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From the 10/15/2021 release of VAERS data:

Found 17,128 cases where Vaccine is COVID19 and Patient Died



Case Details

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VAERS ID: 1589102 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-07-15
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Atrial fibrillation (Permanent AF under xarelto (stopped / repeated falls)); Cardiac valve disease (with preserved ejection fraction)
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: L452R mutation
CDC Split Type: FRPFIZER INC202101038911

Write-up: acute respiratory distress; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB FR-AFSSAPS-RS20212589. A 91-year-old female patient received the first dose of bnt162b2 (COMIRNATY) on 04Feb2021 (lot number: EK9788) Intramuscularly administered in arm right at single dose; the second dose of bnt162b2 (COMIRNATY) on 25Feb2021 (lot number: EM6950) Intramuscularly administered in arm left at single dose for COVID-19 immunisation. Medical Histories included Arterial hypertension, valvular heart disease with preserved ejection fraction, permanent Atrial Fibrillation under Xarelto (stopped / repeated falls). Concomitant medications were not reported. Covid history was not known. About 5 months later, SARS-CoV-2 PCR test was positive (Search for the variant was L452R mutation) on 15Jul2021. The next day, 16Jul2021, the patient presented with acute respiratory distress leading to death on 20Jul2021. Vaccine failure confirmed around 5 months after the D2 of the Comirnaty vaccine in a 91-year-old patient who resulted in her death. 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 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; acute respiratory distress


VAERS ID: 1589610 (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: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101040500

Write-up: Death; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108111509374350-4VC9J, Safety Report Unique Identifier is GB-MHRA-ADR 25785192. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jun2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included clinical trial participant. Patient had not had symptoms associated with COVID-19. Concomitant medications were not reported. Historical vaccine included BNT162B2 (lot number and expiry date not known), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced death on 08Jun2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. Case narrative: Death. Patient had not tested positive for COVID-19 since having the vaccine. Clinical trial participant No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1589611 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   Days after onset: 47
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101040978

Write-up: Heart failure (medical history of cardiac failure); This is a spontaneous report from a contactable consumer.This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202108111615184330-3YGFF , Safety Report Unique Identifier GB-MHRA-ADR 25785352. A 91-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 as dose 1, single for covid-19 immunisation. Medical history included cardiac failure. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medication(s) included bisoprolol (BISOPROLOL) taken for an unspecified indication from 1993 to an unspecified stop date. The patient experienced heart failure (cardiac failure) (death) led to death 6 weeks later on 14Jan2021. The patient died on 02Mar2021. It was not reported if an autopsy was performed. No relate to possible blood clots or low platelet counts. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Heart failure


VAERS ID: 1589614 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101040715

Write-up: Death sudden; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202108112122135440-FPD5H, Safety Report Unique Identifier GB-MHRA-ADR 25786827. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included ongoing suspected COVID-19 (unsure when symptoms started). She was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced death sudden on 02Aug2021. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unknown date. The patient died on 02Aug2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1589616 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-07-16
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101040696

Write-up: Miscarriage/Missed miscarriage; This is a spontaneous report from a contactable other HCP. This is a report received from the Regulatory Authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202108112216401540-RQHOR], Safety Report Unique Identifier [GB-MHRA-ADR 25787123]. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28May2021 (Lot Number: ET8885) as dose 1, single for COVID-19 Immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced Miscarriage/Missed miscarriage on 16Jul2021. The event was assessed as serious (fatal and Congenital anomaly). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 04Aug2021. The patient died on 16Jul2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: Missed miscarriage of child confirmed on 16th July. Festus had stopped growing some weeks earlier. She was likely in week 1-2 of pregnancy at the time of being vaccinated. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Miscarriage/Missed miscarriage


VAERS ID: 1589620 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
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: GBPFIZER INC202101047381

Write-up: Brain death; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202108121906052060-KSIDE. Safety Report Unique Identifier GB-MHRA-ADR 25790882. A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Unsure if patient had had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced brain death on an unspecified date. The patient died on 14Jul2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Brain death


VAERS ID: 1589657 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
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: 2021-08-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Covid-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101046217

Write-up: died having recently tested positive for COVID-19; died having recently tested positive for COVID-19; This is a spontaneous report from a contactable consumer via company representative. A non-pregnant female patient (reporter''s mother) of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Dec2020 (Batch/lot number and expiration date unknown) as dose 1, single, and her 2nd single BNT162B2 on an unspecified date (Batch/lot number and expiration date unknown) was understood to be delivered in line with UK guidance at the time for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Prior the vaccination, the patient wasn''t diagnosed with COVID-19. In the reporter''s own words, the patient had health issues (numerous underlying medical conditions). The patient died having recently tested positive for COVID-19 on 12Aug2021. It was not reported if an autopsy was performed. No follow-up attempts are Possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died having recently tested positive for COVID-19


VAERS ID: 1589676 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiomyopathy, Coronary artery disease, Headache
SMQs:, Cardiomyopathy (narrow), Other ischaemic heart disease (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202101038746

Write-up: Headache; myocardial lessions; Coronary heart disease; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number GR-GREOF-20216582. A 51-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 27May2021 (Batch/Lot Number: unknown) as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient experienced headache (death, life threatening), myocardial lessions (death, medically significant, life threatening) and coronary heart disease (death, medically significant, life threatening) all on 27May2021. The patient (reporter''s husband) was a quite young and healthy man, he was working very hard, they walked too much in their free time so they did not realize that patient had a problem with his heart. Two days after patient followed the Pfizer vaccine he felt asleep on afternoon (29May2021) and patient never woke up. The death certificate states recent lessions on myocardium and coronary heart disease. They were waiting for toxicology. The patient died on 29May2021. An autopsy was not performed. The outcome of events was fatal. No follow-up attempts possible. No further information expected. Batch/Lot numbers cannot be obtained.; Reported Cause(s) of Death: Headache; myocardial lessions; Coronary heart disease


VAERS ID: 1589677 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   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: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: body temperature; Result Unstructured Data: Test Result:fever
CDC Split Type: GRPFIZER INC202101045670

Write-up: Death (heart failure); Fever; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB GR-GREOF-20216686. A 89-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 23Jul2021 at 89-year-old (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunization. Medical history included covid-19 from Dec2020. The patient''s concomitant medications were not reported. He did the first dose of the vaccine for covid-19 immunization on Jul2021 and had for 2 days fever. At 18:00 on 23Jul2021, the afternoon after a while, he developed again fever and the next day was found dead and issued from physician at home a death certificate. Cause of death was reported as heart failure. The patient died on 24Jul2021. It was not reported if an autopsy was performed. Outcome of events was fatal. The lot number for BNT162b2 was not provided and will be requested during follow up; Reported Cause(s) of Death: fever; Heart failure


VAERS ID: 1589693 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-05-01
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Haemorrhagic cerebral infarction, Inappropriate schedule of product administration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 53
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Brain CT; Result Unstructured Data: Test Result:basal ganglia hemorrhage right side
CDC Split Type: HUPFIZER INC202101039648

Write-up: Hemorrhagic cerebral infarction; 23Mar2021 1st dose/ 13Jun2021 2nd dose; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number HU-OGYI-673421. This spontaneous, serious case was received via the Regulatory Authority on 26Jul2021, concerning hemorrhagic cerebral infarction after the administration of Comirnaty concentrate for dispersion for injection (30 micrograms of COVID-19 mRNA Vaccine, MAH: BioNTech Manufacturing GmbH/ Pfizer). On 13Jun2021 at 8:00 a.m., the 69-year-old male patient received the second dose of COMIRNATY (COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran) concentrate for dispersion for injection (strength: 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine, intramuscularly, left arm, batch number: FD1921). First dose was given on 23Mar2021, batch number: ET7205. On 01May2021 the patient was hospitalized due to stroke (hemorrhagic cerebral infarction) causing left hemiparesis and confusion. Cranial CT (Computed tomography) showed right basal ganglia hemorrhage. During his observation, his general condition continued to decline. No meaningful contact could be made with him. Comfort treatment was provided. On 23Jun2021 at 2:00 a.m., the patient died among the symptoms of stroke complications. Autopsy was not done. The cause of death was reported as hemorrhagic cerebral infarction. Medical history included hypertension, concomitant medicaton was not reported. No further information is expected. Sender Comment: The patient died 10 days after the second dose of Comirnaty vaccine. Cause of death was hemorrhagic cerebral infarction, which occurred before vaccination (5 weeks after the first dose). The reported death and Comirnaty is considered not related. The case is serious due to hospitalization and fatal outcome.; Reported Cause(s) of Death: Hemorrhagic cerebral infarction


VAERS ID: 1589720 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-30
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dilated cardiomyopathy; Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC202101020610

Write-up: Acute heart failure to chronic; 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. The reugaltory authority number of the first case is [IS-IMA-4078]. A 69-years-old male patient received dose 1 of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 13Apr2021 as dose 1, single for covid-19 immunization. The medical history included congestive cardiomyopathy, cardiac failure. The patient concomitant medications were not reported. On 30Apr2021 the patient experienced acute heart failure to chronic. It was reported that 16 days after the first injection (30Apr2021) the patient heart failure gets worsened and was hospitalized. The outcome of the event was fatal. No follow-up attempts are possible, information on batch number cannot be obtained. ; Sender''s Comments: Linked Report(s) : IS-PFIZER INC-202101010444 the same patient, different doses and events; Reported Cause(s) of Death: Acute heart failure to chronic


VAERS ID: 1589722 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210836024

Write-up: DEATH; This spontaneous report received from a social media (twitter) via a company representative concerned a 30 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, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. In 2021, the patient died from unknown cause of death. The outcome was fatal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210836024-Covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1589795 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-06-25
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Angiocardiogram, Computerised tomogram thorax, Coronary angioplasty, Echocardiogram abnormal, Endotracheal intubation, Interstitial lung disease, SARS-CoV-2 test
SMQs:, Angioedema (broad), Interstitial lung disease (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 15
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: Acute interstitial pneumonitis
Allergies:
Diagnostic Lab Data: Test Name: Angiograph coronary; Result Unstructured Data: Test Result:no information; Test Name: chest CT; Result Unstructured Data: Test Result:Chest which documented unexplained interstitial-li; Comments: Chest which documented unexplained interstitial-like pneumonia (involving$g 50% of the lungs); Test Name: Coronary angioplasty; Result Unstructured Data: Test Result:no information; Test Name: Echocardiogram abnormal; Result Unstructured Data: Test Result:FE VSn 30%; Test Name: Endotracheal intubation; Result Unstructured Data: Test Result:no information; Test Name: covid-19; Test Result: Negative
CDC Split Type: ITPFIZER INC202101045738

Write-up: Acute myocardial infarction; Pneumonia interstitial; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority [IT-MINISAL02-769011] A 77-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 08May2021 (Batch/Lot Number: Unknown) (at the age of unknown) as Dose 2, single for COVID-19 immunisation. Medical history included acute interstitial pneumonitis unknown if ongoing. The patient''s concomitant medications were not reported. On 25Jun2021, the patient at hospital arrived for acute myocardial infarction and subsequent documentation (during hospitalization of interstitial-like pneumonia of nature to be determined). PTCA 1 o + 1 Medicated Stent on proximal VAT was effectively performed (chronic occlusive disease of Cx and Cdx with good collateral circulation remains. Echocardiogram FE VSn 30%. During the hospitalization it was not possible to wean the patient from the respirator, which is why he performed CT scan - Chest which documented unexplained interstitial-like pneumonia (involving$g 50% of the lungs) and worsened in the following days (various Molecular swabs x Covid-19: Neg) .. For the progressive worsening Clinical-Radiological on 03Jul2021 the Patient was transferred to Reanimation proceeding to IOT. Despite the various Interventional maneuvers no recovery of the clinical picture and on 10Jul2021 Cardio-respiratory arrest with Declaration of Death.) The patient underwent lab tests and procedures which included angiocardiogram: no information, computerised tomogram thorax: chest which documented unexplained interstitial-li on Chest which documented unexplained interstitial-like pneumonia (involving$g 50% of the lungs) ,coronary angioplasty: no information, echocardiogram abnormal: fe vsn 30% , endotracheal intubation: no information, sars-cov-2 test: negative. The patient died on 10Jul2021. It was unknown if an autopsy was performed. Reporter comment: Patient aged 77 arrives in the Hemodynamics Room for extended Anterolateral STEMI (HUB path). Effectively performed PTCA 1 o + 1 Medicated stent on proximal IVA (chronic occlusive disease of Cx and Cdx remains with good collateral circulation). At Echocardiogram FE VSn 30%. During the hospitalization it was not possible to wean the patient from the respirator, which is why he performed CT scan which documented the picture of unexplained interstitial-like pneumonia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Patient aged 77 arrives in the Hemodynamics Room hospital PRIVACY for extended Anterolateral STEMI (HUB path). Effectively performed PTCA 1 o + 1 Medicated stent on proximal IVA (chronic occlusive disease of Cx and Cdx remains with good collateral circulation). At Echocardiogram FE VSn 30%. During the hospitalization it was not possible to wean the patient from the respirator, which is why he performed CT scan which documented the picture of unexplained interstitial-like pneumonia.; Reported Cause(s) of Death: Pneumonia interstitial; Acute myocardial infarction


VAERS ID: 1589798 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Heart rate increased, Peripheral swelling, Ultrasound scan
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Dehydration (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: CARDIOASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Coronary artery occlusion; Coronary stent placement (2); Hypercholesterolemia
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Name: ultrasound; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101045763

Write-up: weight on the chest; swelling in the left leg; rapid heartbeats; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB [IT-MINISAL02-769339]. An 83-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 29Apr2021 (Lot Number: Unknown) (at the age of unknown) as Dose 1, single for COVID-19 immunisation. Medical history included hypercholesterolemia, arterial hypertension with 60% occluded coronary arteries, 2 coronary stents. Concomitant medication included acetylsalicylic acid (CARDIOASPIRIN). On 02May2021, the patient reported swelling in the left leg, weight on the chest, rapid heartbeats; she did blood tests, ultrasounds. The patient was deceased; she in anamnesis she presented with hypercholesterolemia, arterial hypertension with 60% occluded coronary arteries, 2 coronary stents. She died in the house alone. The daughters had her cremated and did not even consider the autopsy. The patient died on an unspecified date in 2021. An autopsy was not performed. Sender Comment: 04Aug2021 Pharmacovigilance : requests for further information to the reporter such as lot, skin site, vaccination time, detailed clinical report, test reports performed with diagnosis, clinical history, concomitant drugs taken, any allergies. Reporter comment: High blood pressure, coronary occlusion one at 60%, put 2 coronary stents, high cholesterol. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reporter''s Comments: High blood pressure, coronary occlusion one at 60%, put 2 coronary stents, high cholesterol.; Reported Cause(s) of Death: rapid heartbeats; swelling in the left leg; weight on the chest


VAERS ID: 1589871 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Subarachnoid 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: 2021-08-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Subarachnoid haemorrhage
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: Test Result:subarachnoid haemorrhage; Comments: (Aneurysm ruptured of the anterior communicating artery was suspected)
CDC Split Type: JPPFIZER INC202101002614

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21122476. The patient was a 52-year-old female. Body temperature before vaccination was not provided. The family history was not provided. The patient had medical history of subarachnoid haenorrhage in 2012. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not reported). On 02Aug2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Aug2021 at around 17:00 (Estimated time, one day after the vaccination), the patient experienced subarachnoid haemorrhage. On 03Aug2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 03Aug2021, 17:00, the patient was found dead in a prone position in the floor of the living room of her home. Although an autopsy was performed, CT showed subarachnoid haemorrhage (Aneurysm ruptured of the anterior communicating artery was suspected). In 2012, the patient had medical history of subarachnoid haemorrhage. She had no underlying diseases such as hypertension. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The event was unrelated to BNT162b2 vaccination. The police considered that the report was on a voluntary base of the medical institution. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the temporal association and known safety profile ,the fatal event subarachnoid hemorrhage was assessed unrelated to the suspect product BNT162B2 or comirnaty,patient had already relevant medical history of subarachnoid hemorrhage.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1589949 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Blood pressure decreased, Blood pressure measurement, Body temperature, Cardio-respiratory arrest, Cholelithiasis, Coma scale, Coma scale abnormal, Computerised tomogram, Diverticulum intestinal, Dizziness, Dysstasia, Feeding disorder, Fibrin D dimer, Fibrin degradation products, Fibrinolysis increased, Haematochezia, Heart rate, Heart rate decreased, Hyperhidrosis, Intestinal dilatation, Intestinal ischaemia, PCO2, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Vestibular disorders (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: blood pressure; Result Unstructured Data: Test Result:increased to 80s mmHg; Comments: after 23:05; Test Date: 20210803; Test Name: blood pressure; Result Unstructured Data: Test Result:66/41 mmHg; Comments: at 23:05; Test Date: 20210803; Test Name: blood pressure; Result Unstructured Data: Test Result:40 to 50s mmHg; Comments: after 23:05; Test Date: 20210803; Test Name: blood pressure; Result Unstructured Data: Test Result:30s mmHg; Comments: after 23:05; Test Date: 20210803; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Comments: at 10:00; Test Date: 20210803; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: at 23:05; Test Date: 20210803; Test Name: CS; Result Unstructured Data: Test Result:300; Comments: at 23:05; Test Date: 20210803; Test Name: Contrast-enhanced CT; Result Unstructured Data: Test Result:no pulmonary thromboembolism.; Comments: no pulmonary thromboembolism. Significant expansion was observed from the ascending colon to the transverse colon. Thinning of the wall and poor perfused area were observed, and insufficient intestinal blood flow was suspected.; Test Date: 20210803; Test Name: ct; Result Unstructured Data: Test Result:no findings of acute period in the head; Comments: The findings for which aspiration was suspected were poor in the trachea and the lung field. No significant findings were observed except for the gallstones and the colon diverticulum.; Test Date: 20210803; Test Name: fibrin d dimer; Result Unstructured Data: Test Result:81 ug/ml; Comments: after 23:05; Test Date: 20210803; Test Name: FDP; Result Unstructured Data: Test Result:426 ug/ml; Comments: after 23:05; Test Date: 20210803; Test Name: pulse rate; Result Unstructured Data: Test Result:110; Comments: at 23:05; Test Date: 20210804; Test Name: pulse rate; Result Unstructured Data: Test Result:decreased; Comments: at 3:00; Test Date: 20210803; Test Name: PCO2; Result Unstructured Data: Test Result:100s mmHg; Comments: after 23:05
CDC Split Type: JPPFIZER INC202101024001

Write-up: heart rate decreased; a large amount of bloody stool; blood pressure was 66/41 mmHg; Coma Scale (CS) was 300; Cardio-respiratory arrest; vomiting; apnoea; pyrexia of 39 degrees Celsius; large amount of sweating; light-headed feeling; difficulty in standing; Meal intake was poor; gallstones; colon diverticulum; increased fibrinolytic system; Significant expansion was observed from the ascending colon to the transverse colon; insufficient intestinal blood flow was suspected; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122853. A 64-year-old and 6-month-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown), dose 2 via an unspecified route of administration on 02Aug2021 15:00 at the age of 64 years old (Batch/Lot number was not reported) as single dose for covid-19 immunization. Body temperature before vaccination was unknown. The family history was not provided. The patient had medical history of dementia Alzheimer''s type. Concomitant medications were not reported. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date not reported) for COVID-19 immunisation. On 03Aug2021 at 22:20 (one day and 7 hours, 20 minutes after the vaccination), the patient experienced cardio-respiratory arrest. The course of the event was as follows: On 02Aug2021 at 15:00, the patient received the second dose of BNT162b2 vaccination. On 03Aug2021, at 10:00, the patient had pyrexia of 39 degrees Celsius. She had a large amount of sweating. Since the patient had light-headed feeling, she had difficulty in standing. Meal intake was poor. At 20:30, the patient took a meal (jelly and others). At 22:05, no abnormalities were observed. At 22:20, the patient had vomiting and apnoea. At 22:35, the ambulance service arrived. The patient experienced cardio-respiratory arrest. The airway was secured with a laryngeal tube (LT). Although adrenaline a total of 2 mg was administered, the patient had asystole. At 23:02, the patient was transferred to the reporting hospital. Adrenaline 1 mg was administered. At 23:05, the heart rate returned. The blood pressure was 66/41 mmHg, the pulse rate was 110, Coma Scale (CS) was 300, and the body temperature was 36.2 degrees Celsius. The LT was removed, and tracheal intubation was performed. The course was observed with the blood pressure of 40 to 50s mmHg. When noradrenaline was intravenously injected by 0.2 mg, the blood pressure increased to 80s mmHg; however, it decreased in a short time. CT showed no findings of acute period in the head. The findings for which aspiration was suspected were poor in the trachea and the lung field. No significant findings were observed except for the gallstones and the colon diverticulum. A central venous catheter (CV) was placed, and continuous administration of noradrenaline (2 mg/hour) was initiated; however, the blood pressure was 30s mmHg. Although the frequency of breath and the amount of ventilation was increased, the PCO2 was 100s mmHg. The FDP was 426 ug/mL, and the D-dimer was 81 ug/mL, which showed increased fibrinolytic system. Contrast-enhanced CT was additionally performed, which showed no pulmonary thromboembolism. Significant expansion was observed from the ascending colon to the transverse colon. Thinning of the wall and poor perfused area were observed, and insufficient intestinal blood flow was suspected. On 04Aug2021, 02:10 (one day, 11 hours, and 10 minutes after vaccination), the patient had a large amount of bloody stool. At 03:00, the heart rate decreased. At 03:15, the patient had asystole. At 03:45, the patient died. It was not reported if an autopsy was performed. Therapeutic measures were taken as the result of Cardio-respiratory arrest and Blood pressure decreased. On 04Aug2021 (2 days after the vaccination), the outcome of the events was fatal. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were heat illness and intestinal ischaemia. The reporting physician commented as follows: Since the findings which was the cause of the sudden change could not be confirmed, extrinsic death such as heat illness could not be ruled out. Although the pathological condition was considered to occur secondary to intestinal ischaemia, it was judged by the physician that the possibility of secondary change due to prolongation of subsequent shock was suspected. In addition, since the patient had pyrexia and cardio-pulmonary arrest after the vaccination, the causality between the events and the vaccination could not be ruled out. The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardio-respiratory arrest; light-headed feeling; large amount of sweating; difficulty in standing; Meal intake was poor; vomiting; apnoea; blood pressure was 66/41 mmHg; Coma Scale (CS) was 300; gallstones; colon diverticulum; increased fibrin


VAERS ID: 1589953 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Computerised tomogram thorax, Headache, Hypophagia, Malaise, Oxygen saturation, Pneumonia, Pyrexia, Sepsis, Somnolence, X-ray
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 11
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: Escherichia sepsis
Allergies:
Diagnostic Lab Data: Test Date: 20210527; Test Name: blood test; Result Unstructured Data: Test Result:no problem; Test Date: 20210530; Test Name: Chest x-ray; Result Unstructured Data: Test Result:ground glass opacity on both lung fields; Test Date: 20210527; Test Name: CT; Result Unstructured Data: Test Result:no problem; Test Date: 20210530; Test Name: chest CT; Result Unstructured Data: Test Result:bilateral diffuse nodular shadow and ground glass; Comments: opacity; Test Date: 20210530; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased %; Comments: in the middle of the night; Test Date: 20210530; Test Name: oxygen saturation; Test Result: 67 %; Comments: on three liters of oxygen, at 05:30; Test Date: 20210527; Test Name: x-ray; Result Unstructured Data: Test Result:no problem
CDC Split Type: JPPFIZER INC202101026332

Write-up: sepsis; severe pneumonia; impossible to take food and fluid; a tendency of somnolence; intense headache; malaise; pyrexia; This is a spontaneous report from a contactable pharmacist received from the Agency. Regulatory authority report number is v21123167. A 92-year and 2-month-old female patient received first dose of COVID-19 Vaccine (unknown manufacture, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization on 18May2021 at unspecified time. Age at vaccination was 92-year and 2-month-old. Body temperature before vaccination was not reported. The patient family history was not reported. Medical history included sepsis due to Escherichia coli (hospitalized in Oct2020). Points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) were unknown because the patient was hospitalized after vaccination at the another facility. On 19May2021 at unspecified time (one day after the vaccination), the patient experienced headache, malaise and pyrexia. On 29May2021, the patient experienced a tendency of somnolence and impossible to take food and fluid. On 30May2021 (twelve days after the vaccination), the patient experienced severe pneumonia. On 30May2021 (twelve days after the vaccination), the patient was admitted to the hospital. On 30May2021 (twelve days after the vaccination), the patient died. The course of the event was as follows: On 18May2021, the patient received the vaccination. After that, on 19May2021, the patient started to have intense headache, malaise and pyrexia. On 20May2021, the patient visited the hospital of the reporting pharmacist. Antipyretic analgesic was prescribed, and fever declined, but headache remained. On 27May2021, the patient visited another hospital. No problem on the examinations including blood test, x-ray and computerised tomogram (CT). On 29May2021, the patient became impossible to take food and fluid, and had a tendency of somnolence. On 30May2021 in the middle of the night, respiratory discomfort occurred, oxygen saturation decreased and sweating in the large amount. At 05:30, oxygen saturation decreased to 67 % on three liters of oxygen, therefore the patient was urgently transported to the hospital of the reporting pharmacist. Chest x-ray showed ground glass opacity on both lung fields and chest CT showed bilateral diffuse nodular shadow and ground glass opacity. The patient was hospitalized for severe pneumonia. The reporting pharmacist classified the event as serious (hospitalization) and assessed that the causality between the event and COVID-19 Vaccine as unassessable. There was no other possible cause of the event such as any other diseases. The reporting pharmacist commented as follows: the patient was hospitalized for sepsis due to Escherichia coli before (in Oct2020) too. The patient was hospitalized for severe pneumonia and sepsis again this time, but presumably she was already in the state of disseminated intravascular coagulation (DIC) and did not recover. It looked vaccination had involved in that trigger. Outcome of pneumonia was fatal. Outcome of pyrexia was resolved. Outcome of headache was not resolved. Outcome of other events was unknown. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: severe pneumonia


VAERS ID: 1589954 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Aspiration, Body temperature, Gastrooesophageal reflux disease, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Hostility/aggression (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: URSO [URSODEOXYCHOLIC ACID]; NOBELZIN; LANSOPRAZOLE; MYSLEE; HOCHUEKKITO [ANGELICA ACUTILOBA ROOT;ASTRAGALUS SPP. ROOT;ATRACTYLODES LANCEA RHIZOME;BUPLEURUM FALC; RISPERIDONE; TAZOPIPE
Current Illness: Pneumonia aspiration
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction (hospitalized); Dementia (hospitalized); Diabetes mellitus (hospitalized); Hepatic cancer (hospitalized); Hepatitis C (hospitalized); Hospitalisation; Pressure sore (hospitalized); Reflux oesophagitis (hospitalized)
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101026440

Write-up: Asphyxia due to aspiration or gastrooesophageal reflux; Respiratory arrest; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21123522. And the follow-up was received from the same contactable physician via regulatory authority. The patient was a 74-year-old male. Body temperature before vaccination was 36.9 degrees centigrade. The patient had no family history. Medical history included dementia, hepatitis C, hepatic cancer, diabetes mellitus, reflux oesophagitis, cerebral infarction, and pressure sore (the patient was hospitalized in the reporting hospital due to dementia, hepatitis C, hepatic cancer, diabetes mellitus, reflux oesophagitis, cerebral infarction, and pressure sore). Concomitant medications included oral ursodeoxycholic acid (URSO), oral zinc acetate (NOBELZIN), oral lansoprazole, oral zolpidem tartrate (MYSLEE), oral HOCHUEKKITO, oral risperidone as needed, and piperacillin sodium, tazobactam sodium (TAZOPIPE) via a lateral injection tube for possibility of pneumonia aspiration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 06Jul2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number: EY5422, Expiration date 31Aug2021) intramuscular in arm left at 12:00, and experienced right sided complete paralysis due to cerebral infarction on 16Jul2021. On 27Jul2021 at 15:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date: 30Sep2021) intramuscular in arm left as a single dose for COVID-19 immunization (74 years old at vaccination). On 28Jul2021 at 11:50 (20 hours and 20 minutes after the vaccination), the patient experienced respiratory arrest. The patient was determined to have asphyxia due to aspiration (or gastrooesophageal reflux). On 28Jul2021, the patient died. No autopsy was done. The cause of patient death was reported as follows: aspiration or gastrooesophageal reflux (swallowing ability was decreased due to dementia, reflux oesophagitis and cerebral infarction; thus, the patient was prone to aspiration). The patient has not been tested for COVID-19 since the vaccination. The physician classified the events as serious (death, prolonged hospitalization). The course of the event was as follows: The patient was in the reporting hospital due to dementia and reflux oesophagitis. On 06Jul2021, the patient received the first dose of BNT162b2. On 16Jul2021, the patient experienced right sided complete paralysis due to cerebral infarction. Afterwards, the symptom tended to improve. The patient was receiving tazobactam via a lateral injection tube for a possibility of pneumonia aspiration. Originally, the swallowing ability was not sufficient; however, decreased swallowing ability was observed from a few days before and sputum increased. On 27Jul2021 at 15:30, the patient received the second dose of BNT162b2. On 28Jul2021 at 11:50, the patient experienced respiratory arrest. The patient was determined to have asphyxia due to aspiration. The reporting physician classified the event as serious (death) and assessed the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases reported as follows: The swallowing ability decreased due to symptoms such as dementia, reflux oesophagitis, and cerebral infarction; thus, the patient was prone to aspiration. The reporting physician commented as follows: Originally, the swallowing ability was not sufficient; however, decreased swallowing ability was observed from a few days before and sputum increased. The reporting physician considered that the patient experienced asphyxia due to aspiration or gastrooesophageal reflux.; Sender''s Comments: Based on the close temporal relationship, the association between the events asphyxia due to aspiration (or gastroesophageal reflux) and respiratory arrest with COMIRNATY use can not be fully excluded. Advanced age and past medical history of reflux may have been contributory. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : JP-PFIZER INC-202101046489 Same reporter/patient/drug, Different event/dose; Reported Cause(s) of Death: respiratory arrest; Asphyxia due to aspiration or gastrooesophageal reflux; Asphyxia due to aspiration or gastrooesophageal reflux; Asphyxia due to aspiration or gastrooesophageal reflux


VAERS ID: 1589956 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Vaccination site pain
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: 2021-07-23
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Chronic schizophrenia (the patient had been hospitalized for approximately 30 years for chronic schizophrenia.); Hospitalisation (the patient had been hospitalized for approximately 30 years for chronic schizophrenia.); Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101029642

Write-up: Cardio-respiratory arrest; Vaccination site pain; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122885. A 69-year and 3-month-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 19Jul2021 15:00 (Lot Number: EW0207; Expiration Date: 30Sep2021, at the age of 69-year-old) as single dose for covid-19 immunisation. Medical history included chronic schizophrenia, cardiac failure chronic, and renal failure. Since 1989, the patient had been hospitalized for approximately 30 years for chronic schizophrenia. The family history was not provided. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. Body temperature before vaccination was 36.3 degrees centigrade on 19Jul2021. After the vaccination on 19Jul2021, the patient had only vaccination site pain, and no significant changes were observed. On 23Jul2021 at 18:00 (4 days and 3 hours after the vaccination), the patient experienced cardio-respiratory arrest. No changes were observed until the evening. However, after supper, the patient was found to have cardio-respiratory arrest. The outcome of the event cardio-respiratory arrest was fatal, for event vaccination site pain was unknown. The patient died on 23Jul2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were cardiac failure chronic and renal failure.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1589959 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-04
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Body temperature, C-reactive protein increased, Delirium, Disseminated intravascular coagulation, Dyspnoea, Electrocardiogram ambulatory, Embolism, Erythema, Oxygen saturation, Pain in extremity, Platelet count, Purpura, Pyrexia, Thrombocytopenia, Thrombosis
SMQs:, Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 2
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: FEBURIC; LIXIANA; TAKEPRON; MAGMITT
Current Illness: Hyperuricaemia
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation paroxysmal; Transient ischaemic attack
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: creatinine; Result Unstructured Data: Test Result:1.70; Test Date: 20210805; Test Name: creatinine; Result Unstructured Data: Test Result:2.14; Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210805; Test Name: CRP; Result Unstructured Data: Test Result:19.6; Test Date: 202006; Test Name: Holter ECG; Result Unstructured Data: Test Result:no onset of atrial fibrillation; Test Date: 20210805; Test Name: SpO2; Test Result: 98 %; Test Date: 20210728; Test Name: platelet count; Result Unstructured Data: Test Result:19.7; Test Date: 20210805; Test Name: platelet count; Result Unstructured Data: Test Result:10.7
CDC Split Type: JPPFIZER INC202101029915

Write-up: disseminated intravascular coagulation syndrome; Dyspnoea; Several purple areas were observed in the both lower legs (the left lower leg, the posterior surface of both thighs, the right sole) and the chest/purpura; Pyrexia of 39.3 degrees Celsius; Delirium nocturnal; Redness in left lower leg/Redness in buttock; Left lower leg pain; thrombosis; thromboembolism; thrombocytopenia; This is a spontaneous report from a contactable physician received via the Regulatory Authority. Regulatory authority report number is v21122960. The 98-year-old male patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FC9880, Expiration date: 30Sep2021) via intramuscular route of administration on 30Jul2021 at 09:00 in the arm right for COVID-19 immunization at the age of 98 years old. The body temperature before the second vaccination was 36.5 degrees Celsius. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received oral medications febuxostat (FEBURIC), edoxaban tosilate hydrate (LIXIANA), lansoprazole (TAKEPRON), and magnesium oxide (MAGMITT) within 2 weeks of vaccination. The administration of oral edoxaban tosilate hydrate 30 mg was stopped on 28Jul2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medical history included hyperuricaemia (underlying disease), transit ischaemic attack (past medical history), and atrial fibrillation paroxysmal (past medical history). The patient underwent ECG every 1 or 2 months since Apr2020. The Holter ECG showed no onset of atrial fibrillation in Jun2020. On 09Jul2021 at 09:00, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Lot# EW0203, Expiration date 30Sep2021) via intramuscular route of administration in the arm right for COVID-19 immunization at the age of 98 years old. On 30Jul2021 at 09:00 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FC9880, Expiration date: 30Sep2021) via intramuscular route of administration in the arm right for COVID-19 immunization. On 04Aug2021 at 17:00 (5 days and 8 hours after the second dose of the vaccination), the patient experienced the events. On 04Aug2021 in the evening, the patient experienced thrombosis (including thromboembolism, and limited to those with thrombocytopenia). The description of the events were reported as follows: On 04Aug2021 in the evening (5 days after the second dose of the vaccination), the patient experienced left lower leg pain. On 05Aug2021 (6 days after the second dose of the vaccination), although the patient usually visited the reporting hospital on foot without assistance, he visited with a wheelchair. The redness and pain in the left lower leg were noted. At 12:45 (6 days, 3 hours, and 45 minutes after the second dose of the vaccination), the patient was admitted to the reporting hospital. At 19:00 (6 days and 10 hours after the second dose of the vaccination), although the patient had dyspnoea, the SpO2 was 98%. Several purple areas were observed in the both lower legs (the left lower leg, the posterior surface of both thighs, the right sole) and the chest. The patient experienced pyrexia of 39.3 degrees Celsius. The patient experienced delirium nocturnal. The platelet count was 10.7 (it was 19.7 on 28Jul2021), the CRP was 19.6, and the creatinine was 2.14 (it was 1.70 on 28Jul2021). On 06Aug2021, at 06:00 (6 days and 21 hours after the second dose of the vaccination), administration of oxygen 2 L was initiated. At 07:00 (6 days and 22 hours after the second dose of the vaccination), redness in the buttock which was not observed at night was confirmed. At 08:24 (6 days, 23 hours, and 24 minutes after the second dose of the vaccination), the patient died. At the time of death, well-defined purple areas, which were considered purpura, were found on the left lower leg, the posterior surface of both thighs, and the right sole. The imaging examination was not performed, and the blood examination (D-dimer, prothrombin time, fibrinogen) was not performed. The events resulted in doctor''s office/urgent care, hospitalization and death. The number of the hospitalization was reported as 2 days. Hospitalization prolonged was reported as "no". The outcome of the events was fatal with treatment including administration of oxygen 2 L. The reporting physician assessed the event as serious (death, hospitalization). The patient died on 06Aug2021. The cause of death was reported as disseminated intravascular coagulation syndrome. It was unknown if autopsy was performed. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Although the patient was an elderly of 98-year-old, he was doing fine until the evening on 04Aug2021.; Sender''s Comments: The event of Disseminated intravascular coagulation, pain in extremity, erythema, dyspnoea, purpura, pyrexia, delirium, thrombosis, embolism, thrombocytopenia, is assessed as possibly related to the suspect drug "BNT162B2" based on strong temporal association but consider also possible contributory effects from patient''s medical history and/or concomitant medications. 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: Left lower leg pain; Redness in left lower leg/Redness in buttock; Dyspnoea; Several purple areas were observed in the both lower legs (the left lower leg, the posterior surface of both thighs, the right sole) and the chest/purpura; Pyrexia of 39.3 d


VAERS ID: 1589961 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Computerised tomogram, Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210804; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 202108; Test Name: Postmortem computerised tomogram (CT); Result Unstructured Data: Test Result:suspected pulmonary arterial thromboembolism
CDC Split Type: JPPFIZER INC202101030070

Write-up: Thrombosis; suspected pulmonary arterial thromboembolism; This is a spontaneous report from a contactable physician (coroner) received from the regulatory authority. Regulatory authority report number is v21123529. A 73-year-old female patient received 2nd dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FD1945, Expiration date 31Oct2021) on 04Aug2021 at unspecified time via an unspecified route of administration as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees centigrade. The patient had no family history. Medical history included parkinson''s disease. On 08Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were unknown) for COVID-19 immunization. Concomitant drugs were not provided. On 05Aug2021 (one day after the vaccination), the patient experienced thrombosis. On 05Aug2021 at 10:34 (one day after the vaccination), the patient died. The course of the event was as follows: On 05Aug2021 at about 09:30 (one day after the vaccination), a home-visiting nurse visited the patient home and found the patient lost consciousness in the prone position. Medical team was called, and the patient was transported to the local hospital. At 10:34, the patient was confirmed dead. It was reported to the police as unusual death. On 06Aug2021, the reporting physician performed a postmortem inspection by request from the police. Postmortem computerised tomogram (CT) in Aug2021 showed the cause of death was suspected pulmonary arterial thromboembolism. The reporter did not receive the result of blood test from hospital. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was that the patient had the medical history of Parkinson''s disease. The reporting physician commented as follows: The patient died from pulmonary arterial thromboembolism on the next day of vaccination. The reporter thought there were different opinions if blood clot would be formed in a day after the vaccination, but the reporter could not judge, and the patient family desired to report the case to regulatory authority.; Reported Cause(s) of Death: suspected pulmonary arterial thromboembolism; thrombosis; Autopsy-determined Cause(s) of Death: suspected pulmonary arterial thromboembolism


VAERS ID: 1589962 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: Test Date: 20210725; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101030121

Write-up: Death; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122579. A 51-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration on 25Jul2021 11:00 (Lot Number: FC5947; Expiration Date: 30Sep2021) as single dose for covid-19 immunization at the age of 51 years old. The patient medical history and concomitant medications were not reported. Family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient previously received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on an unknown date as single dose for covid-19 immunisation. The patient experienced death on an unspecified date. The course of the event was as follows: On 25Jul2021, the patient did not appear to have any particular abnormalities when he came to the reporting clinic for the second vaccination. The patient was vaccinated as usual. No particular abnormalities were observed at the time of the vaccination. However, the police contacted the reporting physician afterward that the patient had died. The physician did not examine the patient and did not have information. Therefore, the physician could not report on adverse reactions or the death. A separate report from the police would be made; however, the physician submitted the report with the information that the physician could confirm. The reporting physician did not classify the event and did not assess the causality between the event and BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: unknown at the reporting clinic. The patient underwent lab tests and procedures which included Body temperature before vaccination was 36.3 degrees centigrade on 25Jul2021. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: death


VAERS ID: 1589963 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Chest X-ray, Computerised tomogram, Pneumonia, Pulmonary alveolar haemorrhage, Septic shock
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), Toxic-septic shock conditions (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 46
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: Atypical mycobacterial lower respiratory tract infection; Bronchiectasis; Hemodialysis; Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: Blood pressure; Result Unstructured Data: Test Result:suddenly decreased; Test Date: 20210624; Test Name: body temperature; Result Unstructured Data: Test Result:37s Centigrade; Comments: from evening; Test Date: 20210625; Test Name: body temperature; Result Unstructured Data: Test Result:38s Centigrade; Test Date: 20210626; Test Name: Chest X-ray; Result Unstructured Data: Test Result:showed Pulmonary alveolar hemorrhage; Test Date: 20210626; Test Name: CT; Result Unstructured Data: Test Result:showed Pulmonary alveolar hemorrhage
CDC Split Type: JPPFIZER INC202101030759

Write-up: Septic shock due to pneumonia; Septic shock due to pneumonia; Pulmonary alveolar hemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122863. A 71-year and 1-month-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration 24Jun2021, at patient age of 71-year-old, as a single dose for COVID-19 immunization. Relevant medical history included Bronchiectasis, pulmonary non-tuberculous mycobacterial infection, and renal failure chronic (hemodialysis).There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The family history was not provided. Concomitant medications were not reported. Body temperature before vaccination was not provided. On 24Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2. On 24Jun2021 (the day of the vaccination), the patient experienced pulmonary alveolar hemorrhage. On 26Jun2021 (2 days after the vaccination), the patient was admitted to the hospital. On 09Aug2021 (One month/16 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 24Jun2021 (the day of vaccination), at night, the patient had pyrexia of 37s degrees Celsius. On 25Jun2021 (one day after vaccination), the patient had pyrexia of 38s degrees Celsius, bloody sputum, and dyspnea. On 26Jun2021 (2 days after vaccination), after the patient received hemodialysis at another hospital, she was emergently transferred to the reporting hospital. The patient was diagnosed with pulmonary alveolar hemorrhage on the chest X-ray and CT. The intubation was performed for respiratory failure. Artificial respiration was initiated. On 08Jul2021 (14 days after vaccination), the extubation was performed, and the patient was being treated for the primary disease. On 09Aug2021 (one month and 16 days after vaccination), the patient had sudden blood pressure decreased. Septic shock due to pneumonia was considerable. Although the patient was managed with an artificial ventilator again, oxygenation could not be maintained. On the same day, the patient was confirmed to die. It was not reported if autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were Bronchiectasis, pulmonary non-tuberculous mycobacterial infection, and renal failure chronic (hemodialysis). The reporting physician commented as follows: Although the patient experienced pulmonary alveolar hemorrhage after the vaccination, it improved with treatment. It was considered that the patient died due to septic shock caused by pneumonia during the treatment of the primary disease. Thus, the causality between the event and the vaccination was considered unlikely.; Reported Cause(s) of Death: septic shock; pneumonia; Pulmonary alveolar hemorrhage


VAERS ID: 1589964 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dialysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101030762

Write-up: Death; This is a spontaneous case from a non-contactable physician received via a Pfizer colleague. An 8-decade-old patient of an unspecified gender received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: unknown, Expiration date: unknown) in Jul2021 at single dose for COVID-19 immunisation. The patient was receiving dialysis and was orally taking a tranquilizer. The patient''s concomitant medications were not reported. On unknown date in Jul2021 (the day of vaccination), the patient received the first dose of BNT162B2. On unknown date in Aug2021 (unknown days/hours/minutes after the vaccination), the patient experienced death. On unknown date in Aug2021 (unknown days after the vaccination), the outcome of the event was fatal. The patient died in Aug2021. It was not reported if autopsy was performed. The course of the event was as follows: Approximately 2 weeks ago, the patient received the first dose of BNT162B2 vaccination. Approximately 10 days later, the patient died. The patient lived alone. The cause of death and the situation were unknown. The causality between the event and BNT162B2 was unknown. The outcome of the event was fatal. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: The information available in this report is limited, and does not allow a medically meaningful assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. The case will be re-assessed when relevant information, particularly the cause of death, 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: Death


VAERS ID: 1589965 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-06-29
   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: Medical History/Concurrent Conditions: Cerebral infarction; Internal carotid artery stenosis (left)
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101030767

Write-up: cerebral haemorrhage; This is a spontaneous report from a contactable physician (inoculator) received from the regulatory authority. Regulatory authority report number is v21122942. The patient was an 89-year-old male. Age at vaccination was 89-year-old. Body temperature before vaccination was 37.0 degrees centigrade. The patient had no family history. Medical history included cerebral infarction and left internal carotid artery stenosis. On 28Jun2021 at 16:37 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 29Jun2021 in the morning (one day after the vaccination), the patient experienced cerebral haemorrhage. On 29Jun2021 (one day after the vaccination), the patient died. The course of the event was as follows: The reporting clinic was the primary care clinic for the patient, and the patient came to the clinic to get vaccinated while he was in hospital for an orthopedic disorder. The patient returned to hospital soon after the vaccination. The following matter was told by the patient family when the family contacted to the reporter: There was no specific change on the day of vaccination. The next morning, since the patient was unawakened, various examinations were performed and the patient was diagnosed with cerebral haemorrhage. The death was confirmed. The attending physician explained to the patient family that the association could not be identified. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. It was reported that there was/were other possible cause(s) of the event such as any other diseases, but details were not reported. The reporting physician did not provide any further comment. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cerebral haemorrhage


VAERS ID: 1589966 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101030790

Write-up: Death; This is a spontaneous report from a contactable physician received from a Pfizer colleague. Information regarding the patient was not obtained. Body temperature before vaccination, family history, medical history, and concomitant medication were not reported. On an unknown date (the day of vaccination), the patient received the single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: not reported, Expiration date: not reported) via an intramuscular route for COVID-19 immunization. On an unknown date (after the vaccination), the patient experienced death. The outcome of the event death was fatal. The course of the event was as follows: Around Jun2021 (approximately 3 days after the vaccination), the police told the reporting physician by phone that the patient died. It was not provided if autopsy was performed. The reporting physician did not classify the event and did not assess the causal relationship between the event and BNT162b2. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event death and the suspect drug cannot be assessed as related. The case will be reassessed once new information is available; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1589968 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure, Dehydration, Myocardial infarction
SMQs:, Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   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: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination normal
CDC Split Type: JPPFIZER INC202101031862

Write-up: This is a spontaneous report from a contactable other health professional received from the Regulatory Authority. Regulatory authority report number is v21122933. A 78-year and 6-month-old female patient received 1st dose of BNT162B2 (COMIRNATY, Lot number: FD1945, Expiration date: 31Oct2021) at single dose via an unknown route on 26Jul2021 11:00 at 78-year-old for COVID-19 immunisation. Body temperature before vaccination was 36.5 degrees centigrade. Family history and concomitant medication were not reported. Medical history included diabetes mellitus. On 01Aug2021 or 02Aug2021 (6 or 7 days after the vaccination), the patient experienced cardiac failure. On 02Aug2021 (7 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 26Jul2021, at the time of the medical interview, the reporter was concerned that the patient had a very quiet voice; however, the reporter confirmed with the patient that she had no abnormalities. The body temperature was also normal; thus, the reporter decided that the patient would be vaccinated. On the morning of Monday, 02Aug2021, Police Station contacted the reporter by phone that the patient had died at home, and the police asked about the date of vaccination and the patient''s condition on the day of vaccination. On Saturday, 07Aug2021, the patient''s daughter told the reporter by phone that the cause of death was cardiac failure. The vaccinating physician determined that the patient had cardiac failure due to other factors such as dehydration because the hot days continued from the day of vaccination to 02Aug2021 of the death. Just in case, this case was reported because of the death within one week after the vaccination. The reporting other health professional classified the event as serious (death) and assessed the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was suspected cardiac failure due to myocardial infarction. The reporting other health professional commented as follows: The vaccinating physician requested an investigation because the patient''s family was concerned about the causal relationship between the event and the vaccination.; Sender''s Comments: Based on the temporal relationship, the association between the fatal events cardiac failure, myocardial infaction, and dehydration with COMIRNATY use can not be fully excluded. Advanced age and risk factor such as a medical history of diabetes mellitus may have been contributory as well. 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: Cardiac failure; suspected cardiac failure due to myocardial infarction; dehydration


VAERS ID: 1589970 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9873 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood creatinine, Blood sodium, Body mass index, C-reactive protein, Computerised tomogram, Diarrhoea, Hepatic function abnormal, Pyrexia, Sepsis, Vasculitis, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vasculitis (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   Days after onset: 8
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: Anxiety neurosis; Depression; Emaciation (BMI 14, 14.8); Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: Cr; Test Result: 2.5 mg/dl; Comments: at the time of hospitalization, advanced prerenal failure; Test Date: 20210807; Test Name: Blood sodium; Result Unstructured Data: Test Result:114 mmol/L; Comments: at the time of hospitalization, hyponatraemia; Test Name: BMI; Result Unstructured Data: Test Result:14; Test Name: BMI; Result Unstructured Data: Test Result:14.8; Test Date: 20210807; Test Name: CT; Result Unstructured Data: Test Result:advanced intestinal oedema and ascites; Comments: at the time of hospitalization; Test Date: 20210807; Test Name: CT; Result Unstructured Data: Test Result:showed advanced intestinal oedema and ascites.; Test Date: 20210807; Test Name: CRP; Test Result: 26 mg/dl; Comments: at the time of hospitalization, high; Test Date: 20210807; Test Name: white blood cell; Result Unstructured Data: Test Result:30000s /mm3; Comments: at the time of hospitalization, significant increase
CDC Split Type: JPPFIZER INC202101032265

Write-up: vasculitis; hepatic function disorder; sepsis; Acute renal failure; intense diarrhoea; pyrexia; This is a spontaneous report from a contactable attending physician received from the regulatory authority. Regulatory authority report number is v21122904. A 55-year and 11-month-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 02Aug2021 10:00 (vaccination at age of 55 years old) (Lot Number: FC9873; Expiration Date: 30sep2021) as dose 2, single for covid-19 immunisation. Medical history included emaciation (BMI 14, 14.8), depression, anxiety neurosis, hypothyroidism. On an unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FC8736, Expiration date 30Sep2021) for COVID-19 immunisation and experienced pyrexia. The patient''s concomitant medications were not reported. The patient experienced vasculitis, hepatic function disorder on 02Aug2021 21:00, and pyrexia on 02Aug2021 with outcome of unknown, intense diarrhoea on 05Aug2021 with outcome of unknown, sepsis and acute renal failure on an unspecified date. The patient was hospitalized for vasculitis and hepatic function disorder from 07Aug2021 to an unknown date, hospitalized for sepsis and Acute renal failure from 07Aug2021 to 10Aug2021. The patient died of Vasculitis, Hepatic function abnormal, sepsis and acute renal failure. The clinical course reported as below: On 02Aug2021 at 21:00 (eleven hours after the vaccination), the patient experienced vasculitis and hepatic function disorder. On 07Aug2021 (five days after the vaccination), the patient was admitted to the reporter hospital. On 10Aug2021 (eight days after the vaccination), the outcome of the event was fatal. The patient experienced pyrexia and diarrhoea after the first dose of vaccination, and improved. In the night of the day of the second vaccination, pyrexia similar to the first dose occurred. On the third day(05Aug2021), intense diarrhoea occurred. On the fifth day(07Aug2021), the patient was transported by ambulance due to worsened general condition and was admitted to hospital. At the time of hospitalization, significant increase of white blood cell (30000s /uL) and high blood C-reactive protein (CRP) (26 mg/dL), advanced prerenal failure (creatinine (Cr) at 2.5 mg/dL), hyponatraemia (114 mmol/L) and computerised tomogram (CT) showed advanced intestinal oedema and ascites. The patient was hospitalized for sepsis and acute renal failure. Although the patient was treated with antibacterial drugs and fluid infusion, exacerbation did not stop, and the patient died on the fourth day(10Aug2021) of hospitalization. The reporting physician classified the event as serious (hospitalization) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was considered as the vaccine-induced serious adverse reactions because similar symptoms to the first vaccination occurred again at the second vaccination. Underlying condition of emaciation (BMI 14.8) and the administration of psychiatric drugs for panic disorder affected in some way, plus, there was a possibility that the patient had conditions that have not been diagnosed. However, in any case, the events would not occur if the patient did not receive the vaccination.; Reported Cause(s) of Death: vasculitis; hepatic function disorder; sepsis; acute renal failure


VAERS ID: 1589971 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREDONINE [PREDNISOLONE]; MICOMBI COMBINATION; CARBAZOCHROME SULFONATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Pulmonary fibrosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101035424

Write-up: acute ischaemic myocardial infarction; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An 85-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 28Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included hypertension, pulmonary fibrosis. Concomitant medications included prednisolone (PREDONINE); hydrochlorothiazide, telmisartan ; CARBAZOCHROME SULFONATe; all ongoing. On 04Jun2021, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 28Jun2021 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY). On an unknown date, the patient experienced acute ischaemic myocardial infarction due to coronary infarction. The patient lived alone, and she was not in contact, and thus, the situation was confirmed. On 18Jul2021 (20 days after vaccination), the patient was found to collapse at her home, and she was confirmed to die. Postmortem examination by the police was performed at her nearby hospital. It was not reported if an autopsy was performed (as reported). It was judged that the patient died due to ischaemic heart disease. Although the causality between the event and the vaccination was unknown, since the patient died after the vaccination, the family reported to the physician. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the plausible temporal relation, the association between the event of Acute myocardial infarction and the suspect product of BNT162B2 cannot be completely ruled out. The confounding factors for the event are medical history of hypertension and pulmonary fibrosis and elderly age of the patient. 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: acute ischaemic myocardial infarction; Ischaemic heart disease


VAERS ID: 1589972 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary artery thrombosis
SMQs:, Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101035641

Write-up: Deep vein thrombosis leg right; left and right pulmonary trunk thrombosis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123005. A 61-year and 3-month-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FD0889, Expiration date 30Sep2021), via an unspecified route of administration, on 05Aug2021 (at the age of 61-year and 3-month-old), at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. Body temperature before vaccination was not provided. Family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient previously took first dose of BNT162B2 (COMIRNATY, Lot# EY5422, Expiration date 31Aug2021), via an unspecified route of administration, on 15Jul2021 (at the age of 61-year-old), at single dose, for COVID-19 immunization. On 06Aug2021 (one day after the vaccination), the patient experienced deep vein thrombosis leg right, and left and right pulmonary trunk thrombosis. The course of the event was as follows: On 15Jul2021, the patient received the first dose of BNT162b2 vaccination. On 05Aug2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 06Aug2021 (one day after vaccination), the patient had slight physical deconditioning and dyspnea on exertion. On 10Aug2021 (5 days after vaccination), the patient left home to visit a clinic by bicycle. On the way, the patient collapsed, and he was emergently transferred and was treated; however, he did not regain consciousness. Patient died on 10Aug2021. As proceedings of Act for Investigations, an autopsy was performed (on 11Aug2021). The causes of death were deep vein thrombosis leg right, and left and right pulmonary trunk thrombosis. The reporting physician classified the event as serious (death). The causality between the event and BNT162b2 was not provided. It was not reported whether there was any other possible cause of the event such as any other diseases. The reporting physician commented as follows: Thrombosis due to vaccination was strongly suspected. On 10Aug2021 (5 days after the vaccination), the outcome of the events was fatal.; Reported Cause(s) of Death: deep vein thrombosis leg right; left and right pulmonary trunk thrombosis


VAERS ID: 1589973 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Computerised tomogram, Death, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: CT; Result Unstructured Data: Test Result:the cause of death could not be determined; Comments: after died
CDC Split Type: JPPFIZER INC202101035658

Write-up: the cause of death could not be determined; cardio-respiratory arrest; pyrexia for two days; This is a spontaneous report from a contactable attending physician received from the regulatory authority. Regulatory authority report number is v21123540. A 34-years-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on 02Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 06Aug2021 at 06:50 (four days after the vaccination), the patient died. The course of the event was as follows: After the vaccination, the patient had the symptoms including pyrexia from 02Aug2021 for two days. On the third day, it improved. On the fourth day, the patient was found in the state of cardio-respiratory arrest and transported by ambulance to the reporter hospital. Autopsy was done and results was available. The patient did not react to resuscitation and was confirmed dead. The police performed postmortem examination and computerised tomogram (CT), but the cause of death could not be determined. The reporting physician classified the event as serious (death) and assessed that the causality between the event and COVID-19 Vaccine as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician did not provide any further comment. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: the cause of death could not be determined; Autopsy-determined Cause(s) of Death: the cause of death could not be determined


VAERS ID: 1589974 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ammonia, Body temperature, Computerised tomogram head, Hepatic encephalopathy
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Noninfectious encephalopathy/delirium (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 14
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: Hepatic cancer (underlying disease); Hepatic cirrhosis; Psoriasis
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: Ammonia; Result Unstructured Data: Test Result:90s; Comments: high; Test Date: 20210711; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210712; Test Name: Head CT; Result Unstructured Data: Test Result:no abnormality
CDC Split Type: JPPFIZER INC202101035714

Write-up: Hepatic encephalopathy; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21123020. A 71-year-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EW0201, Expiration date: 30Sep2021) via an intramuscular route on 11Jul2021 at 16:00 (the day of vaccination) (71-year-old at vaccination), as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.2 degrees centigrade. Family history and concomitant medication were not reported. Medical history included hepatic cancer (underlying disease), hepatic cirrhosis, and psoriasis. On 12Jul2021 at 04:00 (12 hours after the vaccination), the patient experienced hepatic encephalopathy. On 12Jul2021 (1 day after the vaccination), the patient was admitted to the hospital. On 26Jul2021 (15 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was regularly visiting the reporting hospital for hepatic cirrhosis and hepatic cancer (he had also psoriasis). On 11Jul2021, the patient received the vaccine. Afterwards, the patient drove a car and had no abnormalities. However, on 12Jul2021 at 04:00, the patient did something strange, such as sprinkling faeces and urine. On the same day at 08:00, the patient was taken to the hospital by ambulance. On admission, a detailed examination was performed; a head CT showed no abnormalities, and the ammonia level was high at 90s. On the same day, the patient was hospitalized and was treated for the hepatic encephalopathy. Although the encephalopathy was temporarily resolving, the general condition gradually deteriorated. On 26Jul2021 at 03:55, the patient died. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (hospitalization) and assessed the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were hepatic cirrhosis and hepatic cancer aggravated. The reporting physician commented as follows: The causes of death were considered to be hepatic cirrhosis and hepatic cancer; however, it could not be ruled out that the vaccine would trigger the occurrence of encephalopathy.; Reported Cause(s) of Death: hepatic cirrhosis; hepatic cancer; Hepatic encephalopathy


VAERS ID: 1589977 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Antineutrophil cytoplasmic antibody, Body temperature, C-reactive protein, Glycosylated haemoglobin, Imaging procedure, Large intestine perforation, Neutrophil count, PO2, White blood cell count
SMQs:, Interstitial lung disease (broad), Gastrointestinal perforation (narrow), Guillain-Barre syndrome (broad), Ischaemic colitis (narrow), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (regularly went to hospital and received treatment); Cardiac failure chronic (regularly went to hospital and received treatment); Prostatic hyperplasia
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: serum; Result Unstructured Data: Test Result:4.5 IU/ml; Comments: positive with low value, on hospitalization; Test Date: 20210528; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210605; Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade; Comments: before hospitalization; Test Date: 20210605; Test Name: CRP; Test Result: 6.20 mg/dl; Test Date: 20210605; Test Name: HbA1c; Test Result: 6.9 %; Test Date: 202102; Test Name: Chest image; Result Unstructured Data: Test Result:slightly showed infiltrative shadow and reticular; Comments: slightly showed infiltrative shadow and reticular shadow of bilateral pulmonary lower lobe periphery; Test Date: 20210605; Test Name: Chest image; Result Unstructured Data: Test Result:Chest image showed post-resection of left upper le; Comments: Chest image showed post-resection of left upper lob, decreased volume of bilateral lungs due to enlarged non-segmental infiltrative shadow and ground-glass opacity. Left atrial enlargement and a small amount of left pleural effusion were observed.; Test Date: 20210609; Test Name: Chest image; Result Unstructured Data: Test Result:abnormal shadow; Test Date: 20210620; Test Name: Image; Result Unstructured Data: Test Result:perforation of sigmoid colon; Test Date: 20210605; Test Name: Neut; Test Result: 90.5 %; Test Date: 20210605; Test Name: PaO2; Result Unstructured Data: Test Result:92 mmHg; Comments: (unit: torr)on O2 with 6 l/min., hypoxaemia; Test Date: 20210605; Test Name: WBC; Result Unstructured Data: Test Result:12920 /mm3; Comments: (unit /ul)
CDC Split Type: JPPFIZER INC202101036732

Write-up: acute respiratory distress syndrome; lower abdominal pain started to exaggerate/perforation of sigmoid colon; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21123031. The patient was a 77-year-old male. Body temperature before vaccination was 36.4 degrees centigrade. The patient had no specific family history. Medical history included cardiac disease (the patient regularly went to hospital and received the treatment for atrial fibrillation and chronic cardiac failure) and prostatic hyperplasia. The patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration on 28May2021 at 10:23 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. On 04Jun2021 (seven days after the vaccination), the patient was admitted to the reporter hospital. On 05Jun2021 at 12:13 (eight days after the vaccination), the patient experienced acute respiratory distress syndrome. On 25Jun2021 (twenty-eight days after the vaccination), the patient died and was discharged from hospital. The outcome of event Perforation colon was unknown. The patient died on 25Jun2021 due to acute respiratory distress syndrome. It was unknown if an autopsy was performed. The course of the event was as follows: In the morning of 04Jun2021, rapid chills, shivering and pyrexia occurred. On 05Jun2021, chills, dizziness and visual hallucination presented, and due to pyrexia at 40 degrees in Celsius, an ambulance was called. The patient was admitted to the reporter hospital. White blood cell (WBC) at 12920/ul (mm3), neutrophil (Neut) at 90.5 %, C-reactive protein (CRP) at 6.20 mg/dL, hemoglobin A1c (HbA1c) at 6.9 %, partial pressure of oxygen (PaO2) at 92 torr (mmHg) on oxygen (O2) at six liters per minute, and was hypoxaemia. Chest image showed post-resection of left upper lobe, decreased volume of bilateral lungs due to enlarged non-segmental infiltrative shadow and ground-glass opacity. Left atrial enlargement and small amount of left pleural effusion were observed. The patient was in the state of acute respiratory distress syndrome and received steroid pulse therapy. The patient became afebrile, but hypoxaemia exacerbated and on 07Jun2021, endotracheal intubation and respiratory management began. On 09Jun2021, the patient was on O2 at three liters per minute and weaned off the respiratory management. However, abnormal shadow on chest image waxed and waned and hypoxaemia prolonged. On 19Jun2021, lower abdominal pain started to exaggerate. Image on 20Jun2021 showed perforation of sigmoid colon. The patient was treated with antibacterial drugs. On 24Jun2021, chills and shivering became unstable and lung lesion exacerbated. On 25Jun2021, the patient died. The reporting physician classified the event as serious (hospitalization, death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient was an old age male who had been aware of aspiration to some degree. Image in Feb2021 slightly showed infiltrative shadow and reticular shadow of bilateral pulmonary lower lobe periphery. On hospitalization in Jun2021, serum myeloperoxidase-anti-neutrophil cytoplasmic antibody was positive with low value of 4.5 (less than 3.5) IU/mL. The patient got acute respiratory distress syndrome seven days after the first dose of vaccination, had twenty-one days of hospitalization course and died. Other elements to cause acute respiratory distress syndrome were not identified. Inoculation of Comirnaty and exacerbation of lung lesion had an anteroposterior relation and it was necessary to consider as the adverse events.; Reported Cause(s) of Death: acute respiratory distress syndrome


VAERS ID: 1589978 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-12
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Depressed level of consciousness, Dysphagia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gallbladder cancer (had been pointed out for some years); Senile dementia (SDAT4/B2(4:care required all the time, B2:bedridden,capable to ride a wheel chair with nursing care))
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101037032

Write-up: depressed level of consciousness; Appetite completely lost; swallowing reflex also lost; This is a spontaneous report from a contactable physician received from the regulatory autority. Regulatory authority report number is v21123065. A 97-year and 1-month-old female patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 04Jun2021 13:00 (Lot Number: EY2173; Expiration Date: 31Aug2021, at the age of 97-year and 1-month-old) as single dose for covid-19 immunisation. Medical history included senile dementia of Alzheimer type (SDAT) 4/B2 (4: care required all the time, B2: bedridden, capable to ride a wheel chair with nursing care), gallbladder cancer (had been pointed out for some years). The patient''s concomitant medications were not reported. On 12Jun2021 at 17:10 (eight days after the vaccination), the patient experienced depressed level of consciousness, appetite completely lost and swallowing reflex also lost. The course of the event was as follows: Gallbladder cancer had been pointed out for some years, but there were no symptoms at all. On 12Jun2021, depressed level of consciousness. Appetite completely lost. Swallowing reflex also lost. The reporter (physician) convinced the patient family and performed (illegible) drip infusion, but no effect. Medications of magnesium oxide (MAGMITT) 2 tablets and alfacalcidol 1 tablet had been informed to administrate. On 19Jun2021 (fifteen days after the vaccination), the outcome of the events was fatal. The patient died on 19Jun2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. The reporter assumed that there was no other possible cause of the event such as any other diseases. The reporting physician did not provide any further comment.; Reported Cause(s) of Death: swallowing reflex also lost; Depressed level of consciousness; Appetite completely lost


VAERS ID: 1589980 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Arthralgia, Body temperature, Brain natriuretic peptide, Brain natriuretic peptide increased, C-reactive protein, C-reactive protein increased, Decreased appetite, Dyspnoea exertional, Ejection fraction, Glycosylated haemoglobin, Glycosylated haemoglobin increased, Hypoxia, Imaging procedure, Oxygen saturation, PaO2/FiO2 ratio, Pneumonia, Respiratory failure, Sputum purulent, White blood cell count, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 19
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: LIXIANA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4; Comments: 1st dose, before vaccination; Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3; Comments: 2nd dose, before vaccination; Test Date: 20210714; Test Name: BNP; Result Unstructured Data: Test Result:309.8 pg/mL; Test Date: 20210714; Test Name: CRP; Test Result: 25.61 mg/dl; Test Name: LVEF; Test Result: 20 %; Comments: Cardiac failure chronic; Test Date: 20210714; Test Name: HbA1c; Test Result: 6.6 %; Test Date: 20210714; Test Name: Chest images; Result Unstructured Data: Test Result:ground glass and infiltrative shadows; Comments: extensive non-segmented ground glass and infiltrative shadows in the bilateral lungs with a background of strong emphysematous changes and a strong tendency for contraction and collapse in the subpleural alveolar region; Test Date: 20210714; Test Name: SpO2; Test Result: 84 %; Comments: Hypoxaemia; Test Date: 202107; Test Name: SpO2; Result Unstructured Data: Test Result:less than 90 %; Comments: measured at home; Test Date: 20210714; Test Name: paO2/fiO2; Result Unstructured Data: Test Result:about 90; Comments: Acute respiratory distress syndrome; Test Date: 202107; Test Name: paO2/fiO2; Result Unstructured Data: Test Result:150; Test Date: 20210714; Test Name: WBC; Result Unstructured Data: Test Result:11660 /mm3
CDC Split Type: JPPFIZER INC202101037172

Write-up: This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21123032. The patient was an 81-year-old male. Body temperature before vaccination was 36.3 degrees centigrade on 05Jul2021, 36.4 degrees centigrade on 14Jun2021. Family history: no special notes. Medical history included heart disease (cardiac failure chronic with left ventricular ejection fraction (LVEF) of 20%). Concomitant medication included edoxaban tosilate (LIXIANA). On 14Jun2021 at 15:46, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number: EY5420, Expiration date: 31Aug2021) for COVID-19 immunization. On 05Jul2021 at 14:55 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FA5829, Expiration date: 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 14Jul2021 at 11:05 (8 days, 20 hours and 10 minutes after the vaccination), the patient experienced acute respiratory distress syndrome with paO2/fiO2 of about 90. On 14Jul2021 (9 days after the vaccination), the patient was admitted to the hospital. On 25Jul2021 (20 days after the vaccination), the outcome of this event was fatal. The course of the event was as follows: On 06Jul2021, shoulder pain and loss of appetite occurred, and dyspnoea on exertion gradually aggravated. On 14Jul2021, the patient was admitted to the reporting hospital from the emergency department of the hospital. The patient had hypoxaemia with SpO2 in room air of 84%. The patient had previously had cardiac failure chronic with LFEF of 20%. WBC was 11660/uL, CRP was 25.61 mg/dL, BNP was 309.8 pg/mL, and HbA1c was 6.6%. Chest images showed extensive non-segmented ground glass and infiltrative shadows in the bilateral lungs with a background of strong emphysematous changes and a strong tendency for contraction and collapse in the subpleural alveolar region. The patient had acute respiratory distress syndrome with paO2/fiO2 of about 90, and treatment was started with endotracheal intubation, respiratory management, and high-dose corticosteroid. Although the acute inflammatory findings improved, paO2/fiO2 did not improve from 150 in Jul2021. On the evening of 23Jul2021, sputum purulent sharply increased, and ventilator associated pneumonia occurred. The patient was treated with antibiotics; however, he did not respond to them. On 25Jul2021, the patient died. It was unknown if autopsy was done. The reporting physician classified the event as serious (hospitalization) and assessed the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient was a late-stage elderly man, who apparently had never had aspiration. Immediately after the second vaccination, the patient experienced loss of appetite, and SpO2 measured at home was less than 90% in Jul2021. The patient was poorly responsive to medical treatment, high-dose corticosteroid, and experienced respiratory failure death on 25Jul2021 due to combined ventilator associated pneumonia while a respiratory management was being continued. In this clinical course, other factors contributing to acute respiratory distress syndrome were not identified. There was a temporal relationship between the vaccination and the symptoms, and it was necessary to consider them as adverse events. The outcome of events Acute respiratory distress syndrome, Ventilator associated pneumonia, Respiratory failure death were fatal, outcome of other events were unknown.; Reported Cause(s) of Death: Respiratory failure death; Acute respiratory distress syndrome with paO2/fiO2 of about 90; Ventilator associated pneumonia


VAERS ID: 1589981 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Aspiration, Blood creatinine, Body temperature, Brain natriuretic peptide, C-reactive protein, Imaging procedure, Neutrophil count, Oxygen saturation, PO2, White blood cell count
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Creatinine (CRTN); Test Result: 1.80 mg/dl; Test Date: 20210630; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before the first COVID-19 vaccination; Test Date: 20210721; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before the second COVID-19 vaccination; Test Date: 20210802; Test Name: body temperature; Result Unstructured Data: Test Result:38.9 Centigrade; Test Date: 20210801; Test Name: BNP; Result Unstructured Data: Test Result:541.2 pg/mL; Test Date: 20210801; Test Name: CRP; Test Result: 2.44 mg/dl; Test Date: 20210801; Test Name: Chest images; Result Unstructured Data: Test Result:extensive abnormal shadows; Test Date: 20210801; Test Name: Neut; Test Result: 86.6 %; Test Date: 20210801; Test Name: SpO2; Test Result: 70 %; Comments: aggravated hypoxaemia; Test Date: 20210801; Test Name: paO2; Result Unstructured Data: Test Result:58; Comments: torr; with oxygen given at 10 L per minute; Test Date: 20210801; Test Name: WBC; Result Unstructured Data: Test Result:1410 /mm3
CDC Split Type: JPPFIZER INC202101037854

Write-up: aspiration; Acute respiratory distress syndrome; This is a spontaneous report from a contactable physician. This is the 1st of 2 reports, for the second dose. The first report is received from the regulatory authority. Regulatory authority report number is v21123030. An 89-year-old male patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration at age of 89 years old on 21Jul2021 (Lot Number: FC8736; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included cardiac disease. Body temperature was 36.6 degrees Centigrade before the first vaccination on 30Jun2021 and was 36.6 degrees before the second vaccination on 21Jul2021. The patient had no family history. Concomitant medication included oral rivaroxaban (XARELTO). On 30Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number FA7338, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The patient developed pyelonephritis within 1 month of the first COVID-19 vaccination. The patient experienced acute respiratory distress syndrome on 01Aug2021 20:51, aspiration on an unspecified date. The patient was hospitalized for events acute respiratory distress syndrome and aspiration from 01Aug2021 to 03Aug2021. Therapeutic measures were taken. The patient died on 03Aug2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: On 26Jul2021 (5 days after the vaccination), (masking). On 01Aug2021 at noon (11 days after the vaccination), the patient presented with nausea, chest tightness and pyrexia of more than 37 degrees Centigrade (38.9 Centigrade on 02Aug2021), for which antimicrobial agent was administered via intravenous drip infusion. At approximately 17:00, the patient began to have increased dyspnoea, and aggravated hypoxaemia at 70% of oxygen saturation (SpO2). The patient was transported to emergency department of the reporting physician''s hospital and hospitalized there. Laboratory data included that on 01AUG2021: white blood cell count (WBC) was 1410/uL, neutrophils (Neut) 86.6%, C-reactive protein (CRP) 2.44 mg/dL, Creatinine (CRTN) 1.80 mg/dL, brain natriuretic peptide (BNP) 541.2 pg/mL, and partial pressure of arterial oxygen (paO2) 58 torr with oxygen given at 10 L per minute; that represented acute respiratory distress syndrome. Chest images showed extensive abnormal shadows. On 02Aug2021 (12 days after the vaccination), the patient was transferred to the respiratory medicine. He received methylprednisolone (mPSL) at 500 mg for steroid pulse therapy. Five hours later, the patient had chills, shivering and pyrexia of 38.9 degrees Centigrade. Without improvement, the patient died on 03Aug2021 (13 days after the vaccination). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101042398 same source and patient, different drug(1st dose) and event; Reported Cause(s) of Death: Acute respiratory distress syndrome; aspiration


VAERS ID: 1589982 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   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: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Initial rhythm showed asystole
CDC Split Type: JPPFIZER INC202101039136

Write-up: cardio-respiratory arrest; the left shoulder felt heavy; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21123064. A 57-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot#: FC3661, Expiration Date: 30Sep2021) at single dose on 06Jul2021 at the age of 57-year-old for COVID-19 immunization. Body temperature before vaccination was unknown. Medical history included hypertension. The patient had mother and younger brother. Concomitant medication was not reported. On 07Jul2021 (1 day of after the vaccination), sensation of heaviness of the shoulder appeared. On 08Jul2021 (2 days of after the vaccination), the patient developed cardio-respiratory arrest and died on 08Jul2021. The course of the events was as follows: On 07Jul2021, the patient complained that the left shoulder felt heavy and he wanted to apply a compress. On 08Jul2021 at 12:40, the patient''s mother confirmed that the patient returned home from outside. It was confirmed for the last time that he was fine. At 14:20, the mother found that the patient collapsed in a room and called an ambulance. At 14:53, the patient was transferred to the reporter''s hospital by an ambulance. Initial rhythm showed asystole on electrocardiogram. Adrenaline 8 ampules in total was administered. For 40 minutes, resuscitation was performed. However, spontaneous circulation was not returned. At 03:43, the patient''s death was confirmed. It was not reported if an autopsy was performed. The outcome of event cardio-respiratory arrest was fatal. The outcome of rest event was unknown. The reporting physician assessed the causality between the event and BNT162b2 as unassessable. The seriousness assessment for the event was unknown. The reporting physician commented as follows: The patient was transferred to a hospital in a state of cardio-respiratory arrest, so the causal relationship with BNT162b2 was unknown.; Reported Cause(s) of Death: cardio-respiratory arrest


VAERS ID: 1589983 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-06-10
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Decreased appetite, Dysphagia, General physical health deterioration
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MAGMITT; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer surgery; Cerebral infarction; Senility (IV/C1); Uterine cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: Body temperature; Result Unstructured Data: Test Result:35.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101039144

Write-up: appetite impaired; loss of swallowing reflex; Reduced general condition; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21123067. The patient was a 94-year and 9-month-old female (age at vaccination was 94-year and 9-month old). Body temperature before vaccination was 35.5 degrees centigrade on 11May2021. Family history was not reported. Medical history included cerebral infarction, operation for uterine cancer, and geriatric syndrome (IV/C1). Concomitant medication included oral magnesium oxide (MAGMITT) and oral warfarin 1 mg, taken for unspecified indications, started in May2020 and were ongoing. On 20Apr2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported) for COVID-19 immunization. On 11May2021 at 13:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ER7449, Expiration date 30Jun2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 10Jun2021 at around 11:00 (29 days 22 hours after the vaccination), the patient experienced appetite impaired and loss of swallowing reflex. On 09Jul2021 (59 days after the vaccination), the patient died. It was unknown if an autopsy was done. The course of the event was as follows: On 10Jun2021, the patient developed appetite impaired and loss of swallowing reflex. Terminal care and forced feeding were refused from the beginning, and the patient died of reduced general condition. Since May2020, the patient has been hospitalized and medications administered included MAGMITT (illegible) and WARFARIN 1 mg (illegible). The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was presumably no other possible cause of the event such as any other diseases. The outcome of the events appetite impaired and loss of swallowing reflex was unknown. ; Reported Cause(s) of Death: Reduced general condition


VAERS ID: 1589984 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-08
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Chest X-ray, Depressed level of consciousness, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aphagia; Gavage (gastric tube); Senile dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Test Name: chest x-ray; Result Unstructured Data: Test Result:no problem
CDC Split Type: JPPFIZER INC202101039169

Write-up: Depressed level of consciousness; cardiac arrest; pyrexia at 38.3 degrees; This is a spontaneous report from a contactable physician received from the RA. Regulatory authority report number is v21123068. The patient was a 95-year and 5-month-old female. Age at vaccination was 95-year and 5-month-old. Body temperature before vaccination was 36.5 degrees centigrade on 02Jul2021. The patient family history was not reported. Medical history included senile dementia, senile syndrome, gavage by gastric tube, aphagia, 4/C2. On 10Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not reported) for COVID-19 immunization. On 02Jul2021 at 13:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 08Jul2021 at 06:00 (six days after the vaccination), the patient experienced pyrexia. On 12Jul2021 (ten days after the vaccination), the outcome of the event was fatal. It was unknown if an autopsy was performed. The course of the event was as follows: On 08Jul2021, pyrexia at 38.3 degrees in celsius occurred. Penicillin was administered but no effect. Depressed level of consciousness. The patient got cardiac arrest. No problem on chest x-ray. Medication being taken was only magnesium oxide (MAGMITT) 2 tablets per day. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. The reporter assumed that there was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Although the patient was fed by gastric tube due to aphagia, she could communicate on admission in Jun2021.; Reported Cause(s) of Death: Depressed level of consciousness; cardiac arrest; pyrexia


VAERS ID: 1589985 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-12
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Depressed level of consciousness, Feeding disorder, Lethargy
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic 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: 2021-06-19
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Senile dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202101039184

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123066. The patient was a 90-year and 11-month-old female. Body temperature before vaccination was 35.6 degrees centigrade on 04Jun2021. Family history and concomitant medication were not reported. Medical history included senile dementia (SDAT) (IV/C1). On 04Jun2021 at 13:00 (the day of vaccination), the patient aged 90 received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EY2173, Expiration date: 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jun2021 at an unknown time (12 days after the vaccination), the patient experienced unable to ingest orally. On 19Jun2021 (15 days after the vaccination), the outcome of the event was fatal. It was unknown if an autopsy was performed. The course of the event was as follows: On 12Jun2021 around 08:30, the patient experienced depressed level of consciousness and had an absent response to meal assistance. No pyrexia was noted. The patient progressed to a lethargic state. Oral intake continued to wax and wane. On 16Jun2021, eventually, the patient was unable to ingest orally. Forced nutrition was rejected. On 19Jun2021, the patient died. During the clinical course, only Pico sulfate was administered. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. The reporting physician assumed that there was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Unable to ingest orally; Depressed level of consciousness; Lethargic state.


VAERS ID: 1589986 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis coronary artery, Cardiac arrest, Cerebral arteriosclerosis, Emphysema, Fall, Pneumothorax, Traumatic haemothorax
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   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 INC202101042069

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123184. An 85-year-old male patient received 1st single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT number: EY3860, expiration date: 31Aug2021) via an unspecified route of administration on 30Jun2021 at age of 85-year-old for COVID-19 immunisation. Medical history and concomitant medications were not reported. Body temperature before vaccination and family history were unknown. It was unknown whether there were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 06Jul2021 at an unknown time (6 days after the vaccination), the patient experienced pneumothorax resulting from emphysema. On 06Jul2021 at 10:27 (6 days after the vaccination), the outcome of the event was fatal. Autopsy was performed, and the cause of death was determined as haemopneumothorax due to rupture of emphysematous bulla. It was reported that the event pneumothorax resulting from emphysema required emergency room visit. The course of the event was as follows: On 30Jun2021 (the day of vaccination), the patient received a vaccination against the new coronavirus. On 06Jul2021 after breakfast (6 days after the vaccination), the patient was said to have suddenly fallen down while waiting at home for the daycare staff to pick him up. He was transported to the hospital but developed cardiac arrest. Resuscitation was unsuccessful, and he was confirmed dead. Unknown cause of death led to administrative autopsy done on 07Jul2021. Haemopneumothorax due to rupture of emphysematous bulla was diagnosed as the cause of death. Other findings included coronary arteriosclerosis and basilar arteriosclerosis (advanced). The reporting physician classified the event pneumothorax resulting from emphysema as serious (death) and assessed the causality between the event pneumothorax resulting from emphysema and BNT162b2 as unassessable. Other possible causes of the event pneumothorax resulting from emphysema such as any other diseases included coronary arteriosclerosis. The reporting physician commented as follows: Details about the causal relationship with rupture of bulla were unknown. Outcome of Pneumothorax resulting from emphysema/ Haemopneumothorax due to rupture of emphysematous bulla was fatal, of cardiac arrest was not recovered, of the other events was unknown.; Reported Cause(s) of Death: Haemopneumothorax due to rupture of emphysematous bulla; Haemopneumothorax due to rupture of emphysematous bulla; Autopsy-determined Cause(s) of Death: Haemopneumothorax due to rupture of emphysematous bulla; Haemopneumothorax due to rupture of emphysematous bulla; coronary arteriosclerosis; basilar arteriosclerosis (advanced)


VAERS ID: 1589988 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101056638

Write-up: Ventricular tachycardia; ventricular arrhythmia; cardio-respiratory arrest; This is a spontaneous report from a contactable nurse received via Medical information group. A 60-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF0843; Expiration Date: 31Oct2021), via an unspecified route of administration on 11Aug2021 (the day of vaccination), as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 15Aug2021 at 01:25 (4 days after the vaccination), the patient experienced ventricular tachycardia. The course of the event was as follows: On 11Aug2021, the patient received the vaccine. Subsequently, the patient had no marked adverse reaction. On 15Aug2021 at 01:25, the patient suddenly experienced ventricular tachycardia, which is a ventricular arrhythmia, resulting in cardio-respiratory arrest. One hour later at 02:35, death was confirmed. The cause of death was due to ventricular tachycardia, ventricular arrhythmia and cardio-respiratory arrest On 15Aug2021 (4 days after the vaccination) the events was fatal. The reporting nurse assessed that the causality between the event and BNT162b2 as unassessable. The reporting nurse commented as follows: According to the primary physician, it was not clear whether the event was caused by the vaccine. Complication involving cardiac muscle due to the vaccine could not be denied and causality was unknown. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on temporal relationship there is reasonable possibility of causal association between the reported events Ventricular tachycardia, Ventricular arrhythmia and Cardio-Respiratory arrest and the suspect drug BNT162B2. 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: ventricular arrhythmia; cardio-respiratory arrest; Ventricular tachycardia


VAERS ID: 1590098 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Brain herniation, Cerebral haemorrhage, Chills, Meningitis, Physical deconditioning, Restlessness, Thrombocytopenic purpura, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP072379

Write-up: Meningitis (decerebrate rigidity); Thrombosis with thrombocytopenia; Brain herniation; Cerebral hemorrhage; Thrombocytopenic purpura; Restlessness; Physical deconditioning; Chills; This case was received via Regulatory Authority (Reference number: 2021TJP072379) on 11-Aug-2021 and was forwarded to Moderna on 15-Aug-2021. This case, initially reported to the Regulatory Authority by a (physician), was received via the RA (Ref, v21122858). On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: Unknown. On 03-Aug-2021, the patient received the 2nd dose of this vaccine. On 04-Aug-2021, in the morning, the patient had physical deconditioning and rested at home. At 18:00, chills developed. At 20:00, the patient had restlessness and was taken to a hospital by ambulance. On arrival, JCS/100, BT: 38.3 degrees Celsius, and SPO2: 97% (10 L of O2 mask). Decerebrate rigidity was noted, and meningitis was suspected. Cerebrospinal fluid test showed no increase in cell count. Thereafter, bleeding tendency became significant. Platelets decreased. thrombosis with thrombocytopenia (TTS) after the vaccination was suspected. It was considered to be thrombocytopenic purpura. Steroid pulse IVIG and plasma exchange were performed, but no improvement was noted. Brain herniation due to cerebral hemorrhage was suspected. On 09-Aug-2021, the patient died. The outcome of physical deconditioning, chills, restlessness, meningitis (decerebrate rigidity), thrombosis with thrombocytopenia, thrombocytopenic purpura, brain herniation, and cerebral hemorrhage was reported as fatal. 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 causal relationship with the vaccine is questionable.; Sender''s Comments: Very limited information regarding these events has been provided at this time. Additional information required.; Reported Cause(s) of Death: Physical deconditioning; Chills; Unrest; Meningitis; Thrombosis; Thrombocytopenic purpura; Brain herniation; Cerebral hemorrhage


VAERS ID: 1590108 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRMODERNATX, INC.MOD20212

Write-up: breathing difficulty; thrombosis; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing difficulty) and THROMBOSIS (thrombosis) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced THROMBOSIS (thrombosis) (seriousness criteria death, hospitalization and medically significant). On 31-Jul-2021, the patient experienced DYSPNOEA (breathing difficulty) (seriousness criteria death and hospitalization). The patient was hospitalized on 31-Jul-2021 due to DYSPNOEA and THROMBOSIS. The patient died on 07-Aug-2021. The reported cause of death was breathing difficulty and Thrombosis. It is unknown if an autopsy was performed. Concomitant products were not provided. Treatment medication were not reported. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: breathing difficulty; thrombosis


VAERS ID: 1590349 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101038822

Write-up: Not feeling well; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00658355. An 86-years-old male patient received bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration, on 06Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no Previous COVID-19 infection. Past drug therapy was unknown. On 08Feb2021 the patient was not feeling well following administration of covid-19 vaccine Pfizer. Onset latency: 2 days after start of vaccine. The patient was died on 13Feb2021. The cause of death was unknown. It was unknown if an autopsy was performed. Reporter''s comments: BioNTech/Pfizer vaccine (Comirnaty); Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): unknown, available: yes; Previous COVID-19 infection: No The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1590585 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 231C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, COVID-19, Cough, Decreased appetite, Malaise, Pyrexia, SARS-CoV-2 antibody test
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), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: SARS-CoV-2 rapid antibody test; Result Unstructured Data: positive
CDC Split Type: PHJNJFOC20210824925

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-300097137] concerned a 67-year-old male 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: 231C21A and expiry: unknown) dose was not reported,1 total administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUL-2021, the patient already had fever. On 23-JUL-2021, the patient had cough and loss of taste. On 24-JUL-2021 (same day of vaccination), the patient had loss of appetite, and body malaise. On 01-AUG-2021, the patient tested covid-19 positive (SARS-CoV-2 rapid antibody test positive). On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of covid-19 positive, cough, loss of taste, loss of appetite, body malaise and fever on an unspecified date. This report was serious (Death); Sender''s Comments: V0: 20210824925-COVID-19 VACCINE AD26.COV2.S-COVID-19 positive, loss of appetite, body 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). V0: 20210824925-COVID-19 VACCINE AD26.COV2.S-fever, cough, loss of taste. This event(s) is considered not related. The event(s) shows an incompatible temporal relationship.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1590609 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Coronary artery thrombosis, Electrocardiogram
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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: Medical History/Concurrent Conditions: Paroxysmal atrial fibrillation; Prostate cancer; Prostatectomy; Radiotherapy
Allergies:
Diagnostic Lab Data: Test Name: Coronary angiography; Result Unstructured Data: Test Result:revealed occlusions/ distal embolization in the di; Comments: revealed occlusions/ distal embolization in the distal part of the left anterior descending coronary artery, in the first diagonal branch, and in the distal part of the dominant right coronary artery, with large thrombus; Test Name: Coronary angiography; Result Unstructured Data: Test Result:What is noteworthy, full patency of the left anter; Comments: What is noteworthy, full patency of the left anterior descending coronary artery and first diagonal branch, and no signs of previous thrombus were observed in the control left coronary artery angiogram; Test Name: electrocardiogram; Result Unstructured Data: Test Result:acute ST-segment elevation myocardial infarction o; Comments: acute ST-segment elevation myocardial infarction of the inferior wall was diagnosed
CDC Split Type: PLPFIZER INC202101042391

Write-up: This is a literature report from JACC: Cardiovascular Interventions, 2021, vol 14 (9); pgs e103-e104 (DOI: 10.1016/j.jcin.2021.03.003) entitled Acute Coronary Tree Thrombosis After Vaccination for COVID-19. The author would like to present a clinical case of a serious adverse event, possibly linked to 1 of the vaccines for COVID-19. An 86-year-old man with a history of prostate cancer treated with prostatectomy and radiotherapy in 2006 and, until recently, with androgen receptor inhibitor (enzalutamide), had paroxysmal atrial fibrillation (treated with apixaban 2.5 mg twice a day), without any previous allergies to drugs or vaccines, was qualified to receive vaccination for COVID-19. On January 27, 2021, the patient received the first dose of Pfizer-BioNTech vaccine. Approximately 30 min after the injection, the patient collapsed. Based on electrocardiogram findings, acute ST-segment elevation myocardial infarction of the inferior wall was diagnosed (Figure 1A, Electrocardiogram (ECG) on admission) and was referred to the author''s center. On admission, the patient was unconscious, with clinical and hemodynamic signs of cardiogenic shock and recurrent bradyarrhythmias. Coronary angiography revealed occlusions/ distal embolization in the distal part of the left anterior descending coronary artery, in the first diagonal branch, and in the distal part of the dominant right coronary artery, with large thrombus (Figures 1B, initial left coronary artery angiography with occlusion of the left anterior descending artery and the first diagonal branch (arrows) and 1C, initial right coronary artery angiography with large thrombus (arrow)). The primary percutaneous coronary intervention of the right coronary artery with manual aspiration thrombectomy was performed, along with coronary balloon angioplasty and glycoprotein IIb/IIIa receptor inhibitor (eptifibatide) administration, resulting in coronary flow improvement (Figure 1D, right coronary artery after percutaneous coronary intervention). What is noteworthy, full patency of the left anterior descending coronary artery and first diagonal branch, and no signs of previous thrombus were observed in the control left coronary artery angiogram (Figure 1E, control angiography of the left coronary artery). This could be related to the very short time between the thromboembolic event and the treatment. Unfortunately, on January 30, 2021, the patient died. Although it is not possible to ascertain a causal relationship between vaccination and cardiac events, it is important to remember that that the mechanisms of thrombotic events in COVID-19 are still poorly understood. Moreover, the Kounis syndrome-as an adverse event after vaccination-may also be a possible explanation for the presented clinical situation. Therefore, the presented case of triple coronary artery thrombosis in a patient recently vaccinated against COVID-19 may provide a causative link between those facts. The study was approved by an appropriate Institutional Review Board. Information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the available information, pathogenesis of disease and known product profile, the causal relationship between the reported Coronary artery thrombosis and the use of BNT162B2 is unlikely. The abrupt presentation of the triple coronary artery thrombosis after vaccination does not seem to be biologically plausible and may likely be due to some underlying condition which developed over time. 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: triple coronary artery thrombosis


VAERS ID: 1590615 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dysarthria, Dyspnoea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202101038816

Write-up: ICD-10 I46 Cardiac arrest; R96 Other sudden death, cause unknown; Dyspnoea / shortness of breath; slurred speech; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [PL-URPL-3-854-2021]. A 72-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via intramuscular on the left arm on 30Jun2021 at 11:54 (Lot Number: FD8274; Expiration Date: 30Oct2021) at the age of 72-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 02Jul2021 at 3:50 am, the ambulance doctor pronounced death. Cause of death I46 cardiac arrest, R96 other sudden death due to unknown cause. Call to the patient for shortness of breath and slurred speech. Dyspnoea, slurred speech, and cardiac arrest on the second post-vaccination day are unexpected side effects of the Comirnaty vaccine. An anaphylactic reaction cannot be ruled out, but it is unlikely to occur on the second day after vaccination (anaphylaxis usually occurs several to several minutes after vaccination). Due to the insufficient amount of information (including the unknown cause of death), a cause-and-effect relationship has not been assessed. Privacy was reported as death occurred less than 48 hours after vaccination. There was a time relationship between the administration of the vaccine and the onset of symptoms (which was the reason for the reporting of the event). The reporting person classified them as severe. URPL also classified the application as heavy. The outcome of events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: ICD-10 R96 Other sudden death, cause unknown; ICD-10 I46 Cardiac arrest


VAERS ID: 1590617 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-06-01
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Angiogram, Arteriosclerosis, Arteriosclerosis coronary artery, Cardiac arrest, Coronary artery stenosis, Dyspnoea, Electrocardiogram, Left ventricular failure, Pulmonary oedema, Renal failure
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMOKSIKLAV 2S; NOVOMIX; EUTHYROX N; NEDAL; TORVACARD; GLUCOPHAGE FORTE; POLAPRIL; INDAPEN SR; STEPCIL
Current Illness: Arterial hypertension; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis; Hypothyroidism; Obesity; Surgery (state after thyroid surgery due to lump (goiter)); Surgery (resection of the lump of the left vocal fold); Thrombosis
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: Angiography; Result Unstructured Data: critical coronary vessel narrowing; LAD: severe calcifications; LAD: disseminated critical atherosclerotic lesions; Test Date: 20210602; Test Name: ECG; Result Unstructured Data: recent myocardial infarction
CDC Split Type: PLMODERNATX, INC.MOD20212

Write-up: Approximately 1 month after the 2nd dose of the vaccine - oppressive breathlessness; 22/06/2021 - exacerbation of shortness of breath, she could not breathe; LAD: severe calcifications; sudden cardiac arrest in the mechanism of asystole; LAD: disseminated critical atherosclerotic lesions; sudden cardiac arrest in the mechanism of asystole; critical coronary vasoconstriction; Pulmonary oedema; left ventricular damage; Kidney failure; Acute respiratory failure; This case was received via Regulatory Authority. This regulatory authority case was reported by a consumer and describes the occurrence of RENAL FAILURE (Kidney failure), ACUTE RESPIRATORY FAILURE (Acute respiratory failure), ARTERIOSCLEROSIS (LAD: severe calcifications), the first episode of CARDIAC ARREST (sudden cardiac arrest in the mechanism of asystole), LEFT VENTRICULAR FAILURE (left ventricular damage), ARTERIOSCLEROSIS CORONARY ARTERY (LAD: disseminated critical atherosclerotic lesions), PULMONARY OEDEMA (Pulmonary oedema), the second episode of CARDIAC ARREST (sudden cardiac arrest in the mechanism of asystole), CORONARY ARTERY STENOSIS (critical coronary vasoconstriction) and DYSPNOEA (Approximately 1 month after the 2nd dose of the vaccine - oppressive breathlessness; 22/06/2021 - exacerbation of shortness of breath, she could not breathe) in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Thrombosis, Hypothyroidism, Arteriosclerosis, Obesity, Surgery (resection of the lump of the left vocal fold) in 2012 and Surgery (state after thyroid surgery due to lump (goiter)) in 1992. Concurrent medical conditions included Arterial hypertension and Type II diabetes mellitus. Concomitant products included RAMIPRIL (POLAPRIL) for Arterial hypertension, AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOKSIKLAV 2S) from 02-Jun-2021 to 08-Jun-2021 for Dyspnea, CILOSTAZOL (STEPCIL) for Thrombosis, INSULIN ASPART, INSULIN ASPART PROTAMINE (CRYSTALLINE) (NOVOMIX) and METFORMIN HYDROCHLORIDE (GLUCOPHAGE FORTE) for Type II diabetes mellitus, LEVOTHYROXINE SODIUM (EUTHYROX N), NEBIVOLOL HYDROCHLORIDE (NEDAL), ATORVASTATIN CALCIUM (TORVACARD) and INDAPAMIDE (INDAPEN SR) for an unknown indication. On 16-Apr-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. In June 2021, the patient experienced RENAL FAILURE (Kidney failure) (seriousness criteria death, hospitalization and medically significant), ACUTE RESPIRATORY FAILURE (Acute respiratory failure) (seriousness criteria death, hospitalization and medically significant), LEFT VENTRICULAR FAILURE (left ventricular damage) (seriousness criteria death, hospitalization and medically significant) and PULMONARY OEDEMA (Pulmonary oedema) (seriousness criteria death, hospitalization and medically significant). On 23-Jun-2021, after starting mRNA-1273 (Spikevax), the patient experienced ARTERIOSCLEROSIS (LAD: severe calcifications) (seriousness criteria death and hospitalization), the first episode of CARDIAC ARREST (sudden cardiac arrest in the mechanism of asystole) (seriousness criteria death, hospitalization and medically significant), ARTERIOSCLEROSIS CORONARY ARTERY (LAD: disseminated critical atherosclerotic lesions) (seriousness criteria death and hospitalization), the second episode of CARDIAC ARREST (sudden cardiac arrest in the mechanism of asystole) (seriousness criteria death, hospitalization and medically significant) and CORONARY ARTERY STENOSIS (critical coronary vasoconstriction) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Approximately 1 month after the 2nd dose of the vaccine - oppressive breathlessness; 22/06/2021 - exacerbation of shortness of breath, she could not breathe) (seriousness criteria death and hospitalization). The patient died on 23-Jun-2021. The reported cause of death was sudden cardiac arrest in the mechanism of asystole. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, Electrocardiogram: abnormal (abnormal) recent myocardial infarction. On 23-Jun-2021, Angiogram: abnormal (abnormal) critical coronary vessel narrowing; LAD: severe calcifications; LAD: disseminated critical atherosclerotic lesions. Treatment medication was not provided by the reporter Company Comment: This is a case of death of a 72-year-old female patient after receiving unknown dose of vaccine on 16-APR-2021 (Lot number 3001442). Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected. 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: This is a case of death of a 72-year-old female patient after receiving unknown dose of vaccine on 16-APR-2021 (Lot number 3001442). Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected. 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: sudden cardiac arrest in the mechanism of asystole


VAERS ID: 1590618 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-09
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ROSUVASTATIN; TELMISARTAN - TABLET
Current Illness: Allergy to venom (allergy to bee venom (swelling)); Benign spinal cord neoplasm NOS (benign tumor in the spinal cord (neck region)); Cholesterol high; Chronic obstructive pulmonary disease (in the past treated for chronic obstructive pulmonary disease); Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Neurologist consultation
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLJNJFOC20210826949

Write-up: THE PATIENT DIED. SUDDEN CARDIAC ARREST OCCURRED; R.96. SUDDEN UNEXPLAINED DEATH; BRUISE AT THE VACCINATION SITE (DIAMETER 4 CM); This spontaneous report received from a consumer via a Regulatory Authority [PL-URPL-DML-MLP.4401.2.513.2021] concerned a 66 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included: neurologist consultation, and concurrent conditions included: chronic obstructive pulmonary disease (in the past treated for chronic obstructive pulmonary disease), benign spinal cord neoplasm NOS (not otherwise specified) [benign tumor in the spinal cord (neck region)], allergy to venom [allergy to bee venom (swelling)], cholesterol high, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD986 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-JUN-2021 for prophylactic vaccination. Concomitant medications included Zahron (rosuvastatin) for cholesterol high, and Telmisartan for hypertension. On 09-JUN-2021, the patient experienced bruise at the vaccination site (diameter 4 cm). On 14-JUL-2021, the patient experienced sudden cardiac arrest and died on the same day. The cause of death was unknown at the time of report. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of sudden cardiac arrest on 14-JUL-2021, and the outcome of bruise at the vaccination site (diameter 4 cm) was not reported. This report was serious (Death).; Sender''s Comments: V0; 20210764579-covid-19 vaccine ad26.cov2.- Sudden cardiac arrest, Death. This events are considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: MEDICAL HISTORY; Reported Cause(s) of Death: CARDIAC ARREST; SUDDEN DEATH, CAUSE UNKNOWN


VAERS ID: 1591060 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Bacteraemia, Endocarditis, Heart rate, Respiratory rate, SARS-CoV-2 test, Urosepsis
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

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? Yes
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hypothyroidism; Incontinence
Allergies:
Diagnostic Lab Data: Test Name: heart rate; Result Unstructured Data: Test Result:Rapid; Test Name: breathing pattern; Result Unstructured Data: Test Result:rapid; Test Date: 20210120; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210128; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210205; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210210; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: CAPFIZER INC202101022572

Write-up: Diagnosed with urosepsis; bacteremia; infective endocarditis.; This is a spontaneous report from a contactable consumer (reported as "patient") and other health care professional. This 89- year-old female patient (not pregnant at time of Vaccination) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 15Jan2021 11:00 via an unknown route in left arm at 89- year-old for Covid-19 immunization. Medical history included hypothyroid, dementia, and incontinence. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant drug was not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, but received other medications the patient within 2 weeks of vaccination. Past drug history included known allergies with codeine. Patient experienced onset of vomiting on 20Jan2021, then low-grade fever, rapid heart rate, rapid breathing pattern, steady decline in health, eventually leading to hospitalization on 05Feb2021 for duration of 13 days. Patient was diagnosed with urosepsis, bacteremia and eventually infective endocarditis. Treatment received included IV treatment and cardiac care. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No hospitalization prolonged applied. The event onset date was 20Jan2021. Lab data included Nasal Swab on 20Jan2021, 28Jan2021, 05Feb2021, 10Feb2021: all negative. Patient died on 17Feb2021. Outcome of the events was fatal.; Sender''s Comments: The events of Urosepsis, bacteremia and Endocarditis are assessed as possibly related to the suspect drugBNT162B2 based on temporal association, but consider also possible contributory effects from patient''s medical history and/or concomitant medications 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: urosepsis; bacteremia; infective endocarditis


VAERS ID: 1591118 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-24
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Endocarditis
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? Yes
Died? Yes
   Date died: 2021-05-24
   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: Acute fatty liver; Enlargement heart (590 g); Extravasation blood (Hemorrhage under the dura mater right half of the cranial cavity, left temporal muscle, ...); Uterine myoma (Malignant neoplasm of uterine muscle (fibroid))
Preexisting Conditions: Medical History/Concurrent Conditions: Brain swelling (1260 g; with occipital pressure cone); Heart valve replacement; Ligament disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101038605

Write-up: This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number CZ-CZSUKL-21009282. A 47-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: EY3014) intramuscular on 08May2021 at single dose for COVID-19 immunisation. Medical history - autopsy report included biological heart valve replacement (stopped), condition after surgical replacement of the crescent valve of the heart and part of the thoracic heart: ongoing extravasation blood (Hemorrhage under the dura mater in the right half of the cranial cavity (48 g), hemorrhage in the left temporal muscle, hemorrhages in the soft skulls (in the left parietal region and in the parietal occipital region in the midline) and subcutaneous hemorrhages on the trunk, upper and lower limbs), ongoing uterine myoma (Malignant neoplasm of uterine muscle (fibroid)), ongoing enlargement heart (Swelling and dilation of the heart (590 g)), swelling of the brain (1260 g) with occipital pressure cone stopped, ongoing acute fatty liver, and ligamentous adhesions of the left lung with the pleura. There were no concomitant medications. The patient experienced acute infectious inflammation biological replacement of the crescent valve (death, disability, medically significant, life threatening, congenital anomaly) on 24May2021. The outcome of the event was fatal. The patient died on 24May2021. An autopsy was performed that revealed acute inflammation of the biological replacement of the crescent-shaped heart valve. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute infectious inflammation Biological replacement of the crescent valve; Autopsy-determined Cause(s) of Death: acute inflammation of the biological replacement of the crescent-shaped heart valve


VAERS ID: 1592209 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-10
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Cardiogenic shock, Echocardiogram, Fibrin D dimer, Hyperkalaemia, Interchange of vaccine products, Off label use, Pneumonia, Pulmonary embolism, Right ventricular failure, Septic shock, Troponin T
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210810; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:Right heart failure; Test Date: 20210809; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:7.59 ug/ml; Test Date: 20210810; Test Name: Troponin T; Result Unstructured Data: Test Result:0.073
CDC Split Type: DEPFIZER INC202101054540

Write-up: This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-PEI-202100163909. A male patient of an unspecified age received bnt162b2 (COMIRNATY) (strength: 0.3 ml), dose 2 via an unspecified route of administration on 28Jul2021 (Batch/Lot number was not reported) as dose 2, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. First vaccination was administered with covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA) on 04Mar2021 (batch unknown). On 10Aug2021 the patient experienced lung embolism. Fibrin D Dimer 7.59 ?g/ml 09Aug2021; Troponin T 0.073 10Aug2021. Transthoracic echocardiography: Right heart failure 10Aug2021. Respiratory failure - pneumonia; Sepsis - septic shock; Cardiogenic shock; Hyperkalemia; Acute kidney failure; Lung embolism. Therapeutic measures included anticoagulation, high dose catecholamines, alteplase (ACTILYSE). Differential diagnosis excluded: pneumothorax, hypoxia, myocardial infarction. The outcome was fatal for lung embolism. The outcome of other event was unknown. This event lung embolism is serious due to death, hospitalization, life threatening. The patient died on 10Aug2021. It was not reported if an autopsy was performed. The PEI assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1592220 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products, Off label use, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Medication errors (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101056168

Write-up: Lung embolism; First vaccination was administered with Vaxzevria/ second dose of Comirnaty; First vaccination was administered with Vaxzevria/ second dose of Comirnaty; This is a spontaneous report from an other healthcare professional downloaded from the Regulatory Authority-WEB DE-PEI-202100164946. A 83-years-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration at the age of 83-years-old on 28Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (VAXZEVRIA) at the age of 82-years-old on 04Mar2021(Batch/Lot number was not reported) as single dose for covid-19 immunisation. On 10Aug2021, the patient experienced lung embolism. This report was serious - death, hospitalization, life threatening. The outcome of the event lung embolism was fatal. The patient died 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. No further information is expected.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1592223 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 1 - / -

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

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: Alcohol abuse; Nicotine abuse; Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy (10 years ago); Infarct myocardial (10 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101061861

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, Safety Report Unique Identifier DE-PEI-202100165267. A 56-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Aug2021 (Lot Number: FE9174) as dose 1, single for COVID-19 immunization. Medical history included ongoing nicotine abuse from an unknown date, apoplexy from 2011 (reported as 10 years ago) to an unknown date (not ongoing), ongoing obesity from an unknown date, ongoing alcohol abuse from an unknown date, infarct myocardial on an unknown date in 2011 (reported as 10 years ago) to an unknown date (not ongoing). The patient''s concomitant medications were not reported. On 07Aug2021, 2 days after vaccination, the patient had an unknown cause of death. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1592409 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-08
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F030A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
   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:
Current Illness: Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101056006

Write-up: This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021159793, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100163364. An 89-year-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 29Jul2021 (Lot Number: 1F030A) as dose 2, single for covid-19 immunisation. Medical history included ongoing dementia. There was no allergies. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on 08Aug2021. The patient died on 08Aug2021. An autopsy was not performed. Sender''s comments: Are you or the person affected aware of any allergies? If yes, which ones? no Information on risk factors or previous illnesses Dementia, but otherwise fit in case of vaccination / death. Result of Assessment: Comirnaty/ event(s): Unknown cause of death/ PEI: D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 1592410 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease; Blood pressure high
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101056011

Write-up: pneumonia; Pyrexia; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021159893, Safety Report Unique Identifier DE-PEI-202100163459. This is first of two reports. A 78-years-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing Alzheimer''s disease; ongoing high blood pressure. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization and 3 days after the first dose development of high fever, generalised muscle cramps as well as severe pneumonia with strong drop in oxygen saturation - after 14 days slow improvement of health condition. The patient experienced relapse/new pneumonia, hospitalisation with medication plus oxygen administration; pyrexia. The outcome of the event pneumonia was fatal, of the event pyrexia was not recovered. The patient died on 20Apr2021. 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) : DE-PFIZER INC-202101067461 same patient, different dose; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1592431 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Myocardial infarction
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101048486

Write-up: This is a spontaneous report from a contactable physician via COVAES. A 39-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunization. Historical vaccine included BNT162B2 (COMIRNATY) dose 1, single for COVID-19 immunization. The patient had no medical history. The patient''s concomitant medications were not reported. The patient experienced myocardial infarction 5 days after second dose (death, hospitalization) on 11Aug2021 01:30. The patient was hospitalized for 1 day due to myocardial infarction, 5 days after second dose. The patient received treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or used any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient died on 11Aug2021 due to myocardial infarction and cardiogenic shock. An autopsy was performed, and results were not provided. Information on the lot/batch number has been requested.; Sender''s Comments: based on the available information the fatal events and the suspected vaccine cannot be completely ruled out; Reported Cause(s) of Death: Myocardial infarction; Cardiogenic Shock.


VAERS ID: 1592437 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1DO14A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia, SARS-CoV-2 test
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac arrhythmia; Pacemaker insertion (cardiac); Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: DEPFIZER INC202101067542

Write-up: This is a spontaneous report from a contactable consumer received via COVAES portal. An 87-year-old female patient received 2nd single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT number: 1DO14A, expiration date unknown) via an unspecified route of administration on 02Jun2021 at age of 87-year-old for COVID-19 immunisation. Medical history (previous illnesses that were treated at the clinic in Mar2021) included pulmonary embolism, inserting a pacemaker because of abnormal cardiac arrhythmias, adjustment of blood pressure and heart rate by means of medication. Patient previously received 1st dose of BNT162B2 (COMIRNATY) on an unspecified date for COVID-19 immunisation. On 01Jul2021, patient died of the consequences of a pneumonia. On 02Jun2021, she got her second Biontech vaccination. At the time of admission to the hospital, the corona test was negative. The reporter was afraid the second Biontech vaccination weaken patient''s immune system and so she had catch pneumonia in the summer. Until patient''s death, she was treated to the complete satisfaction. However, they refused an autopsy. Patient died on 01Jul2021. Autopsy was not performed.; Reported Cause(s) of Death: consequence of a pneumonia


VAERS ID: 1592438 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101067665

Write-up: This is a spontaneous report from a contactable physician based on the information received by Pfizer from Biontech [manufacturer control number: 80239], license party for COMIRNATY. A 16-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration in Mar2021 (lot number and expiry date: unknown) as dose 2, single; via an unspecified route of administration in Jan2021 (lot number and expiry date: unknown) as dose 1, single for COVID-19 immunisation. The patient''s medical history and patient''s concomitant medications were not reported. On unspecified date, the patient was found dead in bed at the age of 16. The autopsy did not reveal any cause. Presumably had a rhythmogenic event that led to death.; Sender''s Comments: The causal relationship between bnt162b2 and the event Arrhythmia (Fatal) cannot be assessed 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: rythmogenic event led to death


VAERS ID: 1592507 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-30
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram cerebral, Blood bicarbonate, Blood glucose, Blood lactic acid, Blood potassium, Blood pressure measurement, Blood sodium, Electrocardiogram, Fraction of inspired oxygen, Haemoglobin, Heart rate, Investigation, Laboratory test, Lumbar puncture, Meningoencephalitis viral, Meningoradiculitis, Neurological examination, PCO2, PO2, Pharyngitis, Physical examination, Platelet count, Procalcitonin, Protein total, SARS-CoV-2 test, Scan brain, White blood cell count, pH body fluid
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210810; Test Name: Angiogram cerebral; Result Unstructured Data: Test Result:Absence of opacification of the M3-M4 segment of b; Comments: Absence of opacification of the M3-M4 segment of both MCAs (left MCA does not completely opacify / right MCA only segment M1-M2, in a filiform manner) and internal cerebral veins (FRAMPES scale, 4 vessels) nor pericalous arteries or vein of Galen (DUPAS, 7 glasses). Criteria for Brain Death are met.; Test Name: HCO3; Result Unstructured Data: Test Result:26; Comments: no units reported; Test Date: 20210810; Test Name: blood glucose; Result Unstructured Data: Test Result:good; Test Name: lactic; Result Unstructured Data: Test Result:0.9; Comments: no units reported; Test Name: K; Result Unstructured Data: Test Result:4.19; Comments: no units reported; Test Date: 20210810; Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Name: Na; Result Unstructured Data: Test Result:124; Comments: no units reported; Test Name: ECG; Result Unstructured Data: Test Result:VIRAL ENCEPHALITIS. CHEYNE-STOKES. ATELCTASIA RIGH; Test Date: 20210810; Test Name: FiO2; Result Unstructured Data: Test Result:0.35; Comments: no units reported; Test Name: Hg; Result Unstructured Data: Test Result:14; Comments: no units reported; Test Date: 20210810; Test Name: heart rate; Result Unstructured Data: Test Result:85; Comments: bpm, no murmurs; Test Name: Radiology Image; Result Unstructured Data: Test Result:Infiltrate with laminar atelectasis in the right b; Comments: Infiltrate with laminar atelectasis in the right base; Test Name: tests; Result Unstructured Data: Test Result:without significant alterations except for lymphop; Test Date: 202108; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:COMPATIBLE WITH VIRAL MENINGOENEPHALITIS; Comments: COMPATIBLE WITH VIRAL MENINGOENEPHALITIS; Test Date: 20210730; Test Name: magnetoencephalography; Result Unstructured Data: Test Result:Unknown Results; Test Name: pCO; Result Unstructured Data: Test Result:48; Comments: no units reported; Test Name: pH; Result Unstructured Data: Test Result:7.35; Test Date: 20210810; Test Name: physical examination; Result Unstructured Data: Test Result:Abdomen: globular, soft. without masses or megalie; Comments: Abdomen: globular, soft. without masses or megalies Hyperreflexic Osteotendinous reflexes except right patellar. Left plantar cutaneous response in retreat, Right indifferent. Extremities: no edema or signs of VTT; Test Name: platelets; Result Unstructured Data: Test Result:149000; Comments: no units reported; Test Name: pO2; Result Unstructured Data: Test Result:40; Comments: no units reported; Test Name: procalcitonin; Result Unstructured Data: Test Result:normal; Test Name: TP ratio; Result Unstructured Data: Test Result:1.16; Comments: no units reported; Test Date: 20210730; Test Name: COVID-19 virus test/antigen test; Test Result: Negative ; Test Date: 20210808; Test Name: CT with no contrast; Result Unstructured Data: Test Result:no pathologies; Test Name: leucocytes; Result Unstructured Data: Test Result:4820; Comments: no units reported
CDC Split Type: ESPFIZER INC202101055775

Write-up: This is a spontaneous report from a contactable Pharmacist downloaded from the Regulatory Authority-WEB ES-AEMPS-970838. A 28-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 14Jul2021 (Lot Number: FC1435) as DOSE 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced viral meningoencephalitis (death, hospitalization) on 30Jul2021, meningoradiculitis (death, hospitalization) on 31Jul2021, acute pharyngitis (non-serious) on 31Jul2021 with outcome of unknown. The patient underwent lab tests and procedures which included angiogram cerebral: absence of opacification of the M3-M4 segment of both MCAs (left MCA does not completely opacify / right MCA only segment M1-M2, in a filiform manner) and internal cerebral veins (FRAMPES scale, 4 vessels) nor pericalous arteries or vein of Galen (DUPAS, 7 glasses). Criteria for Brain Death are met on 10Aug2021, blood bicarbonate: 26 on an unknown date, blood glucose: good on 10Aug2021, blood lactic acid: 0.9 on an unknown date, blood potassium: 4.19 on an unknown date, blood pressure measurement: normal on 10Aug2021, blood sodium: 124 on an unknown date, electrocardiogram: viral encephalitis. cheyne-stokes. atelctasia righ on an unknown date, fraction of inspired oxygen: 0.35 on 10Aug2021, haemoglobin: 14 on an unknown date, heart rate: 85 bpm on 10Aug2021; Radiology - Image: Infiltrate with laminar atelectasis in the right base on an unknown date, a battery of tests: without significant alterations except for lymphop on an unknow date, lumbar puncture: compatible with viral meningoenephalitis in Aug2021, pco2: 48 on an unknown date, CT with no contrast: no pathologies on 08Aug2021. The clinical course reported as following: on 30Jul2021, patient started with headache, magnetoencephalography and fever and an antigen test was done at the pharmacy being negative. On 31Jul2021, it was assessed in health center where they advised sueroral and paracetamol. On 31Jul2021, patient experienced sore throat, non-thermometered fever, vomiting. On 02Aug21, it was reviewed in the health center with acute pharyngitis and they advised azithromycin. On 04Aug20021, telephone contact reported headache. On 06Aug2021 06:56 home assistance reported that the headache for a week of evolution accompanied by fever and vegetative symptoms, upon they arrival, patient sitting disoriented with disturbance of attention, agitated that didn''t cooperate. Family members reported that this condition has started abruptly and has recently been in the hospital less than an hour ago. On 06Jun2021 they observed a battery of tests performed recently without significant alterations except for lymphopenia without absolute leukocytosis with hypoxemia. It was decided to transfer to the hospital with a diagnosis of probable herpetic encephalitis hospital income. Lumbar puncture. Clear liquid with fast exit rate. CSF: compatible with viral meningitis. Psychomotor agitation persists that requires sedation cursing admission in intensive care unit. Intensive Care Unit evolution as of 10Aug2021 Exploration: Overall Impression: Severe Attitude: calm, Awareness: CGS Glasgow Coma Scale M4 O3 V2 Respiratory: Spontaneous with BIPAP IPAP 16 EPAP 10 FiO2 0.35. Presents Cheyne-Stone BMV pattern Circulatory: Rhythmic at 85 bpm no murmurs Hemodynamics: Blood pressure maintained without amines. Abdomen: globular, soft. without masses or megalies. Nervous System: CGS 9 (M4 O3 V2) with preserved trunk reflexes. Hyperreflexic Osteotendinous reflexes except right patellar. Left plantar cutaneous response in retreat, Right indifferent. Extremities: no edema or signs of VTT Kidney and Internal ennvironment: D 1535 BH +2573 blood glucose levels good. Supplementary tests: Analytical - Microbiology: pH 7.35 pCO48 pO2 40 HCO3 26 lact 0.9 Leuc 4820 sec 88% Hg 14 platelets 149000 TP 1.16 ratio 1.23 Frenal normal Na 124 K 4.19 procalcitonin normal. Radiology - Image: Infiltrate with laminar atelectasis in the right base. ECG: Other Explorations. Clinical Judgment: viral encephalitis. cheyne-stokes. atelctasia right. Clinical picture compatible with symptoms of meningoencephalitis after vaccination in the AESI window period but with clinical judgement of viral meningoencephalitis. Death on 10Aug2021 with clinical judgement of viral meningoencephalitis. Patient died on 10Aug2021, it''s known if the autopsy was conducted.; Reported Cause(s) of Death: viral meningoencephalitis; Meningoradiculitis


VAERS ID: 1592598 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-03-20
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dysphagia, Motor dysfunction, Muscular weakness, Musculoskeletal disorder, Musculoskeletal stiffness, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Memory impaired
Preexisting Conditions: Medical History/Concurrent Conditions: Cirrhosis of liver; Hypertension; Mental disorder NOS; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101056109

Write-up: This is a spontaneous report from a contactable consumer (patient''s father) downloaded from the Regulatory Authority-WEB FI-FIMEA-20213931. A 74-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration in Jan2021 (Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included cirrhosis of liver, mentally ill, hypertension, type 2 diabetes and ongoing memory disorder from 2017. Weak but stable condition and did well at home, but in January received the 1st coronary vaccination from which the downturn began. Concomitant medication was not reported. At first, the patient swallowing became more difficult. Before, even the big drugs had been swallowed well, now they got stuck in the palate, then the legs became weak and he was sometimes "petrified", no proper contact with him could be established. In 2021, the patient experienced musculoskeletal disorder. Condition fluctuated drastically in Feb2021. Sometimes he was at home until the legs became powerless again. Went back and forth 4-5 times between home and health station. In Mar2021, the feet ceased to function completely, thus went to the department. The right hand also stopped working and there was a fever all the time against which the wide-spectrum antibiotic did not help. Eventually, the ability to swallow was lost and no hydration was given anymore when the doctor said it would be prolonging the inevitable. On 20Mar2021, the patient died. Personally, the reporter would consider that the organism of a poor-condition elderly person failed as a result of the vaccine. Until then, though, the patient was just fine and suddenly this happened after the vaccination. The cause of death was unknown. Autopsy was unknown. The outcome of limbs stiffness and motor dysfunction 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: unknown.


VAERS ID: 1592628 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-03-30
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Hypertension arterial; Ischemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20201223; Test Name: SARS-CoV-2 test; Test Result: Negative.
CDC Split Type: FRPFIZER INC202101056097

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BR20213096. A 91-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 10Feb2021 (Lot Number: EJ 6789) as single dose for covid-19 immunisation. Medical history included cardiac failure, atrial fibrillation, hypertension, myocardial ischaemia. The patient''s concomitant medications were not reported. The patient experienced death unexplained on 30Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Dec2020. 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: unexplained death.


VAERS ID: 1592634 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-07-25
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC6984 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time ratio, Activated partial thromboplastin time ratio decreased, Alanine aminotransferase, Bacterial test positive, Blood creatine phosphokinase, Blood culture, Blood electrolytes, Blood fibrinogen, C-reactive protein, COVID-19 pneumonia, Computerised tomogram thorax, Creatinine renal clearance, Culture urine, Fall, Lactobacillus test positive, Legionella infection, Legionella test, Platelet count, Prothrombin time, Red blood cells urine, SARS-CoV-2 test, Sputum culture, Troponin, Troponin I, Urine analysis, Vaccination failure, White blood cell count, White blood cells urine
SMQs:, Lack of efficacy/effect (narrow), Accidents and injuries (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   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: KARDEGIC; SIMVASTATIN; GLICAZIDA; AMLODIPINE; FUROSEMIDE; LEVEMIR; METFORMIN; INEXIUM [ESOMEPRAZOLE MAGNESIUM]
Current Illness: Hypertension arterial; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Acromioplasty; Algodystrophy; Rotator cuff syndrome (left)
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: activated partial thromboplastin time ratio; Result Unstructured Data: Test Result:1.02; Test Date: 20210726; Test Name: Alanine transaminase; Result Unstructured Data: Test Result:normal; Test Date: 20210726; Test Name: CPK; Result Unstructured Data: Test Result:1645 IU/l; Test Date: 20210726; Test Name: blood culture; Result Unstructured Data: Test Result:negative; Test Date: 20210726; Test Name: Ionogram; Result Unstructured Data: Test Result:normal; Test Name: fibrinogen; Result Unstructured Data: Test Result:$g9.0 g/l; Test Date: 20210727; Test Name: thoracic CT with contrast; Result Unstructured Data: Test Result:Covid 19 pneumonia with moderate involvement, no s; Comments: Covid 19 pneumonia with moderate involvement, no systematic condensation, no pulmonary embolism. CT reassessment was not performed during hospitalization and after worsening hypoxia; Test Name: CRP; Result Unstructured Data: Test Result:253 mg/l; Test Date: 20210726; Test Name: CRP; Result Unstructured Data: Test Result:206 mg/l; Test Date: 20210726; Test Name: Clearance; Result Unstructured Data: Test Result:71 ml/min; Test Date: 20210726; Test Name: Urine culture; Result Unstructured Data: Test Result:positive for lactobacillus sp 10 7 CFU / ml and Es; Comments: positive for lactobacillus sp 10 7 CFU / ml and Escherichia coli$g 10 7 CFU / ml; Test Date: 20210728; Test Name: Urine culture; Result Unstructured Data: Test Result:negative initially; Test Date: 20210728; Test Name: lagionella pneumophils PCR; Test Result: Positive ; Comments: results available on 10Aug2021, twice positive; Test Date: 20210726; Test Name: legionella urinary antigen; Test Result: Negative ; Test Date: 20210726; Test Name: Platelets; Result Unstructured Data: Test Result:180 x10 9/l; Test Date: 20210726; Test Name: Prothrombin time; Test Result: 74 %; Test Date: 20210726; Test Name: Red blood cells urine; Result Unstructured Data: Test Result:less or equl to 5; Comments: /mm3; Test Date: 20210726; Test Name: Covid-19 virus test; Test Result: Positive ; Comments: on nasopharyngeal swab: positive with the presence of the L452 R mutation; Test Name: long culture of the input sputum; Result Unstructured Data: Test Result:positive to Legionella whose final result; Comments: positive to Legionella whose final result and phenotype are pending; Test Name: Troponin; Result Unstructured Data: Test Result:decreasing; Test Date: 20210726; Test Name: Troponin I HS; Result Unstructured Data: Test Result:4959 ng/L; Comments: normal range: <47; Test Date: 20210726; Test Name: pneumococcal urinary Antigen; Test Result: Negative ; Test Date: 20210726; Test Name: Leukocyte count; Result Unstructured Data: Test Result:6.87 x10 9/l; Test Date: 20210726; Test Name: White blood cells urine; Result Unstructured Data: Test Result:79; Comments: /mm3
CDC Split Type: FRPFIZER INC202101056092

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BS20211531. An 83-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular in left arm on 26Apr2021 (Lot Number: ET6956), dose 2 intramuscular in left arm on 07Jun2021 (Lot Number: FC6984), all at single dose for COVID-19 immunisation. Medical history included algodystrophy, ongoing type 2 diabetes mellitus and ongoing hypertension arterial; Surgical history included rotator cuff syndrome left and acromioplasty. The patient had no history of COVID-19. No drug addiction. Lifestyle: lives alone at home with helpers, drives and does his shopping. Concomitant medications included acetylsalicylate lysine (KARDEGIC), simvastatin, gliclazide (GLICAZIDA), amlodipine, furosemide, insulin detemir (LEVEMIR), metformin, esomeprazole magnesium (INEXIUM), all taken for unspecified indication(s) from unspecified date(s). On Day 45, 25Jul2021 Hospitalization for mechanical fall with prolonged state of being on the ground. The assessment carried out on 26Jul2021 highlights: A dissociated inflammatory syndrome: leukocytes = 6.87 x10 9/ l [3.8 -10.0], CRP = 206 mg / l [0-5], PCT not specified; Coagulation: Prothrombin time = 74%, activated partial thromboplastin time ratio = 1.02, platelets = 180 10 9/l, fibrinogen not reported; Ionogram: normal; CPK = 1645 U / l [46-171], troponin I HS 4959 ng / L [<47]; Renal function: clearance = 71 ml / min; Normal ALAT (Alanine transaminase); A PCR test (26Jul2021) looking for coronavirus on nasopharyngeal swab: positive with the presence of the L452 R mutation; A bacteriological assessment: negative blood cultures, negative Legionella and pneumococcal urinary Ag, Urine examination: White blood cells (leucocytes) = 79 / mm3, red blood cells = <5 / mm3, Urine culture positive for lactobacillus sp 10 7 CFU / ml and Escherichia coli$g 10 7 CFU / ml, urine culture 28Jul2021 negative initially. The injected thoracic CT with contrast of 27Jul2021 shows Covid 19 pneumonia with moderate involvement, no systematic condensation, no pulmonary embolism. CT reassessment was not performed during hospitalization and after worsening hypoxia. From a therapeutic point of view, the patient benefited from: Antibiotic therapy with cefotaxime from 26Jul2021 to 01Aug for multi-sensitive urine test E Coli positive; preventive anticoagulation 26Jul2021 then curative from 27Jul2021; Oxygen therapy by nasal oxygen from 28Jul2021: 5 l/min on 28Jul, 10 l/min on 30Jul then 17 l/min with a high concentration mask; Treatment with dexamethasone (6 mg per day) started on 27Jul2021 and TOCILIZUMAB (2 doses of 600 mg given) from 28Jul2021. CRP was at this time at 253 mg/ml and fibrinogen$g9.0 g/l. The respiratory evolution is unfavorable with persistence and increase in hypoxia requiring an intensive care unit advice which does not retain any indication for high flow oxygen therapy or intensive care. The patient was found dead in his room on 01Aug2021. The department doctor contacted did not rule out a worsening of the COVID pneumonia. A pulmonary edema and / or a coronary syndrome seems excluded because the troponin was decreasing. However, he reported that a long culture of the input sputum returns positive to Legionella whose final result and phenotype are pending. On 10Aug2021, the National Research Center of Legionella biologist confirms that the Cytobacteriological examination of sputum of 28Jul2021 is twice positive for legionella pneumophila PCR, the long culture is in progress but will not be available for 8 days. In conclusion: vaccine failure at Day45 of a complete vaccination schedule complicated by a fatal SARS covid 19 pneumonia. The possibility of legionellosis is being considered due to the double positivity of legionella pneumophila PCR. Long pending culture result. The outcome of events vaccination failure, sars covid 19 pneumonia, and legionella pneumophila infection considered as fatal, the outcome of other events was unknown. The patient died on 01Aug2021. An autopsy was not performed.; Reported Cause(s) of Death: SARS covid 19 pneumonia; SARS covid 19 pneumonia; legionella pneumophila infection


VAERS ID: 1592640 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Chills, Condition aggravated, Headache, Hepatic vein thrombosis, Lung cancer metastatic, Myocardial infarction, Pulmonary embolism, Pyrexia, Tendonitis, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 80
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101055172

Write-up: This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BX20217293. A 54-year-old male patient received 2nd dose of BNT162B2 (COMIRNATY, lot number EK9788) at single dose on 01Feb2021 via an unknown route for COVID-19 immunisation. Medical history included Metastatic lung cancer. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (COMIRNATY, lot number EM0477) on 11Jan2021 for COVID-19 immunisation. Serious adverse event was reported as Hepatic vein thrombosis, Embolism pulmonary/embolie pulmonaire massive, and Thrombocytopenia with onset date of 23Apr2021. It was reported as death from massive pulmonary embolism with hepatic vein thrombosis and thrombocytopenia in the context of recent discovery of metastatic lung cancer two and a half months on 23Apr2021. The clinical course was reported as follows: On Day 2 of D2, asthenia, headache, fever, chills, back arthralgia and MI, left elbow tendonitis (injected side), dyspnea, dry cough similar to that of whooping cough. dry cough similar to that of whooping cough. Antibiotic therapy was initiated. Patient had persistent cough at Day 71 appearance of blood expectoration when coughing, always with dyspnea and arthralgia. After exploration, diagnosis of metastatic lung cancer was made. 2 and a half months after D2, on 23Apr2021, death in a context of hepatic vein thrombosis, pulmonary embolism and thrombocytopenia. Outcome of hepatic vein thrombosis, pulmonary embolism and thrombocytopenia was death. Outcome of the other events was medically significant. The case was not medically confirmed. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Parenteral; Reported Cause(s) of Death: Embolism pulmonary/embolie pulmonaire massive; Hepatic vein thrombosis; Thrombocytopenia


VAERS ID: 1592684 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure increased, Body temperature decreased, Brain death, Brain hypoxia, C-reactive protein, Cardiac arrest, Coma, Computerised tomogram, Computerised tomogram head, Echocardiogram, Electrocardiogram, Electroencephalogram, Full blood count, Headache, Magnetic resonance imaging, Pain in extremity, SARS-CoV-2 antibody test positive, Ultrasound Doppler
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 27
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: Asthma; Barlow''s syndrome; Marfan''s syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: arterial pressure; Result Unstructured Data: Test Result:90/60 mmHg; Test Date: 20210713; Test Name: temperature control; Result Unstructured Data: Test Result:36 Centigrade; Test Date: 20210713; Test Name: CT scan; Result Unstructured Data: Test Result:The ascending aorta is moderately dilated; Comments: No aortic dissection or large vsx, no intracranial bleeding, the super sigmoid aortography does not show any aortic insufficiency; Test Date: 20210715; Test Name: CT scan; Result Unstructured Data: Test Result:appearance of parenchymal parenchymal hemispherica; Comments: appearance of parenchymal parenchymal hemispherical hemispherical right upper cerebellar areas of ischemic appearance; Test Date: 20210713; Test Name: brain CT scan; Result Unstructured Data: Test Result:no bleeding; Comments: no traumatic injury; Test Date: 20210723; Test Name: brain CT scan; Result Unstructured Data: Test Result:stability of ischemic; Comments: lesions appearance of cerebral edema compatible with anoxo-ischemic lesions, put under Mannitol; Test Date: 20210727; Test Name: brain CT scan; Result Unstructured Data: Test Result:increase in cerebral edema; Comments: reaching almost the entire sustentorial stage, sudden episodes of desaturation.; Test Date: 20210713; Test Name: C-reactive protein; Result Unstructured Data: Test Result:1.4; Test Name: Trans-thoracic echocardiography; Result Unstructured Data: Test Result:finding a 30%; Comments: altered left ventricular ejection fraction with kinetic disorders suggestive of Takotsubo; Test Date: 20210713; Test Name: Electrocardiography; Result Unstructured Data: Test Result:Not very evocative; Comments: Respiratory rate; Test Date: 20210723; Test Name: electroencephalogram; Result Unstructured Data: Test Result:flat; Comments: with a few waves of intermittent activity; Test Date: 20210727; Test Name: electroencephalogram; Result Unstructured Data: Test Result:Pathological; Comments: Keppra introduction; Test Date: 20210713; Test Name: complete blood count; Result Unstructured Data: Test Result:normal; Test Date: 20210713; Test Name: cardiac magnetic resonance imaging; Result Unstructured Data: Test Result:cardio; Comments: in favor of a takotsubo; Test Date: 20210713; Test Name: covid; Test Result: Positive ; Comments: (Ig G antiS and antiN and IgM), re-reading of the entry serology concluded with a Covid infection starting at the same time as the anti-covid vaccination; Test Date: 20210713; Test Name: Left transcranial doppler; Result Unstructured Data: Test Result:left more disturbed; Comments: than the right (Vdiastolic 20 vs 40 on the right)
CDC Split Type: FRPFIZER INC202101056242

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [FR-AFSSAPS-MP20215396]. A 15-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 11Jul2021 07:30 (Lot Number: Unknown) (at the age of 15-year-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing asthma, ongoing Barlow''s syndrome, ongoing Marfan''s syndrome. The patient''s concomitant medications were not reported. In good health overall, apart from a loss of 10kg over one year (since entering high school). During the day (11Jul2021), asthenia and isolated arm pain. The next day (12Jul2021), headaches yielding under Doliprane. On 13Jul2021, around 16:30 (last moment conscious view), her mother drops her off to her father. Father watered the garden and she cleaned the garage to prepare for her birthday party. On 13Jul2021 17:20, her father found her in cardio respiratory arrest, back to the ground, next to a ladder. No flow was unknown. At 17:30 arrival of firefighters: 2 external electric shocks were given and 1 mg of adrenaline injected. Moderately reactive pupils. At 17:50 arrival of Specialist mobile emergency unit: asystole (Life-threatening). Two injections of 1 mg of adrenaline, transition to ventricular fibrillation. 2 external electric shock, 2 ampule of Cordarone and one ampule of Calcium Gluconate. Return to regular sinus rythme without disturbance of repolarization and resumption of a pulse. Orotracheal intubation (probe no 6). New: 1 external electric shock, one ampule of Cordarone and 1 mg of adrenaline. Return of a sinus rhythm but presence of a sub ST in infero lateral. 90/60 mmHg arterial pressure excluding sedation. Tight areactive bilateral miosis pupils. Ventilated in Ventilator-Associated Conditions but presence of spontaneous ventilation requiring sedation by Hypnovel and Sufentanyl and 10 mg of Nimbex. Parallel introduction of Noradrenaline 0.8 mg/h. No filling. In total: low flow of 30 minutes. Recovered and transfer to intensive care. Examinations: biology: complete blood count normal, C-reactive protein 1.4. Coroner considered as normal no coronary dissection. Computed tomography scan Computed tomography arterial portography: No aortic dissection or large vsx, no intracranial bleeding, the super sigmoid aortography does not show any aortic insufficiency. The ascending aorta is moderately dilated. Computerised tomogram head: no bleeding, no traumatic injury. Electrocardiogram: Not very evocative. Respiratory rate. Maintenance of sedation, temperature control at 36 degrees. Complicated cardiac arrest of a Takotsubo. Trans-thoracic echocardiography finding a 30% altered left ventricular ejection fraction with kinetic disorders suggestive of Takotsubo (post stress?). More doubt about intra-left ventricular thrombus. Low left ventricular filling pressures. Integral time speed= 8. Inferior vena cava= 15. 15Jul2021 Appearance in the morning of continual clonies of the multiple sulfatase deficiency, put under Keppra increased to 750x2. Electroencephalography results pending + Left transcranial doppler more disturbed than the right (Vdiastolic 20 vs 40 on the right), Control contrast enhanced computed tomography scan superimposable at the level of large vsx, but appearance of parenchymal parenchymal hemispherical hemispherical right upper cerebellar areas of ischemic appearance. 20Jul2021 pathological awakening, inhalation lung disease, myocarditis assessment in progress (negative). 23Jul2021 no sign of wakign up flat electroencephalogram alternating with a few waves of intermittent activity. Computered tomography scan stability of ischemic lesions appearance of cerebral edema compatible with anoxo-ischemic lesions, put under Mannitol. Cardio: cardiac magnetic resonance imaging in favor of a takotsubo, myocarditis unlikely, infective and immunological workup negative. 27Jul2021 Pathological electroencephalogram, Keppra introduction. Computered tomography scan increase in cerebral edema reaching almost the entire sustentorial stage, sudden episodes of desaturation. The COVID serology returns positive (Ig G antiS and antiN and IgM), re-reading of the entry serology concluded with a Covid infection starting at the same time as the anti-covid vaccination. 30Jul2021 retro-rolandic aspect of brain death, vegetative coma. Decision to limit therapy. Complete file no further information. The patient died on 07Aug2021. An autopsy was not performed. Cause of Death: Anoxia cerebral and Cardiac arrest while outcome of the 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: Cardiac arrest; Anoxia cerebral


VAERS ID: 1592685 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: MP20215979) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Death occurred on August 2021 The patient died in August 2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No treatment drug information provided. No concomitant drug information provided. Company comment: This is a case of Death Not Otherwise Specified in a 28-year-old male patient, that occurred at an unspecified number of days after receiving first dose of vaccine (Lot number unknown). Very limited information regarding the date of death and the clinical details pertaining to death, medical history, and concomitant medication was provided at this time. No further information is expected.; Sender''s Comments: This is a case of Death Not Otherwise Specified in a 28-year-old male patient, that occurred at an unspecified number of days after receiving first dose of vaccine (Lot number unknown). Very limited information regarding the date of death and the clinical details pertaining to death, medical history, and concomitant medication was provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of Death


VAERS ID: 1592686 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2405 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Angiogram, Anosmia, Arthralgia, Bence Jones proteinuria, Benign prostatic hyperplasia, Biopsy oesophagus, Biopsy stomach, Blood albumin, Blood culture, Blood iron, Blood pressure diastolic, Blood pressure systolic, Blood sodium, C-reactive protein, Colitis, Computerised tomogram head, Cough, Crepitations, Decreased appetite, Diverticulitis, Endoscopy, Fungal infection, Granulocyte count, Heart rate, Heart rate increased, Hypoacusis, Immunohistochemistry, Investigation, Liver function test, Microbiology test, Multiple organ dysfunction syndrome, Musculoskeletal pain, Oedema peripheral, Productive cough, Protein albumin ratio, Proteinuria, Prothrombin level, Pulmonary mass, Pyrexia, Serology test, Sputum test, Systemic lupus erythematosus, Ultrasound scan, Urine analysis, Weight, Weight decreased, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hearing impairment (narrow), Chronic kidney disease (broad), Arthritis (broad), Noninfectious diarrhoea (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 84
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 19 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: Thoracic angioscan; Result Unstructured Data: Test Result:aspecific right laterobasal pulmonary micronodule; Comments: no pulmonary embolism, aspecific right laterobasal pulmonary micronodule; no evidence of recent or old tuberculosis.; Test Date: 20210531; Test Name: bence jones proteinuria; Test Result: Negative ; Test Date: 20210608; Test Name: Esophageal biopsies; Result Unstructured Data: Test Result:confirmed esophageal mycosis; Test Date: 20210608; Test Name: Gastric biopsy; Result Unstructured Data: Test Result:absence of glandular atrophy; Comments: absence of glandular atrophy, intestinal metaplasia, signs of activity or dysplasia; Test Date: 20210528; Test Name: Albumin; Result Unstructured Data: Test Result:29 g/l; Comments: Hypoalbuminemia; Test Date: 20210531; Test Name: Albumin; Result Unstructured Data: Test Result:25 g/l; Comments: Hypoalbuminemia; Test Date: 20210528; Test Name: blood cultures; Result Unstructured Data: Test Result:Sterile; Test Date: 20210531; Test Name: hyperferritinemia; Result Unstructured Data: Test Result:604.57 ng/L; Comments: hyperferritinemia; Test Date: 20210621; Test Name: diastolic blood pressure; Result Unstructured Data: Test Result:65; Test Date: 20210621; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:106; Test Date: 20210528; Test Name: Hyponatremia; Result Unstructured Data: Test Result:131 mmol/L; Comments: hyponatremia; Test Date: 20210531; Test Name: Hyponatremia; Result Unstructured Data: Test Result:131 mmol/L; Comments: hyponatremia, no other blood ionogram abnormality; Test Date: 20210609; Test Name: brain CT scan; Result Unstructured Data: Test Result:without abnormality; Test Date: 20210528; Test Name: CRP; Result Unstructured Data: Test Result:47 mg/l; Test Date: 20210531; Test Name: CRP; Result Unstructured Data: Test Result:37 mg/l; Test Date: 20210608; Test Name: Endoscopy oeso-gastro-duodenal; Result Unstructured Data: Test Result:peptic oesophagitis; Comments: peptic oesophagitis and probable oesophageal candidosis, gastritis, bulbitis. Ulcer of the tip of the bulb.; Test Date: 20210525; Test Name: Polynuclear neutrofile; Result Unstructured Data: Test Result:10878 /mm3; Test Date: 20210528; Test Name: Polynuclear neutrofile; Result Unstructured Data: Test Result:9540 /mm3; Test Date: 20210621; Test Name: Heart rate; Result Unstructured Data: Test Result:109; Comments: bpm; Test Date: 20210608; Test Name: Immunohistochemical; Result Unstructured Data: Test Result:negative anti-HP antibodies.; Comments: Immunohistochemical study performed with negative anti-HP antibodies.; Test Date: 20210602; Test Name: pulmonary artery scan; Result Unstructured Data: Test Result:no deep tumor syndrome; Test Date: 20210528; Test Name: liver function; Result Unstructured Data: Test Result:No abnormalities in the liver function; Test Date: 20210531; Test Name: acid-fast bacillus; Test Result: Negative ; Test Date: 20210531; Test Name: hypoproteinemia; Result Unstructured Data: Test Result:58 g/l; Test Date: 20210531; Test Name: Proteinuria; Result Unstructured Data: Test Result:0.20 g/l; Test Date: 20210528; Test Name: prothrombin; Result Unstructured Data: Test Result:58% %; Test Date: 20210525; Test Name: serology; Result Unstructured Data: Test Result:HBV serology in favour of a vaccination; Comments: HBV serology in favour of a vaccination, HCV and HEV serologies negative.; Test Date: 20210603; Test Name: serology; Result Unstructured Data: Test Result:Auto antibody anti nuclear positive; Comments: Auto antibody anti nuclear positive, anti native DNA negative, SSA/Ro +, SSB/La -,Sm -,U1RNP -,Scl70 -,Jo-1 -. ANCA + Serologies Q fever, brucellosis, HIV negative. Toxoplasmosis, EBV and CMV serology in favor of old infections. Covid-19 serology: IgG positive.; Test Date: 20210528; Test Name: cytobacteriological examination of sputum; Result Unstructured Data: Test Result:unknown results; Comments: contamination by saliva; Test Date: 20210527; Test Name: Ultrasound; Result Unstructured Data: Test Result:Hypertrophic prostate (210 cc).; Comments: no hepatic, pancreatic, renal or splenic abnormalities. Inflammation of the descending colon and numerous diverticula. Hypertrophic prostate (210 cc).; Test Date: 20210525; Test Name: cytobacterioligical urine exam; Result Unstructured Data: Test Result:without anomaly; Test Date: 20210528; Test Name: Body weight; Result Unstructured Data: Test Result:loss of 8kg in two months kg; Test Date: 20210621; Test Name: Body weight; Test Result: 58.4 kg; Test Date: 20210525; Test Name: hyperleukocytosis; Result Unstructured Data: Test Result:13700 /mm3; Comments: hyperleukocytosis; Test Date: 20210528; Test Name: hyperleukocytosis; Result Unstructured Data: Test Result:11840 /mm3; Comments: hyperleukocytosis
CDC Split Type: FRPFIZER INC202101056237

Write-up: edema of the lower limbs to mid-calf; multiple organ failure; 109 beats per minute; bilateral crackles; knee and ankle pain on mobilization; confirmed esophageal mycosis; Disseminated lupus erythematosus; Weight loss of 8kg in two months; aspecific right laterobasal pulmonary micronodule; Hypertrophic prostate (210 cc); Inflammation of the descending colon; Inflammation of the descending colon and numerous diverticula; arthromyalgia syndrome; Severe fever; anorexia; agueusia; anosmia; partial hearing loss; Cough; sputum; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-MP20216051. This is first of two reports, for the second dose. An elderly male patient received BNT162B2 (COMIRNATY), intramuscularly on 23Apr2021 (Lot Number: EX2405) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no history of COVID-19. The patient previously received first dose of COMIRNATY on 02Apr2021 (lot number: ER9480) and experienced severe diarrhea for 2 or 3 days accompanied by joint pains on 04Apr2021.The patient experienced disseminated lupus erythematosus on 03Jun2021 and multiple organ failure on 16Jul2021 which were considered serious due to death. The patient experienced edema of the lower limbs to mid-calf on 28May2021 which was considered serious due to hospitalization from 28May2021 to 16Jun2021. The patient also experienced inflammation of the descending colon and numerous diverticula on 27May2021, severe fever, anorexia, agueusia, anosmia, partial hearing loss, cough, sputum on 23Apr2021, arthromyalgia syndrome on 18May2021, confirmed esophageal mycosis on 08Jun2021, hypertrophic prostate (210 cc) on 27May2021, weight loss of 8kg in two months and aspecific right laterobasal pulmonary micronodule on 28May2021, 109 beats per minute, bilateral crackles and knee and ankle pain on mobilization on 21Jun2021. Description of the events was as follows: 23Apr2021: following the Dose 2, appearance of an important fever (temperature not known), with anorexia, agueusia, anosmia, partial hearing loss, dry cough then sputum treated with SYMBICORT and AUGMENTIN 1gx3 and SOLUPRED 20 mg during 3 days. 10May2021: Appearance of a fever, the cough becomes oily. 18May2021: Cough cured but arthromyalgia syndrome appeared: prescription of BIPROFENID. 25May2021: hyperleukocytosis (13700/mm3) with Polynuclear neutrofile (10878/mm3), HBV serology in favour of a vaccination, HCV and HEV serologies negative. cytobacterioligical urine exam without anomaly. 27May2021: Ultrasound: no hepatic, pancreatic, renal or splenic abnormalities. Inflammation of the descending colon and numerous diverticula. Hypertrophic prostate (210 cc). 28May2021: Hospitalization. On clinical examination: edema of the lower limbs to mid-calf, agueusia, anosmia. Weight loss of 8kg in two months. Bio: hyperleukocytosis (11840/mm3) with polynuclear neutrofile (9540/mm3), prothrombin at 58%, C-reactive protein at 47 mg/l. No abnormalities in the liver function. Hypoalbuminemia (29 g/l). Hyponatremia at 131 mmol/l. Sterile blood cultures. Cytobacteriological examination of sputum : contamination by saliva. Thoracic angioscan: no pulmonary embolism, aspecific right laterobasal pulmonary micronodule; no evidence of recent or old tuberculosis. 31May2021: Search for BAAR in the explorations: negative. CRP 37 mg/l, hyponatremia 131 mmol/l, no other blood ionogram abnormality. Hypoalbuminemia at 25 g/l, hypoprotidemia at 58 g/l, hyperferritinemia at 604.57 ng/l. Proteinuria at 0,20 g/l, negative bence jones proteinuria. 02Jun2021: AP scan: no deep tumor syndrome. 03Jun2021 : Auto Ac anti nuclear positive, anti native DNA negative, SSA/Ro +, SSB/La -,Sm -,U1RNP -,Scl70 -,Jo-1 -. ANCA + Serologies Q fever, brucellosis, HIV negative. Toxoplasmosis, EBV and CMV serology in favor of old infections. Covid-19 serology: IgG positive. 08Jun2021: Endoscopy oeso-gastro-duodenal: peptic oesophagitis and probable oesophageal candidosis, gastritis, bulbitis. Ulcer of the tip of the bulb. Esophageal biopsies: confirmed esophageal mycosis. Gastric biopsies: absence of glandular atrophy, intestinal metaplasia, signs of activity or dysplasia. Immunohistochemical study performed with negative anti-HP antibodies. 09Jun2021: brain CT scan without abnormality. 16Jun2021: discharge from hospital. 21Jun2021: Hospitalization. On admission: apyretic, weight 58.4 kg, 109 beats per minute, systolic blood pressure 106 and Blood pressure diastolic 65, Dry cough, bilateral crackles, edema of the lower limbs , knee and ankle pain on mobilization; EVOLUTION: 16Jul2021: death at 6 a.m. The outcome of the events except disseminated lupus erythematosus and multiple organ failure was unknown. It was unknown if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101067929 same patient/product, different dose, similar event; Reported Cause(s) of Death: Disseminated lupus erythematosus; multiple organ failure


VAERS ID: 1592703 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-09
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood count, Blood creatine phosphokinase, Blood creatinine, Blood potassium, Computerised tomogram head, Electrocardiogram, Encephalopathy, Fibrin D dimer, Glomerular filtration rate, PCO2, PO2, Prothrombin time ratio, Respiratory arrest, Troponin, pH body fluid
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DIAMICRON; LEVOTHYROX; TAREG; ALDACTONE [SPIRONOLACTONE]; ELISOR; MOPRAL [OMEPRAZOLE]; PREVISCAN [FLUINDIONE]; DAFALGAN; XELEVIA
Current Illness: Gross obesity (overweight = 180 kg); Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Diabetes mellitus non-insulin-dependent; Fall (ECG(Echocardiogram): T wave negative in D3, CPK = 1531, troponin = 62.2 , normal brain scan); Hyperkalemia; Leg amputation; Pulmonary embolism; Rhabdomyolysis; Vertebral fracture (indication to wear a corset; no surgery)
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: bicarbonates; Result Unstructured Data: Test Result:39.9 mmol/L; Test Date: 20210708; Test Name: blood count; Result Unstructured Data: Test Result:normal; Test Date: 20210628; Test Name: CPK; Result Unstructured Data: Test Result:1531; Test Date: 20210708; Test Name: creatinine; Result Unstructured Data: Test Result:84 umol/l; Test Date: 20210628; Test Name: blood potassium; Result Unstructured Data: Test Result:5.3 mol/L; Test Date: 20210628; Test Name: head scan; Result Unstructured Data: Test Result:rhabdomyolysis; Test Date: 20210628; Test Name: ECG; Result Unstructured Data: Test Result:negative T wave in D3; Test Date: 20210708; Test Name: D-dimers; Result Unstructured Data: Test Result:3500 ng/ml; Test Date: 20210708; Test Name: GFR; Result Unstructured Data: Test Result:82 ml/min; Comments: ml/min/1.73 m(squared); Test Date: 20210708; Test Name: pco2; Result Unstructured Data: Test Result:86 mmHg; Test Date: 20210708; Test Name: ph; Result Unstructured Data: Test Result:4.27; Test Date: 20210708; Test Name: po2; Result Unstructured Data: Test Result:56.7 mmHg; Test Date: 20210708; Test Name: prothrombin ratio; Test Result: 37 %; Test Date: 20210628; Test Name: troponin; Result Unstructured Data: Test Result:62.2
CDC Split Type: FRPFIZER INC202101045352

Write-up: This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-PA20211343. A 67-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 05Jul2021 (Batch/Lot Number: Unknown) as DOSE 1, 0.3 mL, single for covid-19 immunisation. Medical history included gross obesity (overweight = 180 kg) (ongoing), non-insulin dependent diabetes, Atrial fibrillation (Afib), Pulmonary embolism, ongoing hypothyroidism, and amputation of the 2 lower limbs. Patient lives at home with assistance; autonomous for the toilet. Concomitant medications included gliclazide (DIAMICRON); levothyroxine sodium (LEVOTHYROX); valsartan (TAREG); spironolactone (ALDACTONE [SPIRONOLACTONE]); pravastatin sodium (ELISOR); omeprazole (MOPRAL [OMEPRAZOLE]); fluindione (PREVISCAN [FLUINDIONE]); paracetamol (DAFALGAN); and sitagliptin phosphate (XELEVIA). The patient fell at home on 28Jun2021, emergency room visit: ECG(Echocardiogram): T wave negative in D3, CPK = 1531, troponin = 62.2 , normal brain scan; rhabdomyolysis with hyperkalemia (K = 5.3 mol/L), fracture of the vertebral body of D12; indication to wear a corset; no surgery. On 05Jul2021, patient received the first dose of COMIRNATY. On 08Jul2021, Blood count (CBC) normal, PT = 37%, D-Dimer (STA R Max2 technique) = 3500 ng/mL (N < 500=); Blood gases: ph = 4.27, p CO2 = 86 mm Hg, pO2 = 56.7 mm Hg, bicarbonates = 39.9 mmol/L; creatinine = 84 umol/L GFR = 82 ml/mn/1.73 m2. During hospitalization: put on Kayexalate and switched to insulin. Notion of encephalopathy. On 09Jul2021: death by probable respiratory arrest due to false routes. In total: Death due to respiratory arrest on false routes, 5 days after Dose 1 in a 67-year-old man with multiple co-morbidities. The event respiratory arrest was considered serious (fatal, hospitalization, and life-threatening) by the regulatory authority. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: probable respiratory arrest on a false route.


VAERS ID: 1592724 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-06
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Death
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: 2021-08-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101056232

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RN20212466. Case from a health professional report via the Ministry portal number 20210806094252940. A 31-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: FE8244), intramuscularly administered in left arm on 28Jul2021 as dose 2, single for COVID-19 immunisation. The patient had no medical history. The patient had no history of COVID-19 and had not been tested for COVID 19. The patient was treated with the daily pill long-term since 12Jan2021. The patient previously received first dose of BNT162B2 (COMIRNATY) and no notion of adverse reaction during the 1st injection of COMIRNATY. On 06Aug2021 in the morning: patient found in bed in cardiorespiratory arrest in asystole not recovered by the medical emergency services team. No notion of toxic intake. No notable personal or family cardiovascular history. No functional complaint reported by the relatives in the previous days. In total, a 31-year-old patient with no history of illness died 10 days after the 2nd dose of COMIRNATY vaccine, with no obvious cause found. The outcome of the event "Cardio-respiratory arrest" was not recovered. The patient died on 06Aug2021. It was unknown if an autopsy was done.; Reported Cause(s) of Death: Death unexplained.


VAERS ID: 1592747 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-08-02
   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: Diabetes mellitus; Hodgkin''s lymphoma
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: feverish; Result Unstructured Data: Test Result:feverish
CDC Split Type: FRPFIZER INC202101055179

Write-up: Sudden death; feverish patient; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the RA, regulatory authority number FR-AFSSAPS-TO20216527. A 69-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 30Jul2021 (Batch/Lot Number: FF0680) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus and Hodgkin''s lymphoma. The patient''s concomitant medications were not reported. 01Aug2021, feverish patient. During the night, the female patient called the firefighters: they find her dead. Death of unknown cause. The patient died on 02Aug2021. An autopsy was not performed. Outcome of feverish was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: unknown cause


VAERS ID: 1593404 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, SARS-CoV-2 test, Transient ischaemic attack
SMQs:, Myocardial infarction (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   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: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101040969

Write-up: Heart attack; transient ischaemic attack; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108101124436550-DX5CE, Safety Report Unique Identifier (GB-MHRA-ADR 25778984) An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 08Feb2021 (Lot Number: Not known) 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. The patient experienced transient ischaemic attack on 14Feb2021, heart attack on an unspecified date. The patient underwent lab tests included Negative COVID-19 test. The outcome of events was fatal. The patient died on 15Feb2021. It was not reported if an autopsy was performed. Transient ischaemic attack followed by a heart attack, which led to death. 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.; Reported Cause(s) of Death: Transient ischaemic attack; heart attack


VAERS ID: 1593425 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       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: 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: GBMODERNATX, INC.MOD20212

Write-up: Breathing arrested; This case was received via Regulatory Authority (Reference number: 25784244) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RESPIRATORY ARREST (Breathing arrested) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RESPIRATORY ARREST (Breathing arrested) (seriousness criteria death and medically significant). The reported cause of death was Breathing arrested. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. Company Comment:Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Breathing arrested


VAERS ID: 1593519 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   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: HKPFIZER INC202101068333

Write-up: This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (regulatory authority number: not provided) based on information received by Pfizer from BioNtech SE (manufacturer control number: HK-Fosun-2021FOS003036), license party for BNT162B2 (COMIRNATY). An 82-year-old male patient received BNT162B2 (COMIRNATY), via unknown route of administration on 09Jul2021 (Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient''s medical history, concomitant medications, and past product were not reported. Previously, the patient experienced unknown adverse event(s) and was hospitalized on an unknown date. The patient experienced intracerebral hemorrhage (unspecified date in Jul2021). The patient died on 14Jul2021 due to intracerebral haemorrhage. It was unknown if an autopsy was performed. Intracerebral haemorrhage met the seriousness criterion of death. The regulatory authority considered there was no clinical evidence to indicate the event was caused by vaccine. This case would be included in the COVID-19 vaccines Adverse events Response and Evaluation Programme of the University of Hong Kong for analysis. Relatedness of drug to reaction/event: Source of Assessment: Reporter; Result of Assessment: Possible Source of Assessment: Company; Result of Assessment: Possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: INTRACEREBRAL HAEMORRHAGE


VAERS ID: 1593536 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Throat irritation, Vaccination failure
SMQs:, 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? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Positive
CDC Split Type: ITJNJFOC20210831407

Write-up: This spontaneous report received from a consumer via a company representative concerned an 80 year old male 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, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on 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 throat problems, covid 19 infection, and suspected clinical vaccination failure, and was hospitalized for 6 days (date unspecified). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the patient died from covid 19, and throat problems. 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 covid 19 infection, throat problems and suspected clinical vaccination failure on an unspecified date. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000189701. The suspected product quality complaint that reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender''s Comments: V0: 20210831407- COVID-19 VACCINE AD26.COV2.S- Throat problems, COVID 19. 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). 20210831407-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: Covid 19; THROAT PROBLEMS


VAERS ID: 1593589 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-07-12
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2336 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Branchial cyst, Chest pain, Lymphadenitis, Lymphadenopathy, Pericarditis, Ultrasound scan
SMQs:, Systemic lupus erythematosus (broad), Congenital, familial and genetic disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (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: 2021-07-29
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease
Allergies:
Diagnostic Lab Data: Test Name: ultrasound; Result Unstructured Data: Test Result:swollen and inflamed lymph node detected; Comments: shows it in very bad condition
CDC Split Type: ITPFIZER INC202101045692

Write-up: This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-768842. A 75-year-old male patient received bnt162b2 (COMIRNATY, lot number: FC2336), dose 2 intramuscular, administered in arm left on 09Jun2021 as dose 2, 0.3 mL, single for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease. The patient''s concomitant medications were not reported. The patient previously took acetylsalicylic acid and experienced drug allergy. The patient previously received first dose of bnt162b2 (COMIRNATY, lot number: FA4597) on 19May2021 for COVID-19 Immunization. On 12Jul2021 swollen and inflamed lymph node detected by ultrasound, that show it in very bad condition. Pericarditis detected by immediate entry into emergency room privacy and hospitalization. After two days death occurred. - Actions taken (Immediate help by 112, accompanied by his daughter, always present, and hospitalized as quickly as possible in the aforementioned hospital, UTIC(intensive care unit) department.) - Impact on quality of life (10/10) - COVID 19 COMIRNATY VACCINE ( PFIZER): Administration site (left shoulder) Booster dose number (2) Description of reaction (Enlarged and inflamed lymph node detected by ultrasound, that show it in very bad condition. Pericarditis detected by immediate entry into the emergency room of privacy and subsequent hospitalization in UTIC ) On 19May2021 first dose Janssen Lotto FA4597, on 09Jun2021 second dose Janssen batch FC2336, on 12Jul2021 pericarditis detected in the emergency room, suspected branchial cyst, liquid leaks from the neoformation, treatment with antibiotic and surgical evaluation. on 28Jul2021 chest pain, hospitalization in UTIC, coronary angiography. on 29Jul2021 death. Reports are awaited. the notification V-202108-032654-2 is canceled as it is the same patient but the family members have not been able to insert everything in a single card. The patient died on 29Jul2021. It was unknown if an autopsy was performed. Reporter comment: Chronic obstructive pulmonary disease, acetylsalicylic acid allergy, wearer of tibial intramedullary nail due to road polytrauma.; Reported Cause(s) of Death: Swollen and inflamed lymph node; suspected branchial cyst; Pericarditis; Pain chest; Swollen and inflamed lymph node.


VAERS ID: 1593591 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-07-17
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Cardiac arrest
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), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLINA [FOLIC ACID]; ATORVASTATINA EG
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101056205

Write-up: This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB IT-MINISAL02-769580. A 49-year-old male patient received first dose of BNT162B2 (COMIRNATY), via intramuscular, administered in left arm on 27Jun2021 (Lot Number: FE2625) as 0.3 ml single dose for covid-19 immunisation. Medical history included slight hypercholesterolemia. Concomitant medications included folic acid (FOLINA) from 01Feb2020 to 17Jul2021; atorvastatin calcium (ATORVASTATINA EG) from 01Feb2020 to 17Jul2021. On 17Jul2021, the patient experienced irreversible cardio-circulatory arrest from acute coronary syndrome. The outcome of the events was fatal. The patient died on 17Jul2021. It was not reported if an autopsy was performed. Reporter Comment: Contacted the reporter, he did not report particular previous pathologies, if not slight hypercholesterolemia, on a family basis. Sender Comment: 11Aug2021: death ISTAT card loaded.; Reporter''s Comments: Contacted the reporter, he did not report particular previous pathologies, if not slight hypercholesterolemia, on a family basis.; Reported Cause(s) of Death: Irreversible cardio-circulatory arrest from Acute coronary syndrome; Irreversible cardio-circulatory arrest from Acute coronary syndrome.


VAERS ID: 1593592 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Fall, Fatigue, Investigation, Platelet count, Platelet count decreased, Pyrexia, Sepsis, Spinal fracture
SMQs:, Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: CLOPIDOGREL; ASPIRINETTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: platelet count; Result Unstructured Data: Test Result:low; Test Name: impact on quality of life; Result Unstructured Data: Test Result:10; Comments: 10/10
CDC Split Type: ITPFIZER INC202101055013

Write-up: This is a spontaneous report from contactable consumer downloaded from the Regulatory Authority-WEB IT-MINISAL02-769734. A 90-yeaer-old male patient received 2nd dose of BNT162B2 (COMIRNATY, lot number FA5831) at single dose on 08May2021 intramuscular in right arm for COVID-19 immunisation. Medical history included mild heart failure and allergy to penicillin. Concomitant drugs included clopidogrel and acetylsalicylic acid (ASPIRINETTA). Serious adverse event was reported as "healthy person, after second dose Pfizer sudden collapse, fever for 3 days, fall, hospitalization for fracture and platelet collapse. Death from blood sepsis after 4 days of hospitalization" with onset date of 12May2021 and seriousness criterion of death. The clinical course was reported as follows: after 2 days from the second vaccine dose the dynamic patient until that moment was fatigued and tired, after 5 days the fever also rises and following a nocturnal fall with a fracture of a vertebra and was hospitalized. Low platelet values were found during hospitalization. Lab data included impact on quality of life : 10/10. Outcome of healthy person, after second dose Pfizer sudden collapse, fever for 3 days, fall, hospitalization for fracture and platelet collapse. Death from blood sepsis after 4 days of hospitalization was fatal. Outcome of the other event was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: healthy person, after second dose Pfizer sudden collapse, fever for 3 days, fall, hospitalization for fracture and platelet collapse. Death from blood sepsis after 4 days of hospitalization; healthy person, after second dose Pfizer sudden collapse.


VAERS ID: 1593593 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-04-20
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Ascites, Biopsy pancreas, Carbohydrate antigen 19-9, Carcinoembryonic antigen, Computerised tomogram, Computerised tomogram abdomen, Gamma-glutamyltransferase, Metastases to liver, Metastases to lung, Metastases to lymph nodes, Metastases to the mediastinum, Pancreatic carcinoma, Tumour marker test, Ultrasound abdomen
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 54
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EFFICIB
Current Illness: Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Biopsy pancreas; Result Unstructured Data: Test Result:no information; Test Name: ca; Result Unstructured Data: Test Result:23446 ng/ml; Test Name: Carcino-fetal antigen; Result Unstructured Data: Test Result:12.06 ng/ml; Test Name: ct; Result Unstructured Data: Test Result:Shows ascitic effusion, mass of pancreatic tail (d; Comments: Shows ascitic effusion, mass of pancreatic tail (d = 10cm), mesenteric lymphadenomegalies. Peritoneal carcinosis. Neoplastic ascites. Hepatic, pulmonary metastases; Test Date: 20210505; Test Name: Abdomen CT; Result Unstructured Data: Test Result:no information; Test Name: gt range; Result Unstructured Data: Test Result:314 IU/l; Test Date: 20210515; Test Name: Tumour marker test; Result Unstructured Data: Test Result:no information; Test Date: 20210420; Test Name: Ultrasound abdomen; Result Unstructured Data: Test Result:no information
CDC Split Type: ITPFIZER INC202101056418

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-769755. An 82-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Right on 20Mar2021 09:00 (Batch/Lot Number: ET3620) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included type 2 diabetes mellitus from 12Jan2018 to 14Jul2021. Concomitant medication included metformin hydrochloride, sitagliptin phosphate (EFFICIB) taken for diabetes mellitus. The patient previously received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 20Feb2021 15:00 (Batch/Lot Number: EP9598) as single dose for covid-19 immunisation. On 20Apr2021, the patient experienced rapidly progressing pancreatic tail carcinoma (d= 9cm), immediately complicated with carcinosis, neoplastic ascites, liver and lung metastases, and mediastinal lymph nodes (ca 19.9 = 23,446, x 600 nn), Liquid formation between spleen and left kidney (d = 9 cm) of indeterminate nature (dilated splenic flexure of the colon? Other). No other abdominal injuries; Ca 19.9 = 23446 (normal value & lt; 37 ng / ml) Cea = 12.06 (normal value & lt; 7 ng / ml) GT range = 314 (normal value & lt; 55 U / L; CT scan performed + 15 days from abdominal ultrasound examination. Shows ascitic effusion, mass of pancreatic tail (d = 10cm), mesenteric lymphadenomegalies. Peritoneal carcinosis. Neoplastic ascites. Hepatic, pulmonary metastases and mediastinal lymph nodes (Ca 19.9 = 23,446, x 600 NN). The patient underwent lab tests and procedures which included biopsy pancreas: no information on unknown date, carbohydrate antigen 19-9: 23446 ng/ml on unknown date, Carcino-fetal antigen: 12.06 ng/ml on unknown date, computerized tomogram: Shows ascitic effusion, mass of pancreatic tail (d = 10cm), mesenteric lymphadenomegalies. Peritoneal carcinosis. Neoplastic ascites. Hepatic, pulmonary metastases on unknown date, Abdomen CT: no information on 05May2021, gamma-glutamyltransferase: 314 iu/l on unknown date, Tumour marker test: no information on 15May2021, ultrasound abdomen: no information on 20Apr2021. The patient died on 13Jun2021. It was not reported if an autopsy was performed. Sender Comment: Initial information of 10Aug2021: since it is a clinical picture of dubious attributability to one of the two doses received, I left the two doses as suspicious, as the doctor stated. Information dated 11Aug2021: clinical report of the referring physician is attached. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Ascites; Hepatic metastases; Lymph node metastases; Metastases to the mediastinum; Pulmonary metastases; Pancreatic carcinoma.


VAERS ID: 1593595 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-29
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101055050

Write-up: This is a spontaneous report from contactable Consumer downloaded from the Regulatory Authority-WEB IT-MINISAL02-769783. A 67-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via intramuscular in arm/shoulder left on 24May2021 (Lot Number: FC3558) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 03May2021 (Lot Number: EX7389) as single dose for COVID-19 immunization. The patient experienced fulminant leukemia with cerebral hemorrhage on 29Jun2021. The invention included ambulance intubation of the terminal ileum (TI). After a few hours, the patient experienced death. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Fulminant leukemia with cerebral hemorrhage; Fulminant leukemia with cerebral hemorrhage


VAERS ID: 1593708 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-15
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Cerebral infarction, Magnetic resonance imaging head, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Head MRI; Result Unstructured Data: Test Result:the finding of acute cerebral infarction; Comments: in the left corona radiata
CDC Split Type: JPPFIZER INC202101042056

Write-up: This is a spontaneous report from a contactable pharmacist received via Medical Information Team and a physician from the Regulatory Authority, Regulatory authority report number: v21123327. An 84-years-and 1-month-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 30Jun2021 at 16:00 (Batch/Lot Number: FC5947; Expiration Date: 30Sep2021) as dose 2, single (at the age of 84-years-old) for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Family history was not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 09Jun2021 (Batch/Lot Number: EY0779, expiration date: 31Aug2021) as dose 1, single for Covid-19 immunisation. The course of the event ''sudden death'' was as follows: On 09Jun2021, the patient received the first vaccination. On 30Jun2021, the patient received the second vaccination. On 15Jul2021 at 15:00, inarticulateness and right hemiplegia appeared. Head Magnetic Resonance Imaging (MRI) showed the finding of acute cerebral infarction in the left corona radiata, for which the patient was emergently admitted to the neurosurgery department of the reporting hospital and conservative therapy was initiated. The patient was hospitalized for acute cerebral infarction (cerebral infarction) from Jul2021 to an unknown date. On 31Jul2021 at 11:20, a nurse visited the patient''s room and found that the patient was in cardio-respiratory arrest. Lifesaving measures was performed; however, on the same day at 12:12, death was confirmed. Therapeutic measures were taken as a result of sudden death, acute cerebral infarction and cardio-respiratory arrest. The patient died on 31Jul2021. The outcome of the event sudden death was fatal while the outcome of the rest of the events was unknown. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the events and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: the patient developed cerebral infarction 15 days after the second vaccination, and experienced sudden death 31 days after the second vaccination. Although causality between the event and the vaccine was unknown, the case involved no comorbidity that could directly result in death.; Reported Cause(s) of Death: Sudden death.


VAERS ID: 1593709 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Decreased appetite, Embolic cerebral infarction, Investigation
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   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: Medical History/Concurrent Conditions: Deep venous thrombosis NOS; Dyslipidaemia; Hypertension; Hyperuricaemia; Vertigo
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: Imaging test; Result Unstructured Data: Test Result:brain stem infarction
CDC Split Type: JPPFIZER INC202101044140

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123298. The patient was an 88-year and 2-month-old female. Body temperature before vaccination was not reported. Medical history included hypertension, dyslipidaemia, hyperuricaemia, deep venous thrombosis and benign paroxysmal vertigo. Concomitant medications and family history were not provided. On 11Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose (dose 1, single) for COVID-19 immunization. On 02Jul2021 in the afternoon (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose (dose 2, single) for COVID-19 immunization. On 05Jul2021 at 09:00 (3 days after the vaccination), the patient experienced embolic cerebral infarction (cerebral infarction caused by arrhythmia) . The patient was admitted to the reporter''s hospital on the same day (05Jul2021). On 08Jul2021 (6 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: According to the patient''s family, after the vaccination, the patient had lost appetite. On 05Jul2021 at 07:30, the patient had a conversation with her son and thereafter her son confirmed (illegible). The patient had no symptoms at this time. The shuttle bus of the senior day care center came, but they could not get hold of her, so they contacted her son. The son found that the patient collapsed at home, and then she was transferred to the reporter''s hospital. Since her respiratory status was unstable, intubation was performed. Imaging test showed finding of brain stem infarction (on 05Jul2021). Based on the result, embolic cerebral infarction was diagnosed. Conservative therapy was performed. On 08Jul2021, the patient died. It was not reported if an autopsy was performed. Outcome of the event decreased appetite was unknown while outcome of the remaining events was fatal. The reporting physician classified the events as serious (hospitalization) and assessed the causality between the event and BNT162b2 as unassessable. Cerebral infarction caused by arrhythmia was considered as an other possible cause. The reporting physician commented as follows: After the vaccination, decreased appetite was noted, and the possibility that it (illegible) circulatory dynamics could not be denied. Therefore, the causal relationship with BNT162b2 could not be proved.; Reported Cause(s) of Death: embolic cerebral infarction (cerebral infarction caused by arrhythmia); embolic cerebral infarction (cerebral infarction caused by arrhythmia)


VAERS ID: 1593710 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-22
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Bacterial test, Cardiovascular disorder, Enterocolitis, Intestinal perforation, Peritonitis, Pyrexia, Vasculitis, Viral test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal perforation (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Vasculitis (narrow), Noninfectious diarrhoea (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: 2021-07-18
   Days after onset: 26
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: Aortic aneurysm; Hypertension; Stent placement
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: bacterial type; Test Result: Negative ; Test Date: 20210623; Test Name: viral type; Test Result: Negative
CDC Split Type: JPPFIZER INC202101044364

Write-up: Abdominal pain/Enterocolitis; Pyrexia; Intestinal perforation; enterocolitis originating from vasculitis; Peritonitis perforative; arteriosclerosis was severe; potential blood flow disorder; This is a spontaneous report from a contactable physician received from the RA. The regulatory authority report number is v21123299. An 85-year and 10-month-old male patient received bnt162b2 (COMIRNATY; Batch/Lot number was not reported), via an unspecified route of administration, on 13Jun2021 (the day of the vaccination, at the age of 85 years old) as dose number unknown, single for COVID-19 immunisation. Body temperature before vaccination and family history were not reported. Medical history included hypertension and aortic aneurysm (a stent was placed). Concomitant medications were not reported. On 22Jun2021 at 22:30 (9 days after the vaccination), the patient experienced enterocolitis and pyrexia. On 23Jun2021 at unknown time (10 days after the vaccination), the patient was admitted to the hospital because of abdominal pain and pyrexia. On 18Jul2021 at unknown time (35 days after the vaccination), the patient experienced intestinal perforation. On 18Jul2021 (35 days after the vaccination), the outcome of the events was fatal. The cause of death was reported as peritonitis perforative. The course of the events was as follows: On 23Jun2021 (10 days after the vaccination), the patient was admitted to the hospital because of abdominal pain and pyrexia. There were findings of enterocolitis; viral type and bacterial type were negative. The symptoms were temporarily alleviated. However, the patient repeatedly had a relapse of the symptoms when starting to eat, due to which vaccination-associated enterocolitis originating from vasculitis was diagnosed. Steroid was started. The symptoms had improved, but a sudden change occurred on 18Jul2021; even intestinal perforation was noted, risk was high, therefore the patient did not wish for surgical treatment. On 18Jul2021 at 16:21 (35 days after the vaccination), the patient died. The reporting physician classified the event enterocolitis and pyrexia as serious (death) and assessed that the events enterocolitis and pyrexia were related to BNT162b2. The seriousness and causality of the other events were not clearly reported. Other possible causes of the events such as any other diseases: Aside from aortic aneurysm, arteriosclerosis was severe, and there was potential blood flow disorder. The outcome of the events was fatal. The patient died on 18Jul2021. It was not reported if an autopsy was performed. Reporter''s comment: Although peritonitis perforative was the cause of death, enterocolitis or vasculitis was considered as the underlying cause. This case was considered consistent with post-vaccination death cases.; Reported Cause(s) of Death: Peritonitis perforative


VAERS ID: 1593711 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-13
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Pallor, Respiratory arrest, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (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: Medical History/Concurrent Conditions: Cerebral haemorrhage; Left hemiplegia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101045201

Write-up: This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21123339. An 84-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FC5295; Expiration Date: 30Sep2021), via an unspecified route of administration on 03Aug2021 13:30 as dose 1, single for COVID-19 immunisation. Medical history included cerebral haemorrhage and left hemiplegia. The family history was not provided. The patient''s concomitant medications were not reported. Body temperature before vaccination was not provided. 10 days after the vaccination, on 13Aug2021 at 06:30, the patient experienced vomiting; at 07:00, the patient experienced pallor facial, respiratory arrest and loss of consciousness. The course of the event was as follows: On 13Aug2021, at 06:30 (10 days after vaccination), the patient experienced vomiting. At 07:00, the patient experienced pallor facial, respiratory arrest, and loss of consciousness. At 07:20, although cardiopulmonary resuscitation (CPR) was performed, the patient was confirmed to die at 07:49. The patient died on 13Aug2021. An autopsy was not performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as un-assessable. Reporter Comment: On 03Aug2021, after the vaccination, the patient''s physical condition was favorable. However, the condition suddenly changed, and he died. Although the assessment was impossible, the event onset was 10 days after the vaccination and no other specified findings were observed.; Reporter''s Comments: On 03Aug2021, after the vaccination, the patient''s physical condition was favorable. However, the condition suddenly changed, and he died. Although the assessment was impossible, the event onset was 10 days after the vaccination and no other specified findings were observed.; Reported Cause(s) of Death: Vomiting; Pallor facial; Respiratory arrest; loss of consciousness.


VAERS ID: 1593712 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome
SMQs:, Myocardial infarction (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Aortic valve replacement; Atrial fibrillation; End stage renal failure; Haemodialysis (Monday, Wednesday, Friday)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101048557

Write-up: This is a spontaneous report from a contactable physician received via Regulatory Authority. A non-pregnant 80-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 18Jun2021 09:45 (the day of vaccination) (Batch/Lot Number: FA7338; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included aortic valve replacement, angina pectoris, atrial fibrillation, and end stage renal failure. The patient received hemodialysis (Monday, Wednesday, and Friday) within 2 weeks of vaccination. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historically received the first dose of COMIRNATY (Lot number EY0779; Expiration Date 31Aug2021) on 28May2021 for COVID-19 immunisation. On 20Jun2021 at 09:00 (one day/23 hours/15 minutes after the vaccination), the patient experienced acute coronary syndrome. The event resulted in emergency room/department or urgent care, hospitalization on an unspecified date in 2021. The reported event was as follows: On 21Jun2021 (three days after vaccination), the patient died. Duration of hospitalization was 2 days. Death cause was acute coronary syndrome. Autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was fatal with treatment including a drip infusion of morphine. The reporting physician assessed the event as serious (life-threatening, hospitalization, and death).; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event acute coronary syndrome (fatal) the suspect drug. 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: Acute coronary syndrome.


VAERS ID: 1593714 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-08-14
   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: Depression
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: Body temperature; Result Unstructured Data: Test Result:unknown; Comments: Body temperature before vaccination was not reported
CDC Split Type: JPPFIZER INC202101049790

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority; the Regulatory Authority report number is v21123437. A 49-year and 1-month-old male patient received the first dose of BNT162b2 (COMIRNATY) Solution for injection (batch/lot number and expiration date were unknown) via an unspecified route of administration on 12Aug2021 at 11:00 (the day of vaccination), as DOSE 1, SINGLE for COVID-19 immunization at 49 years and 1 month old (age at vaccination). Body temperature before vaccination was not reported. The patient''s medical history included depression from an unknown date. Family history and concomitant medications were not reported. On 14Aug2021 at around 08:00 (around 1 day 21 hours after the vaccination), the patient experienced cardio-respiratory arrest. On 14Aug2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 14Aug2021 at around 08:00, the patient was found lying in the living room at home by his family, who requested an ambulance. The patient was in cardio-respiratory arrest. 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: Autopsy at a medical examiner''s office was requested. The batch/lot number for BNT162B2 was not provided and will be requested during follow-up.; Reported Cause(s) of Death: Cardio-respiratory arrest.


VAERS ID: 1593715 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9909 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Artery dissection, Autoimmune haemolytic anaemia, Blood bilirubin, Blood creatinine, Blood test, Blood urea, C-reactive protein, Computerised tomogram, Coombs direct test, Fall, Haemoglobin, Haptoglobin, Hepatic infarction, Investigation, Liver disorder, Metabolic acidosis, Mouth haemorrhage, Multiple organ dysfunction syndrome, Pain, Plasminogen activator inhibitor, Platelet count, Platelet count decreased, Pneumonia, SARS-CoV-2 test, Splenic infarction, Thrombin-antithrombin III complex, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haemolytic disorders (narrow), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREDONINE [PREDNISOLONE]; ACELIO; ZOSYN; PRALIA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fish allergy; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: Bilirubin total; Test Result: 0.9 mg/dl; Test Date: 20210729; Test Name: Bilirubin total; Test Result: 1 mg/dl; Test Date: 20210804; Test Name: Bilirubin total; Test Result: 7.3 mg/dl; Test Date: 20210808; Test Name: Bilirubin total; Test Result: 16.6 mg/dl; Test Date: 20210809; Test Name: Bilirubin total; Test Result: 19.9 mg/dl; Test Date: 20210531; Test Name: Creatinine; Test Result: 1.1 mg/dl; Test Date: 20210724; Test Name: Creatinine; Test Result: 1.48 mg/dl; Test Date: 20210725; Test Name: Creatinine; Result Unstructured Data: Test Result:Cr was aggravated from 1.9 to 4.5 mg/dl; Test Date: 20210729; Test Name: Creatinine; Test Result: 5.85 mg/dl; Comments: 5.8 revealed renal failure; Test Date: 20210804; Test Name: Creatinine; Result Unstructured Data: Test Result:2.2 (under dialysis) mg/dl; Test Date: 20210808; Test Name: Creatinine; Result Unstructured Data: Test Result:1.2 (under dialysis) mg/dl; Test Date: 20210809; Test Name: Creatinine; Result Unstructured Data: Test Result:1.2 (under dialysis) mg/dl; Test Date: 20210812; Test Name: Blood test; Result Unstructured Data: Test Result:autoimmune haemolytic anaemia was also noted; Test Date: 20210729; Test Name: BUN; Result Unstructured Data: Test Result:121.2; Comments: revealed renal failure; Test Date: 20210808; Test Name: Contrast-enhanced CT; Result Unstructured Data: Test Result:hepatic infarction and splenic infarction; Comments: revealed thrombus in the coeliac artery and superior mesenteric artery with findings of hepatic infarction and splenic infarction; Test Date: 20210721; Test Name: CT; Result Unstructured Data: Test Result:pneumonia; Test Date: 2021; Test Name: Coombs direct test; Result Unstructured Data: Test Result:positive; Test Date: 20210729; Test Name: CRP; Result Unstructured Data: Test Result:ranged between 6 and 8 showing persistently high i; Comments: ranged between 6 and 8 showing persistently high inflammatory markers; Test Date: 20210531; Test Name: Haemoglobin; Result Unstructured Data: Test Result:12.2 g/dl; Test Date: 20210724; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.6 g/dl; Test Date: 20210729; Test Name: Haemoglobin; Result Unstructured Data: Test Result:8.7 g/dl; Test Date: 20210804; Test Name: Haemoglobin; Result Unstructured Data: Test Result:8.7 g/dl; Test Date: 20210808; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.6 g/dl; Test Date: 20210809; Test Name: Haemoglobin; Result Unstructured Data: Test Result:9.1 g/dl; Test Date: 2021; Test Name: Haptoglobin; Result Unstructured Data: Test Result:decreased; Test Date: 2021; Test Name: ADAMTS-13 activity; Test Result: 13 %; Test Date: 2021; Test Name: PAI-1; Result Unstructured Data: Test Result:19.1; Test Date: 20210531; Test Name: Platelet; Result Unstructured Data: Test Result:434000 /mm3; Test Date: 20210724; Test Name: Platelet; Result Unstructured Data: Test Result:226000 /mm3; Test Date: 20210729; Test Name: Platelet; Result Unstructured Data: Test Result:42000 /mm3; Test Date: 20210804; Test Name: Platelet; Result Unstructured Data: Test Result:60000 /mm3; Test Date: 20210808; Test Name: Platelet; Result Unstructured Data: Test Result:28000 /mm3; Test Date: 20210809; Test Name: Platelet; Result Unstructured Data: Test Result:12000 /mm3; Test Date: 2021; Test Name: platelets; Result Unstructured Data: Test Result:ranged from 26000 to 88000; Comments: showing platelets decreased; Test Date: 20210721; Test Name: platelets; Result Unstructured Data: Test Result:decreased; Test Date: 20210729; Test Name: platelets; Result Unstructured Data: Test Result:decreased; Comments: from 400000 to 50000; Test Date: 20210729; Test Name: SARS-COV-2 PCR; Result Unstructured Data: Test Result:negative; Test Date: 2021; Test Name: TAT; Result Unstructured Data: Test Result:5.2; Test Date: 20210531; Test Name: White blood cell; Result Unstructured Data: Test Result:12400 /mm3; Test Date: 20210724; Test Name: White blood cell; Result Unstructured Data: Test Result:36000 /mm3; Test Date: 20210729; Test Name: White blood cell; Result Unstructured Data: Test Result:18730 /mm3; Test Date: 20210804; Test Name: White blood cell; Result Unstructured Data: Test Result:25850 /mm3; Test Date: 20210808; Test Name: White blood cell; Result Unstructured Data: Test Result:23670 /mm3; Test Date: 20210809; Test Name: White blood cell; Result Unstructured Data: Test Result:25820 /mm3
CDC Split Type: JPPFIZER INC202101049799

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is i21103089 and v21123371. An 82-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FC9909, Expiration date 30Sep2021), dose 2 intramuscular on 19Jul2021 (the day of vaccination, at the age of 82-year-old) as dose 2, 0.3 ml single for COVID-19 immunization. Medical history included rheumatoid arthritis. It was unknown whether the patient had drinking and smoking habits. The patient had allergy to mackerel. Concomitant medications included prednisolone (PREDONINE) taken for rheumatoid arthritis; paracetamol (ACELIO); piperacillin sodium, tazobactam sodium (ZOSYN); denosumab (PRALIA). The patient was on treatment of rheumatoid arthritis since in her 40s (started using prednisolone at 2 mg in ''Sep2021'' (as reported)). On 14Jun2021 at unknown time, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) at a dose of 0.3 ml intramuscularly as a single dose for COVID-19 immunization. On 21Jul2021 at unknown time (2 days after the vaccination), the patient experienced pneumonia, acute renal failure, platelets decreased, and autoimmune haemolytic anaemia. On 29Jul2021 at unknown time (10 days after the vaccination), the patient experienced intra-abdominal artery dissection, hepatic infarction, and splenic infarction. On 12Aug2021 (24 days after the vaccination), the outcome of all the events was fatal. It was unknown whether autopsy was done. The course of the events was as follows: Body temperature before vaccination was unknown. On 19Jul2021 (the day of vaccination), the patient fell, had pain, and was admitted to the previous hospital. On 21Jul2021 (2 days after the vaccination), the patient was pointed out to have pneumonia and was treated, but no improvement was obtained, and progression of renal failure was noted. On 21Jul2021 (2 days after the vaccination), CT revealed pneumonia, and tazobactam sodium was started. On 22Jul2021 (3 days after the vaccination), MINOMYCIN was added. On 25Jul2021 (6 days after the vaccination), the regimen was changed to MEROPEN + MINOMYCIN. The creatinine (Cr) was aggravated from 1.9 to 4.5. On 29Jul2021 (10 days after the vaccination), the patient was transferred to the reporting hospital. Platelets decreased (from 400000 to 50000) was noted with oral mucosa bleeding (onset on 21Jul2021). The patient was mechanically ventilated. Continuous hemodiafiltration was started. Pneumonia slightly improved temporarily, and the mechanical ventilator was removed, but the C-reactive protein (CRP) ranged between 6 and 8 (under administration of PREDNISOLONE 40 mg) showing persistently high inflammatory markers. Management with a mechanical ventilator was required. On 29Jul2021 (10 days after the vaccination), SARS-COV-2 polymerase chain reaction (PCR) test was negative. On the same date, the patient was transferred to the reporting hospital. Treatment indicated for pneumonia bacterial was continued, but the imaging findings of pneumonia showed little improvement. On 29Jul2021, the blood urea nitrogen (BUN) was 121.2 and the Cr was 5.8, which revealed renal failure; continuous hemodiafiltration was performed. The platelets (PLT) ranged from 26000 to 88000, showing platelets decreased in 2021. On 08Aug2021 (20 days after the vaccination), marked aggravation of liver disorder was noted, and contrast-enhanced computerised tomography (CT) revealed thrombus in the coeliac artery and superior mesenteric artery with findings of hepatic infarction and splenic infarction. Radical treatment was difficult under the general condition, and the patient was mechanically ventilated again and received blood purification therapy. On 08Aug2021 (20 days after the vaccination), aggravation of liver disorder and acidosis was observed. An intensive care was given in the intensive care unit (ICU), but acidosis progressed. However, metabolic acidosis did not improve, and the general condition worsened. On 12Aug2021 (24 days after the vaccination), the patient died. Autoimmune haemolytic anaemia was also noted on a blood test. Lab data was as follows: on 31May2021, white blood cell 12400/ul, platelet 434000/ul, haemoglobin 12.2 g/dL, creatinine 1.1 mg/dL; on 24Jul2021, white blood cell 36000/ul, platelet 226000/ul, haemoglobin 11.6 g/dL, creatinine 1.48 mg/dl, bilirubin total 0.9 mg/dL; on 29Jul2021, white blood cell 18730/ul, platelet 42000/ul, haemoglobin 8.7 g/dL, creatinine 5.85 mg/dl, bilirubin total 1 mg/dL; on 04Aug2021, white blood cell 25850/ul, platelet 60000/ul, haemoglobin 8.7 g/dL, creatinine 2.2 mg/dl (under dialysis), bilirubin total 7.3 mg/dL; on 08Aug2021, white blood cell 23670/ul, platelet 28000/ul, haemoglobin 11.6 g/dL, creatinine 1.2 mg/dl (under dialysis), bilirubin total 16.6 mg/dL; on 09Aug2021, white blood cell 25820/ul, platelet 12000/ul, haemoglobin 9.1 g/dL, creatinine 1.2 mg/dl (under dialysis), bilirubin total 19.9 mg/dL. There were no other procedure/diagnosis besides the above drugs. On 12Aug2021 (24 days after the vaccination), the patient died (a complication of autoimmune haemolytic anaemia was also noted based on haptoglobin decreased in 2021 and positive coombs direct test in 2021). On unspecified date in 2021, the patient experienced multi-organ failure. Cause of death included Pneumonia, acute renal failure, platelets decreased, Autoimmune haemolytic anaemia, Intra-abdominal artery dissection, hepatic infarction, splenic infarction and multi-organ failure (respiratory failure, renal failure, hepatic failure). The outcome of the remaining events was unknown. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unknown. The reporting physician commented as follows: The patient with underlying condition of rheumatoid arthritis experienced symptoms including pneumonia, renal failure, platelets decreased, and oral mucosal disorder on the second day from the coronavirus vaccination and ultimately died of multi-organ failure (respiratory failure, renal failure, hepatic failure) about 19 days later. Coombs direct test was positive and haptoglobin decreased was present; manifestation of autoimmune haemolytic anaemia was considered, but at the time of diagnosis, aggressive therapeutic intervention was difficult because of progressing irreversible organ disorder. For differentiation of thrombotic microangiopathy, ADAMTS-13 activity was measured (13%) but did not meet the diagnosis criteria. Regarding the platelets decreased, the thrombin antithrombin complex (TAT) and plasminogen activator inhibitor-1 (PAT-1) (TAT 5.2, PAI-1 19.1) were not high enough to consider septic disseminated intravascular coagulation (DIC), and a pathology that was different from typical septic DIC was suspected. Considering that the present underlying disease of rheumatoid arthritis had been reportedly stable under outpatient treatment and that the symptoms occurred 2 days after the vaccination, the possible relation with the vaccination could not be denied. The reporting physician commented as follows: The patient died of pneumonia, acute renal failure, platelets decreased, coagulation disorder, and multi-organ failure including hepatic failure. The relation with the vaccine was also conceivable considering that the symptoms developed 2 days after the vaccination against the coronavirus.; Reported Cause(s) of Death: Pneumonia; Autoimmune haemolytic anaemia; Intra-abdominal artery dissection; hepatic infarction; splenic infarction; acute renal failure; platelets decreased; multi-organ failure (respiratory failure, renal failure, hepatic failure)


VAERS ID: 1593716 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood test, Body temperature, Condition aggravated, Decreased appetite, Glycosylated haemoglobin, Hepatic failure
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: JARDIANCE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholic; Diabetes mellitus aggravated; Heavy drinker; Hepatic failure
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: Glu; Result Unstructured Data: Test Result:156; Test Date: 20210615; Test Name: Blood test; Result Unstructured Data: Test Result:revealed diabetes mellitus aggravated; Test Date: 20210804; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210615; Test Name: HbA1c; Test Result: 8.2 %
CDC Split Type: JPPFIZER INC202101049806

Write-up: This is a spontaneous report from a contactable nurse received from the Regulatory Authority. Regulatory authority report number is v21123875. An 81-year-old (81-year and 5-month-old) male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FD1945; Expiration Date: 31Oct2021), via an unspecified route of administration on 04Aug2021 at 14:40 (at the age of 81-years-old) as dose 2, single for COVID-19 immunisation, body temperature before vaccination was 36.6 degrees centigrade. Medical history included end stage alcoholic hepatic failure, alcoholic, heavy drinker who regularly drank 2 bottles of whisky a week from an unknown date, diabetes mellitus aggravated from 15Jun2021 to an unknown date. Concomitant medication included empagliflozin (JARDIANCE) taken for an unspecified indication from 15Jun2021 to an unspecified stop date. The patient previously received the first dose of COMIRNATY on 15Jul2021 for COVID-19 immunisation. The patient experienced inappetence on 05Aug2021 at 16:51, further aggravation of the general condition on 05Aug2021 (1 day after the vaccination) and hepatic failure associated with chronic alcohol poisoning on an unspecified date. The clinical course of the events was as follows: The patient was an alcoholic and a heavy drinker who regularly drank 2 bottles of whisky a week. The family did not wish for a hospital treatment. The previous hospital considered it difficult to continue the treatment; the patient was referred to the reporting clinic and was receiving a home-visit medical care. There had been fluctuation in his dietary intake. On 15Jun2021, a blood test revealed diabetes mellitus aggravated. The HbA1c was 8.2%, and the glucose (Glu) was 156. Empagliflozin 10 mg was added. On 15Jul2021, the patient received the first vaccination at his and his family''s request. No significant change was noted after the vaccination. On 04Aug2021 (the day of vaccination), a home visit was made for the vaccination. Since a week before, the patient had experienced decreased appetite and had tended to have aggravated general condition, but no pyrexia occurred, and the vital signs showed no abnormalities. The vaccination was done after a consultation with the patient and his family. On 05Aug2021 (1 day after the vaccination), further aggravation of the general condition was reported. On the same date at 16:45, an irregular house visit was made, and at 16:51, the patient was attended on his deathbed at home. The cause of death was diagnosed as hepatic failure associated with chronic alcohol poisoning. The patient died on 05Aug2021. It was unknown if an autopsy was performed. The reporting nurse classified the event inappetence as serious (death) and assessed that the event inappetence was unrelated to BNT162b2. The seriousness and causality of the other events were not clearly reported. Other possible causes of the event inappetence such as any other diseases included aggravated condition associated with alcoholic hepatic failure. The reporting nurse commented as follows: Despite the course of aggravated general condition, the second BNT162b2 vaccination was performed after a consultation with the patient and his family. Under the present exacerbation of the underlying disease, poor dietary intake and others were also noted in the morning on the same day, but the BNT162b2 vaccination was given as there was no significant changes in the vital signs. On the next day, the patient died, but the patient had no symptoms like allergic reaction and pyrexia that were suggestive of BNT162b2-related side effects. Based on the course, death due to hepatic function aggravated associated with chronic alcohol poisoning was considered.; Reported Cause(s) of Death: Hepatic failure associated with chronic alcohol poisoning.


VAERS ID: 1593717 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-14
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101050089

Write-up: This is a spontaneous report from a contactable physician (inoculator) received via Regulatory Authority. This report received from the Regulatory Authority. Regulatory authority report number is v21123499. A non-pregnant 57-year and 9-month-old female patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC9880, Expiration date 30Sep2021) intramuscularly in the left arm on 04Aug2021 at 12:30 (the day of vaccination; at the age of 57-year and 9-month-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included diabetes mellitus. Body temperature before vaccination was 37.0 degrees centigrade on 04Aug2021. The patient family history was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. Concomitant medications were not reported. On 14Jul2021 (at the age of 57 years old), the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number EW0203, Expiration date 30Sep2021) intramuscularly in the left arm as single dose for COVID-19 immunisation. On 14Aug2021 at unspecified time (9 days 11 hrs 30 min after the vaccination), the patient died (death). The event resulted in department or urgent care, death. Cause of death, if autopsy performed, if treatment received for the event, if the patient was diagnosed with COVID-19 prior to vaccination, if the patient had been tested for COVID-19 since the vaccination were unknown. The course of the event was as follows: The patient condition changed suddenly at home, she was transported to another hospital and confirmed dead. It was reported by police, therefore details including time was unknown. Because the patient had not received the diabetes management at the reporter hospital, it was unknown if there were other possible causes of the event. The reporting physician assessed the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. The reporting physician did not provide any further comment. Outcome of the event was fatal. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Death/condition changed suddenly at home.


VAERS ID: 1593718 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure abnormal, Blood pressure measurement, Body temperature, Cardiac arrest, Chills, Coma scale, Dizziness, Dyspnoea, Fall, Head injury, Heart rate, Heart rate decreased, Interstitial lung disease, Loss of consciousness, Oxygen saturation, Oxygen saturation decreased, Pneumothorax, Respiratory rate decreased, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BAYASPIRIN; PREDNISOLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder; Hospitalisation; Interstitial pneumonia; Renal disease; Restlessness
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: BP; Result Unstructured Data: Test Result:not increased easily; Test Date: 20210709; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210712; Test Name: JCS; Result Unstructured Data: Test Result:100; Comments: During computerised tomography; Test Date: 20210712; Test Name: JCS; Result Unstructured Data: Test Result:300; Test Date: 20210712; Test Name: HR; Result Unstructured Data: Test Result:decreased; Test Date: 20210712; Test Name: SpO2; Result Unstructured Data: Test Result:70s %; Comments: with oxygen mask at 10 L; Test Date: 20210712; Test Name: Xp; Result Unstructured Data: Test Result:right pneumothorax; Test Date: 20210712; Test Name: Xp; Result Unstructured Data: Test Result:Alleviated pneumothorax
CDC Split Type: JPPFIZER INC202101051319

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123477. An 87-year and 5-month-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0201, Expiration date 30Sep2021) via an unspecified route of administration on 09Jul2021 (the day of vaccination, at age of 87 years old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included heart disease and kidney disease. The patient had been admitted and treated for interstitial pneumonia from 03Jun2021 to 25Jun2021; patient with strong restlessness was discharged. Body temperature before vaccination was 36.3 degrees Centigrade on 09Jul2021. The patient family history was not reported. Concomitant medications included acetylsalicylic acid (BAYASPIRIN) as a blood thinner, and oral prednisolone (PSL; PREDNISOLONE). On 18Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 10Jul2021 (1 day after the vaccination), the patient experienced interstitial pneumonia. On 11Jul2021 (2 days after the vaccination), the patient was admitted to the reporting physician''s hospital. On 12Jul2021 (3 days after the vaccination), the patient died. The outcome of the event was fatal. The course of the event was as follows: On 09Jul2021 (the day of vaccination), the patient received the second dose of COVID-19 vaccine. On 10Jul2021 (1 day after the vaccination), the patient presented with dizziness, chills and dyspnoea. The patient fell down three times, and hit the back of the head. Neither wound nor queasy was present. On 11Jul2021 (2 days after the vaccination), dizziness, chills and dyspnoea persisted. However, the patient did not visit hospital or consult on the phone. He kept an eye on his own symptoms. As the symptoms persisted even at night, the patient visited the reporting physician''s hospital after contacting by phone. On 12Jul2021 at 03:00 (3 days after the vaccination), after hospitalization, respiratory condition was gradually aggravated. Oxygen saturation (SpO2) was 70s% even with oxygen mask at 10 L, so nurse call was answered. A call was made to the patient''s eldest son. Informed consent (IC) was done, and Do Not Attempt Resuscitation (DNAR) was reaffirmed. Central venous catheter (CV) was inserted. After CV insertion, right pneumothorax was revealed through X-ray photograph (Xp) performed for confirmation. During computerised tomography (CT), level of consciousness depressed at 100 on Japan Coma Scale (JCS). Shortly after returning the room, drainage for right pneumothorax was performed using a CV tube. Approximately 500 cc air was drained. Pneumothorax was confirmed to be alleviated by Xp later. Urgent drainage made lung expansion. However, blood pressure (BP) was not increased easily, level of consciousness was at 300 on JCS, heart rate (HR) decreased, breathing became feeble. Then, the patient went into cardiac arrest (arrest). Despite DNAR, cardiopulmonary resuscitation (CPR) was performed; however, the patient did not come back to life. As natural course, the death was confirmed at 07:03. Events Interstitial pneumonia, dizziness, chills, dyspnoea reported hospitalized from 11Jul2021 to 12Jul2021. Events Interstitial pneumonia, dizziness, chills, dyspnoea, right pneumothorax resulted in physician office visit. Treatment received for events Interstitial pneumonia, cardiac arrest, dizziness, chills, dyspnoea, right pneumothorax, Oxygen saturation (SpO2) was 70s%. The outcome of events Interstitial pneumonia and cardiac arrest was fatal, the event right pneumothorax was recovering, while of the other events was unknown. It was not reported if an autopsy was performed. The reporting physician classified the event interstitial pneumonia as serious (hospitalization) and assessed it was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was interstitial pneumonia. Reporter comment: The patient had been admitted and treated for interstitial pneumonia from 03Jun2021 to 25Jun2021. Then, the patient with strong restlessness was discharged. Due to aggravated respiratory condition, he was readmitted on 11Jul2021. The patient had been taking oral prednisolone (PSL; PREDNISOLONE).; Reported Cause(s) of Death: cardiac arrest; Interstitial pneumonia.


VAERS ID: 1593719 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-31
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood pressure decreased, Blood pressure measurement, Blood sodium, Body temperature, C-reactive protein, Computerised tomogram, Heart rate, Ileus, Radioallergosorbent test, Vital signs measurement, White blood cell count, pH body fluid
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal obstruction (narrow), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blister (blisters of lower limbs (unknown cause)); Epilepsy; Ileus (At the age of 25, the patient had undergone laparotomy for ileus due to pica.); Ileus adhesive; Laparotomy (At the age of 25, for ileus due to pica.); Pica (At the age of 25, the patient had undergone laparotomy for ileus due to pica.); Psychomotor development impaired; Psychosomatic disease; Seafood allergy (possibility of seafood allergy (3.56 for shrimps and 3.60 for crabs on RAST)
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: auscultation; Result Unstructured Data: Test Result:Sound in the abdomen was weak; Comments: with metallic sound; Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result:75/44; Comments: after examinations; Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result:97/64; Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result:decreased were noted during the surgery; Test Date: 20210731; Test Name: Na; Result Unstructured Data: Test Result:140; Test Date: 20210726; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination; Test Date: 20210731; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210801; Test Name: CT; Result Unstructured Data: Test Result:ileus was diagnosed; Comments: At 10:45; Test Date: 20210731; Test Name: CRP; Result Unstructured Data: Test Result:1.52; Test Date: 20210731; Test Name: HR; Result Unstructured Data: Test Result:70s; Test Date: 20210731; Test Name: pH; Result Unstructured Data: Test Result:7.389; Test Name: RAST; Result Unstructured Data: Test Result:3.56 for shrimps and 3.60 for crabs; Test Date: 20210801; Test Name: vital signs; Result Unstructured Data: Test Result:poor vital signs; Comments: such as blood pressure decreased; during the surgery; Test Date: 20210731; Test Name: WBC; Result Unstructured Data: Test Result:9500
CDC Split Type: JPPFIZER INC202101056683

Write-up: This is a spontaneous report from a contactable physician received via Regulatory Authority; the Regulatory Authority report number is v21123584. A 50-year and 7-month-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 26Jul2021 09:52 (Batch/Lot Number: EY4834; Expiration Date: 31Aug2021) at the age of 50-year-old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications including antiepileptic agent within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included repeated blisters of lower limbs (unknown cause), suggestive of a possibility of seafood allergy (3.56 for shrimps and 3.60 for crabs on radioallergosorbent test [RAST]) (no history of immediate reaction). Other medical history included delayed psychomotor development of unknown cause, severe psychosomatic disease, epilepsy, ileus, pica, and ileus adhesive. At the age of 25, the patient had undergone laparotomy for ileus due to pica. After that, the patient had a history of several episodes of ileus adhesive, which had been improving with conservative therapy at each time. The patient family history has nothing in particular. On 05Jul2021, at the age of 50-year-old, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. On 26Jul2021 at 09:52 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection. Body temperature before vaccination was 36.1 degrees Centigrade. On 31Jul2021, the patient experienced ileus. The event resulted in emergency room/department or urgent care, hospitalization and death. The patient was hospitalized on 01Aug2021 and discharged on 02Aug2021. On 01Aug2021 (6 days after the vaccination), the patient died. The outcome of the event was fatal with treatment including partial intestinal tract resection, and the intensive care such as artificial respiration management and vasopressor administration. The course of the event was as follows: On 31Jul2021 at around 05:00 (5 days after the vaccination), 2 episodes of yellow bloody vomiting, and abdominal distension developed. Enema administration enabled a large amount of soft feces excretion. Body temperature (BT) was 36.2 degrees Centigrade, and heart rate (HR) was 70s. Laboratory data included that white blood cell count (WBC) was 9500, C-reactive protein (CRP) 1.52, pH 7.389, and sodium (Na) 140. Fluid replacement was initiated, and then the patient was given nothing to eat. In the afternoon, enema was administered again, but there was a small amount of feces reaction. Although abdominal distension was improved, tense abdomen persisted. On 01Aug2021 at 01:25, enema was administered as tense abdomen persisted, and a large amount of normal feces was observed. Afterward, the patient had 4 episodes of bile-like vomiting. At 06:00, gastric tube was inserted. Air and 590 mL of bile-like fluid were drained. Sound in the abdomen was weak with metallic sound. Fluid replacement challenge was initiated. At 10:45, computerised tomography (CT) was performed, and ileus was diagnosed. After examinations, blood pressure (BP) decreased to 75/44, for which extracellular fluid challenge was given at the maximum dose, then BP was improved to 97/64. The patient was transported to another hospital, where he underwent laparotomy for partial intestinal tract resection. However, poor vital signs such as blood pressure decreased were noted during the surgery. Despite the intensive care including catecholamine at higher than maximum dose, the patient could not be saved. On 02Aug2021, the patient was discharged dead from the hospital. Autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician classified the event as serious (Death, Hospitalized) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases: ''''At the age of 25, the patient had undergone laparotomy for ileus due to pica. After that, the patient had a history of several episodes of ileus adhesive, which had been improving with conservative therapy at each time. '''' The reporting physician commented as follows: With having delayed psychomotor development of unknown cause, he was a severe psychosomatic disease patient, currently treated with bed rest and in need of total assistance. The patient had a history of laparotomy, and ileus was repeated. For that, bowel management such as enema and faecal disimpaction was continued for days. At this time, the event abruptly occurred without any symptoms until the previous day. Causality with BNT162b2 vaccine was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: blood pressure decreased; ileus


VAERS ID: 1593720 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Cardioembolic stroke; Ischaemic heart disease; Stent placement (4 to 5 years before)
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101058245

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123517. The patient was an 83-year and 1-month-old male. Body temperature before vaccination was 36.3 degrees centigrade on 27Jul2021. The family history was not provided. The patient had medical histories of cardioembolic stroke, cardiac stent placement, ischaemic heart disease, and angina pectoris. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunisation. On 27Jul2021 at 10:48 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) via an unspecified route of administration as a single dose at the age of 83-year-old for COVID-19 immunization. On 03Aug2021 at 04:00 (6 days/17hours/12 minutes after the vaccination), the patient experienced dyspnoea. On 03Aug2021 (7 days after the vaccination), the outcome of the event was fatal. It was unknown if an autopsy was performed. The course of the event was as follows: The patient underwent cardiac stent placement 4 to 5 years before. After the patient was admitted to the reporting hospital, he complained of chest pressure sensation several times; however, the symptom did not persist, and he was followed up. On 02Aug2021 (6 days after vaccination), in the morning, although the patient had chest symptom, no obvious objective findings were observed. On 03Aug2021, at around 04:00 (6 days, 17 hours, and 12 minutes after vaccination), the patient complained of dyspnoea. At 04:10 (6 days, 17 hours, and 22 minutes after vaccination), when the patient was examined by the doctor on duty, he had cardio-respiratory arrest. Although cardiopulmonary resuscitation (CPR) was performed for approximately 1 hour, no return of spontaneous circulation was obtained. 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 ischaemic heart disease. The reporting physician commented as follows: The patient had medical history of ischaemic heart disease. However, the event occurred 1 week after the vaccination, and thus, it could not be ruled out that the event was a side reaction.; Reported Cause(s) of Death: Dyspnoea; Cardio-respiratory arrest


VAERS ID: 1593721 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101058278

Write-up: This is a spontaneous report from a contactable physician received via sales representative. A 58-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown), via an unspecified route of administration on 14Aug2021 at age of 58-year-old as single dose for covid-19 immunisation. The patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) on unknown date for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 14Aug2021 (the same day of the vaccination), the patient experienced death. The outcome of the event was fatal. Cause of death was not reported. It was not reported if an autopsy was performed. The reporting physician''s seriousness and causality assessment of the event was not reported. 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 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: Death.


VAERS ID: 1593722 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood glucose abnormal, Blood pressure fluctuation, Blood pressure measurement, Body temperature, Chills, Fatigue, Heart rate, Oxygen saturation, Pyrexia, Respiratory arrest, Tremor, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: TRAZENTA; THYRADIN S; POLYFUL; CALCIUM LACTATE; CELECOXIB; REBAMIPIDE; FUROSEMIDE; AZILVA; AMLODIPINE BESILATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Osteoporosis; Trochanteric femoral fracture (was admitted to the reporting hospital on 22Jun2021 for rehabilitation after surgery); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210813; Test Name: blood sugar; Result Unstructured Data: Test Result:245; Comments: at 22:30; Test Date: 20210813; Test Name: blood pressure; Result Unstructured Data: Test Result:101/56; Comments: at 08:00; Test Date: 20210813; Test Name: blood pressure; Result Unstructured Data: Test Result:75/50; Comments: at 20:00; Test Date: 20210813; Test Name: blood pressure; Result Unstructured Data: Test Result:85/66; Comments: at 21:20; Test Date: 20210813; Test Name: blood pressure; Result Unstructured Data: Test Result:131/70; Comments: at 22:30; Test Date: 20210812; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210812; Test Name: body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Comments: at 15:00; Test Date: 20210812; Test Name: body temperature; Result Unstructured Data: Test Result:39.4 Centigrade; Comments: at 16:35; Test Date: 20210812; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: at 20:00; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Comments: at 07:00; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Comments: at 10:00; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Comments: at 14:00; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:38.9 Centigrade; Comments: at 20:00; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Comments: at 21:20; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: at 22:30; Test Date: 20210813; Test Name: pulse rate; Result Unstructured Data: Test Result:120; Comments: at 20:00; Test Date: 20210813; Test Name: pulse rate; Result Unstructured Data: Test Result:67; Comments: at 22:30; Test Date: 20210813; Test Name: pulse rate; Result Unstructured Data: Test Result:40s; Comments: at 22:45; Test Date: 20210812; Test Name: SpO2; Test Result: 97 %; Comments: at 20:00; Test Date: 20210813; Test Name: SpO2; Test Result: 97 %; Comments: at 07:00; Test Date: 20210813; Test Name: SpO2; Test Result: 99 %; Comments: at 08:00; Test Date: 20210813; Test Name: SpO2; Test Result: 88 %; Comments: at 20:00; Test Date: 20210813; Test Name: SpO2; Result Unstructured Data: Test Result:88 to 94 %; Comments: at 21:20; Test Date: 20210813; Test Name: SpO2; Result Unstructured Data: Test Result:88 to 96 %; Comments: at 22:30
CDC Split Type: JPPFIZER INC202101058606

Write-up: Respiratory arrest; blood pressure was 101/56, 75/50, 85/66, 131/70; upper navel pain; Pyrexia of 39.4 degrees Celsius; Chills; Tremor; Fatigue; Vomiting; This is a spontaneous report from a contactable nurse received from the Regulatory Authority. The regulatory authority report number is v21123564. An 89-year and 1-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 12Aug2021 at 10:10 (the day of vaccination) (Lot number FC8736, Expiration date 30Sep2021) at the age of 89 years, as dose 1, single for COVID-19 immunization. The patient had medical histories of type 2 diabetes mellitus, osteoporosis, and hypertension. On 22Jun2021, the patient was admitted to the reporting hospital for rehabilitation after surgery for right trochanteric femoral fracture (at another hospital). The concomitant medications included oral linagliptin (TRAZENTA), oral levothyroxine sodium (THYRADIN-S), oral polycarbophil calcium (POLYFUL), oral calcium lactate, oral celecoxib, oral rebamipide, oral furosemide, oral azilsartan (AZILVA), and oral amlodipine besilate. Body temperature before vaccination was 36.3 degrees centigrade. On 12Aug2021 at 16:35 (6 hours and 25 minutes after the vaccination), the patient experienced pyrexia of 39.4 degrees Celsius, chills, fatigue, tremor, and vomiting. On 13Aug2021 at 07:00 (20 hours 50 minutes after the vaccination), the patient experienced upper navel pain. On 13Aug2021 at 22:47 (one day and 12 hours 37 minutes after the vaccination), the patient experienced respiratory arrest. On 13Aug2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 12Aug2021, 11:30, the patient took one pack of Mei Balance Mini as a side dish. At 15:00, the body temperature was 37.3 degrees Celsius, and the patient had no symptoms. At 16:35, the body temperature was 39.4 degrees Celsius, and the patient had chills, tremor, and fatigue, and she vomited a small amount of food component. The patient was instructed to orally take acetaminophen (CALONAL). The patient had vomiting again, and she was unable to orally take the drug. The patient did not eat dinner. At 20:00, the body temperature was 37.8 degrees Celsius, and the SpO2 was 97%, and no fatigue, queasy, or vomiting was noted. On 13Aug2021, at 07:00, the body temperature was 38.3 degrees Celsius, the SpO2 was 97%. No pulmonary sound was heard, no queasy was noted, and upper navel pain was noted. At 08:00, when the patient drunk a half bottle of milk for breakfast, she vomited a small amount. The blood pressure was 101/56, the SpO2 was 99%. At 10:00, the body temperature was 37.3 degrees Celsius. The patient took a pack of Mei Balance Mini and a pudding for lunch. At 11:30, administration of TRIFLUID 500 and metoclopramide hydrochloride was performed. At 14:00, the body temperature was 37.9 degrees Celsius, and no queasy was noted. Administration of SOLULACT 500 was performed. At 20:00, the body temperature was 38.9 degrees Celsius, the pulse rate was 120, the blood pressure was 75/50, and the SpO2 was 88%. The patient responded to being called. Pulmonary sound were observed and aspiration was performed. An oxygen 5 L was initiated with reservoir. At 21:20, the body temperature was 38.5 degrees Celsius, the SpO2 was 88-94%, the blood pressure was 85/66. The patient had nodding of head. Administration of meropenem hydrate (MEROPENEM) 0.5 g was performed. At 22:30, the body temperature was 37.8 degrees Celsius, the SpO2 was 88-96%, the blood pressure was 131/70, and the pulse rate was 67. The respiration was calm. The blood sugar was 245. At 22:45, the pulse rate was 40s on the monitor. At 22:47, the patient had respiratory arrest. Cardiac massage was performed, and administration of (illegible character), VEEN-D 500, an intravenous injection of etilefrine hydrochloride (EFFORTIL) 1/2 A, administration of physiological saline 100, and dopamine hydrochloride (INOVAN INJECTION) 1A were initiated. At 23:26, the patient was confirmed to die (at 23:20, the family members arrived). Outcome of respiratory arrest was fatal, of all other events was unknown. The reporting other healthcare professional (nurse) classified the event as serious (death) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: respiratory arrest


VAERS ID: 1593723 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101070070

Write-up: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 73-year-old female patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on 03Aug2021 (the day of vaccination), as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Aug2021, the patient died. The cause of death was not reported. It was unknown if an autopsy was performed. The inoculator (physician) requested the detail information to the patient family. Information regarding lot/batch number has been requested.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of unknown cause of death 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: Death


VAERS ID: 1593809 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, International normalised ratio increased, Rash macular
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
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: Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101045730

Write-up: This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00661089. An 81-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 14Apr2021 as dose 2, single for COVID-19 immunization. Medical history included myocardial infarction from an unknown date. Concomitant medications include unspecified anticoagulants from 2015. The patient had no previous COVID-19 infection. The patient previously received the first dose of BNT162B2 (COMIRNATY), on 10Mar2021, for COVID-19 immunization and experienced INR increased. The patient experienced cerebral bleeding, blood values too high after first and second vaccination/INR increased, and little red dots on his skin on an unspecified date. The patient was hospitalized for the events. The patient died in the hospital on 02May2021. It was not reported if an autopsy was performed. Information on the batch/lot number has been requested.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty):yes. ADRs: Blood values at thrombosis clinic too high Date:10Mar2021 Diagnostic procedures:No, the sudden death from the brain haemorrhage has not been associated with the vaccination by the hospital.I did see that after the first injection my father''s blood values started to fluctuate and after the second he died.After his death I saw small red dots on his skin.; Reported Cause(s) of Death: INR increased; Little red dots on his skin; cerebral hemorrhage


VAERS ID: 1593811 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chills, Fatigue, Gastrointestinal haemorrhage, Malaise, Mouth haemorrhage, Myalgia, Pulmonary haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADALAT; LORAZEPAM; VITAMIN D [COLECALCIFEROL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (no longer since Sep2020 after osmotic demyelination); Cardiac disorder; Hyponatraemia; Osmotic demyelination syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101054646

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00662069. A 46-year-old male patient received the second dose of bnt162b2 (COMIRNATY) on 21Jul2021 (lot number: FF0688) via unknown route of administration at single dose for COVID-19 immunisation. Medical histories included hyponatraemia; Osmotic demyelination syndrome; Alcohol abuse from unknown date to Sep2020 (no longer since Sep2020 after osmotic demyelination); Cardiac disorder. Concomitant medications included nifedipine (ADALAT); lorazepam; colecalciferol (VITAMIN D). Previous COVID-19 infection was reported as No. Patient received the first dose of bnt162b2 (COMIRNATY) on 16Jun2021 via unknown route of administration at single dose for covid-19 immunisation and experienced No adverse event. Patient experienced Myalgia, Not feeling well, Cold chills, Fatigue; both on 28Jul2021. See above, possible gastrointestinal/lung hemorrhage, although no blood seen in bed or on outside. DD cardiac arrest. Patient was found deceased 9 days on 30Jul2021 after 2nd vaccination, old blood in mouth, possible gastric bleeding. 2 days before death not well with earlier mentioned complaints, patient did not want to see a general practitioner despite family contacting the practice about this. Of course it cannot be determined that there is a relation with the (2nd) vaccination. Patient also used nifedipine, vitamin D and once daily Lorazepam. Patient had no cardiac history, but was familiar with rehabilitation after osmotic demyelination upon correction of hyponatremia. Could live independently again. In history alcohol abuse, but not since Sep2020 after osmotic demyelination. The outcome of events Patient was found deceased 9 days after 2nd vacc, old blood in mouth, possible gastric bleeding/ possible gastrointestinal/lung hemorrhage; lung hemorrhage; cardiac arrest was fatal. The outcome of other events was unknown. At autopsy no striking findings, mortician found old blood in mouth. Differential diagnosis: gastric bleeding? Sender Comment: Although vaccination date was given as 28Jul all reactions were reported with latency times in days, that consistently pointed towards a vaccination date of 21Jul, therefore adapted. Reporter''s Comments Text: Patient was found deceased 9 days after 2nd vacc, old blood in mouth, possible gastric bleeding. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Patient was found deceased 9 days after 2nd vacc, old blood in mouth, possible gastric bleeding.; Reported Cause(s) of Death: Patient was found deceased 9 days after 2nd vacc, old blood in mouth, possible gastric bleeding; lung hemorrhage; cardiac arrest; Patient was found deceased 9 days after 2nd vacc, old blood in mouth, possible gastric bleeding/ possible gastrointestinal.


VAERS ID: 1593812 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-07-15
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7082 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN; ALLOPURINOL; DISTIGMINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101056223

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00664825. A 74-year-old male patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 23May2021 (Batch/Lot Number: FA7082) as single dose for covid-19 immunisation. The patient medical history was not reported. Patient did not have COVID-19 infection previously. Concomitant medication included losartan; allopurinol and distigmine. The patient previously took first dose of BNT162B2 (COMIRNATY, strength: 0.3ml), via an unspecified route of administration on 18Apr2021 as single dose for covid-19 immunisation. On 15Jul2021, patient experienced sudden hard death: sudden death, without any reason/sudden cardiac death. The outcome of the event was fatal. The patient died on 15Jul2021. 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 hard death: Sudden death, without any reason/Sudden cardiac death


VAERS ID: 1593832 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / 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? 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: PHJNJFOC20210838682

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority (PHIFDA, PH-PHFDA-300098943) concerned a 63 year old male with an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213C21A expiry: Unknown) dose was not reported, 1 total administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced cough, difficulty breathing, covid infection. On an unspecified date, the patient died due to cough, (difficulty breathing), and covid infection. 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).; Sender''s Comments: V0: 20210838682-COVID-19 VACCINE AD26.COV2.S- cough, (dob) difficulty breathing, COVID infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COUGH; DOB; COVID INFECTION


VAERS ID: 1593837 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-27
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Cough
SMQs:, Anaphylactic reaction (broad), 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: 20210727; Test Name: Blood pressure; Result Unstructured Data: ELEVATED
CDC Split Type: PHJNJFOC20210838885

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099469] concerned a 71 year old male 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: unknown, and expiry: unknown) dose was not reported, with frequency time 1 total administered on 27-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 27-JUL-2021, at 11:23 the patient experienced hypertension and cough. Laboratory data included: Blood pressure (NR: not provided) elevated. On an unspecified date, the patient died due to hypertension and cough. It was unknown, if an autopsy was performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210838885-COVID-19 VACCINE AD26.COV2.S-Hypertension, Cough. 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: HYPERTENSION; COUGH.


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