Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
not feeling well for about 12 hours after each dose; This non-serious case was reported by a consumer via sales rep and described the occurrence of feeling unwell in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of malaise (For tolerance of 1st dose refer case US2025AMR105885). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: not feeling well for about 12 hours after each dose). Rechallenge with Shingrix was positive. The outcome of the feeling unwell was resolved (duration 12 hrs). It was unknown if the reporter considered the feeling unwell to be related to Shingrix. It was unknown if the company considered the feeling unwell to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR105885 Additional Information: GSK Receipt Date: 12-AUG-2025 The patient was approximately 55 years old. Patient got both doses of Shingrix as indicated. Patient not felt well for about 12 hours after each dose but recovered the next day.; Sender's Comments: US-GSK-US2025AMR105885:case for 1st dose