Adverse Event Reporting
| VAERS ID | 1477399 |
|---|---|
| Gender | Male |
| Age | 96 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EY0573 |
| Number of vaccinations | 2 |
| Vaccinated | 2021-06-25 |
| Onset | 2021-06-30 |
| Condition | Died |
Symptoms
- Death
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Constipation; Essential tremor; Insomnia
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Death; This is a spontaneous report from a contactable physician received via the Agency.
A 96-year-old male patient received BNT162B2 (COMIRNATY), second dose intramuscular in the left arm on 25Jun2021 at 15:30 at age of 96-years-old (Lot number EY0573, Expiration date 30Sep2021) as dose 2, single for COVID-19 immunisation.
The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
The patient received several unspecified medicines within 2 weeks of vaccination.
Prior to vaccination, the patient was not diagnosed with COVID-19.
It was unknown if the patient had allergies to medications, food, or other products.
Other medical history included essential tremor, constipation and insomnia.
On 04Jun2021 at 15:00, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization.
On 25Jun2021 at 15:30 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization at a clinic/emergency room.
On 30Jun2021 at 14:00 (5 days after the vaccination), the patient was found dead and no treatment was received.
(The event resulted in death) The cause of death was unknown.
It was unknown if an autopsy was performed.
The patient did not receive treatment for the event.
Since the vaccination, the patient has not been tested for COVID-19.
The causality assessment was not provided.
; Sender's Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes.
The underlying disease may provide an alternative cause for this 96 years old patient.
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: Unknown cause of death