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

Found 22,193 cases where Vaccine is COVID19 and Patient Died

Government Disclaimer on use of this data



Case Details (Sorted by Age)

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VAERS ID: 1742239 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-04-17
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Fall, Herpes zoster, Interstitial lung disease, X-ray
SMQs:, Interstitial lung disease (narrow), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data: Test Name: computerized tomogram; Result Unstructured Data: Test Result:pneumonia; Test Name: x-ray; Result Unstructured Data: Test Result:pneumonia
CDC Split Type: DEPFIZER INC202101263692

Write-up: interstitial pneumonia; fall at home; herpes zoster; This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech (manufacturer control number: 88692), license party for Comirnaty. An 85-years-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included dementia. The patient''s concomitant medications were not reported. The patient developed severe herpes zoster on 17Apr2021 and interstitial pneumonia on 04May2021. The lung problems on 04May2021. At first, micro metastases were suspected and CT (computerized tomogram) and X-ray were performed which gave a diagnosis of pneumonia. He was transferred to hospital (due to pneumonia) on 29May2021 and on 05Aug2021 he died in a hospice. He also fell at home, but it was unclear at what time in the course of events. The second dose was not administered. The outcome of the event interstitial pneumonia was fatal. The outcome of the other events was unknown. The patient died on 05Aug2021. It was not reported if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on temporal relationship the possibility of causal association between the reported events Interstitial pneumonia, Herpes Zoster, Fall and the suspect drug BNT162B2 cannot be excluded. 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: interstitial pneumonia


VAERS ID: 1742443 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal growth restriction, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101239544

Write-up: stop of growth of the embryo; Maternal Exposure During Pregnancy; This is as spontaneous report received from a contactable consumer. The same reporter reported events after both vaccine doses for the mother and the fetus. This is the report for the fetus. The original report was downloaded from the EudraVigilance-FR-AFSSAPS-PS20212091. A fetus patient received bnt162b2 (COMIRNATY) via transplacental since the patient''s mother received the 2nd dose of bnt162b2 (COMIRNATY) intramuscular in the left arm on 31Jul2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced stop of growth of the embryo and maternal exposure during pregnancy. This a report of a spontaneous miscarriage 13 days after the second injection of the Comirnaty vaccine. There was a strong coincidence between the date of the stop of growth of the embryo given by the doctor and the date of this second injection. The embryo stopped at 6 WA + 6 days. Outcome of the event was fatal. No follow-up attempts possible. No further information expected. ; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101263402 Maternal case; Reported Cause(s) of Death: stop of growth of the embryo; Maternal Exposure During Pregnancy


VAERS ID: 1742722 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-23
Onset:2020-12-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 39
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: Hashimoto''s thyroiditis (He had hashimotos thyroiditus, was auto immune. Took levothyroxine.); Immunodeficiency (auto immune, 91 years old)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101252725

Write-up: Death; became very sick; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109211325489570-EP3E7, Safety Report Unique Identifier GB-MHRA-ADR 25974734. A 92-year-old male patient received Bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 23Dec2020, as first dose, single for COVID-19 immunisation. Medical history included immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef)), hashimotos thyroiditus. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient previously took levothyroxine for hashimotos thyroiditus. The patient experienced very sick on 25Dec2020 with outcome of unknown. The patient experienced death on 02Feb2021. "My father became very sick within two days of taking the first Pfizer vaccine, and was bedridden with rapid degeneration for the following six weeks until his untimely death on 2nd February 2021. He had ordered a large Christmas hamper to enjoy that remained untouched. He was auto immune, 91 years old but otherwise had been relatively fit and not sick. He had no idea that this was an mRNA experimental genetic therapy. He was not informed by any doctors of its potential dangers. He was coerced by NHS into taking a deadly cocktail." Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient died on 02Feb2021 due to unknown cause of death. It was unknown whether an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1742791 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Anuria, Condition aggravated, Death, Dyspnoea, Fibrin D dimer increased, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), 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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: HYDROXYUREA
Current Illness: Angina pectoris (under medication and received erythropoietin in conservative dosage)
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease (under medication and received erythropoietin in conservative dosage); Hypertension (under medication and received erythropoietin in conservative dosage)
Allergies:
Diagnostic Lab Data: Test Name: D-dimer; Result Unstructured Data: Test Result:increased; Comments: without pulmonary embolism
CDC Split Type: GRPFIZER INC202101256734

Write-up: angina pectoris pain; tachycardia; dyspnea; increased d-dimers; POSSIBLE THROMBOSIS OF CORONARY BLOOD VESSELS; anuria; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number GR-GREOF-20217725. An 87-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on an unspecified date (Lot Number: not reported) at a single dose for covid-19 immunisation. Medical history included hypertension, chronic renal disease, and ongoing angina pectoris (she was under medication and received erythropoietin in conservative dosage). Concomitant medication included hydroxyurea. On unspecified date, the patient experienced possible thrombosis of coronary blood vessels, anuria, angina pectoris pain, tachycardia, dyspnea and increased d-dimers. About two months after the COMIRNATY vaccination on unspecified date, the patient presented angina pectoris pain, tachycardia and dyspnea where MD recommendation she was admitted to hospital where diagnosed increased d-dimers without pulmonary embolism confirmation. After a few days, she died with anuria. Events angina pectoris pain, tachycardia, dyspnea and increased d-dimers required physician office visit. Outcome of the events angina pectoris pain, tachycardia, dyspnea and increased d-dimers was unknown. The patient died on an unspecified date due to possible thrombosis of coronary blood vessels, anuria. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: anuria; POSSIBLE THROMBOSIS OF CORONARY BLOOD VESSELS


VAERS ID: 1742798 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101265822

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable healthcare professional via agency (Regulatory authority report number: not provided) based on information received by Pfizer from company (manufacturer control number: HK-Fosun-2021FOS003573), license party for bnt162b2 (COMIRNATY). In the preceding week till 11:59 pm on 12-Sep-2021, agency received two death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. This case was split for 1 of 2 death cases. A 65-year-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), unknown on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient died due to unknown cause of death. The event unknown cause of death met the seriousness criterion of death. It was not reported if an autopsy was performed. Death is not a common adverse event in the package insert of COMIRNATY, so its expectedness is: unexpected. Given the limited information available to date, it is difficult to exclude a causal relationship, and the relationships between death and COMIRNATY were considered as possible. This is one of seven reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003569 (master case), 2021FOS003570, 2021FOS003571, 2021FOS003572, 2021FOS003573, 2021FOS003574 and 2021FOS003575. Company comment: The medical review comments of department on the report of death as follows: The seriousness of death was serious. Death is not a common adverse event in the package insert of COMIRNATY, so its expectedness is: unexpected. Given the limited information available to date, it is difficult to exclude a causal relationship, and the relationships between death and COMIRNATY were considered as possible. Causality assessment Unknown cause of death Per Reporter=Possible Per Company=Possible No follow-up attempts are possible; no information is required.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101266039 Same reporter/suspect, different patient; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1742854 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-09-23
   Days after onset: 53
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: Non-smoker
Preexisting Conditions: Comments: No other pathologies reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210948196

Write-up: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via social media via a company representative concerned a 36 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: non smoker, and other pre-existing medical conditions included: No other pathologies reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total dose, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date in AUG-2021, the patient experienced suspected covid-19 infection (suspected clinical vaccination failure) and was hospitalized for one month in intensive care unit (date unspecified). He had been intubated for a few days at the hospital and on 23-SEP-2021 at 14:00, patient passed away. It was unknown whether autopsy was performed. It was reported that he may have contracted the virus while he was on duty. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 23-SEP-2021 and the outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening). The case is associated with Product quality complaint.; Sender''s Comments: V0. 20210948196-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS 20210948196-COVID-19 VACCINE AD26.COV2.S- Suspected covid-19 infection. This event is considered unassessable. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: SARS COVID 19 INFECTION


VAERS ID: 1742975 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   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: COVID-19 pneumonia aggravated; Diabetes mellitus; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101250401

Write-up: cardiac decompensation; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority report number is IT-MINISAL02-787472. A 87 year old female patient received bnt162b2 (Comirnaty, Formulation: Solution for injection, Batch/Lot number: EJ6790) dose 1,0.3 ML Via an Intramuscular route of administration on 19Feb2021 at 13:30 pm as a single dose for COVID-19 immunisation. The patient''s medical history includes diabetes mellitus, COVID-19 pneumonia aggravated and arterial Hypertension. Concomitant drugs were not reported. She received the first dose of Pfizer vaccine, Symptoms appeared after 4 days. Her condition worsened. Patient undergone cardiac decompensation on 23Feb2021 an experienced death on 26Feb2021. The outcome of the event was Fatal. Reporter''s comments: The patient suffered from diabetes mellitus. She had been found positive for Covid 19 one month before vaccination and isolated until remission of symptoms, which were not severe. She received the first dose of Pfizer vaccine immediately thereafter. Her condition worsened until she died. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1743240 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Infarction
SMQs:, Myocardial infarction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   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: Smoker (smoked occasionally)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTJNJFOC20210943014

Write-up: INFARCTION NOS; DEATH; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, LT-SMCA-4293) on 22-SEP-2021 concerned 30 year old male of unspecified race and ethnic origin. The patient''s weight was 112 kilograms, and height was 185 centimeters. The patient''s concurrent medical history included smoker (smoked occasionally). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C18-02 and expiry: unknown) 0.5 ml, 1 total administered on 08-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 11-AUG-2021, the patient died from infarction nos. An autopsy was performed on an unspecified date. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 11-AUG-2021. This report was serious (Death, Other Medically Important Condition, and Life Threatening).; Reported Cause(s) of Death: INFARCTION NOS


VAERS ID: 1743242 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRIX; THYROZOL; CORONAL [BISOPROLOL FUMARATE]; CO AMLESSA; ETACIZINS; MOXONIDIN HEXAL; ROSULIP PLUS [EZETIMIBE;ROSUVASTATIN CALCIUM]
Current Illness: Arrhythmia NOS; Cardiac failure; Coronary heart disease; Dyslipidaemia; Primary hypertension; Thyrotoxicosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVPFIZER INC202101263031

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number LV-SAM-2021096611. A 74-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 14Sep2021 12:45 (Lot Number: FF0900) as second dose, 0.3ml single for covid-19 immunisation. Medical history included coronary heart disease, arrhythmia NOS, primary hypertension, cardiac failure, thyrotoxicosis, dyslipidaemia all ongoing. Concomitant medications included spironolactone (SPIRIX) for primary hypertension, cardiac failure from 14Feb2017; thiamazole (THYROZOL) for thyrotoxicosis from 20Jul2021 and ongoing; bisoprolol fumarate (CORONAL [BISOPROLOL FUMARATE]) for cardiac failure, coronary heart disease, primary hypertension from 26Nov2019 and ongoing; amlodipine besilate, indapamide, perindopril erbumine (CO AMLESSA) for primary hypertension from 03Sep2019 and ongoing; ethacizine (ETACIZINS) for arrhythmia NOS from 23Nov2011 and ongoing; moxonidine (MOXONIDIN HEXAL) for primary hypertension from 25Feb2020 and ongoing; ezetimibe, rosuvastatin calcium (ROSULIP PLUS [EZETIMIBE;ROSUVASTATIN CALCIUM]) for dyslipidaemia from 30Oct2020 and ongoing. The patient previously took bnt162b2 (COMIRNATY) on unspecified date (Lot Number: not reported) as first dose, single for covid-19 immunisation. The patient experienced death on unspecified date (also reported as 19Jun2021, pending clarification). It was reported that the patient was found dead in bed - precise time of death not known. The patient did not complain of any symptoms after receiving the first or second vaccination dose. The patient died of unknown cause. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: death


VAERS ID: 1743248 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-28
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-28
   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: Medical History/Concurrent Conditions: Surgery (The patient was transferred to a higher-level care that could handle her condition.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210952687

Write-up: SICK; DEATH; This spontaneous report received from a consumer via social media concerned a female of an unspecified age, race, and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included: surgery and she was transferred to a higher-level care that could handle her condition. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose and therapy start date were not reported, frequency time was 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient got sick. The patient was in intensive care unit (reported as the Covid unit). On 28-AUG-2021, the patient died from an unknown cause. It was unspecified if an autopsy was performed. It was reported that the patient did not want to take the vaccine because of her religious beliefs but she was forced to take the vaccine. The patient got her first dose of vaccine after surviving this entire pandemic. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was serious (Death). This case, from the same reporter is linked to 20210945121.; Sender''s Comments: V0: 20210952687 -covid-19 vaccine ad26.cov2.s- Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1744870 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-14
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101248219

Write-up: Adverse event following immunisation; Pain in extremity; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 626642. A 56-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Aug2021 patient experienced adverse event following immunization and pain in extremity. Outcome of both events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Adverse event following immunisation; Pain in extremity


VAERS ID: 1745871 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-15
   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: Cardiac failure; Sleep apnea syndrome; Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210956619

Write-up: DEATH; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, DE-DCGMA-21193497) on 29-SEP-2021 and concerned a 69 year old female of unspecified race and ethnic origin. The patient''s weight was 124 kilograms, and height was 165 centimeters. The patient''s concurrent conditions included: sleep apnea syndrome, and cardiac failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: UNKNOWN) dose was not reported, 1 total administered on 26-MAY-2021 for an unspecified indication. The batch number was not reported. Per, procedure no follow-up will be requested for this case. No concomitant medications were reported. On 15-SEP-2021, the patient experienced death and the patient died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1745986 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Encephalitis autoimmune, Generalised tonic-clonic seizure, Loss of consciousness, Lumbar puncture, Postictal state
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-20
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient had no significant medical history.
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Lumbar puncture; Result Unstructured Data: Normal
CDC Split Type: COJNJFOC20210952991

Write-up: POSSIBLE AUTOIMMUNE ENCEPHALITIS; POSTICTAL STATE; TONIC-CLONIC SEIZURE; LOSS OF CONSCIOUSNESS; CARDIOGENIC SHOCK; This spontaneous report received from a health care professional via INVIMA Colombian health authority concerned a 25 year old of unspecified sex, race and ethnic origin. The patient''s height, and weight were not reported. The patient had no significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213A21A, expiry: 21-DEC-2021) 1 total dose administered on 13-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 16-JUL-2021, patient underwent a medical consult and was sent to the Emergency Room in postictal state due to tonic-clonic seizure. Later the patient was admitted to the Intensive Care Unit (ICU) as the patient did not fully recover consciousness. A lumbar puncture was performed which was normal. Multiple laboratory tests were requested in search of the origin, evaluation by the neurology service suggested possible autoimmune encephalitis. The patient was hospitalized for unspecified number of days. On 20-AUG-2021, the patient died from cardiogenic shock. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to cardiogenic shock on 20-AUG-2021, and the outcome of possible autoimmune encephalitis, postictal state, tonic-clonic seizure and loss of consciousness was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: This spontaneous report received from a health care professional via Colombian health authority, INVIMA, concerned a 25-year-old of person of unknown gender, and unspecified ethnicity who experienced tonic-clonic seizures, loss of consciousness, and possible autoimmune encephalitis 3 days after vaccination with a fatal progression. The patient had no significant medical history and concomitant medications were not reported. Three days after vaccination the patient was sent to the emergency room in a postictal state following tonic-clonic seizures. The patient was admitted to the ICU due to lack of consciousness. A lumbar puncture was performed and the results were reported as normal. Multiple lab tests were performed but the lab results were not provided. Neurology evaluation suggested a possible autoimmune encephalitis. The patient died due to cardiogenic shock 7 days after vaccination but clinical details were not provided. It was unknown if an autopsy was performed. Information regarding other potential etiologies was insufficient, and the occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the events are assessed to have an indeterminate relationship with vaccination.; Reported Cause(s) of Death: CARDIOGENIC SHOCK


VAERS ID: 1745988 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRW2 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial bypass operation; Chronic renal insufficiency (stage 4); Coronary heart disease; Diabetes mellitus insulin-dependent; Polyneuropathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101215694

Write-up: The patient died 2 days after the first vaccination with Biontec; This is a spontaneous report downloaded from a regulatory authority. Regulatory authority report number: DE-PEI-CADR2021177563 with Safety Report Unique Identifier: DE-PEI-202100187883. An 82-year-old female patient received bnt162b2 (COMIRNATY) dose 1 via an unspecified route of administration on 18Aug2021 (Lot Number: SCRW2) as single dose for COVID-19 immunisation. Medical history included ongoing coronary artery disease, ongoing arterial bypass operation, ongoing polyneuropathy, ongoing chronic renal insufficiency stage 4, ongoing diabetes mellitus insulin-dependent. No known allergy. The patient''s concomitant medications were not reported. The patient experienced the patient died on 20Aug2021, 2 days after the first vaccination with bnt162b2. An autopsy was not performed. Relatedness of Comirnaty to event Unknown cause of death: was D. Unclassifiable per RA.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1745989 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-08-29
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101222573

Write-up: Pulmonary haemorrhage under resuscitation; Acute dyspnoea; Asystolia; This is a spontaneous report from a non-contactable consumer downloaded from a regulatory authority. DE-PEI-CADR2021178429 Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100188431. A 50-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 11Jul2021 (Batch/Lot Number: Unknown) as SINGLE for covid-19 immunisation. The patient medical history was reported as none (no previous illnesses). concomitant medications were not reported. The patient''s weight was 80 kg, and height was 180 cm. The patient experienced acute dyspnoea and asystolia on 29Aug2021. On 11Sep2021 the patient experienced Pulmonary haemorrhage under resuscitation. The patient died in Sep2021. It was not reported if an autopsy was performed. The outcome of event Lung hemorrhage was fatal and for other events was not resolved. This report is serious - hospitalization. Sender Comment: Information on risk factors or previous illnesses No previous illnesses No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pulmonary haemorrhage under resuscitation


VAERS ID: 1746011 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-29
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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101244734

Write-up: Died; This is a spontaneous report from a non-contactable consumer. A 21-year-old female patient received BNT162B2(COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose (dose number unknown) for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient (student driver) died after Corona vaccination. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Died


VAERS ID: 1746226 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCUD8 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood glucose, Blood pressure measurement, Body mass index, Body temperature, Carbon dioxide, Coma scale, Confusional state, Ejection fraction, Heart rate, Hypercapnic coma, Hypertension, Nervous system disorder, Neurological examination, Oxygen saturation, Respiratory rate, SARS-CoV-2 test, Tachypnoea, pH body fluid
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-16
   Days after onset: 15
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: Acute kidney failure; AFib (Chronic atrial fibrillation (Afib) not anticoagulated due to the increased risk of bleeding); Chronic alcoholism; Congestive (dilated) cardiomyopathy; Corneal graft; COVID-19; Dementia; Dilated cardiomyopathy (Ethylic dilated cardiomyopathy (LVEF 40% in 2017)); Fall (- Fall at home complicated by rhabdomyolysis); Gout; Hemorrhage of gastrointestinal tract, unspecified; Hyperuricaemia; Obesity (Obesity (BMI 34)); Peripheral arterial occlusive disease; Prostate adenoma; Rhabdomyolysis (- Fall at home complicated by rhabdomyolysis); Shakiness; Starvation; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: HCO3; Result Unstructured Data: Test Result:31.7 mmol/L; Test Date: 202109; Test Name: blood glucose; Result Unstructured Data: Test Result:2.65 g/l; Test Date: 202109; Test Name: blood pressure; Result Unstructured Data: Test Result:133 per 84 mmHg; Test Name: body mas index; Result Unstructured Data: Test Result:34; Test Date: 202109; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 202109; Test Name: co2; Result Unstructured Data: Test Result:53.7 mmHg; Test Date: 202109; Test Name: glasgow score; Result Unstructured Data: Test Result:4 pts including eyes: 2, verbal: 1, motor: 1; Test Date: 2017; Test Name: FEVG; Test Result: 40 %; Test Date: 202109; Test Name: heart rate; Result Unstructured Data: Test Result:71; Comments: per minute; Test Date: 202109; Test Name: neurological examination; Result Unstructured Data: Test Result:Vigilance: abnormal,; Comments: Vigilance: abnormal, Glasgow score: 4pts including eyes: 2, verbal: 1, motor: 1; Test Date: 202109; Test Name: oxygen saturation; Test Result: 98 %; Test Date: 202109; Test Name: ph; Result Unstructured Data: Test Result:7.21; Test Date: 202109; Test Name: respiratory rate; Result Unstructured Data: Test Result:36; Comments: per minute; Test Date: 20210915; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101256392

Write-up: superficial polypnea; Confusional state; Neurological disorder NOS; Hypercapnic coma; BP left arm: 133/84mmHg; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-AN20213725. A 76-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: SCUD8) via intramuscularly on 13Sep2021 as dose 1, single for covid-19 immunization. Medical history included Ethylic dilated cardiomyopathy (LVEF 40% in 2017), Covid 19 in February 2021, Dementia, Chronic atrial fibrillation (Afib) not anticoagulated due to the increased risk of bleeding, Obesity (BMI 34), Type 2 diabetes, Fall at home complicated by rhabdomyolysis, Bilateral blindness. Failed corneal transplant, multiple surgeries, Digestive hemorrhage, oeso-gastro-duodenal fibroscopy (FOGD) refusal (2021), Distal obliterative arteriopathy of the lower limbs (OAMI), Circumcision for a phimosis sequellar to a lichen sclerosus (2010), uninvestigated tremors. Concomitant medications were not reported. The Person at risk of developing severe COVID-19 disease. The Patient living in an EHPAD (Residential facility for dependent elderly people) vaccinated with a first dose of COMIRNATY vaccine on 13Sep2021. The next morning on 14Sep2021, the patient presented a sudden confusion with superficial polypnea, which motivated his admission to the emergency room. Confusion then coma in a patient with multiple comorbidities vaccinated the day before with a first dose of comirnaty vaccine. On 15Sep2021 appearance of a deficit of the left hemisphere, no BBK, deviation of the mouth possibly. Decision of limitation or discontinuation of active therapies (LATA), no complementary explorations. Death of the patient was on 16Sep2021. Confusion then coma in a patient with multiple comorbidities vaccinated the day before by a 1st dose of Comirnaty. The patient underwent lab tests and procedures which included blood bicarbonate: 31.7 mmol/l, blood glucose: 2.65 g/l, blood pressure measurement: 133 per 84 mmhg, body temperature: 36.4 centigrade, carbon dioxide: 53.7 mmhg, coma scale: 4 pts including eyes: 2, verbal: 1, motor: 1, heart rate: 71 per minute, neurological examination: vigilance: abnormal, Glasgow score: 4pts including eyes: 2, verbal: 1, motor: 1 , oxygen saturation: 98 %, ph body fluid: 7.21, respiratory rate: 36 on an unspecified date in Sep2021, body mass index: 34, ejection fraction: 40 % on an unspecified date in 2017, sars-cov-2 test: negative on 15Sep2021. Outcome of the events neurological disorder NOS, confusional state, superficial polypnea were not resolved and outcome was unknown for BP left arm: 133/84mmHg.; Reported Cause(s) of Death: Hypercapnic coma


VAERS ID: 1746305 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-08-19
   Days after vaccination:190
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

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: 2021-09-02
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210819; Test Name: sars-cov-2 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101256385

Write-up: tested positive for covid on 19Aug2021; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority EudraVigilance-WEB. The regulatory authority report number is FR-AFSSAPS-MP20217282. A 96-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: EJ6788) via an intramuscular route of administration on 10Feb2021 into left arm as dose 2, single for COVID-19 immunization; patient had earlier received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number EJ6788) via an intramuscular route of administration into left arm on 20Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant were not reported. It was reported that time Interval between Beginning of Drug Administration and Start of Reaction / Event was 212 days and time Interval between Last Dose of Drug and Start of Reaction / Event 191 days. On 19Aug2021 the patient had experienced COVID-19 confirmed by positive COVID-19 test. Main clinical signs was not described. On 19 Aug2021 the patient underwent lab test and procedures which included sars-cov-2 PCR test and diagnose with SARS COV-19 positive result. Characterization of the virus, variant: unknown. It was unknown if an autopsy was performed, and the reported cause of death was COVID-19 confirmed by positive COVID-19 test. The outcome of the event was fatal on 02sep2021 (death on 02Sep2021 as a result of the infection). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test


VAERS ID: 1746306 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-08-23
   Days after vaccination:160
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / OT

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? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-23
   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: Dementia Alzheimer''s type
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: SARS-CoV-2 test; Test Result: Positive; Comments: Positive PCR test delta variant
CDC Split Type: FRPFIZER INC202101256378

Write-up: Symptomatic COVID (delta variant) with signs of seriousness and commitment to the vital prognosis: Alteration of the general condition, dyspnea (desaturation, put on O2), cough; Symptomatic COVID (delta variant) / COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable other health care professional downloaded from the regulatory authority EudraVigilance-WEB. The regulatory authority report number is FR-AFSSAPS-MP20217364 An 85-years-old male patient received bnt162b2 (COMIRNATY, solution for injection; lot number: ET3620, expiry date: unknown) intramuscularly administered in left arm on 16Mar2021 as dose 2, single and bnt162b2 (COMIRNATY, solution for injection; lot number: EP2163, expiry date: unknown) intramuscularly administered in left arm on 23Feb2021 as dose 1, single for COVID-19 immunization. Patient''s medical history included ongoing dementia alzheimer''s type. The patient''s concomitant medications were not reported. On 23Aug2021, the patient experienced symptomatic covid (delta variant) with signs of seriousness and commitment to the vital prognosis: alteration of the general condition, dyspnea (desaturation, put on o2), cough; symptomatic covid (delta variant) / covid-19 confirmed by positive covid-19 test. The patient underwent lab tests and procedures which included SARS-CoV-2 test: Positive / Positive PCR test, delta variant on 04Aug2021.The patient died on 23Aug2021. It was not reported if an autopsy was performed. The outcome of the events was fatal on 23Aug2021. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: COVID-19


VAERS ID: 1746322 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-08-13
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Oxygen saturation, 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: 2021-08-19
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EU
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholism; Arterial hypertension; Dementia (alcoholic); Depression; Gastrectomy; GDU; Mental deficiency; Psychosis (schizophrenic psychosis); Suicide attempt (schizophrenic psychosis with 1 suicide attempt in 1999 and 2 in 2012); Type 2 diabetes mellitus (requiring insulin)
Allergies:
Diagnostic Lab Data: Test Date: 20210813; Test Name: oxygen saturation; Test Result: 85 %; Test Date: 20210813; Test Name: Covid-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101256700

Write-up: Vaccination failure; Covid-19; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20213749. A 72-years-old male patient received bnt162b2 (COMIRNATY, formulation: Solution for injection, lot number: EP9605), dose 2 intramuscular on 15Mar2021 as dose 2, single, dose 1 intramuscular on 24Feb2021 (Batch/Lot Number: EP2163) as dose 1, single for covid-19 immunisation. Paracetamol (DOLIPRANE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included depression, intellectual disability, type 2 diabetes mellitus requiring insulin, hypertension from an unknown date and unknown if ongoing , gastrectomy from 1988 to an unknown date , alcoholism from 1988 to an unknown date , gastroduodenal ulcer from 1987 to an unknown date , psychotic disorder, schizophrenic psychosis , dementia from an unknown date and unknown if ongoing, alcoholic , suicide attempt from 1999 to an unknown date schizophrenic psychosis with 1 suicide attempt in 1999 and 2 in 2012. Concomitant medications included haloperidol (HALDOL, zopiclone (IMOVANE), tropatepine hydrochloride (LEPTICUR), metformin (METFORMIN), mianserin (MIANSERIN) macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]), cyamemazine (TERCIAN [CYAMEMAZINE]), trimebutine maleate (TRIMEBUTIN), nacl (NACL), insulin glargine (ABASAGLAR), dexamethasone (DEXAMETHASONE) and enoxaparin sodium (LOVENOX [ENOXAPARIN SODIUM]) taken for an unspecified indication, start and stop date were not reported. On 13Aug2021, the patient experienced vaccination failure and covid-19 The patient underwent lab tests and procedures which included oxygen saturation: 85 % on 13Aug2021, sars-cov-2 test: positive on 13Aug2021. Therapeutic measures were taken as a result of covid-19. The patient died on 19Aug2021. It was not reported if an autopsy was performed. The outcome of the event vaccination failure was fatal. The event covid-19 outcome was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1746360 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-09-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Angiogram, Coronary artery thrombosis, Echocardiogram, Electrocardiogram, Fibrin D dimer, Physical examination, Troponin
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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KARDEGIC; BRILIQUE; PANTOPRAZOLE; BISOPROLOL; RAMIPRIL; INSPRA; AMLOR; LASILIX [FUROSEMIDE]; ATORVASTATINE [ATORVASTATIN]; ABASAGLAR; APIDRA; PREGABALINE; SERESTA; ZOPICLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute pulmonary oedema (Hospitalized in May2021 for ischemic acute lung edema); Angioplasty; Coronary artery occlusion; Coronary artery stenosis; Coronary stent placement; Ejection fraction low; Hypertension arterial; Insulin-dependent diabetes mellitus; Ischaemic heart disease; Leg amputation (2 legs)
Allergies:
Diagnostic Lab Data: Test Name: Coronary angiography; Result Unstructured Data: Test Result:stenosis of the proximal anterior interventricular; Comments: Significant stenosis of the proximal anterior interventricular artery. Chronic obstruction of the middle circumflex artery (small intestine downstream bed). Insignificant lesion of the first marginal. Significant stenosis of the proximal right coronary artery (dominated).; Test Date: 20210905; Test Name: Coronary angiography; Result Unstructured Data: Test Result:Tritronascular lesions.; Comments: Equivalent to acute coronary syndrome with ST segment elevation at H+15 Significant thrombotic restenosis of the focal proximal anterior interventricular artery at the site of implantation of the active stent. Chronic occlusion of the middle circumflex artery. Insignificant lesion of the first marginal. Significant stenosis of the proximal right coronary artery.; Test Name: transthoracic echocardiography; Result Unstructured Data: Test Result:ejection fraction altered to 35-40%; Comments: ejection fraction altered to 35-40%, flow preserved, severe anterolateral hypokinesia, apical and middle third of the infero-septal wall, lower basal third, the entire infero-lateral and apical wall, apical third of the antero-septal wall -septal. Minimal mitral insufficiency; Test Name: ECG; Result Unstructured Data: Test Result:Regular sinus rhythm at 94 bpm; Comments: Regular sinus rhythm at 94 bpm, PR at 120 ms, fine QRS, normal axis, no over or under offset, flattening of T waves in V4-V5-V6; Test Date: 20210905; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm 110 bpm; Comments: sinus rhythm 110 bpm, under ST shift in inferolateral; Test Date: 20210905; Test Name: D dimers; Result Unstructured Data: Test Result:1610 ng/L; Test Date: 20210905; Test Name: Clinical examination; Result Unstructured Data: Test Result:no chest pain. Stable hemodynamics.; Comments: no chest pain. Stable hemodynamics. Neck pain reproduced on palpation of C7T1; Test Date: 20210905; Test Name: troponin; Result Unstructured Data: Test Result:7636 ng/L
CDC Split Type: FRPFIZER INC202101222924

Write-up: Coronary thrombosis; Non ST segment elevation acute coronary syndrome/chest pain, atypical, neck pain type and in the left arm, suspected of false movement; This is a spontaneous report from a contactable physician downloaded from the regulatory authority; report number FR-AFSSAPS-PC20213770. A 67-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 26Aug2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. Medical history included insulin-dependent diabetes, hypertension arterial, ischaemic heart disease stented in 2020, hospitalized in May2021 for ischemic acute lung edema. Transthoracic echocardiography: ejection fraction altered to 35-40%, flow preserved, severe anterolateral hypokinesia, apical and middle third of the infero-septal wall, lower basal third, the entire infero-lateral and apical wall, apical third of the antero-septal wall -septal. Minimal mitral insufficiency, ECG (electrocardiogram): Regular sinus rhythm at 94 bpm, PR at 120 ms, fine QRS, normal axis, no over or under offset, flattening of T waves in V4-V5-V6, Coronary angiography: Significant stenosis of the proximal anterior interventricular artery. Chronic obstruction of the middle circumflex artery (small intestine downstream bed). Insignificant lesion of the first marginal. Significant stenosis of the proximal right coronary artery (dominated). Successful angioplasty of the proximal anterior interventricular artery. Implantation of 2 active stents, patient with both legs amputated. Concomitant medications included acetylsalicylate lysine (KARDEGIC) 75 mg in the morning; ticagrelor (BRILIQUE) 90 mg morning and evening to continue 12 months minimum; pantoprazole 20 mg in the morning; bisoprolol 2.5 mg in the morning and evening; ramipril 2.5 mg in the morning and evening; eplerenone (INSPRA) 25 mg in the morning; amlodipine besilate (AMLOR) 5 mg in the morning; furosemide (LASILIX [FUROSEMIDE]) 40 mg in the morning; atorvastatine [atorvastatin] (ATORVASTATINE [ATORVASTATIN]) 10 mg in the evening; insulin glargine (ABASAGLAR) 22 IU in the evening; insulin glulisine (APIDRA) 6 IU morning, midday, evening; pregabaline 75 mg 1 in the morning; oxazepam (SERESTA) 10 mg in the evening; zopiclone 7.5mg in the evening; all taken for an unspecified indication, start and stop date were not reported. Patient presented an acute coronary syndrome on 04Sep2021 at 23:00. During coronary angiography, patient experienced extension of the thrombosis on 05Sep2021. Death of the patient. Clinical course was reported as 04Sep2021 at 23:00: Occurrence of chest pain, atypical, neck pain type and in the left arm, suspected of false movement. Call to urgent medical aid service at 02:00 (05Sep2021) who decided on a transfer to the emergency room. On emergency: Clinical examination (05Sep2021): no chest pain. Stable hemodynamics. Neck pain reproduced on palpation of C7T1. Pain relieved by simple and positional analgesics. ECG (05Sep2021) to emergencies: sinus rhythm 110 bpm, under ST shift in inferolateral. Blood test (05Sep2021): D dimers 1610 ng/L, troponine 7636 ng/L. Due to suspicion of an acute coronary syndrome without ST segment elevation: indication for coronary angiography. Coronary angiography (05Sep2021): Tritronascular lesions. Equivalent to acute coronary syndrome with ST segment elevation at H+15. Significant thrombotic restenosis of the focal proximal anterior interventricular artery at the site of implantation of the active stent. Chronic occlusion of the middle circumflex artery. Insignificant lesion of the first marginal. Significant stenosis of the proximal right coronary artery. Patient received predilation of the anterior interventricular artery. Implantation of an active stent. Immediately after implantation of the extensive thrombosis of the anterior interventricular artery and guiding stent with cardiocirculatory arrest. Extension of thrombosis to the circumflex. Transient recanalization of the anterior interventricular artery and circumflex with resumption of rhythm. New cardiac arrest with thrombosis of the common trunk. Anticoagulation received: 9000U of enoxaparin sodium (LOVENOX) IV 2h before the procedure. 9000U heparin at the time of thrombosis. Death of the patient after 30 minutes of massage with inability to recover a heartbeat and coronary flow. Clinicians were surprised by the numerous coronary thromboses during revascularization, pointing out the unusual nature of these multithromboses. Patient was hospitalized for the events. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the events was fatal. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Coronary thrombosis; acute coronary syndrome


VAERS ID: 1746440 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-05-10
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Fatigue, Hypoxia, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (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: 2021-05-20
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic hepatitis C; Dementia; Ischemic stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101279979

Write-up: Vaccination failure; The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10May2021 (no variant testing).; fatigue; fever; hypoxia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-RE20211527. A 96-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EM0477, expiration: Apr2021), via intramuscular route of administration, administered in Arm Left on 18Jan2021 as dose 1, single and patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EK9788, expiration: May2021), via intramuscular route of administration, administered in left arm on 08Feb2021 as dose 2, single for covid-19 immunisation. Medical history included ischaemic stroke from an unknown date and unknown if ongoing, chronic hepatitis c from an unknown date and unknown if ongoing, dementia from an unknown date and unknown if ongoing. Concomitant medications included Kardegic (Acetylsalicylate Lysine) taken for an unspecified indication, start and stop date were not reported; Alprazolam taken for an unspecified indication, start and stop date were not reported; Transipeg (Macrogol 3350;Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous) taken for an unspecified indication, start and stop date were not reported; Zopiclone taken for an unspecified indication, start and stop date were not reported. Patient considered to be at risk of developing a severe form of COVID-19 disease. The patient experienced vaccination failure on 10May2021. Onset of fatigue, fever and hypoxia on 10May2021, requiring the use of anticoagulants, antibiotics and oxygen. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10May2021 (no variant testing). The patient died on 20May2021, following a very degraded general condition with slip form before infection with Covid-19. It was not reported if an autopsy was performed. Summary of Investigation: Lot number: EK9788, expiration: May2021 and Lot Number: EM0477, expiration: Apr2021. Conclusion: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced RA ID resulted in the following conclusion: Reference RA ID 5648370 (see File attachment in this investigation record). The complaint for adverse event/LOE of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. regulatory authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. FDA 15-day report on QAEF must be checked as NO. Reporter confirmed that it was after the 1st dose that the patient developed the symptoms. No follow-up attempts possible. No further information expected. Information about batch number has been obtained. Follow-up (17Aug2021). New information via Product Quality Group included: investigation results. Follow-up (23Sep2021): This is a follow-up report to confirm previously submitted information for case 202101057364 was incorrectly submitted to the trading partners with the Authority number of FR-AFSSAPS-2021058512. Case 202101057364 is now considered invalid, Corresponding information is re-entered under new manufacturer reporter number 202101279979 under correct Authority number FR-AFSSAPS-RE20211527. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: COVID-19; fatigue; fever; hypoxia; Vaccination failure


VAERS ID: 1746486 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Foetal heart rate, Foetal heart rate abnormal, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-05
   Days after onset: 52
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: 20210905; Test Name: Foetal heart rate; Result Unstructured Data: Test Result:stopped
CDC Split Type: FRPFIZER INC202101210953

Write-up: my baby''s heart suddenly stopped without reason one and a half month after the injection whereas there was no anomaly; my baby''s heart suddenly stopped without reason one and a half month after the injection whereas there was no anomaly; 2 weeks pregnant at the time of injection; This is a spontaneous report from a contactable consumer (patient''s mother) received via COVID-19 adverse event self-reporting solution. This is a fetus report. A fetus patient of an unspecified gender exposed to BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot Number: unknown), via transplacental route which was administered to her mother in her left arm on 15Jul2021 as dose number unknown, single for COVID-19 immunisation for her mother. The patient''s medical history and concomitant medication was not reported. The patient was 2 weeks fetus. The patient''s mother was a 32-year-old female. The mother was 2 weeks pregnant at the time of injection on 15Jul2021. Pregnancy was normal. Then the mother reported that her baby''s heart suddenly stopped without reason one and a half month after the injection, whereas there was no anomaly. It was not reported if an autopsy was performed. No follow up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: 2 weeks pregnant at the time of injection; heart suddenly stopped without reason one and a half month after the injection whereas there was no anomaly


VAERS ID: 1746869 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-17
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   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: GBMODERNATX, INC.MOD20213

Write-up: Death; This case was received via Regulatory Authority (RA) (Reference number: GB-MHRA-ADR 25969869) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 17-Jun-2021 The patient died on 17-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment medication was provided. Company comment: This case concerns a patient with unknown gender and age with no relevant medical history, who experienced the unexpected event of Death. The event occurred unknown days after the second dose of Spikevax . The rechallenge is not applicable since the event occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a patient with unknown gender and age with no relevant medical history, who experienced the unexpected event of Death. The event occurred unknown days after the second dose of Spikevax . The rechallenge is not applicable since the event occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1746928 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dysstasia, Fatigue, Myocardial ischaemia
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Other ischaemic heart disease (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 68
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEPONEX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202101216010

Write-up: Myocardial ischaemia; Exhaustion/Fatigue; Dizziness; could not stand on his feet; This is a spontaneous report from a contactable consumer downloaded from the regualtory authority, regulatory authority number GR-GREOF-20217340. A 61-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 28May2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included clozapine (LEPONEX). The patient was under treatment with antipsychotics for years. On 31May2021 he started feeling constant fatigue, dizziness, exhaustion. He could not stand on his feet. The patient experienced myocardial ischaemia on an unspecified date. The patient died on 07Aug2021. Myocardial ischaemia was the cause of death. He did not have a medical history of heart problem. It was unknown if an autopsy was performed. The outcome of the event myocardial ischaemia was fatal, the outcome of the other events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Myocardial ischaemia


VAERS ID: 1746929 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-20
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-22
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202101216061

Write-up: Chest pain; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number GR-GREOF-20217664. An 81-year-old male patient received the first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Lot Number: Unknown) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Aug2021 he had chest pain (fatal) and on 22Aug2021 he died. The cause of his death was thrombosis of the myocardium. It was not reported if an autopsy was performed. Outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Chest pain; THROMBOSIS OF THE MYOCARDIUM


VAERS ID: 1746967 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Respiratory disorder, Suspected COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-17
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210945519

Write-up: RESPIRATORY COMPLICATIONS DUE TO INFECTION; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative concerned a 70 year old male of unknown race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, frequency time 1 total, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 04-AUG-2021, the patient became infected 3 months after administration of Covid-19 vaccine ad26.cov2.s (suspected covid-19 infection and suspected clinical vaccination failure). On 17-AUG-2021, the patient died from respiratory complications due to infection. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20210945519-Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210945519-Covid-19 vaccine ad26.cov2.s-respiratory complications due to infection, suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: RESPIRATORY COMPLICATIONS DUE TO INFECTION


VAERS ID: 1747041 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-30
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Fatigue, Haemorrhagic stroke, Pain in extremity, Paraesthesia, Vascular pain
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 88
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial (Controlled and on medication for years)
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple allergies (Unspecified past allergies resolved by clinical examinations between January and July 2021)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101228428

Write-up: Pain legs; Memory loss transient; Hemorrhagic stroke; Pins and needles; Exhaustion; Vein pain; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-785945. An 82-year-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection), via intramuscular route on 16Apr2021 (Lot Number: EX0893) as single dose for COVID-19 immunisation. Medical history included ongoing hypertension arterial and on medication for years, multiple allergies (unspecified past allergies resolved by clinical examinations between Jan2021 and Jul2021). The patient concomitant medication was not reported. Patient previously received first dose of bnt162b2 (COMIRNATY; solution for injection), via intramuscular route on 26Mar2021 (Lot Number and expiry date was not reported) as single dose for COVID-19 immunization. On 30Apr2021, the patient experienced pins and needles, exhaustion, vein pain. On 30Apr2021 he experienced haemorrhagic stroke (remained there until 27Jul2021). On unknown date in May2021, patient experienced memory loss transient. On 21Jul2021, patient experienced pain legs. The patient was hospitalized for pain legs from 21Jul2021 to 27Jul2021. The patient died on 27Jul2021. It was unknown whether autopsy was performed. Health Authority comments: 13Sep: Reporter only became aware of the various episodes of adverse events his/her father experienced following the second dose afterwards. The reporter was asked for concomitant drugs habitually taken by the patient, hospital admission records including medical history, therapies undertaken and evolution of the clinical picture from the onset to haemorrhagic stroke and death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pins and needles; Vein pain; Exhaustion; Memory loss transient; Pain legs; Hemorrhagic stroke


VAERS ID: 1747053 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Oxygen saturation, Pneumonitis
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 3
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:
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:93
CDC Split Type: ITPFIZER INC202101250259

Write-up: A guest patient in a nursing home visited on the night of 13Apr2021 presents a likely allergic reaction and cough with an antihistamine prescription. Sat o2 goes down and in ER, pneumonia is found.; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-788365. A 80-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: ET7205, Expiration date: unknown), intramuscular, administered at an unspecified anatomical location on 06Apr2021 (Batch/Lot Number: ET7205) as dose number unknown, 0.3 ml, single for COVID-19 immunization. The patient''s medical history and concomitant medications were unknown. On 13Apr2021 the patient experienced a guest patient in a nursing home visited on the night of 13apr2021 presents a likely allergic reaction and cough with an antihistamine prescription. sat o2 goes down and in er, pneumonia is found. The end date for event pulmonitis was 16Apr2021. Patient is subsequently taken to the ER and hospitalized for pneumonia in patients with negative antigen. And positivity for covid 19 in November. The patient underwent lab tests and procedures which included oxygen saturation which showed 93 result on 13Apr2021. Therapeutic measures were taken as a result of a guest patient in a nursing home visited on the night of 13apr2021 presents a likely allergic reaction and cough with an antihistamine prescription. sat o2 goes down and in er, pneumonia is found. The patient died on 16Apr2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: We are waiting to insert further documentation; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1747056 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-08-24
   Days after vaccination:160
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Hyperpyrexia, Investigation, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatopathy; Kidney dysfunction
Allergies:
Diagnostic Lab Data: Test Name: Impact on quality of life; Result Unstructured Data: Test Result:10/10
CDC Split Type: ITPFIZER INC202101250526

Write-up: drug ineffective; Sick with Covid 19 with symptoms; cough; myalgia; Hyperpyrexia; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-788503. A 89-years-old patient of an unspecified gender received the second dose of BNT162B2 (COMIRNATY) intramuscular, administered in Arm Left/left shoulder on 17Mar2021 (Batch/Lot number was not reported) as dose 2, 0.3 ml single; the first dose intramuscular, administered in Arm Left on 24Feb2021 (Batch/Lot number was not reported) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included Hepatopathy, renal dysfunction. The patient''s concomitant medications were not reported. On 24Aug2021, the patient experienced drug ineffective, sick with COVID-19 with symptoms, Cough, myalgia, hyperpyrexia. Impact on quality of life (10/10). All events were assessed as serious with seriousness criteria of death, hospitalization. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter comments: Hepatopathy, onset of renal dysfunction. The lot number for BNT162B2, was not provided and will be requested during follow up.; Reporter''s Comments: Liver disease, onset of renal dysfunction; Reported Cause(s) of Death: drug ineffective; sick with COVID-19 with symptoms; Cough; myalgia; hyperpyrexia


VAERS ID: 1747221 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3064 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Chest X-ray, Condition aggravated, Death, Dyspnoea, Hypoxia, Oxygen saturation, Pneumonia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-10
   Days after onset: 1
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: CONCOR; ATORVASTATIN; VALTRICOM; DUOPLAVIN; SPIRIX
Current Illness: Adiposis; Heart failure (Patient has shortness of breath on a daily basis due to chronic heart failure and adiposis); Primary hypertension (Stage 2)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 pneumonia; Headache (Patient had a headache episode prior to vaccination; used 1 ibuprofen tablet to resolve headache.); Pneumonia; Shortness of breath
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: chest x-ray; Result Unstructured Data: Test Result:severe, bilateral pneumonia; Test Date: 20210909; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:less than 50 %; Test Name: Oxygen saturation; Test Result: 92 %
CDC Split Type: LVPFIZER INC202101216267

Write-up: Hypoxemia; Severe, bilateral pneumonia; Unknown cause of death; Body temperature increased; Aggravation of shortness of breath due to adiposis and chronic heart failure; Aggravation of shortness of breath due to adiposis and chronic heart failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number LV-SAM-2021096593. A 71-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 08Sep2021 (Batch/Lot Number: FE3064) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included pneumonia from Aug2020 to Aug2020, ongoing cardiac failure chronic (Patient has shortness of breath on a daily basis due to chronic heart failure and adiposis), headache on 08Sep2021 (Patient had a headache episode prior to vaccination. Patient used 1 ibuprofen containing tablet to resolve headache), covid-19 pneumonia in Dec2020, ongoing Primary hypertension Stage 2, ongoing Adiposis. Concomitant medication included clopidogrel, acetylsalicylic acid (DUOPLAVIN) 75 mg/100 mg tablets, 1 tablet once per day, indication not specified; bisoprolol fumarate (CONCOR) tablets, 2.5 mg once per day, for the indication of Heart failure; amlodipine, valsartan, hydrochlorothiazide (VALTRICOM) 10 mg/160 mg/12,5 mg tablets, 1 tablet once per day, for the indication of primary hypertension; spironolactone (SPIRIX) 25 mg tablets, 1 tablet once per day, for the indication of primary hypertension; 40 mg atorvastatin containing tablets, 1 tablet once per day, indication not specified. On 09Sep2021 (24 hours after vaccination) the patient started to experience body temperature increased and aggravation of existing disorder (prior to vaccination the patient experienced shortness of breath due to them being overweight and having chronic heart failure; after vaccination the patient experienced worsening of shortness of breath). The emergency medical services (EMS) were called on two occasions. On 09Sep2021 at 19:00 the EMS measured hypoxemia (SpO2 <50% which was treated with oxygen inhalations after which the patient''s SpO2 was 92%), the patient was hospitalized. On 09Sep2021 the patient had a chest x-ray which showed bilateral pneumonia (severe, bilateral pneumonia). The patient died on 10Sep2021 at 06:55. Autopsy was in progress. Cause of death was not specified. The outcome of hypoxia, body temperature increased, condition aggravated and bilateral pneumonia is reported as unknown. The reporter has been contacted in order to gather follow-up information. No follow up attempts possible. No further information is expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1747223 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Blood bilirubin, Blood chloride, Blood creatinine, Blood sodium, Blood urea, Body temperature, C-reactive protein, COVID-19 pneumonia, Cardiac failure, Chest X-ray, Dyspnoea, Fibrin D dimer, Glomerular filtration rate, Granulocyte count, Haematocrit, Haemoglobin, Hip fracture, Hypoxia, Investigation, Lymphocyte count, Mean platelet volume, Monocyte count, Neutrophil count, Nitrite urine, Platelet count, Procalcitonin, Red blood cell count, Red cell distribution width, Respiratory failure, SARS-CoV-2 antibody test, SARS-CoV-2 test, Tachypnoea, Thrombocytopenia, Vaccination failure, White blood cell count, X-ray
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteoporosis/osteopenia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 51 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Atrial fibrillation (under Dabigatran); Breast cancer; Congestive heart failure; Femur fracture; Gastrooesophageal reflux disease; Hyperthyroidism; Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: bilirubin; Result Unstructured Data: Test Result:26.6 micromol/l; Test Date: 20210827; Test Name: serum chloride; Result Unstructured Data: Test Result:90.4 mmol/L; Test Date: 20210828; Test Name: serum chloride; Result Unstructured Data: Test Result:87.2 mmol/L; Test Date: 20210829; Test Name: serum chloride; Result Unstructured Data: Test Result:87.9 mmol/L; Test Date: 20210907; Test Name: serum chloride; Result Unstructured Data: Test Result:84.6 mmol/L; Test Date: 20210910; Test Name: serum chloride; Result Unstructured Data: Test Result:82.5 mmol/L; Test Date: 20210912; Test Name: serum chloride; Result Unstructured Data: Test Result:94.3 mmol/L; Test Date: 20210827; Test Name: creatinine; Result Unstructured Data: Test Result:63 umol/l; Test Date: 20210828; Test Name: creatinine; Result Unstructured Data: Test Result:102 umol/l; Test Date: 20210829; Test Name: creatinine; Result Unstructured Data: Test Result:97 umol/l; Test Date: 20210907; Test Name: creatinine; Result Unstructured Data: Test Result:43 umol/l; Test Date: 20210910; Test Name: creatinine; Result Unstructured Data: Test Result:67 umol/l; Test Date: 20210912; Test Name: creatinine; Result Unstructured Data: Test Result:88 umol/l; Test Date: 20210910; Test Name: serum sodium; Result Unstructured Data: Test Result:134 mmol/L; Test Date: 20210827; Test Name: serum urea; Result Unstructured Data: Test Result:9.9 mmol/L; Test Date: 20210828; Test Name: serum urea; Result Unstructured Data: Test Result:15.4 mmol/L; Test Date: 20210829; Test Name: serum urea; Result Unstructured Data: Test Result:19.4 mmol/L; Test Date: 20210907; Test Name: serum urea; Result Unstructured Data: Test Result:12.7 mmol/L; Test Date: 20210910; Test Name: serum urea; Result Unstructured Data: Test Result:15.3 mmol/L; Test Date: 20210827; Test Name: body temperature; Result Unstructured Data: Test Result:39; Test Date: 20210706; Test Name: chest X-Ray; Result Unstructured Data: Test Result:possible airspace opacification in left lower zone; Test Date: 20210713; Test Name: chest X-Ray; Result Unstructured Data: Test Result:increased opacification at left lung base with par; Comments: with partial obscuration of left heart border. No pneumothorax or pleural effusions; Test Date: 20210804; Test Name: chest X-Ray; Result Unstructured Data: Test Result:lung congestion, heart enlarged, no pleural effusi; Test Date: 20210829; Test Name: chest X-Ray; Result Unstructured Data: Test Result:Airspace shadowing seen in the projection of the l; Comments: Airspace shadowing seen in the projection of the left lower lung zone and retrocardiac area with obscuration of the left hemidiaphragm in keeping with a consolidation; Test Date: 20210908; Test Name: chest X-Ray; Result Unstructured Data: Test Result:airspace shadowing in the left retrocardiac area w; Comments: airspace shadowing in the left retrocardiac area with an associated small left pleural effusion, round opacities noted in the right upper and middle lung zone as well as the left upper lung zone.; Test Date: 20210911; Test Name: chest X-Ray; Result Unstructured Data: Test Result:left retrocardiac opacification as well as increas; Comments: left retrocardiac opacification as well as increased patchy ill defined opacification in the right lower lung zone; Test Date: 20210827; Test Name: CRP; Result Unstructured Data: Test Result:11 mg/l; Test Date: 20210828; Test Name: CRP; Result Unstructured Data: Test Result:209 mg/l; Test Date: 20210829; Test Name: CRP; Result Unstructured Data: Test Result:251 mg/l; Test Date: 20210907; Test Name: CRP; Result Unstructured Data: Test Result:2 mg/l; Test Date: 20210910; Test Name: CRP; Result Unstructured Data: Test Result:242 mg/l; Test Date: 20210912; Test Name: CRP; Result Unstructured Data: Test Result:120 mg/l; Test Date: 20210828; Test Name: D-Dimer; Result Unstructured Data: Test Result:2924 ng/ml; Test Date: 20210907; Test Name: D-Dimer; Result Unstructured Data: Test Result:1355 ng/ml; Test Date: 20210910; Test Name: D-Dimer; Result Unstructured Data: Test Result:868 ng/ml; Test Date: 20210827; Test Name: GFR; Result Unstructured Data: Test Result:82, 47, 50, 128, 77, 56; Test Date: 20210828; Test Name: GFR; Result Unstructured Data: Test Result:82, 47, 50, 128, 77, 56; Test Date: 20210829; Test Name: GFR; Result Unstructured Data: Test Result:82, 47, 50, 128, 77, 56; Test Date: 20210907; Test Name: GFR; Result Unstructured Data: Test Result:82, 47, 50, 128, 77, 56; Test Date: 20210910; Test Name: GFR; Result Unstructured Data: Test Result:82, 47, 50, 128, 77, 56; Test Date: 20210912; Test Name: GFR; Result Unstructured Data: Test Result:82, 47, 50, 128, 77, 56; Test Date: 20210827; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.18 x10 9/l; Test Date: 20210829; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.62 x10 9/l; Test Date: 20210907; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.54 x10 9/l; Test Date: 20210910; Test Name: immature granulocytes; Result Unstructured Data: Test Result:1.41 x10 9/l; Test Date: 20210912; Test Name: immature granulocytes; Result Unstructured Data: Test Result:1.30 x10 9/l; Test Date: 20210829; Test Name: haematocrit; Test Result: 33.8 %; Test Date: 20210907; Test Name: haematocrit; Test Result: 33.1 %; Test Date: 20210910; Test Name: haematocrit; Test Result: 31.2 %; Test Date: 20210912; Test Name: haematocrit; Test Result: 32.3 %; Test Date: 20210827; Test Name: haemoglobin; Result Unstructured Data: Test Result:12.5 g/dl; Test Date: 20210829; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.9 g/dl; Test Date: 20210907; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.9 g/dl; Test Date: 20210910; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.1 g/dl; Test Date: 20210912; Test Name: haemoglobin; Result Unstructured Data: Test Result:9.3 g/dl; Test Date: 20210827; Test Name: MSU for C/S; Result Unstructured Data: Test Result:Serratia ficaria cultivated; Test Date: 20210827; Test Name: lymphocytes; Result Unstructured Data: Test Result:1.0 x10 9/l; Test Date: 20210829; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.33 x10 9/l; Test Date: 20210907; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.52 x10 9/l; Test Date: 20210910; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.88 x10 9/l; Test Date: 20210912; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.32 x10 9/l; Test Date: 20210910; Test Name: mean platelet volume; Result Unstructured Data: Test Result:13.9 fl; Test Date: 20210912; Test Name: mean platelet volume; Result Unstructured Data: Test Result:13.8; Test Date: 20210907; Test Name: monocytes; Result Unstructured Data: Test Result:4.04 x10 9/l; Test Date: 20210910; Test Name: monocytes; Result Unstructured Data: Test Result:8.85 x10 9/l; Test Date: 20210912; Test Name: monocytes; Result Unstructured Data: Test Result:4.69 x10 9/l; Test Date: 20210827; Test Name: neutrophils; Result Unstructured Data: Test Result:10.77 x10 9/l; Test Date: 20210829; Test Name: neutrophils; Result Unstructured Data: Test Result:27.45 x10 9/l; Test Date: 20210907; Test Name: neutrophils; Result Unstructured Data: Test Result:23.98 x10 9/l; Test Date: 20210910; Test Name: neutrophils; Result Unstructured Data: Test Result:31.33 x10 9/l; Test Date: 20210912; Test Name: neutrophils; Result Unstructured Data: Test Result:13.13 x10 9/l; Test Date: 20210827; Test Name: Nitrites; Result Unstructured Data: Test Result:positive; Comments: pH 9.0; Test Date: 20210827; Test Name: platelets; Result Unstructured Data: Test Result:137 x10 9/l; Test Date: 20210829; Test Name: platelets; Result Unstructured Data: Test Result:84 x10 9/l; Test Date: 20210907; Test Name: platelets; Result Unstructured Data: Test Result:144 x10 9/l; Test Date: 20210910; Test Name: platelets; Result Unstructured Data: Test Result:84 x10 9/l; Test Date: 20210912; Test Name: platelets; Result Unstructured Data: Test Result:61 x10 9/l; Test Date: 20210907; Test Name: Procalcitonin; Result Unstructured Data: Test Result:0.068 ng/ml; Test Date: 20210829; Test Name: red cell count; Result Unstructured Data: Test Result:3.66 x10 12/l; Test Date: 20210907; Test Name: red cell count; Result Unstructured Data: Test Result:3.63 x10 12/l; Test Date: 20210910; Test Name: red cell count; Result Unstructured Data: Test Result:3.39 x10 12/l; Test Date: 20210912; Test Name: red cell count; Result Unstructured Data: Test Result:3.09 x10 12/l; Test Date: 20210827; Test Name: red cell distribution width; Test Result: 15.8 %; Test Date: 20210829; Test Name: red cell distribution width; Test Result: 15.7 %; Test Date: 20210907; Test Name: red cell distribution width; Test Result: 15.4 %; Test Date: 20210910; Test Name: red cell distribution width; Test Result: 15.8 %; Test Date: 20210912; Test Name: red cell distribution width; Test Result: 15.9 %; Test Date: 20210912; Test Name: Covid IgG; Result Unstructured Data: Test Result:more than 1000, positive; Test Date: 20210706; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:negative; Test Date: 20210708; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:negative; Test Date: 20210710; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:negative; Test Date: 20210713; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:negative; Test Date: 20210726; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:negative; Test Date: 20210804; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:negative; Test Date: 20210825; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:negative; Test Date: 20210827; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:positive; Comments: new infection, CT 32; Test Date: 20210907; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:positive; Comments: CT 18; Test Date: 20210827; Test Name: WBC; Result Unstructured Data: Test Result:12.84 x10 9/l; Test Date: 20210829; Test Name: WBC; Result Unstructured Data: Test Result:28.93 x10 9/l; Test Date: 20210907; Test Name: WBC; Result Unstructured Data: Test Result:29.15 x10 9/l; Test Date: 20210910; Test Name: WBC; Result Unstructured Data: Test Result:42.55 x10 9/l; Test Date: 20210912; Test Name: WBC; Result Unstructured Data: Test Result:19.49 x10 9/l; Test Date: 20210706; Test Name: hip right X-Ray; Result Unstructured Data: Test Result:displaced right subcapital fracture; Test Date: 20210706; Test Name: lumbar spine and SI joints X-Ray; Result Unstructured Data: Test Result:grade 1 anterolisthesis of L4 on L5. Multilevel de; Comments: Multilevel degenerative changes throughout lumbar spine. SI joints intact
CDC Split Type: MTPFIZER INC202101259173

Write-up: hip fracture; hypoxemia (SpO2 70% on RA); respiratory failure (Decreased SpO2); heart failure (Known case of CHF but no signs of decompensation); thrombocytopenia (84000 dropped to 61000); Tachypnea (RR more than 30); dyspnea/shortness of breath; Asthma worsened; covid-19 infection; Pneumonia due to Covid-19 Infection (Bilateral basal/ left mid-zone); This is a spontaneous report from a contactable physician. A 87-years-old female patient received BNT162B2 (COMIRNATY Formulation: solution for injection Lot Number: EJ6788) via intramuscular, administered in Arm Left on 05Feb2021 as dose 2, single for COVID-19 immunisation and received first dose BNT162B2 (COMIRNATY Formulation: solution for injection Lot Number: EJ6796) via intramuscular on 15Jan2021 as single for COVID-19 immunisation. Relevant Medical history included cardiac failure congestive, asthma, breast cancer from, atrial fibrillation under Dabigatran, hyperthyroidism from an unknown date and unknown if ongoing, femur fracture from Jul2021 to an unknown date, non-tobacco user, gastrooesophageal reflux disease from an unknown date and unknown if ongoing. Concomitant medications included bumetanide (BUMETANIDE); diltiazem (DILTIAZEM); carbimazole (CARBIMAZOLE); dabigatran (DABIGATRAN); tamoxifen (TAMOXIFEN); bromhexine (BROMHEXINE); lactulose (LACTULOSE); beclometasone (BECLOMETHASONE); salbutamol (SALBUTAMOL) taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced covid-19 infection, pneumonia due to covid-19 infection, She had been admitted to the acute general hospital on the 06Jul2021 due to a hip fracture until the 26Aug2021 During the period of hospitalization she had a total of eight COVID swabs - all negative. On the 26Aug2021 she was transferred to a long term care facility. On Covid diagnosis she was transferred to a COVID ward in the facility. The patient was not admitted to an Intensive Care Unit, dyspnea/shortness of breath, tachypnea, hypoxemia, respiratory failure, heart failure, thrombocytopenia (84000 dropped to 61000), asthma worsened. The patient display clinical signs at rest indicative of severe systemic illness: Fever of 39 on 27Aug2021, Decreased SPO2 on RA, RR more than 30 per minute. The patient required supplemental oxygen: Oxygen 15L/min via NRM. The patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Patient died at the long term care facility due to COVID IgG more than 1000 on 12Sep2021. Primary cause of death was Pneumonia due to Covid-19 Infection. Other contributory causes was CHF, AF on NOACs, Ca Breast, Asthma, GORD, Pathological Fracture Right Neck of Femur July 2021. On 06Jul2021 the patient underwent lab test and procedures included SARS Cov2 RT PCR: negative, Hip right X-Ray: displaced right subcapital fracture, Lumbar spine and SI Joints X-Ray: Grade 1 anterolisthesis of L4 on L5. Multilevel degenerative changes throughout lumbar spine. SI joints intact. Chest X-Ray: possible airspace opacification in left lower zone. On 08Jul2021 she had SARS Cov2 RT PCR: negative. On 10Jul2021 she had SARS Cov2 RT PCR: negative. On 13Jul2021 she had SARS Cov2 RT PCR: negative, Chest X-Ray: increased opacification at left lung base with partial obscuration of left heart border. No pneumothorax or pleural effusions. On 26Jul2021 She had SARS Cov2 RT PCR: negative. On 04Aug2021 she had SARS Cov2 RT PCR: negative, Chest X-Ray: lung congestion, heart enlarged, no pleural effusion. On 25Aug2021 she had SARS Cov2 RT PCR: negative. On 27Aug2021 She had SARS Cov2 RT PCR: positive CT32, blood creatinine: 63 [45-84 umol/l], body temperature: 39 (no units provided), c-reactive protein: 11 [0-5 mg/L], WBC 12.84 [4.30 - 11.40 x10^9/L], neutrophils 10.77 [1.90 - 7.70 x 10^9/l], immature granulocytes 0.18 [0 -0.09x10^9/L], lymphocytes 1 [1.30 -3.60 x 10^9], red cell distribution width 15.8 [11.9-14.6 %], urea serum 9.9 [1.7-8.3 mmol/l], chloride 90.4 [98-107 mmol/l], MSU for C/S: Serratia ficaria cultivated. On 28Aug2021 She had her blood creatinine: 102 [45-84 umol/l], c-reactive protein: 209 [0-5 mg/l], D-Dimer 2924 [0-500 ng/ml], serum urea 15.4 [1.7-8.3 mmol/l], chloride 87.2 [98-107 mmol/l], bilirubin 26.6 [0-21 micromol/l]. On29Aug2021 she had her blood creatinine: 97 [45-84 umol/l], chest x-ray: abnormal, c-reactive protein: 251 [0-5 mg/l], Chest X-Ray: Airspace shadowing seen in the projection of the left lower lung zone and retrocardiac area with obscuration of the left hemidiaphragm in keeping with a consolidation, WBC 28.93 [4.30 - 11.40 x10^9/L], neutrophils 27.45 [1.90 - 7.70 x 10^9/l], immature granulocytes 0.62 [0 -0.09x10^9/L], lymphocytes 0.33 [1.30 -3.60 x 10^9], red cell distribution width 15.7 [11.9-14.6 %], red cell count: 3.66 [3.90-5.40x10^12/L], haemoglobin 10.9 [12-15.5 g/dl], haematocrit 33.8 [35.6-46%], platelets 84 [132-349x10^9/L], serum urea 19.4 [1.7-8.3 mmol/l], chloride 87.9 [98-107 mmol/l]. On 07Sep2021 she had SARS Cov2 RT PCR: positive CT18, blood creatinine: 43 [45-84 umol/l], c-reactive protein: 2 [0-5 mg/l], D-Dimer 1355 [0-500 ng/ml], WBC 29.15 [4.30 - 11.40 x10^9/L], neutrophils 23.98 [1.90 - 7.70 x 10^9/l], immature granulocytes 0.54 [0 -0.09x10^9/L], lymphocytes 0.52 [1.30 -3.60 x 10^9], monocytes 4.04 [0.40 - 1.10x10^9/L], red cell distribution width 15.4 [11.9-14.6 %], red cell count: 3.63 [3.90-5.40x10^12/L], haemoglobin 10.9 [12-15.5 g/dl], haematocrit 33.1 [35.6-46%], platelets 144 [132-349x10^9/L], serum urea 12.7 [1.7-8.3 mmol/l], chloride 84.6 [98-107 mmol/l], procalcitonin 0.068 [0.02-0.046 ng/ml]. On 08Sep2021 she had Chest X-Ray: airspace shadowing in the left retrocardiac area with an associated small left pleural effusion, round opacities noted in the right upper and middle lung zone as well as the left upper lung zone. On 10Sep2021 she had her blood creatinine: 67 [45-84 umol/l], c-reactive protein: 242 [0-5 mg/l], WBC 42.55 [4.30 - 11.40 x10^9/L], neutrophils 31.33 [1.90 - 7.70 x 10^9/l], immature granulocytes 1.41 [0 -0.09x10^9/L], lymphocytes 0.88 [1.30 -3.60 x 10^9], monocytes 8.85 [0.40 - 1.10x10^9/L], red cell distribution width 15.8 [11.9-14.6 %], red cell count: 3.39 [3.90-5.40x10^12/L], haemoglobin 10.1 [12-15.5 g/dl], haematocrit 31.2 [35.6-46%], platelets 84 [132-349x10^9/L], mean platelet volume: 13.9 [9.4-13.4 fl], D-Dimer 868 [0-500 ng/ml], serum urea 15.3 [1.7-8.3 mmol/l], chloride 82.5 [98-107 mmol/l], serum sodium 134 [136-145 mmol/l]. On 11Sep2021 she had chest x-ray: left retrocardiac opacification as well as increased patchy ill defined opacification in the right lower lung zone. On 12Sep2021 she had her blood creatinine: 88 [45-84 umol/l], c-reactive protein: 120 [0-5 mg/l], WBC 19.49 [4.30 - 11.40 x10^9/L], neutrophils 13.13 [1.90 - 7.70 x 10^9/l], immature granulocytes 1.30 [0 -0.09x10^9/L], lymphocytes 0.32 [1.30 -3.60 x 10^9], monocytes 4.69 [0.40 - 1.10x10^9/L], red cell distribution width 15.9 [11.9-14.6 %], red cell count: 3.09 [3.90-5.40x10^12/L], haemoglobin 9.3 [12-15.5 g/dl], haematocrit 32.3 [35.6-46%], platelets 61 [132-349x10^9/L], mean platelet volume: 13.8 [9.4-13.4 fl], serum urea 15.1 [1.7-8.3 mmol/l], chloride 94.3 [98-107 mmol/l].The outcome of event Pneumonia due to Covid-19 Infection (Bilateral basal/ left mid-zone) was fatal. The outcome of events was unknown. Therapeutic interventions included treatment with Dexamethasone 6mg iv dly from 28Aug2021 to 07Sep2021.; Sender''s Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 pneumonia, Hip facture, hypoxia, respiratory failure, cardiac failure, thrombocytopenia and the suspect drug BNT162B2 cannot be excluded. 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: Pneumonia due to Covid-19 Infection; Pneumonia due to Covid-19 Infection


VAERS ID: 1747377 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-14
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Myocardial infarction, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Epilepsy
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID test; Test Result: Negative ; Test Date: 20210914; Test Name: COVID test; Test Result: Positive
CDC Split Type: PHPFIZER INC202101220095

Write-up: myocardial infarction; Covid test positive; Covid test positive; This is a spontaneous report from a contactable physician. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included epilepsy, asthma. The patient''s concomitant medications were not reported. The patient experienced myocardial infarction (death) on an unspecified date, covid test positive (medically significant) on 14Sep2021 with outcome of unknown. It was reported that the patient received the full dose of Pfizer covid-19 vaccine. The patient''s covid-19 test result was negative last 07Sep2021. Unfortunately, on 14Sep2021, the patient died because of myocardial infarction as a final diagnosis. Covid test was also performed and it turned out the patient was Covid -19 positive. The patient died on 14Sep2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Myocardial infarction, COVID-19, Drug ineffective cannot be excluded. 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: myocardial infarction


VAERS ID: 1749217 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-17
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction
SMQs:, Myocardial infarction (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101262327

Write-up: Acute myocardial infarction; This is a spontaneous report from a non-contactable consumer or other non HCP downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100194305. A 59-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05May2021 (Batch/Lot Number: EX3599) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced acute myocardial infarction (death, hospitalization, life threatening) on 17May2021. The patient died on an unspecified date. An autopsy was not performed. Sender comment: The patient was in the PRIVACY Clinic and the PRIVACY Clinic; Autopsy after death was rejected by the relatives. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1749253 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: 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: Lung disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101274122

Write-up: Covid19 infection 3-4 month after two Comirnaty doses in April; Covid19 infection 3-4 month after two Comirnaty doses in April; This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 89051], license party for Comirnaty. A 72-years-old female patient received first and second dose of bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration in Apr2021 as single dose for covid-19 immunisation. Medical history included lung disease from an unknown date. Concomitant medications were not reported. The patient had Covid-19 infection 3-4 month afterwards. Patient died on an unknown date. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded/assessed. 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: COVID-19


VAERS ID: 1749285 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-07-30
   Days after vaccination:100
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6326 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time ratio, Alanine aminotransferase, Aspartate aminotransferase, Auscultation, Basophil count, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, COVID-19 pneumonia, Chest X-ray, Eosinophil count, Fibrin D dimer, Gamma-glutamyltransferase, Glomerular filtration rate, Haematocrit, Haemoglobin, Interleukin level, International normalised ratio, Lymphocyte count, Mean cell haemoglobin, Mean cell volume, Monocyte count, Neutrophil count, Oxygen saturation, Platelet count, Prothrombin level, Prothrombin time, Prothrombin time ratio, Pyrexia, Red blood cell count, Red cell distribution width, SARS-CoV-2 test, Serum ferritin, Vaccination failure, Vaccine associated enhanced disease, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   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: Depression; Dyslipidaemia; Hypertension arterial; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: Activated Partial Thromboplastin Time; Result Unstructured Data: Test Result:31 sec; Test Date: 20210804; Test Name: APTT ratio; Result Unstructured Data: Test Result:1.00; Test Date: 20210804; Test Name: GPT; Result Unstructured Data: Test Result:21 IU/l; Test Date: 20210804; Test Name: GOT; Result Unstructured Data: Test Result:55 IU/l; Test Name: auscultation; Result Unstructured Data: Test Result:with basal crackles; Test Date: 20210804; Test Name: Absolute basophils; Result Unstructured Data: Test Result:0.02 x10 9/l; Test Date: 20210804; Test Name: Basophils; Test Result: 0.30 %; Test Date: 20210804; Test Name: Creatine kinase; Result Unstructured Data: Test Result:56 IU/l; Test Date: 20210804; Test Name: Creatinine; Test Result: 1.00 mg/dl; Test Date: 20210804; Test Name: Derived fibrinogen; Test Result: 919 mg/dl; Test Date: 20210804; Test Name: Glucose; Test Result: 155 mg/dl; Test Date: 20210804; Test Name: LDH; Result Unstructured Data: Test Result:463 IU/l; Test Date: 20210804; Test Name: Potassium; Result Unstructured Data: Test Result:4.70 mmol/L; Test Name: blood pressure; Result Unstructured Data: Test Result:135/85; Test Date: 20210804; Test Name: Sodium; Result Unstructured Data: Test Result:142 mmol/L; Test Date: 20210804; Test Name: Urea; Test Result: 64 mg/dl; Test Name: body temperature; Result Unstructured Data: Test Result:fever; Test Date: 20210731; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:Free costophrenic sinuses, increased density with; Comments: Free costophrenic sinuses, increased density with air bronchogram in lingula.; Test Date: 20210804; Test Name: Absolute eosinophils; Result Unstructured Data: Test Result:0.10 x10 9/l; Test Date: 20210804; Test Name: Eosinophils; Test Result: 1.30 %; Test Date: 20210804; Test Name: D-dimer; Result Unstructured Data: Test Result:1413 ng/ml; Test Date: 20210804; Test Name: GGT; Result Unstructured Data: Test Result:76 IU/l; Test Date: 20210804; Test Name: ESTIMATED GFR; Result Unstructured Data: Test Result:53 mL/min/1.73 m2; Test Date: 20210804; Test Name: Hematocrit; Test Result: 40.40 %; Test Date: 20210804; Test Name: Hemoglobin; Result Unstructured Data: Test Result:12.50 g/dl; Test Date: 20210804; Test Name: Interleukin; Result Unstructured Data: Test Result:472.0 pg/mL; Test Date: 20210804; Test Name: INR; Result Unstructured Data: Test Result:1.12; Test Date: 20210804; Test Name: Absolute lymphocytes; Result Unstructured Data: Test Result:0.50 x10 9/l; Test Date: 20210804; Test Name: Lymphocytes; Test Result: 6.50 %; Test Date: 20210804; Test Name: Mean erythrocyte corpuscular hemoglobin concentration; Result Unstructured Data: Test Result:30.90 g/dl; Test Date: 20210804; Test Name: Red cell mean corpuscular hemoglobin; Test Result: 27.90 pg; Test Date: 20210804; Test Name: Mean corpuscular volume; Result Unstructured Data: Test Result:90.20 fL; Test Date: 20210804; Test Name: Absolute monocytes; Result Unstructured Data: Test Result:0.22 x10 9/l; Test Date: 20210804; Test Name: Monocytes; Result Unstructured Data: Test Result:2.80; Test Date: 20210804; Test Name: Absolute Neutrophils; Result Unstructured Data: Test Result:6.89 x10 9/l; Test Date: 20210804; Test Name: Neutrophil; Test Result: 89.10 %; Test Name: saturation o2; Result Unstructured Data: Test Result:86-90 %; Comments: Mass Air Flow; Test Name: saturation o2; Test Result: 90 %; Comments: with reservoir mask; Test Date: 20210804; Test Name: Platelets; Result Unstructured Data: Test Result:334 x10 9/l; Test Date: 20210804; Test Name: Prothrombin activity; Test Result: 82.0 %; Test Date: 20210804; Test Name: Prothrombin Time; Result Unstructured Data: Test Result:13 sec; Test Date: 20210804; Test Name: COAGULATION Prothrombin time ratio; Result Unstructured Data: Test Result:1.1; Test Date: 20210804; Test Name: Hematies; Result Unstructured Data: Test Result:4.48 x10 12/l; Test Date: 20210804; Test Name: Red cell distribution width; Test Result: 15.30 %; Test Name: covid-19 test; Test Result: Positive ; Test Date: 20210804; Test Name: Ferritin; Result Unstructured Data: Test Result:496.0 ng/ml; Test Date: 20210804; Test Name: Leukocytes; Result Unstructured Data: Test Result:7.73 x10 9/l
CDC Split Type: ESPFIZER INC202101262658

Write-up: Vaccine associated enhanced disease; Vaccination failure; COVID-19 pneumonia; Fever; This is a spontaneous report from a contactable pharmacist downloaded from the WEB, regulatory authority number ES-AEMPS-976565. A 81-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EW2239), via an unspecified route of administration, administered in arm on 31Mar2021 as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot Number: EW6326), via an unspecified route of administration, administered in arm on 21Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hypertension arterial, type 2 diabetes mellitus, dyslipidaemia, depression; all from an unknown date and unknown if ongoing. Concomitant medications were not reported. Narrative stated that the patient with the aforementioned antecedents came for about a week with low-grade fever, marked asthenia and a dry cough, the COVID-19 antigen test was carried out on an unspecified date (reported as today), being positive. No dyspnea, no chest pain, no other symptoms accompanying admission. On follow-up, the patient complained of severe asthenia and dyspnea just talking. She denied pain. Fever persisted. Pulmonary auscalation (PA) with basal crackles. MMIIs without edema. Blood pressure (BP) 135/85. Oxygen saturation (SAT O2) with Mass Air Flow 86-90%. Very bad clinical situation. Sat O2 90 with reservoir mask. The patient underwent lab tests and procedures which included auscultation: with basal crackles, blood pressure measurement: 135/85, body temperature: fever, oxygen saturation: Mass Air Flow 86-90 % and 90 with reservoir mask, sars-cov-2 test: positive on an unspecified date. On 04Aug2021, blood test revealed Hematies: 4.48 x10^12/L (4.20 - 5.00), Hemoglobin: 12.50 g/dL (12.00 - 15.50), Hematocrit: 40.40 % (36.00 - 44.30), Mean corpuscular volume: 90.20 fL (81 - 99), Red cell mean corpuscular hemoglobin: 27.90 pg (26.00 - 33.00), Mean erythrocyte corpuscular hemoglobin concentration: 30.90 g/dL (31.00 - 36.00), Red cell distribution width: 15.30 % (11.00 - 15.50), Leukocytes: 7.73 x10^9/L (4.00 - 11.00), Neutrophils: 89.10 % (50 - 80), Absolute Neutrophils: 6.89 x10^9/L (1.50 - 7.50), Lymphocytes: 6.50 % (15 - 50), Absolute lymphocytes: 0.50 x10^9/L (1.00 - 4.00), Monocytes: 2.80 % (3 - 10), Absolute monocytes: 0.22 x10^9/L (0.15 - 0.90), Eosinophils: 1.30 % (0 - 4), Absolute eosinophils: 0.10 x10^9/L (0.05 - 0.50), Basophils: 0.30 % (0 - 1), Absolute basophils: 0.02 x10^9/L (0.01 - 0.20), Platelets: 334 x10^9/L (130 - 450), Coagulation Prothrombin time ratio: 1.1 (0.8 - 1.2), Prothrombin activity: 82.0 % (75 - 130), Prothrombin Time: 13 sec (9 - 15), INR: 1.12 (0.80 - 1.20), Activated Partial Thromboplastin Time (aPTT): 31 sec (24 - 40), APTT ratio: 1.00 (0.8 - 1.3), Derived fibrinogen: 919 mg/dL (150 - 600), D-dimer: 1413 ng/mL (0 - 500); Clinical chemistry included Glucose: 155 mg/dL (82 - 115), Urea: 64 mg/dL (16 - 48.5), Creatinine: 1.00 mg/dL (0.5 - 0.9), ESTIMATED GFR: (CKD-EPI) 53 mL/min/1.73 m2, Sodium: 142 mmol/L (136 - 146), Potassium: 4.70 mmol/L (3.5 - 5.3), LDH: 463 UI/L (135 - 250), Creatine kinase (CK): 56 IU/L, GOT: 55 UI/L (0 - 32), GPT: 21 UI/L (0 - 33), GGT: 76 UI/L (0 - 40), Ferritin: 496.0 ng/mL, Interleukin 6: 472.0 pg/mL (0 - 7). On 31Jul2021, chest x-ray: Free costophrenic sinuses, increased density with air bronchogram in lingula. The patient died on 05Aug2021. It was not reported if an autopsy was performed. The outcome of the events was fatal and fever was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1750706 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-08-01
   Days after vaccination:178
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Alanine aminotransferase, Anaemia, Aspartate aminotransferase, Auscultation, Blood alkaline phosphatase, Blood creatinine, Blood folate, Blood lactate dehydrogenase, Blood potassium, Blood pressure decreased, Blood pressure measurement, Blood sodium, Blood thyroid stimulating hormone, Blood urea, Body temperature, C-reactive protein, COVID-19, Chronic kidney disease, Coma scale, Culture stool, Dehydration, Diarrhoea, Disorientation, Gamma-glutamyltransferase, Haemoglobin, Haemoglobin decreased, Heart rate, Hypothermia, Investigation, Lipase, Oxygen saturation, Oxygen saturation decreased, Pallor, Pancreatitis acute, SARS-CoV-2 test, Serum ferritin, Tachycardia, Transferrin saturation, Ultrasound kidney, Vaccination failure, Vitamin B12, Vitamin D, Vomiting, White blood cell count, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Haematopoietic erythropenia (broad), Lack of efficacy/effect (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-29
   Days after onset: 28
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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (complicated by behavioral disorders without follow-up consultation); Carotid endarterectomy; Cerebral atrophy; Cholangitis acute; Cholelithiasis; Chronic renal failure (GFR 32ml / min / m2 and single right kidney); Convulsive seizure (attributed to cortico-subcortical atrophy, patient put on levetiracetam); Crural hernia; Dyslipidemia; Femoral neck fracture; Hypertension arterial; Pancreatic disorder; Pancreatobiliary sphincterotomy; Pott''s disease (to be confirmed with destruction of the left kidney); Right cataract
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: GPT; Result Unstructured Data: Test Result:17 IU/l; Test Date: 20210821; Test Name: GOT; Result Unstructured Data: Test Result:63 IU/l; Test Date: 202108; Test Name: Lung auscultation; Result Unstructured Data: Test Result:no sinoatrial block, vesicular murmur + / +; Comments: no sinoatrial block, vesicular murmur + / +; Test Date: 20210821; Test Name: ALP; Result Unstructured Data: Test Result:84 IU/l; Test Date: 20210821; Test Name: serum creatinine; Result Unstructured Data: Test Result:547 umol/l; Test Date: 20210821; Test Name: Vitamin B9; Result Unstructured Data: Test Result:8.0 nmol/L; Test Date: 20210821; Test Name: LDH; Result Unstructured Data: Test Result:459 IU/l; Test Date: 20210821; Test Name: potassium; Result Unstructured Data: Test Result:4.6 mmol/L; Test Date: 202108; Test Name: blood pressure; Result Unstructured Data: Test Result:121/54; Test Date: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:hypotensive; Test Date: 20210821; Test Name: sodium; Result Unstructured Data: Test Result:147 mmol/L; Test Date: 20210821; Test Name: TSH; Result Unstructured Data: Test Result:1.29 MiU/L; Test Date: 20210821; Test Name: urea; Result Unstructured Data: Test Result:48 mmol/L; Test Date: 202108; Test Name: body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Test Date: 20210826; Test Name: body temperature; Result Unstructured Data: Test Result:hypothermic Centigrade; Test Date: 202108; Test Name: glasgow; Result Unstructured Data: Test Result:15; Test Date: 20210821; Test Name: C-reactive protein; Result Unstructured Data: Test Result:128 mg/l; Test Date: 20210823; Test Name: stool culture; Test Result: Negative ; Test Date: 20210821; Test Name: GGT; Result Unstructured Data: Test Result:11 IU/l; Test Date: 202102; Test Name: hemoglobin; Result Unstructured Data: Test Result:11.2 g/dl; Test Date: 20210821; Test Name: hemoglobin; Result Unstructured Data: Test Result:6.1 g/dl; Comments: aregenerative macrocytic anemia; Test Date: 20210823; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.2 g/dl; Test Date: 20210825; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.1 g/dl; Test Date: 20210826; Test Name: hemoglobin; Result Unstructured Data: Test Result:7.4 g/dl; Test Date: 20210827; Test Name: hemoglobin; Result Unstructured Data: Test Result:7.3 g/dl; Test Date: 202108; Test Name: pulse; Result Unstructured Data: Test Result:102; Comments: bpm; Test Date: 202108; Test Name: Rectal touch; Result Unstructured Data: Test Result:no melena no rectal bleeding brown stools on the f; Comments: no melena no rectal bleeding brown stools on the finger cot; Test Date: 20210825; Test Name: lipase; Result Unstructured Data: Test Result:986 IU/l; Test Date: 202108; Test Name: oxygen saturation; Test Result: 100 %; Test Date: 20210821; Test Name: oxygen saturation; Test Result: 70 %; Comments: in EPHAD; Test Date: 20210821; Test Name: oxygen saturation; Test Result: 83 %; Comments: on arrival to ER; Test Date: 20210812; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Presence of the L452R mutation. Absence of E484K and E484Q mutation; Test Date: 20210821; Test Name: ferritin; Result Unstructured Data: Test Result:2546 ug/L; Comments: ferritinemia; Test Date: 20210821; Test Name: transferrin saturation coefficient; Result Unstructured Data: Test Result:0.13; Test Date: 20210821; Test Name: renal ultrasound; Result Unstructured Data: Test Result:does not find an obstructive cause; Comments: Empty bladder containing urinary catheter balloon. Lipomatous atrophy of the right kidney, it measures 8.5 cm long axis. Absence of pyelocalicular dilation. Simple 22 mm cyst of the superior pole. The left kidney is not visualized in the renal compartment in the left hypochondrium.; Test Date: 20210821; Test Name: Vitamin B12; Result Unstructured Data: Test Result:361 pmol/L; Test Date: 20210821; Test Name: Vitamin D; Result Unstructured Data: Test Result:11.4 ug/L; Test Date: 20210821; Test Name: leukocyte count; Result Unstructured Data: Test Result:5.13 x10 9/l; Test Date: 20210821; Test Name: chest X-ray; Result Unstructured Data: Test Result:poor quality; Comments: bilateral interstitial syndrome, bilateral base blunting
CDC Split Type: FRPFIZER INC202101256743

Write-up: PCR CoVid 19 positive; PCR CoVid 19 positive; Acute pancreatitis due to SarsCoV2; Acute on chronic anemia on digestive hemorrhage; Acute anuric on chronic renal failure; T 35.7 C; SatO2 83% at high concentration oxygen mask at 15L; dehydration; diarrhea; BP 121/54; Skin pallor; temporospatial disorientation; Tachycardiac; episodes of vomiting; abdomen remains tender on palpation; a new drop in hemoglobin to 7.4g / dL; This is a spontaneous report from a contactable physician downloaded from the WEB FR-AFSSAPS-CN20212852. A 87-year-old female patient received the second dose and the first dose of BNT162B2 (COMIRNATY), the second dose on 04Feb2021 (Lot Number: Unknown), the first dose on 13Jan2021 (Lot Number: Unknown), both via intramuscular as single dose for COVID-19 immunization. Medical history included severe chronic renal failure (GFR 32ml / min / m2 and single right kidney), alzheimer''s dementia diagnosed in 2015 complicated by behavioral disorders without follow-up consultation, Pott''s disease (to be confirmed with destruction of the left kidney), HTA from 1982, acute lithiasic cholangitis from 2009, pancreatic reaction from 2009, sphincterotomy from 2009, endarterectomy of left internal carotid from 2009, dyslipidemia, generalized tonicoclonic convulsive seizure (attributed to cortico-subcortical atrophy, patient put on levetiracetam) from 2009, cortico-subcortical atrophy, endoscopic retrograde cholangiopancreatography and sphincterotomy extracting the calculus of the lower common bile duct, prophylactic cholecystectomy initially planned not performed from 2009, right cataract from 2008, bilateral crural hernia from 1955 and Intermediate Hip Prosthesis on left femoral neck fracture from 2017. History of COVID-19 was none. PCR test history was none. Allergic history was unknown. Concomitant medication included acetylsalicylate lysine (KARDEGIC), oxazepam (SERESTA), levetiracetam (KEPPRA [LEVETIRACETAM]), metoprolol succinate (SELOZOK LP), macrogol 4000, potassium chloride, sodium bicarbonate and sodium chloride (MOVICOL [MACROGOL 4000;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]). The patient admitted to the emergency room on 21Aug2021 for 70% desaturation under 10L of O2 at the EHPAD. PCR CoVid 19 positive on 12Aug2021 despite vaccination. Lives in nursing home, treatment before admission: -ASA Kardegic 75mg 0-1-0; oxazepam Seresta 10mg 1-1-1; levetiracetam Keppra 500mg 1-0-1; metoprolol Selozok LP 95mg 1/2-0-0; macrogol Movicol 1-0-0. Rtat PCR Screening. Presence of the L452R mutation. Absence of E484K and E484Q mutations. Sequencing in progress. On arrival at the emergency room, questioning impossible, SatO2 83% at high concentration oxygen mask at 15L. The biological assessment reveals acute renal failure over major chronic (serum creatinine 547umol / L, urea 48mmol / L), renal ultrasound does not find an obstructive cause, probable dehydration on diarrhea, no indication for dialysis after consultation with nephrologists in the face of comorbidities. Opinion taken from the resuscitators and in agreement with the patient''s family, absence of invasive resuscitation in view of the age and comorbidities. Exclusive symptomatic management. The patient was transferred to a conventional CoVid 19 unit for further treatment. Admission clinical examination: T 35.7 C, Pulse 102bpm, BP 121/54, SatO2 100% under 10L; Skin pallor, Glasgow 15, temporospatial disorientation; Skin fold ++; Tachycardiac, no mottling; ASDI no defense; Rectal touch: no melena no rectal bleeding brown stools on the finger cot; Lung auscultation: no sinoatrial block, vesicular murmur + / +; Medical summary of the stay: 1. On the respiratory level; Rapid improvement in the respiratory state in the context of probable inhalation pneumonia on vomiting which explained the initial desaturation. The patient had received DEXAMETHASONE from 22Aug2021 to 27Aug2021 and antibiotic therapy with AUGMENTIN from 22Aug2021 to 26Aug2021. The patient was weaned from oxygen on 26Aug with a good clinical and biological evolution. 2. On the renal level. Severe acute renal failure on chronic renal failure. Probable acute tubular necrosis on dehydration on digestive losses. Gradual improvement in renal function and resumption of diuresis after IV rehydration while remaining vigilant on the risk of cardiac decompensation due to too rapid hypertonic rehydration. 3. On the digestive level. Significant initial digestive losses attributed to a digestive form of SarsCoV2 infection. There were also reportedly episodes of vomiting. The abdomen remains tender on palpation. Absence of faecal faeces on rectal examination carried out twice during hospitalization. The stool culture of 23Aug is negative. Faced with an increase in abdominal pain on 25Aug, a new hepatic assessment was taken as well as a lipase which returned to 986U / L without any significant anomaly in the associated hepatic assessment, in particular without an argument for lithiasic migration. This lipase elevation is attributed to acute SarsCoV2 pancreatitis. In the context, simple symptomatic treatment is instituted. On 26Aug, the patient was hypothermic, hypotensive with mottling, in the hypothesis of a bacteremia at digestive point of call, antibiotic therapy with ROCEPHINE and FLAGYL was started. 4. In terms of anemia. Hemoglobin level at 11.2g / dL in Feb2021. On arrival at the emergency room, anemia at 6.1g / dL aregenerative macrocytic. The patient benefited on 22Aug2021 from the transfusion of a red blood cell with a good transfusion yield (8.2g / dL on 23Aug2021 and 8.1g / dL on 25Aug2021). Probably multifactorial origin of this acute on chronic anemia: anemia unmasked by rehydration; iron deficiency; inflammation; chronic renal failure. There are then no signs of externalization, in particular no melena or rectal blood loss. On 26Aug2021, melena found in the protection with signs of poor clinical tolerance (hypotension, mottling) on a new drop in hemoglobin to 7.4g / dL. Taking into account the age and the comorbidities, it seems unreasonable to consider a fibroscopy, the patient is put on IPP 80mg then 8mg / h IV, receives 500cc of NaCl in free flow and a new red blood cell pellet in a vital emergency. Good response in terms of blood pressure and general condition but poor transfusion performance with a control hemoglobin at 7.3g / dL. A new red blood cell bag was transfused without emergency on 27Aug with a collegial decision not to continue transfusions beyond this in the absence of improvement. Chest x-ray from 21Aug: poor quality x-ray, bilateral interstitial syndrome, bilateral base blunting. Renal ultrasound of 21Aug2021: Results: Empty bladder containing urinary catheter balloon. Lipomatous atrophy of the right kidney, it measures 8.5 cm long axis. Absence of pyelocalicular dilation. Simple 22 mm cyst of the superior pole. The left kidney is not visualized in the renal compartment in the left hypochondrium. Conclusion: Lack of argument for a cause obstructing this acute renal failure.Bio from 21Aug: Na + 147mmol / L, K + 4.6mmol / L; Serum creatinine 547umol / L, Urea 48.1mmol / L; ALP 84U / L, GGT 11U / L, GOT 63U / L, GPT 17U / L; LDH 459U / L; CRP 128mg / L, leukocytes 5.13G / L; Ferritinemia 2546ug / L, transferrin saturation coefficient 0.13; TSH 1.29mIU / L; Vitamin B12 361pmol / L, Vitamin B9 8.0nmol / L; Vitamin D 11.4ug / L; Hb 6.1g / dL aregenerative macrocytic; Co-culture of 23Aug: negative; SarsCoV2 lung disease complicated by aspiration pneumonia; Acute pancreatitis due to SarsCoV2; Acute on chronic anemia on digestive hemorrhage; Acute anuric on chronic renal failure. Faced with the lack of clinical improvement and the patient''s discomfort, a collective decision was taken to exclusively palliative care. MORPHINE for analgesia and MIDAZOLAM for anxiolytic are introduced on 27Aug in the evening. The patient died on 29Aug2021. Autopsy was none. The outcome of vaccination failure, Covid-19, acute pancreatitis, chronic anemia and chronic renal failure was fatal. The outcome of other events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: unknown cause of death; Vaccination failure; PCR CoVid 19 positive; Acute pancreatitis; Chronic anemia; Chronic renal failure


VAERS ID: 1750723 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-08-13
   Days after vaccination:129
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Body temperature, C-reactive protein, COVID-19, Drug ineffective, Glomerular filtration rate, Neutrophil count, SARS-CoV-2 test, White blood cell count
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: 2021-08-30
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EU
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic nephropathy; End stage renal failure; Mixed dementia; NIDDM; Obesity; Retinopathy diabetic
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: pulmonary auscultation; Result Unstructured Data: Test Result:unknown results; Test Date: 20210813; Test Name: hyperthermia; Result Unstructured Data: Test Result:38.1 Centigrade; Test Date: 20210820; Test Name: C-reactive protein; Result Unstructured Data: Test Result:97; Test Date: 20210813; Test Name: GFR; Result Unstructured Data: Test Result:12 ml/min; Test Date: 20210820; Test Name: neutrophil count; Result Unstructured Data: Test Result:21 x10 9/l; Test Date: 20210813; Test Name: test SARS-Cov-2 PCR; Test Result: Positive ; Comments: DELTA L452R variant; Test Date: 20210820; Test Name: leukocyte count; Result Unstructured Data: Test Result:22 x10 9/l; Comments: inflammatory hyperleukocytosis syndrome
CDC Split Type: FRPFIZER INC202101256730

Write-up: Drug ineffective; COVID-19 / hyperthermia at 38.1 C and cough; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB FR-AFSSAPS-LM20212489. An 87-year-old female patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular on 06Apr2021 (Lot Number: EW2239) as single dose for COVID-19 immunization. Medical history included obesity, end stage renal failure, mixed dementia, niddm, retinopathy diabetic and diabetic nephropathy. Concomitant medication included furosemide, mirtazapine, repaglinide, atorvastatin, cyamemazine, nicardipine hydrochloride, colecalciferol, bifonazole, candesartan cilexetil, insulin aspart, insulin aspart protamine (crystalline) (NOVOMIX) and methoxy polyethylene glycol-epoetin beta (MIRCERA). Positive PCR test for the DELTA L452R variant. Placed under oxygen therapy in 2L of oxygen. Hospitalized for behavioral disorder on mixed dementia on 29Jul2021 leading to the introduction of olanzapine, improvement of thymia. During hospitalization, on 13Aug2021, the patient was hyperthermia at 38.1 C and cough. But deterioration of respiratory functions up to 15L of 02. Introduction of corticosteroid therapy at 6 mg / day from 13Aug2021, and anticoagulation at a preventive dose with calciparin adapted to renal function (GFR 12 ml / min). Multi-daily monitoring. On 20Aug2021: focus on pulmonary auscultation, inflammatory hyperleukocytosis syndrome at 22 G / L, polynuclear neutrophils 21 G / L and CRP at 97. Antibiotic therapy with AUGMENTIN adapted to renal function. When the daughter was questioned, her mother had expressed the wish not to be resuscitated in case of cardiopulmonary arrest. Progressive worsening with passage to palliative care on 24Aug2021, therapeutic adaptation for palliative purposes. Death on 29Aug2021. In total: serious vaccine failure with the delta variant at 4 months after the end of the full antiCovid-19 vaccine schedule. NB: Accountability made "without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures". On 30Aug2021, the patient experienced death. Autopsy was none. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: infection COVID 19; Drug ineffective


VAERS ID: 1750725 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-09-05
   Days after vaccination:213
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, COVID-19, Cardiac failure, Oxygen saturation, Respiratory distress, SARS-CoV-2 test, Vaccination failure, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-07
   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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EU
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Depressive disorder; Hypercholesterolaemia; Hypertension arterial; Insufficiency renal; Overweight; Pulmonary embolism; Type 2 diabetes mellitus; Venous insufficiency
Allergies:
Diagnostic Lab Data: Test Name: saturation; Test Result: 29 %; Comments: desaturation and cyanosis; Test Date: 20210906; Test Name: saturation; Test Result: 78 %; Comments: respiratory distress; Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: Nasopharyngeal sample, Amplidiag Mobidiag real-time PCR technique, Search for mutation E484K; E484Q; L452R: not carried out because viral load in the sample too low to allow additional investigations
CDC Split Type: FRPFIZER INC202101273881

Write-up: Cardio respiratory decompensation; Covid-19; vomiting; disturbances of consciousness; respiratory distress; Vaccination failure; This is a spontaneous report from a contactable other-healthcare professional downloaded from the WEB, regulatory authority number FR-AFSSAPS-LM20212610. A 90-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EJ6788), via intramuscular route of administration on 04Feb2021 as dose 2, single for covid-19 immunization. The patient received first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EM0477) via intramuscular route of administration on 14Jan2021 as dose 1, single for covid-19 immunization. The patient medical history included venous disease, overweight, hypercholesterolaemia, depression disorder, Insufficiency renal, hypertension arterial, type 2 diabetes mellitus, chronic obstructive pulmonary disease, pulmonary embolism from an unknown date and unknown if ongoing. The patient concomitant medications included bisoprolol fumarate (BISOPROLOL FUMARATE), paracetamol (PARACETAMOL), allopurinol (ALLOPURINOL), ramipril (TRIATEC [RAMIPRIL]), citalopram hydrochloride (CITALOPRAM HYDROCHLORIDE), insulin glargine (LANTUS), fluindione (PREVISCAN [FLUINDIONE]), furosemide (LASILIX [FUROSEMIDE]), macrogol (TRANSIPEG [MACROGOL]), rosuvastatin calcium (CRESTOR), esomeprazole magnesium (INEXIUM [ESOMEPRAZOLE MAGNESIUM]) taken for an unspecified indication, start and stop date were not reported. On unspecified date patient experienced covid-19 and vomiting, on 05Sep2021, the patient experienced vaccination failure, on 06Sep2021 the patient experienced cardiorespiratory decompensation, disturbances of consciousness, respiratory distress. It was reported that cardio respiratory decompensation during the night of Sunday 05Sep2021 to Monday 06Sep2021, prompting emergency hospitalization. The patient was hospitalized for cardiorespiratory decompensation from 06Sep2021 to an unknown date. She is put under oxygen (O2) at 15L then non-invasive ventilation (NIV), furosemide, bicarbonates. The patient underwent lab tests and procedures which included oxygen saturation was 29 % desaturation and cyanosis on unspecified date, oxygen saturation was 78 % respiratory distress on 06Sep2021. Sars-cov-2 test was positive, Nasopharyngeal sample, Amplidiag Mobidiag real-time PCR technique, Search for mutation E484K; E484Q; L452R: not carried out because viral load in the sample too low to allow additional investigations on an unspecified date. Therapeutic measures were taken as a result of cardiorespiratory decompensation, disturbances of consciousness, respiratory distress, vomiting. The patient died on 07Sep2021 and autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; Covid-19; Cardio respiratory decompensation; disturbances of consciousness; respiratory distress; vomiting


VAERS ID: 1750740 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-08-20
   Days after vaccination:200
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, COVID-19 pneumonia, Drug ineffective, Dyspnoea, Hypoxia, Oedema, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-30
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial; Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101256377

Write-up: probable acute pulmonary edema; dyspnea with edema; dyspnea with edema; hypoxia; Drug ineffective; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MP20217586, Safety Report Unique Identifier FR-AFSSAPS-2021129935. A 74-years-old female patient received bnt162b2 (COMIRNATY), the second dose via intramuscular on Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing hypertension arterial, ongoing hypothyroidism, obesity from an unknown date. The patient''s concomitant medications were not reported. The patient experienced covid-19 pneumonia on 20Aug2021, drug ineffective on 20Aug2021, hypoxia on 30Aug2021, dyspnea with edema on an unspecified date, probable acute pulmonary edema on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 20Aug2021. The patient died on 30Aug2021. An autopsy was not performed. The outcome of the events drug ineffective, covid-19 pneumonia and hypoxia was fatal, while other events were unknown. Reporter''s Comments: Record of inefficiency. Person vaccinated against SarsCov2. Vaccination with Comirnaty. Last vaccination carried out in Feb2021. History of disease: Positive PCR test on 20Aug2021. Main clinical signs: dyspnea with edema and probable acute pulmonary edema. Evolution: death on 30Aug2021 by hypoxia. Characterization of the virus: not carried out. Complete file, no further information. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Record of inefficiency. Person vaccinated against SarsCov2. Vaccination with Comirnaty. Last vaccination carried out in Feb2021. History of disease: Positive PCR test on 20Aug2021. Main clinical signs: dyspnea with edema and probable acute pulmonary edema. Evolution: death on 30Aug2021 by hypoxia. Characterization of the virus: not carried out. Complete file, no further information.; Reported Cause(s) of Death: covid pneumonia; Drug ineffective; hypoxia


VAERS ID: 1750768 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Cardio-respiratory arrest, Computerised tomogram, Computerised tomogram head, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Electroencephalogram, Full blood count, HIV antibody, Hepatitis C virus test, Magnetic resonance imaging, Platelet count, Pleural effusion, SARS-CoV-2 antibody test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 pneumonitis; Gallbladder polyp (end of 2020); Heart malformation; Hepatic cyst (end of 2020); Infectious mononucleosis; Miscarriage; Myocarditis (post Covid treated by Flecaine); Pregnancy ectopic
Allergies:
Diagnostic Lab Data: Test Name: angiography; Result Unstructured Data: Test Result:healthy, network without notable infiltration; Comments: healthy, network without notable infiltration; Test Date: 20210519; Test Name: Chest CT scan; Result Unstructured Data: Test Result:No acute proximal pulmonary embolism. Multiple pat; Comments: No acute proximal pulmonary embolism. Multiple patches of diffused frosted glass within the posterior segments of the upper and lower lobes associated with a bi-basal pneumonia with right pleural effusion.; Test Name: Brain scanner; Result Unstructured Data: Test Result:no intracranial bleeding; Test Name: transthoracic echocardiogram (TTE); Result Unstructured Data: Test Result:last normal; Test Name: ECG; Result Unstructured Data: Test Result:no repolarization abnormalities; Comments: no repolarization abnormalities; Test Name: holter ECG; Result Unstructured Data: Test Result:rare has premature ventricular contraction (PVC); Comments: rare has premature ventricular contraction (PVC); Test Name: Electroencephalography; Result Unstructured Data: Test Result:Table of generalized status epilepticus; Comments: Table of generalized status epilepticus; Test Name: complete blood count (CBC); Result Unstructured Data: Test Result:ok; Test Name: Hepatitis C virus; Test Result: Negative ; Test Name: HIV serology; Test Result: Negative ; Test Date: 20210527; Test Name: Cerebral magnetic resonance imaging (MRI); Result Unstructured Data: Test Result:Diffuse cytotoxic edema of the supra-tentorial bil; Comments: Diffuse cytotoxic edema of the supra-tentorial bilateral and symmetrical white matter in favor of post-anoxic encephalopathy lesions. Possible stigmata of status epilepticus associated with cortical involvement.; Test Name: Functional magnetic resonance imaging (MRI); Result Unstructured Data: Test Result:Very extensive severe SB involvement.; Comments: Very extensive severe SB involvement.; Test Date: 202007; Test Name: myocardial MRI; Result Unstructured Data: Test Result:Viral myocarditis diagnosed on myocardial MRI comp; Comments: Viral myocarditis diagnosed on myocardial MRI complicated by ESV and ESA; Test Name: Platelet; Result Unstructured Data: Test Result:ok; Test Name: COVID-19 serology; Test Result: Negative
CDC Split Type: FRPFIZER INC202101256694

Write-up: Cardio-respiratory arrest; right pleural effusion; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PA20211215. A 42-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via intramuscular on 17May2021 (Lot Number: Unknown) as 0.3 ml dose for COVID-19 immunization. Medical history included not ongoing myocarditis (post Covid treated by Flecaine) from 01Mar2020, not ongoing non-severe COVID pneumonia from Mar2020, not ongoing infectious mononucleosis from 01Jan2018, discovery of a mitral valve malformation with AV Block: 2nd degree, Mobitz II, known mitral leak in 2007, Viral myocarditis diagnosed on myocardial MRI complicated by ESV and ESA, treated with Flecaine with cardiological monitoring (last normal transthoracic echocardiogram (TTE), holter ECG: rare has premature ventricular contraction (PVC) in Jul2020, 2 children 4 miscarriages (9 months of corticosteroids) and liver cysts and gallbladder polyps (end of 2020). The patient had no known allergy. No cardiac history in siblings of 4. On 05May2021, flecaine stop. Concomitant medication included flecainide acetate (FLECAINE) from an unknown date to 05May2021. The patient previously received aspirin and experienced poorly irrigated placenta. On 19May2021 at 00:35, the patient experienced Cardio-respiratory arrest. On 19May2021 at 00:35, the patient experienced cardiopulmonary arrest, no prodrome, no abnormal motion, eye revulsion, put on cardiac massage immediately. No flow of 1-2min; cardiac massage relayed by BSPP, delivery of an external electric shock without resumption of activity. On arrival of the hospital, Ventricular fibrillation tracing, resumption of cardiac activity after 2 Defibrillation and 300 mg of amiodarone, low flow 30 min. Resuscitation care included: Electroencephalography (EEG): no repolarization abnormalities, Coronary angiography: healthy, network without notable infiltration. EEG: Table of generalized status epilepticus. Brain scanner: no intracranial bleeding. Chest CT scan 19May2021: No acute proximal pulmonary embolism. Multiple patches of diffused frosted glass within the posterior segments of the upper and lower lobes associated with a bi-basal pneumonia with right pleural effusion. Cerebral magnetic resonance imaging (MRI) 27May21: Diffuse cytotoxic edema of the supra-tentorial bilateral and symmetrical white matter in favor of post-anoxic encephalopathy lesions. Possible stigmata of status epilepticus associated with cortical involvement. Functional magnetic resonance imaging (MRI): Very extensive severe SB involvement. No overdose in Flecaine. COVID-19 serology was negative. HIV serology and Hepatitis C virus neg, serology compatible with vaccination for Hepatitis B virus. Complete blood count (CBC) Platelets ok. Evolution: Faced with an extremely unfavorable neurological prognosis, a state of convulsive evil refractory after Cardiac arrest to all optimal and maximalist therapies, a very severe anoxoischemic encephalopathy, it is decided to limit active therapies and a secondary discontinuation of therapies. The patient died on 04Jun2021. Note that a request for support by genetic counseling for investigation and monitoring of the family in this context of rhythm disturbance of unknown etiology in the patient. (14-year-old son who presented cardiological symptoms in July 2020 for which myocarditis was suspected). In total, 42-year-old woman, with ATCD ballooning of the mitral valve in 2016 associated with an Atrioventricular block (AV block) 2, and myocarditis in July 2020 suspected post covid revealed by arrhythmias and treated with Flecaine, which presents a Cardiac arrest recovered from shockable arrhythmia with a normal etiological assessment (normal coronography, angio CT and normal thorax) whose neurological evolution is unfavorable. The patient died on 04Jun2021. Autopsy was unknown. The outcome of cardio-respiratory arrest was fatal. The outcome of other event was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardio-respiratory arrest on VT (Ventricular tachycardia) with very severe anoxo-ischemic encephalopathy of unfavorable outcome after limitation and discontinuation of active therapies.


VAERS ID: 1750857 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-16
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 1 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Fatigue, Shock haemorrhagic
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), Hypovolaemic shock conditions (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bowel obstruction; Diabetes mellitus; Left hemicolectomy; Limb injury
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101256672

Write-up: huge fatigue; Shock haemorrhagic; Cardio-respiratory arrest; This is a spontaneous report from a contactable consumer (patient''s daughter) downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-ST20213180. A 78-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 19May2021 (Batch/Lot Number: FA4598) as DOSE 1, 0.3ML SINGLE for covid-19 immunisation; dabigatran etexilate mesilate (PRADAXA), oral from an unspecified date (Batch/Lot Number: Unknown) to 16Jun2021, at 110 mg, once daily for an unspecified indication; febuxostat (ADENURIC); silodosin (SILODYX); betaxolol hydrochloride (KERLONE); amiloride hydrochloride, furosemide (LOGIRENE); tiotropium bromide monohydrate (SPIRIVA); formoterol fumarate (FORMOAIR); beclometasone dipropionate (BECLOJET), all via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication; gliclazide (DIAMICRON), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for diabetes mellitus. Medical history included diabetes mellitus, Bowel obstruction, Left hemicolectomy, wound in the leg all from an unknown date. The patient''s concomitant medications were not reported. The patient experienced shock hemorrhagic and cardio-respiratory arrest on 16Jun2021, huge fatigue on an unspecified date. Per death certificate, the patient died on 16Jun2021 due to hemorrhage from a wound in the leg. Patient on anticoagulant aggravating this hemorrhage which caused shock and cardio-respiratory arrest. His death was linked to his anticoagulant treatment in connection with his illnesses. The attending physician was contacted on 30Aug2021 but was not aware of the patient''s death. The action taken in response to the events for all suspect drugs was not applicable. The patient died on 16Jun2021. An autopsy was not performed. The outcome of events Shock hemorrhagic and Cardio-respiratory arrest was fatal, of the event fatigue was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Shock hemorrhagic; Cardio-respiratory arrest


VAERS ID: 1750871 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Foetal growth restriction, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
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: FRPFIZER INC202101264073

Write-up: intratuerine death; maternal exposure during pregnancy, 2nd trimester; Foetal growth retardation; This is a spontaneous report from a contactable consumer (parent) reporting different events for mother/fetus. This is second of two reports, for the fetus. The first report was downloaded from Regulatory Authority-WEB, The regulatory authority report number FR-AFSSAPS-PA20211492. An unspecified age and gender patient (fetus) received the second dose (initial Pfizer dose) of BNT162B2 (COMIRNATY) via transplacental on 28May2021 (Batch/Lot Number: EX6537) as 0.3 ml dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced intratuerine death. In 2021, the patient experienced foetal growth retardation. On 28May2021, the patient experienced maternal exposure during pregnancy, 2nd trimester. From a fetal point of view, severe intrauterine growth retardation (below the 3rd percentile) diagnosed at 19 weeks of amenorrhea. Therapeutic measures were taken for intratuerine death. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of foetal growth retardation was not recovered. The outcome of death fetal was fatal. The outcome of Maternal exposure during pregnancy, second trimester was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101256690 mother/child, same drug; Reported Cause(s) of Death: intratuerine death


VAERS ID: 1750872 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal hypokinesia, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-22
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101287162

Write-up: Decrease in active fetal movements at 28 weeks of pregnancy plus 1 day/. At 11:00 pm: No heart sounds on ultrasound, finding fetal death in utero; received Comirnaty at at 26 weeks of pregnancy.; This is a spontaneous report from a contactable pharmacist. This is the second of two reports. The first report is a report downloaded from the Regulatory Authority-WEB [FR-AFSSAPS-LY202110428]. This pharmacist reported events for both the mother and the baby. This is the baby (fetus) case. A fetus patient of unspecified gender received BNT162B2 (COMIRNATY solution for injection; lot number: FE8244), via transplacental route of administration. The patient''s mother is a 28-year-old female mother who received the dose of BNT162B2 (COMIRNATY solution for injection; lot number: FE8244), via intramuscular on 07Aug2021 (at the age of 28-years-old) at dose number unknown, single in the left arm for COVID-19 immunisation at 26 weeks of pregnancy. The patient''s medical history and concomitant medications were not reported. The mother''s medical history included no smoking and Factor V Leiden mutation (heterozygous). The mother has no concomitant medications. Estimated last menstrual period of the patient''s mother was on 15Feb2021. The pregnancy progressed without any complications. On 22Aug2021 at 17:00, there was a decrease in active fetal movements at 28 weeks of pregnancy plus 1 day. At 23:00, no heart sounds on ultrasound, finding fetal death in utero. The fetus did not show any edema or major malformation, placenta devoid of any unusual areas. Normal amount of anechoic amniotic fluid. The patient died on 22Aug2021 at 23:00. The patient was delivered prematurely on 25Aug2021 by vaginal route. It was unknown if autopsy was done. Outcome of the event fetal movements decreased was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101215949 maternal case;FR-AFSSAPS-LY202110428 AFSSAPS; Reported Cause(s) of Death: Decrease in active fetal movements at 28 weeks of pregnancy plus 1 day/. At 11:00 pm: No heart sounds on ultrasound, finding fetal death in utero


VAERS ID: 1751525 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-08-15
   Days after vaccination:66
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Investigation
SMQs:, 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: 2021-08-24
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: investigations; Result Unstructured Data: Test Result:Unknown results; Comments: Countless investigations after brain hemorrhage
CDC Split Type: NLPFIZER INC202101256680

Write-up: Cerebral infarction; Cerebral infarction; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB NL-LRB-00686668. A 67-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 10Jun2021 (Batch/Lot Number: Unknown) as dose 2, single, dose 1 via an unspecified route of administration on 07May2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced cerebral infarction (death, caused or prolonged hospitalization) on 15Aug2021, cerebral infarction on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included investigation: unknown results (Countless investigations after brain hemorrhage). The patient died on 24Aug2021. It was not reported if an autopsy was performed. Treatment included cerebral infarction is treated with hospitalization and IC. The outcome of cerebral infarction is fatal. Drugs and latency: 1. covid-19 vaccin pfizer solution for injection, cerebral infarction: 2 months after start. Case Summary and Reporter''s Comments Text: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Cerebral hemorrhage Date: 07May2021. cerebral hemorrhages (2x). Hospitalization information: Cerebral hemorrhage and complications. Additional information ADR: Twice brain hemorrhage. COVID-19. Previous COVID-19 infection: No. Other diagnostic procedures: Countless investigations after brain hemorrhage. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cerebral hemorrhage


VAERS ID: 1751547 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-08-01
   Days after vaccination:158
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Decreased appetite, General physical health deterioration, Hypogeusia, Hyposmia, Oxygen saturation decreased, Palliative care, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), 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: 2021-09-13
   Days after onset: 43
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living in care
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: NOPFIZER INC202101273964

Write-up: palliative care; Oxygen saturation decreased; Fever; Hypogeusia; Cough; hyposmia; COVID-19; Vaccination failure; decreased appetite; reduced general condition; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uz8y39. A 86-years-old female patient received second dose of bnt162b2 (COMIRNATY,Solution for injection, Lot number: EP9598, Expiration date: unknown), via intramuscular on 24Feb2021 and first dose intramuscular on 03Feb2021, single for covid-19 immunisation. Medical history included living in residential institution. The patient''s concomitant medications were not reported. The patient was isolated after COVID-19 was established. Initially the patient was asymptomatic/in habitual state for several days, before she gradually became more tired and with reduced general condition and decreased appetite on Aug2021. The patient became in need of oxygen therapy from 01Sep2021 and also received dexamethasone and penicillin intravenous due to suspicion of bacterial superinfection. The patient was already treated with Fragmin due to immobilisation. She became in need of oxygen therapy by mask (7 L9 to sustain SpO2 $g92 %, fever and cough without clinical suspicion of fluid in lungs/pleura(ascites increase) from sep2021. The patient complained of hypogeusia and hyposmia on sep2021. The patients condition further deteriorated and from 06Sep2021 it was decided to start palliative care. The patient died on 13Sep2021. The Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1751650 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-25
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Administration site pain, Blood test, Brain oedema, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Cerebrovascular accident, Computerised tomogram head, Fatigue, Fibrin D dimer, Heparin-induced thrombocytopenia test, Nausea, Paresis, Platelet count, Thrombocytopenia, Thrombosis, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (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), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-29
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hematuria (Unexplained); Thrombocytopenia (Unexplained); Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: Thrombocyte count; Result Unstructured Data: 70 10*9/L; Test Date: 202109; Test Name: Blood test NOS; Result Unstructured Data: thrombosytopenia; Test Date: 202109; Test Name: Fibrin D dimer; Result Unstructured Data: Increased; Test Date: 202109; Test Name: Head CT; Result Unstructured Data: cerebral sinus thrombosis, bleeding iright hemisphere, cerebral oedema; Test Date: 202109; Test Name: Heparin-induced platelet antibody; Result Unstructured Data: Positive
CDC Split Type: SIJNJFOC20210959243

Write-up: CEREBRAL VENOUS SINUS THROMBOSIS; THROMBOCYTOPENIA; CEREBRAL HEMORRHAGE; STROKE; CEREBRAL EDEMA; BLOOD CLOT; OTHER PARESIS/PARALYSIS; NAUSEA; VOMITING; ADMINISTRATION SITE PAIN; TIREDNESS; This spontaneous report was received from a social media post via a company representative, various news articles and regulatory authority and concerned a 20 year-old female patient. The patient''s weight and height were not reported. The patient''s t medical history included unexplained hematuria and thrombocytopenia starting 23-JUN-2021; it was unknown if these conditions were continuing at present. Previous laboratory results were: 23-JUN-2021 thrombocyte count 70 10*9/L (NR not provided). The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number XE393) 1 dose for prophylactic vaccination on 16-SEP-2021. No concomitant medications were reported. On 25-SEP-2021, 9 days after receiving the vaccine, the patient experienced administration site pain, tiredness and headache. On 26-SEP-2021 she experienced nausea and vomiting. On 27-SEP-2021, the patient became ill with headache, impaired consciousness, blood clot, suffered a stroke and was hospitalized. The patient received a head CT which showed cerebral venous sinus thrombosis, bleeding into the right hemisphere, and cerebral edema. Heparin-induced platelet antibody (anti-PF4) - positive; Fibrin D dimer - increased; blood test (NOS) - thrombocytopenia; HIT. The patient was also experiencing encephalitis, encephalopathy. After extensive consultation with hematologists, internists - specialists in vascular diseases; it was determined to be a VITT syndrome (vaccine induced thrombocytopenic thrombosis) "ot" TTS (thrombosis with thrombocytopenia syndrome). The patient had not taken any medications to accelerate her condition. On 29-SEP-2021, the head of the emergency neurology department reported that the patient had died that morning, adding that it was not yet possible to say exactly whether the it was related with the vaccination of the patient. Although brain death had not been officially confirmed yet, there were positive clinical tests indicating brain death. The physician stated the demonstration of a direct link with the vaccine was a matter of further procedures which have not been carried out; there was a reasonable suspicion that there was a causal link between the vaccination and complication. The outcome of the events as follows: administration site pain was recovered; tiredness, headache, nausea, vomiting were unknown. Outcome of thrombocytopenia, other paresis/paralysis, cerebral hemorrhage, CVST, cerebral edema and stroke were fatal. It was unknown if an autopsy was performed. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. This report was serious (Death, Hospitalization, Medically Important). This case was linked, via the same reporter and social media post, to case 20210550911.; Sender''s Comments: V0: This spontaneous report was received from a social media post, various news articles and regulatory authority and concerned a 20-year-old female patient who experienced cerebral venous sinus thrombosis (CVST) with cerebral hemorrhage, cerebral edema, and thrombocytopenia 11 days after vacine. Medical history included unexplained hematuria and thrombocytopenia (platelet count of 70,000 at that time) starting approximately 3 months prior to vaccination; it was unknown if these conditions were ongoing at the time of the event. No concomitant medications were reported. On day 9, the patient experienced administration site pain, tiredness and headache. On day 10, she experienced nausea and vomiting. On day 11, the patient became ill with headache, impaired consciousness, blood clot, suffered a stroke and was hospitalized. The patient received a head CT which showed CVST, bleeding into the right hemisphere, and cerebral edema. Heparin-induced platelet antibody (anti-PF4) was positive; D dimer was increased; thrombocytopenia was present without a reported value. The patient was also experiencing encephalitis, encephalopathy. After extensive consultation with hematologists, internists - specialists in vascular diseases; it was determined to be a VITT syndrome (vaccine induced thrombocytopenic thrombosis) or TTS (thrombosis with thrombocytopenia syndrome). The patient had not taken any medications to accelerate her condition. Although brain death had not been officially confirmed yet, there were positive clinical tests indicating brain death. Although the pre-existing history of thrombocytopenia approximately 3 months prior to vaccine may have contributed, based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration - BC) and considering the low platelet count and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.; Reported Cause(s) of Death: THROMBOCYTOPENIA; PARESIS; CEREBRAL HEMORRHAGE; CEREBRAL VENOUS SINUS THROMBOSIS; CEREBRAL EDEMA; STROKE


VAERS ID: 1752878 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-07-02
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003188 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Fatigue, Headache, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactose intolerant
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20213

Write-up: Decreased appetite; Pain in extremity; Headache; Pyrexia; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Decreased appetite), PAIN IN EXTREMITY (Pain in extremity), HEADACHE (Headache), PYREXIA (Pyrexia) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3003188) for COVID-19 vaccination. The patient''s past medical history included Lactose intolerant. Concomitant products included ALLOPURINOL for an unknown indication. On 02-Jun-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 02-Jul-2021, the patient experienced DECREASED APPETITE (Decreased appetite) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in extremity) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Pyrexia) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 03-Jul-2021, DECREASED APPETITE (Decreased appetite), PAIN IN EXTREMITY (Pain in extremity), HEADACHE (Headache), PYREXIA (Pyrexia) and FATIGUE (Fatigue) had resolved. The patient died on 28-Mar-1963. The cause of death was not reported. It is unknown if an autopsy was performed. No treatment medication details was reported. Company comment: This case concerns a male patient, unknown age, with no relevant medical history, who experienced the unexpected events of headache, pain in extremity, pyrexia, fatigue and decreased appetite. The events occurred approximately 1 day after the second dose of Moderna vaccine. The rechallenge is not applicable as a third dose is not expected. The reporter assessed the events as likely related to the product. The events headache, pyrexia and fatigue are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. Regulatory report has Date of Death as 28 March 1963, which is probably an error and may have been date of birth, however, as it is a RA report, it was captured as such.; Reporter''s Comments: The case is non-serious and unlabelled. Due to temporal relationship and the known safety profile of the vaccine, the causality is assessed as probable.; Sender''s Comments: This case concerns a male patient, unknown age, with no relevant medical history, who experienced the unexpected events of headache, pain in extremity, pyrexia, fatigue and decreased appetite. The events occurred approximately 1 day after the second dose of Moderna vaccine. The rechallenge is not applicable as a third dose is not expected. The reporter assessed the events as likely related to the product. The events headache, pyrexia and fatigue are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. Regulatory report has Date of Death as 28 March 1963, which is probably an error and may have been date of birth, however, as it is a RA report, it was captured as such.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1752966 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210959893

Write-up: BODY WEAKNESS; LOSS OF APPETITE; FEVER; DIFFICULTY OF BREATHING; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300107475] concerned a 73 year old female of an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 209L21A expiry: unknown) dose was not reported, 1 total administered on 03-AUG-2021 for an unknown indication. No concomitant medications were reported. On 04-AUG-2021, the patient experienced difficulty of breathing. On an unspecified date, the patient experienced body weakness, loss of appetite, and fever. On an unspecified date, the patient died from difficulty of breathing, body weakness, fever, and loss of appetite. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the events difficulty of breathing, body weakness, loss of appetite, and fever was fatal. This report was serious (Death).; Sender''s Comments: V0: 20210959893-COVID-19 VACCINE AD26.COV2.S-difficulty of breathing, body weakness, loss of appetite, fever. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: DIFFICULTY OF BREATHING; BODY WEAKNESS; FEVER; LOSS OF APPETITE


VAERS ID: 1753062 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-03-16
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

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: 2021-03-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210316; Test Name: SARS-COV-2; Result Unstructured Data: Test Result:SARS-COV-2 infection; Comments: SARS-COV-2 infection. Variant PCR-based: n.a. Sequenced variant: n.a. n501y-positive: No.
CDC Split Type: ATPFIZER INC202101262627

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory authority report number is AT-BASGAGES-2021-044516. A 91-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Lot Number: EJ6134) intramuscular on 04Feb2021 (unknown age at time of vaccination) as single dose, the first dose of bnt162b2 (COMIRNATY, Lot Number: EJ6796) intramuscular on 14Jan2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure and SARS-COV-2 infection on 16Mar2021. Verbatim: Variant PCR-based: n.a. Sequenced variant: n.a. n501y-positive: No. On 16Mar2021 the patient experienced SARS-CoV-2 infection death, vaccination failure. The outcome of the events was fatal. The patient died on 16Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1753063 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-07
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Laboratory 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: 2021-03-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: n501y; Result Unstructured Data: Test Result:positive was no
CDC Split Type: ATPFIZER INC202101262607

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-044517. A 92-year-old female patient received BNT162B2 (COMIRNATY) dose 2 (lot number: Ej6136) Intramuscular on 01Feb2021 at single dose, dose 1 (lot number: Ej6796) Intramuscular on 11Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 07Mar2021 the patient experienced SARS-CoV-2 infection, Vaccination failure. Patient died on 07Mar2021. Unknown if autopsy was done. positive (2021) was No. Regulatory authority comment from 21Sep2021: no further info available (medical history, symptoms,...) No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1753067 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-03-31
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

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: 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: n.a. Sequenced variant: B.1.1.7 n501y-positive: yes
CDC Split Type: ATPFIZER INC202101262618

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority AT-BASGAGES-2021-044524 A 66-years-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on 11Feb2021 (Batch/Lot Number: EJ6136) as single dose, dose 1 intramuscular on 19Jan2021 (Batch/Lot Number: EL1491) as single dose for covid-19 immunisation. The patient medical history was none. Concomitant medications were not reported. The patient experienced sars-cov-2 infection (covid-19) on 31Mar2021, vaccination failure on 31Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Variant PCR-based: n.a. Sequenced variant: B.1.1.7 n501y-positive: yes). The patient died on 31Mar2021 due to the events. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1753069 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

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: 2021-04-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: covid; Test Result: Positive ; Comments: Variant PCR-based: n.a. Sequenced variant: B.1.1.7 n501y-positive: yes
CDC Split Type: ATPFIZER INC202101262614

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number AT-BASGAGES-2021-044526. An 82-year-old female patient received the first dose of bnt162b2 (COMIRNATY) on 14Jan2021 (lot number: EJ6796) Intramuscularly at single dose; the second dose of bnt162b2 (COMIRNATY) on 05Feb2021 (lot number: EJ6134) Intramuscularly at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On unknown date the patient experienced SARS-CoV-2 infection, Vaccination failure. Lab data included covid on unknown date: Variant PCR-based: n.a.; Sequenced variant: B.1.1.7; n501y-positive: yes. The outcome of the events was fatal. Patient died on 08Apr2021. It was unknown reported if patient had an Autopsy. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1753071 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-04-13
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 2 - / OT

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: 2021-04-13
   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: Test Name: covid-19 test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ATPFIZER INC202101262622

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority AT-BASGAGES-2021-044528. A 96-year-old female patient received BNT162B2(COMIRNATY), dose 2 intramuscular on 20Jan2021 (Lot Number: EL1491) at single dose, dose 1 intramuscular on 30Dec2020 (Lot Number: EJ6796) at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 13Apr2021 the patient experienced SARS-CoV-2 infection death, Vaccination failure. The patient underwent lab tests included covid-19 test: Unknown results. The outcome of events was fatal. The patient died on 13Apr2021. It was not reported if an autopsy was performed. This report was reported as serious. BASGAGES comment from 21Sep2021: no further info available (medical history, symptoms,...) 1st vaccine batch/lot: EJ6796 2nd vaccine batch/lot: EL1491 No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1753095 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-08-15
   Days after vaccination:163
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

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: 2021-08-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: sars-cov-2 test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n.a. n501y-positive: No.
CDC Split Type: ATPFIZER INC202101262669

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority AT-BASGAGES-2021-045416. A 70-year-old male patient received the second dose and the first dose of BNT162B2 (COMIRNATY), the second dose on 05Mar2021 (Lot Number: EP2166), the first dose on 12Feb2021 (Lot Number: EJ6790), both via intramuscular as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 15Aug2021 the patient experienced SARS-CoV-2 infection death, vaccination failure. Variant PCR-based: B.1.617.2. Sequenced variant: n.a. n501y-positive: No. The patient died on 15Aug2021. Autopsy was unknown. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination failure; covid-19


VAERS ID: 1753108 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-08-18
   Days after vaccination:130
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

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: 2021-08-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: covid; Result Unstructured Data: Test Result:positive; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n.a. n501y-positive: No.
CDC Split Type: ATPFIZER INC202101262600

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory authority number AT-BASGAGES-2021-045932. A 78-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 10Apr2021 (Batch/Lot Number: EW2246) as dose 2, single; dose 1 intramuscular on 20Mar2021 (Batch/Lot Number: ET1831) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Aug2021, the patient experienced SARS-CoV-2 infection, death, vaccination failure. The patient''s outcome was fatal. The patient underwent lab tests and procedures which included covid: positive on an unknown date (Variant PCR-based: B.1.617.2. Sequenced variant: N.A. n501y-positive: No.). The patient died on 18Aug2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1753109 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-08-19
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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: 2021-08-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101262631

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-045951. A 71-year-old male patient received bnt162b2 (COMIRNATY), first single dose intramuscular on 10Mar2021 (Batch/Lot Number: ET1831), and second single dose intramuscular on 31Mar2021 (Batch/Lot Number: ET3620) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 19Aug2021 the patient experienced SARS-CoV-2 infection and vaccination failure. Variant PCR-based was not applicable. Variant Sequenced was not applicable. positive was Unknown. The patient died on 19Aug2021 for the SARS-CoV-2 infection. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1753121 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-08-20
   Days after vaccination:143
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

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: 2021-08-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2; Sequenced variant: n.a.; n501y-positive: No.
CDC Split Type: ATPFIZER INC202101262660

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable physician downloaded from the regulatory authority AT-BASGAGES-2021-046177. An 89-year-old male patient received 1st dose of BNT162B2 (COMIRNATY, Lot Number: ET1831) via intramuscular on 09Mar2021, 2nd dose of BNT162B2 (COMIRNATY, Lot Number: ET7205) via intramuscular on 30Mar2021, both as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 20Aug2021, the patient experienced SARS-CoV-2 infection with positive SARS-CoV-2 test (Variant PCR-based: B.1.617.2; Sequenced variant: n.a.; n501y-positive: No.). The outcome of the events was fatal. The patient died on 20Aug2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test


VAERS ID: 1753125 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-08-26
   Days after vaccination:97
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0681 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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: 2021-08-26
   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:
Allergies:
Diagnostic Lab Data: Test Name: Variant PCR-based; Result Unstructured Data: Test Result:B.1.617.2; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: not aplicable n501y-positive: No
CDC Split Type: ATPFIZER INC202101262663

Write-up: SARS-CoV-2 infection; Drug ineffective; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-046821. An 81-year-old male patient received the second dose and the first dose of BNT162B2 (COMIRNATY), the second dose on 21May2021 (Lot Number: FC0681), the first dose on 09Apr2021 (Lot Number: ET7205), both via intramuscular as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication was none. On 26Aug2021 the patient experienced SARS-CoV-2 infection death, Vaccination failure. Variant PCR-based: B.1.617.2. Variant Sequenced: not applicable. n501y-positive was none. The patient died on 26Aug2021. Autopsy was unknown. The outcome of events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Drug ineffective; SARS-CoV-2 infection


VAERS ID: 1754424 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain injury, Immune thrombocytopenia, Immunology test, Interchange of vaccine products, Off label use, Purpura, Rhabdomyolysis, Seizure
SMQs:, Rhabdomyolysis/myopathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (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: Hypertension arterial; Hypothyroidism; Psychosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: ELISA; Result Unstructured Data: Test Result:thrombocytopenia; Comments: Free platelet-reactive antibodies as a sign of immune thrombocytopenia detected via ELISA.
CDC Split Type: DEPFIZER INC202101262998

Write-up: Vaxzevria vaccination about 12 weeks before Comirnaty; Vaxzevria vaccination about 12 weeks before Comirnaty; Immune thrombocytopenia; seizure; rhabdomyolysis; purpura; severe hypoxic brain damage; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, DE-DCGMA-21192074, Safety Report Unique Identifier DE-PEI-202100146360. A 72-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 16Jun2021 (at the age of 72-year-old) as dose 2 (initial pfizer dose) at 0.3 ml, single for COVID-19 immunisation. Medical history included ongoing psychosis, ongoing hypertension arterial and ongoing hypothyroidism. The patient''s concomitant medications were not reported. The patient previously received covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA) as dose 1 for COVID-19 immunisation (VAXZEVRIA vaccination about 12 weeks before COMIRNATY). The patient experienced immune thrombocytopenia on an unspecified date in 2021. On 13Jul2021 Free platelet-reactive antibodies as a sign of immune thrombocytopenia detected via ELISA. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. Relatedness of COMIRNATY and to reaction, was assessed as "D. Unclassifiable" by PEI. Reporter''s comment: Course: Suspected preclinical seizure -resuscitation with ROSC - rhabdomyolysis, thrombocytopenia, purpura, severe hypoxic brain damage, seizures -death. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Immune thrombocytopenia; seizures; rhabdomyolysis; purpura; severe hypoxic brain damage


VAERS ID: 1754609 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-11
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-28
   Days after onset: 78
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Infarct myocardial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101262534

Write-up: epileptical attack; stroke; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority -WEB DE-PEI-CADR2021180577, Safety Report Unique Identifier DE-PEI-202100191942. A 77-year-old female patient received bnt162b2 (COMIRNATY) strength: 0.3 mL, via an unspecified route of administration on 19May2021 (Batch/Lot Number: Unknown) as dose number unknown, single for covid-19 immunisation. Medical history included infarct myocardial from Apr2020 and ongoing. The patient''s concomitant medications were not reported. The patient experienced stroke and epileptic seizure / epileptical attack for the first time on 11Jun2021, then in middle July for the second time and finally in August for the third time. As a result, her mother died on 28Aug2021. An autopsy was not performed. The assessment for both events with the suspect product Comirnaty is: D. Unclassifiable. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Accident cerebrovascular; Epileptic fit


VAERS ID: 1754611 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-04
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death, Chest pain, Loss of consciousness
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), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101272550

Write-up: Cardiac death; Chest pain; unconscious; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority WEB DE-PEI-CADR2021182763 and Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100195376. A 42-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, Lot number unknown), via an unknown route, in Jul2021 at single dose (dose number unknown) for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On the night of 04Aug2021, this patient woke up with severe chest pain. When the rescue workers arrived, the patient was already unconscious and could not be brought back to life despite an hour and a half of attempts at resuscitation. The patient died on 04Aug2021 due to the events. No autopsy was performed. Relatedness of drug to reactions/events Source of assessment Result of Assessment D. Unclassifiable No follow-up attempts are possible. Information about Batch/Lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: chest pain; unconscious; Cardiac death


VAERS ID: 1754688 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-29
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Aortic valve incompetence, Body temperature, Cerebral haemorrhage, Coma scale, Computerised tomogram, Depressed level of consciousness, Hemiparesis, Hydrocephalus, Mitral valve incompetence, Oxygen saturation, Physical examination, Pneumonia, Respiratory distress, Respiratory failure, Respiratory rate, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), 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), 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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   Days after onset: 14
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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Ex-smoker; Hypertension (with difficult pharmacological control); Mitral insufficiency
Allergies:
Diagnostic Lab Data: Test Name: angiogram; Result Unstructured Data: Test Result:detecting no signs of contrast extravasation; Test Name: body temperature; Result Unstructured Data: Test Result:increased; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:3; Comments: decrease in the level of consciousness up to coma; Test Name: CT scan; Result Unstructured Data: Test Result:a voluminous right cortical intraparenchymal hemat; Comments: a voluminous right cortical intraparenchymal hematoma of 143cc volume was observed that did not condition signs of acute hydrocephalus of unknown etiology; Test Name: oxygen saturation; Result Unstructured Data: Test Result:slight tendency to eupneic desaturation; Test Name: physical examination; Result Unstructured Data: Test Result:NIHSS 25 stands out at the expense of decreased le; Comments: NIHSS 25 stands out at the expense of decreased level of consciousness and right hemispheric symptoms; Test Name: physical examination; Result Unstructured Data: Test Result:with NIHSS 20; Test Name: tachypneic; Result Unstructured Data: Test Result:2 4bpm with a 100% FIO2
CDC Split Type: ESPFIZER INC202101262770

Write-up: the level of consciousness decreased; respiratory distress; hemiparesis; Cerebral haemorrhage; bronchoaspiratory pneumonia; respiratory failure; mild mitral and aortic insufficiency; mild mitral and aortic insufficiency; tachypneic at 2 4rpm with a 100% FIO2; acute hydrocephalus; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB ES-AEMPS-1006839. A 95-year-old male patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular on 19Apr2021 (Lot Number: EW9127) as 0.3 ml dose for COVID-19 immunization. Medical history included hypertension (with difficult pharmacological control), mild mitral and aortic insufficiency, mild mitral and aortic insufficiency and ex-smoker. Concomitant medication included acetylsalicylic acid (ADIRO), hydrochlorothiazide, losartan potassium (LOSARTAN/HYDROCHLOROTHIAZIDE), omeprazole, sertraline, bimatoprost (LUMIGAN) and ipratropium bromide (ATROVENT). The patient previously received the first dose of BNT162B2 via intramuscular on 25Mar2021 (Batch/Lot Number: ET7205) as single dose for COVID-19 immunization. The patient admitted due to cerebral hemorrhage. History of HTN with difficult pharmacological control, mild mitral and aortic insufficiency. Former smoker. Independent and without cognitive impairment. Usual treatment with Adiro 100mg / d, losartan-hydrochlorothiazide 50 / 12.5mg / 12h, omeprazole 20mg / d, sertraline 50mg / d, lumigan, atrovent. On 29Apr, the level of consciousness decreased and the appearance of hemiparesis on the left side and respiratory distress began, for which he was referred to a hospital. Upon arrival at the ER, he was tachypneic at 2 4rpm with a 100% FIO2. It stabilizes at the respiratory level. On physical examination, NIHSS 25 stands out at the expense of decreased level of consciousness and right hemispheric symptoms. A simple CT scan was performed in which a voluminous right cortical intraparenchymal hematoma of 143cc volume was observed that did not condition signs of acute hydrocephalus of unknown etiology. CT angiography is performed, detecting no signs of contrast extravasation. In this context, acute stroke measures are carried out, under strict blood pressure control, requiring the start of urapidil on 29Apr at 6:38 p.m., which is later suspended. In the Stroke Unit, the patient is stationary with NIHSS 20; No signs of discomfort with a slight tendency to eupneic desaturation that is corrected with oxygen therapy. Poor vital and functional prognosis. In the next 24-48 hours he remains clinically stable, it is decided to place NGS for enteral nutrition. He presented fever in the context of possible bronchial aspiration, so treatment with antibiotic was started. It passes to a neurovascular plant pending evolution. From admission to the ward, the patient presents a progressive neurological and systemic deterioration, with a decrease in the level of consciousness up to coma (Glasgow Coma Scale 3 in the last 4 days) and progressive respiratory failure in the context of probable bronchoaspirative pneumonia and low level of consciousness. Finally exitus on 13May2021. Immediate cause: respiratory failure. Intermediate cause: bronchoaspiratory pneumonia. Root cause: Cortical cerebral hemorrhage possibly secondary to amyloid angiopathy. The patient died on 13May2021. Autopsy was unknown. The outcome of cerebral haemorrhage, bronchopneumonia and respiratory failure was fatal. The outcome of other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Bronchopneumonia; Respiratory failure; Cerebral haemorrhage


VAERS ID: 1754697 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-08-15
   Days after vaccination:191
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Cough, Dyspnoea, General physical health deterioration, Oxygen saturation, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Chronic kidney disease; Dyslipidaemia; Hepatopathy; Hypertension arterial; Oligophrenia
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: fever; Result Unstructured Data: Test Result:38.8 Centigrade; Test Date: 2021; Test Name: Oxygen saturation; Test Result: 89 %; Test Date: 2021; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:94-95 %; Comments: with oxygen therapy; Test Date: 2021; Test Name: Oxygen saturation; Test Result: 88 %; Test Date: 20210811; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: ESPFIZER INC202101273608

Write-up: Vaccination failure; COVID-19 respiratory infection; Oxygen saturation low; General physical health deterioration; Breathing difficult; Cough; Fever/38.8 Centigrade; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-976726. An 89-year-old non-pregnant (also at the time of vaccination) female patient received bnt162b2 (COMIRNATY), administered in Arm on 15Jan2021 (Batch/Lot Number: EM0477) as DOSE 1, SINGLE then on 05Feb2021 (Batch/Lot Number: EL8723) as DOSE 2, SINGLE both given via an unspecified route of administration for COVID-19 immunization. Medical history included hepatopathy, abdominal aortic aneurysm, hypertension arterial, chronic kidney disease, dyslipidaemia, and oligophrenia. Concomitant medications were not reported. In 2021 (also reported as 15Jan2021-pending clarification), the patient was institutionalized with productive cough, fever of 38.8 centigrade, oxygen saturation low (sat O2) of 89% and also 88% and breathing difficult. The patient had home oxygen therapy then it normally saturates 94-95%. It was later reported that the patient had vaccination failure as she had COVID-19 respiratory infection with positive COVID-19 antigen test on 15Aug2021 (also reported as 15Jan2021). Despite discharge, she was admitted again due to deterioration of general condition. The patient then died in 2021 due to general physical health deterioration, vaccination failure as she had COVID-19 respiratory infection, Oxygen saturation low and Breathing difficult. Outcome of cough and pyrexia were recovering. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information expected. ; Reported Cause(s) of Death: Oxygen saturation low; COVID-19 respiratory infection; Breathing difficult; Vaccination failure; General physical health deterioration


VAERS ID: 1754698 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-07-30
   Days after vaccination:177
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Chest X-ray, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Cardiac valvulopathy (Mitral); Cognitive deterioration; Hypertension arterial; Permanent atrial fibrillation
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:Bilateral infiltrate more in left hemithorax; Test Date: 20210730; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210807; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ESPFIZER INC202101273589

Write-up: Vaccination failure; COVID-19 pneumonia; Fever; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority number ES-AEMPS-976851. A 91-year-old non-pregnant female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Jan2021 (Batch/Lot Number: EM0477) as DOSE 1, SINGLE and then via an unspecified route of administration on 03Feb2021 (Batch/Lot Number: EL8723) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cardiac valvulopathy (Mitral), permanent atrial fibrillation, cognitive deterioration, and hypertension arterial. The patient''s concomitant medications were not reported. On 30Jul2021, the patient experienced fever, vaccination failure, and covid-19 pneumonia. The patient with the pathological history previously described who was admitted for COVID-19 Pneumonia, presenting poor clinical evolution being finally exitus (as reported). The patient underwent lab tests and procedures which included thorax x-ray: bilateral infiltrate more in left hemithorax on 07Aug2021, COVID-19 antigen test: positive on 30Jul2021, and COVID-19 PCR test: positive on 07Aug2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. All events resulted to fatal outcome on unspecified date. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia; Vaccination failure


VAERS ID: 1754784 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Lung neoplasm malignant
SMQs:, Non-haematological malignant tumours (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:
Allergies:
Diagnostic Lab Data: Test Name: lung image; Result Unstructured Data: Test Result:clean; Comments: Before vaccination, the lungs were imaged and then they were clean
CDC Split Type: FIPFIZER INC202101262741

Write-up: Lung neoplasm malignant; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number FI-FIMEA-20214851. A 53-years-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 2021 (batch/lot number: unknown) as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lung neoplasm malignant on 01Jul2021. It was reported patient had aggressive lung cancer onset after the second dose of the vaccine. The patient underwent lab tests and procedures which included chest x-ray was clean (before vaccination, the lungs were imaged and then they were clean). The outcome of event was fatal. The patient died on an unspecified date. 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: Lung neoplasm malignant


VAERS ID: 1754793 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-08-01
   Days after vaccination:125
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood sodium, C-reactive protein, COVID-19, Cough, Drug ineffective, Dyspnoea, Heart rate, Hyponatraemia, Investigation, Klebsiella infection, N-terminal prohormone brain natriuretic peptide, Neurological examination, Oedema peripheral, Oxygen saturation, Oxygen saturation decreased, Productive cough, Pulmonary physical examination, SARS-CoV-2 test, Specialist consultation, Sputum test, White blood cell count
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-07
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiomyopathy; Carpal tunnel syndrome; Chronic lymphocytic leukaemia (Jan2021, untreated); Gout; Hip prosthesis user; Hypercholesterolaemia; Tachyarrhythmia; Thyroid nodule
Allergies:
Diagnostic Lab Data: Test Name: cardiologic exam; Result Unstructured Data: Test Result:normal; Test Name: cytobacteriological examination of sputum; Result Unstructured Data: Test Result:cam back positive for Klebsiella pneumoniae; Test Date: 20210831; Test Name: leukocyte count; Result Unstructured Data: Test Result:30 x10 9/l; Test Name: blood pressure; Result Unstructured Data: Test Result:130 per 80 mmHg; Test Date: 20210831; Test Name: Hyponatremia; Result Unstructured Data: Test Result:130 mmol/L; Test Date: 20210831; Test Name: CRP; Result Unstructured Data: Test Result:217 mg/l; Test Name: heart rate; Result Unstructured Data: Test Result:100; Comments: bpm; Test Name: digestive examination; Result Unstructured Data: Test Result:normal; Test Name: naurological examination; Result Unstructured Data: Test Result:normal; Test Date: 20210831; Test Name: nptrobnp; Result Unstructured Data: Test Result:21000 ng/L; Test Name: oxygen saturation; Test Result: 75 %; Test Date: 20210831; Test Name: oxygen saturation; Test Result: 46 %; Test Date: 20210905; Test Name: oxygen saturation; Test Result: 89 %; Test Name: pulmonary examination; Result Unstructured Data: Test Result:a bilateral vesicular murmur; Comments: Lung examination finding a bilateral vesicular murmur, symmetrical with bilateral crackling cough with sputum, indrawing, no cyanosis.; Test Date: 20210831; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101262820

Write-up: Hyponatremia at 130 mmol/l; cough with sputum; Drug ineffective; SARS-COV2 pneumonia; pneumoniaie infection / positive pnemoniae; lower limbs oedema; oxygen saturation low/ Blood gases show a saturation of 46%; cough; dyspnea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-AM20212569. A 87-year-old male patient received the second dose and the first dose of BNT162B2 (COMIRNATY), the second dose on 29Mar2021 (Lot Number: ER9470), the first dose in Feb2021 (Lot Number: Unknown), both via intramuscular as single dose for COVID-19 immunization. Medical history included cardiomyopathy, tachyarrhythmia, carpal tunnel syndrome, chronic lymphocytic leukaemia (Jan2021, untreated), gout, thyroid nodule, hip prosthesis user and hypercholesterolaemia. Concomitant medication included pantoprazole, allopurinol, acetylsalicylate lysine (KARDEGIC), spironolactone, furosemide, bisoprolol and amiodarone. In August 2021, the patient experienced cough, lower extremity edema and dyspnea. Emergency room visit on 31Aug2021. On entry inflammatory syndrome with leukocytes at 30 G/l, CRP at 217 mg/l. Hyponatremia at 130 mmol/l and NT pro BNP at 21 000 ng/l. Blood gases show a saturation of 46%. Put on oxygen. Positive COVID test. Introduction of antibiotic therapy associated with corticosteroid therapy. Clinical examination showed a blood pressure of 13/8 cmHg, a heart rate of 100 beats per minute and an oxygen saturation of 75% under 15L. Neurological, digestive and cardiac examination without any particularity. Presence of edema of the lower limbs. ulmonary examination revealed a bilateral, symmetrical vesicular murmur with bilateral crepitus, cough with sputum, draught, no cyanosis. Faced with this oxygen dependence with 15 L oxygen by mask allowing only a 75% saturation, decision to transfer to the intensive care unit with decision not to intubate in view of the history. The general condition then deteriorated with a saturation of 89% on 05Sep2021 under 100% Opti flow and NIV at 95%. The ECBC came back positive for pneumoniae and PIPERACILLIN / TAZOBACTAM was started. On 06Sep2021, the patient was unresponsive. Death on 07Sep2021. Autopsy was unknown. CRPV intervention: recovery of the hospitalization report. The outcome of drug ineffective and COVID-19 was fatal. The outcome of other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute respiratory failure


VAERS ID: 1754826 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   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: Advanced cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101278635

Write-up: Death NOS; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-BX20218971. A 72-year-old male patient received the first dose of bnt162b2 (COMIRNATY) Intramuscularly on 20May2021 (lot: EW6126) as single dose for COVID-19 immunisation. No history of COVID. Medical history included Advanced cancer/metastatic cancer. Concomitant medications were not reported. The patient experienced Death 3 days after first dose without further details. It was unknown if Autopsy Done. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1754914 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Vaccination failure
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: 2021-09-01
   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: Acute coronary syndrome; Arterial hypertension; Chronic obstructive airways disease; Dermatosclerosis; Insulin-requiring type 2 diabetes mellitus; Ischaemic heart disease; Obesity; Sleep apnea syndrome
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210959880

Write-up: INTERSTITIAL PNEUMONIA DUE TO COVID-19; VACCINATION FAILURE; This spontaneous report received from a health care professional via Regulatory Authority (EVHUMAN Vaccines, FR-AFSSAPS-PV20212858) on 30-SEP-2021 concerned a 58 year old male of an unspecified race and ethnic origin. The patient''s weight was 113 kilograms and height was 170 centimeters. The patient''s concurrent conditions included acute coronary syndrome, sleep apnea syndrome, insulin-requiring type 2 diabetes mellitus, chronic obstructive airways disease, obesity, dermatosclerosis, arterial hypertension and ischaemic heart disease. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C11-02, expiry: unknown) 0.5 ml dose, frequency time 1 total administered on 27-JUL-2021 for covid-19 vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced interstitial pneumonia due to covid-19 and vaccination failure. On 01-SEP-2021, the patient died from multi organ failure and covid-19. An autopsy was not performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of interstitial pneumonia due to covid-19 and vaccination failure on 01-SEP-2021. The outcome of the events interstitial pneumonia due to covid-19 and vaccination failure was fatal This report was serious (Death). The case was associated with product quality complaint (PQC); Reported Cause(s) of Death: MULTI ORGAN FAILURE; COVID-19


VAERS ID: 1755149 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-20
Onset:2021-09-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial ischaemia, SARS-CoV-2 test
SMQs:, Other ischaemic heart disease (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-22
   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: COPD (mild COPD); Prostate cancer; Prostatectomy (prostate ca- prostatectomy 2019)
Allergies:
Diagnostic Lab Data: Test Date: 20210922; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101265201

Write-up: Acute myocardial ischemia; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109231306586340-GL4ES, Safety Report Unique Identifier GB-MHRA-ADR 25983597. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 20Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included prostatectomy in 2019 for prostate CA, mild chronic obstructive pulmonary disease. Patient had 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 acute myocardial ischemia on 22Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 22Sep2021. Patient had not tested positive for COVID-19 since having the vaccine. The patient died on 22Sep2021. It was not reported if an autopsy was performed. The outcome of event Acute myocardial ischemia was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Acute myocardial ischemia


VAERS ID: 1755185 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal hypokinesia, Maternal exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 17
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: 20210613; Test Name: ultrasound; Result Unstructured Data: Test Result:the baby, fluid and cord flow
CDC Split Type: GBPFIZER INC202101281229

Write-up: Foetal movements decreased; Maternal exposure during pregnancy/Third-trimester (29-40 weeks).; This is a spontaneous report from a contactable consumer (parent/mother). This is the second of 2 reports. The first report is received from the Regulatory Agency (RA), GB-MHRA-WEBCOVID-202109112001135070-KJBAQ. This consumer reported information for both mother and baby. This is the baby case. A female fetus patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW3143) via transplacental route on 27May2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The fetus experienced foetal movements decreased on 10Jun2021, serious for death and hospitalization, and maternal exposure during pregnancy/third-trimester (29-40 weeks) on 27May2021. The clinical course of the event was described as follows: On the morning of 10Jun2021, the mother attended maternity triage at hospital for reduced foetal movements, after a quiet early morning. Baby started moving when mother was hooked up to the CTG, but there was a reduction in fundal height from 33cm (as recorded during regular monitoring on 06Jun2021) to 31cm, when exactly 34 weeks on 10Jun2021 and so forecast to be 34cm. After good movements from baby for the rest of Thursday and all day Friday, she was more subdued on Saturday. At a regular midwife appointment on Sunday, 13Jun2021 (at 34+3), no heartbeat could be found. Mother was walked to maternity triage and this was confirmed further by a midwife and three doctors, including ultrasound checks of the baby, fluid and cord flow. Mother was induced and gave birth at 05:01 at 35+2. The patient (fetus) died on 13Jun2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101191534 Mother case; Reported Cause(s) of Death: Maternal exposure during pregnancy/Third-trimester (29-40 weeks).; Foetal movements decreased


VAERS ID: 1755400 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Thrombophlebitis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101262696

Write-up: Thrombophlebitis; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-789285. This consumer reported different event for the same patient for the second dose of Comirnaty. This is the first of two reports. An 89-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via intramuscular on 31Mar2021 (Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included diabetes. Concomitant medication was not reported. On 05Apr2021, the patient experienced thrombophlebitis. On an unspecified date, the patient died. Autopsy was unknown. Reported Dosage of Comirnaty vaccine: 0.3 mg, cyclical. Comments: 20Sep2021 - With reference to what happened, it was ask: suspected medicinal product lot, concomitant therapies of the patient for the declared pathology and for the others present. results of exams taken. The outcome of event was fatal. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reporter''s Comments: diabetes, pluripathology; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202101272620 same patient, different event for 2nd dose of Comirnaty; Reported Cause(s) of Death: Thrombophlebitis


VAERS ID: 1755404 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-07-13
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial tachycardia, Cardiomegaly, Fall, Ischaemia
SMQs:, Cardiac failure (broad), Supraventricular tachyarrhythmias (narrow), Accidents and injuries (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101262445

Write-up: atrial tachycardia; Death by collapse; abnormally enlarged heart; microischemia; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-789580. A 72-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: Unknown), via an unspecified route of administration on 21Apr2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 13Jul2021, patient experienced collapse in the emergency room of PRIVACY (abnormally enlarged heart) and microischemia. Emergency room admission. Impact on quality of life (10/10). On an unspecified date, patient experienced atrial tachycardia. The patient died on an unspecified date. It was not reported if an autopsy was performed. Autopsy recommended, but reporter didn''t want his father to open for 2 time. The outcome of events collapse, abnormally enlarged heart and microischemia was fatal. The outcome of event atrial tachycardia was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death by collapse; abnormally enlarged heart; microischemia


VAERS ID: 1755446 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101268990

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This case is 1st of 6 cases. A elderly (at age of 90s to 100s years) patient of an unspecified gender received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (dose number unknown) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced platelets decreased (non-serious) on an unspecified date and death on an unspecified date. Cause of death was unknown and it was not reported if an autopsy was performed. Outcome of the event platelets decreased at the time of death was unknown. The reporting physician commented that the causality between the events and BNT162b2 was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event death and suspect drug BNT162B2 cannot be excluded. 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. Linked Report(s) : JP-PFIZER INC-202101269101 Same reporter, same events,different patient;JP-PFIZER INC-202101269194 Same reporter, same events,different patient;JP-PFIZER INC-202101269278 Same reporter, same events,different patient;JP-PFIZER INC-202101269353 Same reporter, same events,different patient;JP-PFIZER INC-202101269416 Same reporter, same events,different patient; Reported Cause(s) of Death: death.


VAERS ID: 1755447 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: platelet count; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC202101269101

Write-up: Death; Platelets decreased; This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported same events for 6 patients. This case is the 2nd of 6 reports. An elderly (at age of 90s to 100s years) patient of an unspecified gender received BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unspecified route of administration, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On unknown date, the patient developed platelet decreased, non-serious. On unknown date, the patient experienced death. The cause of death was unknown. Outcome of the event platelets decreased at the time of death was unknown. It was unknown if an autopsy was performed The reporting physician commented that the causality between the events and BNT162B2 was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events death and the administration of the vaccine cannot be excluded. 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.,Linked Report(s) : JP-PFIZER INC-202101268990 Same reporter, same events,different patient; Reported Cause(s) of Death: death


VAERS ID: 1755450 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101269353

Write-up: death; Platelets decreased; This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 6 patients. This is the 5th of 6 cases. An elderly patient (at age of 90s to 100s years) of an unspecified gender received a single unspecified dose of bnt162b2 (COMIRNATY; Solution for injection, Lot number and Expiration date not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation, at the clinic. The patient medical history and concomitant medications were not reported. On an unknown date (unknown day(s) after vaccination), the patient experienced platelets decreased, with unknown outcome. On an unknown date (unknown day(s) after vaccination), the patient experienced death. The outcome was fatal. It was not reported if an autopsy was performed.The reporting physician commented that the causality between the events and BNT162b2 was unknown. The lot number for BNT162b2, was not provided and will be requested during follow up.; 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.,Linked Report(s) : JP-PFIZER INC-202101268990 Same reporter, same events,different patient; Reported Cause(s) of Death: death


VAERS ID: 1755451 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: platelets; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC202101269416

Write-up: death; Platelets decreased; This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 6 patients. This is the sixth of six reports. An elderly patient (reported as at age of 90s to 100s years) of an unspecified gender received a single unspecified dose number of BNT162b2 (COMIRNATY, solution for injection, lot number and expiration date not reported) via an unspecified route of administration on an unspecified date at dose number unknown, single for COVID-19 immunisation, at the clinic. The patient medical history and concomitant medications were not provided. On an unknown date (unknown days after vaccination), the patient experienced platelets decreased. On an unknown date (unknown days after vaccination), the patient experienced death. The outcome of death was fatal, while the outcome of the other event was unknown. It was unknown if an autopsy was performed. The reporting physician commented that the causality between the events and BNT162b2 was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: The event death is assessed as related to COMIRNATY use and documented as such in the global safety database until sufficient information is available to allow an unrelated causality assessment. 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.,Linked Report(s) : JP-PFIZER INC-202101268990 Same reporter, same events,different patient; Reported Cause(s) of Death: death


VAERS ID: 1755453 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Food allergy
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 INC202101274264

Write-up: buckwheat allergy; This is a spontaneous report from a contactable consumer received via Medical Information Team. A patient of unspecified age and gender received BNT162b2 (COVID-19 Vaccine -MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE dose (DOSE NUMBER UNKNOWN) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced buckwheat allergy on an unspecified date. According to the reporter, although the reporter did not know if the patient had received the vaccination of Pfizer or MODEERNA, the patient died from buckwheat allergy.The reporter called the call center to ask whether the reporter could get the vaccination although he/she also had food allergy.The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: buckwheat allergy


VAERS ID: 1755474 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-09-04
   Days after vaccination:194
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Altered state of consciousness, Blood creatinine, Blood urea, C-reactive protein, COVID-19, Chest X-ray, Culture, Dyspnoea, Escherichia test positive, Glomerular filtration rate, Haemoglobin, Lethargy, Lower respiratory tract infection, Lymphocyte count, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Nitrite urine present, Oxygen saturation, Oxygen saturation decreased, Platelet count, Prothrombin time, Red blood cells urine positive, Respiratory rate, SARS-CoV-2 test, Sepsis, Urine analysis, Vaccination failure, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-19
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; COPD; Diverticular disease; Ex-smoker; GERD; Glaucoma; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: creatinine; Result Unstructured Data: Test Result:108; Comments: High fell to normal on 16/09; Test Date: 20210914; Test Name: creatinine; Result Unstructured Data: Test Result:125; Comments: High fell to normal on 16/09; Test Date: 20210915; Test Name: creatinine; Result Unstructured Data: Test Result:103; Comments: High fell to normal on 16/09; Test Date: 20210916; Test Name: creatinine; Result Unstructured Data: Test Result:83; Comments: High fell to normal on 16/09; Test Date: 20210918; Test Name: creatinine; Result Unstructured Data: Test Result:66; Comments: High fell to normal on 16/09; Test Date: 20210911; Test Name: Urea; Result Unstructured Data: Test Result:19; Comments: High throughout (Rise and fall); Test Date: 20210914; Test Name: Urea; Result Unstructured Data: Test Result:32; Comments: High throughout (Rise and fall); Test Date: 20210915; Test Name: Urea; Result Unstructured Data: Test Result:26; Comments: High throughout (Rise and fall); Test Date: 20210916; Test Name: Urea; Result Unstructured Data: Test Result:22; Comments: High throughout (Rise and fall); Test Date: 20210918; Test Name: Urea; Result Unstructured Data: Test Result:13; Comments: High throughout (Rise and fall); Test Date: 20210911; Test Name: Imaging for COVID-Pneumonia; Result Unstructured Data: Test Result:No evidence of consolidation; Comments: No significant abnormality; Test Date: 20210911; Test Name: C-reactive protein; Result Unstructured Data: Test Result:121; Comments: HIGH but consistent fall; Test Date: 20210914; Test Name: C-reactive protein; Result Unstructured Data: Test Result:69; Comments: HIGH but consistent fall; Test Date: 20210915; Test Name: C-reactive protein; Result Unstructured Data: Test Result:58; Comments: HIGH but consistent fall; Test Date: 20210916; Test Name: C-reactive protein; Result Unstructured Data: Test Result:32; Comments: HIGH but consistent fall; Test Date: 20210918; Test Name: C-reactive protein; Result Unstructured Data: Test Result:24; Comments: HIGH but consistent fall; Test Date: 20210912; Test Name: Culture; Result Unstructured Data: Test Result:E coli cultivated; Test Date: 20210911; Test Name: EGFR; Result Unstructured Data: Test Result:58; Comments: Low to normal; Test Date: 20210914; Test Name: EGFR; Result Unstructured Data: Test Result:49; Comments: Low to normal; Test Date: 20210915; Test Name: EGFR; Result Unstructured Data: Test Result:61; Comments: Low to normal; Test Date: 20210916; Test Name: EGFR; Result Unstructured Data: Test Result:79; Comments: Low to normal; Test Date: 20210918; Test Name: EGFR; Result Unstructured Data: Test Result:102; Comments: Low to normal; Test Date: 20210916; Test Name: Haemoglobin; Result Unstructured Data: Test Result:14; Comments: 1 abnormal reading, otherwise within normal; Test Date: 20210911; Test Name: lymphocytes; Result Unstructured Data: Test Result:1.2; Comments: All Low; Test Date: 20210914; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.8; Comments: All Low; Test Date: 20210916; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.6; Comments: All Low; Test Date: 20210918; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.8; Comments: All Low; Test Date: 20210911; Test Name: Neutrophil; Result Unstructured Data: Test Result:11; Comments: All High; Test Date: 20210914; Test Name: Neutrophil; Result Unstructured Data: Test Result:17; Comments: All High; Test Date: 20210916; Test Name: Neutrophil; Result Unstructured Data: Test Result:19; Comments: All High; Test Date: 20210918; Test Name: Neutrophil; Result Unstructured Data: Test Result:11; Comments: All High; Test Date: 20210911; Test Name: NT pro BNP; Result Unstructured Data: Test Result:4277; Comments: High; Test Name: oxygen saturation; Test Result: 87 %; Comments: on RA; Test Date: 20210911; Test Name: Platelet count; Result Unstructured Data: Test Result:363; Comments: High fell to normal on 16/09; Test Date: 20210914; Test Name: Platelet count; Result Unstructured Data: Test Result:364; Comments: High fell to normal on 16/09; Test Date: 20210916; Test Name: Platelet count; Result Unstructured Data: Test Result:291; Comments: High fell to normal on 16/09; Test Date: 20210918; Test Name: Platelet count; Result Unstructured Data: Test Result:208; Comments: High fell to normal on 16/09; Test Date: 20210911; Test Name: PT; Result Unstructured Data: Test Result:10.9; Comments: Normal; Test Name: Respiratory rate; Result Unstructured Data: Test Result:more than 25 bpm; Test Date: 20210911; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:Detected - CT 17; Test Date: 20210912; Test Name: Urine analysis; Result Unstructured Data: Test Result:Positive for nitrites, RBCs; Test Date: 20210911; Test Name: WBC; Result Unstructured Data: Test Result:13.6; Comments: All High; Test Date: 20210914; Test Name: WBC; Result Unstructured Data: Test Result:18.4; Comments: All High; Test Date: 20210916; Test Name: WBC; Result Unstructured Data: Test Result:19.9; Comments: All High; Test Date: 20210918; Test Name: WBC; Result Unstructured Data: Test Result:11.9; Comments: All High
CDC Split Type: MTPFIZER INC202101281111

Write-up: COVID-19; COVID-19; lower respiratory tract infection; sepsis; E coli cultivated in culture; Positive for nitrites, RBCs in urine analysis; Positive for nitrites, RBCs in urine analysis; increasing lethargy; SOB; SpO2 86%; Acute kidney injury; altered consciousness (lethargic); This is a spontaneous report from a contactable physician. A 99-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscularly administered in the left arm on 22Feb2021 (lot number: EL0725) as dose 2, single and intramuscularly administered in the left arm on 01Feb2021 (lot number: EJ6134) as dose 1, single, both for COVID-19 immunization. Medical history included hypertension, chronic obstructive pulmonary disease (COPD), gastrooesophageal reflux disease (GERD), benign prostatic hyperplasia, glaucoma, diverticulum disease and ex- smoker, all from an unknown date and unknown if ongoing. Concomitant medications included latanoprost, ipratropium bromide (ATROVENT), beclomethasone, dutasteride, tamsulosin hydrochloride (COMBODART), omeprazole, brimonidine tartrate (BRYMONT), melatonin (CIRCADIN) and colecalciferol (FORTE D), all taken for unspecified indications, start and stop dates were not reported. The patient experienced sepsis on 19Sep2021, lower respiratory tract infection on an unspecified date, COVID-19 on 11Sep2021, acute kidney injury, altered consciousness (lethargic) on an unspecified date in 2021, increasing lethargy, shortness of breath (SOB), SpO2 86% on 04Sep2021, E. coli cultivated in culture and positive for nitrites, RBCs in urine analysis on 12Sep2021. The patient was hospitalized for COVID-19 from 11Sep2021 to an unknown date for 8 days. It was reported that the patient underwent a nasal swab (RT-PCR) that was positive on 11Sep2021 (new infection). He was admitted from elderly home on 11Sep2021 and died on the 19Sep2021 in the hospital (8 days hospitalization). He had visited emergency department on 04Sep2021 for increasing lethargy, SOB and SpO2 86% RA but discharged back on same day (Covid negative at discharge). Patient deceased in hospital on the 19Sep2021. He had episodes of hypoxia SpO2 - 87% on RA. He had normal face mask - 10L/min, low Saturations, RR more than 25bpm. He had received treatment with Dexamethasone 6mg iv dly from 11Sep2021 to 18Sep2021 and antibiotics - Levofloxacin. It was also reported that the patient had respiratory, renal and neurological symptoms during the COVID-19 illness such as dyspnoea, tachypnoes, hypoxemia. Acute kidney injury. Altered consciousness (lethargic). Primary cause of death was reported as sepsis as a consequence of lower respiratory tract infection as a consequence of COVID-19. Contributory causes included chronic obstructive pulmonary disease. The patient underwent lab tests and procedures which included creatinine: 108 on 11Sep2021, 125 on 14Sep2021, 103 on 15Sep2021, 83 on 16Sep2021, 66 on 18Sep2021 (all were noted to be high fell to normal on 16Sep2021); urea: 19 on 11Sep2021, 32 on 14Sep2021, 26 on 15 Sep2021, 22 on 16Sep2021, 13 on 18Sep2021 [all were noted to be high throughout (rise and fall)]; imaging for COVID-Pneumonia: no evidence of consolidation (no significant abnormality) on 11Sep2021; C-reactive protein: 121 on 11Sep2021, 69 on 14Sep2021, 58 on 15Sep2021, 32 on 16Sep2021, 24 on 18Sep2021 (all were noted to be high but consistent fall); Culture: E coli cultivated on 12Sep2021; EGFR: 58 on 11Sep2021, 49 on 14Sep2021, 61 on 15Sep2021, 79 on 16Sep2021, 102 on 18Sep2021 (all were noted to be low to normal); Haemoglobin: 14 (1 abnormal reading, otherwise within normal) on 16Sep2021; lymphocytes: 1.2 on 11Sep2021, 0.8 on 14Sep2021, 0.6 on 16Sep2021, 0.8 on 18Sep2021 (all low); Neutrophil: 11 on 11Sep2021, 17 on 14Sep2021, 19 on 16Sep2021, 11 on 18Sep2021 (all high); NT pro BNP: 4277 (high); oxygen saturation: 87% on RA on an unspecified date; platelet count: 363 on 11Sep2021, 364 on 14Sep2021, 291 on 16Sep2021, 208 on 18Sep2021 (all noted to be high fell to normal on 16Sep2021); PT: 10.9 (normal) on 11Sep2021; Respiratory rate: more than 25 bpm on an unspecified date; SARS-CoV-2 PCR test: Detected - CT 17 on 11Sep2021; Urine analysis: Positive for nitrites, RBCs on 12Sep2021; and WBC: 13.6 on 11Sep2021, 18.4 on 14Sep2021, 19.9 on 16Sep2021 and 11.9 on 18Sep2021. The patient died on 19Sep2021 due to sepsis as a consequence of lower respiratory tract infection as a consequence of COVID-19. Contributory causes included chronic obstructive pulmonary disease. An autopsy was not performed. The outcome of the events sepsis, lower respiratory tract infection, vaccination failure, COVID-19 was fatal while the outcome of all other events was unknown. No follow-up attempts are needed. 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 all reported events cannot be totally excluded.The impact of this report 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: sepsis; lower respiratory tract infection; COVID-19; COVID-19; Chronic obstructive pulmonary disease


VAERS ID: 1755521 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-13
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Contusion, Nasal disorder
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), Acute central respiratory depression (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101263042

Write-up: Cardiac arrest; Scabs in the nose; Bruises all over the body; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00686771. An 83-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 02Feb2021 (Batch/Lot Number: Unknown) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previous COVID-19 infection was No. The patient experienced scabs in the nose on 13Feb2021, bruises all over the body on 13Feb2021 and cardiac arrest on 15Feb2021. Bruises and scabs were reported 13Feb2021, but may had been there for longer. The GP (physician) saw no reason for further investigation into the sudden death because there was no indication of a crime. She was old and a heart attack or brain haemorrhage seemed the logical cause of death. Cardiac arrest had officially been reported as the cause of death. There was no diagnostic procedures. The patient died suddenly on 15Feb2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: cardiac arrest; Scabs in the nose; Bruises all over the body


VAERS ID: 1755523 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal growth restriction, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101277378

Write-up: maternal exposure during pregnancy, first trimester; fetal growth restriction; This is a spontaneous report from a contactable consumer (patient''s mother). This consumer reported information for both mother and fetus. This is a fetal report. Two reports out of three are serious. The original report was downloaded from the Regulatory Authority-WEB NL-LRB-00684090. A fetus patient of an unspecified gender was exposed to bnt162b2 (COMIRNATY) transplacental on 03Aug2021 (lot number and expiry date: unknown) as dose 2, 0.3 ml, single, for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced maternal exposure during pregnancy, first trimester on 03Aug2021, and fetus growth restriction on unspecified date in 2021. The first Covid vaccination took place before mother''s pregnancy, while the second vaccination took place during pregnancy. The fetus stopped dividing at approximately 6 weeks. Miscarriage occurred last week at approximately 10 weeks The fetus died on an unspecified date in 2021. It was unknown if an autopsy was performed. Sender''s comment: Since the nature of the reported reaction does imply seriousness according to one of the CIOMS critera, the reaction was considered as serious by the regulatory authority. Reporter''s comment: BioNTech/Pfizer vaccin (Comirnaty): Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): yes . Date: 22Jun2021. Miscarriage. Additional information ADR: At the time of the second vaccination I was pregnant. According to the gyn''s calculations, a few days later the embryo stopped dividing. Citizen service number available: yes. Confounding factors. Vaccine exposure during pregnancy week: I was not pregnant at the time of the first vaccination. Previous COVID-19 infection: No. Follow-up: Miscarriage occurred last week at approx. 10 weeks. The fetus stopped dividing at approx. 6 weeks. No follow-up attempts are possible, information on batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101263453 mother case;NL-PFIZER INC-202101229191 mother case; Reported Cause(s) of Death: fetal growth restriction


VAERS ID: 1755573 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Death, Malaise, Off label use, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (had been treated for many years and had all parameters within the normal range while taking meds); Smoker (but was not diagnosed with any chronic disease)
Allergies:
Diagnostic Lab Data: Test Date: 20210923; Test Name: low-grade fever; Result Unstructured Data: Test Result:low grade fever
CDC Split Type: PLPFIZER INC202101269681

Write-up: Malaise; Pain in arm; Shoulder pain; low grade fever; who took the 3rd dose of your vaccine; Death; This is a spontaneous report from a contactable consumer received by e-mail. A 70-year-old male patient received the third dose of BNT162B2 (COMIRNATY, solution for injection, Lot number unknown), via an unspecified route, on 22Sep2021 at single dose for COVID-19 immunisation. Relevant medical history included hypertension (he had been treated for many years and had all parameters within the normal range while taking medication) and smoker (but was not diagnosed with any chronic disease). No relevant concomitant medications were provided. On 23Sep2021 (the day after receiving the vaccine), the patient complained of malaise and low grade fever. After several hours of improvement (seemed to be feeling better), in the evening he had a pain in his arm and shoulder. The patient left at night (most likely in the morning) from Friday to Saturday. The patient was retired and led a quiet life, almost not exposed to stress at all. The patient received the vaccine at the aesthetic medicine clinic. The doctor was unable to find out the exact cause and recommended that it be reported through the vaccination center. The cause of death was unknown. The outcome of malaise, pain in arm and shoulder and low-grade fever at the time of death was unknown. It was unknown if an autopsy was performed. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: death


VAERS ID: 1758034 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Creatinine renal clearance, Immunisation, Off label use, 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: 2021-09-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KARDEGIC; BISOPROLOL; FUMAFER; LOXAPAC [LOXAPINE]; TRANSIPEG [MACROGOL]; OXAZEPAM; PARACETAMOL; PAROXETINE; DIFFU-K; TRAMADOL; SODIUM VALPROATE; ZYMAD; NORMACOL STANDARD; LOXAPAC [LOXAPINE]; INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Arterial hypertension; Artificial cardiac pacemaker user (Pace-maker (Dec2016) for sinus dysfunction, last check-up in Apr2021 with non-anticoagulated AF passages despite a theoretical indication); Bladder retention; Chronic renal failure (Creatinine clearance 31ml / min)); Cognitive disorders; COVID-19; Decompensation cardiac (Patient hospitalized at the end of Jul2021 for cardiac decompensation predominantly on the left side of ischemic and valvular heart disease with FE known to have been preserved, possibly related to the stopping of furosemide on 01Jul2021 and with an absence of compliance with the salt-free diet.); Depressive state; Dyslipidemia; Ischemic heart disease; Stroke; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: creatinine clearance; Result Unstructured Data: Test Result:31 ml/min
CDC Split Type: FRPFIZER INC202101272237

Write-up: death; received the third dose of BNT162B2; received the third dose of BNT162B2; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB [FR-AFSSAPS-CN20212980]. An 87-year-old male patient received the third dose of BNT162B2 (COMIRNATY) via intramuscular on 15Sep2021 (Lot Number: Unknown) at the age of 87-year-old male as single dose for COVID-19 immunization. Medical history included COVID-19 from Oct2020, severe ischemic heart disease with tri-truncular lesions under medical treatment: LVEF 65% from 2014, pace-maker (from Dec2016) for sinus dysfunction, last check-up in Apr2021 with non-anticoagulated AF passages despite a theoretical indication, calcified aortic stenosis moderately tight, stroke, chronic renal failure not explored (Creatinine clearance 31ml / min), Cognitive disorders with behavioral disorders and disinhibition stabilized under treatment, urine retention, depressive syndrome, cardiac decompensation (Patient hospitalized at the end of Jul2021 for cardiac decompensation predominantly on the left side of ischemic and valvular heart disease with FE known to have been preserved, possibly related to the stopping of furosemide on 01Jul2021 and with an absence of compliance with the salt-free diet), arterial hypertension, dyslipidemia and type 2 diabetes. Allergic history was unknown. Concomitant medication included acetylsalicylate lysine (KARDEGIC), bisoprolol, ferrous fumarate (FUMAFER), loxapine (LOXAPAC [LOXAPINE]), macrogol (TRANSIPEG [MACROGOL]), oxazepam, paracetamol, paroxetine, potassium chloride (DIFFU-K), tramadol, sodium valproate, colecalciferol (ZYMAD), sterculia urens (NORMACOL STANDARD), LOXAPINE (LOXAPAC [LOXAPINE]) and insulin. On 16Sep2021, the patient experienced death in bed in 16Sep2021 at 08:35. No adverse effects immediately after vaccination. The outcome of sudden death was fatal. The outcome of other events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1758045 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-20
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-23
   Days after onset: 34
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Arterial hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20211001442

Write-up: VACCINATION FAILURE; This spontaneous report received from a physician Via a Regulatory authority (Vaccines, FR-AFSSAPS-NC20214442) on 01-OCT-2021 concerned an 87 year old male of an unspecified race and ethnic origin. The patient''s height and weight were not reported. The patient''s pre-existing medical conditions included: Arterial hypertension. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) 1 dosage forms, frequency time 1 total administered on 01-MAR-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 20-JUL-2021, the patient experienced vaccination failure. On 23-AUG-2021, the patient died from vaccination failure. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Reported Cause(s) of Death: VACCINATION FAILURE


VAERS ID: 1758069 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-30
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Multiple organ dysfunction syndrome
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), 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 (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Congestive (dilated) cardiomyopathy; Heart disorder; Hypertension arterial; Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Skull trauma
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210823446

Write-up: ARREST CARDIAC; MULTIORGAN FAILURE; This spontaneous report received from a physician via a Regulatory Authority (FR-AFSSAPS-PP20211035) on 30-SEP-2021 and concerned a 60 year old male of unknown race and ethnicity. The patient''s weight was 75 kilograms and height was 175 centimeters. The patient''s past medical history included: skull trauma and concurrent conditions included: hypothyroidism, congestive (dilated) cardiomyopathy, probable heart disease and hypertension arterial. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C13-04, expiry: unknown) 1 dosage forms, 1 total, administered on 29-JUN-2021 for covid-19 vaccination. Drug start period was 2 days. Duration of drug administration was reported as 1 day. No concomitant medications were reported. On 30-JUN-2021, the patient had arrest cardiac and multiorgan failure. It was reported that not explored, described dilatation, who presented a cardio-respiratory arrest the day following the vaccination with unfavorable evaluation through multi-organ failure conducting to death at day 5 after injection. No causality was revealed (ischemic, embolic, toxic, metabolic, infectious, absence of fulminant myocarditis at myocardiac biopsy). The autopsy was refused by the family. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of multiorgan failure on 04-JUL-2021. This report was serious (Death). This case, from the same reporter is linked to 20210764291, 20210801702, 20210764291, 20210832446, 20210858936 and 20210729626. Additional information was received on 30-sep-2021. The following information was updated and incorporated into the case narrative: Cessation date was added for event (multiorgan failure), patient history (Heart disorder) was subsumed under probable heart disease.; Sender''s Comments: V0- 20210823446- Covid-19 vaccine ad26.cov2.S � Arrest cardiac, Multiorgan failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: MULTI ORGAN FAILURE


VAERS ID: 1758142 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Suspected COVID-19, 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: 2021-09-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: positive
CDC Split Type: ITJNJFOC20211001062

Write-up: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINE FAILURE; This spontaneous report received from a patient via social media via a company representative concerned a 36-year-old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient got tested positive for Covid-19 (suspected clinical vaccine failure and suspected covid-19 infection), and was admitted in Intensive Care on 06-SEP-2021 after showing positive signs for Covid-19. On 23-SEP-2021, the patient died from covid-19 infection. It was reported that, "He died after days of agony, following a dramatic worsening of his health condition following vaccination". It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected clinical vaccine failure was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). The report was associated with product quality complaint: 90000195633. This case, from the same reporter is linked to 20211001082.; Sender''s Comments: V0: 20211001062-COVID-19 VACCINE AD26.COV2.S-suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211001062-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID-19 INFECTION


VAERS ID: 1758305 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anosmia, Dizziness, Pain
SMQs:, Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210960115

Write-up: BODYACHE/ACHE; LOSS OF SMELL; DIZZINESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300107654] concerned a 73 year old female of an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 209C21A, expiry: unknown) dose was not reported, with frequency time 1 total administered on 03-AUG-2021 for an unknown indication. No concomitant medications were reported. On 04-AUG-2021, the patient experienced body ache, loss of smell, and dizziness. On an unspecified date, the patient experienced ache. On an unspecified date, the patient died from body ache/ache, loss of smell, and dizziness. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210960115-covid-19 vaccine ad26.cov2.s-body ache/ache, loss of smell, dizziness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BODYACHE/ACHE; LOSS OF SMELL; DIZZINESS


VAERS ID: 1760077 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-08-31
   Days after vaccination:204
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210831; Test Name: SARS Covid-2 PCR; Test Result: Positive ; Comments: Variant PCR-based B.1.617.2 Sequenced variant: n.a. n501y-positive: No.
CDC Split Type: ATPFIZER INC202101272368

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-044583. A 95-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 08Feb2021 (Batch/Lot Number: EK9788) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 14Jan2021 (Batch/Lot Number: EJ6797) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Aug2021, the patient experienced SARS-CoV-2 infection, vaccination failure, with fatal outcome. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 31Aug2021 (Variant PCR-based B.1.617.2 Sequenced variant: n.a. n501y-positive: No). The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, no further information is expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1760078 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-08-10
   Days after vaccination:178
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / OT

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: not available n501y-positive: no
CDC Split Type: ATPFIZER INC202101272104

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the Regulatory Authority-WEB (regulatory authority number AT-BASGAGES-2021-044584). A 96-year-old female patient received the first dose of BNT162B2 (COMIRNATY) intramuscular on 20Jan2021 (Lot Number: EL1491) as single dose and the second dose of BNT162B2 (COMIRNATY) intramuscular on 13Feb2021 (Lot Number: EJ6790) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 10Aug2021, the patient experienced vaccination failure and SARS-CoV-2 infection, both with fatal outcome; the patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures on an unspecified date, which included PCR test which was positive (Variant PCR-based: B.1.617.2. Variant Sequenced: not available. n501y-positive: no). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1760155 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-24
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4958 / 2 LA / OT

Administered by: Other       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: 2021-06-25
   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: Ache (persistent pain disorder); Adiposis; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101273429

Write-up: Reaction febrile; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-DCGMA-21191857. A 60-year-old male patient received second dose of BNT162b2 (COMIRNATY), intramuscular, administered in arm left on an unspecified date (Lot Number: FD4958) as single dose for COVID-19 immunisation. Medical history included ongoing adiposis, ongoing hypertension arterial and ongoing ache (pain persistent pain disorder). The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162b2 (COMIRNATY) on an unspecified date (Lot Number: ID014A) as single dose for COVID-19 immunisation. The patient experienced reaction febrile on 24Jun2021. The event was reported as fatal, the patient died on 25Jun2021. It was not reported if an autopsy was performed. The institute assessed relatedness of drug to reaction/event as unclassifiable.; Reported Cause(s) of Death: Reaction febrile


VAERS ID: 1760425 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Exhaustion; General malaise; Infarct myocardial; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101272685

Write-up: Unknown cause of death; Arrhythmia; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority number DE-PEI-CADR2021182599, Safety Report Unique Identifier DE-PEI-202100195723. A 70-year-old female patient received BNT162B2 (COMIRNATY) on 21Jul2021, at single dose, for COVID-19 immunisation. Relevant medical history included infarct myocardial on an unspecified date, in 2016. The patient''s weight was 55 kg, and height was 152 cm. Concomitant medications were unknown. On 22Jul2021, the patient experienced arrhythmia. On 23Jul2021 the patient died. Unknown cause of death was reported. No autopsy was done. The patient''s outcome was: unknown for arrhythmia, fatal for unknown cause of death. This report is serious - death. Result of assessment for Unknown cause of death/PEI / D. Unclassifiable Result of assessment for Arrhythmia/PEI / D. Unclassifiable Sender Comment: The person did not concern have any known allergies. Details of risk factors or previous diseases Minor heart attack 2016, smoker / general malaise, exhaustion. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1760552 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-09-04
   Days after vaccination:192
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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: 2021-09-09
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 antigen test; Test Result: Negative ; Comments: She did an antigen and RT PCR test on 23Aug2021, they were negative before the 23rd; Test Date: 20210823; Test Name: SARS-CoV-2 antigen test; Result Unstructured Data: Test Result:Results not reported; Test Name: SARS-CoV-2 RT-PCR test; Test Result: Negative ; Comments: She did an antigen and RT PCR test on 23Aug2021, they were negative before the 23rd; Test Date: 20210823; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Test Result:Results not reported
CDC Split Type: FRPFIZER INC202101273890

Write-up: Vaccination failure; Suspected Covid-19; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LL20216421. An 84-year-old female patient received two doses of BNT162B2 (COMIRNATY), the 1st injection on 03Feb2021 and the 2nd injection on 24Feb2021, both intramuscularly, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 17Aug2021, appearance of asthenia and hyperthermia. She did an antigen and RT PCR test on 23Aug2021, they were negative before the 23rd. The patient was hospitalized on 04Sep2021. Suspected COVID-19 was reported. The patient died on 09Sep2021. It was unknown if autopsy was done. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Suspected COVID-19; Drug ineffective


VAERS ID: 1760554 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH9951 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dysphagia, Heart rate, Immunisation, Off label use, Oxygen saturation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIFFU K; IPRATROPIUM; ROSUVASTATINE [ROSUVASTATIN]; NICORANDIL; TRINITRINE; RISPERIDONE; OXAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Aspiration pneumonia (last episode on 03Sep2021); Cardiac pacemaker insertion; COPD; Decompensation cardiac; Deglutition disorder; Dementia aggravated; Dyslipidemia; Hypertension arterial; Infarct myocardial; Living in residential institution; Type I second degree atrioventricular block
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: arterial tension; Result Unstructured Data: Test Result:103/48; Comments: within 1st hour after vaccination; Test Date: 20210914; Test Name: arterial tension; Result Unstructured Data: Test Result:108/56; Comments: 15min later; Test Date: 20210914; Test Name: temperature; Result Unstructured Data: Test Result:35.5; Comments: within 1st hour after vaccination; Test Date: 20210914; Test Name: temperature; Result Unstructured Data: Test Result:35.5; Comments: 15min later; Test Date: 20210914; Test Name: pulse; Result Unstructured Data: Test Result:69; Comments: within 1st hour after vaccination; Test Date: 20210914; Test Name: pulse; Result Unstructured Data: Test Result:69; Comments: 15min later; Test Date: 20210914; Test Name: saturation; Result Unstructured Data: Test Result:96; Comments: within 1st hour after vaccination; Test Date: 20210914; Test Name: saturation; Result Unstructured Data: Test Result:95; Comments: 15min later
CDC Split Type: FRPFIZER INC202101262861

Write-up: Sudden death; deglutition trouble; off label use; booster; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-LM20212591. A 90-year-old male patient received the third dose of BNT162B2 via intramuscular on 14Sep2021 (Lot Number: FH9951) as single dose for COVID-19 immunization. Medical history included deglutition disorder, AFib from 2012, hypertension arterial, dyslipidaemia, COPD, infarct myocardial from 1988, decompensation cardiac from 2012, cardiac pacemaker insertion from 2016, type I second degree atrioventricular block from 2012, dementia aggravated, long-term care unit resident and aspiration pneumonia (last episode on 03Sep2021). Concomitant medications included potassium chloride (DIFFU K), ipratropium, rosuvastatine [rosuvastatin], nicorandil, glyceryl trinitrate (TRINITRINE), risperidone from an unspecified date to 14ep2021 and oxazepam from an unspecified date to 10Sep2021. The patient previously received the second dose and the first dose of BNT162B2, the first dose on 16Feb2021 (Lot Number: EMP6950), the second dose on 09Mar2021 (Lot Number: EP2166), both via an unspecified route of administration as single dose for COVID-19 immunization. Clinical condition (interview with the healthcare team present on 09/14 evening): no change compared to its usual condition on 14Sep2021 after vaccination. No new symptoms, no nurse or doctor intervention. Dined well in the evening of 14Sep2021. In the evening had a bronchial aspiration because congested, without dyspnea. Saturation not measured. Found deceased during the night during the last round of the night shift. In summary: Death in a 90-year-old patient, with multiple pathologies, with swallowing disorders and several episodes of aspiration pneumonia, occurring after the 3rd dose of COVID vaccine, with no identified post-vaccination symptoms, except for am aspiration trouble the evening before his death. Living in medicalised facility for elderly people. General condition: altered, polypathological with swallowing disorder and aspiration complicated by inhalation pneumopathy (last episode on 03Sep2021); fluctuating clinical condition with periods of drowsiness and restlessness. Peri-vaccination monitoring of 14Sep2021 (systematic monitoring sheet): no effect after previous doses. Treatment included, Ongoing as of 14Sep2021, diffu K 600 mg, ipratropium, Rosuvastatin 5 mg: 1: day. Nicorandil 10 mg. Trinitrine 5 mg. Risperidone if needed and Oxazepam 10 if needed (last taken on 10Sep2021). Therapeutic modification in the previous 15 days: switch to taking Risperidone if needed (was under Risperidone 0.5 mg / day systematically before) this treatment was administered every day from 10Sep2021 to 14Sep2012). On 14Sep2021, within 1st hour after vaccination, arterial tension: 103/48, 15min later, arterial tension: 108/56. On 14Sep2021, within 1st hour after vaccination, temperature was 35.5, 15min later, temperature was 35.5. On 14Sep2021, within 1st hour after vaccination, pulse was 69, 15min later, pulse was 69. On 14Sep2021, within 1st hour after vaccination, saturation was 96, 15min later was 95. The patient died on an unspecified date. Autopsy was unknown. The outcome of events was fatal.; Reported Cause(s) of Death: Sudden death; Deglutition disorder; Off label use; Booster


VAERS ID: 1760582 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-07-16
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood creatine phosphokinase, Blood creatinine, C-reactive protein, Chronic obstructive pulmonary disease, Gamma-glutamyltransferase, Myoglobin blood, N-terminal prohormone brain natriuretic peptide, Platelet count, Respiratory acidosis, SARS-CoV-2 test, Troponin, White blood cell count
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 18
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: ENALAPRIL EG; ULTIBRO BREEZHALER [GLYCOPYRRONIUM BROMIDE;INDACATEROL MALEATE]; EUPANTOL; LERCANIDIPINE HYDROCHLORIDE; PAROXETINE HYDROCHLORIDE; ESIDREX; RIVAROXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Alcohol use (Between 10 and 40 g per day); Chronic obstructive pulmonary disease; Chronic sinusitis; Depression; Embolism pulmonary; Ex-tobacco user; Hypercholesterolaemia; Hypertension arterial; Prevention
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:35 IU/l; Comments: Units:U/L; Test Date: 20210719; Test Name: ASAT; Result Unstructured Data: Test Result:60 IU/l; Comments: Units:U/L; Test Date: 20210719; Test Name: Creatine phosphokinase; Result Unstructured Data: Test Result:657 IU/l; Comments: Units:U/L; Test Date: 20210719; Test Name: Creatinine; Result Unstructured Data: Test Result:81 umol/l; Test Date: 20210719; Test Name: C-reactive protein; Result Unstructured Data: Test Result:29.7 mg/l; Test Date: 20210719; Test Name: Gamma GT; Result Unstructured Data: Test Result:65 IU/l; Comments: Units:U/L; Test Date: 20210719; Test Name: Myoglobin blood; Result Unstructured Data: Test Result:391 IU/l; Comments: Units:U/L; Test Date: 20210719; Test Name: NT-proBNP; Result Unstructured Data: Test Result:234.1 pg/mL; Test Date: 20210719; Test Name: Platelet count; Result Unstructured Data: Test Result:303000 /mm3; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210719; Test Name: Troponin; Result Unstructured Data: Test Result:57 ng/L; Test Date: 20210719; Test Name: White blood cell count; Result Unstructured Data: Test Result:18800 /mm3
CDC Split Type: FRPFIZER INC202101273108

Write-up: Chronic obstructive airways disease exacerbated / exacerbation of COPD; hypercapnic acidosis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-NY20214371. A 70-year-old male patient received the first dose of BNT162B2 (COMIRNATY, mRNA encoding the peak viral protein (S) of SARS-CoV-2) via intramuscular on 05Jun2021 (Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included hypercholesterolemia, chronic sinusitis, chronic obstructive pulmonary disease (COPD), abdominal aortic aneurysm, ex-tobacco user, depression, embolism pulmonary (since 2020), prevention, hypertension arterial and alcohol use (between 10 and 40 g per day). Concomitant medication included enalapril maleate (ENALAPRIL EG) taken for hypertension arterial, glycopyrronium bromide, indacaterol maleate (ULTIBRO BREEZHALER [GLYCOPYRRONIUM BROMIDE;INDACATEROL MALEATE]) taken for COPD, pantoprazole sodium sesquihydrate (EUPANTOL) taken for prevention, lercanidipine hydrochloride taken for hypertension arterial, paroxetine hydrochloride taken for depression, hydrochlorothiazide (ESIDREX) taken for hypertension arterial and rivaroxaban taken for embolism pulmonary. On 16Jul2021, 42 day after the beginning of drug administration, 42 days after the last drug administration, the patient developed exacerbation of chronic obstructive pulmonary disease which led to death on 03Aug2021. On 16Jul2021, occurrence of exacerbation of chronic obstructive pulmonary disease. Evolution: Death. The patient was hospitalized in pneumology on 16Jul2021 for an exacerbation of COPD. The initial management consisted of corticosteroid therapy and probabilistic treatment with AUGMENTIN from 18Jul2021 without documentation for the moment with an increase in sputum. The Covid PCR test is negative. During the night of 18Jul2021 to 19Jul2021, respiratory deterioration with hypercapnic acidosis and acute respiratory distress refractory to aerosol therapy, transfer to discharge for further treatment. Failure of non-invasive ventilation and respiratory exhaustion, need to intubate the patient and place him under mechanical ventilation, relay of bi-antibiotic therapy with ROCEPHINE and ROVAMYCINE. Note that the patient was able to benefit from a dose of COVID vaccine and that the second was scheduled for 18Jul2021. The patient is transferred to the intensive care suites for treatment. Acute hypercapnic respiratory failure secondary to an exacerbation of COPD with no point of infectious call found. Pneumopathy acquired under mechanical ventilation with septic shock in E. Coli and S. maltophilia. Treatment with VFEND for bronchial aspergillosis. Inability to wean invasive ventilation during the stay. Illusory invasive ventilation weaning project in view of the underlying respiratory terrain. Multifactorial renal failure (sepsis, limb ischemia) occurred during the stay. Limb ischemia with rhabdomyolysis; therapeutic impasse with evolution towards a multi-visceral failure. Faced with multiorgan failure, namely acute renal failure, hyperkalaemia, respiratory, and hemodynamics, most likely due to vascular disease, in a context of COPD Gold IV at Day 14 of invasive ventilation with probable sepsis at the pulmonary starting point treated with BACTRIM, TAZOCILLINE and V- FEND for pulmonary aspergillosis, it was decided not to initiate other invasive therapies, namely no external cardiac massage and no extra-renal purification. This decision is made in agreement with the family. It is in this context the death occurs on 03Aug2021 at 2:58 p.m. Additional tests included On 19Jul2021, Platelet count (Platelet count): 303,000 per cubic millimeter. Leukocyte count (White blood cell count): 18800 per cubic millimeter. Creatinine (Creatinine): 81 micromole per liter. ASAT (ASAT): 60 enzyme unit per liter. Alanine aminotransferase (Alanine aminotransferase): 35 enzyme unit per liter. Blood myoglobin (Blood myoglobin): 391 enzyme unit per liter. Gamma GT (Gamma GT): 65 enzyme unit per liter. Creatine phosphokinase (Creatine phosphokinase): 657 enzyme unit per liter. Troponin (Troponin): 57 nanogram per liter. NT-proBNP (NT-proBNP): 234.1 picogram per milliliter. C-reactive protein (C-reactive protein): 29.7 milligram per liter. Autopsy was unknown. The outcome of chronic obstructive airways disease exacerbated was fatal. The outcome of other event was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Multiple organ failure


VAERS ID: 1760583 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-20
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19, Computerised tomogram, Drug ineffective, Fibrin D dimer, Haemoglobin, Platelet count, Pulmonary embolism, SARS-CoV-2 test, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), 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: 2021-09-07
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Neurosyphilis (treated with corticosteroid therapy)
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: chest CT scan; Result Unstructured Data: Test Result:Typical bi-pulmonary parenchymal involvement; Comments: Typical bi-pulmonary parenchymal involvement with greater than 75% involvement without pulmonary embolism.; Test Date: 20210831; Test Name: Scanner; Result Unstructured Data: Test Result:Right upper segmental pulmonary embolism; Comments: Right upper segmental pulmonary embolism without evidence of acute pulmonary heart. Pejorative evolution of the parenchymal involvement.; Test Date: 20210820; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:2700 ug/ml; Test Date: 20210820; Test Name: Haemoglobin; Result Unstructured Data: Test Result:14 g/dl; Test Date: 20210820; Test Name: Platelet count; Result Unstructured Data: Test Result:354000 /mm3; Test Date: 20210820; Test Name: Test PCR covid-19; Test Result: Positive ; Comments: VARIANT DELTA; Test Date: 20210820; Test Name: White blood cell count; Result Unstructured Data: Test Result:29000 /mm3
CDC Split Type: FRPFIZER INC202101273098

Write-up: Drug ineffective; COVID-19; pulmonary embolism; Acute Respiratory Distress Syndrome; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority report number is FR-AFSSAPS-NY20214412. A 65-year-old male patient received the second dose of BNT162B2 (COMIRNATY, mRNA encoding the peak viral protein (S) of SARS-CoV-2) via intramuscular in Jun2021 (Lot Number: Unknown ) as single dose for COVID-19 immunization. Medical history included neurosyphilis treated with corticosteroid therapy. Concomitant medication was not specified. The patient died on 07Sep2021. ospitalization in intensive care unit for pneumopathy and then pulmonary embolism. Need for ECMO. Recurrent pneumothorax. Fatal outcome. Death 17 days later. CU hospitalization for COVID acute respiratory distress syndrome (ARDS) documented with DELTA variant and complicated by mechanically ventilated acquired pneumonia and pulmonary embolism. Need for extracorporeal membrane oxygenator (ECMO). Recurrent pneumothorax. Unfavourable evolution. Patient died on 07Sep2021 from refractory ARDS. Additional examinations: On 20Aug2021, PCR covid-19 test: positive. Thoracic Angioscan (CT Scan): Typical bi-pulmonary parenchymal involvement with greater than 75% involvement without pulmonary embolism. Leukocyte count: 29000 per cubic millimeter. emoglobin: 14 gram per deciliter. latelet count: 354000 per cubic millimeter. -Dimer: 2700 microgram per milliliter. T scan: right upper segmental pulmonary embolism without signs of acute pulmonary heart disease. Pejorative course of parenchymal involvement. Autopsy was unknown. The outcome of events was fatal. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: COVID-19; Acute Respiratory Distress Syndrome; Embolism pulmonary; Drug ineffective


VAERS ID: 1760600 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-10
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   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: Down''s syndrome; Drug allergy; Edema Quincke''s; Epilepsy; Pervasive developmental disorder; Pneumopathy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20211002082

Write-up: VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (JANSSEN Vaccines, FR-AFSSAPS-RN20212825) on 01-OCT-2021 and concerned a 64 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: drug allergy, pervasive developmental disorder, edema quincke''s, epilepsy, pneumopathy, and down''s syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported and expiry: Unknown) 1 dosage forms, 1 total, administered on 18-JUN-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 10-AUG-2021, the patient experienced vaccination failure. On 01-SEP-2021, the patient died from covid-19 pneumonitis. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Reported Cause(s) of Death: COVID-19 PNEUMONITIS


VAERS ID: 1760614 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-09-05
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood pressure measurement, Body temperature, COVID-19, Heart rate, Oxygen saturation, Physical examination, Respiratory rate, 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: 2021-09-07
   Days after onset: 2
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:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: cardiopulmonary auscultation; Result Unstructured Data: Test Result:patient with bilateral congestion; Test Date: 20210906; Test Name: cardiopulmonary auscultation; Result Unstructured Data: Test Result:Some rhonchi with 2 bases; Test Date: 20210906; Test Name: Arterial blood pressure; Result Unstructured Data: Test Result:15/8; Test Date: 20210905; Test Name: temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210906; Test Name: temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Test Date: 20210905; Test Name: heart rate; Result Unstructured Data: Test Result:100; Test Date: 20210906; Test Name: heart rate; Result Unstructured Data: Test Result:100; Comments: / min, regular; Test Date: 20210906; Test Name: Desaturation; Result Unstructured Data: Test Result:Desaturation this morning; Comments: requiring high concentration mask; Test Date: 20210905; Test Name: pulsed oxygen saturation; Test Result: 91 %; Comments: under 3l O2; Test Date: 20210906; Test Name: abdomen examination; Result Unstructured Data: Test Result:Sensitive abdomen left iliac fossa, defenseless; Test Date: 20210905; Test Name: physical examination; Result Unstructured Data: Test Result:Sleepy patient ++, no marbling; Test Date: 20210906; Test Name: physical examination; Result Unstructured Data: Test Result:sleepy and weak; Test Date: 20210906; Test Name: Respiratory rate; Result Unstructured Data: Test Result:48; Comments: / min polypneic 48 / min with slight draft and thoraco-abdominal swing; Test Date: 20210905; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: variant unknown
CDC Split Type: FRPFIZER INC202101273312

Write-up: vaccination failure confirmed; COVID-19 confirmed by positive COVID PCR test, variant unknown; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority -WEB FR-AFSSAPS-TO20218095. An 89-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: Unknown) on 27May2021 and the first dose of BNT162B2 (Lot Number: Unknown) on 15Apr2021, both via intramuscular at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure confirmed and COVID-19 confirmed by positive COVID PCR test, variant unknown on 05Sep2021. Duration was reported as 3 days. Seen by the doctor on call in the residential care. The patient underwent lab tests and procedures on 05Sep2021 which included COVID-19 PCR test: positive (variant unknown), physical examination: sleepy patient ++, no marbling, cardiopulmonary auscultation: patient with bilateral congestion, pulsed oxygen saturation 91% (under 3l O2), temperature 37.7 Centigrades, heart rate: 100. Discussion with the team, no hospitalization given the significant previous dependence. Therapeutic measures were taken as a result of events and included treatment with corticosteroid therapy and antibiotic therapy administered intramuscularly (IM). On 06Sep2021, worsening of the general condition in 48h. Doctor on duty introduced CST IM + ceftriaxone sodium (ROCEPHINE) IM. Desaturation this morning requiring high concentration mask. Algique to mobilization. The patient underwent lab tests and procedures on 06Sep2021 which included physical examination: sleepy and weak, temperature: 37.2 Centigrade, arterial blood pressure: 15/8, respiratory rate: 48 / min (polypneic 48 / min with slight draft and thoraco-abdominal swing), regular heart sounds: 100/min, cardiopulmonary auscultation: some rhonchi with 2 bases, abdomen examination: sensitive abdomen left iliac fossa, defenseless. Therapeutic measures were taken as a result of events and included treatment with continuation CST IM, stop ceftriaxone sodium IM, stop ceftriaxone sodium IM, continuation O2 with high concentration mask, introduction fentanyl (DUROGESIC) 25mg, introduction of hyoscine (SCOPODERM), introduction midazolam (HYPNOVEL) 10 mg subcutaneously over 24h. Family warned palliative treatment no harsh treatment no hospitalization. The patient died on 07Sep2021. Patient''s death from COVID 19 on 07Sep2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: vaccination failure confirmed; COVID-19 confirmed by positive COVID PCR test, variant unknown


VAERS ID: 1760615 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-08-23
   Days after vaccination:173
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-29
   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: Dementia Alzheimer''s type (very advanced)
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic psychosis
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: Test SARS-CoV-2; Test Result: Positive ; Comments: Variant Delta
CDC Split Type: FRPFIZER INC202101278480

Write-up: Drug Ineffective; Symptomatic Covid-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB - [FR-AFSSAPS-TO20218132]. A 96-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 03Mar2021 (Batch/Lot Number: EP9598) as dose 2, single for covid-19 immunisation. Medical history included ongoing Dementia in very advanced Alzheimer''s disease and Chronic psychosis from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was reported that on 23Aug2021 Symptomatic Covid-19 (also reported as Drug Ineffective). The Sars-Cov-2 test carried out on 23Aug2021: positive with the presence of the Delta variant. On-site medical care respond to current recommendations. The patient died on 29Aug2021 (also reported as EVOLUTION: death on 29Aug2021/ Pneumonie covid-19). An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonie covid-19


VAERS ID: 1761177 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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: Comments: The patient was healthy, active and had no health problems.
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRJNJFOC20211003738

Write-up: DIED DUE TO THE VACCINE; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient''s height, and weight were not reported. The patient was healthy, active and had no health problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date was not reported,1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient died due to the vaccine. On an unspecified date, it was confirmed by examination (autopsy) as the cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to the vaccine on an unspecified date. This report was serious (Death).; Sender''s Comments: V0. 20211003738-COVID-19 VACCINE AD26.COV2.S- Died due to the vaccine. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: DIED DUE TO THE VACCINE; Autopsy-determined Cause(s) of Death: DIED DUE TO THE VACCINE


VAERS ID: 1761185 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Interchange of vaccine products, Off label use
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101288092

Write-up: after 4 days he died; Dose 1 and Dose 2 of CORONAVAC, Dose 3 of COMIRNATY; Dose 1 and Dose 2 of CORONAVAC, Dose 3 of COMIRNATY; This is a spontaneous report from a contactable consumer (patient''s daughter). A male patient of an unspecified age received BNT162b2 (COMIRNATY, Solution for injection), dose 3 via an unspecified route of administration on 04Sep2021 as single dose for COVID-19 immunisation. Medical history included ''He did not have comorbidities, nor any kind of disease. Historic vaccine included Coronavac on 08Feb2021 the first dose and on 08Mar2021 the second dose of Coronavac both for COVID-19 immunization. The patient''s concomitant medications were not reported. As reported, the patient''s daughter stated ''I come through this request an investigation or notification about the happening with the event that occurred with the death of the patient on 08Sep2021, of this current year. An unknown country is a villainy, with good people dying with the lack of prepare of a regulatory authority, deciding that elderly people take vaccines wildly''. Her father took two doses of Coronavac and full vaccinated. Her father had the booster dose on September 4th 2021, he took the Pfizer one and after 4 days he passed away. The patient died on 08Sep2021. It was not reported if an autopsy was performed. The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: after 4 days he died


VAERS ID: 1762456 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-16
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Communication disorder; COVID-19; Immobile; Living in care
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:above 40 Centigrade; Comments: High fever above 40 degrees C
CDC Split Type: DEPFIZER INC202101272639

Write-up: Pyrexia / High fever above 40 degrees C; Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021181185, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100193389. An 83 years-old female patient received BNT162B2 (COMIRNATY, Lot. FE9174) on 21Jul2021, at single dose, for COVID-19 immunisation. The patient''s weight was 80 kg, and height was 165 cm. Concomitant medications were unknown. On 16Aug2021 the patient died. Unknown cause of death was reported. The patient experienced also pyrexia on an unspecified date. The patient''s outcome was: not recovered/not resolved for pyrexia, fatal for unknown cause of death. No autopsy was done. This report is serious - death. Sender''s comments: Information on risk factors or pre-existing conditions severe care, immobile and hardly responsive. Reportedly had Covid19 in Dec2020. Died on 16Aug2021. The time relationship is thus given. / High fever above 40 degrees C. Result of Assessment: Comirnaty/ all event(s): Regulatory Authority: D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1762459 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCPT7 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, 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), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-30
   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: Medical History/Concurrent Conditions: Hypertension; Venous insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101278145

Write-up: Arrhythmia; sudden cardiac arrest; This is a spontaneous report from a non-contactable consumer downloaded from the WEB [DE-PEI-CADR2021183481]. Sender''s Safety Report Unique Identifier is DE-PEI-202100196938. A 41-year-old male patient received BNT162B2 (COMIRNATY, Lot#: SCPT7, Strength: 0.3 mL) at single dose on 24Aug2021 for COVID-19 immunisation. Medical history included hypertension; venous insufficiency. Concomitant medications were not reported. On 30Aug2021, the patient experienced arrhythmia and died the same day. It was sudden cardiac arrest with attempted resuscitation without success. It was unknown if an autopsy was performed. The outcome of events was fatal. This report was serious - death. Sender Comment: Are allergies known for you or the person concerned? If yes, which? no Information about risk factors or pre-existing conditions: Hypertension, well adjusted venous insufficiency / Sudden cardiac arrest with attempted resuscitation without success ; Reported Cause(s) of Death: sudden cardiac arrest; Arrhythmia


VAERS ID: 1762477 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Off label use, Pulmonary embolism
SMQs:, Embolic and thrombotic events, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101293190

Write-up: suspicion of pulmonay embolism; third dose COMIRNATY; third dose COMIRNATY; This spontaneous report was received from a not-contactable physician and based on information received by Pfizer from Biontech [manufacturer control number: 89606], license party for Comirnaty. An 88-year-old female patient (Unknown pregnant) received the third dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the second dose and the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unspecified date, the patient experienced suspicion of pulmonay embolism (patient complained of shortness of breath before death). The patient died on an unspecified date. Autopsy was not reported. The outcome of pulmonary embolism was fatal. The outcome of other events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1762614 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-08-13
   Days after vaccination:189
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Chest X-ray, Diarrhoea, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-17
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation paroxysmal; Cardiac assistance device user; Dementia Alzheimer''s type; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210814; Test Name: Thorax X-ray; Result Unstructured Data: Test Result: pneumonia; Comments: RIGHT BASAL INFILTRATE, LEFT BASAL PLEURITIS; Test Date: 20210814; Test Name: Oxygen saturation; Result Unstructured Data: Test Result: low; Test Date: 20210814; Test Name: SARS-CoV-2 PCR test; Test Result: Positive.
CDC Split Type: ESPFIZER INC202101285121

Write-up: COVID-19 pneumonia; Vaccination failure; Oxygen saturation low; Dyspnea; diarrhoea; This is a spontaneous report from a contactable pharmacist from the Regulatory Authority. The regulatory authority number ES-AEMPS-976741. A non-pregnant 97-year-old female patient received the bnt162b2 (COMIRNATY), dose 2 on 05Feb2021 (Lot Number: EL8723; Expiration Date: 31May2021), dose 1 on 15Jan2021 (Lot Number: EM0477; Expiration Date: 30Apr2021), both dose via an unspecified route of administration, administered in arm as a single dose for covid-19 immunization. The patient was no pregnant at time of vaccination. Medical history included Dementia Alzheimer''s type, Atrial fibrillation paroxysmal, Hypertension arterial, Pacemaker carrier. The patient''s concomitant medications were not reported. On 13Aug2021 the patient presented diarrhoea. On 14Aug2021, the patient experienced covid-19 pneumonia, vaccination failure, oxygen saturation low, dyspnea. All events assessed as serious (death, hospitalization). The patient underwent lab tests and procedures which included chest x-ray pneumonia (right basal infiltrate, left basal pleuritis) on 14Aug2021, oxygen saturation low on 14Aug2021, SARS-CoV-2 PCR test positive on 14Aug2021. The patient died on 17Aug2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EM0477 (dose 1) and lot EL8723 (dose 2). A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, and stability. Concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed. No follow-up attempts are possible, no information is expected. Reported Cause(s) of Death: COVID-19 pneumonia; Vaccination failure; Oxygen saturation low; Dyspnea; Diarrhoea


VAERS ID: 1762646 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-07-19
   Days after vaccination:66
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac disorder, Coma, Delirium, Encephalitis autoimmune, Fall, Fatigue, Infection, Investigation, Lumbar puncture, Metabolic disorder, Oedema peripheral, Orthostatic hypotension, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-26
   Days after onset: 38
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: BETAXOLOL; ESOMEPRAZOLE; NORSET; DUTASTERIDE; KARDEGIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of prostate; Chronic renal failure; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: orthostatic hypotension test; Test Result: Positive ; Comments: orthostatic hypotension test was positive; Test Name: lumbar puncture; Result Unstructured Data: Test Result:autoimmune encephalitis confirmed; Comments: autoimmune encephalitis confirmed by the presence of anti-NMDAR antibodies; Test Date: 20210716; Test Name: Covid polymerase chain reaction test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101278957

Write-up: fatigue; fall; fainting; edema of the lower legs/pitting; cardiac decompensation; orthostatic hypotension; worsening asthenia; harmful delirium; comatose state; infectious and metabolic complications; metabolic complications; Encephalitis autoimmune; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-BX20218847. A 93-years-old male patient received 2nd single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT number: FA5831, expiration date unknown) intramuscularly on 14May2021 for COVID-19 immunisation. Medical history included adenocarcinoma of prostate from an unknown date and unknown if ongoing, hypertension arterial from an unknown date and unknown if ongoing, chronic renal failure from an unknown date and unknown if ongoing. Patient previously received 1st single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT number: EW4815, expiration date unknown) intramuscularly in the left arm on 17Apr2021 for COVID-19 immunisation. Concomitant medications included betaxolol taken for an unspecified indication, start and stop date were not reported; esomeprazole taken for an unspecified indication, start and stop date were not reported; mirtazapine (NORSET) taken for an unspecified indication, start and stop date were not reported; dutasteride taken for an unspecified indication, start and stop date were not reported; acetylsalicylate lysine (KARDEGIC) taken for an unspecified indication, start and stop date were not reported. Autoimmune encephalitis discovered 2 months after dose 2. Patient was hospitalised on 16Jul2021, that was (i.e.) 2 months after dose 2, because of a few days of fatigue with a fall at home and fainting without loss of consciousness. On intake, the patient presented edema of the lower legs, showing pitting to varying degrees without any sign of deep vein thrombosis. Treatment with Lasilix due to suspected cardiac decompensation, offering a reduction in the edema. Regarding the falls, the orthostatic hypotension test was positive, leading to the fitting of compression stockings. During hospitalization, rapidly worsening asthenia followed by harmful delirium and a comatose state. The report showed autoimmune encephalitis confirmed by the presence of anti-NMDAR antibodies on lumbar puncture. Treatment with Vimpat and corticosteroids did not improve the patient''s state of alertness. The patient experienced infectious and metabolic complications on an unspecified date with seriousness criteria of death, encephalitis autoimmune on 19Jul2021 with seriousness criteria of hospitalized on 16Jul2021 and outcome of not recovered, fatigue on an unspecified date with seriousness criteria of hospitalized on 16Jul2021 and outcome of unknown, fall on an unspecified date with seriousness criteria of hospitalized on 16Jul2021 and outcome of unknown, fainting on an unspecified date with seriousness criteria of hospitalized on 16Jul2021 and outcome of unknown, edema of the lower legs/pitting on an unspecified date with seriousness criteria of 16Jul2021 and outcome of unknown, cardiac decompensation on an unspecified date with seriousness criteria of hospitalized on 16Jul2021 and outcome of unknown, orthostatic hypotension on an unspecified date with seriousness criteria of hospitalized on 16Jul2021 and outcome of unknown, worsening asthenia on an unspecified date with seriousness criteria of hospitalization and outcome of unknown, harmful delirium on an unspecified date with seriousness criteria of hospitalization and outcome of unknown, comatose state on an unspecified date with seriousness criteria of hospitalization and outcome of unknown. The patient was hospitalized for encephalitis autoimmune from 16Jul2021 to an unknown date. The patient was hospitalized for fatigue from 16Jul2021 to an unknown date. The patient was hospitalized for fall from 16Jul2021 to an unknown date. The patient underwent lab tests and procedures which included investigation: positive on an unspecified date orthostatic hypotension test was positive, lumbar puncture: autoimmune encephalitis confirmed on an unspecified date autoimmune encephalitis confirmed by the presence of anti-NMDAR antibodies, Covid polymerase chain reaction test was negative on 16Jul2021. Therapeutic measures were taken as a result of encephalitis autoimmune, fatigue, fall, fainting, edema of the lower legs/pitting, cardiac decompensation, orthostatic hypotension, worsening asthenia, harmful delirium, comatose state. The patient died on 26Aug2021. Cause of death was infectious and metabolic complications. It was not reported if an autopsy was performed. NB : Accountability "without prejudice to any investigations that may be carried out in the context of legal or amicable compensation procedures.". No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: infectious and metabolic complications; infectious and metabolic complications


VAERS ID: 1762654 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-08-11
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Drug ineffective, Dyspnoea, Lung disorder, Oxygen saturation, Oxygen saturation decreased, Pulmonary function test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-22
   Days after onset: 11
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; Dyslipidemia
Allergies:
Diagnostic Lab Data: Test Name: saturation; Test Result: 64 %; Comments: under 12 l oxygen; Test Name: pulm impairment; Test Result: 75 %; Comments: pulm impairment
CDC Split Type: FRPFIZER INC202101291875

Write-up: COVID-19; Severe desaturation 64% under 12 l oxygen; dyspnea; pulm impairment; vaccine failure; COVID-19 pneumonitis; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority -WEB, regulatory authority number FR-AFSSAPS-LY202110420. An 88-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: ER2659), via intramuscular on 09Mar2021 as dose 1, single for covid-19 immunization. Medical history included arterial hypertension, dyslipidaemia; both from an unknown date and unknown if ongoing. The concomitant medications were not reported. On an unspecified date, the patient had covid-19, severe desaturation 64% under 12 l oxygen with dyspnea and pulm impairment 75%. On 11Aug2021, the patient experienced covid-19 pneumonitis and vaccine failure. The patient underwent lab tests and procedures which included oxygen saturation: 64 % (under 12 l oxygen), pulmonary function test: 75 % (pulm impairment) on an unspecified date. Continuing care hospitalization on 22Aug2021. The patient died on 22Aug2021. The cause of death was unknown. It was not reported if an autopsy was performed. The outcome of all the events was unknown while covid-19 pneumonitis was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1762673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage, Platelet count, Rectal haemorrhage, Red blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-15
   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: METHOTREXATE; FOLIC ACID; SIMPONI; DIFFU K; BECILAN; BISOPROLOL; XATRAL; ZARZIO; RIFADINE; LOVENOX; DEXAMBUTOL; PIRILENE; RIMIFON
Current Illness: Bone tuberculosis (bone and lung tuberculosis); Thrombocytopenia
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalization (for tuberculosis: in geriatric ward)
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: platelet count; Result Unstructured Data: Test Result:42 x10 9/l; Test Date: 20210910; Test Name: platelet count; Result Unstructured Data: Test Result:42 x10 9/l; Test Date: 20210914; Test Name: platelet count; Result Unstructured Data: Test Result:97 x10 9/l; Test Date: 20210914; Test Name: red blood cells; Result Unstructured Data: Test Result:7.7 g/dl; Comments: anaemia
CDC Split Type: FRPFIZER INC202101278533

Write-up: upper digestive haemorrhage; rectorragia; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Agency (RA)-WEB FR-AFSSAPS-MP20217735.Safety Report Unique Identifier FR-AFSSAPS-2021133140. A 77-year-old male patient received the first dose of BNT162B2 (COMIRNATY, dilutable dispersion for injection) via intramuscular on 13Sep2021 (Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included thrombocytopenia and bone tuberculosis (bone and lung tuberculosis), both ongoing. The patient hospitalized for tuberculosis: in geriatric ward from 26Aug2021 to 10Sep2021 then from 10Sep2021 to 15Sep2021 in internal medicine, patient with thrombocytopenia at 42 G/L from 08Sep2021 to 10Sep2021. (normal coagulation test). Concomitant medication included rifampicin (RIFADINE [RIFAMPICIN]) for tuberculosis from 11Sep2021, levofloxacin (LOVENOX [LEVOFLOXACIN]) for tuberculosis from 12Sep2021, ethambutol dihydrochloride (DEXAMBUTOL) for tuberculosis from 11Sep2021, pyrazinamide (PIRILENE) for tuberculosis from 11Sep2021, isoniazid (RIMIFON) for tuberculosis from 11Sep2021, methotrexate from 2020, folic acid from 2020, golimumab (SIMPONI) from 2020, potassium chloride (DIFFU K), pyridoxine hydrochloride (BECILAN), bisoprolol, alfuzosin hydrochloride (XATRAL) and filgrastim (ZARZIO) from 11Sep2021 to 13Sep2021. On 15Sep2021, the patient experienced rectorragia. The platelet count was 97G/L on 14Sep2021. The patient received a transfusion of packed red blood cells on 14Sep2021. No melena or digestive disturbances on previous days. On 15Sep2021, the patient was found dead with extravasation of red digestive blood (massive rectorrhagia). The question of an upper digestive haemorrhage was also raised. Treatment included: From 11Sep2021 to 13Sep2021: Zarzio 30 MiU. Since 11Sep2021: Dexambutol in 500mg, Rifadine in 600mg, Pirilene in 2000mg and Rimifon in 300mg. Since more than 1 year: methotrexate 5mg/week, folic acid 5mg/week, Simponi S/C once/month. Since unknown: Diffu K, Becilan, bisoprolol 2.5mg, Xatral LP 40mg, Lovenox 0.4. The patient last took methotrexate on 30Aug2021 and then on 13Sep2021. Died during the night of 14/15Sep2021 due to massive haemorrhage. Autopsy was not preformed. The outcome of Bleeding rectal was fatal. The outcome of other event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtain. No further information is expected.; Reported Cause(s) of Death: gastrointestinal bleeding


VAERS ID: 1762754 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy artery, Biopsy skin, Blood bicarbonate, Blood lactic acid, Body temperature, C-reactive protein, Cardiac arrest, Factor II mutation, Factor V Leiden mutation, Giant cell arteritis, Haematemesis, Haemoglobin, Mean cell volume, Microbiology test, Myelocyte count, Normocytic anaemia, PCO2, PO2, Platelet count, Positron emission tomogram, Purpura, Spinal myelogram, Sputum test, Urine analysis, Weight, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (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), Congenital, familial and genetic disorders (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Vasculitis (narrow), Chronic kidney disease (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-12
   Days after onset: 194
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SIMVASTATIN; CORTANCYL; HYZAAR; XATRAL; AVODART; SYMBICORT; VENTOLINE [SALBUTAMOL]; PLAVIX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carpal tunnel syndrome; Cataract bilateral NOS; Dizziness (at the cerebellar level); Dyspnea exertional; Factor II mutation; Factor V Leiden mutation; Hip prosthesis insertion; Hypercholesterolaemia; Hypertension arterial; Ischemic stroke (put on Plavix revealed by dizziness at the cerebellar level); OA hip (Left hip osteoarthritis); Polymyalgia rheumatica (Pseudo Rhizomelic Arthritis treated with Prednisone); Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Biopsy of the temporal artery; Test Result: Negative ; Test Date: 20210830; Test Name: Skin biopsy; Result Unstructured Data: Test Result:fund a neutrophilic infiltrate without sign of vas; Comments: fund a neutrophilic infiltrate without sign of vasculitis; Test Date: 20210911; Test Name: Bicarbonate; Result Unstructured Data: Test Result:6 mmol/L; Test Date: 20210911; Test Name: lactate; Result Unstructured Data: Test Result:12 mmol/L; Test Date: 202106; Test Name: fever; Result Unstructured Data: Test Result:fever; Test Date: 202106; Test Name: CRP; Result Unstructured Data: Test Result:160 mg/l; Comments: infectious / neoplastic assessment negative.; Test Date: 20210826; Test Name: CRP; Result Unstructured Data: Test Result:35 mg/l; Comments: re-increase of the CRP at 6 months of the Dose 2; Test Name: Factor II mutation; Result Unstructured Data: Test Result:mutation without thrombosis; Comments: mutation without thrombosis; Test Name: Factor v mutation; Result Unstructured Data: Test Result:mutation without thrombosis; Comments: mutation without thrombosis; Test Date: 20210826; Test Name: anemia; Result Unstructured Data: Test Result:8.3 g/dl; Test Date: 20210911; Test Name: anemia; Result Unstructured Data: Test Result:6.4 g/dl; Test Date: 20210826; Test Name: MCV; Result Unstructured Data: Test Result:94; Comments: fl; Test Name: bacteriological samples; Result Unstructured Data: Test Result:negativity; Comments: negativity of the bacteriological samples taken, except for an cytobacteriological examination of sputum of 10Sep2021 postive to S maltophilia at 104 and cytobacterioligical urine exam of 28Aug2021; Test Date: 20210826; Test Name: myelocyte; Test Result: 1.7 %; Test Date: 20210911; Test Name: PCO2; Result Unstructured Data: Test Result:12 mmHg; Test Date: 20210911; Test Name: pH; Result Unstructured Data: Test Result:7.30; Test Date: 20210826; Test Name: platelet; Result Unstructured Data: Test Result:223 x10 9/l; Test Date: 20210911; Test Name: Po2; Result Unstructured Data: Test Result:114 mmHg; Test Date: 202106; Test Name: PET CT; Result Unstructured Data: Test Result:Absence of pathological fixation of the vascular w; Comments: Absence of pathological fixation of the vascular walls; Test Date: 20210709; Test Name: Myelogram; Result Unstructured Data: Test Result:apparently normal marrow; Test Date: 20210910; Test Name: cytobacteriological examination of sputum; Result Unstructured Data: Test Result:postive with Stenotrophomonas maltophilia at 104; Comments: postive with Stenotrophomonas maltophilia at 104; Test Date: 20210828; Test Name: cytobacterioligical urine exam; Result Unstructured Data: Test Result:positive for E; Comments: untreated in the absence of functional urinary signs and leukocyturia; Test Date: 202106; Test Name: Weight; Result Unstructured Data: Test Result:loss of 3 kg
CDC Split Type: FRPFIZER INC202101278521

Write-up: Purpura NOS; spontaneous cardiac arrest due to asystole and death of the patient; Haematemesis; Anemia normocytic; Cranial arteritis; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-PC20214292. A 92-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Hypertension arterial from 2012, OA hip (Left hip osteoarthritis), Dyspnea exertional, Hip prosthesis insertion from 2005, Hypercholesterolaemia, Polymyalgia rheumatica (Pseudo Rhizomelic Arthritis treated with Prednisone), Cataract bilateral NOS from 2005, ischaemic stroke from 2012 (put on Plavix revealed by dizziness at the cerebellar level), carpal tunnel syndrome, operated, dizziness (at the cerebellar level), Factor II and V mutation without thrombosis. Family history: Horton''s disease in his sister. Concomitant medications included simvastatin taken for an unspecified indication, start and stop date were not reported; prednisone (CORTANCYL) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, losartan potassium (HYZAAR) taken for an unspecified indication, start and stop date were not reported; alfuzosin hydrochloride (XATRAL) taken for an unspecified indication, start and stop date were not reported; dutasteride (AVODART) taken for an unspecified indication, start and stop date were not reported; budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported; salbutamol (VENTOLINE) taken for an unspecified indication, start and stop date were not reported; clopidogrel bisulfate (PLAVIX) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose bnt162b2 (COMIRNATY, Lot: unknown) in Jan2021 for COVID-19 immunisation and since January: mechanical pain in the left hip and difficulty getting up from a chair, clopidogrel bisulfate (PLAVIX) for ischaemic stroke and experienced dizziness, prednisone for Pseudo Rhizomelic Arthritis. The patient experienced anemia normocytic (death) on Aug2021 , haematemesis (death) on 11Sep2021 14:00, purpura nos (death, hospitalization) on Aug2021 , cranial arteritis (death) on Mar2021 , spontaneous cardiac arrest due to asystole and death of the patient (death) on 12Sep2021. - Mar2021: onset of symptoms of Horton''s disease.- Jun2021: diagnosis of giant cell arteritis (Horton), unproven in front of a clinical associating : Asthenia, loss of 3 kg, fever, bi-temporal headache, claudication of the jaw.CRP at 160 mg / L, infectious / neoplastic assessment negative.- PET CT: Absence of pathological fixation of the vascular walls.- Biopsy of the temporal artery on 04Jun2021 negative.Treated with corticosteroid therapy with good initial response but corticosteroid dependence at 40 mg / day.- mid Jul2021: cortisone-sparing treatment with Metoject 15 mg / week subcutaneously.-10Aug2021: episode of erysipelas of the right lower limb with favorable evolution after 10 days of treatment with Clamoxyl, the venous echo of the lower limbs was without abnormality. In addition, in the aftermath, the appearance of a right perimalleolar ulcer.Then a picture of purpura of the bilateral lower limbs appeared without fever during the decrease in corticosteroids in the aftermath of erysipelas around 30-35 mg of Cortancyl, in parallel with normocytic anemia of progressive worsening over several weeks, with an isolated episode of black stools, asthenia that continues to worsen progressively, no fever at home, no recurrence of headaches.New biology carried out during the follow-up on 26Aug2021 finding anemia at 8.3 g/dL, myelocyte 1.7%, MCV 94 fL platelet 223 x10 9/l, CRP 35 mg/L.On the hematological level:- Multifactorial aregenerative normocytic anemia (iron deficiency, inflammatory syndrome, probable digestive bleeding, underlying myelodysplasia) without other cytopenia. Iron supplementation with Ferinject 100 mg on 30Aug2021- Myelogram on 09Jul2021 showing an apparently normal marrow.- In terms of Horton''s disease:Ineffectiveness of METHOTREXATE, discontinuation of treatment discussion of the introduction of TOCILIZUMAB after elimination of any infectious process.- On the cutaneous and articular level:Immunological assessment looking for small vessel vasculitis: negative.Skin biopsy performed on 30Aug2021 fund a neutrophilic infiltrate without sign of vasculitis.Biological inflammatory syndrome associated with fever with progressive dyspnea NYHA III: negativity of the bacteriological samples taken (unknown date), except for an cytobacteriological examination of sputum of 10Sep2021 postive to S maltophilia at 104 and cytobacterioligical urine exam of 28Aug2021 positive for E blister untreated in the absence urinary functional sign and leukocyturia.-11Sep2021: hemorrhagic shock with anemia with Hb at 6.4 g /dl and clinically well tolerated hypotension: transfusion of 2 RCCs.Around 14:00, first episode of hematemesis, in a patient who remained normotensive. Second episode of hematemesis around 16:00 with the course of a patient who becomes polypneic with mottling all over the body. It is also hypotensive and tachycardic.Femoral arterial blood gas: lactate at 12 mmol/L, pH at 7.30, Bicarbonate 6 mmol/L, PCO2 12 mmHg and Po2 114 mmHg.Vascular filling with 500 ml of isotonic saline in free flow, then transfusion of 2 CGR, (Red Blood Cell Concentrate) allowing a notable clinical improvement with improvement of mottling and disappearance of agitation.-12Sep2021: spontaneous cardiac arrest due to asystole and death of the patient. Evolution: Death.In total: onset of symptoms of Horton''s disease 1 month after Dose 2 of the COMIRNATY vaccine. Then purpura of the lower limbs, normocytic anemia of progressive aggravation, deterioration of the general state and re-increase of the CRP at 6 months of the Dose 2 then digestive haemorrhage on ulcer and hemorrhagic shock leading to the death at 7 months. Therapeutic measures were taken as a result of events. Physician Office Visit for events.The patient died on 12Sep2021. It was not reported if an autopsy was performed. The outcome of events was fatal. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cranial arteritis; Purpura NOS; Haematemesis; Anemia normocytic; spontaneous cardiac arrest due to asystole and death of the patient


VAERS ID: 1762806 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-03-01
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Investigation, Noninfective encephalitis, Pneumonia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Noninfectious encephalitis (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-09-11
   Days after onset: 193
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Investigation; Result Unstructured Data: Test Result:Encephalitis induced by covid vaccine confirmed; Comments: Encephalitis induced by Covid vaccine confirmed
CDC Split Type: GBPFIZER INC202101280753

Write-up: Renal failure; Pneumonia; Encephalitus inflammation of the brain causing myclonic jerks ; falls ; confusion and terrible body injuries; This is a spontaneous report from a contactable consumer (patient''s child). This report is received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-EYC 00261688 and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25997605. A 88-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 parenteral on 21Jan2021 (Lot number was not reported) as single dose for COVID-19 immunisation (age at vaccination unspecified). The patient''s medical history and concomitant medications were not reported. The patient experienced encephalitis inflammation of the brain causing myoclonic jerks, falls, confusion and terrible body injuries. Jerking started on 01Mar2021. Everything fell out of the patient''s hands and was burning himself spilling hot drinks. Then he started falling causing terrible injuries. He went to hospital and broke his hip in there from these jerks making him fall. He had hip operation and then heart. He also experienced kidney failure and pneumonia, onset date not provided. He spent 5 weeks in hospital and ended up in a nursing home in May. He was admitted back to hospital end of June with hallucinations and still jerking. Every test was done to find the cause and it was confirmed: encephalitis induced by COVID vaccine. Seriousness criteria of this report included hospitalization, life-threatening, death. The patient died on 11Sep2021 due to noninfective encephalitis, recorded on the death certificate. It was not reported if an autopsy was performed. The outcome of events kidney failure and pneumonia was unknown. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Noninfective encephalitis


VAERS ID: 1763070 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101287275

Write-up: Myocardial infarct; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109281742054890-YOMIY, Safety Report Unique Identifier GB-MHRA-ADR 26005954. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Mar2021 (lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myocardial infarct (death) on 15Mar2021. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The outcome of the event was fatal. The patient died on 15Mar2021 due to event. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Myocardial infarct


VAERS ID: 1763071 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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 Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101287249

Write-up: Heart pounding; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109282344087230-H7YRO, Safety Report Unique Identifier GB-MHRA-ADR 26007558. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Jan2021 (Batch/Lot Number: Not known) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced heart pounding on 08Jan2021. The seriousness criteria of the event was death and life-threatening. The clinical course was reported as That poisonous vaccine killed her the government is accountable. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included SARS-CoV-2 test: no - negative COVID-19 test on an unspecified date. The outcome of the event was fatal. The patient died on 30Jan2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Heart pounding


VAERS ID: 1763152 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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: HRJNJFOC20211002119

Write-up: DEATH; This spontaneous report received from a consumer via social media (News) and concerned a patient of unspecified age and sex. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, 1 total, administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. As per the reporter, "He was reading news about the case where person died from Janssen vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20211002119-covid-19 vaccine ad26.cov2.s -death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1763178 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-09-08
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood fibrinogen, Cavernous sinus thrombosis, Cerebral venous sinus thrombosis, Coma scale, Coma scale abnormal, Computerised tomogram head, Headache, Lumbar puncture, Platelet count, Seizure, Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-19
   Days after onset: 11
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: 20210908; Test Name: Angiogram; Result Unstructured Data: Test Result:Unknown results; Comments: Results not provided.; Test Date: 202109; Test Name: Fibrinogen; Result Unstructured Data: Test Result:Normal; Test Date: 20210915; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:Unknown results; Comments: Reduced GCS/coma.; Test Date: 20210908; Test Name: Brain CT; Result Unstructured Data: Test Result:Unknown results; Comments: Results not provided.; Test Date: 20210915; Test Name: Brain CT; Result Unstructured Data: Test Result:Unknown results; Comments: CT brain demonstrated left sided intracranial haemorrhage. Review of CT scan by neuroradiology detected CVST.; Test Date: 20210908; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:Unknown results; Comments: Results not provided.; Test Date: 20210916; Test Name: Platelet count; Result Unstructured Data: Test Result:114; Comments: note heparin given already at this stage; Test Date: 20210917; Test Name: Platelet count; Result Unstructured Data: Test Result:91
CDC Split Type: IEPFIZER INC202101278766

Write-up: This is a spontaneous report from a contactable other healthcare professional via Regulatory Authority HPRA, downloaded from the Regulatory Authority-WEB (regulatory authority number IE-HPRA-2021-084778). A 20-year-old male patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 19Aug2021 (Lot number was not reported) as single dose for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (COMIRNATY) on 22Jul2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced CVST (cerebral venous sinus thrombosis) on 15Sep2021, visual disturbance on 08Sep2021, collapse (syncope) on 15Sep2021, headache on 08Sep2021, seizure on 15Sep2021, cavernous sinus thrombosis on an unspecified date and reduced GCS/coma on 15Sep2021; all the events were serious as medically significant and due to hospitalization; the outcome of all the events was fatal. The patient underwent lab tests and procedures which included angiogram: unknown results on 08Sep2021 (Results not provided), blood fibrinogen: normal in Sep2021, coma scale: unknown results on 15Sep2021 (Reduced GCS/coma), computerised tomogram head: unknown results on 08Sep2021 (Results not provided), computerised tomogram head: unknown results on 15Sep2021 (CT brain demonstrated left sided intracranial hemorrhage. Review of CT scan by neuroradiology detected CVST), lumbar puncture: unknown results on 08Sep2021 (Results not provided), platelet count: 114 on 16Sep2021 (note heparin given already at this stage), platelet count: 91 on 17Sep2021. The patient died on 19Sep2021. An autopsy was performed and results were not provided. The cause of death was cavernous sinus thrombosis. On 19Sep2021, the patient died in hospital. An autopsy was directed and the preliminary indications from the clinical investigations were that the cause of death was cavernous sinus thrombosis. On 08Sep2021, the patient presented to hospital with headache and visual disturbance. Investigations performed included, CT brain, CT angiogram and lumbar puncture to rule out a suspected intracranial bleed (results not provided). On an unknown date, the patient was discharged. On 15Sep2021, the patient represented to hospital with collapse, seizure and reduced Glasgow coma scale (GCS). The patient was intubated and CT brain demonstrated left sided intracranial hemorrhage. The review of CT scan by the hospital neuroradiology detected cerebral venous sinus thrombosis (CVST) and the patient was transferred to another hospital. The management included heparin infusion and a catheter-directed thrombectomy. The patient remained in a coma and it was considered a salvage decompression craniotomy would not be beneficial and the patient passed away on 19Sep2021. HIT screen/anti-PF4 antibodies were not performed and the Consultant stated they did not think it was thrombosis with thrombocytopenia syndrome (TTS). Details of blood tests from initial hospitalisation were not available at the time of reporting. At the time of the reporting, a post-mortem was being performed. The provisional cause of death was due to CVST. It was unknown details of any underlying thrombophilia or other cause. Limited past medical history was available but not known by the reporter to have had any significant past medical history or concomitant medication. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: CAVERNOUS SINUS THROMBOSIS


VAERS ID: 1763204 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-23
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asymptomatic COVID-19
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: positive
CDC Split Type: ITJNJFOC20211001082

Write-up: DEATH; DRAMATIC WORSENING OF HEALTH CONDITION FOLLOWING VACCINATION (SUSPECTED COVID-19 INFECTION); SUSPECTED COVID-19 INFECTION; This spontaneous report received from a company representative via social media (News article) concerned a 57 year old male patient (electrician) of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: asymptomatic covid-19. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On unspecified date, the laboratory data of patient included COVID-19 virus test reported as positive. On 06-SEP-2021, the patient experienced suspected covid-19 infection. On the same day he was hospitalized in Intensive Care Unit (ICU) after showing positive signs for Covid-19. The patient got Janssen vaccine even though he was covid-19 positive. On 23-SEP-2021, doctors announced the news of his death, he died, after days of agony in the ICU following dramatic worsening of his health condition following vaccination (suspected covid-19 infection). The patient died from unknown cause of death. He was hospitalized for 17 days. It was not reported, if the autopsy was performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to unknown cause of death on 23-SEP-2021, and the outcome of dramatic worsening of health condition following vaccination (suspected covid-19 infection) and suspected covid-19 infection was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211001062.; Sender''s Comments: V0: 20211001082-COVID-19 VACCINE AD26.COV2.S.- Death, Dramatic worsening of health condition following vaccination (suspected covid-19 infection), suspected covid-19 infection. This events is considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1763374 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   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: Blood pressure high; Cardiovascular disorder; Clotting disorder; Overweight; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101273627

Write-up: CEREBRAL HEMORRAGIA; HEADACHE; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB IT-MINISAL02-790467 A 75-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 01May2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation . Medical history included type 2 diabetes mellitus , overweight , cardiovascular disorder , hypertension, coagulopathy. The patient''s concomitant medications were not reported. The patient received the first dose of BNT162B2 vaccine on 10Apr2021. The patient experienced cerebral hemorrhage on 05May2021 with fatal outcome , headache (medically significant) on 02May2021 with outcome of unknown. The patient died on 05May2021. It was not reported if an autopsy was performed. Course of the event. headache on 02May2021; cerebral hemorrhage on 05May2021. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1763375 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-08-25
   Days after vaccination:161
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / 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: 2021-08-25
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101273623

Write-up: Found by a passer-by lying on the ground during a training outing with a racing bike, with no signs of a disastrous fall. Alerted on 118, health workers tried to revive him.; This is a spontaneous report from a contactable consumer via Regulatory Authority, downloaded from the regulatory agency-WEB (regulatory authority report number is IT-MINISAL02-790496). An 80-year-old male patient received the second dose of BNT162B2 (COMIRNATY) intramuscular on 17Mar2021 (Lot Number: EP9598) at 0.3 mL single for COVID-19 immunisation. Relevant medical history was not reported. There were no concomitant medications. On 25Aug2021, the patient was "found by a passer-by lying on the ground during a training outing with a racing bike, with no signs of a disastrous fall. Alerted on 118, health workers tried to revive him". The reporter was not aware of the symptoms preceding the outcome and reported that the patient did not have coexisting medical conditions and was not taking concomitant therapies. The patient received treatment with adrenaline and oxygen, resuscitation for 15 minutes, then the death was ascertained. No autopsy was performed. Reporter''s comment: No previous illnesses. No follow-up attempts possible. No further information expected.; Reporter''s Comments: No previous illnesses; Reported Cause(s) of Death: Sudden death


VAERS ID: 1763376 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Paralysis, Renal impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tumour lysis syndrome (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101278870

Write-up: renal dysfunction; Paralysis; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority. IT-MINISAL02-790654. A 92-year-old male patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in arm left on an unspecified date (Batch/Lot number was not reported) as single dose, at an unspecified age, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced renal dysfunction and paralysis both on 12Apr2021, seriousness criteria of the events reported as death and hospitalization. Actions taken (Hospitalization and analysis of adverse reactions). Impact on quality of life (10/10). The outcome of the events was fatal. The patient died in 2021. It was unknown if an autopsy was performed. Sender Comment: 23Sep2021 regulatory authority: requests for follow-up information from the reporter regarding autopsy report and vaccination date. Waiting. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: renal dysfunction; Paralysis


VAERS ID: 1763386 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac disorder, Cerebrovascular accident, Renal failure, Thrombosis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 147
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: Coronavirus infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101285136

Write-up: thrombosis; atrial fibrillation; Cerebrovascular accident; kidney insufficiency; heart disease; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB IT-MINISAL02-791629. A 78-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in arm left on 01Feb2021 (Lot Number: EJ6136) as single dose for covid-19 immunisation. Medical history included COVID infection. The patient''s concomitant medications were not reported. The patient experienced atrial fibrillation, cerebrovascular accident and thrombosis on 17Feb2021; kidney insufficiency and heart disease in 2021 with outcome of unknown. Atrial fibrillation, cerebrovascular accident and thrombosis were reported as serious (death, hospitalization). The patient died on 15Jul2021 due to atrial fibrillation, cerebrovascular accident and thrombosis. It was not reported if an autopsy was performed. Outcome of atrial fibrillation, cerebrovascular accident and thrombosis was fatal, of kidney insufficiency and heart disease was unknown. Reporter''s comments: The adverse reaction led to another clinically relevant condition - Concomitant conditions: heart disease, kidney insufficiency, Previous coronavirus infection: yes - Reaction time: 10:00 - Posted by Covid19-file. No follow-up attempts are possible. No further information is expected. ; Reporter''s Comments: The adverse reaction led to another clinically relevant condition - Concomitant conditions: heart disease, kidney insufficiency, Previous coronavirus infection: yes - Reaction time: 10:00 - Posted by Covid19-file; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202101195563 same product, different patient/events; Reported Cause(s) of Death: Cerebrovascular accident; atrial fibrillation; thrombosis


VAERS ID: 1763388 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Prostatic hypertrophy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101285349

Write-up: Standstill cardiac (cardiac arrest); This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB. This is a report received from the regulatory Authority. Regulatory authority number IT-MINISAL02-791680. An 84-year-old male patient received first dose of BNT162B2 (COMIRNATY; Solution for injection; Lot Number: FG4686), via an unspecified route of administration on 06Sep2021 as dose 1, single for covid-19 immunisation. Medical history included benign prostatic hypertrophy from an unknown date and unknown if ongoing and atrial fibrillation from an unknown date and unknown if ongoing. Patient''s impact on quality of life with Comairnaty was 10/10 COVID 19 COMIRNATY VACCINE (PFIZER): Booster dose number (1). The patient''s concomitant medications were not reported. On 17Sep202, the patient experienced standstill cardiac (cardiac arrest). The patient died with standstill cardiac on an unspecified date. It was unknown if an autopsy was performed. Reporter''s comment: prostatic hypertrophy atrial fibrillation. Sender''s comments: 24Sep2021 Pharmacovigilance contacted reporter updated form requested medical report of GP. Waiting.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1763400 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: 2021-09-01
   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: ITPFIZER INC202101285625

Write-up: Sudden death; This is a spontaneous report from a contactable consumer, received via portal. A 12-year-old female patient received an unknown dose of BNT162B2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Prior to vaccination, it was unknown whether the patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient been tested for COVID-19. It was unknown whether the patient received other vaccines within 4 weeks prior to the COVID vaccine. In Sep2021, the patient experienced sudden death. It was not reported if an autopsy was performed. People talking about the event that happened to a 12-year-old girl. They said the girl was found dead in her bed by her parents about 3 weeks ago, the day after vaccination with BNT162B2 (unknown dose). She confirmed that she had no further information and was unable to obtain it. Treatment was unknown. The outcome of event was fatal. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1763505 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Platelet count, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: platelets; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC202101269278

Write-up: death; Platelets decreased; This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 6 patients. This is the fourth of six reports. An elderly patient (reported as at age of 90s to 100s years) of an unspecified gender received a single unspecified dose number of BNT162b2 (COMIRNATY, solution for injection, lot number and expiration date not reported) via an unspecified route of administration on an unspecified date at dose number unknown, single for COVID-19 immunisation, at the clinic. The patient medical history and concomitant medications were not provided. On an unknown date (unknown days after vaccination), the patient experienced platelets decreased. On an unknown date (unknown days after vaccination), the patient experienced death. The outcome of death was fatal, while the outcome of the other event was unknown. It was unknown if an autopsy was performed. The reporting physician commented that the causality between the events and BNT162b2 was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of event death cannot be totally excluded/assessed. 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.,Linked Report(s) : JP-PFIZER INC-202101268990 Same reporter, same events,different patient; Reported Cause(s) of Death: death


VAERS ID: 1763515 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal hypokinesia, Maternal exposure during pregnancy, Umbilical cord abnormality
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-09-21
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101285757

Write-up: true knot of umbilical cord; fetal movement decreased; Maternal exposure during pregnancy; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21128064. This physician reported information for both mother and fetus. This is a fetus report. A fetus patient of an unspecified gender received the first dose of bnt162b2 (COMIRNATY), transplacental on 16Sep2021 15:30 (Lot number FG0978, Expiration date 30Nov2021) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced maternal exposure during pregnancy (death, congenital anomaly) on 16Sep2021, true knot of umbilical cord (death, congenital anomaly) on 21Sep2021, fetal movement decreased (death, congenital anomaly) on 16Sep2021. The patient was a fetus at gestational age 35 weeks. The patient''s mother was a 35-year and 6-month-old female (age at vaccination was 35 years and 6 months old). On 21Sep2021 in the morning (5 days after the vaccination), the patient experienced true knot of umbilical cord. The event resulted in intra-uterine death. The mother has been visiting another hospital regularly for medical examination. Expected date of delivery was 17Oct2021. Fetal movement was felt until 15Sep2021 (gestational week 35 day 3). However, since the mother received vaccine on 16Sep2021, fetal movement decreased. On 21Sep2021, the mother visited another hospital for pregnancy examination and was told to have intra-uterine death. The mother was referred to the reporting hospital and examined again but it was intra-uterine death as has been expected. On the same day, the mother was admitted to hospital and labor induction was performed. On 22Sep2021 (gestational week 36 day 3), the mother had vaginal delivery (stillbirth). True knot of umbilical cord was noted. The reporting physician classified the event as serious (congenital anomaly) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was true knot of umbilical cord. The reporting physician commented as follows: Direct cause of death was true knot of umbilical cord. Causality between worsening of blood flow due to true knot of umbilical cord and vaccination was unknown (assumed as probably unrelated). The outcome of the events was fatal. The patient died on 21Sep2021 due to events. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101285858 maternal case; Reported Cause(s) of Death: fetal movement decreased; Maternal exposure during pregnancy; true knot of umbilical cord


VAERS ID: 1763517 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-21
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, C-reactive protein, C-reactive protein increased, Death, White blood cell disorder
SMQs:, Haematopoietic leukopenia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THYRADIN; TENELIA; MEVALOTIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Dyslipidaemia; Thyroid function decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: blood test; Result Unstructured Data: Test Result:no abnormalities; Comments: at the reporting hospital; Test Date: 20210921; Test Name: blood test; Result Unstructured Data: Test Result:abnormal WBC level; Comments: visited a different hospital; Test Date: 20210921; Test Name: CRP; Test Result: Positive ; Comments: visited a different hospital
CDC Split Type: JPPFIZER INC202101288734

Write-up: died; CRP was positive; Abnormal WBC level; This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 69-year-old female patient received second dose of BNT162B2 (COMIRNATY), via intramuscular on 09Sep2021 as single dose, for covid-19 immunisation. The patient medical history included thyroid function decreased, diabetes mellitus and dyslipidaemia. Concomitant medications included thyroid (THYRADIN) for thyroid function decreased, teneligliptin hydrobromide (TENELIA) for diabetes mellitus, and pravastatin sodium (MEVALOTIN) for dyslipidaemia (all medications were administered for a long time). The patient previously took the first dose of BNT162b2 (COMIRNATY), via an unspecified route of administration as a single dose for COVID-19 immunisation. On 23Sep2021 (14 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 08Sep2021, blood test was performed at the reporting hospital and no abnormalities were noted. On 09Sep2021, the patient received the second dose of the vaccination. On 21Sep2021, since the patient could not consume meals, she visited a different hospital. The reporter was informed by the hospital that C-reactive protein (CRP) was positive and abnormal white blood cell (WBC) level was noted, and the patient died. The outcome of the event died was fatal, for other events was unknown. The patient was died on 23Sep2021. It was not reported if an autopsy was performed. The reporting physician classified the event (death) as serious (fatal outcome) and assessed that the event was probably related to BNT162B2. The reporting physician commented as follows: The blood test performed on 08Sep2021 did not show abnormalities, but considering the report of abnormal blood test results (21Sep2021), the causal relationship with BNT162B2 was suspected. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new 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: died


VAERS ID: 1763570 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-08-18
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute pulmonary oedema, Blood creatinine, Blood culture, Blood thromboplastin, C-reactive protein, COVID-19 pneumonia, Cardiac failure congestive, Cardiogenic shock, Chest X-ray, Chronic kidney disease, Computerised tomogram, Glomerular filtration rate, Haemoglobin, Heart rate, International normalised ratio, Lymphocyte count, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet count, Respiratory rate, SARS-CoV-2 test, Vaccination failure, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-23
   Days after onset: 5
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: ATORVASTATIN; SPIRONOLACTONE; AMIODARONE; BROMAZEPAM; BUMETANIDE; METOLAZONE; IMDUR; OMEPRAZOLE; WARFARIN; ENTRESTO; SLOW-K; ALLOPURINOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Chronic heart failure (EF 45%); Chronic kidney disease stage 4; Coronary artery disease; Defibrillator/pacemaker insertion; Hypertension; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: APTT; Result Unstructured Data: Test Result:1.29 to 54.9; Comments: High and rising on 18, 19, 20, 21 and 22Aug2021; Test Name: CREATININE; Result Unstructured Data: Test Result:246 to 147; Comments: HIGH but falling on 18, 19, 20, 21 and 22Aug2021; Test Name: Blood culture; Result Unstructured Data: Test Result:Staph epidermidis, Gram positive cooci; Comments: On 18, 19, 22 and 23Aug2021; Test Name: PTT; Result Unstructured Data: Test Result:21.6 to 67.4; Comments: High and rising on 18, 19, 20, 21 and 22Aug2021; Test Date: 20210818; Test Name: CXR; Result Unstructured Data: Test Result:Lungs clear, normal; Test Date: 20210819; Test Name: CT; Result Unstructured Data: Test Result:No active pulmonary lesion seen; Comments: normal CT; Test Name: C-REACTIVE PROTEIN; Result Unstructured Data: Test Result:25 to 73; Comments: VERY HIGH AND RISING on 18, 19, 20, 21 and 22Aug2021; Test Name: EGFR; Result Unstructured Data: Test Result:24 to 44; Comments: LOW on 18, 19, 20, 21 and 22Aug2021; Test Name: HEMOGLOBIN; Result Unstructured Data: Test Result:12.9 to 13.3; Comments: low on 18, 19, 20, 21 and 22Aug2021; Test Name: Heart rate; Result Unstructured Data: Test Result:120 to 130bpm; Test Date: 20210818; Test Name: Heart rate; Result Unstructured Data: Test Result:83 bpm; Test Name: INR; Result Unstructured Data: Test Result:1.9 to 5.9; Comments: High and rising on 18, 19, 20, 21 and 22Aug2021; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.63 fell to 0.28; Comments: Low and decreasing on 18, 19, 20, 21 and 22Aug2021; Test Name: NEUTROPHILS; Result Unstructured Data: Test Result:4.0 to 8.6; Comments: Normal, rose to high on 18, 19, 20, 21 and 22Aug2021; Test Name: SpO2; Test Result: 88 %; Comments: on 5ml/L NRM; Test Name: SpO2; Test Result: 86 %; Comments: on 5L/min NRB; Test Date: 20210818; Test Name: SpO2; Test Result: 95 %; Comments: on RA; Test Date: 20210821; Test Name: PCO2; Result Unstructured Data: Test Result:37 mmHg; Test Date: 20210822; Test Name: PCO2; Result Unstructured Data: Test Result:64 mmHg; Test Date: 20210821; Test Name: PH; Result Unstructured Data: Test Result:7.45; Test Date: 20210822; Test Name: PH; Result Unstructured Data: Test Result:7.23; Test Name: PLATELET COUNT; Result Unstructured Data: Test Result:220 to 193; Comments: Normal on 18, 19, 20, 21 and 22Aug2021; Test Date: 20210821; Test Name: PO2; Result Unstructured Data: Test Result:113 mmHg; Test Date: 20210822; Test Name: PO2; Result Unstructured Data: Test Result:59 mmHg; Test Name: Respiratory rate; Result Unstructured Data: Test Result:30/min; Test Date: 20210818; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:Detected - CT 22; Test Name: WBC; Result Unstructured Data: Test Result:5.7-9.7; Comments: NORMAL on 18, 19, 20, 21 and 22Aug2021
CDC Split Type: MTPFIZER INC202101296436

Write-up: Nasal swab (RT-PCR) - positive; Nasal swab (RT-PCR) - positive; CKD worsened due to dehydration; Cardiogenic shock; Acute pulmonary edema; Congestive heart failure; This is a spontaneous report from a contactable physician. A 65-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: ET6956, Expiry date: Unknown) via intramuscularly, administered in Arm Left on 24Apr2021 as dose 1, single and dose 2 intramuscularly, administered in Arm Left on 15May2021 (Lot Number: EX8680, Expiry date: Unknown) as dose 2, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, cardiac failure chronic from an unknown date and unknown if ongoing EF 45%, coronary artery disease from 2012 to an unknown date, aortic valve replacement from 1996 to an unknown date, implantable defibrillator insertion from 2012 to an unknown date, chronic kidney disease and non-tobacco user from an unknown date and unknown if ongoing. Concomitant medication included atorvastatin (ATORVASTATIN) 80mg nocte, spironolactone (SPIRONOLACTONE) 25mg BD, amiodarone (AMIODARONE) 200mg dly, bromazepam (BROMAZEPAM) 3mg TDS, bumetanide (BUMETANIDE) 1mg (2-2-1), metolazone (METOLAZONE) 1 tab prn, isosorbide mononitrate (IMDUR) 60mg dly, omeprazole (OMEPRAZOLE) 20mg BD, warfarin (WARFARIN), sacubitril valsartan sodium hydrate (ENTRESTO)24/6mg dly, potassium chloride (SLOW-K) 2 tabs dly and allopurinol (ALLOPURINOL) 200mg dly taken for an unspecified indication, start and stop date were not reported. The patient underwent a nasal swab (RT-PCR) that was positive on 18Aug2021 (new infection). Admitted on 18Aug2021. Initially patient was admitted onto a COVID ward, then transferred to CCU on the 23Aug2021. On admission SpO2 was 95% on RA; pulse 83 bpm; afebrile. Patient progressively worsened over the next few days. CKD worsened due to dehydration Prior to CCU transfer patient had an SpO2 of 86% on 5L/min NRB, RR - 30/min, and HR of 120 to 130bpm. Oxygen supplementation at 5L/min increased SpO2 to 88% on NRM. Patient became unresponsive on the 23Aug2021 and CPR was performed. Patient was subsequently intubated. Patient deceased in hospital on the 23Aug2021. Cause of death: Cardiogenic shock consequent to acute pulmonary oedema, congestive heart failure, aortic valve replacement, pneumonia and COVID-19 positive. Patient was treatment with Dexamethasone 6mg dly (19Aug2021-23Aug2021) till date of death. The patient underwent lab tests and procedures which included activated partial thromboplastin time: 1.29 to 54.9 on High and rising on 18, 19, 20, 21 and 22Aug2021, blood creatinine: 246 to 147 on HIGH but falling on 18, 19, 20, 21 and 22Aug2021, blood culture: staph epidermidis, gram positive cooci on unspecified date On 18, 19, 22 and 23Aug2021, blood thromboplastin: 21.6 to 67.4 on high and rising on 18, 19, 20, 21 and 22Aug2021, chest x-ray: lungs clear, normal on 18Aug2021, computerised tomogram: no active pulmonary lesion seen on 19Aug2021 normal CT , c-reactive protein: 25 to 73 on very high and raising on 18, 19, 20, 21 and 22Aug2021, glomerular filtration rate: 24 to 44 on low on 18, 19, 20, 21 and 22Aug2021, haemoglobin: 12.9 to 13.3 on low on 18, 19, 20, 21 and 22Aug2021, heart rate: 120 to 130bpm on an unknown date, heart rate: 83 bpm on 18Aug2021, international normalised ratio: 1.9 to 5.9 on High and rising on 18, 19, 20, 21 and 22Aug2021, lymphocyte count: 0.63 fell to 0.28 on low and decreasing on 18, 19, 20, 21 and 22Aug2021, neutrophil count: 4.0 to 8.6 on normal, rose to high on 18, 19, 20, 21 and 22Aug2021 , oxygen saturation: 88 % on 5ml/L NRM. Therapeutic measures were taken as a result covid-19 and vaccination failure. The patient died on 23Aug2021. An autopsy was not performed. The outcome of the event Chronic kidney disease was unknown and all other events were fatal. No follow-up attempts required. No more information are expected.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new 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: Cardiogenic shock


VAERS ID: 1763631 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-09-07
   Days after vaccination:193
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

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: 2021-09-12
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Exposure to SARS-CoV-2 (He was exposed to coronavirus (known route of infection) probably 05Sep2021. During hospitalization.); Multimorbidity (Summary: Multimorbid and had been hospitalized and treated for pyelonephritis and sepsis.); Pyelonephritis (Summary: Multimorbid and had been hospitalized and treated for pyelonephritis and sepsis.); Sepsis (Summary: Multimorbid and had been hospitalized and treated for pyelonephritis and sepsis.)
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: NOPFIZER INC202101279026

Write-up: Covid-19 infection; Covid-19 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB NO-NOMAADVRE-FHI-2021-Ug921q. An 89-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection) intramuscularly for 1st single dose on 05Feb2021 (LOT/Batch number and expiration date unknown) and intramuscularly for 2nd single dose on 26Feb2021 (LOT number: EP2166, expiration date unknown) for COVID-19 immunisation. Medical history included sepsis from 05Sep2021, multimorbidity, exposure to SARS-CoV-2 from 05Sep2021, COVID-19 from 12Sep2021, pyelonephritis from 05Sep2021. Patient was multimorbid and had been hospitalized and treated for pyelonephritis and sepsis. He was exposed to coronavirus (known route of infection) probably 05Sep2021, during hospitalization. After transfer to short-term nursing home on 07Sep2021, he developed new symptoms consistent with covid-19 infection (cough, tingling, impaired general condition) and tested positive on antigen rapid test. The symptom picture developed rapidly with somatic delirium and fall and the patient was considered to be in the terminal phase shortly after transfer to a nursing home. Outcome of the events was fatal. The patient died 12Sep2021. Cause of death was reported as COVID-19 related. It was unknown if an autopsy was performed. COVID-19 antigen test on 07Sep2021 was positive. VOC (variant of concern) not known, but presumed to be Delta. Events latency with dose 2 was reported as 194 Days, with dose 1 was 215 Days. Reporters comments and additional relevant information: Reported as a case of vaccine failure. The patient was fully vaccinated with Comirnaty, first dose 05Feb2021, second dose 26Feb2021. He was exposed to coronavirus (known route of infection) probably 05Sep2021, during a hospitalization. He was multimorbid and had been hospitalized and treated for pyelonephritis and possible sepsis during hospitalization. After transfer to short-term nursing home 07Sep2021, he developed new symptoms consistent with covid-19 infection (cough, tingling, impaired general condition) and tested positive on antigen rapid test. The symptom picture developed rapidly with somatic delirium and fall and the patient was considered to be in the terminal phase shortly after transfer to a nursing home. The patient died 12Sep2021. regulatory authority: New information per telephone with reporter 23Sep2021: VOC (variant of concern) not known, but presumed to be Delta. Cause of death: covid-19 related. The regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and COVID-19 event as no relationship. The regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and Vaccination failure, as possible. The lot number for the vaccine, Comirnaty dose 1, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Covid-19 infection; Covid-19 infection


VAERS ID: 1763644 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal disorder, Investigation, Maternal exposure during pregnancy, Trisomy 21, Ultrasound antenatal screen
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? Yes
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: VITAMIN D [VITAMIN D NOS]; FOLATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Fetal investigations; Result Unstructured Data: Test Result:other fetal abnormalities; Comments: It was also proven that the fetus most likely had Downs syndrome; Test Name: Fetal nuchal translucency ultrasound; Result Unstructured Data: Test Result:clear thick nuchal fold
CDC Split Type: NOPFIZER INC202101292300

Write-up: Maternal exposure during pregnancy, first trimester; Fetal abnormalities, fetus had a clear thick nuchal fold and also other fetal abnormalities; Down''s syndrome; This is a spontaneous report from a non-contactable consumer (parent) via Regulatory Authority, downloaded from the Regulatory Authority-WEB (NO-NOMAADVRE-PASRAPP-2021-Ud2ar1; NO-NOMAADVRE-E2B_00050908). This consumer reported events for both mother and fetus. This is the fetus case. Only this case is serious. A fetus received BNT162B2 (COMIRNATY) dose 2 transplacental, administered to the 26-year-old mother intramuscular in the left arm, on 13May2021 (Batch/Lot number was not reported) as initial Pfizer dose single for COVID-19 immunisation. The fetus received the first dose for COVID-19 immunisation with COVID-19 vaccine NRVV AD (CHADOX1 NCOV-19) (VAXZEVRIA; Formulation: Suspension for injection) on 17Feb2021 (Batch/lot number: Unknown) transplacental via the mother (intramuscular in the right arm). The patient medical history was not reported. Concomitant medications included vitamin D taken for an unspecified indication, start and stop date were not reported; folic acid (FOLATE) taken for an unspecified indication, start and stop date were not reported. The patient experienced maternal exposure during pregnancy, first trimester on an unspecified, disorder fetal NOS in 2021 with fatal outcome and Down''s syndrome in 2021 with outcome unknown. The mother was revaccination with different COVID-19 vaccine and early foetal death occurred. The mother reported that the fetus died in the womb in week 11+4. The mother reported that it was discovered that the fetus had a clear thick nuchal fold and also other fetal abnormalities. It was also proven that the fetus most likely had Down''s syndrome. It was unknown if an autopsy was performed. Reporter Comment: Contact with healthcare professionals: Physician, Nurse. The patient reported that the fetus died in the womb in week 11+4. The patient reported that it was discovered that the fetus had a clear thick nuchal fold and also other fetal abnormalities. It was also proven that the fetus most likely had Downs syndrome. The Regulatory Authority did not provide a causality assessment. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: Contact with healthcare professionals: Physician, Nurse. The patient reported that the fetus died in the womb in week 11+4. The patient reported that it was discovered that the fetus had a clear thick nuchal fold and also other fetal abnormalities. It was also proven that the fetus most likely had Downs syndrome.; Sender''s Comments: Linked Report(s) : NO-PFIZER INC-202101272746 Mother/fetus case; Reported Cause(s) of Death: Disorder foetal NOS


VAERS ID: 1763767 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Fatigue, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 18
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; General physical condition decreased; Living in nursing home
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: PTPFIZER INC202101272855

Write-up: Prostration; COVID-19; Breathing difficult; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency-WEB [Regulatory Authority number PT-INFARMED-T202109-846], Safety Report Unique Identifier PT-INFARMED-T202109-846. An 88-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular on 21Jan2021 (Batch/Lot number was not reported) as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included ongoing dementia, ongoing general physical health deterioration, ongoing living in residential institution. There were no concomitant medications. The patient experienced prostration (caused death) on 23Jan2021, COVID-19 (caused death) on 23Jan2021, breathing difficult (caused death) on 23Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Jan2021. Therapeutic measures were taken as a result of the events and included treatment with forced nasal oxygenation. The patient died due to the events on 10Feb2021. An autopsy was not performed. Reporter Comment: Concomitant Medication-No Medication Error Occurred?-No Other Information-No significant particular illnesses, with the exception of physical and mental degradation due to age, particularly dementia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Concomitant Medication-No Medication Error Occurred?-No Other Information-No significant particular illnesses, with the exception of physical and mental degradation due to age, particularly Dementia.; Reported Cause(s) of Death: COVID-19; Breathing difficult; Prostration


VAERS ID: 1763818 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Condition aggravated, Heart rate, Lung disorder
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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: Atrial fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:Low
CDC Split Type: SEPFIZER INC202101273990

Write-up: Heart arrhythmia; Lung function impaired; Condition aggravated; This is a spontaneous report from a contactable consumer downloaded from the RA, regulatory authority number SE-MPA-2021-084932. Additional identifier SE-VISMA-1632079444651. An 88-year-old male patient received the second dose of BNT162B2 (COMIRNATY) on an unspecified date, in 2021, at single dose, for COVID-19 immunisation. Relevant medical history included atrial fibrillation from an unspecified date and ongoing. The patient previously, on 25Feb2021, received the first dose of BNT162B2 (COMIRNATY) at single dose, for COVID-19 immunisation. On an unspecified date, in 2021, the patient experienced heart arrhythmia. The man fainted a few times, heart rate was low from time to time, lung function was impaired, oxygen was added as much as possible, treated at the hospital, but died 20 days after second dose of vaccine (condition aggravated). Outcome: fatal. Cardiac arrhythmia and impaired lung function were the causes of death. It was unknown if autopsy was done. Report assessed as serious, death. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrhythmia; Lung function decreased; Condition aggravated


VAERS ID: 1763820 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, Pneumonia, X-ray
SMQs:, Eosinophilic pneumonia (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: X-ray; Result Unstructured Data: Test Result:"maybe" pneumonia was found; Comments: "maybe" pneumonia was found
CDC Split Type: SEPFIZER INC202101285433

Write-up: Inappropriate schedule of vaccine administered; Death; reporter stated that "maybe" pneumonia was found; This is a spontaneous report from a contactable consumer downloaded from the RA, regulatory authority number SE-MPA-2021-085637. A 99-year-old male patient received bnt162b2 (COMIRNATY), second dose via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY) on 04Mar2021 (batch/lot number was unknown) as single dose for covid-19 immunisation and experienced slightly worse related to his normal condition. Reporter stated that the man was old and fragile but could more or less take care of himself. The reporter stated that after the first dose of the vaccine the man became slightly worse related to his normal condition. The man was unable to go to the health center to take the second dose so it was given at home about 6 weeks after the first dose. Two days after the second dose the man was taken by ambulance to hospital, X-ray investigation was performed and the reporter stated that "maybe" pneumonia was found and furthermore the reporter stated that the pneumonia did not respond to antibiotics. The man died later after less than a week in hospital (in Apr2021), cause of death was not stated in the report. It was not reported if an autopsy was performed. Report was assessed as serious: death. The outcome for death was fatal, for other event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1763830 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-09-13
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Body temperature increased, Cardiac failure acute, Cardiopulmonary failure, Pulmonary oedema, Pulse absent, Seizure
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: 2021-09-13
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: UAPFIZER INC202101234120

Write-up: pulse absent; seizure; body temperature increased; Asphyxiation; cardiopulmonary failure; pulmonary oedema; acute coronary failure; The initial case was missing the following minimum criteria: reporter was unidentifiable. Upon receipt of follow-up information on 28Sep2021, this case now contains all required information to be considered valid. This is a spontaneous report received contactable reporters of consumer and a health care professional via the RA. A 19-years-old male patient received 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Apr2021 15:05 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced seizure on 13Sep2021 20:15 , pulse absent on 13Sep2021 20:35 , asphyxiation on 13Sep2021, body temperature increased on 13Sep2021. The patient died on 13Sep2021. It was not reported if an autopsy was performed. On 13Sep2021 near 21:00 a team of emergency medical assistance has fixed the death of a 19-year-old man. Based on the results of the examination, the preliminary cause of death was established: a cardiopulmonary failure, pulmonary oedema, acute coronary failure. Additional investigations were taken. For this purpose, material was taken for histological and toxicological examination. The residual cause of death will be established after receiving of the results of laboratory investigations within a month. Outcome of seizure, pulse absent, asphyxiation, cardiopulmonary failure, pulmonary oedema, and acute coronary failure was fatal. Outcome of body temperature increased was unknown. According to the information to the RA, on 13Apr2021 about 15:05, the man was vaccinated against COVID-19 with the Comirnaty / Pfizer-BioNTech vaccine. More than 5 people were vaccinated from the same vial, they all feel good. Within 30 minutes of medical observation after vaccination, the patient had no complaints of well-being. This case is currently being reviewed by the RA.; Reported Cause(s) of Death: cardiopulmonary failure; pulmonary oedema; acute coronary failure; seizure; pulse absent; Asphyxiation


VAERS ID: 1765820 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-06
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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101304890

Write-up: death; This is a spontaneous report from a contactable physician. This case is received by Pfizer from Biontech (manufacturer control number: 90226]), license party for Comirnaty. A female patient of unspecified age received bnt162b2 (COMIRNATY) on an unspecified date as single dose (Dose number and lot numbers unknown) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient died on an unspecified date. It was In general many side effects. It was not reported if Autopsy Done. The outcome of the event was fatal. Lot/batch number has been requested.; 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. 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: 1765993 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Chest pain, Condition aggravated, Echocardiogram, Electrocardiogram, Fatigue, Haematoma, International normalised ratio, International normalised ratio increased, Mobility decreased, Myocardial infarction, SARS-CoV-2 test, Troponin, Ultrasound abdomen
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 82
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: CABOZANTINIB S-MALATE; PREVISCAN [FLUINDIONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Metastasis; Renal carcinoma (Renal carcinoma detected in Jul2015 (stage pT3c) and operated on 30Jul2015.); Stent placement; Surgery (Renal carcinoma detected in Jul2015 (stage pT3c) and operated on 30Jul2015.)
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: coronarography; Result Unstructured Data: Test Result:subocclusive and repermeabilised lesion; Comments: subocclusive and repermeabilised lesion of the middle left anterior descending artery at the stent entry with good downstream quality and marked atheroma of the rest of the network with no significant lesion; Test Name: cardiac ultrasound; Result Unstructured Data: Test Result:hypokinesia; Comments: modest antero-apical hypokinesia, left ventricular ejection fraction preserved at more than 50% no pericardial detachment; Test Name: electrocardiography; Result Unstructured Data: Test Result:negative antero-septal T waves; Test Date: 20210630; Test Name: electrocardiography; Result Unstructured Data: Test Result:wide anterior T waves; Comments: wide anterior T waves with initial inferior mirror outline; Test Name: INR; Result Unstructured Data: Test Result:1.88; Test Date: 20210519; Test Name: INR; Result Unstructured Data: Test Result:2.26; Test Date: 20210608; Test Name: INR; Result Unstructured Data: Test Result:6.68; Test Date: 20210621; Test Name: INR; Result Unstructured Data: Test Result:1.56; Test Date: 20210708; Test Name: INR; Result Unstructured Data: Test Result:4.16; Test Date: 20210713; Test Name: INR; Result Unstructured Data: Test Result:6.19; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210630; Test Name: Troponin; Result Unstructured Data: Test Result:1400 ng/L; Test Date: 20210610; Test Name: abdominal ultrasound; Result Unstructured Data: Test Result:no evidence of a deep haematoma
CDC Split Type: FRPFIZER INC202101262350

Write-up: Infarct myocardial; thoracic pain; International normalised ratio increased; Haematoma; Loss of mobility; Persistent fatigue; Resurgence of the pains linked to the disease (renal carcinoma); This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number FR-AFSSAPS-LY202110890. A 74-year-old male patient received first dose of BNT162b2 (COMIRNATY), intramuscular on 02Jun2021 (Lot Number: FA8016) as single dose for COVID-19 immunisation. Medical history was reported as follow: renal carcinoma detected in Jul2015 (stage pT3c) and operated on 30Jul2015. Pulmonary and mediastinal metastatic evolution in Sep2016. Treatment with SUNITINIB from Sep2016 to Dec2019, stent placement on an unknown date. Concomitant medications included cabozantinib s-malate and fluindione (PREVISCAN, 20 mg, tablet), both taken for an unspecified indication, start and stop date were not reported. The clinical course was reported as follows: on 02Jun2021 vaccination with a first dose of the COMIRNATY. 24 hours after the vaccination (03Jun2021), onset of significant and persistent fatigue that caused loss of mobility and a resurgence of the pains linked to the disease (renal carcinoma), with onset of a giant haematoma on the torso. On 08Jun2021 increase in the international normalized ratio value to 6.68 (Normal value between 2 and 3). On 30Jun2021 in a context of a radiology treatment session for his disease, the patient presented with thoracic pain. Following the results of the electrocardiography and the coronarography, the patient was admitted to hospital (on 30Jun2021) for ongoing medical care for myocardial infarction. Rapid ongoing medical care: the left anterior descending artery was treated with a new active stent, with a good angiographic outcome, no recurrence of the thoracic pain. The patient underwent lab tests and procedures which included coronarography: subocclusive and repermeabilised lesion of the middle left anterior descending artery at the stent entry with good downstream quality and marked atheroma of the rest of the network with no significant lesion on 30Jun2021; cardiac ultrasound: modest antero-apical hypokinesia, left ventricular ejection fraction preserved at more than 50% no pericardial detachment on an unspecified date; electrocardiography: negative antero-septal t waves on an unspecified date and wide anterior T waves with initial inferior mirror outline on 30Jun2021 , international normalized ratio (INR, 2-3): 1.88 on an unspecified date, 2.26 on 19May2021, 6.68 on 08Jun2021, 1.56 on 21Jun2021, 4.16 on 08Jul2021 and 6.19 on 13Jul2021; SARS-CoV-2 test: negative on an unspecified date; troponin: 1400 ng/l on 30Jun2021; abdominal ultrasound: no evidence of a deep haematoma on 10Jun2021. Therapeutic measures were taken as a result of the events and included treatment with KARDEGIC, PLAVIX, PREVISCAN 20mg, BISOC 1.25mg, ATORVASTATINE 80mg, RAMIPRIL 2.5mg, PARACETAMOL, PANTOPRAZOLE 20mg, ACTISKENAN. The patient outcome of the events haematoma, thoracic pain and international normalized ratio increased was recovered, the outcome of loss of mobility was not recovered, the outcome of the other events was fatal. The patient died on 24Aug2021. 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: Infarct myocardial; fatigue; Resurgence of the pains linked to the disease (renal carcinoma)


VAERS ID: 1766210 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101294554

Write-up: Pulmonary embolus; This is a spontaneous report from a contactable physician received from the regulatory authority report number GB-MHRA-TPP22299854C1627689YC1632234200553, Safety Report Unique Identifier GB-MHRA-ADR 26010421. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jul2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history included: No significant past medical history. Fit and well 40 year old. Concomitant medications were not reported. On 10Jul2021 (as reported), the patient experienced pulmonary embolus with fatal outcome. The patient died on 10Jul2021 (as reported). It was not reported if an autopsy was performed. The clinical course was reported as follows: Patient died 3 days after having Pfizer vaccine. Massive Pulmonary Embolus. Reporter''s comments This Patient died 3 days after receiving the Pfizer vaccine. Cause of death: Pulmonary Embolism. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained; Reporter''s Comments: This Patient died 3 days after receiving the Pfizer vaccine. Cause of death: Pulmonary Embolism.; Reported Cause(s) of Death: Pulmonary Embolism


VAERS ID: 1766784 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Fall, Fatigue, Myocarditis
SMQs:, Accidents and injuries (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-16
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101289374

Write-up: Uncomfortable; General tiredness; Fall on stairs; the patient might experience myocarditis after vaccination and cause the death; This is a spontaneous report from a non-contactable physician via Pfizer medical colleague. An adult male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 02Sep2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that: the patient felt uncomfortable, general tiredness, and had been fall on stairs. The patient was expired on sofa at the morning of 16Sep2021. The reporter suspected all those events might related to the BNT162b2 Vaccine. He guessed the patient might experience myocarditis after vaccination and cause the death. The patient outcome of myocarditis was fatal and unknown for the other events. An autopsy was not performed. The events occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Myocarditis. 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: Myocarditis


VAERS ID: 1767788 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-04-27
   Days after vaccination:82
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Sars-CoV-2 PCR test; Test Result: Positive; Comments: Variant PCR-based: B.1.1.7 Variant sequenced : N/A n501y-positive: yes
CDC Split Type: ATPFIZER INC202101272111

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-044533. A 95-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, (Batch/Lot Number: EK9788)) via intramuscular on 04Feb2021 as single dose, the patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, (Batch/Lot Number: EJ6797)) via an unspecified route of administration on 14Jan2021 as, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Apr2021, The patient experienced vaccination failure, sars-cov-2 infection. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on Variant PCR-based B.1.1.7 Variant sequenced n501y. The patient died on unknown date. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 1767866 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101272235

Write-up: Died in the sauna that night; towards the evening of 16Mar2021: shivering; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority number AT-BASGAGES-2021-049054. A 81-years-old male patient received bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: ET1831, expiry date: not reported), via an unspecified route of administration on 12Mar2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient lived in his own household without support, was mentally and physically fit (= healthy) and did physical work on the ladder / scaffolding on his house construction site until the last day. On 16 Mar2021, the patient died in the sauna that night, towards the evening of 16mar2021: shivering. The patient died on 16Mar2021. It was not reported if an autopsy was performed. Clinical outcome of the events was reported as fatal for death and unknown for chills. Relatedness of drug to reaction(s)/event(s): Death: Source of assessment: Primary Source Reporter /Result of Assessment: Conditional/ Unclassified Chills: Source of assessment: Primary Source Reporter /Result of Assessment: Conditional/ Unclassified No follow-up attempts are possible. No further information is expected.


VAERS ID: 1767923 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-12
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bone pain, COVID-19, Computerised tomogram, Gait disturbance, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Osteonecrosis (broad), Hypoglycaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN; GLIBENCLAMIDE; RANITIDINE
Current Illness: Diabetes
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: COVID-19 virus test positive; Result Unstructured Data: positive; Test Date: 20210813; Test Name: Computerised tomography; Result Unstructured Data: 80% of the lungs affected
CDC Split Type: BRJNJFOC20211003593

Write-up: SUSPECTED COVID 19; SUSPECTED CLINICAL VACCINATION FAILURE; PAIN IN THE BONES; DIFFICULTY TO WALK; This spontaneous report received from a consumer concerned a 54-year-old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: diabetes. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported. Batch number: unknown, expiry: unknown) frequency One total, dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included glibenclamide for diabetes. Metformin for diabetes, and ranitidine for diabetes. On 12-Aug-2021, the patient was tested positive for Covid-19 with 80% of the lungs affected, which was confirmed as suspected Covid 19 and suspected clinical vaccination failure. On the same date patient experienced pain in the bones and difficulty to walk, patient had the symptoms difficulty to breath . The patient was hospitalized on the same date. The number of days hospitalization and discharge information was not reported. Laboratory data included: COVID-19 virus test positive (NR: not provided) positive. On 13-AUG-2021, Laboratory data included: Computerized tomography (NR: not provided) 80% of the lungs affected. On an unspecified date the patient died from suspected covid-19. It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from suspected Covid 19 on an unspecified date, had not recovered from pain in the bones, and difficulty to walk, and the outcome of suspected clinical vaccination failure was not reported.. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211003768. The report is associated with product quality complaints.; Sender''s Comments: V0: 20211003593-covid-19 vaccine ad26.cov2.s - suspected covid 19, pain in the bones, and difficulty to walk. This event(s) is considered unassessable. The event(s) has a compa