Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
reports not feeling well for a day or so 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 male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose on an unknown date, for tolerance of 1st dose of Shingrix, refer case US2025AMR072293). 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: reports not feeling well for a day or so after each dose). Rechallenge with Shingrix was positive. The outcome of the feeling unwell was resolved (duration 1 day). 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:US2025AMR072293 Additional Information: GSK Receipt Date: 02-JUN-2025 The Patient reported that he had a dose of Shingrix. The patient reported not feeling well for a day or so after each dose.; Sender's Comments: US-GSK-US2025AMR072293:Same Patient/ 1st dose