Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 55TH4 | — |
Bell's palsy; This serious case was reported by a consumer and described the occurrence of bell's palsy in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 55TH4) for prophylaxis. Previously administered products included Shingrix (patient had 1st dose on 09-NOV-2024, with batch number GA99K). Concurrent medical conditions included diabetes. Concomitant products included metformin, levothyroxine, atorvastatin and lisinopril. On 26-APR-2025, the patient received the 2nd dose of Shingrix. On 29-AUG-2025, 125 days after receiving Shingrix, the patient experienced bell's palsy (Verbatim: Bell's palsy) (serious criteria hospitalization and GSK medically significant). The outcome of the bell's palsy was not resolved. 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: 10-SEP-2025 The reporter reported seriousness for bell's palsy as intervention required.; Sender's Comments: A case of Bell's palsy, 125 days after receiving Shingrix, in a 58-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factor (Concurrent medical conditions included diabetes).
Diabetes
METFORMIN; LEVOTHYROXINE; ATORVASTATIN; LISINOPRIL