Adverse Event Reporting
| VAERS ID | 2539880 |
|---|---|
| Gender | Female |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | GJ7141 |
| Number of vaccinations | 5 |
| Vaccinated | 2022-12-16 |
| Onset | 2022-12-18 |
| Condition | Life Threatening Permanent Disability |
Symptoms
- Brain death
Current Illness
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Brain death; This is a spontaneous report received from a contactable reporter(s) (Nurse).
Regulatory number: v2210003290.
A 36-year-old female patient received BNT162b2, BNT162b2 omi ba.
4-5 (COMIRNATY RTU FOR BA.
4-5), on 16Dec2022 as dose 5 (booster), 0.
3 ml single (Lot number: GJ7141, Expiration Date: 29Feb2024) intramuscular for covid-19 immunisation.
The patient's relevant medical history and concomitant medications were not reported.
Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization.
The following information was reported: BRAIN DEATH (disability, medically significant, life threatening) with onset 18Dec2022, outcome "unknown".
Clinical course: On 18Dec2022, the patient's condition changed suddenly and she was transported to PRIVACY Hospital.
Reporter considered that the event was serious(Permanent or significant impairment/dysfunction) and the Causality between the suspect drug and event was not provided.
; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162b2, BNT162b2 omi ba.
4-5 and the reported event brain 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 RAs, Ethics Committees, and Investigators, as appropriate.