Received Jun 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
She reports injection site patient and soreness after both doses; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose and had injection site pain and soreness, refer case US2025AMR077805). 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 injection site pain (Verbatim: She reports injection site patient and soreness after both doses). Rechallenge with Shingrix was positive. The outcome of the injection site pain was resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR077805 Additional Information: GSK receipt date: 12-JUN-2025 The patient has had both doses of Shingrix. She reported that injection site pain and soreness after both doses. She did not report how long the pain and soreness lasted.; Sender's Comments: US-GSK-US2025AMR077805:same patient dose 2