Adverse Event Reporting
| VAERS ID | 938068 |
|---|---|
| Gender | Male |
| Age | 46 |
| StateCode | CA |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | |
| Vaccinated | 2020-12-18 |
| Onset | 2020-12-23 |
| Condition | Permanent Disability |
Symptoms
- SARS-CoV-2 test negative
- Facial paralysis
- Magnetic resonance imaging brain abnormal
- Facial pain
- Noninfective encephalitis
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Psoriasis
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20201223; Test Name: MRI; Result Unstructured Data: Test Result:T2 hyperintensity; Comments: Brain MRI done showing T2 hyperintensity in the brainstem and basal ganglia, suspicious for inflammation; Test Name: COVID-19; Result Unstructured Data: Test Result:Negative
Write-up
patient developed acute onset of right-sided facial palsy and pain; patient developed acute onset of right-sided facial palsy and pain; Brain MRI done showing T2 hyperintensity in the brainstem and basal ganglia, suspicious for inflammation; This is a spontaneous report from a contactable physician.
A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 18Dec2020 at SINGLE DOSE for COVID-19 immunization.
Medical history included psoriasis.
No COVID prior vaccination.
It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine.
No known allergies.
Concomitant medications (received within 2 weeks of vaccination) included fluoxetine.
days following vaccination,on 23Dec2020,the patient developed acute onset of right-sided facial palsy and pain.
Brain MRI done showing T2 hyperintensity in the brainstem and basal ganglia, suspicious for inflammation.
Work-up is ongoing.
AE Resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage].
It was unknown if the event was treated.
The event was assessed as serious for Disabling/Incapacitating.
The patient had been tested for COVID post vaccination (covid test result-Negative).
The outcome of the events werenot recovered Information about lot/batch number has been requested.
; Sender's Comments: A possible causal relationship between acute onset of right-sided facial palsy and pain with MRI findings suspicious for brain inflammation and BNT162B2 cannot be completely ruled out considering the temporal relationship.
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.