Adverse Event Reporting
| VAERS ID | 1485750 |
|---|---|
| Gender | Female |
| Age | 87 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EY5423 |
| Number of vaccinations | 2 |
| Vaccinated | 2021-06-24 |
| Onset | 2021-06-25 |
| Condition | Died |
Symptoms
- Vomiting
- Blood pressure measurement
- Death
- Body temperature
- Oxygen saturation
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Chronic subdural haematoma; Diabetes mellitus; Subdural haematoma evacuation
Other Medications
CILOSTAZOL; AMANTADINE; LINAGLIPTIN; METFORMIN; BISOPROLOL
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20210625; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:132/82; Test Date: 20210624; Test Name: Body temperature; Result Unstructured Data: Test Result:36.
5 Centigrade; Comments: before vaccination; Test Date: 20210625; Test Name: Body temperature; Result Unstructured Data: Test Result:36.
4 Centigrade; Test Date: 20210625; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:92-94 %
Write-up
not breathing, sudden death of unidentifiable cause; Vomiting; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority.
Regulatory authority report number is v21118039.
The patient was an 87-year-old female.
Body temperature before vaccination was 36.
5 degrees centigrade.
Family history was not reported.
Medical history included diabetes mellitus and surgery for chronic right subdural haematoma.
On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported).
Concomitant medication included cilostazol, amantadine, linagliptin, metformin, and bisoprolol, all taken for unspecified indications, start and stop dates were not provided.
On 24Jun2021 at 15:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization.
On 25Jun2021 at 10:00 (19 hours after the vaccination), the patient experienced vomiting.
On 26Jun2021 at 07:10, the patient was found in the state of respiratory arrest/not breathing.
On 26Jun2021 (2 days after the vaccination), the outcome of the event was fatal.
The course of the event was as follows: The patient lived in a nursing home.
On 24Jun2021 (Thursday), the patient received the second dose of the vaccine.
The patient signed consent form on her own.
Immediately after the vaccination, there was no abnormality.
On 25Jun2021 (Friday) at 10:00, the patient vomited.
In the evening, the patient vomited again.
Blood pressure was 132/82, body temperature was 36.
4 degrees centigrade, and oxygen saturation was 92-94%.
On 26Jun2021 (Saturday) at 06:15, the patient talked with a staff and said that the patient was going to eat breakfast.
At 07:10, when the patient was visited to be awakened, the patient was not breathing.
A nurse at the facility was emergently called in and suction was conducted; however, nothing was suctioned.
There was no foreign matter or vomitus in oral cavity.
The course was explained to family member and autopsy imaging (AI) was recommended; however, family member did not request it, and examination was not conducted.
The reporting physician classified the event as serious (medically significant) and assessed that the causality between the event and BNT162b2 as unassessable.
Other possible cause of the event such as any other diseases was unknown.
The reporting physician commented as follows: On the following day of the vaccination, the patient vomited.
On the following in the morning, the patient had no vomiting.
Immediately after the patient expressed her will to eat breakfast, the patient experienced sudden death of unidentifiable cause.
There were no findings suggestive of sudden cardiac death, intracranial lesion, or foreign matter in respiratory tract (asphyxia).
Autopsy imaging was recommended but it was not requested and examination was not conducted; thus, the cause could not be identified.
; Reported Cause(s) of Death: sudden death of unidentifiable cause