Received Sep 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Patient said she ended up with Bells Palsy after receiving vaccines; This is a spontaneous report received from an Other HCP from a sales representative. An adult female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE; UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "Patient said she ended up with Bells Palsy after receiving vaccines". It was unknown if therapeutic measures were taken as a result of bell's palsy. Clinical course: Patient said she ended up with Bells Palsy after receiving vaccines. Patient received any other vaccines on the same date as the vaccine was "Unknown". Patient received any other vaccines within 4 weeks prior to the vaccine was "Unknown". patient took any other medications within 2 weeks of the event starting was "Unknown". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event bells palsy based on the known safety profile 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.