Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Bell's palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: Bell's palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported. It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. The company considered the bell's palsy to be unrelated to Shingles vaccine. Additional Information: GSK receipt date: 22-SEP-2025 This case was reported by a patient via interactive digital media. Reporter stated that patient got the shingles vaccine and had a reaction causing Bell's palsy. This case is linked with case US2025AMR122529, reported by the same reporter.; Sender's Comments: A case of Bell's palsy ,an unknown date, an unknown time after receiving Shingles vaccine, in a female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. US-GSK-US2025AMR122529:same reporter