Received Feb 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Bell's palsy; This serious case was reported by a physician via sales rep and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Influenza vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (unknown deltoid) and Influenza vaccine. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (Verbatim: Bell's palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was unknown. The reporter considered the bell's palsy to be related to Shingrix. The company considered the bell's palsy to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 04-FEB-2025 The patient received Shingrix and Influenza vaccine at the same time and experienced bell's palsy. It was unknown if reporter considered the bell's palsy to be related to Influenza vaccine.; Sender's Comments: Bell's palsy is an unlisted event which is considered unrelated to GSK drug Shingrix.