Adverse Event Reporting
| VAERS ID | 986115 |
|---|---|
| Gender | Female |
| Age | 65 |
| StateCode | CA |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EJ1685 |
| Number of vaccinations | 2 |
| Vaccinated | 2021-01-12 |
| Onset | 2021-01-21 |
| Condition | Hospitalized Life Threatening Permanent Disability |
Symptoms
- SARS-CoV-2 test negative
- Cerebrovascular accident
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: COVID-19
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Name: BP; Result Unstructured Data: Test Result:normal; Test Date: 20210122; Test Name: Nasal Swab-PCR; Test Result: Negative
Write-up
Suffered a massive MCA stroke; This is a spontaneous report from a Contactable Nurse.
A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), intramuscularly in left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization.
Medical history included covid prior vaccination.
Known allergies: None.
The patient's concomitant medications were not reported.
The patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1685), intramuscularly in right arm on 21Dec2020 03:00 PM at single dose for COVID-19 immunization.
The patient was not pregnant while receiving vaccine.
Facility type vaccine: Hospital.
If other vaccine in four weeks: No.
Other medications in two weeks: No.
The patient suffered a massive MCA (Middle cerebral artery) stroke on 21Jan2021 08:00 after getting second covid vaccine with outcome of not recovered.
No history of hypertension, elevated cholesterol or medical issues.
No medication being taken.
Daily BP (Blood pressure) reading normal.
Covid test post vaccination: Nasal Swab-PCR on 22Jan2021 with result negative.
If treatment for AE: Unknown.
The event was resulted in: Emergency room/department or urgent care, Hospitalization (Number of days hospitalization: 4), Life threatening illness (immediate risk of death from the event), Disability or permanent damage.
; Sender's Comments: The event middle cerebral artery stroke appeared 8 days after administration BNT162B2.
The Company considers that the event is less likely related to suspect BNT162B2 injection given the weak time association.
The status (bleeding or infarction) and cause of the stroke would be helpful for further assessment.
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.