Received May 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | ZH54E | — |
Bell's palsy after first dose; This serious case was reported by a other health professional via call center representative and described the occurrence of bell's palsy in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number ZH54E) for prophylaxis. On 31-JAN-2026, the patient received the 1st dose of Shingrix. On 06-FEB-2026, 6 days after receiving Shingrix, the patient experienced bell's palsy (Verbatim: Bell's palsy after first dose) (serious criteria GSK medically significant). The outcome of the bell's palsy was unknown. It was unknown if 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: 22-APR-2026 The physician assistant reported that an immunocompetent patient got first dose of Shingrix and developed Bell's palsy on 06-FEB-2026 and had to go to the emergency room on 07-FEB-2026.; Sender's Comments: A case of Bell's palsy (not meeting BC Criteria), 6 days after receiving 1st dose of Shingrix in a 56-year-old female patient. Case lacks further information on medical history, concurrent conditions and clinical details. 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.