Adverse Event Reporting
| VAERS ID | 1235808 |
|---|---|
| Gender | Female |
| Age | |
| StateCode | IL |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EL9266 |
| Number of vaccinations | 1 |
| Vaccinated | |
| Onset | 2021-03-10 |
| Condition | Hospitalized Life Threatening Permanent Disability |
Symptoms
- Cerebral venous sinus thrombosis
Current Illness
Preexisting Conditions
Other Medications
PIMTREA
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Brain clot: acute thrombosis of the Left transverse sinus, left sigmoid sinus and upper left internal jugular vein cerebral sinus venous thrombosis; This is a spontaneous report from a contactable nurse.
A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (reported as 19Mar2021; pending clarification).
(Batch/Lot Number: EL9266) as single dose for covid-19 immunization.
The patient's medical history was not reported.
The patient was not pregnant at the time of vaccination.
Concomitant medication included desogestrel, ethinylestradiol (PIMTREA) taken for an unspecified indication, start and stop date were not reported.
The patient previously took diflucan and experienced allergy.
The patient experienced brain clot: acute thrombosis of the left transverse sinus, left sigmoid sinus and upper left internal jugular vein cerebral sinus venous thrombosis (hospitalization, disability, life threatening) on 10Mar2021 12:45.
The patient was hospitalized for brain clot: acute thrombosis of the left transverse sinus, left sigmoid sinus and upper left internal jugular vein cerebral sinus venous thrombosis for 6 days.
The patient was treated with Heparin and Coumadin.
The event resulted in: doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage.
The patient received the second dose of bnt162b2 on an unspecified date (reported as 18Mar2021; pending clarification), lot number: EN6204, on right arm.
The patient was recovering from the event.
The patient was not diagnosed with COVID prior to vaccination.
Patient has not been tested for COVID post vaccination.
; Sender's Comments: Based on the current available information, the events occurred prior to BNT162B2 administration (this information need be clarified).
The reported events are considered as an intercurrent or underlying condition which is not related to the suspected drug at this time.
The case will be reassessed if additional information becomes available.
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.