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From the 11/19/2021 release of VAERS data:

Found 19,249 cases where Vaccine is COVID19 and Patient Died

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1654889 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-09
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Decreased appetite, Dysarthria, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852673

Write-up: APPETITE LOST; WEAKNESS; HEADACHE; SLURRED SPEECH; FEVER; CHILLS; This spontaneous report received from a physician via a Regulatory Authority [PHIFDA, PH-PHFDA-300101328] concerned a 72 year old male of an unspecified race and ethnic origin. 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, intramuscular, batch number: 1-213C21A, expiry: unknown) dose was not reported, frequency time 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021 22:00, the patient experienced fever, chills, weakness, headache, slurred speech. On 17-AUG-2021 22:00, the patient experienced appetite lost. On an unspecified date, the patient died due to fever, chills, appetite lost, weakness, headache, and slurred speech. It was unknown that 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: 20210852673-COVID-19 VACCINE AD26.COV2.S- Fever, chills, appetite lost, weakness, headache, and slurred speech. 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: FEVER; CHILLS; APPETITE LOST; WEAKNES; HEADACHE; SLURRED SPEECH


VAERS ID: 1654890 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Haematoma, Malaise
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Hypertension (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: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: Blood pressure; Result Unstructured Data: Elevated
CDC Split Type: PHJNJFOC20210852762

Write-up: HEMATOMA; GENERAL MALAISE; ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300100484] concerned a 74 year old female of unknown race and ethnicity. 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: 213C21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) Elevated. On 08-AUG-2021, the patient experienced hematoma on both upper and lower extremities and body malaise. On an unspecified date, the patient died from elevated blood pressure, hematoma, and general malaise. 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: 20210852762-COVID-19 VACCINE AD26.COV2.S-blood pressure, hematoma, and general malaise. 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: ELEVATED BLOOD PRESSURE; HEMATOMA; GENERAL MALAISE


VAERS ID: 1654891 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-08
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205024 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea
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? 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: PHJNJFOC20210852828

Write-up: COVID-19; COUGH; SHORTNESS OF BREATH; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300100971] concerned a 57 year old female 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, intramuscular and batch number: 205024 expiry: Unknown) dose was not reported, 1 total, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, the patient experienced cough, shortness of breath. On an unspecified date, the patient experienced covid-19, and was hospitalized. On an unspecified date, the patient died from cough, shortness of breath, and covid-19. 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, Life Threatening and Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210852828-Covid-19 vaccine ad26.cov2.S- Covid-19, Cough, Shortness of breath. 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: COUGH; SHORTNESS OF BREATH; COVID-19


VAERS ID: 1654892 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21AL2021060 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cellulitis
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852838

Write-up: LEG PAIN WITH CELLULITIS; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 48 year old male of unspecified race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 213C21AL2021060 expiry: unknown) dose was not reported, 1 total administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021 at 14:40, the patient experienced leg pain with cellulitis, and was hospitalized (date unspecified). On an unspecified date, the patient died from leg pain with cellulitis. It was unknown if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0- 20210852838-Covid-19 vaccine ad26.cov2.S-Leg pain with cellulitis. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: LEG PAIN WITH CELLULITIS


VAERS ID: 1654894 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Cough, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852924

Write-up: LOSS OF TASTE; FEVER; COUGH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA: PH-PHFDA-300101403] concerned an 83 year old male. 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, intramuscular, batch number: 209021A expiry: unknown) dose was not reported, 1 total, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced cough and fever. On 15-AUG-2021, the patient experienced loss of taste. On an unspecified date, the patient died from cough, loss of taste, and fever. 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: 20210852924 -covid-19 vaccine ad26.cov2.s- cough, loss of taste, and 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: COUGH; LOSS OF TASTE; FEVER


VAERS ID: 1654895 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852972

Write-up: MUSCLE PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300101184] concerned a 62 year old female of 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: 212C21A, expiry: unknown) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021 08:00, the patient experienced muscle pain, and was hospitalized (date unspecified). It was reported that 8 days after vaccination, the patient had loss of appetite and body malaise. On an unspecified date, the patient died from muscle pain. 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, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210852972-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Muscle pain. 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: MUSCLE PAIN


VAERS ID: 1654898 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 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: Test Date: 20210811; Test Name: Body temperature; Result Unstructured Data: =38?C
CDC Split Type: PHJNJFOC20210853148

Write-up: FEVER =38?C; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300101308] concerned a 74 year old female of unspecified race and ethnic origin. 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, intramuscular, batch number: unknown; expiry: unknown) dose was not reported, start therapy date was 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 11-AUG-2021, the patient experienced fever greater than or equal to 38-degree C. Laboratory data included: Body temperature (NR: not provided) greater than or equal to 38-degree C. It was reported that, one week after vaccination the patient developed fever followed by cough. On 13-Aug-2021, the patient developed difficulty of breathing and was brought to the institution, but she expired along the way. It was unspecified if an autopsy was performed. On an unspecified date, the patient died from fever greater than or equal to 38-degree C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0-20210853148-Covid-19 vaccine ad26.cov2.S- Fever greater than or equal to 38 degree C. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: FEVER =38?C


VAERS ID: 1654903 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4342 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death neonatal, Maternal exposure timing unspecified
SMQs:, Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 6
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: PLPFIZER INC202101086729

Write-up: perinatal death of a newborn; Maternal Drug Exposure; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is PL-URPL-3-819-2021. A fetus patient of an unspecified gender received the first dose of BNT162B2 (COMIRNATY) via transplacental (parent route of administration: intramuscular) on 08Jun2021 17:30 (Lot Number: FD4342; Expiration Date: 30Sep2021) as single dose for COVID-19 immunisation. The patient''s mother is a 25-year-old female, age at the vaccination is also 25-year-old. The mother medical history included pregnancy normal. The mother delivered the pregnancy via cesarean delivery. The fetal outcome is neonatal death. The patient medical history and concomitant medications were not reported. The patient had maternal drug exposure on 08Jun2021 17:30, perinatal death of a newborn on 14Jun2021 09:49. Seriousness of the events was reported as death, hospitalization (from Jun2021), medically significant. The outcome of the events was fatal. The patient died on 14Jun2021. It was unknown if an autopsy was performed. Clinical course: The notification (notification type: parent-child) PL-URPL-3-819-2021 was sent to Agency via the system on 25Jun2021 from the district sanitary and epidemiological station. Report related to PL-URPL-3-812-2021 (the report concerns the mother of the deceased patient). Amniotic fluid drained within 5 days after administration of 1st dose of the vaccine on 13Jun2021, surgical delivery, perinatal death of the newborn, a blood clot was found in the umbilical vein afterbirth. After medical consultation, it was established: the course of pregnancy without complications without comorbidities. The reporting person classified them as severe. Due to the assessment of the reporting person, the nature of the side effects and the death of the newborn, the agency classified the report as "serious". Health result: death (on 14Jun2021). The data contained in the electronic report are all available to agency - in the case of obtaining additional information, another version will be sent. Sender''s comment: Report related to PL-URPL-3-812-2021 (the report concerns the mother of the deceased patient). COMIRNATY is an mRNA vaccine against COVID-19 (with modified nucleosides). All reported adverse reactions are not included in COMIRNATY''S Summary of Product Characteristics. Until 07Jul2021 in the database, 13 cases of fetal death were reported after the administration of the COMIRNATY vaccine to the mother. Agency sent an e-mail to the relevant sanitary and epidemiological station with a request for additional information (including: regarding the mother''s medical history (possible chronic diseases, medications used, etc.) and on which week of pregnancy the patient took the vaccine. with a station employee, it was found that the station asked the hospital in writing for the patient''s medical documentation, which, if obtained, will be forwarded to agency, and a follow-up will be sent to EV. The temporal relationship speaks for a cause-and-effect relationship. The reporting person classified them as severe. Due to the assessment of the reporting person, the nature of the side effects and the death of the newborn, the ARMP classified the report as "serious". Relatedness of drug to all reactions/events Source of assessment: NCA Method of assessment: agency Result of Assessment: unclassifiable No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : PL-PFIZER INC-202101086726 mother case; Reported Cause(s) of Death: perinatal death of a newborn; Maternal Drug Exposure


VAERS ID: 1654917 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Covid-19 test; Result Unstructured Data: Test Result:Delta infection have been registered
CDC Split Type: ROPFIZER INC202101085751

Write-up: one person vaccinated with complete scheme had been infected with COVID 19 , Delta type and died; one person vaccinated with complete scheme had been infected with COVID 19 , Delta type and died; Report from Medical Life, 2021, 32 (1644); page 3 entitled Anti-COVID vaccination, IN ALMOST ALL COMMUNES. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, reported as "vaccination activities against COVID-19"), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In recent weeks, there is a slow but sustained increase in the number of cases. Thus, the analysis performed by the Institute of Public Health for the last two weeks of July showed that 81.5% of the newly confirmed cases and 92.6% of the deaths are registered in unvaccinated persons. According to the report published by the National Institute of Public Health, as of August 8th (08Aug2021), a total of 313 cases of Delta infection have been registered. Of these new cases, over 80% occurred in unvaccinated individuals. A total of 19 deaths were recorded, of which only one person vaccinated with complete scheme. The patient underwent lab tests and procedures which included covid-19 virus test showed that delta infection have been registered on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. The information about lot number and expiration date cannot be obtained. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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/Delta type and died; COVID-19/Delta type and died


VAERS ID: 1654942 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, 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: 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: TRPFIZER INC202101087038

Write-up: Covid-19; Covid-19; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Biontech manufacturer control number 81317, license party for BNT162B2. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient vaccinated with 2 doses of Covid 19 M-RNA gene therapy vaccine which was biontech, but had covid 19 and died, patient''s spouse was also had covid-19 and was intubated, was currently alive. Reporter required information about vaccine protection, if patient had covid-19 because two doses were not enough and should the 3rd dose be given. The outcome of the events was fatal. The patient died due to Covid-19 on unknown date. It was not reported if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Covid-19; Covid-19


VAERS ID: 1655346 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood test, COVID-19 pneumonia, Cough, Death, Diarrhoea, Dyspnoea, Fatigue, Headache, Oxygen saturation decreased, Pain, SARS-CoV-2 antibody test, SARS-CoV-2 test, Thrombosis, X-ray
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (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: 2021-08-08
   Days after onset: 17
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: COVID-19; High cholesterol; Seasonal allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: blood tests; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Test Date: 20210803; Test Name: Sars-cov-2 antibody test; Result Unstructured Data: Test Result:positive; Test Date: 20210612; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:positive; Test Date: 20210803; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:positive; Test Date: 20210803; Test Name: x-rays; Result Unstructured Data: Test Result:UNKNOWN RESULTS
CDC Split Type: ZAPFIZER INC202101090680

Write-up: potential blood clot; Coughing; Diarrhoea; Body aches; passed away; Oxygen levels started to fall; Severe shortness of breath; Bilateral atypical infiltrates consistent with moderate Covid-19 pneumonia; High blood pressure; Tired; Severe headache; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included patient tested positive for Covid-19 on 12Jun2021, high cholesterol and seasonal allergies. The patient''s concomitant medications cholesterol medications. The patient was reported to have experienced high blood pressure on 22Jul2021 after vaccination, later on the same day the patient complained of tiredness, severe headache. The patient was reported to have made notes about the adverse events he experienced which included coughing, breathing difficulty, and received therapeutic interventions, diarrhoea and body aches. On 27Jul2021, the patient consulted a general practitioner (GP), he was prescribed with antibiotics. On 30Jul2021, the patient saw a second doctor who suspected Covid-19 as symptoms were typical to Covid-19 symptoms. The patient was prescribed with medications, name of treatment not specified. The doctor also recommended test for Covid-19. On 31Jul2021, the symptoms are reported to have got worse, oxygen levels started to fall (oxygen saturation decreased) and had slight shortness of breath, with raised blood pressure and running stomach. Oxygen machine was acquired at home setting, was put on nasal oxygen. There were improvements in his oxygen levels, which fluctuated. On 01Aug2021, the medical doctor advised that the patient goes for Covid-19 test, on 03Aug2021 the patient went to hospital (not admitted) for medical tests/blood tests and -x-rays including Covid-19 test, and tested positive for Covid-19 (Sars-cov-2 antibody test positive). The doctors are said to have been concerned about potential blood clots and commented that there were bilateral atypical infiltrates consistent with moderate covid-19 pneumonia (covid-19 pneumonia), he had high infection count (covid-19). He was given medication for diarrhea, and also adjusted medications for blood thinning & infection. The symptoms continued. On 05Aug2021, the patient was admitted to hospital; tests were done, there were concerns of thickness of blood/potential blood clot (blood viscosity increased). On 06Aug2021, he developed severe shortness of breath. He was transferred to another hospital on 08Aug2021 mourning, he passed away on the evening of 08Aug2021. Tests included Sars-cov-2 test: positive both on 12Jun2021 and 03Aug2021. It was not reported if an autopsy was performed. The outcome of passed away was fatal, Bilateral atypical infiltrates consistent with moderate covid-19 pneumonia, high blood pressure, coughing and oxygen levels started to fall was unknown, of other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: passed away


VAERS ID: 1656737 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-11
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Haemoglobin, Myelosuppression, Platelet count, Procalcitonin, Septic shock, Thrombocytopenia, White blood cell count
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Toxic-septic shock conditions (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   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: Medical History/Concurrent Conditions: Arterial hypertension; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: CRP; Result Unstructured Data: Test Result:increased; Test Date: 20210816; Test Name: hemoglobin; Result Unstructured Data: Test Result:5.2; Test Date: 20210816; Test Name: thrombocytes; Result Unstructured Data: Test Result:0; Test Date: 20210816; Test Name: procalcitonin; Result Unstructured Data: Test Result:increased; Test Date: 20210816; Test Name: leukocytes; Result Unstructured Data: Test Result:0.2
CDC Split Type: DEPFIZER INC202101094946

Write-up: thrombocytes 0; septic shock with bone marrow suppression; septic shock with bone marrow suppression; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority unique case identification number DE-PEI-CADR2021164812, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100168864. A 77-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: unknown, strength: 0.3 ml) (mRNA tozinameran) on 06Aug2021 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus type 2 and arterial Hypertension. It was unknown whether the patient had known of allergies. The patient''s concomitant medications were not reported. On 11Aug2021, the patient experienced thrombocytopenia and septic shock. On 11Aug2021, the patient had cough and fever was at her general practitioner. On 16Aug2021, she was admitted to the intensive care unit with hemoglobin 5.2, thrombocytes 0 and leukocytes 0.2 with increased C-reactive protein and procalcitonin which suggested septic shock with bone marrow suppression. The patient was intubated and reanimated shortly after admission and unfortunately died in a hospital. The patient died on 16Aug2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included hemoglobin: 5.2, thrombocytes: 0, leukocytes: 0.2, C-reactive protein: increased, procalcitonin: increased, all were on 16Aug2021. This report was serious - death. The outcome of 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: septic shock with bone marrow suppression; thrombocytes 0


VAERS ID: 1657343 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-08-01
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Blood fibrinogen, Blood test, Cardiac arrest, Computerised tomogram, Dyspnoea, Fibrin D dimer, Haematoma, Investigation, Platelet count, Platelet factor 4, Prothrombin time, Pulmonary embolism, SARS-CoV-2 test, Thrombocytopenia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Childhood asthma; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: Activated partial thromboplastin time; Result Unstructured Data: Test Result:47; Test Name: Fibrinogen; Result Unstructured Data: Test Result:2.5; Test Name: Blood film; Result Unstructured Data: Test Result:reactive, eosinophilia; Test Name: CT scan; Result Unstructured Data: Test Result:Pulmonary embolism with right heart strain; Test Date: 20210817; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:20000; Test Name: PF4 HIT assay optical density; Result Unstructured Data: Test Result:0.14; Test Date: 20210817; Test Name: Platelet count; Result Unstructured Data: Test Result:21; Test Name: Platelet factor 4; Result Unstructured Data: Test Result:Anti-PF4 antibodies were not identified; Test Name: Prothrombin time; Result Unstructured Data: Test Result:21; Test Date: 20210817; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101101462

Write-up: platelet count <150 A -109/L; dyspnoea; Pulmonary embolus; Haematoma; cardiac arrest; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108201609338840-XX1AM, Safety Report Unique Identifier GB-MHRA-ADR 25830450. A 28-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 03Jul2021 (Batch/Lot Number: not known) as single dose for covid-19 immunisation. Medical history included non-tobacco user, childhood asthma. The patient''s concomitant medications were not reported. The patient previously took heparin. The patient experienced pulmonary embolism on 10Aug2021, cardiac arrest in Aug2021 with outcome of not recovered, dyspnoea on 17Aug2021 with outcome of not recovered, platelet count <150 A -109/L on 17Aug2021 with outcome of unknown, haematoma on 09Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included activated partial thromboplastin time: 47, fibrinogen: 2.5, CT scan: pulmonary embolism with right heart strain, fibrin d dimer: 20000 on 17Aug2021, platelet count (150-450): 21 on 17Aug2021, platelet factor 4: anti-pf4 antibodies were not identified, prothrombin time: 21, COVID-19 virus test: no - negative covid-19 test on 17Aug2021, Blood film: reactive, eosinophilia, PF4 HIT assay optical density: 0.14. The patient died on an unspecified date. An autopsy was not performed. Event pulmonary embolism was reported as death. Other events were reported as non serious. Patient had not had symptoms associated with COVID-19. Past Medical History Previous COVID infection: No PMHx of Thrombosis was No. 1st degree family history of thrombosis was No. PRESENTATION: Date of presentation: 17Aug2021, Site of Thrombosis: PE. Platelet count at presentation: 21 Platelet count (lowest): 21. Medication at admission: None of the above. Coagulation screen PT 21 APTT 47 TCT [No Reply] Fibrinogen 2.5 D-dimers 20000 PF4 antibodies sent was Yes - result known. Commenced on anticoagulation was No. Treatment to date: Platelets was Yes. FFP, No Cryo, No IVIg, Yes Main presenting features: Buttock haematoma after minimal trauma 9/8/21. bloods not done at this time. presented 17/8/21 with dyspnoea. CT scan showed Pulmonary embolism with right heart strain. Cardiac arrest in intensive care. Patient outcome: Death Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Report relate to possible blood clots or low platelet counts. Thromboembolic event / Thombocytopenia additional questions Please specify the details of the event: "Buttock haematoma after minimal trauma 09Aug2021. bloods not done at this time. presented 17Aug2021with dyspnoea. CT scan showed Pulmonary embolism with right heart strain. Cardiac arrest in intensive care" How was this diagnosed?: "CTPA" What was the date of diagnosis?: "18Aug2021" What date was the platelet count measured?: "17Aug2021" What date was the D-dimer measured?: "17Aug2021" Has the patient had any previous reactions to medications, especially heparin or anticoagulants?: "no" Is there any additional medical history, not already provided, that relates to previous venous or arterial thromboses?: "no" Does the patient have confirmed or suspected autoimmune or inflammatory disease, including vasculitis?: "no" Does the patient have history of, or current, malignancy?: "No" What was the lowest platelet count after vaccine (usual normal range 150-450) and what date was this measured?: "21" What was the last platelet count before vaccine if known, and what date was this measured? (usual normal range 150-450): "unknown" Was the patient reviewed by a haematologist? If yes, please provide details on diagnosis or differential diagnoses.: "yes. possible VITT or antiphospholipid syndrome" Was a haemorrhage identified? If yes, please provide additional details: "no" Does the patient have a history of, or concurrent, intracranial malignancy?: "No" Does the patient have concurrent or recent intracranial infections?: "No" Has the patient had recent surgical or medical interventions to the central nervous system (including lumbar puncture)?: "No" Has the patient had a recent trauma/head injury?: "No" PT: "21" Activated Partial Thromboplastin Clotting Time (aPTT): "47" Fibrinogen: "2.5" Thrombophilia screen: "lupus positive (patient on fondaparinux when sample taken)" Blood film findings: "reactive, eosinophilia" PF4 HIT assay optical density: "0.14" HIT assay used: FOLLOW-UP 20Aug2021: Buttock haematoma after minimal trauma 09Aug2021. bloods not done at this time. presented 17Aug2021 with dyspnoea. CT scan showed Pulmonary embolism with right heart strain. Cardiac arrest in intensive care. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolus


VAERS ID: 1657367 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-02
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; COPD; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response); Pneumonia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:negative
CDC Split Type: GBPFIZER INC202101101523

Write-up: positive covid-19 test; positive covid-19 test; Covid Pneumonia; Death wishes; This is a spontaneous report from a contactable consumer (patient''s child). This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108230957340520-7O5VH, Safety Report Unique Identifier GB-MHRA-ADR 25835188. A 71-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on Jun2021 (Batch/Lot Number: Not known) as single dose for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 with unknown lot number on unspecified date at single dose for COVID-19 immunization. Medical history included pneumonia, chronic obstructive pulmonary disease, pneumonia, chronic obstructive pulmonary disease, pneumonia, chronic obstructive pulmonary disease, pneumonia, chronic obstructive pulmonary disease, clinical trial participant, immunodeficiency. Taking other treatments or medicines, not listed above, known to lower the immune response. The patient''s concomitant medications were not reported. The patient experienced pneumonia on an unspecified date, positive covid-19 test on unspecified date, suicidal ideation on 02Aug2021. All events were reported as death. The patient died on 15Aug2021. It was not reported if an autopsy was performed. Consumer believed the vaccine caused the death of his dad. He requested to see chest X-ray and never got a response. He had both vaccines - consumer didn''t know which brand. Patient already had COPD and has had pneumonia twice. Consumer was estranged from sister so had no access to his death certificate but consumer was fairly confident from hospital visits that Covid Pneumonia would be put on his death certificate, which meant his entire life would have been lived in a lie because he did not have Covid. He tested negative when he was admitted, he tested negative several times - but he was put on a Covid ward??? Then consumer got informed just before his death that he tested positive for COVID-19. If the vaccines were so good - how did he got Covid. Patient had not tested positive for COVID-19 since having the vaccine. Clinical trial participant. COPD and Pneumonia previously. Patient had not had symptoms associated with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death wishes; positive covid-19 test; positive covid-19 test; Covid Pneumonia


VAERS ID: 1657515 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-11
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypertensive heart disease, Myocardial ischaemia
SMQs:, Hypertension (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101093368

Write-up: Acute ischaemic heart failure due to Hypertensive heart disease; Acute ischaemic heart failure due to Hypertensive heart disease; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21124458. A 57-year-old male patient received 1st dose of BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Solution for injection, Lot number unknown, Expiration date unknown) at single dose via an unknown route on 06Jul2021 at 57-year-old for COVID-19 immunisation. Medical history and concomitant drug were not provided. Body temperature before vaccination was unknown. The family history was unknown. The medical history was unknown. On 11Jul2021 at 18:00 (5 days after the vaccination), the patient experienced acute ischaemic heart failure and hypertensive heart disease. On 11Jul2021 (5 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 11Jul2021 (5 days after the first dose of BNT162b2 vaccination), the patient died. The patient died on his back on the floor of his bedroom in his house. Until approximately 6 hours before the time when the patient was found dead, no abnormalities were observed (the patient talked to his family). The cause of death was acute ischaemic heart failure due to hypertensive heart disease (assumed). The autopsy findings were as follows: There were no autopsy findings which suggested significant relationship between the cause of death and the vaccination. The reporting physician classified the event as non-serious and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was hypertensive heart disease. The reporting physician commented as follows: There was no possibility of death which was related to the vaccination. The specific adverse drug reactions which the reporting physician did not know were different issue. Although it was not considered that the event was related to the vaccination, this case was reported at the family''s strong wish. The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Acute ischaemic heart failure due to Hypertensive heart disease; Acute ischaemic heart failure due to Hypertensive heart disease


VAERS ID: 1657516 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-14
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Extradural haematoma, Fall, Mobility decreased, Speech disorder, Subarachnoid haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-21
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101098422

Write-up: Cardiac arrest; Subarachnoid haemorrhage; extradural haematoma; fell down; he could not move his right hand; difficulty in speaking clearly; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21124539. The patient was a 70-year and 7-month-old male. Body temperature before vaccination was not reported. The patient received the 2nd dose of BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (at the age of 70-year-old) as single dose for COVID-19 immunisation. Information on medical history and concomitant medications was unknown. It was not reported if the patient had family history. The patient previously received the 1st single dose of COVID-19 vaccine (Manufacture unknown) for COVID-19 immunisation. On 21Aug2021 at 00:35 (after the vaccination), the patient experienced cardiac arrest and died (on 21Aug2021). It was unknown if an autopsy was performed. The outcome of events Subarachnoid haemorrhage, Extradural haematoma, Fall, Mobility decreased and Speech disorder was unknown. The course of the events was as follows: On 14Aug2021, the patient fell down. Since then, he could not move his right hand and had difficulty in speaking clearly. However, he did not visit a hospital immediately (illegible). On 21Aug2021, he was found in CPA (cardiopulmonary arrest) and transferred to a hospital by an ambulance. The reporting physician classified the event Cardiac arrest as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Subarachnoid haemorrhage and extradural haematoma were considered as possible causes of the event.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1657617 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1-213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210853382

Write-up: BODY WEAKNESS; LOSS OF APPETITE / DECREASE IN APPETITE; This spontaneous report received from a physician via a Regulatory Authority [PH-PHFDA-300101150] concerned a 33 year old male. 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: 1-213C21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021 at 08:00, the patient experienced body weakness and loss of appetite / decrease in appetite. On an unspecified date, in AUG-2021, the patient died from body weakness, and loss of appetite / decrease in appetite. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from body weakness, and loss of appetite / decrease in appetite on an unspecified date, in AUG-2021. This report was serious (Death).; Sender''s Comments: V0: 20210853382-COVID-19 VACCINE AD26.COV2.S-BODY WEAKNESS, LOSS OF APPETITE / DECREASE IN APPETITE (with fatal outcome). These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: BODY WEAKNESS; LOSS OF APPETITE / DECREASE IN APPETITE


VAERS ID: 1657618 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213CIA / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (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), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210853425

Write-up: ALTERED STATE OF CONSCIOUSNESS; DYSPNOEA; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA:PH-PHFDA-300100149] concerned a 71 year old female. 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, intramuscular, batch number: 213CIA, and expiry: UNKNOWN) dose was not reported,1 total administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, at 15:00, the patient experienced dyspnoea. On 06-AUG-2021, at 17:50, the patient experienced altered state of consciousness (change in sensorium) On an unspecified date, the patient died from dyspnea and altered state of consciousness. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of dyspnoea and altered state of consciousness on an unspecified date. This report was serious (Death).; Sender''s Comments: V0: 20210853425-Covid-19 vaccine ad26.cov2.s -Altered state of consciousness, Dyspnoea. 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: DYSPNEA; ALTERED STATE OF CONSCIOUSNESS


VAERS ID: 1657620 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Bone pain, Cardiac arrest, Malaise, Myocardial infarction, Syncope, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 28
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: PRENESSA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rash; Drug allergy (allergy to salicylates, developed a rash); Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202101095498

Write-up: Cardiac arrest; Myocardial infarction; Thrombus; Faint; Weakness; Bone pain; Malaise; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority PL-URPL-DML-MLP.4401.2.570.2021. A 65-years-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 31Mar2021 (Lot Number: EW8904) at the age of 65-year-old, as dose 1, single for covid-19 immunisation. Medical history included hypertension; drug allergy (allergy to salicylates), the patient developed a rash. The patient did not have COVID. Concomitant medications included perindopril erbumine (PRENESSA) taken for hypertension. In Apr2021, one week after vaccination the patient began to feel bad-bone pain, weakness. The patient went to the doctor. The doctor prescribed painkillers diclofenac sodium (OLFEN) tab. and etofenamate (DIFORTAN) ointment. On 17Apr2021 the patient fainted, an ambulance was called and the patient was admitted to the hospital. In the hospital, he was diagnosed with a heart attack/ myocardial infarction and two blood clots/ thrombus, and he was sent for surgery. On 28Apr2021 the surgery was performed. Consequences of the side effect included from 17Apr2021 patient was hospitalized. The reporting person did not assess the severity of the adverse reaction. The Agency classified the notification as severe (hospitalization or its extension, death). Therapeutic measures were taken as a result of bone pain, malaise, weakness, myocardial infarction and thrombus. The outcome of events was fatal. The patient died on 29Apr2021. Cause of death was cardiac arrest. An autopsy was not performed. Assessment between Comirnaty and events "Bone pain, Malaise, Faint, Weakness, Thrombus" was possible per Source: NCA /Method: WHO. Assessment between Comirnaty and events "Cardiac arrest, Surgery, Myocardial infarction" was unassessable per Source: NCA /Method: WHO. Sender''s comment: Malaise is an expected side effect of Comirnaty, included in the Summary of Product Characteristics; while bone pain, weakness, fainting, heart attack, blood clots are unexpected side effects of the vaccine. Till now it has not been proven that the intake of mRNA vaccines, including Comirnaty, is associated with an increased risk of thrombotic events. Due to insufficient information, it is not possible to know whether the heart attack was due to the vaccine. It should be remembered that there were factors predisposing to a heart attack - arterial hypertension, male gender, age. Some of the side effects, such as myocardial infarction, asthenia (weakness), fainting, are listed as expected in the Summary of Product Characteristics of Prenessa (perindopril), taken by the patient for hypertension. There is a time relationship between receiving the vaccine and the appearance of side effects. The reporting person did not specify whether the side effect was serious. The Agency due to hospitalization and death of the Patient assessed it as heavy. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1657700 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiovascular disorder, Death
SMQs:, Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypercholesterolaemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; Cardiovascular disease; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) and CARDIOVASCULAR DISORDER (Cardiovascular disease) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Diabetes and Hypercholesterolaemia. On 04-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and CARDIOVASCULAR DISORDER (Cardiovascular disease) (seriousness criterion death). The reported cause of death was cardiovascular disease. An autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided Treatment medication was not provided Company Comment: This case refers to a 66-year-old female with a medical history of hypertension, diabetes and hypercholesterolaemia who died approximately 3 weeks after receiving the dose 1 of the product mRNA-1273. The cause of death reported as cardiovascular disease according to the autopsy. Although there is a temporal relationship between the vaccine administration and the events, a role of underlying conditions cannot be completely excluded. Very limited information regarding the baseline status of underlying conditions and relevant diagnostic results and the events has been provided at this time.; Sender''s Comments: This case refers to a 66-year-old female with a medical history of hypertension, diabetes and hypercholesterolaemia who died approximately 3 weeks after receiving the dose 1 of the product mRNA-1273. The cause of death reported as cardiovascular disease according to the autopsy. Although there is a temporal relationship between the vaccine administration and the events, a role of underlying conditions cannot be completely excluded. Very limited information regarding the baseline status of underlying conditions and relevant diagnostic results and the events has been provided at this time.; Reported Cause(s) of Death: cardiovascular disease


VAERS ID: 1657701 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600-CDC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Foetal death, Ultrasound foetal
SMQs:, Termination of pregnancy and risk of abortion (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: Maternal exposure during pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Fetal ultrasound; Result Unstructured Data: Normal Fetal ultrasound indicated normal fetal heartbeat.; Test Date: 20210715; Test Name: Fetal ultrasound; Result Unstructured Data: Abnormal Fetal ultrasound indicated: no fetal heartbeat.
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Fetal demise; This regulatory authority case was reported by a physician and describes the occurrence of FOETAL DEATH (Fetal demise) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600-CDC) , while the mother received the product for COVID-19 vaccination. The patient''s past medical history included Maternal exposure during pregnancy. On 14-Jul-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Jul-2021, the patient was diagnosed with FOETAL DEATH (Fetal demise) (seriousness criteria death and medically significant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Intrauterine Fetal Death. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Ultrasound foetal: normal (normal) Normal Fetal ultrasound indicated normal fetal heartbeat.. On 15-Jul-2021, Ultrasound foetal: abnormal (abnormal) Abnormal Fetal ultrasound indicated: no fetal heartbeat.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported . Treatment information was not provided. Patient reported that the hospital was going to perform a fetal autopsy and labor induction will be performed on the patient the next day (07/16). The case is still pending confirmation on whether a fetal autopsy will be performed. Company Comment: This is a case of maternal exposure during breastfeeding with associated adverse event of foetal death. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This is a case of maternal exposure during breastfeeding with associated adverse event of foetal death. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1657908 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       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: USPFIZER INC202101100128

Write-up: I have lost 7 friends and a friend of my son 14 years; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for twelve patients. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated "I have lost 7 friends and a friend of my son 14 years." The cause of death was unknown. It was unknown if autopsy was done. The 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.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101100059 Same reporter/event/drug, different patient; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1657934 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4421 / 1 - / -

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

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: Medical History/Concurrent Conditions: COPD; Diabetes mellitus; Dialysis (Is on dialysis as an outpatient); Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202101099741

Write-up: When his girlfriend arrived home from work at about 18.00 on 18Aug2021 he was found on the floor deceased.; This is a spontaneous report from a contactable other hcp. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Aug2021 12:54 (vaccination at age of 58 years old) (Lot Number: FG4421; Expiration Date: 03Sep2021) as First single dose for covid-19 immunization. Medical history included diabetes mellitus, hypertension, chronic obstructive pulmonary disease, dialysis - on dialysis as an outpatient. The patient''s concomitant medications were not reported. It is reported that when his girlfriend arrived home from work at about 18.00 on 18Aug2021 he was found on the floor deceased. The patient died on 18Aug2021. Diluent Batch/Lot Number: L1954; Expiration Date: May2023. Date and time of reconstitution 17Aug2021 at 10H30. This is the only information for this report.; Sender''s Comments: The causal relationship between bnt162b2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: found the floor deceased.


VAERS ID: 1657969 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-08-16
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004228 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pyrexia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20212

Write-up: Sudden death; Pyrexia; This case was received via Pharmaceuticals (Reference number: 2021TJP082021AA) on 21-Aug-2021 and was forwarded to Moderna on 28-Aug-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the Regulatory Authority (Ref, v21124408). On 18-Jul-2021, the patient received the 1st dose of the vaccine. On 15-Aug-2021, the patient received the 2nd dose of the vaccine. On 16-Aug-2021, the patient experienced pyrexia of 38.5 degrees Celsius. On 17-Aug-2021, pyrexia subsided. On 18-Aug-2021, the patient was found dead at home. It was a sudden death. The outcome of pyrexia was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The patient was a 38-year-old male with no apparent past medical history and died suddenly 3 days after receiving the vaccine, and the possibility of an adverse reaction cannot be ruled out. The patient experienced pyrexia on the day following vaccination. Whether the pyrexia was associated with an adverse reaction or other diseases is unknown at present. An autopsy was performed, and the cause of death is currently being investigated.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1657978 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Cerebral haemorrhage, Death, Dizziness, Fall
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 12
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Cerebral hemorrhage; accidently fell; Death; dizzy; weakness; This regulatory authority case was reported by an other health care professional and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral hemorrhage), DEATH (Death), DIZZINESS (dizzy), ASTHENIA (weakness) and FALL (accidently fell) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced DIZZINESS (dizzy) (seriousness criterion death) and ASTHENIA (weakness) (seriousness criterion death). On 07-Jul-2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral hemorrhage) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced FALL (accidently fell) (seriousness criterion death). The patient died on 14-Jul-2021. The reported cause of death was Cerebral haemorrhage, Dizzy and Weakness. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Cerebral haemorrhage; dizzy; Weakness


VAERS ID: 1657980 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Haematemesis, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Altered state of consciousness; Vomited blood; Weakness of limbs; This regulatory authority case was reported by an other health care professional and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) and MUSCULAR WEAKNESS (Weakness of limbs) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced MUSCULAR WEAKNESS (Weakness of limbs) (seriousness criteria death and hospitalization). On 24-Jul-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 24-Jul-2021 to 25-Jul-2021 due to ALTERED STATE OF CONSCIOUSNESS, HAEMATEMESIS and MUSCULAR WEAKNESS. The patient died on 25-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not provided. The patient could not lift his arms for three days, starting from July 14 2021. Subsequently, everything was rather normal and the patient only experienced mild symptoms, but he was found collapsed on the ground in his home at noon on July 24. He was taken to Hospital and was only 3 ? 4 on the coma scale. He underwent a full body examination and brain examination, and two out of six parts of his brain were found to be black. Patient also vomited blood when he was fed liquid food. The patient passed away in the morning on July 25 2021. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1657981 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Fall, Head injury
SMQs:, Accidents and injuries (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: Eye disorder (regularly sought medical attention at Hospital); Mental disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: death; head trauma from impact; death was preliminarily suspected to be caused by a fall from the bed to the ground; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (death), HEAD INJURY (head trauma from impact) and FALL (death was preliminarily suspected to be caused by a fall from the bed to the ground) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Mental disorder and Eye disorder (regularly sought medical attention at Hospital). On 10-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (death) (seriousness criteria death and medically significant), HEAD INJURY (head trauma from impact) (seriousness criterion death) and FALL (death was preliminarily suspected to be caused by a fall from the bed to the ground) (seriousness criterion death). The reported cause of death was head trauma and Fall. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEATH (death), HEAD INJURY (head trauma from impact) and FALL (death was preliminarily suspected to be caused by a fall from the bed to the ground) to be possibly related. Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: unknown cause of death; head trauma; fall


VAERS ID: 1658076 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-22
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 22-Jul-2021 The patient was treated with ADRENALIN [EPINEPHRINE] on 22-Jul-2021 for Adverse event, at a dose of 1mg/1mL/Amp 0.1%(Epinephrine), total of 10 Amp. The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. It was reported that Start of CPR 22 Jul 2021 at 09:47 a.m. Adrenalin 1mg/1mL/Amp 0.1%(Epinephrine), total of 10 Amp. End of CPR 22 Jul 2021 at 10:20 a.m. the patient''s vital signs did not recover after CPR. Treatment information was not provided by the reporter. Company comment: This case of death of a 79-year-old female patient 21 days after administration of mRNA-1273. Although a temporal association exist between the vaccine administration and the reported events, critical details such as the patient''s detailed medical history, autopsy findings and cause of death are lacking. No further information is expected.; Sender''s Comments: This case of death of a 79-year-old female patient 21 days after administration of mRNA-1273. Although a temporal association exist between the vaccine administration and the reported events, critical details such as the patient''s detailed medical history, autopsy findings and cause of death are lacking. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1658077 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600-CDC / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   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:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: brain stem hemorrhage; Intracerebral and brain stem hemorrhage; This regulatory authority case was reported by an other health care professional and describes the occurrence of BRAIN STEM HAEMORRHAGE (brain stem hemorrhage) and CEREBRAL HAEMORRHAGE (Intracerebral and brain stem hemorrhage) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600-CDC) for COVID-19 vaccination. No Medical History information was reported. On 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced BRAIN STEM HAEMORRHAGE (brain stem hemorrhage) (seriousness criteria death and medically significant) and CEREBRAL HAEMORRHAGE (Intracerebral and brain stem hemorrhage) (seriousness criteria death and medically significant). The patient died on 18-Jul-2021. The reported cause of death was intracerebral and brain stem hemorrhage and intracerebral and brain stem hemorrhage. An autopsy was performed, but no results were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BRAIN STEM HAEMORRHAGE (brain stem hemorrhage) and CEREBRAL HAEMORRHAGE (Intracerebral and brain stem hemorrhage) to be possibly related. Concomitant product was not provided. Treatment medication was not reported. The patient received the vaccine on 12-Jul-2021, and he had no breathing or pulse when his family discovered him on 18-Jul-2021. The patient''s family suspected his death to be related to the vaccine and judicial autopsy was performed on 22-Jul-2021 to clarify the cause of death. The medical examiner preliminary determined the cause of death as intracerebral and brain stem hemorrhage. Sender''s unique identifier number: TW-TFDA-TVS-1100003778.; Sender''s Comments: Medical history was not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Intracerebral and brain stem hemorrhage; Intracerebral and brain stem hemorrhage


VAERS ID: 1658418 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Lung disorder, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (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: Comments: Patient did not have any associated comorbities.
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRJNJFOC20210854425

Write-up: SEPSIS; COMPROMISED LUNG; PASSED AWAY; This spontaneous report received from a consumer concerned a 72 year old male of unknown race and ethnic origin. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Patient did not have any associated comorbities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, 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. The reporter mentioned about a neighbour who was a volunteer in the Janssen covid-19 test. After vaccination the patient got hospitalized with compromised lung and needed to be intubated for approximately 10 days. After the extubation the patient got sepsis and passed away. The cause of death was unknown. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of compromised lung and sepsis was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210854425-Covid-19 vaccine ad26.cov2.s -Passed away, sepsis. 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: 1659377 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis
SMQs:, 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: 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: AUPFIZER INC202101119514

Write-up: Myocarditis; This is a spontaneous report from a contactable physician via a sales representative. A 5-decade-old (reported as early 40s) male patient received 1st dose of BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had received the first injection of Comirnaty. A short but unknown amount of time after that the patient became unwell, was diagnosed with myocarditis and subsequently died in hospital. The patient died on an unspecified date due to myocarditis. It was unknown if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: The causal relationship between bnt162b2 and the event myocarditis (Fatal) cannot be fully assessed/excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Myocarditis


VAERS ID: 1659382 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood test, Cardiovascular disorder, Cerebrovascular accident, Coagulopathy, Computerised tomogram, Death, Echocardiogram, Magnetic resonance imaging head, Myocardial infarction, Nervous system disorder
SMQs:, Haemorrhage laboratory terms (broad), Myocardial infarction (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes
Allergies:
Diagnostic Lab Data: Test Name: coronarography; Result Unstructured Data: Test Result:unknown results; Test Name: Blood test; Result Unstructured Data: Test Result:unknown results; Test Name: CT scan; Result Unstructured Data: Test Result:unknown results; Test Name: Echocardiography; Result Unstructured Data: Test Result:unknown results; Test Name: MRI brain; Result Unstructured Data: Test Result:unknown results
CDC Split Type: BEPFIZER INC202101107463

Write-up: Passing away; Cardiovascular problem; Acute Cerebrovascular Accident; Blood clotting problem; Neurological problem; massive left wall myocardial infarction; This is a spontaneous report from a contactable other hcp downloaded from the RA, regulatory authority number BE-FAMHP-DHH-N2021-105579. A 74-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 17Apr2021 (Lot Number: ET9096) as dose 2, single for COVID-19 immunisation. Medical history included Diabetes. The patient''s concomitant medications were not reported. The patient experienced cardiovascular problem (death, hospitalization, life threatening) on an unspecified date, acute cerebrovascular accident (death, hospitalization, life threatening) on an unspecified date, passing away (death, hospitalization, life threatening) on an unspecified date, blood clotting problem (death, hospitalization, life threatening) on an unspecified date, neurological problem (death, hospitalization, life threatening) on an unspecified date, massive left wall myocardial infarction (death, hospitalization, life threatening) on an unspecified date. The patient underwent lab tests and procedures which included coronarography, Blood test, CT scan, Echocardiography, MRI brain, all with unknown results. Therapeutic measures were taken as a result of the events. The patient died on 19Aug2021. The outcome of the events was fatal. It was not reported if an autopsy was performed. Reporter''s comment: Treatment - Yes coronarography with stenting, amiodarone and IV Evolution of the ADR - Deceased Situations - Other: Gene therapy instead of vaccination Examinations - Blood analysis, CT scan, coronarography, echo Cor, MRI brain ADR description - Acute CVA + massive left wall heart attack No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - Yes coronarography with stenting, amiodarone and IV Evolution of the ADR - Deceased Situations - Other: Gene therapy instead of vaccination Examinations - Blood analysis, CT scan, coronarography, echo Cor, MRI brain ADR description - Acute CVA + massive left wall heart attack; Reported Cause(s) of Death: Acute Cerebrovascular Accident; Passing away; Blood clotting problem; Neurological problem; massive left wall myocardial infarction; Cardiovascular problem


VAERS ID: 1659406 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-29
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0578 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101102429

Write-up: cannot make any conclusion for the reason of death/not sure if vaccine relates to the death or not; This is a spontaneous report received via the Regulatory Auhtority from a non-contactable physician. An 18-years-old female patient (not pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Jun2021 (Batch/Lot Number: Ey0578) (at the age of 18-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The most recent COVID-19 vaccine was administered at Health Clinic/Administration facility. Medical history was None. There were no known allergies. There was no relevant past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications received within 2 weeks of vaccination. The healthy patient was noticed diseased in her bed by parents on 29Jun2021. Autopsy was taken but cannot make any conclusion for the reason of death. She had Pfizer vaccine on 12Jun2021, not sure if vaccine related to the death or not. There was no treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient died on 29Jun2021. Autopsy was done. Autopsy-determined cause of patient death was No. There were no autopsy remarks. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible 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.; Reported Cause(s) of Death: cannot make any conclusion for the reason of death/not sure if vaccine relates to the death or not


VAERS ID: 1659426 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Decreased appetite, Fatigue, Neoplasm progression, Pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Malignancy related conditions (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
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: Cancer; Diabetes
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: covid test; Test Result: Negative
CDC Split Type: CRPFIZER INC2021850787

Write-up: had cancer and his symptoms just started to develop after the second dose; constant cough; tiredness; poor appetite; body aches; This is a spontaneous report from a contactable consumer (patient''s daughter) by email. A 63-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus and cancer. The patient''s concomitant medications were not reported. The patient previously took first dose bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) on unspecified date as DOSE 1, SINGLE for COVID-19 Immunization. Reporter father was vaccinated with the second dose of his vaccine 3 weeks ago and continues with the side effects on an unspecified date the patient had experienced constant cough, tiredness, poor appetite, and body aches. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on Jun2021. The patient passed away two weeks ago in Aug2021. Neither he (patient) nor the reporter had idea that he had cancer and his symptoms just started to develop after the second dose. It was unknown if autopsy was performed. The outcome of the event ''had cancer and his symptoms just started to develop after the second dose'' was fatal, of the events constant cough, tiredness, poor appetite, and body aches was not recovered. Information on the lot/batch number has been requested. Follow-up (26Aug2021): New information reported from a contactable consumer (daughter of patient) includes: upgrade to serious, medical history, event details. The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: had cancer and his symptoms just started to develop after the second dose


VAERS ID: 1659544 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRW2 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   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: Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101108003

Write-up: Unknown cause of death; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100173467. A 63-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 12Aug2021 (Lot Number: SCRW2) at age of 63-year-old as single dose for covid-19 immunisation. Medical history included tobacco user. The patient''s concomitant medications were not reported. The patient previously took 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Jul2021 as single dose for covid-19 immunisation and no adverse event. On 14Aug2021 the patient experienced Unknown cause of death. It was not reported if an autopsy was performed. Regulatory authority assessed relationship between Unknown cause of death and bnt162b2 was Unclassifiable. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1659613 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3095 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Adenocarcinoma of oesophagus; Atrial fibrillation; Chronic kidney disease; Clotting disorder; Heart disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101088418

Write-up: unknown cause of death/ death of the patient today (death); This is as spontaneous report received from a non-contactable consumer downloaded from the RA. The regulatory authority report number is DE-PEI-CADR2021165488, Safety report unique identifier DE-PEI-202100170353. A 95-year-old male patient received second dose of BNT162B2 (COMIRNATY) (Lot Number: FC3095) via unspecified route single dose for COVID-19 immunisation on 11Jun2021. Medical history included ongoing adenocarcinoma of oesophageal, ongoing chronic kidney disease, ongoing heart disorder, ongoing clotting disorder, ongoing atrial fibrillation. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY, strength: 0.3 ml) for COVID-19 immunization on 30Apr2021 and experienced general physical condition decreased, coagulation therapy (unspecified) for coagulopathy and had no adverse event. The patient experienced unknown cause of death/ death of the patient today (death) on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed. Relatedness Assessment of to the events was reported as unclassifiable. (Source of assessment: RA). Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? none Information on risk factors or previous illnesses Pre-fibrillation, coagulation therapy, oesophageal cancer approx. 15 years ago, cardiac insufficiency, renal insufficiency / s. Patient old but active and fit except for slight frailty, home environment, to the best of my knowledge not even in need of nursing care. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101100524 Same patient, different dose, different event; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1659614 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101107834

Write-up: Fell asleep and never woke up; 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-CADR2021166446. Safety Report Unique Identifier DE-PEI-202100172177. A 59-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: unknown, strength: 0.3 ml) (mRNA tozinameran), on 16Jun2021 at single dose for COVID-19 immunisation. Medical history was none. The patient had no signs, complaints or intolerance. The patient had no known allergies. The patient''s concomitant medications were not reported. The patient experienced fell asleep and never woke up on an unspecified date. The patient also experienced unknown cause of death. The patient died on an unspecified date. It was not reported if an autopsy was performed. This report was serious - death. Relatedness of BNT162B2 to the event unknown cause of death was reported as D unclassifiable by the regulatory authority. The outcome of 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: Fell asleep and never woke up


VAERS ID: 1659615 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-31
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: 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: Abstains from alcohol; Family history of cardiovascular disorder; Non-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101107879

Write-up: Infarct myocardial; This is a spontaneous report received from a non-contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-CADR2021167151, Safety report unique identifier DE-PEI-202100172555. A 61-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: unknown, strength: 0.3 ml) (mRNA tozinameran) on 27Jul2021 at single dose for COVID-19 immunisation. The patient had no known allergies. No previous illnesses, no tablet intake, non-smoker, slim, athletic, hardly any alcohol, family history of unaffected cardiovascular diseases. Workload as always. The patient''s concomitant medications were not reported. The patient experienced infarct myocardial on an unspecified date. Immediately after the heart attack symptoms first appeared (also reported as he suddenly died after 3 weeks of a heart attack without warning), the team was on site within 5 minutes. Dead after 45 minutes of resuscitation. The patient died on an unspecified date. It was not reported if an autopsy was performed. This report was serious - death. Relatedness of BNT162B2 to event was assessed as D. Unclassifiable by regulatory authority. The outcome of 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: Infarct myocardial


VAERS ID: 1659616 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-08-10
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1231 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   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: DEPFIZER INC202101107882

Write-up: intense dead; This is a spontaneous report received from a non-contactable consumer or other hcp downloaded from the Regulatory Authority. The regulatory authority report number is DE-PEI-CADR2021167829, Safety report unique identifier DE-PEI-202100173132. A 71-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: 1231, strength: 0.3 ml) (mRNA tozinameran) on 09Jul2021 at single dose for COVID-19 immunisation. The patient had no known allergies. The patient had no heart disease before vaccination. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown, strength: 0.3 ml) on an unspecified date at single dose for COVID-19 immunisation. The patient experienced intense dead (unknown cause of death) on 10Aug2021. The patient died on 10Aug2021. It was not reported if an autopsy was performed. This report was serious - death. Relatedness of BNT162B2 to events was assessed as D. Unclassifiable by the RA. The outcome of event was fatal.; Reported Cause(s) of Death: intense dead


VAERS ID: 1659831 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-28
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: FRPFIZER INC202101107998

Write-up: sudden death/cardio-respiratory arrest/heart failure/cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, FR-AFSSAPS-BR20213279. A 64-year-old male patient received second dose of BNT162B2 (COMIRNATY), via intramuscular, administered in left arm on 18Jun2021 (Batch/Lot Number: FC5435) as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Jun2021, the patient experienced cardio-respiratory arrest at home. Document documented after contact with the doctor in charge of the (Emergency medical aid service): Returning from vacation the day before, the patient was gardening. His wife found him with heart failure in the garden. Intervention of the SMUR 15-20 minutes after: medical resuscitation for 30 minutes, without recovery. Suspected diagnosis: cardiac arrest. In total: the athlete patient with no previous history and no medical follow-up, which occurred 10 days after a 2nd dose of vaccine with comirnaty, probable sudden death while he was gardening. Absence of prodrome. The outcome of the event was fatal. The patient died on 28Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death/cardio-respiratory arrest/heart failure/cardiac arrest


VAERS ID: 1659844 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Aggression, Agitation, Anxiety, Blood creatinine, Blood sodium, Blood urea, Body temperature, Cardiac failure, Chest X-ray, Cognitive disorder, Cyanosis, Death, Disorientation, Echocardiogram, Ejection fraction, Electrocardiogram, Fall, General physical health deterioration, Haemorrhagic stroke, Hypothermia, Inflammation, Malaise, Muscular weakness, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, Oxygen saturation decreased, Physical examination, Polycythaemia, Red blood cell count, Renal function test, Restlessness, SARS-CoV-2 test, Scan brain, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 75
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 32 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Atrial fibrillation; Cholecystectomy; Heart failure; Insufficiency cardiac; Ischemic stroke; Neurodegenerative disorder; Varicose vein
Allergies:
Diagnostic Lab Data: Test Name: serum creatinine; Result Unstructured Data: Test Result:17.3; Test Name: Na +; Result Unstructured Data: Test Result:150 mmol/L; Test Date: 20210428; Test Name: Na +; Result Unstructured Data: Test Result:decrease mmol/L; Test Date: 20210426; Test Name: natremia; Result Unstructured Data: Test Result:166 mEq/l; Test Date: 20210430; Test Name: natremia; Result Unstructured Data: Test Result:154 mEq/l; Test Name: urea; Result Unstructured Data: Test Result:1.21 mmol/L; Test Date: 2021; Test Name: body temperature; Result Unstructured Data: Test Result:hypothermia at 35 Centigrade; Test Date: 20210415; Test Name: chest x-ray; Result Unstructured Data: Test Result:Enlargement of the cardio-mediastinal silhouette.; Comments: Enlargement of the cardio-mediastinal silhouette. Lack of pleural effusion. Presence of multiple bilateral infracentimetric opacities. In the differential diagnosis, we can evoke the hypothesis of a miliaria.; Test Name: echocardiography; Result Unstructured Data: Test Result:Ultrasound in favor of rhythmic heart disease with; Comments: Ultrasound in favor of rhythmic heart disease with impaired systolic function and LVEF estimated at 35%. Bi-atrial dilation. Moderate mitral insufficiency. Dilation of the ascending aorta and valsalva sinus. Filling pressures in the gray area E / E 10.; Test Name: LVEF; Test Result: 35 %; Test Name: ECG; Result Unstructured Data: Test Result:complete arrhythmia due to atrial fibrillation wit; Comments: complete arrhythmia due to atrial fibrillation with left anterior hemiblock.; Test Name: pro-BNP; Result Unstructured Data: Test Result:11 377; Test Name: desaturation; Result Unstructured Data: Test Result:tendency to desaturation (patient being limited in; Comments: tendency to desaturation (patient being limited in invasive care); Test Date: 20210428; Test Name: desaturation; Result Unstructured Data: Test Result:put under O2 4L; Test Name: physical examination; Result Unstructured Data: Test Result:Restless, uncooperative, aggressive patient. Delus; Comments: Restless, uncooperative, aggressive patient. Delusional speech. No confusion but the presence of a temporo-spatial disorientation.; Test Date: 20210426; Test Name: polycythemia; Result Unstructured Data: Test Result:polycythemia; Test Name: renal failure; Test Result: 46 mL; Test Date: 20210426; Test Name: renal failure; Test Result: 9 mL; Comments: 9mL VS 46mL at entry; Test Name: covid-19 PCR; Result Unstructured Data: Test Result:unknown results; Test Name: brain scan; Result Unstructured Data: Test Result:shows signs of a hemorrhagic stroke.; Comments: shows signs of a hemorrhagic stroke.; Test Date: 20210429; Test Name: brain scan; Result Unstructured Data: Test Result:No acute abnormality detectable. Pan-sinusitis.; Test Date: 20210505; Test Name: brain scan; Result Unstructured Data: Test Result:Hyperdensity at the level of the basilar trunk whi; Comments: Hyperdensity at the level of the basilar trunk which may correspond to a hemorrhagic stroke in the territory of the perforators of the basilar trunk. Cortico-subcortical atrophy.; Test Date: 20210426; Test Name: cytobacterioligical urine exam; Result Unstructured Data: Test Result:inflammatory syndrome
CDC Split Type: FRPFIZER INC202101107987

Write-up: inflammatory syndrome; reactive polycythemia; Acute renal failure; AEG (deterioration of general condition); Muscular weakness; fall; Feeling sick; Decompensation cardiac; Acrocyanosis affecting all 4 limbs; hypothermia at 35 Centigrade; tendency to desaturation; Major cognitive impairment; Restless; aggressive; temporo-spatial disorientation; agitation and anxiety; agitation and anxiety; Death; Hemorrhagic stroke; This is a spontaneous report from a contactable consumer and physician downloaded from the Regulatory Authority (FR-AFSSAPS-CN20212736). A 80-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 14Apr2021 (Lot Number: unknown) as dose 2, single for covid-19 immunisation. History of COVID-19: no. PCR test history: yes. Medical history included Insufficiency cardiac, arterial hypertension, Cholecystectomy, Cure of varicose veins of the lower limbs, Atrial fibrillation, Heart failure, Ischemic stroke with sequelae, Mixed neurodegenerative pathology. The patient''s concomitant medications were not reported. The patient experienced death on 29Jun2021 14:25, decompensation cardiac (death, hospitalization) on 15Apr2021, hemorrhagic stroke (death) on 05May2021, AEG (deterioration of general condition) on 15Apr2021 with outcome of not recovered, muscular weakness (hospitalization) on 15Apr2021 with outcome of not recovered, fall (hospitalization) on 15Apr2021 with outcome of not recovered, feeling sick (hospitalization) on 15Apr2021 with outcome of not recovered, acute renal failure (hospitalization) on 19Apr2021 with outcome of not recovered, acrocyanosis affecting all 4 limbs (hospitalization) in 2021 with outcome of unknown, hypothermia at 35 centigrade (hospitalization) on 2021 with outcome of unknown, tendency to desaturation (hospitalization) in 2021 with outcome of unknown, inflammatory syndrome (hospitalization) on 26Apr2021 with outcome of unknown, reactive polycythemia (hospitalization) on 26Apr2021 with outcome of unknown, major cognitive impairment (hospitalization) in 2021 with outcome of unknown, Restless (hospitalization) in 2021 with outcome of unknown, aggressive (hospitalization) in 2021 with outcome of unknown, temporo-spatial disorientation (hospitalization) in 2021 with outcome of unknown, agitation and anxiety (hospitalization) in 2021 with outcome of unknown. Clinical course reported as following: Adverse effects: Onset of discomfort and loss of tone on Day 1. Medical hospitalization report from 16Apr2021 to 18May2021. Reason for hospitalization: Left cardiac decompensation with AEG (deterioration of general condition) and difficult home maintenance. Admitted to the emergency room on 15Apr2021 for AEG (deterioration of general condition) and slip syndrome since the injection of the 2nd dose of vaccine Pfizer. Notion of fall following a slip of her walker due to muscle weakness. The clinical and biological assessment concludes with cardiac decompensation, which is why the patient is transferred to medicine for treatment. 19Apr2021: Not compliant for the treatment. Increase in furosemide but appearance of hyponatremia and renal failure. Biology of the day: Na +: 150 mmol / L, urea: 1.21 mmol / L, serum creatinine: 17.3, pro-BNP: 11 377. 23Apr2021: Dehydration which increases because patient refuses to drink and tears off all IV or SC device. Regression of acute lung edema signs. 26Apr2021: Dehydration. Biology: natremia at 166mEq / L (N: 135-145mEq / L). 2L infusion. 27Apr2021: After the cardiologist''s opinion, the treatment should be continued identically: anticoagulant, diuretic, beta-blocker, digoxin. Acrocyanosis affecting all 4 limbs, hypothermia at 35 Centigrade, tendency to desaturation (patient being limited in invasive care). Biology of 26Apr2021: inflammatory syndrome, dehydration, electrolyte disturbances, reactive polycythemia and renal failure at 9mL VS 46mL at entry. 28Apr2021: No major dyspnea but desaturation put under O2 4L / min. Do not take anything by mouth. Biology decrease in serum sodium, improvement in renal function. Biological inflammatory syndrome -$g cytobacterioligical urine exam to do. Put on ceftriaxone. 30Apr2021: Get better and start eating and communicating. Biological control: natremia at 154mEq / L (N: 135-145mEq / L). Decrease in the dose of Furosemide and increase in intake. O2 weaning because good saturation. Stationary state with episode of agitation and anxiety. Intervention request from the mobile palliative care team for massage and relaxing music. The follow-up brain scan shows signs of a hemorrhagic stroke. The images were transferred to neurosurgery for opinion: no surgical indication. On 17May2021, the patient is calm and present. Resumption of feeding by nasogastric tube. Patient transferred on 18May2021 to USSR (Aftercare and Rehabilitation Unit). Physical examination: Restless, uncooperative, aggressive patient. Delusional speech. No confusion but the presence of a temporo-spatial disorientation. Oxygen patient. No dyspnea. ECG: complete arrhythmia due to atrial fibrillation with left anterior hemiblock. Biology: Chest x-ray from 15Apr2021: Enlargement of the cardio-mediastinal silhouette. Lack of pleural effusion. Presence of multiple bilateral infracentimetric opacities. In the differential diagnosis, we can evoke the hypothesis of a miliaria. Brain scanner from 29Apr2021: No acute abnormality detectable. Pan-sinusitis. Brain scanner from 05May2021: Hyperdensity at the level of the basilar trunk which may correspond to a hemorrhagic stroke in the territory of the perforators of the basilar trunk. Cortico-subcortical atrophy. Echocardiography: Ultrasound in favor of rhythmic heart disease with impaired systolic function and LVEF estimated at 35%. Bi-atrial dilation. Moderate mitral insufficiency. Dilation of the ascending aorta and valsalva sinus. Filling pressures in the gray area E / E 10. In total: Cardiac decompensation in a favorable PAO picture under treatment. Hemorrhagic stroke. Acute renal failure. Major cognitive impairment. Palliative care. Death of the patient on 29Jun2021 at 14:25. The patient died on 29Jun2021. An autopsy was not 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: Decompensation cardiac; Hemorrhagic stroke; Death


VAERS ID: 1659852 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-08-05
   Days after vaccination:154
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Respiratory distress, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Hypersensitivity (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: 2021-08-08
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: PCR; Test Result: Positive ; Comments: test came back positive on 06Aug2021 with a C1 variant
CDC Split Type: FRPFIZER INC202101107981

Write-up: COVID-19 test positive/cough, fever; COVID-19 test positive/cough, fever; Distress respiratory; This is a spontaneous report from a contactable consumer dwnloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-LL20215646. A 99-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE, dose 1 intramuscular on 28Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 05Aug2021 the patient presented with a cough, fever, respiratory distress. 05Aug2021 polymerase chain reaction (PCR) test. The test came back positive on 06Aug2021 with a C1 variant. Hospitalization on 07Aug2021. Death of the patient on 08Aug2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. NB: Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: COVID-19 test positive/cough, fever; COVID-19 test positive/cough, fever; respiratory distress


VAERS ID: 1659853 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-08-06
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, General physical health deterioration, 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: 2021-08-10
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: PCR test, positive with a C1 variant
CDC Split Type: FRPFIZER INC202101107976

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; Reduced general condition; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-LL20215650. An 89-year-old female patient received the first dose of BNT162B2 (COMIRNATY, batch/lot number and expiration date not provided), via intramuscular, on 28Jan2021, and second dose of BNT162B2 (COMIRNATY, batch/lot number and expiration date not provided), via intramuscular, on 04Mar2021, both at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced vaccination failure, COVID-19 and reduced general condition, all on 06Aug2021, with seriousness "death and hospitalized". It was reported on 06Aug2021 the patient presented with a cough and deterioration of the general condition, fever. Patient was hospitalized on 10Aug2021. The patient underwent lab tests and procedures, which included 07Aug2021 PCR test, the test came back positive on 09Aug2021 with a C1 variant. The outcome of the events was fatal. Patient death on 10Aug2021. 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: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; Reduced general condition


VAERS ID: 1659887 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101107959

Write-up: Sudden death unexplained; he did not feel good; This is a spontaneous report from a contactable other health professional downloaded from the RA regulatory authority number FR-AFSSAPS-MP20216694. A 60-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Aug2021 (Batch/Lot number was not reported) in the afternoon at the age of 60 years old as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 13Aug2021, in the evening, the patient called his family because he did not feel good. When his family came to see him, the found him dead on his bed. The patient experienced sudden death unexplained on 13Aug2021. The patient died on 13Aug2021. An autopsy was performed that revealed deteriorated pulmonary status (chronic obstructive pulmonary disease). The autopsy showed that the patient was cachectic, in bad general physical status, and toothless. The autopsy revealed also the pulmonary status was altered with lesions of chronic obstructive pulmonary disease and the coronary arteries were atheromatous. No histology performed and no toxicity test. The outcome of event sudden death unexplained was fatal, outcome of other event was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death unexplained; Autopsy-determined Cause(s) of Death: coronary arteries were atheromatous; Deteriorated pulmonary status; cachectic; in bad general physical status; toothless


VAERS ID: 1659960 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-08-09
   Days after vaccination:179
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, COVID-19, Cyanosis, Diarrhoea, Hyperthermia, Oxygen saturation, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test, Vaccination failure, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: HYDROCORTISONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade; Comments: low reactivity hyperthermia; Test Date: 20210810; Test Name: body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Test Date: 20210810; Test Name: body temperature; Result Unstructured Data: Test Result:39.5 Centigrade; Comments: at the end of the day; Test Date: 20210811; Test Name: O2 saturation; Test Result: 70 %; Comments: put under O2 6L; Test Date: 20210811; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Sequencing not performed on the sample in question. But test on a positive test sample for EHPAD, Delta variant detected on 100% of samples.
CDC Split Type: FRPFIZER INC202101108013

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; Desaturation; cyanosis of the cheeks; hyperthermia at 40; Fever at 38.2; vomiting; diarrhea; hyperthermia going up to 39.5 at the end of the day; asthenia; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-RS20212736. A 63-year-old male patient received the second dose and first dose of BNT162B2 (COMIRNATY), the second dose on 11Feb2021 (Lot Number: Unknown), the first dose on 21Jan2021 (Lot Number: Unknown), both via intramuscular as single dose for COVID-19 immunization. Medical history was not known. Covid history was not known. Concomitant medication included hydrocortisone. On 09Aug2021, around 6 months later, the patient presents with asthenia. On 10Aug2021, the patient experienced fever at 38.2, vomiting, diarrhea, marked asthenia with hyperthermia going up to 39.5 at the end of the day. On 11Aug2021, the patient experienced desaturation (70 put under O2 6L) / crowding / cyanosis of the cheeks. Visit of the doctor to review the treatment with hydrocortisone (increase). Usual treatment was not known. PCR positive on 11Aug2021. Sequencing not performed on the sample in question. But test on a positive test sample for EHPAD, delta variant detected on 100% of samples. Hospitalization decision (patient with low reactivity hyperthermia at 40). The events caused in hospitalization. Death in transport. Autopsy was not reported. The cause of death 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: unknown


VAERS ID: 1659989 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-08-07
   Days after vaccination:150
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP905 / 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: 2021-08-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Bilateral cataracts; Bladder cancer (Diverticular pT2G3); Knee surgery NOS; Limb operation
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: variant COVID
CDC Split Type: FRPFIZER INC202101107544

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test/bronchopulmonary infection/respiratory condition worsened; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-TS20213664. An 85-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 10Mar2021 (Batch/Lot Number: EP905) as dose 2, single, dose 1 intramuscular on 17Feb2021 (Batch/Lot Number: EM6950) as dose 1, single for covid-19 immunisation. Medical history included bladder cancer (Diverticular pT2G3), atrial fibrillation (AFib), Bilateral cataract, Right knee and right forearm surgery. The patient''s concomitant medications were not reported. patient hospitalized in neurology for a blocked urinary catheter and a bronchopulmonary infection. The patient''s respiratory condition worsened, and the PCR returned positive for variant COVID (07Aug2021). Despite antibiotic therapy and appropriate care, the condition worsened resulting in the patient''s death on 07Aug2021. 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: 1660012 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Deep vein thrombosis, Dizziness, Dyspnoea, Dysstasia, Electrocardiogram, Fatigue, Hypopnoea, Inappropriate schedule of product administration, Movement disorder, Otorrhoea, Pain in extremity, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 17
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; COLECALCIFEROL; ESOMEPRAZOLE; PREDNISOLONE; SALBUTAMOL; TAMSULOSIN; ZOLEDRONIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Giant cell arteritis; Hiatus hernia (With stricture.); Comments: Please note I expect his general practitioner and/or rheumatology consultant will also submit a yellow card report.
Allergies:
Diagnostic Lab Data: Test Date: 20210416; Test Name: Blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210416; Test Name: ECG; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202101111574

Write-up: Pulmonary embolism; Deep vein thrombosis; climbing stairs particularly difficult; Shallow breathing; Exhaustion; Difficulty in standing; Dizziness; Ear discharge; Pain in leg; Breathlessness; Chest discomfort; Patient received second dose on 31Mar2021 and first dose of bnt162b2 on 16Jan2021 for covid-19 immunization.; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-EYC 00259124. A 75-year-old male patient received second dose of bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; zoledronic acid (ZOLEDRONIC ACID), parenteral from 07Apr2021 (Batch/Lot number was not reported) to 07Apr2021, at for an unspecified indication. Medical history included giant cell arteritis from Dec2020, asthma, hiatus hernia from an unknown date and unknown if ongoing With stricture. Concomitant medications included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]); colecalciferol (COLECALCIFEROL); esomeprazole (ESOMEPRAZOLE); prednisolone (PREDNISOLONE); salbutamol (SALBUTAMOL); tamsulosin (TAMSULOSIN). The patient previously took first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH) on 16Jan2021 for covid-19 immunization. The patient experienced pulmonary embolism on an unspecified date, deep vein thrombosis on an unspecified date, shallow breathing on 09Apr2021, exhaustion on 09Apr2021, difficulty in standing on 09Apr2021, dizziness on 09Apr2021, ear discharge on 09Apr2021, pain in leg on 09Apr2021, breathlessness on 09Apr2021, chest discomfort on 09Apr2021 with outcome of recovered on 12Apr2021. Seriousness criteria of the events pulmonary embolism, deep vein thrombosis, shallow breathing, exhaustion, difficulty in standing, dizziness, ear discharge, pain in leg, breathlessness was death, disability, medically significant. The patient underwent lab tests and procedures which included blood test: not provided on 16Apr2021, electrocardiogram: not provided on 16Apr2021. The action taken in response to the event for zoledronic acid was permanently withdrawn on 07Apr2021. The patient died on 17Apr2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: Ear discharge. My husband received the zoledronic acid infusion on Wednesday 07Apr2021, he felt fine that evening and ok on Thursday 08Apr2021. By Friday 09Apr2021 there was a significant deterioration when he walked to the pharmacy and back home, about one mile, ''had to stop and sit on wall to rest several times, chest very tight, breathing shallow and, needed to use inhaler. Reached home exhausted and legs feeling leaden. Remainder of day spent resting. Saturday 10Apr2021, condition worse, could only just manage a few hundred yards, remainder of day spent resting. Sunday 11Apr2021, similar to Saturday. Note: climbing stairs particularly difficult. He also remarked ''I have giant cell arteritis, had a zoledronic (sic) Acid infusion last Wednesday 07Apr2021 and I am suffering serious side effects: shortness of breath, shallow breathing, struggle to stand upright, dizziness''. Medication Error Details: I cannot say other than my husband became extremely unwell two days after receiving this zoledronic acid infusion. Seek Advice Details: General practitioner appointment Thursday 15Apr2021. General practitioner called patient into surgery. General practitioner ordered electrocardiogram and blood test for next day Friday 16Apr2021. Patient died of pulmonary embolism, deep vein thrombosis on Saturday 17Apr2021. No follow-up attempts are possible. Information about batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101116584 Same patient and dose, different event.; Reported Cause(s) of Death: deep vein thrombosis; Pulmonary embolism


VAERS ID: 1660398 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Balance disorder, Diarrhoea, Dyspnoea, Gait inability, Gastrointestinal pain, Mobility decreased, Myocarditis, Peripheral swelling, SARS-CoV-2 test, Sepsis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Flu vaccination
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101105483

Write-up: Myocarditis; breathlessness; Mobility decreased; Diarrhea; Sepsis; Gut pain; Swelling of feet; loss of power in legs; unable to stand or walk; unable to stand or walk; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108231512492360-BXPIC. Safety Report Unique Identifier is GB-MHRA-ADR 25837225. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported and Expiration date was unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 DOSE immunisation. Medical history included flu vaccination. Patient has not had symptoms associated with COVID-19. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) taken for flu vaccination. The patient experienced breathlessness, myocarditis, mobility decreased / loss of mobility, severe diarrhea, sepsis, gut pain, swelling of feet, loss of power in legs, unable to stand or walk. The patient was admitted to hospital and put on a catheter. The event was serious with caused/prolonged hospitalization, disabling/incapacitating and other medically important condition. The COVID-19 virus test was no - negative covid-19 test. The patient died on 04Jul2021. The reported course of death was myocarditis. It was not reported if an autopsy was performed. The outcome of myocarditis was fatal. The outcome of breathlessness, mobility decreased diarrhea, sepsis, gut pain and swelling of feet was not recovered. The outcome of other events was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Myocarditis


VAERS ID: 1660405 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 102
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: GBPFIZER INC202101105397

Write-up: Anal bleeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108241710094870-GII9S. Safety Report Unique Identifier GB-MHRA-ADR 25841953. A 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 Immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient experienced anal bleeding on 13Apr2021 with fatal outcome which was reported as serious with death, hospitalization. The patient died on 24Jul2021. It was not reported if an autopsy was performed. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Anal bleeding


VAERS ID: 1660406 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Painful respiration, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive test
CDC Split Type: GBPFIZER INC202101111381

Write-up: Cough; respiratory difficulty; Painful respiration; 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-202108251219508020-JFZD3, Safety Report Unique Identifier GB-MHRA-ADR 25846570. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included suspected covid-19 from 03Mar2021 and ongoing. The patient''s concomitant medications were not reported. The patient experienced painful respiration on 03Mar2021, cough and respiratory difficulty on an unspecified date. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: inconclusive test. The patient died on an unspecified date. An autopsy was not performed. Outcome of painful respiration was fatal, outcome of other events 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: Painful respiration


VAERS ID: 1660467 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute hepatic failure, Acute kidney injury, Alanine aminotransferase, Amylase, Aspartate aminotransferase, Auscultation, Base excess, Basophil count, Basophil percentage, Bilirubin conjugated, Blood alkaline phosphatase normal, Blood bicarbonate, Blood bilirubin, Blood calcium, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood magnesium, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, C-reactive protein, Carbon dioxide, Cardiac arrest, Chronic hepatic failure, Coagulation factor deficiency, Coma, Coma scale, Dyspnoea, Electrocardiogram, Electrolyte imbalance, Eosinophil count, Eosinophil percentage, Fibrin D dimer, Gamma-glutamyltransferase, Haematocrit, Haemoglobin, Hepatic failure, Hypotension, International normalised ratio, Investigation, Laboratory test, Liver disorder, Lymphocyte count, Lymphocyte percentage, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Metabolic acidosis, Monocyte count, Monocyte percentage, Neutrophil count, Neutrophil percentage, Oxygen saturation, PCO2, PO2, Plasma viscosity, Platelet count, Protein total, Rectal examination, Red blood cell sedimentation rate, Red cell distribution width, SARS-CoV-2 test, Salt intoxication, Shock, Somnolence, Subacute hepatic failure, Thrombocytopenia, Toxic encephalopathy, Troponin I, Vitamin D, White blood cell count, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
   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: Alcoholic cirrhosis of liver; Diabetes (Diabetes); Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalisation (last discharge 26Jul2021.)
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: Activated Partial Thromboplastin; Test Result: 42 s; Test Date: 20210807; Test Name: Activated Partial Thromboplastin; Test Result: 78 s; Test Date: 20210808; Test Name: Activated Partial Thromboplastin; Test Result: 53 s; Test Date: 20210807; Test Name: s-alanine aminotransferase; Result Unstructured Data: Test Result:297; Comments: U/L; Test Date: 20210807; Test Name: s-alanine aminotransferase; Result Unstructured Data: Test Result:631; Comments: U/L; Test Date: 20210808; Test Name: s-alanine aminotransferase; Result Unstructured Data: Test Result:2530; Comments: U/L; Test Date: 20210807; Test Name: S-Amylase; Result Unstructured Data: Test Result:129; Comments: U/L; Test Date: 20210808; Test Name: S-Amylase; Result Unstructured Data: Test Result:156; Comments: U/L; Test Date: 20210807; Test Name: s-Asparagine aminotransferase; Result Unstructured Data: Test Result:250; Comments: U/L; Test Date: 20210807; Test Name: s-Asparagine aminotransferase; Result Unstructured Data: Test Result:999; Test Date: 20210808; Test Name: s-Asparagine aminotransferase; Result Unstructured Data: Test Result:5090; Comments: U/L; Test Date: 20210807; Test Name: Auscultatory; Result Unstructured Data: Test Result:over the lungs bilaterally audible suspicion of br; Comments: over the lungs bilaterally audible suspicion of breathing with inspiratory crepitations bilaterally basal. Heart action correct, muffled tones, no noise, blood pressure 85/45 mmHg.; Test Date: 20210808; Test Name: excess of bases; Result Unstructured Data: Test Result:-23.4 mmol/L; Test Date: 20210807; Test Name: Basophiles; Result Unstructured Data: Test Result:0.24 x10 9/l; Test Date: 20210807; Test Name: Basophiles; Result Unstructured Data: Test Result:0.20 x10 9/l; Test Date: 20210808; Test Name: Basophiles; Result Unstructured Data: Test Result:0.10 x10 9/l; Test Date: 20210807; Test Name: Basophiles%; Test Result: 0.8 %; Test Date: 20210807; Test Name: Basophiles%; Test Result: 0.8 %; Test Date: 20210808; Test Name: Basophiles%; Test Result: 0.5 %; Test Date: 20210807; Test Name: D-Bilirubin; Result Unstructured Data: Test Result:98 umol/l; Test Date: 20210807; Test Name: s-Alkaline Phosphatase; Result Unstructured Data: Test Result:189; Comments: U/L; Test Date: 20210808; Test Name: s-Alkaline Phosphatase; Result Unstructured Data: Test Result:274; Comments: U/L; Test Date: 20210808; Test Name: HCO3; Result Unstructured Data: Test Result:8.2 mmol/L; Test Date: 20210807; Test Name: S-T-Bilirubin; Test Result: 137.2 umol; Test Date: 20210808; Test Name: S-T-Bilirubin; Test Result: 145.1 umol; Test Date: 20210807; Test Name: s-calcium; Result Unstructured Data: Test Result:2.16 mmol/L; Test Date: 20210808; Test Name: s-calcium; Result Unstructured Data: Test Result:2.25 mmol/L; Test Date: 20210807; Test Name: s-creatine kinase; Result Unstructured Data: Test Result:3300; Comments: U/L; Test Date: 20210807; Test Name: s-creatine kinase; Result Unstructured Data: Test Result:8140; Comments: U/L; Test Date: 20210808; Test Name: s-creatine kinase; Result Unstructured Data: Test Result:9300; Comments: U/L; Test Date: 20210807; Test Name: creatine kinase myocardial band; Result Unstructured Data: Test Result:136; Comments: U/L; Test Date: 20210807; Test Name: creatine kinase myocardial band; Result Unstructured Data: Test Result:310; Comments: U/L; Test Date: 20210808; Test Name: creatine kinase myocardial band; Result Unstructured Data: Test Result:350; Comments: U/L; Test Date: 20210807; Test Name: S-creatinine; Result Unstructured Data: Test Result:194 umol/l; Test Date: 20210807; Test Name: S-creatinine; Result Unstructured Data: Test Result:218 umol/l; Test Date: 20210808; Test Name: S-creatinine; Result Unstructured Data: Test Result:267 umol/l; Test Date: 20210807; Test Name: Fibrinogen; Result Unstructured Data: Test Result:3.0 g/l; Test Date: 20210807; Test Name: Fibrinogen; Result Unstructured Data: Test Result:1.4 g/l; Test Date: 20210808; Test Name: Fibrinogen; Result Unstructured Data: Test Result:1.0 g/l; Test Date: 20210807; Test Name: S-glucose; Result Unstructured Data: Test Result:11.1 mmol/L; Test Date: 20210807; Test Name: S-glucose; Result Unstructured Data: Test Result:5.3 mmol/L; Test Date: 20210808; Test Name: S-glucose; Result Unstructured Data: Test Result:3.5 mmol/L; Test Date: 20210807; Test Name: s-Lactate dehydrogenase; Result Unstructured Data: Test Result:520; Comments: U/L; Test Date: 20210807; Test Name: s-Lactate dehydrogenase; Result Unstructured Data: Test Result:1461; Comments: U/L; Test Date: 20210808; Test Name: s-Lactate dehydrogenase; Result Unstructured Data: Test Result:5940; Test Date: 20210807; Test Name: s-Magnesium; Result Unstructured Data: Test Result:1.13 mmol/L; Test Date: 20210808; Test Name: s-Magnesium; Result Unstructured Data: Test Result:1.09 mmol/L; Test Date: 20210807; Test Name: s-Potassium; Result Unstructured Data: Test Result:5.4 mmol/L; Test Date: 20210807; Test Name: s-Potassium; Result Unstructured Data: Test Result:6.8 mmol/L; Test Date: 20210808; Test Name: s-Potassium; Result Unstructured Data: Test Result:6.9 mmol/L; Test Date: 20210807; Test Name: blood pressure; Result Unstructured Data: Test Result:85/45 mmHg; Test Date: 20210807; Test Name: S-Natrium; Result Unstructured Data: Test Result:132 mmol/L; Test Date: 20210807; Test Name: S-Natrium; Result Unstructured Data: Test Result:133 mmol/L; Test Date: 20210808; Test Name: S-Natrium; Result Unstructured Data: Test Result:134 mmol/L; Test Date: 20210807; Test Name: S-UREA; Result Unstructured Data: Test Result:8.7 mmol/L; Test Date: 20210807; Test Name: S-UREA; Result Unstructured Data: Test Result:8.6 mmol/L; Test Date: 20210808; Test Name: S-UREA; Result Unstructured Data: Test Result:8.0 mmol/L; Test Name: body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Test Date: 20210808; Test Name: ctCO2; Result Unstructured Data: Test Result:9.3 mmol/L; Test Date: 20210807; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:8.0; Test Date: 20210807; Test Name: s-C-Reactive Protein; Result Unstructured Data: Test Result:36.9 mg/l; Test Date: 20210807; Test Name: s-C-Reactive Protein; Result Unstructured Data: Test Result:23.8 mg/l; Test Date: 20210808; Test Name: s-C-Reactive Protein; Result Unstructured Data: Test Result:19.2 mg/l; Test Date: 20210807; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:sinus rhythm, frequency 71 / min., Intermediate el; Comments: sinus rhythm, frequency 71 / min., Intermediate el. os, PR Interval 264 ms (1st degree Atrioventricular AV block), without STT coupling change; Test Date: 20210807; Test Name: Eosinophiles; Result Unstructured Data: Test Result:0.41 x10 9/l; Test Date: 20210807; Test Name: Eosinophiles; Result Unstructured Data: Test Result:0.21 x10 9/l; Test Date: 20210808; Test Name: Eosinophiles; Result Unstructured Data: Test Result:0.06 x10 9/l; Test Date: 20210807; Test Name: Eosinopfiles%; Test Result: 1.3 %; Test Date: 20210807; Test Name: Eosinopfiles%; Test Result: 0.9 %; Test Date: 20210808; Test Name: Eosinopfiles%; Test Result: 0.3 %; Test Date: 20210808; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:30 mg/l; Test Date: 20210807; Test Name: S-Gamma-glutamyl transferase; Result Unstructured Data: Test Result:172; Comments: U/L; Test Date: 20210807; Test Name: S-Gamma-glutamyl transferase; Result Unstructured Data: Test Result:114; Comments: U/L; Test Date: 20210808; Test Name: S-Gamma-glutamyl transferase; Result Unstructured Data: Test Result:104; Comments: U/L; Test Date: 20210807; Test Name: Hematocrite; Test Result: 0.499 l; Comments: L/L; Test Date: 20210807; Test Name: Hematocrite; Test Result: 0.391 l; Comments: L/L; Test Date: 20210808; Test Name: Hematocrite; Test Result: 0.358 l; Comments: L/L; Test Date: 20210807; Test Name: Haemoglobin; Result Unstructured Data: Test Result:161 g/l; Test Date: 20210807; Test Name: Haemoglobin; Result Unstructured Data: Test Result:125 g/l; Test Date: 20210808; Test Name: Haemoglobin; Result Unstructured Data: Test Result:115 g/l; Test Date: 20210807; Test Name: International Normalized Ratio; Result Unstructured Data: Test Result:2.10; Test Date: 20210807; Test Name: International Normalized Ratio; Result Unstructured Data: Test Result:2.60; Test Date: 20210808; Test Name: International Normalized Ratio; Result Unstructured Data: Test Result:2.68; Test Date: 20210807; Test Name: large unstained cells; Result Unstructured Data: Test Result:0.36 x10 9/l; Test Date: 20210807; Test Name: large unstained cells; Result Unstructured Data: Test Result:0.32 x10 9/l; Test Date: 20210808; Test Name: large unstained cells; Result Unstructured Data: Test Result:0.30 x10 9/l; Test Date: 20210807; Test Name: large unstained cells%; Test Result: 0.0 %; Test Date: 20210807; Test Name: large unstained cells%; Test Result: 0.0 %; Test Date: 20210808; Test Name: large unstained cells%; Test Result: 0.0 %; Test Date: 20210807; Test Name: laboratory findings; Result Unstructured Data: Test Result:show a pronounced coagulation disorder, electrolyt; Comments: show a pronounced coagulation disorder, electrolyte imbalance, liver and kidney failure, severe metabolic acidosis; Test Date: 20210807; Test Name: Lymphocytes; Result Unstructured Data: Test Result:2.14 x10 9/l; Test Date: 20210807; Test Name: Lymphocytes; Result Unstructured Data: Test Result:1.89 x10 9/l; Test Date: 20210808; Test Name: Lymphocytes; Result Unstructured Data: Test Result:2.12 x10 9/l; Test Date: 20210807; Test Name: Lymphocytes%; Test Result: 7.7 %; Test Date: 20210807; Test Name: Lymphocytes%; Test Result: 9.2 %; Test Date: 20210808; Test Name: Lymphocytes%; Test Result: 12.5 %; Test Date: 20210807; Test Name: mean corpuscular hemoglobin; Test Result: 34.5 pg; Test Date: 20210807; Test Name: mean corpuscular hemoglobin; Test Result: 34.5 pg; Test Date: 20210808; Test Name: mean corpuscular hemoglobin; Test Result: 34.8 pg; Test Date: 20210807; Test Name: mean corpuscular hemoglobin concentration; Result Unstructured Data: Test Result:322 g/l; Test Date: 20210807; Test Name: mean corpuscular hemoglobin concentration; Result Unstructured Data: Test Result:319 g/l; Test Date: 20210808; Test Name: mean corpuscular hemoglobin concentration; Result Unstructured Data: Test Result:321 g/l; Test Date: 20210807; Test Name: mean corpuscular volume; Result Unstructured Data: Test Result:107.0; Comments: fL; Test Date: 20210807; Test Name: mean corpuscular volume; Result Unstructured Data: Test Result:108.2; Comments: fL; Test Date: 20210808; Test Name: mean corpuscular volume; Result Unstructured Data: Test Result:108.4; Comments: fL; Test Date: 20210807; Test Name: Mean Platelet Volume; Result Unstructured Data: Test Result:10.6; Comments: fL; Test Date: 20210807; Test Name: Mean Platelet Volume; Result Unstructured Data: Test Result:10.7; Comments: fL; Test Date: 20210808; Test Name: Mean Platelet Volume; Result Unstructured Data: Test Result:11.5; Comments: fL; Test Date: 20210807; Test Name: Monocytes; Result Unstructured Data: Test Result:1.23 x10 9/l; Test Date: 20210807; Test Name: Monocytes; Result Unstructured Data: Test Result:0.90 x10 9/l; Test Date: 20210808; Test Name: Monocytes; Result Unstructured Data: Test Result:0.94 x10 9/l; Test Date: 20210807; Test Name: Monocytes%; Test Result: 3.8 %; Test Date: 20210807; Test Name: Monocytes%; Test Result: 3.8 %; Test Date: 20210808; Test Name: Monocytes%; Test Result: 4.9 %; Test Date: 20210807; Test Name: Neutrophiles; Result Unstructured Data: Test Result:27.87 x10 9/l; Test Date: 20210807; Test Name: Neutrophiles; Result Unstructured Data: Test Result:20.38 x10 9/l; Test Date: 20210808; Test Name: Neutrophiles; Result Unstructured Data: Test Result:15.87 x10 9/l; Test Date: 20210807; Test Name: Neutrophiles%; Test Result: 86.4 %; Test Date: 20210807; Test Name: Neutrophiles%; Test Result: 85.3 %; Test Date: 20210808; Test Name: Neutrophiles%; Test Result: 81.8 %; Test Name: oxygen saturation; Result Unstructured Data: Test Result:94-95 %; Test Date: 20210808; Test Name: oxygen saturation; Test Result: 92.7 %; Test Date: 20210808; Test Name: pCO2; Result Unstructured Data: Test Result:5.03; Comments: kPa; Test Date: 20210808; Test Name: pH Acidity; Result Unstructured Data: Test Result:6.953; Test Date: 20210807; Test Name: Plasma viscosity; Result Unstructured Data: Test Result:0.34; Test Date: 20210807; Test Name: Plasma viscosity; Result Unstructured Data: Test Result:0.26; Test Date: 20210808; Test Name: Plasma viscosity; Result Unstructured Data: Test Result:0.25; Test Date: 20210807; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:94 x10 9/l; Test Date: 20210807; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:61 x10 9/l; Test Date: 20210808; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:52 x10 9/l; Test Date: 20210808; Test Name: Partial Pressure of Carbon Dioxide; Result Unstructured Data: Test Result:13.15; Comments: kPa; Test Date: 20210807; Test Name: S-Proteine; Result Unstructured Data: Test Result:52 g/l; Test Name: Digitorectal examination; Result Unstructured Data: Test Result:unknown results; Test Date: 20210807; Test Name: Erythrocytes; Result Unstructured Data: Test Result:4.67; Comments: x1012/L; Test Date: 20210807; Test Name: Erythrocytes; Result Unstructured Data: Test Result:3.61; Comments: x1012/L; Test Date: 20210808; Test Name: Erythrocytes; Result Unstructured Data: Test Result:3.30; Comments: x1012/L; Test Date: 20210807; Test Name: red cell distribution width - coefficient of variation; Test Result: 16.1 %; Test Date: 20210807; Test Name: red cell distribution width - coefficient of variation; Test Result: 16.1 %; Test Date: 20210808; Test Name: red cell distribution width - coefficient of variation; Test Result: 16.4 %; Test Date: 20210807; Test Name: s-chloride; Result Unstructured Data: Test Result:94 mmol/L; Test Date: 20210808; Test Name: s-chloride; Result Unstructured Data: Test Result:95 mmol/L; Test Date: 2021; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210807; Test Name: high-sensitivity troponin; Result Unstructured Data: Test Result:46.2 pg/mL; Test Date: 20210807; Test Name: high-sensitivity troponin; Result Unstructured Data: Test Result:165.5 pg/mL; Test Date: 20210808; Test Name: high-sensitivity troponin; Result Unstructured Data: Test Result:790.6 pg/mL; Test Date: 20210807; Test Name: D Vitamin; Result Unstructured Data: Test Result:8.0 mg/l; Comments: ci4000; Test Date: 20210807; Test Name: D Vitamin; Result Unstructured Data: Test Result:17.8 mg/l; Comments: ci4000; Test Date: 20210808; Test Name: D Vitamin; Result Unstructured Data: Test Result:30.0 mg/l; Test Date: 20210807; Test Name: Leucocyte count; Result Unstructured Data: Test Result:32.26 x10 9/l; Test Date: 20210807; Test Name: Leucocyte count; Result Unstructured Data: Test Result:23.91 x10 9/l; Test Date: 20210808; Test Name: Leucocyte count; Result Unstructured Data: Test Result:19.39 x10 9/l
CDC Split Type: HRPFIZER INC202101096000

Write-up: Cardiac arrest; Thrombocytopenia; Toxic encephalopathy; Alcoholic liver failure; Acute or subacute liver failure; Acute or subacute liver failure; Chronic liver failure; Shock; Acute renal failure; shortness of breath; Acquired coagulation factor deficiency; Liver obstruction; hypotensive; somnolent; electrolyte imbalance; severe metabolic acidosis; In state a coma; This is a spontaneous report from a contactable physician downloaded from the WEB regulatory authority number HR-HALMED-300050368. A 68-year-old male patient received BNT162B2 (COMIRNATY), 2nd dose intramuscular on 04Aug2021 (Batch/Lot number and expiration date were not reported) as 0.3ml, a single dose for covid-19 immunisation. Medical history included hospitalization from an unknown date to 26Jul2021, last discharge 26Jul2021, ongoing hypertension, ongoing Alcoholic cirrhosis of liver, ongoing Diabetes. The patient previously received 1st dose of BNT162B2 (COMIRNATY), intramuscular on 24Jun2021 (Batch/Lot number and expiration date were not reported) as 0.3ml, a single dose for covid-19 immunisation. The patient''s concomitant medications were not reported. The patient experienced in state a coma, thrombocytopenia, toxic encephalopathy, alcoholic liver failure, acute or subacute liver failure, chronic liver failure, shock, acute renal failure, shortness of breath, acquired coagulation factor deficiency, liver obstruction, hypotensive, somnolent, electrolyte imbalance, severe metabolic acidosis, all on 07Aug2021, cardiac arrest on 08Aug2021. The outcome of the event in state a coma, cardiac arrest was death, outcome of rest events was unknown. Therapeutic measures were taken as a result of all events. The patient died on 08Aug2021. An autopsy was performed that revealed peritonitis acute, abscessus hepatis, chirrhosis hepatis. Clinical course: The patient was admitted to the Intensive Care Unit on 07AUG in the morning, in a state of coma, and in which he was found at home. The patient has a history of alcoholic cirrhosis of the liver, diabetes, hypertension, all visible in the Hospital information system, with the last discharge 26Jul21. Rapid Antigen test for Sars Cov2 negative, received the 1st dose of vaccine 24Jun with side effects nausea, vomiting, headache, and subsequently learned about receiving the second dose 04AUG2021. Upon admission, all necessary intensive care measures, mechanical ventilation, inotropic support were performed. The laboratory findings show a pronounced coagulation disorder, electrolyte imbalance, liver and kidney failure, severe metabolic acidosis. All of the above is attempted to be corrected, but further deterioration of the situation follows, despite all the implemented measures, and the fatal outcome occurred on 08Aug2021. at 11:20. An autopsy was requested to define the cause of death. Additional information received 17Aug2021: Diagnosis: The main diagnosis: K70.3 Alcoholic liver cirrhosis. Other diagnoses: D68.4 Acquired coagulation factor deficiency, D69.6 Thrombocytopenia, unspecified, El 1.65 Insulin-independent diabetes mellitus with poor control, G92 Toxic encephalopathy, IlO Essential (primary) hypertension, 146.9 Cardiac arrest, unmarked, K70.4 Alcoholic liver failure, K72.0 Acute or subacute liver failure, K72.1 Chronic liver failure, K7_2.9 Liver obstruction, unspecified, N17.9 Acute renal failure, unspecified, R40.2 Coma, unspecified, R57.9 Shock, unspecified, Therapy: Ampicillin 4 x lg oral, Tazocin 4.5 g intravenous x3, Noradrenaline 10mg / 50ml cont, Dopamine 100/250 ml cont, Calcium gluconate 2x10 ml, SoluMedrol 2x40 mg, Na2HCO3 8.4% 50 mlx2, Vitamin K 2 ampoulle, Actrapid as needed, Controloc ampoule 40 mg intravenous, portalak syrup, sorbisteride 2 months per probe, fibrinogen lgr intravenous, hygroton 25 mg, fursemide + edemid forte, adrenaline 1 mg as needed, atropine 1 mg as needed, dosage form 500 ml + as needed, Voluven 500 ml, 10% Glucose 500 ml + 16 injection Actrapid, fresh frozen plasma x5, 20% Manitol 2x125 ml + 1/2 ampoulle fursemide. History and status: From the anamnesis Emergency call to Combined Emergency Hospital Admission, comatose patient, brought in accompanied by the emergency medical care team in an unconscious state. Found in the toilet without consciousness, shortness of breath, he allegedly sat on the toilet bowl from 2 hours. From the previously known alcoholic cirrhosis of the liver, a diabetic on oral hypoglycemic therapy. Treated at the Internal Medicine Department in July this year due to acute liver failure, discharged on 26Jul2021 with therapy: Medrol 24 mg for a week, then 16 mg for a week, then 8 mg until control, Acipan 40 mg 2 x 1, Fursemide 40 mg 2 x 1, Aldactone 100 mg on the second day, Normabel 2 mg 2 x 1, Oleovit D3 8 drops daily, Vilspox 50/1000 mg 1 + 0 + 1, Reodon 1 mg 3 x 1 before meals with glucose control, and if necessary 3 x 2. Vaccinated with the 1st dose of Covid-19 Pfizer vaccine in June of this year, the 2nd dose is unknown. Examined by the on-duty internist who administers: Controloc 2 ampoulle in 250 ml dosage form., Fursemide amp. intravenous, dosage form 500 ml intravenous, 02 12 / L per mask with tank. A urinary catheter is placed. Negotiated admission to the intensive care unit. From the status Brought on the transporter accompanied by the on-duty internist and medical technician. On admission to the intensive care unit somnolent, previously comatose, now discreetly responds by sobbing and moving his hands to a stronger stimulus, difficult or no way to open his eyes, pupils are isochoric, react to light, sclera are icteric, dry, sticky secretion. On Combined Emergency Hospital Admission breathed spontaneously, however dyspnoeic, saturation with 12 I oxygen about 94-95%. Stronger osteomuscular build, threatened, skin darker red, icteric, spider nevus on the skin of the thoracic region, afebrile, more hypothermic (axillary temperature around 35.8 centigrade). Traces of hematized blood are visible in the oral cavity, so far there is no visible active bleeding. Auscultatory over the lungs bilaterally audible suspicion of breathing with inspiratory crepitations bilaterally basal. Heart action correct, muffled tones, no noise, blood pressure 85/45 mmHg. Electrocardiogram performed on Combined Emergency Hospital Admission: sinus rhythm, frequency 71 / min., Intermediate el. os, PR Interval 264 ms (1st degree Atrioventricular AV block), without STT coupling change. The abdomen is above the level of the thoracic hair, soft, it seems painless on palpation, the liver and spleen do not seem enlarged, however, the assessment is difficult due to the enlarged abdomen, postoperative scar laparotomy cholecystectomy, peristalsis is less audible. On the lower limbs bilaterally pasty edema of the lower legs, on the right forearm a bend due to skin peeling acquired allegedly during transport. A urinary catheter was placed, in the urine bag scanty urine. Digitorectal examination was also performed on Combined Emergency Hospital Admission: there were traces of normocolored stool in the ampoule. Findings: 07Aug2021. Leukocytes 32.26 x109/L, Erythrocytes 4.67 x1012/L, Haemoglobin 161 g/L, Hematocrite 0.499 L/L, mean corpuscular volume MCV 107.0 fl, mean corpuscular hemoglobin MCH 34.5 pg, MCHC mean corpuscular hemoglobin concentration 322 g/L, red cell distribution width - coefficient of variation 16.1 %, Thrombocytes 94 x109/L, Mean Platelet Volume MPV 10.6 fl, Neutrophiles 27.87 x109/L, Lymphocytes 2.14 x109/L, Monocytes 1.23 x109/L, Eosinophiles 0.41 xl09/L, Basophiles 0.24 x109/L, LUC large unstained cells 0.36 x109/L, Neutrophiles% 86.4 rel %, Lymphocytes% 7.7 rel%, Monocytes% 3.8 rel%, Eosinopfiles% 1.3 rel%, Basophiles% 0.8 rel%, large unstained cells LUC% 0.0 rel%, PV Plasma viscosity 0.34, INR International Normalized Ratio 2.10, APTV Activated Partial Thromboplastin 42 s, Fibrinogen 3.0 g/L, S-glucose 11.1 mmol/L, S-UREA 8. 7 mmol/L, S-creatinine 194 umol/L, S-AST Asparagine aminotransferase 250 U/L, S-?ALT alanine aminotransferase 297 U/L, S-GGT Gamma-glutamyl transferase 172 U/L, S-CK creatine kinase 3300 U/L, S-CK-MB creatine kinase myocardial band 136 U/L, S-LDH Lactate dehydrogenase 520 U/L, S-Natrium 132 mmol/L, S-Potassium 5.4 mmol/L, D-D Vitamin ci4000 8.0 mg/L, S-C-Reactive Protein 36.9 mg/L, high-sensitivity troponin hsTni 46.2 pg/ml Leukocytes 23.91 x109/L, Erythrocytes 3.61 x1012/L, Haemoglobin 125 g/L, Hematocrite 0.391 L/L, mean corpuscular volume MCV 108.2 fl, mean corpuscular hemoglobin MCH 34.5 pg, mean corpuscular hemoglobin concentration MCHC 319 g/L, red cell distribution width - coefficient of variation 16.1 %, Thrombocytes 61 x109/l, Mean Platelet Volume MPV 10.7 fl, Neutrophiles 20.38 x109/L, Lymphocytes 1.89 x109/L, Monocytes 0.90 x109/L, Eosinophiles 0.21 x109/L, Basophiles 0.20 x109/L,large unstained cells LUC 0.32 x109/L, Neutrophiles% 85.3 rel%, Lymphocytes% 9.2 rel %, Monocytes% 3.8 rel%, Eosinophiles % 0.9 rel%, Basophiles% 0.8 rel%, LUC large unstained cells % 0.0 rel%, PV Plasma viscosity 0.26, INR International Normalized Ratio 2.60, APTV Activated Partial Thromboplastin 78 s, Fibrin 1.4 g/L, S-Glucose 5.3 mmol/L, S-UREA 8.6 mmol/L, S-creatinine 218 umol/L, S-T-Bilirubin 137.2 umol/L, S-D-Bilirubin 98 umol/L, S-AST Asparagine aminotransferase 999 U/L, 5-ALT alanine aminotransferase 631 U/L, s-GGT Gamma-glutamyl transferase 114 U/L, S-ALP Alkaline Phosphatase 189 U/L, s-Amylase 129 U/L, S-CK creatine kinase 8140 U/L, S-CK-MB creatine kinase myocardial band 310 U/L, S-LDH Lactate Dehydrogenase 1461 U/L, S-Natrium 133 mmol/L, S-Potassium 6.8 mmol/L, S-CI 94 mmol/L, S-Calcium 2.16 mmol/L, D-D vitamin ci4000 17 .8 mg/L, S-C-Reactive Protein 23.8 mg/L, S-Proteine 52 g/L, S-Magnesium 1.13 mmol/L, hsTni high-sensitivity troponin 165.5 pg/ml. On 08Aug2021: Leukocytes 19.39 x109/L, Erythrocytes 3.30 x1012/L, Haemoglobin 115 g/L, Hematocrite 0.358 L/L, mean corpuscular volume MCV 108.4 fl, mean corpuscular hemoglobin MCH 34.8 pg, mean corpuscular hemoglobin concentration MCHC 321 g/L,red cell distribution width - coefficient of variation RDW-KV 16.4 %, Thrombocytes 52 xl09/l, Mean Platelet Volume MPV 11.5 fl, Neutrophiles 15.87 xl09/L, Lymphocytes 2.12 x109/L, Monocytes 0.94 x109/L, Eosinophiles 0.06 x109/L, Basophiles 0.10 x109/L, LUC large unstained cells 0.30 xl09/L, Neutrophiles% 81.8 rel%, Lymphocytes% 12.5 rel %, Monocytes% 4.9 rel%, Eosinophiles% 0.3 rel q10, Basophiles% 0.5 rel %, LUC large unstained cells % 0.0 rel %, (act) pH Acidity 6.953, (ak) Partial Pressure of Carbon Dioxide pCO2 5.03 kPa, (act) pO2 13.15 kPa, (act )Act HCO3 plasma bicarbonate concentration 8.2 mmol/L, (ak) BE(B) excess of bases -23.4 mmol/L, (act) the saturation of hemoglobin with oxygen sO2 92.7 %, (act) ctCO2 total plasma carbon dioxide 9.3 mmol/L, PV Plasma viscosity 0.25, INR International Normalized Ratio 2.68, APTV Activated Partial Thromboplastin53 s, Fibrin 1.0 g/L, S-Glucose 3.5 mmol/L, S-UREA 8.0 mmol/L, S-creatinine 267 umol/L, S-T-BILirubin 145.1 umol/L, S-AST Asparagine aminotransferase 5090 U/L, S-ALT alanine aminotransferase 2530 U/L, S-GGT Gamma-glutamyl transferase 104 U/L, S-ALP Alkaline Phosphatase 274 U/L, S-AMYlase 156 U/L, S-CK creatine kinase 9300 U/L, S-CK-MB creatine kinase myocardial band 350 U/l, S-LDH Lactate Dehydrogenase 5940 U/L, S-Natrium 134 mmol/L, S-Potassium 6.9 mmol/L, s-Chloride 95 mmol/L, s-calcium 2.25 mmol/l, D-D vitamin ci4000 30.0 mg/L, S-C-Reactive Protein 19.2 mg/L, S-Magnesium 1.09 mmol/L, high-sensitivity troponin hsTni 790.6 pg/m. Fibrin D dimer (normal range: less than 0.5mg/l): 30mg/l. On 08Aug2021 02:48: During yesterday (07.08.) After admission to the intensive care unit, the patient was somnolent to comatose, hypotensive, Glasgow coma scale GCS about 8, intubated and connected to a respirator (IPPV intermittent positive pressure ventilation ), he was placed Sanger sequencing NGS, Central venous catheter CVK in venous Jugl. int. latin right and arterial line in artery cubital latin left Insight into the findings shows a marked increase in L, probably from the recently introduced corticosteroid therapy, however, a potential septic condition is not excluded. On-duty internists suggest decontamination of the intestine with Ampicillin 4 x 1 gr per probe, in addition to which Portalak syrup and deep enema are prescribed. The system intravenous is also included antibiotic (Tazocin), continuous intravenous administration of dopamine and norepinephrine. There is a noticeable increase in liver enzymes and coagulation disorders, which is why fresh frozen plasma, vitamin K and fibrinogen 1 gr. Continue with intravenous fluid replacement and moderate hydration per probe, electrolyte correction, stimulation of diuresis. During the night still hypotension, attempts are made with vasoactive and inotropic support, adrenaline (diluted 1 mg / 20 ml dosage form occasionally in bolus), continues with the administration of fresh frozen plasma, bicarbonate, stimulating diuresis. Worsening of the condition is evident, worsening of liver function, renal function, deterioration of almost all parameters, pronounced metabolic acidosis. 08Aug2021 13: 13: Insight into the Hospital information system shows that the second dose of the vaccine for SARS Cov 2 was received on 04AUG2021. Rapid Antigene test negative. Further deterioration, protracted hypotension without response to inotropic and vasoactive support, anuric, laboratory parameters in further deterioration. Pupils broad, non-reactive, without reflex, without reaction to painful stimulus. Mechanically ventilated. Skin of hull marbled. Asystole occurs, without response to resuscitation measures, and death is declared at 11:20. Cause of death determined by autopsy: Peritonitis acute, Abscessus hepatis, Chirrhosis hepatis. Relevant Medical History and Concurrent Conditions: The patient has a history of alcoholic cirrhosis of the liver, diabetes, hypertension, all visible in the Hospital information system, with the last discharge 26Jul21. Additional information on drug: ADR is adequately labelled: No. A casual relationship between Comirnaty and event Comatose was assessing: Unassessable/Unclassifiable by HALMED and WHO-UMC Causality. Event medically confirmed reported was no while reporter is physician. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardiac arrest; In state a coma; Autopsy-determined Cause(s) of Death: Peritonitis acute; Abscessus hepatis; Chirrhosis hepatis


VAERS ID: 1660534 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-29
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Back pain, Coma, Gastrointestinal necrosis, Intestinal infarction, Myocardial infarction, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder cancer recurrent; Cancer; Gallbladder stones; Lung lobectomy (for cancer); Nephrectomy; Non-Hodgkin''s lymphoma (last recurrence in 2004); Prostate cancer metastatic; Ureter cancer recurrent
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101100261

Write-up: severe abdominal and lumbar pain, vomiting, intestinal infarction, intestinal tract removal surgery in necrosis, pharmacological coma, heart attack; severe abdominal and lumbar pain, vomiting, intestinal infarction, intestinal tract removal surgery in necrosis, pharmacological coma, heart attack; severe abdominal and lumbar pain, vomiting, intestinal infarction, intestinal tract removal surgery in necrosis, pharmacological coma, heart attack; severe abdominal and lumbar pain, vomiting, intestinal infarction, intestinal tract removal surgery in necrosis, pharmacological coma, heart attack; severe abdominal and lumbar pain, vomiting, intestinal infarction, intestinal tract removal surgery in necrosis, pharmacological coma, heart attack; severe abdominal and lumbar pain, vomiting, intestinal infarction, intestinal tract removal surgery in necrosis, pharmacological coma, heart attack; severe abdominal and lumbar pain, vomiting, intestinal infarction, intestinal tract removal surgery in necrosis, pharmacological coma, heart attack; This is a spontaneous report from a contactable consumer or other non-health professional downloaded from the Regulatory Authority Report Number: IT-MINISAL02-773911. An 81-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in arm left on 19Mar2021 (Lot Number: ET3620; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history prostate cancer with metastases, recurrence of bladder and ureter cancer and removal of left kidney, resection of upper left lobe of the lung in 2004 for cancer, gallbladder stones, non-hodgkin''s lymphoma, last recurrence in 2004. The patient''s concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (COMIRNATY, lot EP9598, expiration date 27Jul2021) administered on 26Feb2021 in left deltoid for prophylactic vaccination and no adverse effect experienced. The patient experienced severe abdominal and lumbar pain, vomiting, intestinal infarction, intestinal tract removal surgery in necrosis, pharmacological coma, heart attack on 29Mar2021. The events resulted in hospitalization and drug therapy with negative outcome. The patient needed emergency intervention. Impact on quality of life was 10/10. The patient died in 2021 due to these events. It was not reported if an autopsy was performed. Therapeutic measures were taken as a result of all events. Outcome of all events was fatal. Reporter comment: Prostate cancer with metastases, recurrence of bladder and ureter cancer and removal of left kidney, resection of upper left lobe of the lung 2004 for cancer, gallbladder stones, non-hodgkin''s lymphoma, last recurrence in 2004. Sender comment: 22Aug2021: requests for follow-up information from the reporter. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Prostate cancer with metastases, recurrence of bladder and ureter cancer and removal of left kidney, resection of upper left lobe of the lung 2004 for cancer, gallbladder stones, non-hodgkin''s lymphoma, last recurrence in 2004.; Reported Cause(s) of Death: severe abdominal and lumbar pain, vomiting, intestinal infarction, intestinal tract removal surgery in necrosis, pharmacological coma, heart attack; severe abdominal and lumbar pain, vomiting, intestinal infarction, intestinal tract removal surgery i


VAERS ID: 1660535 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Decreased activity, Hyporeflexia, Somnolence
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN; DEPAKIN; CLOZAPINE.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Diabetes mellitus; Obesity; Schizoaffective disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101100251

Write-up: drowsy state with global motor and reflex slowing up to death; Drowsy state with global motor and reflex slowing up to death; Drowsy state with global motor and reflex slowing up to death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB, regulatory authority number IT-MINISAL02-774041. A 47-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), intramuscular on 03Aug2021 (at an unspecified age) as dose 2, single for covid-19 immunisation; metformin, via an unspecified route of administration from 20Jul2021 (Batch/Lot Number: Unknown) to 18Aug2021, at unspecified dose and frequency for diabetes mellitus; valproate sodium (DEPAKIN), oral from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at 2 DF, daily for an unspecified indication; clozapine, oral from 30Jul2021 (Batch/Lot Number: Unknown) to 18Aug2021, at 2 DF (1.5 mg plus 1.5 mg), daily for depressed state. Medical history included diabetes mellitus, depression with schizo-affective disorder, obesity, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), on 02Jul2021 (at an unspecified age) as dose 1, single for covid-19 immunization. The patient experienced drowsy state with global motor and reflex slowing up to death after second Pfizer dose and initiation of therapy with clozapine (1.5 mg plus 1.5 mg) (death) on an unspecified date. The action taken in response to the events for metformin, valproate sodium, clozapine was no applicable. The outcome of the events was fatal. The patient died on 18Aug2021. It was not reported if an autopsy was performed. Additional information included: Booster dose number (2). History of suspect medication taken: first dose v. suspect (Comrinaty) administered on 02Jul2021. Therapeutic indication of medicine. suspect (clozapine): depressed patient with schizo-affective disorder. Dosage of suspect (Depakin): 2 / day. Other information f. suspect (Depakin): "Prescribed by the doctor. Hired for years. Never suspended. ". Other information f. suspected (metformin): "Prescribed by the doctor. Occasional newly diagnosed DM.". Sender Comment: 20Aug2021 Regional Pharmacovigilance Center CRFV: requests for follow-up information from the reporter regarding the reported case (clinical report, confirmation of suspicions, exact clozapine dosage, any investigations performed, lot number of suspect vaccine. Suspected, additional details of patient . and concomitant drugs, actions taken, ADR date, autopsy report when available). Waiting. The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: drowsy state with global motor and reflex slowing up to death; drowsy state with global motor and reflex slowing up to death; drowsy state with global motor and reflex slowing up to death


VAERS ID: 1660620 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 43
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ENALAPRIL MALEAT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101099132

Write-up: Pulmonary thromboembolism with shortness of breath/dyspnoea and pain in the left lumbar and the left thigh. The pain in the left chest and pain on coughing were severe; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency, Regulatory authority report number v21124681. A 71-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 24May2021 16:00 (at the age of 71 years) (Lot Number: EY2173; Expiration Date: 31Aug2021) as dose 1, single for covid-19 immunization. The patient medical history and family history was not reported. Concomitant medications included enalapril maleate tablet 5mg, 5mg (1 tablet) once daily in morning taken for an unspecified indication, start and stop date were not reported. The body temperature before vaccination was reported as 36.3 degree centigrade. On 26May2021 in the morning (2 days after vaccination), the patient had severe shortness of breath, and pain in the left lumbar and the left thigh. The pain in the left chest and pain on coughing were severe. On 26May2021 at 18:00 (2 days and 2 hours after the vaccination), the patient experienced dyspnoea. Since these symptoms did not resolve after one week, the patient visited the reporting clinic (on 31May2021). On 01Jun2021 (discrepantly reported as 7 days after the vaccination), the patient was admitted to another hospital for detailed examination. On 04Jun2021 (discrepantly reported as 10 days after vaccination), the patient was discharged. Thereafter, the patient rested at his home. On 08Jul2021 (discrepantly reported as one month and 13 days after vaccination), the patient suddenly died at his home. It was unknown if an autopsy was performed. The reporting physician classified the dyspnoea as serious (hospitalization) and pulmonary thromboembolism as serious (hospitalization and death). Causality was assessed that the events were related to BNT162B2. It was not reported if there were other possible causes of the events such as any other diseases. The reporting physician commented as follows: Eventually, the cause of death was pulmonary thromboembolism.; Reported Cause(s) of Death: pulmonary thromboembolism


VAERS ID: 1660621 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Body temperature, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral palsy; Hypertension; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:normal Centigrade
CDC Split Type: JPPFIZER INC202101100889

Write-up: headache; Asphyxia; pyrexia of 39 degree centigrade; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a 33-year-old male. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included cerebral palsy, severe obesity, and hypertension. On 21Jul2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FD0889, Expiration date 30Sep2021) intramuscularly via right arm. On 11Aug2021 at 14:30 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FF4204, Expiration date 31Oct2021) via intramuscular route of administration in the arm right for COVID-19 immunization. On 13Aug2021 at 22:00 (2 days/7 hours/30 minutes after the vaccination), the patient died by asphyxia. The event resulted in death. The outcome of the event asphyxia was fatal without treatment. The reporting physician assessed the event as serious (death). The reported event was as follows: On 12Aug2021 (the next date of vaccination), the patient had pyrexia of 39 degrees Celsius. The fever decreased with aspirin, aluminum glycinate, magnesium carbonate (BUFFERIN) which was the patient''s brought-in medicine. On 13Aug2021, the patient visited the reporting hospital. The body temperature was normal, and the patient was prescribed acetaminophen (CALONAL Tab.500) 3 tablets for 4 days for headache. At that night, after the patient watched a football game of Shimizu S-Pulse (a football team), when he ate a boxed lunch with his father, the patient choked on the food. The patient was transferred to the general hospital; however, he died due to asphyxia. The patient had aspiration more frequently than before due to cerebral palsy. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event asphyxia was fatal, of pyrexia of 39 degree centigrade was recovered, of headache was unknown.; Sender''s Comments: Based on the available information and known disease pathophysiology, asphyxia assessed as not related to BNT162b2 and more likely due to the patient''s risk for developing diseases secondary to cerebral palsy and underlying medical conditions. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: Asphyxia


VAERS ID: 1660623 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Multiple organ dysfunction syndrome, Nucleic acid test, Thrombosis
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Emphysema; Hypertension; Prostatic hyperplasia; Schizophrenia
Allergies:
Diagnostic Lab Data: Test Date: 20210625; Test Name: nucleic acid amplification test; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: JPPFIZER INC202101105697

Write-up: multi-organ failure due to microthrombosis; multi-organ failure due to microthrombosis; This is a spontaneous report from a contactable physician received via Regulatory Authority. An 88-year-old male patient received bnt162b2 (COMIRNATY), vaccinated at age of 88 years old, dose 1 intramuscular on 17Jun2021 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) as DOSE 1, SINGLE for covid-19 immunisation at a clinic/consultation room. Medical history included schizophrenia, hypertension, dyslipidaemia, emphysema, and prostatic hyperplasia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescribed medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 25Jun2021, NEAR test (nucleic acid amplification test, COVID-19 nasal swab test) was performed and it showed negative. The patient had no allergies to medications, food, or other products. On 18Jun2021 (1 day after the vaccination), the patient experienced multi-organ failure due to microthrombosis. The event resulted in hospitalization/death. The patient was hospitalized for 5 days. On 29Jun2021 (12 days after the vaccination), the patient died of multi-organ failure. An autopsy was performed. Microthrombosis was found by the autopsy. The patient received the treatment with antibiotics, antihypertensive and steroid for the event. The assessment of causality was not provided.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events microthrombosis in turn lead to multi organ failure, based compatable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: multi-organ failure due to microthrombosis; multi-organ failure due to microthrombosis; Autopsy-determined Cause(s) of Death: microthrombosis


VAERS ID: 1660627 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-26
   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: Medical History/Concurrent Conditions: Mobitz (type) II atrioventricular block; Myotonic dystrophy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101109646

Write-up: Ventricular fibrillation; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 46-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FF0843; Expiration Date: 31Oct2021), via intramuscular route, administered in Arm Left on 23Aug2021 14:45 (the day of vaccination, at the age of 46-year-old) as Dose 2 single, for COVID-19 immunisation. Other medical history included myotonic dystrophy and Mobitz (type) II atrioventricular block. The patient received prescription drugs within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received vaccine (historical vaccination) included first dose of BNT162b2 (COMIRNATY, Lot number: FF0843, Expiration date 31Oct2021), via intramuscular route in the arm left, on 02Aug2021 at 14:30 (at the age of 46-year-old), as Dose 1 single, for COVID-19 immunisation. Past drug event included ventricular tachycardia due to PRECEDEX or haloperidol. Since the vaccination, the patient has not been tested for COVID-19. On 26Aug2021 at 01:30 (2 days 10 hours 45 minutes after the vaccination), the patient experienced ventricular fibrillation. The event resulted in death. On 26Aug2021, the patient died, and the outcome of the event was fatal with treatment including defibrillation and administration of vasopressor. Death cause was reported as ventricular fibrillation/suspected cardiac death. An autopsy was not performed. The reporting physician classified the event as serious (death). No Follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of ventricular fibrillation. 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: Suspected cardiac death/ventricular fibrillation


VAERS ID: 1660630 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram, Subarachnoid haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210729; Test Name: CT; Result Unstructured Data: Test Result:subarachnoid haemorrhage; Comments: after the death
CDC Split Type: JPPFIZER INC202101119246

Write-up: Subarachnoid haemorrhage; Cardio-respiratory arrest; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Agency . Regulatory authority report number is v21125116. A 59-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Jul2021 16:30 (Lot Number: EW0207; Expiration Date: 30Sep2021) (at the age of 59-years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no family history. The clinical course was as follows: On 27Jul2021, the patient''s body temperature before vaccination was 36.5 degrees centigrade. On 27Jul2021 at 16:30, vaccination was performed. On 29Jul2021 in the morning (1 day, 7 hours and 30 minutes after the vaccination), the patient was fine. The patient stayed alone at her home. On the same day, at night, the family member was not in contact with the patient, and the family member went to see the patient at around 20:00 (2 days, 3 hours and 30 minutes after vaccination). On 29Jul2021 at 20:00 (2 days, 3 hours and 30 minutes after the vaccination), patient was found to have cardio-respiratory arrest. The patient was transferred to the hospital. At 21:55 (2 days, 5 hours and 25 minutes after vaccination), the patient was confirmed to die. Autopsy confirmed to be done and results were available. CT (computed tomography) after the death showed that on 29Jul2021 at 20:00 (2 days, 3 hours and 30 minutes after the vaccination) the patient had subarachnoid haemorrhage. The reporter stated that nothing was reported. The reporting other healthcare professional classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Cardio-respiratory arrest; Subarachnoid haemorrhage; Autopsy-determined Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1660631 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction (at the age of 67); Dementia Alzheimer''s type; Encephalitis (at the age of 2); Hemiparesis (right) (due to encephalitis at the age of 2)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101119274

Write-up: Respiratory arrest; This is a spontaneous report from a contactable physician via a company representative. A 71-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 15Apr2021 (at the age of 71-years-old) as dose 1, single for covid-19 immunization. Medical history included dementia alzheimer''s type , hemiparesis due to encephalitis at the age of 2 and cerebral infarction at the age of 67. The patient''s concomitant medications were not reported. The course of the event was as follows: On 15Apr2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. No particular abnormalities were observed after the vaccination. On 26Apr2021 (11 days after vaccination), the patient died. At the time of round at the previous night, the patient''s condition was as usual. At the time of wake up assistance in the following morning (on 26Apr2021), the patient was confirmed to have respiratory arrest. Although cardiopulmonary resuscitation was performed, the symptom did not improved. The patient died on 26Apr2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. The reporting physician assessed causality between the death and BNT162b2 vaccination as could not be ruled out. The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the close temporal association the possibility of causal association between the event respiratory arrest and the suspect drug BNT162B2 cannot be ruled out.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: Respiratory arrest


VAERS ID: 1660665 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death, Diarrhoea, Rhinorrhoea, Vomiting, X-ray
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: X-ray; Result Unstructured Data: no unusual findings on the X-ray test.
CDC Split Type: KRMODERNATX, INC.MOD20213

Write-up: COVID-19; Death NOS; Diarrhea; Vomiting; Rhinorrhea; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death NOS) and COVID-19 (COVID-19) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). On 13-Aug-2021, the patient experienced RHINORRHOEA (Rhinorrhea). On 16-Aug-2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On 18-Aug-2021, COVID-19 (COVID-19) and VOMITING (Vomiting) outcome was unknown. The patient died on 18-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, RHINORRHOEA (Rhinorrhea) and DIARRHOEA (Diarrhea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, X-ray: normal (normal) no unusual findings on the X-ray test.. Concomitant product was not provided by the reporter. This case was received on 20-AUG-2021 And was forwarded to Moderna on 20-AUG-2021. Treatment product was not provided by the reporter. Patient was diagnosed with asymptomatic COVID-19 on 11AUG2021, 2 days after taking the 1st dose of Moderna vaccine. Since the case was asymptomatic, on 12AUG2021 he was admitted to the residential treatment center. In 13AUG2021 it was reported that the patient experience rhinorrhea, vomiting and diarrhea. On 18AUG2021 patient was found dead. Autopsy has been requested. Company Comment: This case concerns a 60ish year-old male patient with no relevant medical history that was found dead 9 days after taking the 1st dose of the vaccine. He was, also, diagnosed with asymptomatic COVID-19 2 days after receiving the vaccine, and was admitted to a residential treatment center for follow up. During this period it was reported the patient experience rhinorrhea, vomiting and diarrhea. An autopsy was requested since the cause of death is unknown. The mRNA-1273 does not contain a virus capable of causing infection so the occurrence of COVID-19 infection after vaccination is assessed as not related to the vaccine. Regarding the event death, very limited information has been provided, since there''s a temporal association a causal relationship cannot be excluded, but the event CVOID-19 is also a confounder.; Sender''s Comments: This case concerns a 60ish year-old male patient with no relevant medical history that was found dead 9 days after taking the 1st dose of the vaccine. He was, also, diagnosed with asymptomatic COVID-19 2 days after receiving the vaccine, and was admitted to a residential treatment center for follow up. During this period it was reported the patient experience rhinorrhea, vomiting and diarrhea. An autopsy was requested since the cause of death is unknown. The mRNA-1273 does not contain a virus capable of causing infection so the occurrence of COVID-19 infection after vaccination is assessed as not related to the vaccine. Regarding the event death, very limited information has been provided, since there''s a temporal association a causal relationship cannot be excluded, but the event CVOID-19 is also a confounder.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1660733 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood test, Body temperature, Electrocardiogram, Headache, Hyperthermia, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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: Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210817; Test Name: hyperthermia; Result Unstructured Data: Test Result:More than 42 Centigrade; Comments: Fever: More than 42 degrees Celsius; Test Name: ECG; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC202101108113

Write-up: Fever: More than 42 degrees Celsius; Headache; Not feeling well; Nausea; Pain in the joints; This is a spontaneous report from a contactable consumer from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00671119. A 24-year-old male patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 16Aug2021 (Batch/Lot number was not reported) (at age of 24-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever: more than 42 degrees celsius (hyperthermia) (death, hospitalization) on 17Aug2021, headache (headache) (death, hospitalization) on 17Aug2021, not feeling well (malaise) (death, hospitalization) on 16Aug2021, nausea (nausea) (death) on 17Aug2021, and pain in the joints (arthralgia) (non-serious) on 16Aug2021. The patient underwent lab tests and procedures which included blood test: unknown results on unknown date , body temperature: more than 42 centigrade on 17Aug2021, electrocardiogram: unknown results on unknown date. Treatment: Headache, hyperthermia , and malaise is treated with In the hospital. The outcome of generalized joint pain is unknown, of the rest of 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 on batch number cannot be obtained.; Reported Cause(s) of Death: Headache; Malaise; Nausea; Hyperthermia


VAERS ID: 1660735 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-27
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101125979

Write-up: the fetus was found not to have a beating heart; 4 weeks pregnant during the 1st injection; This is a spontaneous report received from a contactable consumer. This is second of two reports. The first report was downloaded from the regulatory authority. The regulatory authority report number is NL-LRB-00666642. The consumer reported information for both mother and fetus. This is a fetus report. A fetus patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 transplacental on 30Jun2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The fetus was found not to have a beating heart (death) on 27Jul2021. Patient mother was 4 weeks pregnant during the 1st injection. At 8 weeks ultrasound, the fetus was found not to have a beating heart. Not saying it''s because of the vaccine, but want to report it anyway. Outcome of event was fatal. Patient died on 27Jul2021. 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.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101073274 fetus/mother case; Reported Cause(s) of Death: the fetus was found not to have a beating heart


VAERS ID: 1660752 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-01
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: NZPFIZER INC202101119237

Write-up: myocarditis; This is a spontaneous report from a contactable other health professional. A female patient an unspecified age received BNT162B2 (Pfizer COVID-19 vaccine, Formulation: Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as dose number, unknown, single for COVLD-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced myocarditis. The event eventually resulted in Death. They have considered that the woman''s death was due to myocarditis, which is known to be a rare side effect of the Pfizer COVID-19 vaccine. They considered that the myocarditis was probably due to vaccination. They noted that there were other medical issues occurring at the same time which may have influenced the outcome following vaccination. This is the first case where a death in the days following vaccination has been linked to the Pfizer COVID-19 vaccine. While we have received other reports of deaths in someone recently vaccinated, none are considered related to vaccination. Details of these cases have been published. They consider that the circumstances of this death are consistent with what is known about myocarditis and the Pfizer vaccine. The outcome of the event was fatal for myocarditis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: myocarditis


VAERS ID: 1660761 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-08-14
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101105094

Write-up: Unresponsive; This is a spontaneous report from a contactable other health care professional. This is a report received from the Regulatory authority report number PH-PHFDA-300100036. A 65-year-old male patient received BNT162B2(COMIRNATY), intramuscularly on 07Jul2021, at 65-year-old, as single dose (Lot Number: FD5996) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced unresponsive on 14Aug2021 07:10. The patient died on Aug2021. The outcome of event was fatal. It was not reported if an autopsy was performed. This case was reported as serious per fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unresponsive


VAERS ID: 1660762 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3430 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Throat irritation
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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:
CDC Split Type: PHPFIZER INC202101111196

Write-up: COVID-19 positive with symptoms; COVID-19 positive with symptoms; Cough; Itchy throat; This is a spontaneous report from a contactable other hcp. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300100326. A 66-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 07Aug2021 (Lot Number: FE3430) at the age of 66-year-old as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced covid-19 positive on 18Aug2021 08:00, cough and itchy throat on 08Aug2021 08:00. Event covid-19 positive considered as serious with medically significant. The outcome of all 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. No further information is expected.; Reported Cause(s) of Death: covid-19 positive; Itchy throat; Cough


VAERS ID: 1660765 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-07-16
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), 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: 2021-07-18
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CVA (admitted for 4 days at Hospital); Diabetes mellitus (for 1 year); Hospitalization; Hypertension (for 1 year)
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: Antigen test; Test Result: Positive
CDC Split Type: PHPFIZER INC202101111197

Write-up: COVID-19/tested for antigen test and with positive result; COVID-19/tested for antigen test and with positive result; Cough; shortness of breath/difficulty of breathing; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory authority report number PH-PHFDA-300101411. A 68-year-old female patient received first dose of BNT162B2 (COMIRNATY), intramuscular on 21Jun2021 (at the age of 68-year-old) as single dose, for covid-19 immunisation. Medical history included diabetes mellitus for 1 year, hypertension for 1 year, cerebrovascular accident (CVA) and admitted for 4 days at Hospital from 24Feb2021 to 28Feb2021. The patient''s concomitant medications were not reported. On 16Jul2021, the patient experienced cough and shortness of breath, COVID-19. On 18Jul2021, the patient was having difficulty of breathing and was brought to Hospital. The patient was also tested for antigen test and with positive result. The outcome of the events was fatal. The patient died on 18Jul2021. 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: COVID-19/tested for antigen test and with positive result; cough; shortness of breath/difficulty of breathing; COVID-19/tested for antigen test and with positive result


VAERS ID: 1660766 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

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: 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: PHPFIZER INC202101111198

Write-up: Heart attack; This is a spontaneous report from a contactable other hcp. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300101477 A 69-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 23Jul2021 at her 69-years-old (Lot Number: fd5996) as dose number unknown, single for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced heart attack on 25Jul2021 12:00 with fatal outcome. 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: Heart attack


VAERS ID: 1660767 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, 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: 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: PHPFIZER INC202101111199

Write-up: Fever; headache; This is a spontaneous report from a contactable other hcp received from the Regulatory authority report number PH-PHFDA-300100785 A 31-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 01Jul2021 (Batch/Lot Number: FD5996) at age of 31-year-old as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient experienced fever, headache on 02Jul2021. The outcome was fatal. 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: Fever; headache


VAERS ID: 1660768 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-08-16
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101111200

Write-up: Difficulty breathing; This is a spontaneous report from a contactable other hcp. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300100949 A 76-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly on 13Jul2021 at the age of 76-year-old (Batch/Lot Number: FD5996) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced difficulty breathing on 16Aug2021. The patient died on an unspecified date and the event was serious due to death. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Difficulty breathing


VAERS ID: 1660769 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Conjunctivitis, Death, Decreased appetite, Oropharyngeal pain, Rash, Skin lesion
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-13
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101111201

Write-up: Patient died; generalized purple lesions on the back; decreased appetite; Conjunctivitis; Sore throat; rash; This is a spontaneous report from a contactable other hcp, received from the Regulatory Authority and Drug Administration. Regulatory authority report number PH-PHFDA-300101401. A 60-year-old male patient received bnt162b2 (COMIRNATY Lot Number: FD5996), intramuscular on 16Jul2021 (at 60-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced conjunctivitis, sore throat, rashes on 26Jul2021, and generalized purple lesions on the back, decreased appetite on 28Jul2021. All non-serious events. The outcome of the events was unknown. On 03Aug2021, the patient admitted to ICU. On 13Aug2021, the patient died. 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: Patient died


VAERS ID: 1660770 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-07-11
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Headache
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: PHPFIZER INC202101111202

Write-up: Headache; Abdominal pain; This is a spontaneous report from a contactable other HCP. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300101410. This 57-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 26Jun2021 (at the age of 56-year-old; Batch/Lot Number: FD5996) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced headache on 11Jul2021, abdominal pain on 11Jul2021. The patient died on an unspecified date. The outcome of events was fatal. 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: Headache; Abdominal pain


VAERS ID: 1660771 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-08-07
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101111203

Write-up: Death; collapse; left upper back pain; severe headache; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300100719. A 35-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 17Jul2021 (Lot Number: FD5996) at the age of 35-years-old as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 07Aug2021 at around 17:20, the patient collapsed after she took a bath and complaints of severe headache and left upper back pain. On 08Aug2021 at around 3:50 am, the patient was no longer responsive/ death. The patient died on 08Aug2021 around 3:50 am. Outcome of the other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1662521 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-14
Submitted: 0000-00-00
Entered: 2021-09-01
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: 2021-08-14
   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: Anticoagulant therapy (In May 2018 had a deep vein thrombosis - was taking Xarelto or Pradaxa ever since); CIDP (chronically getting worse.); Wheelchair user
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis leg (In May 2018 had a deep vein thrombosis.); Comments: chronic inflammatory demyelinating polyneuropathy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210846188

Write-up: FOUND DEAD; This spontaneous report received from a physician by a Regulatory authority (EMEA EVHUMAN NLP, AT-BASGAGES-2021-041285) on 23-AUG-2021 concerned a 51 year old male of unspecified race and ethnic origin. The patient''s weight was 80 kilograms, and height was 180 centimeters. The patient''s past medical history included: In MAY-2018 had a deep vein thrombosis leg, and concurrent conditions included: wheelchair user, anticoagulant therapy (In MAY-2018 had a deep vein thrombosis - was taking Xarelto or Pradaxa ever since), and Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) (MAR-2018), and other pre-existing medical conditions included: chronic inflammatory demyelinating polyneuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: unknown) 1 dosage forms, 1 total administered on 06-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-AUG-2021, the patient found dead. He died from an unknown cause of death. 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 unknown cause of death on 14-AUG-2021. This report was serious (Death).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1663073 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Biliary stones (No previous illnesses, except for gallbladder problems, gallstones 10 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101114664

Write-up: Death; Nausea; This is a spontaneous report received from a contactable consumer downloaded from the WEB. The regulatory authority report number is AT-BASGAGES-2021-27613. A 68-year-old male patient received BNT162B2 (COMIRNATY, lot number: EY3014), via intramuscular on 29Apr2021 at single dose for COVID-19 immunisation. Medical history included not ongoing biliary stones in 2010 (no previous illnesses, except for gallbladder problems, gallstones 10 years ago). The patient''s concomitant medications were not reported. On 06May2021, the patient experienced nausea. On 14May2021, the patient experienced death. As the patient did not come to the agreed meeting with reporter and reporter''s son, they sent the police because they did not have a car. The police found the patient dead in bed. As far as reporter knew the patient was not blue and had neither signs of any incident of the heart, nor was lying cramped rather like asleep in bed. Reporter did not know who had the death certificate, there was no autopsy, as they would have to arrange and pay for this privately. The patient died on 14May2021. An autopsy was not performed. This report was serious - death. The outcome of event death was fatal. The outcome of event nausea was not recovered. Sender''s comment: The report was for my partner. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1663295 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-09
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram pulmonary, Bronchitis, COVID-19, Drug ineffective, Dyspnoea, Fatigue, Headache, Hypoxia, Multiple organ dysfunction syndrome, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (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), 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 (broad), Sepsis (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 24
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: BISOPROLOL; LIPITOR; LASIX [FUROSEMIDE]; ASAFLOW; BELSAR [OLMESARTAN MEDOXOMIL]; TRADONAL; SINTROM; L-THYROXINE [LEVOTHYROXINE]; BROMAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; Aortic valve replacement (Dysfunction of the prosthesis, implantation of prosthesis Carpentier-Edwards Magna of 19 mm diameter); Aortic valve replacement (by implantation of a mechanical prosthesis Saint-Jude); Chronic atrial fibrillation (anticoagulated with Sintrom); Hypercholesterolemia; Hypertension; Hypothyroidism; Non-smoker; Valvular heart disease NOS (relatively stable)
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: Biology Gasometry Lung Angio-Scan; Result Unstructured Data: Test Result:Large ground glass areas within both lung fields..; Comments: Large ground glass areas within both lung fields suggestive of COVID-19 pneumonia with more than 75% critical involvement. Presence of septal thickening and condensation. The angiographic phase is of satisfactory quality and does not reveal any opacification defect of the truncular, lobar or segmental pulmonary arteries. Multiple mediastinal lymph nodes and mediastinal adenomegaly. Some peri-tracheal air bubbles.; Test Date: 2021; Test Name: desaturation; Test Result: 70 %; Test Date: 20210409; Test Name: covid-19 test; Test Result: Positive
CDC Split Type: BEPFIZER INC202101107860

Write-up: multi-organ failure; increased hypoxia; Increased dyspnea; Fatigue; tested positive for COVID-19; tested positive for COVID-19; Bronchitis; Headache; 70% desaturation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB BE-FAMHP-DHH-N2021-105532. An 83-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: unknown) on 26Mar2021 at single dose for COVID-19 immunisation. Medical history included valvular heart disease with preserved ejection fraction (relatively stable), Sp aortic valve replacement by implantation of a mechanical prosthesis Saint-Jude in 1997, implantation of a biological aortic valve prosthesis Carpentier-Edwards Magna of 19 mm diameter (dysfunction of the prosthesis) in 2003, currently degeneration of the prosthesis with increased gradient (27/46 mmHg) - Heart tEam: no surgical/TAVI sanction given the high surgical risk, chronic atrial fibrillation anticoagulated with acenocoumarol (SINTROM), high blood pressure, hypercholesterolemia, substituted hypothyroidism. No smoking or alcohol habits. No known allergies. Lives at home with her husband. Autonomous, helps with shopping. Concomitant medications included bisoprolol at 2.5 mg, 1x/day; atorvastatin calcium (LIPITOR) at 20 mg, 1x/day; furosemide (LASIX) at 40 mg, 1x/day; acetylsalicylic acid (ASAFLOW) at 80 mg, 1x/day; olmesartan medoxomil (BELSAR, strength: 40 mg) at 20 mg, 1x/day; tramadol hydrochloride (TRADONAL, formulation: modified-release tablet) at 100 mg, 2x/day; acenocoumarol for INR between 2 and 3; L-thyroxine (LEVOTHYROXINE) at 50 ug, 1x/day; bromazepam at 6 mg, 1x/day. Reported events included COVID-19, oxygen saturation decreased, dyspnea, fatigue, headache, bronchitis. The patient was admitted via the Emergency Department, at request, for episodes of 70% desaturation, apparently for 2-3 days. The patient was tested positive for COVID-19 on 09Apr2021, following an SARS-CoV-2 infection in her husband (who had to be hospitalised), with onset of headache-like symptoms and bronchitis treated by the attending physician with aerosol and antibiotics (no longer know which), with a favourable evolution. Since 29Apr2021, clinical deterioration with increasing dyspnea and significant fatigue. No cough or sputum. No digestive complaints. No other complaints in the systematic history. Biology Gasometry Lung Angio-Scan (30Apr2021): Large ground glass areas within both lung fields suggestive of COVID-19 pneumonia with more than 75% critical involvement. Presence of septal thickening and condensation. The angiographic phase is of satisfactory quality and does not reveal any opacification defect of the truncular, lobar or segmental pulmonary arteries. Multiple mediastinal lymph nodes and mediastinal adenomegaly. Some peri-tracheal air bubbles. On the respiratory side, increase of her hypoxia and implementation of high flow oxygen therapy 70L 100% in room on 02May2021. Corticotherapy with dexamethazone and therapeutic anticoagulation. Despite this, increased hypoxia and associated multi-organ failure. Statement of death made on 03May2021 at 14:10. No protection from vaccine. For all the events following stop date had been reported as 03May2021. The patient died on 03May2021 at 14:10. It was not reported if an autopsy was performed. The outcome of event drug ineffective was unknown. The outcome of other 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: tested positive for COVID-19; Bronchitis; Headache; 70% desaturation; Increased dyspnea; Fatigue; multi-organ failure; increased hypoxia


VAERS ID: 1663351 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101114588

Write-up: Myocardial infarct; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB CZ-CZSUKL-21009854 A 78-year-old female patient received BNT162B2(COMIRNATY, Lot Number: EX3599), intramuscular on 15Apr2021 at single dose (dose number unknown) for covid-19 immunisation. Medical history included ongoing hypertension. The patient''s concomitant medications were not reported. The patient experienced myocardial infarct on 20Apr2021. The events were serious for being disability, medically significant, life threatening and death. The outcome of event was fatal. The patient died on 20Apr2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Myocardial infarct


VAERS ID: 1663450 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-09
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 2021-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210839152

Write-up: MYOCARDIAL INFARCTION; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, DE-PEI-202100169717) on 24-AUG-2021 and concerned a 66 year old female 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 not reported, batch number: XE393 expiry: UNKNOWN) dose was not reported, 1 total administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021, the patient experienced myocardial infarction and died from infarct myocardial. 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). This case is a duplicate of 20210850424. Additional information was received from Regulatory Authority on 24-AUG-2021. It was determined that 20210850424 was a duplicate of this case. All relevant information regarding this case will be submitted under 20210839152.; Sender''s Comments: V0: 20210839152- Covid-19 vaccine ad26.cov2.s- Myocardial infarction. 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: INFARCT MYOCARDIAL.


VAERS ID: 1663462 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-16
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D016A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: 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), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101114530

Write-up: Renal failure; This is a spontaneous report from a non-contactable consumer downloaded from the WEB, regulatory authority number DE-PEI-202100171818. A 90-year-old male patient received bnt162b2 (COMIRNATY), second single dose via an unspecified route of administration on 01Jun2021 (Batch/Lot Number: 1D016A) for covid-19 immunisation. The patient previously received first dose of bnt162b2 on 14Apr2021 intramuscularly (lot number: ET304507) for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced renal failure (renal failure) (death, hospitalization, life threatening) on 16Jun2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Assessment: Comirnaty/ Renal failure/ PEI: D. Unclassifiable Sender''s comment: Diagnosis: Laboratory No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Renal failure


VAERS ID: 1663560 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autoimmune disorder, Cardiac disorder
SMQs:, Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
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: Autoimmune disorder NOS (for about 15 years); Cardiac disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101126675

Write-up: suspected autoimmune reaction triggered by vaccination; cardiac event requiring re-animation; This is a spontaneous report received from contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 82687], license party for Comirnaty. A 57-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (both at the age of unknown) for covid-19 immunisation. Medical history included cardiac endangerment from 05May2021 and 16Jun2021, suspicion of an autoimmune disease with no proper diagnosis regarding systemic disease, for about 15 years. The patient''s concomitant medications were not reported. On unspecified date, the patient experienced suspicion of autoimmune reaction triggered by vaccination. The patient was quite stable for years, with cardiac endangerment 05May2021 and 16Jun2021, had a cardiac event, requiring reanimated, died on 25Aug2021. It was unknown if an autopsy was performed.; Sender''s Comments: The causal relationship between bnt162b2 and the events autoimmune disorder and cardiac disorder (both fatal) cannot be fully assessed/excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available on the exact patient medical history reported as cardiac endangerment from 05May2021 and 16Jun2021, suspicion of an autoimmune disease with no proper diagnosis. 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: suspected autoimmune reaction triggered by vaccination; cardiac event requiring re-animation


VAERS ID: 1663562 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autoimmune disorder, Diarrhoea, Joint swelling, Skin reaction
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (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: 2021-08-24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autoimmune disorder NOS (for about 15 years)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101129578

Write-up: suspected autoimmune reaction triggered by vaccination; skin changes; joint swelling; diarrhea; This is a spontaneous report received from contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 82687], license party for Comirnaty. A 58-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as dose 1, single, dose 2 via an unspecified route of administration on 26May2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included suspicion of an autoimmune disease with no proper diagnosis regarding systemic disease, for about 15 years. The patient''s concomitant medications were not reported. On unspecified date, the patient experienced skin changes, joint swelling, diarrhea and suspicion of autoimmune reaction triggered by vaccination. The event suspected autoimmune reaction was reported as fatal. The outcome of other events was unknown. The patient died on 24Aug2021. It was not reported if an autopsy was performed.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101126675 same reporter, same drug, similar events, different patients; Reported Cause(s) of Death: suspected autoimmune reaction triggered by vaccination


VAERS ID: 1663641 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-07-19
   Days after vaccination:166
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Drug ineffective
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: 2021-08-02
   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:
CDC Split Type: ESPFIZER INC202101114663

Write-up: COVID-19 pneumonia; Drug ineffective; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, regulatory authority number ES-AEMPS-982230. A 94-years-old non-pregnant female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection), dose 1 intramuscular on 13Jan2021 (Lot Number: EM0477) as DOSE 1, SINGLE, dose 2 intramuscular on 03Feb2021 (Lot Number: EL8723) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 19Jul2021, the patient experienced COVID-19 pneumonia, drug ineffective. It was reported that lack of efficacy was reported after vaccination with two doses of Comirnaty. The patient died on 02Aug2021. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Drug ineffective; COVID-19 pneumonia


VAERS ID: 1663653 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2336 / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Cerebral arteriosclerosis, Epilepsy, Magnetic resonance imaging head, Myocardial infarction, Pulmonary congestion
SMQs:, Cardiac failure (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Ischaemic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Generalised convulsive seizures following immunisation (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 26
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: Benign prostatic hyperplasia; Hypertension; Old myocardial infarction; Paroxysmal atrial fibrillation; Seizures; Thoracic aortic aneurysm (reconstruction 09/181)
Allergies:
Diagnostic Lab Data: Test Name: brain MRI; Result Unstructured Data: Test Result:not explanatory
CDC Split Type: FIPFIZER INC202101114685

Write-up: atherosclerotic cardiovascular disease; Pulmonary congestion; myocardial infarction; unspecified epilepsy; cerebrovascular atherosclerosis; This is a spontaneous report from a contactable consumer and a contactable physician downloaded from the regulatory authority [FI-FIMEA-20214032]. A 72-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot#: FC2336) at single dose given in the left upper arm on 23Jun2021 for COVID-19 immunisation. Medical history included thoracic-abdominal aortic aneurysm, reconstruction 09/181; hypertension; paroxysmal atrial fibrillation; benign prostatic hyperplasia; old myocardial infarction; onwards convulsion seizures from Apr2021. Concomitant medication was not reported. On 27Jun2021, patient experienced atherosclerotic cardiovascular disease and pulmonary congestion. Patient was found dead 4 days after vaccination on 27Jun2021. In the death certificate was written as the underlying disease [disease described as atherosclerotic cardiovascular disease], old myocardial infarction, unspecified epilepsy and cerebrovascular atherosclerosis. Certificate of death: cause of death were atherosclerotic cardiovascular disease. Diseases contributing to death were myocardial infarction (onset Jun2021), unspecified epilepsy (onset Jun2021), cerebrovascular atherosclerosis (onset Jun2021). In Apr2021, patient had onwards convulsion seizures, epilepsy diagnosed Jun2021, brain MRI was not explanatory. The patient was alone at home, last talked on the phone on June 25, found lifeless on the floor on 27Jun2021, lying on his right side / stomach. Generalized moderate-to-severe atherosclerosis found in medical death investigation, old infarct scar in dilated heart, congestion in lung. It was unknown if an autopay was performed. The outcome of events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Myocardial infarction; Unspecified epilepsy; Pulmonary congestion; Atherosclerotic cardiovascular disease; cerebrovascular atherosclerosis


VAERS ID: 1663675 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-08-03
   Days after vaccination:174
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood lactic acid, Blood pressure measurement, Body temperature, COVID-19, Chills, Cough, Dyspnoea, Fibrin D dimer, Heart rate, International normalised ratio, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-1 test, SARS-CoV-2 test, Vaccination failure, pH body fluid
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; FUROSEMIDE; LERCANIDIPINE; LOPERAMIDE; PANTOPRAZOLE; PARACETAMOL; PREGABALIN; FLUINDIONE; RAMIPRIL; LYSINE ACETYLSALICYLATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Above knee amputation (Amputation of left lower limb mid-thigh); Acute myocardial infarction (Acute myocardial infarction$g thrombolysis and 3 stents); Femoral-tibial arterial bypass (Left tibialis femoral bypass); Smoking cessation therapy; Thrombectomy (right femoral)
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: glucose; Result Unstructured Data: Test Result:8.87 mmol/L; Test Date: 20210806; Test Name: glucose; Result Unstructured Data: Test Result:greatly increased mmol/L; Test Name: lactate; Result Unstructured Data: Test Result:2.2 mmol/L; Test Name: blood pressure; Result Unstructured Data: Test Result:152/59 mmHg; Test Name: blood pressure; Result Unstructured Data: Test Result:186/85 mmHg; Test Name: body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Test Name: body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Test Name: fibrin d dimer; Result Unstructured Data: Test Result:increased; Test Name: heart rate; Result Unstructured Data: Test Result:59; Comments: bpm; Test Name: heart rate; Result Unstructured Data: Test Result:84; Comments: bpm; Test Date: 20210805; Test Name: INR; Result Unstructured Data: Test Result:3.8; Test Date: 20210806; Test Name: INR; Result Unstructured Data: Test Result:greatly increased; Test Name: o2 saturation; Test Result: 77 %; Comments: under 15L oxygen; Test Name: o2 saturation; Test Result: 60 %; Comments: 10L O2; Test Name: ph; Result Unstructured Data: Test Result:7.433; Test Name: sars-cov-2 antigen test; Test Result: Positive ; Test Name: sars-cov-2 pcr test; Test Result: Positive ; Comments: Complete genome sequencing: delta 21A variant. (SPIKE gene substitution: T19R, E156G, L452R, T478K, D614G, P681R, D950N) (SPIKE gene deletion: F157-, R158-).
CDC Split Type: FRPFIZER INC202101114976

Write-up: dyspnea; cough; desaturation; chills; Vaccination failure; covid-19 infection; This is a spontaneous report from a contactable other hcp downloaded from the WEB, regulatory authority number FR-AFSSAPS-CN20212740. An 86-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EK9788, Expiry date: unknown), dose 2 intramuscular on 10Feb2021 as dose 2, single and dose 1 intramuscular on 19Jan2021 (Batch/Lot Number: EM0477, Expiry date: unknown) as dose 1, single for covid-19 immunization. Medical history included right femoral thrombectomy, amputation of left lower limb mid-thigh, left tibialis femoral bypass, acute myocardial infarction- thrombolysis and 3 stents and smoking cessation (from an unknown date and unknown if ongoing for all). Patient had no history of COVID-19, no PCR test history and unknown allergic history. Concomitant medications included atorvastatin, furosemide, lercanidipine, loperamide, pantoprazole, paracetamol, pregabalin, fluindione, ramipril and lysine acetylsalicylate (taken for an unspecified indication, start and stop date were not reported for all medications). The patient had vaccination failure, covid-19 infection (death, hospitalization) and chills (death, hospitalization) on 03Aug2021. Appearance of symptoms (chills) on 03Aug2021, without fever or respiratory signs, apart from average oxygen saturation. Antigenic test carried out by the state registered nurse showed positive, validated by PCR test on 04Aug2021. Complete genome sequencing: delta 21A variant. (SPIKE gene substitution: T19R, E156G, L452R, T478K, D614G, P681R, D950N) (SPIKE gene deletion: F157-, R158-). Visit of the doctor, put on corticosteroids and maintain his oxygen. The patient underwent lab tests and procedures which included blood glucose was 8.87 mmol/l, INR (international normalised ratio) 3.8 on 05Aug2021 under 1/4 of a tablet of fluindione per day for a target between 2 and 3, blood sugar at 8.87 mmol / l on 05Aug N 4.11-5.90). On 06Aug2021, INR and glycemia greatly increased in the blood test, blood glucose was greatly increased requested by a private practitioner. On 07Aug2021, onset of dyspnea with desaturation and of a cough. Urgent medical aid service call for hospitalization. On arrival at the emergency room at 6:54 p.m.: temperature was 37.1 degree Celsius, HR (heart rate) 59 bpm, BP (blood pressure) left arm 152/59 mmHg, oxygen saturation 77% under 15L oxygen. Prescription of spiramycin 1.5MUI IV every 8h and cefotaxime 1G IV every 8h. At 9:28 p.m.: lactates 2.2 mmol / l pH 7.433, D-dimers increased. Prescription of low molecular weight heparin in curative (enoxaparin 9000 IU * 2 / day subcutaneous), no prescription of thoracic CT angiography. Constant at 23h24, temperature was 37.1 degree Celsius, HR 84 bpm, TA left arm 186/85 mmHg, oxygen saturation 60% despite 10L O2 mottling and dyspnea. Patient was put on midazolam. Patient had emergency death in critical condition. Therapeutic measures were taken as a result of covid-19 infection, dyspnea, cough, desaturation and chills. The patient died on 07Aug2021. An autopsy was not performed. The clinical outcome of events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: covid-19


VAERS ID: 1663716 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Pyrexia
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 10
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: Atrial fibrillation; Diabetes mellitus; Hypertension arterial; Senile macular degeneration
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210853839

Write-up: Drug ineffective; Fever; COVID-19 respiratory infection; This spontaneous report received from a physician via a regulatory authority (EVHUMAN Vaccines, FR-AFSSAPS-MP20216629) concerned a 76 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: diabetes mellitus, atrial fibrillation, hypertension arterial, and senile macular degeneration. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 dosage forms, 1 total, administered on 26-JUN-2021 for covid-19 vaccination. The duration of drug administration was 1 day. The drug start period and last period was 22 days. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 17-JUL-2021, the patient experienced drug ineffective, fever, covid-19 respiratory infection. On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. On 27-JUL-2021, the patient died from covid-19. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of drug ineffective, fever and covid-19 respiratory infection on 27-JUL-2021. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with product quality complaint.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1663728 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-08
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Investigation, Productive cough, Respiratory failure, Transplant evaluation
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chemotherapy; Cirrhosis liver; Hepatic embolization (for hepatocellular carcinoma); Hepatitis C; Hepatocellular carcinoma; Kidney transplant; Radiotherapy; Smoker
Allergies:
Diagnostic Lab Data: Test Name: tests carried out 1 week before death; Result Unstructured Data: Test Result:no abnormalities; Comments: one week before death; Test Name: pre-transplant assessment; Result Unstructured Data: Test Result:discovery of bundle branch block; Comments: in the heart, no lung abnormalities
CDC Split Type: FRPFIZER INC202101107953

Write-up: Failure respiratory; productive cough in the evening leading to the intake of anticough syrup; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority [FR-AFSSAPS-NC20213646]. A 63-year-old male patient received second dose of BNT162B2 (COMIRNATY) (Lot Number: FD0168) intramuscular in left arm single dose for COVID-19 immunisation on 25Jun2021. Medical history included hepatitis C, hepatocellular carcinoma, cirrhosis, radiotherapy, chemotherapy, embolization for hepatocellular carcinoma from Jan2021, during kidney transplant protocol smoking. During the pre-transplant assessment, it was reported discovery of bundle branch block in the heart, no lung abnormalities. Concomitant medication included propranolol. The patient experienced failure respiratory (death) on 08Jul2021 01:00, productive cough in the evening leading to the intake of anticough syrup on 08Jul2021 with outcome of unknown. On 08Jul2021 that was 2 weeks after vaccination, appearance of a productive cough in the evening leading to the intake of anticough syrup. On 08Jul2021 at 1 am the patient had difficulty breathing, his wife contacted the emergency medical assistance service. Before help arrived, the patient became unwell and despite attempts at resuscitation the patient died. Tests realized 1 week before death showed no anomalies. Conclusion was reported as: respiratory failure leading to the death of the patient 2 weeks after vaccination. The patient died on 08Jul2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Failure respiratory


VAERS ID: 1663757 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-07-19
   Days after vaccination:87
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood creatinine, Blood lactic acid, C-reactive protein, COVID-19, Computerised tomogram thorax, Fibrin D dimer, Lymphocyte count, PCO2, PO2, Platelet count, Red blood cell count, SARS-CoV-2 test, Vaccination failure, White blood cell count, pH body fluid
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: 2021-08-01
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Angiodysplasia; Arrhythmia; Auricular fibrillation; Beta-thalassemia trait; Cancer of prostate (since 6 years treated with laser and hormone therapy); Cardiac failure; Chronic renal insufficiency (stage 3); Haemorrhage of digestive tract; Hypertension arterial; Insulin-requiring type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: bicarbonates; Result Unstructured Data: Test Result:24 mmol/L; Test Date: 20210730; Test Name: Creatinine; Result Unstructured Data: Test Result:116 umol/l; Comments: creatinemia stable; Test Date: 20210730; Test Name: lactate; Result Unstructured Data: Test Result:1.72 mM; Test Date: 20210730; Test Name: Chest CT scan; Result Unstructured Data: Test Result:COVID-19 type pneumonia; Comments: COVID-19 type pneumonia with severe involvement (50-75%), CT pulmonary arterial hypertension; Test Date: 20210730; Test Name: C-reactive protein; Result Unstructured Data: Test Result:146 mg/l; Test Date: 20210730; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:660 ng/ml; Test Date: 20210730; Test Name: lymphocyte count; Result Unstructured Data: Test Result:0.20 x10 9/l; Comments: lymphopenia; Test Date: 20210730; Test Name: pCO2; Result Unstructured Data: Test Result:32 mmHg; Test Date: 20210730; Test Name: pH; Result Unstructured Data: Test Result:7.49; Test Date: 20210730; Test Name: Platelet count; Result Unstructured Data: Test Result:193 x10 9/l; Test Date: 20210730; Test Name: pO2; Result Unstructured Data: Test Result:65 mmHg; Test Date: 20210730; Test Name: Red blood cell count; Result Unstructured Data: Test Result:7.2 g/dl; Comments: microcytic anemia; Test Date: 20210719; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: variant unknown; Test Date: 20210730; Test Name: White blood cell count; Result Unstructured Data: Test Result:5.8 x10 9/l; Comments: leukocytosis
CDC Split Type: FRPFIZER INC202101114833

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-PO20214463. An 82 years old male patient received the first dose of COMIRNATY vaccine (batch ET3620) on 29Mar2021 intramuscularly at 0.3 ml single dose, and then received the second dose of COMIRNATY vaccine (batch EW2246) on 23Apr2021 intramuscularly at 0.3 ml single dose, both for COVID-19 immunisation. Relevant history included complete arrhythmia by atrial fibrillation with heart failure, arterial hypertension, insulin-dependent type II diabetes, ins beta-thalassemia minor, chronic renal failure stage 3, digestive hemorrhage due to angiodysplasia since 2016 complicated by anemia, prostate cancer since 6 years treated with laser and hormone therapy. No information about COVID-19 medical history. The patient had PCR COVID-19 positive on 19Jul2021 (search for variant unknown). Symptomatic patients from 22Jul2021 with fluctuating fever, asthenia, diarrhea associated with feeding difficulties and difficult hydration. The patient was hospitalized on 30Jul2021. At the entrance, Chest CT scan of 30Jul2021: COVID-19 type pneumonia with severe involvement (50-75%), CT pulmonary arterial hypertension. Initiation of treatment with IV ceftriaxone 1g / day, dexamethasone 6mg / day, enoxaparin 4000 IU / day. implementation of oxygen therapy at 8L / min. Laboratory assessment of 30Jul2021: CRP at 146 mg / L, microcytic anemia at 7.2g / dL, platelets at 193 G / L, leukocytosis at 5.8 G / L, lymphopenia at 0.20 G / L, creatinemia stable at 116 umol / L, D-dimer at 660 ng / mL. Control blood gas under oxygen therapy: pH 7.49, pO2 65 mmHg (N 80-100), pCO2 32mmHg (N 35-45), bicarbonates at 24 mmol / L (N 23-27), lactates 1.72mM ( N 0.5-2.0). Worsening of the respiratory picture appeared on 01Aug2021 with oxygen referee at 15L / min. Single dose IV infusion of tocilizumab 680mg received. Death during the night of 02 to 03 Aug2021 (as reported). No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: COVID-19; Vaccination failure


VAERS ID: 1663846 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-06-09
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angiocardiogram, Arrhythmia, Cardiac arrest, Echocardiogram, Myocardial infarction, Myocarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (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: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiogenic shock (Cardiogenic shock with acute left ventricular myocardial infarction)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Coronary angiogram; Result Unstructured Data: No stenosing CHD, but reversible coronary spasm, high-grade restriction of LV function, no indication of pulmonary embolism; Test Name: Heart echo; Result Unstructured Data: Poor EF, cardiac arrest (first VT), then treated therapy-refractory PEA
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Myocarditis; Cardiac arrhythmia; Heart arrest; Infarct myocardial; This case was initially received via Regulatory Authority (Reference number: DE-PEI-202100134159) on 04-Aug-2021. The most recent information was received on 06-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis), ARRHYTHMIA (Cardiac arrhythmia), CARDIAC ARREST (Heart arrest) and MYOCARDIAL INFARCTION (Infarct myocardial) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002620) for Prophylactic vaccination. Concurrent medical conditions included Cardiogenic shock (Cardiogenic shock with acute left ventricular myocardial infarction). On 27-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria death and medically significant), ARRHYTHMIA (Cardiac arrhythmia) (seriousness criteria death and medically significant) and CARDIAC ARREST (Heart arrest) (seriousness criteria death and medically significant). 09-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (Infarct myocardial) (seriousness criteria death and medically significant). The patient died on 09-Jun-2021. The reported cause of death was Myocarditis. An autopsy was performed. The autopsy-determined cause of death was Cardiogenic shock. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiocardiogram: abnormal (abnormal) No stenosing CHD, but reversible coronary spasm, high-grade restriction of LV function, no indication of pulmonary embolism. On an unknown date, Echocardiogram: abnormal (abnormal) Poor EF, cardiac arrest (first VT), then treated therapy-refractory PEA. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was treated therapy refractory PEA. Company comment: This case refers to a 65-year-old male patient with reported ongoing history of myocardial infarction and cardiogenic shock who experienced the serious unexpected events of Myocardial infarction, Myocarditis, Arrhythmia and Cardiac arrest on the same day after receiving the dose 2 of the product mRNA-1273. Very limited information regarding the status of patient''s pre-existing conditions at baseline and the events been provided at this time insufficient for causality assessment. Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Translation document received on 25 Aug 2021 include reporter''s comment updated. On 25-Aug-2021: Non-significant follow-up added on 25 Aug 2021 include no new information.; Sender''s Comments: This case refers to a 65-year-old male patient with reported ongoing history of myocardial infarction and cardiogenic shock who experienced the serious unexpected events of Myocardial infarction, Myocarditis, Arrhythmia and Cardiac arrest on the same day after receiving the dose 2 of the product mRNA-1273. Very limited information regarding the status of patient''s pre-existing conditions at baseline and the events been provided at this time insufficient for causality assessment.; Reported Cause(s) of Death: Myocarditis; Autopsy-determined Cause(s) of Death: Cardiogenic shock


VAERS ID: 1664479 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-02
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: GRPFIZER INC202101115171

Write-up: Death; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number GR-GREOF-20216983. A 72-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. 3 days after the vaccination patient was intubated and after 45 days of hospitalisation patient died. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow up attempts possible. No further information is expected. Lot/batch number was not provided and unable to obtain.; Reported Cause(s) of Death: Death


VAERS ID: 1664546 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-04-02
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; DESUNIN; BISOP; WARFARIN; LANTUS; PRAVASTATIN; GLUCOSE; SEROQUEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deep venous thrombosis femoral; Diabetic; Hypertension; Postural hypotension (in previous months); Subclinical hypothyroidism (in previous months)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101115050

Write-up: SEVERE BLEEDING; FALL; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority number IE-HPRA-2021-082692. Safety Report Unique Identifier IE-HPRA-CVARR2021081617058. A 76-year-old female patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: ET3674 and Expiration date was unknown), via an unspecified route of administration on 25Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included deep vein thrombosis from 2007, hypertension, diabetic, Subclinical hypothyroidism and orthostatic hypotension in previous months. Concomitant medications included folic acid (Manufacturer unknown); colecalciferol (DESUNIN); bisoprolol fumarate (BISOP); warfarin (Manufacturer unknown); insulin glargine (LANTUS); pravastatin (Manufacturer unknown); glucose (Manufacturer unknown) and quetiapine fumarate (SEROQUEL). The patient experienced severe bleeding and fall on 02Apr2021. And was admitted to A&E. The patient died on 03Apr2021. The outcome of events was fatal. The reporter outlined that the patient had a complex medical history, which was also a possible factor. It was not reported if an autopsy was performed. Seriousness criteria reported as fatal and medical significant. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: FALL; SEVERE BLEEDING


VAERS ID: 1664547 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-05-01
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; CADELIUS [CALCIUM;COLECALCIFEROL]; CARDICOR; ELIQUIS; FOLIC ACID; KEPPRA [LEVETIRACETAM]; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Fracture femur; Myocardial infarction; Seizures; Stent placement
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101114977

Write-up: sudden death / found rip in bed; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority report number IE-HPRA-CVARR2021081617059, Safety Report Unique Identifier IE-HPRA-2021-082698. An 80-year-old male patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 08Apr2021 (Lot Number: EW2243) at single dose for COVID-19 immunisation. Medical history included fracture femur from Jul2020, myocardial infarction from 2006, stent placement from 2006, seizure from Jul2020, and atrial fibrillation. Concomitant medications included atorvastatin, calcium/colecalciferol (CADELIUS), bisoprolol fumarate (CARDICOR), apixaban (ELIQUIS), folic acid, levetiracetam (KEPPRA), and ramipril. Patient previously received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 11Mar2021 (Lot Number: unknown) at single dose for COVID-19 immunization. The patient experienced sudden death/found rip in bed on 01May2021 10:00. The reporter outlined the patient experienced a sudden death, and they were awaiting the autopsy report. Patient died on 01May2021 10:00. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death / found rip in bed


VAERS ID: 1664561 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Body temperature, Chest pain, Cough, Diarrhoea, Dyspnoea, Extrasystoles, Heart rate, Hyperhidrosis, Oxygen saturation, Oxygen saturation decreased, Rales, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Amputation above knee; Bedridden; Bypass surgery; Cardiac pacemaker insertion; Drug allergy; Gout; Hypertension; Ischemia cerebral; Kidney failure; Percutaneous coronary intervention; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Test Date: 20210724; Test Name: heart rate; Result Unstructured Data: Test Result:85-88; Comments: bpm; Test Date: 20210724; Test Name: saturation; Test Result: 88 %
CDC Split Type: ITPFIZER INC202101100241

Write-up: excessive sweating; Bpm 85-88 bedridden; saturation 88%; chest pains; breathing difficulties; pain in the abdomen; diarrhea; weight loss; Rales; cough; This is a spontaneous report from a contactable Consumer downloaded from the Regulatory Authority -WEB IT-MINISAL02-769259. A 73-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FF2752), intramuscular, administered in Arm Left on 22Jul2021 (at unknown age) as single dose for COVID-19 immunisation. Medical history included Medtronic pacemaker, left thigh amputate, multiple cerebral ischaemias, cardiac bypasses, PTCA (Percutaneous coronary intervention), stage 5 kidney failure, type 2 diabetes, hypertension, gout, allergic to Ampicillin, bedridden. The patient''s concomitant medications were not reported. On 24Jul2021, the patient had excessive sweating, Bpm 85-88 bedridden, saturation 88%, chest pains, breathing difficulties, pain in the abdomen, diarrhea, weight loss, rales, cough. Treatment received (Buscopan therapy in vein 2 ampoules per day, oxygen therapy, suspension of nutrition). The administration took place on 22Jul by the GP and with the consent of the doctors of the structure. On 27Jul2021 we decided by mutual agreement to suspend the therapies because the patient had endured so many, finally some post vaccination symptoms: fixed temperature of 37.1 ? C during at the weekend, rales, cough. The patient died on 18Aug2021. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Bpm 85-88 bedridden; excessive sweating; saturation 88%; chest pains; breathing difficulties; pain in the abdomen; diarrhea; weight loss; Rales; cough


VAERS ID: 1664653 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-05-04
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test, 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: 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: 20210504; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101100255

Write-up: COVID-19; Vaccination failure; This is a spontaneous report from a contactable consumer or other non-Health care professional downloaded from the Regulatory Authority. Regulatory Authority Report Number: IT-MINISAL02-774037. An 81-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot number: ET7205, expiration date: 31Jul2021) intramuscularly on 06Apr2021 as dose 2, 0.3 ml single for covid-19 immunisation and first dose intramuscularly on 16Mar2021 (Lot Number: ET1831, expiration date: 30Jun2021) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 04May2021, the patient experienced covid-19 and vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04May2021. The end of covid was reported on 21May2021, 28 days post vaccine swab. Diagnosis description was reported as respiratory failure in the course of sars-cov-2 pneumonia. The patient died on an unspecified date. It was not reported if an autopsy was performed. Investigation result was as follow: BNT162B2 (COMIRNATY) (batch/lot number: ET1831, expiration date: 30Jun2021) conclusion: 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 ''ET1831''. 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. PGS Puurs 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. (batch/lot number: ET7205, expiration date: 31Jul2021) conclusion: 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 ET7205. 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. Pfizer 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 corrective and preventative actionswere identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected. Follow-up (27Aug2021and 31Aug2021): New information received from Product Quality Complaint Group and the Regulatory Authority-WEB (IT-MINISAL02-774037) via the same contactable consumer includes: added the investigation results and updated the events onset date (from 26Apr2021 to 04May2021).; Reported Cause(s) of Death: Vaccination failure; respiratory failure in the course of sars-cov-2 pneumonia; respiratory failure in the course of sars-cov-2 pneumonia


VAERS ID: 1664657 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bedridden, Metastasis, Quality of life decreased, X-ray
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 50
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: Gastroesophageal reflux; Hypertension; Lupus erythematosus
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: x-ray; Result Unstructured Data: Test Result:No lung cancer; Comments: Lung cancer not shown in x-ray as of December 2020
CDC Split Type: ITPFIZER INC202101115079

Write-up: Unable to get out of bed - 51 days lying down with fracture of the lumbar vertebrae due to previously undiagnosed metastasis; Unable to get out of bed - 51 days lying down with fracture of the lumbar vertebrae due to previously undiagnosed metastasis; Impact on the quality of life (10/10); This is a spontaneous report from a contactable consumer or other non health care professional downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-774714. A 83-year-old female received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: Not reported), via intramuscular route in right arm (reported as right shoulder) on 31Mar2021, as dose 1, 0.3 ml single (at the age of 83-years-old) for COVID-19 immunization. Medical history included lupus, Hypertension, Gastroesophageal reflux. Concomitant medications were not reported. On 31Mar2021, the patient was unable to get out of bed (51 days lying down since vaccination) with fracture of the lumbar vertebrae due to previously undiagnosed metastasis. Death occurred 51 days after the COMIRNATY vaccine, without the patient ever recovering or getting out of bed. Impact on the quality of life (10/10). Lung cancer not shown in x-ray as of December 2020. Perform palliative care as it is impossible to therapy for the onset of spinal cord and brain metastasis. It was reported that email sent to the reporter and the GP to request the following additional information, detailed clinical report with reports of ER, specialist visits and tests performed and concomitant therapies. The patient had x-ray test and result was Lung cancer not shown in x-ray as of December 2020. The patient died on 20May2021. It was not reported if an autopsy was performed. Health Authority Comment: Lupus - hypertension - gastroesophageal reflux No follow-up attempts possible. Batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Unable to get out of bed - 51 days lying down with fracture of the lumbar vertebrae due to previously undiagnosed metastasis; Unable to get out of bed - 51 days lying down with fracture of the lumbar vertebrae due to previously undiagnosed metastasis


VAERS ID: 1664668 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Congenital anomaly, Maternal exposure during pregnancy
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: ITPFIZER INC202101136342

Write-up: congenital anomaly; Maternal drug exposure; This is a spontaneous report from a contactable physician. This is the second of two reports. The first report is a report downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-770535. This physician reported information for both mother and fetus. This is the fetus report. A fetus patient of an unspecified gender received the first dose of BNT162B2 (COMIRNATY), transplacental on 03Jun2021 (Batch/Lot Number: FA8016) at 0.3 ml single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced congenital anomaly on 15Jul2021, due to which the patient died on an unspecified date. 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.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202101067122 maternal case; Reported Cause(s) of Death: Congenital anomaly


VAERS ID: 1664807 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-25
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 - / -

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

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: Medical History/Concurrent Conditions: Cardiac failure chronic; Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101110896

Write-up: Death; This is a spontaneous report from a contactable physician received via Regulatory Authority. On 28Jul2021 (the day of vaccination), a 77-year-old male patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0583 and Expiration date 31Oct2021) via an unspecified route of administration at the age of 77-year-old as single dose for COVID-19 immunization. Medical history included myocardial infarction and cardiac failure chronic. The concomitant medications included 2 antiplatelet drugs and 2 diuretics. On 07Jul2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA5765, Expiration date 30Sep2021) for COVID-19 immunisation. On 25Aug2021 (28 days after vaccination), the patient experienced death. On 25Aug2021 (28 days after vaccination), the outcome of the event was fatal. The reported event was as follows: On 07Jul2021, the patient received the first dose of BNT162b2 vaccination. On 28Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 25Aug2021 (28 days after vaccination), the patient died at his home. The causality between the event and BNT162b2 vaccination was unknown. It was unknown if autopsy was performed.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1664812 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   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: JPPFIZER INC202101112249

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21124929. The patient was a 69-year and 11-month-old female. Body temperature before vaccination was not provided. The patient received second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FD1945, Expiration date 31Oct2021), via an unspecified route of administration on 06Aug2021 at 15:00, at 69-year-old, as a single dose for COVID-19 immunization. The family history was not provided. No primary diseases and allergies reported. No vaccinations and illnesses within the last one month reported. Medications the patient was taking and past adverse effect history growth status were not provided. On an unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown), as single dose for COVID-19 immunization. On 06Aug2021 at 15:00 (the day of vaccination), the patient received the second dose of BNT162b2. On 07Aug2021 at 10:00 (19 hours after the vaccination), the patient experienced cardio-respiratory arrest. The course of the event was as follows: On 07Jul2021, 09:00 (18 hours after vaccination), the patient experienced cardio-respiratory arrest, and she was transferred. Although cardiopulmonary resuscitation (CPR) was performed, return of circulation was not achieved. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. It was not reported whether there was any other possible cause of the event such as any other diseases. Therapeutic measures were taken as a result of cardio-respiratory arrest included CPR. On 07Aug2021 (one day after the vaccination), the outcome of the event was fatal. It was not reported if an autopsy was performed. The case was reported as serious due to fatal outcome.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1664813 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-24
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute leukaemia, Chronic kidney disease, Sepsis, White blood cell count, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Chronic kidney disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210619; Test Name: WBC; Result Unstructured Data: Test Result:6000; Test Date: 20210724; Test Name: WBC; Result Unstructured Data: Test Result:18600; Test Date: 20210806; Test Name: WBC; Result Unstructured Data: Test Result:89300
CDC Split Type: JPPFIZER INC202101112655

Write-up: sepsis; renal failure chronic; WBC increased; Acute leukaemia; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21125012. The patient was a 63-year and 7-month-old male. The patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5974, Expiration date 30Sep2021), via an unspecified route of administration on 14Jul2021, at 63-year-old, as a single dose for COVID-19 immunization. Body temperature before vaccination was not provided. The family history was not provided. Medical history included diabetes mellitus; hypertension. Concomitant drug included insulin taken for diabetes mellitus. On 14Jul2021 (the day of vaccination), the patient received the first dose of BNT162B2. On 24Jul2021 (10 days after the vaccination), the patient experienced acute leukaemia. On 06Aug2021 (23 days after the vaccination), the patient was admitted to the hospital for all events. The course of the events were as follows: The patient was visiting the diabetic tract medicine department regularly. On 19Jun2021, the blood examination showed white blood cell (WBC) of 6000. On 24Jul2021 (10 days after the vaccination), the WBC increased to 18600. On 06Aug2021 (23 days after the vaccination), the patient was emergently transferred to the reporting hospital. The WBC was 89300. Thus, the patient was admitted to the hospital for leukaemia. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was as follows: The causality between acute leukaemia and BNT162b2 vaccination was difficulty to be proved. On 19Aug2021 (one month/5 days after the vaccination), the outcome of all events was fatal. An autopsy was not performed. The case was reported as serious due to fatal outcome. The reporting physician commented as follows: From 06Aug2021 (23 days after the vaccination) to 19Aug2021 (one month and 5 days after vaccination), the reporting physician became engaged in the medical care for the patient as his attending physician at the reporting hospital. The patient was discharged dead due to acute aggravation of leukaemia, sepsis, and renal failure chronic. Abnormality in the white blood cell count was observed in a short time of 10 days after BNT162b2 vaccination. Thus, the causality between the event and BNT162b2 vaccination could not be ruled out completely, and this case was reported.; Reporter''s Comments: From 06Aug2021 to 19Aug2021, the reporting physician became engaged in the medical care for the patient as his attending physician at the reporting hospital. The patient was discharged dead due to acute aggravation of leukaemia, sepsis, and renal failure chronic. Abnormality in the white blood cell count was observed in a short time of 10 days after BNT162b2 vaccination. Thus, the causality between the event and BNT162b2 vaccination could not be ruled out completely, and this case was reported.; Reported Cause(s) of Death: Sepsis; renal failure chronic; WBC increased; Acute leukaemia


VAERS ID: 1664815 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-12
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Loss of consciousness, Moaning
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   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: BAYASPIRIN; WARFARIN; LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101119249

Write-up: Cerebral haemorrhage; Loss of consciousness; Groans; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21125073. An 81-year and 6-month-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 03AUG2021 (Lot Number: EX3617; Expiration Date: 31Aug2021) at the age of 81-year-old as single dose for COVID-19 immunization. Medical history included cerebral infarction. Body temperature before vaccination was not reported. Family history was not reported. Concomitant medications included acetylsalicylic acid (BAYASPIRIN), warfarin and lansoprazole. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunizaiton. On 12Aug2021, 9 days after the vaccination, the patient experienced cerebral haemorrhage, groans, and loss of consciousness. The clinical course was as follows: Nine days after the second vaccination, the patient suddenly experienced groans and loss of consciousness at night, for which family member requested ambulance. The patient visited emergency department; however, the patient died on the same day due to cerebral haemorrhage. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not provided. The reporting physician commented as follows: The episode occurred 9 days after the vaccination. Causality was unknown. The patient died on 12Aug2021. Autopsy was not reported. The cause of death was cerebral haemorrhage. The outcome of Cerebral haemorrhage was fatal. The outcome of other events was unknown.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1664958 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 9
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: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: COVID-19 virus test; Result Unstructured Data: Positive
CDC Split Type: PHJNJFOC20210852744

Write-up: FEVER, AFTER 2 DAYS FEVER SUBSIDED BUT COUGH AND SHORTNESS OF BREATHE; FEVER, AFTER 2 DAYS FEVER SUBSIDED BUT COUGH AND SHORTNESS OF BREATHE; SWAB RESULT IS POSITIVE; FEVER, AFTER 2 DAYS FEVER SUBSIDED BUT COUGH AND SHORTNESS OF BREATHE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300100241] concerned a 65 year old female. The patient''s height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A and expiry: UNKNOWN) dose was not reported, frequency one total administered on 28-JUL-2021 14:48 for prophylactic vaccination. No concomitant medications were reported. It was reported that, after the vaccination on 28-JUL-2021, the following day (29-JUL-2021), at 09:00 a.m. the patient complained of fever, after 2 days, fever subsided but cough and shortness of breath was experienced by the patient and that was on 31-JUL-2021. Patient''s husband gradually managed the patient''s health condition, gave her hot ginger tea, nutritious fruits and foods. But on 07-AUG-2021, at around 23:00, after taking a bath and eating, she went to sleep and the husband noticed that she was snoring and then she stopped immediately. She manifested seizure and dyspnea. CPR (cardiopulmonary resuscitation) was done by her husband and called for emergency ambulance vehicle. After few minute rescue came and rushed her immediately at hospital. On the same date 07-AUG-2021 at around 23:45 P.M. she died due to fever, cough shortness of breath and covid-19 (fever, after 2 days fever subsided but cough, shortness of breath and swab result is positive). It was unspecified if an autopsy was performed. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210852744- Covid-19 vaccine ad26.cov2.s- Swab result is positive (Covid-19), fever, after 2 days fever subsided but cough, shortness of breath. 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: COVID-19; FEVER; COUGH; SHORTNESS OF BREATH


VAERS ID: 1664959 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-02
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: 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: PHJNJFOC20210852921

Write-up: COVID-19 PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300100979] concerned a 64 year old male. 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, and batch number were not reported) dose was not reported, 1 total, administered on 28-JUL-2021 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 experienced covid-19 pneumonia, and suspected clinical vaccination failure. On an unspecified date, the patient died from covid-19 pneumonia. It was unknown 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 was not reported. This report was serious (Death, and Other Medically Important Condition). This case was associated with Product Quality Complaint and PQC number has been requested.; Sender''s Comments: V0:20210852921-covid-19 vaccine ad26.cov2.s -Covid-19 pneumonia. 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). 20210852921-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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 PNEUMONIA


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