Adverse Event Reporting
| VAERS ID | 1462792 |
|---|---|
| Gender | Female |
| Age | 87 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EY9860 |
| Number of vaccinations | 2 |
| Vaccinated | 2021-06-15 |
| Onset | 2021-06-18 |
| Condition | Died |
Symptoms
- Loss of consciousness
- Back pain
- Computerised tomogram
- Respiratory arrest
- Blood pressure immeasurable
- Body temperature
- Aortic aneurysm rupture
- Aortic dissection
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Arteriosclerosis; Cardiac failure chronic; Hypertension; Old cerebral infarction
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20210615; Test Name: Body temperature; Result Unstructured Data: Test Result:36.
0 Centigrade; Comments: before vaccination; Test Name: CT; Result Unstructured Data: Test Result:revealed aortic dissection and aortic; Comments: revealed aortic dissection and aortic aneurysm rupture; after the vaccination
Write-up
CT revealed aortic dissection and aortic aneurysm rupture; CT revealed aortic dissection and aortic aneurysm rupture; Back pain; Loss of consciousness; Respiratory arrest; blood pressure not palpable; This is a spontaneous report from a contactable physician received from the regulatory authority.
Regulatory authority report number is v21116231.
The patient was an 87-year and 4-month-old female.
Body temperature before vaccination was 36.
0 degrees centigrade on 15Jun2021.
Medical history included hypertension, arteriosclerosis, cardiac failure chronic, and old cerebral infarction.
Family 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).
On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation.
On 15Jun2021 at 21:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY9860, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation.
On 18Jun2021 at 17:00 (2 days 20 hrs after the vaccination), the patient experienced back pain.
On 18Jun2021 at unknown time (reported as 3 days after the vaccination), the patient experienced loss of consciousness and respiratory arrest.
On an unknown date (after the vaccination), computerised tomography (CT) revealed aortic dissection and aortic aneurysm rupture.
Events back pain, loss of consciousness, respiratory arrest resulted in emergency room visit and with treatment received.
On 18Jun2021 (reported as 3 days after the vaccination), the outcome of the events was fatal.
It was not reported whether autopsy was done.
The course of the events was as follows: The patient was regularly visiting the reporting clinic for conditions including hypertension, cardiac failure chronic, and old cerebral infarction On 15Jun2021 around 21:00 (the day of vaccination), the patient received the second BNT162b2 vaccination.
On 18Jun2021 at 17:00 (3 days after the vaccination), the patient visited the reporting hospital with a complaint of back pain.
She experienced loss of consciousness while waiting in the waiting room.
Respiratory arrest occurred, and the blood pressure was not palpable.
While continuing cardiopulmonary resuscitation (CPR), the patient was transported by ambulance to the hospital.
After transport, she was confirmed dead.
CT revealed aortic dissection and aortic aneurysm rupture.
The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable.
Other possible cause of the events such as any other diseases were hypertension and arteriosclerosis.
; Reported Cause(s) of Death: respiratory arrest; CT revealed aortic dissection and aortic aneurysm rupture; CT revealed aortic dissection and aortic aneurysm rupture; back pain; loss of consciousness