Adverse Event Reporting
| VAERS ID | 1419451 |
|---|---|
| Gender | Female |
| Age | 96 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EY2173 |
| Number of vaccinations | 1 |
| Vaccinated | 2021-05-19 |
| Onset | 2021-05-30 |
| Condition | Died |
Symptoms
- Cardiac failure acute
Current Illness
Hyperlipidemia (stable); Hypertension (stable); Osteoporosis (stable)
Preexisting Conditions
Medical History/Concurrent Conditions: Cardiac failure acute; Living in nursing home
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Cardiac failure acute; This is a spontaneous report from a contactable physician via a Pfizer representative.
A 96-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021), via an unspecified route of administration on 19May2021 at single dose at the age of 96-year-old for COVID-19 immunisation.
The patient had a history of cardiac failure acute.
And also she had underlying diseases of hypertension, hyperlipidemia and osteoporosis, but the symptoms of the diseases were stable.
The patient was living in nursing home.
Concomitant medications and family history were not reported.
After the vaccination, no change was noted in her condition.
On 30May2021 at 21:30 (11 days after the vaccination), the patient was found in cardio-respiratory arrest in her room at the nursing home.
An autopsy was performed, and the cause of death confirmed by autopsy was cardiac failure acute.
The physician reported that the causal relationship with BNT162b2 was unknown.
; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine.
Currently there is no clear biological plausibility between the vaccine use and the event cardio-respiratory arrest onset.
The medical history of cardiac failure acute may make a explanation.
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 acute; Autopsy-determined Cause(s) of Death: cardiac failure acute