Received Feb 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
Bells Palsy both times; This is a spontaneous report received from a Nurse. A 72-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Comirnaty (2024-2025 formula) (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Bells palsy both times". The following information was reported: BELL'S PALSY (hospitalization, disability, medically significant), outcome "unknown", described as "Bells Palsy both times". The patient was hospitalized for bell's palsy (hospitalization duration: 1 day(s)). The event "bells palsy both times" required physician office visit and emergency room visit. Clinical course: The patient did not receive any other vaccines on the same date as the Pfizer vaccine and the patient was taking any other medications within 2 weeks prior to the event onset and did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A possibly contributory role of BNT162b2 omicron (kp.2) in triggering the onset of the event BELL'S PALSY might not be fully excluded given known adverse event profile of the suspect vaccine. 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.
Medical History/Concurrent Conditions: Diabetes