Adverse Event Reporting
| VAERS ID | 1442070 |
|---|---|
| Gender | Female |
| Age | 85 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | FC5295 |
| Number of vaccinations | 2 |
| Vaccinated | 2021-06-15 |
| Onset | 2021-06-16 |
| Condition | Died |
Symptoms
- Death
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Cerebral infarction
Other Medications
XARELTO
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Death; This is a spontaneous report from a contactable pharmacist received via COVID-19 Adverse Event Self-Reporting Solution.
This 85-year-old (non-pregnant) female patient received the second dose of BNT162B2 (COMIRNATY; solution for injection, Lot number FC5295 with Expiration Date 30Sep2021), via an unknown route, on 15Jun2021 at single dose for COVID-19 immunisation.
Historical vaccine includes the first dose of BNT162B2 (COMIRNATY; solution for injection, Lot number FC5295 with Expiration Date 30Sep2021) on 25May2021 at single dose for COVID-19 immunisation.
Relevant medical history included cerebral infarction.
Relevant concomitant medications included rivaroxaban (XARELTO).
On 16Jun2021, (1 day after the vaccination), the patient experienced death.
The cause of death was not provided.
On 18Jun2021, (3 day after the vaccination), the death of the patient was reported to a clinic, the vaccination facility.
Since the vaccination, the patient has not been tested for COVID-19.
Autopsy was not performed.
; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event death and 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: death