Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Sleepiness; This non-serious case was reported by a consumer via call center representative and described the occurrence of sleepiness in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 29-MAY-2025, the patient received the 1st dose of Shingrix. On 29-MAY-2025, less than a day after receiving Shingrix, the patient experienced sleepiness (Verbatim: Sleepiness). On 30-MAY-2025, the outcome of the sleepiness was resolved (duration 24 hrs). It was unknown if the reporter considered the sleepiness to be related to Shingrix. It was unknown if the company considered the sleepiness to be related to Shingrix. Additional Information: GSK receipt date: 20-AUG-2025 Reporter and his wife both received their first dose and are scheduled for the second dose as PI recommends. Reporter stated that his wife was very sleepy the entire day. The case is linked with US2025107416 and US2025107983, same reporter.; Sender's Comments: US-GSK-US2025107983:same reporter US-GSK-US2025107416:same patient /another dose