occurrence of side effects. Due to the lack of detailed information (autopsy results, health history, medications taken, etc.), it cannot be ruled out that a factor other than the administered vaccine may have contributed to the death. The reporting person did not classify the seriousness of the adverse reactions. Company classified the notification as serious (death). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Weakness; Body temperature increased; COVID-19 virus test positive


VAERS ID: 1240347 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Dyspnoea, Feeling abnormal, Pneumonia
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: chest x-ray; Result Unstructured Data: Test Result:Good condition
CDC Split Type: PLPFIZER INC2021414327

Write-up: Suspicion of mild pneumonia; Brain fog; Breathing problems/Respiratory problems; This is a spontaneous report received from a contactable consumer (the son of the patient) downloaded from the Medicine Agency (MA) -WEB. The regulatory authority report number is PL-URPL-DML-MLP.4401.2.23.2021. A 85-year-old male patient received the first dose of bnt162b2 (Pfizer vaccine), via an unspecified route of administration on 18Jan2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced suspicion of mild pneumonia, brain fog and breathing problems on 18Jan2021. The patient developed respiratory problems, brain fog on 18Jan2021. The doctor recommended a chest X-ray (good condition), a strong antibiotic, as mild pneumonia was suspected. The patient underwent lab tests and procedures which included chest x-ray: good condition in 2021. The outcome of the events was fatal. The patient died on 09Feb2021 due to events. An autopsy was not performed. Sender comment: Respiratory problems, brain fog, pneumonia are unexpected adverse reactions not reported in section 4.8 of the Pfizer vaccine summary of product characteristics. There is a temporal relationship between the administration of the medicine and the occurrence of the adverse reactions. The possibility that a factor other than the suspected medication may have contributed to the reported adverse reactions cannot be excluded. The reporter did not classify the seriousness of the side effect. URPL classified the report as severe (death). Assessment for all reported events: Source NCA, Method WHO-UMC, Result Possible.; Reported Cause(s) of Death: Suspicion of mild pneumonia; Brain fog; Breathing problems/Respiratory problems


VAERS ID: 1240370 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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? No
Previous Vaccinations:
Other Medications: AMIODARONE; ALLOPURINOL; FLUOXETINE; ACETYLSALICYLIC ACID; PANTOPRAZOLE; DIAZEPAM; FUROSEMIDE; SPIRONOLACTONE; ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021409144

Write-up: Anaphylactic reaction; This is a spontaneous report from a contactable physician and an other HCP downloaded from a regulatory authority-WEB. The Regulatory Authority number: PT-INFARMED-J202104-629. A 61-year-old female patient received first dose of bnt162b2 (COMIRNATY; solution for injection; Batch/Lot Number: EW2243) via intramuscular on 08Apr2021 at 0.3 mL single for COVID-19 immunisation. The patient medical history included advanced stage cardiac disease. The patient was being followed at a palliative care unit of a central hospital. Concomitant medication included amiodarone, allopurinol, fluoxetine, acetylsalicylic acid, pantoprazole, diazepam, furosemide, spironolactone, atorvastatin. The patient was schedule for two doses of vaccine with an interval of at least 21 days between each dose. On 08Apr2021 after receiving the first dose, the patient experienced anaphylaxis reaction. A history of adverse reaction for any drug is unknown. There was no medication error. The event treatment was implemented through the specific anaphylaxis treatment protocol. The adverse picture lasted 2 hours, ending up the patient dying. Evolution of ADR: Death. The patient died on 08Apr2021. It was reported that an autopsy will be performed to determine the cause of death. Autopsy results were not available at the time of the report. Reporter comments: Concomitant Medication-Furosemide, Spironolactone, Amiodarone, ASA, Atorvastatin, Diazepam, fluxetina, pantolprazole, alop. Did Medication Error occur? -No. The reporter assessed relatedness of COMIRNATY to anaphylactic reaction as probable, method of assessment was unknown. No follow-up attempts possible. No further information expected. Follow-up (14Apr2021 and 15Apr2021): This follow-up report is being submitted to amend previously reported information: Listedness amendment. This is a follow-up to notifiy that case 2021409144 and 2021390006 are duplicates. All subsequent follow-up information will be reported under manufacturer report number AER 2021409144. New Information received from the regulatory authority, includes confirmation that cases 2021409144 and 2021390006 correspond to the same case. New information also included: reporter data, suspect drug data, medical history and clinical course details. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Anaphylactic reaction


VAERS ID: 1240371 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apathy, Death, Diarrhoea, Dyspnoea, Hyperhidrosis, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 9
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: ZOLPIDEM; QUETIAPINE; LORAZEPAM; PANTOPRAZOLE; ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Bedridden (totally dependent for activities of daily living with feeding by nasogastric tube); Dementia (probable diagnosis - awaiting neurological consultation)
Allergies:
Diagnostic Lab Data: Test Date: 20210404; Test Name: oxygen saturation; Result Unstructured Data: Test Result:low
CDC Split Type: PTPFIZER INC2021414336

Write-up: Death; Bulky liquid ejection; Intense sweating; Difficulty in breathing; Low oxygen saturation; Apathetic, little response to external stimuli; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is PT-INFARMED-R202104-584. A 87-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 25Mar2021 (Lot Number: ER9470) as 0.3mL, single for covid-19 immunisation. Medical history included atrial fibrillation; suspected dementia (probable diagnosis - awaiting neurological consultation); bedridden user, totally dependent for activities of daily living with feeding by nasogastric tube. Concomitant medications included zolpidem; quetiapine; lorazepam; pantoprazole; apixaban (ELIQUIS), all taken for an unspecified indication, start and stop date were not reported. 48 hours after vaccination on 27Mar2021, the patient was apathetic, responding little to external stimuli. She did not present fever or other clinical alterations. On the 10th day after the vaccination on 04Apr2021, she presented bulky liquid discharge, intense sweating and difficulty breathing. The caregiver reported low oxygen saturation, so she called emergency services and the patient was hospitalized. Death occurred the following day, 11 days after the administration of the vaccine on 05Apr2021. The patient died on 05Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death; Apathetic, little response to external stimuli; Bulky liquid ejection; Intense sweating; Difficulty in breathing; Low oxygen saturation


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