Adverse Event Reporting
| VAERS ID | 1175164 |
|---|---|
| Gender | Male |
| Age | |
| StateCode | MI |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EM9810 |
| Number of vaccinations | 2 |
| Vaccinated | |
| Onset | 2021-03-12 |
| Condition | Permanent Disability |
Symptoms
- Cerebrovascular accident
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Bone cancer; Cancer of prostate
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
stroke in left arm, arm is weaker than the other, strength never came back; This is a spontaneous report from a contactable nurse.
An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in the left arm on an unspecified date (also reported as 12Feb2021 12:00; pending clarification) (batch/lot number: EM9810) as a single dose, and first dose intramuscular, administered in the left arm on 12Feb2021 12:00 (batch/lot number: EL3249) as a single dose for COVID-19 immunisation.
Medical history included cancer, prostate to bone from an unknown date.
The patient has no known drug allergies.
The patient's concomitant medications were not reported.
Facility type vaccine was public health clinic facility.
No other vaccine in four weeks.
No other medications in two weeks.
No Covid prior to vaccination and no Covid tested post vaccination.
On 12Mar2021 (as reported, however, also reported as 13Mar2021; pending clarification), the patient experienced stroke in left arm, arm was weaker than the other, strength never came back.
The adverse event resulted in disability or permanent damage.
No treatment was received for the event.
The outcome of the event was not recovered.
No follow-up attempts are possible.
No further information is expected.
; Sender's Comments: Based on the information provided, it is unlikely that the reported event is related to suspect product.
The reported event is related to this patients underlying morbidity of prostate cancer with metastases to the bone.
The impact of this report on the benefit/risk profile of the Pfizer drug 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