Received Apr 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
The patient lost control of facial muscles- face went slack on one side; This is a spontaneous report received from an Other HCP from a sales representative. An adult female patient (not pregnant) received BNT162b2 (COMIRNATY), in Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FACIAL PARESIS (medically significant), outcome "recovered", described as "The patient lost control of facial muscles- face went slack on one side". It was unknown if therapeutic measures were taken as a result of facial paresis. Clinical course: The patient did not receive any other vaccines on the same date as the reported vaccine. Whether the patient received any other vaccines within 4 weeks prior to the reported vaccine was unknown. The patient use of any other medications within 2 weeks prior to the onset of the event was unknown. The patient lost control of facial muscles, with the face becoming slack on one side. The patient did not know which vaccine was received. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Although it is difficult to establish temporal association between the reported event facial paresis and suspect drug based on the limited information provided in the case, the causal association between the Reported event and the suspect drug cannot be excluded as there is no concrete evidence available to eliminate the causal association. 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.