Received Apr 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | OT |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Bells Palsy; LIVE TELEPHONIC VACCINE GAP ASSESSMENT PROGRAM (LTVGA) This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID:. A 76-year-old female patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 76 years intramuscular for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 28Sep2021, outcome "recovered" (Oct2021), described as "Bells Palsy". The event "bells palsy" required physician office visit. Therapeutic measures were taken as a result of bell's palsy. Clinical course: Patient reported that received a 2nd dose of the COVID19 vaccine in the evening. Patient went to bed and in the morning, Patient woke up with facial drooping on the left side of her face. Patient saw her primary care doctor shortly after and was diagnosed with Bell's Palsy. Patient was not prescribed any medications or treatments but utilized a facial massager to stimulate the area. Patient reports it took approximately 3 weeks to resolve however she still experiences periodic facial swelling on the left side of her face particularly after receiving a influenza vaccine. The reporter's assessment of the causal relationship of "bells palsy" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on known drug safety profile and close temporal association, there is reasonable possibility of causal association between the event Bells Palsy and the suspect drug BNT162B2. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.