Received Jun 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
tiredness; arm soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of fatigue (received first dose in 2018, refer case US2025AMR076267). Concurrent medical conditions included herpes simplex (contacted genital herpes). Concomitant products included aciclovir sodium (Acyclovir) and valaciclovir hydrochloride (Valtrex). 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 tiredness (Verbatim: tiredness) and pain in arm (Verbatim: arm soreness). Rechallenge with Shingrix was positive. The outcome of the tiredness and pain in arm were unknown. It was unknown if the reporter considered the tiredness and pain in arm to be related to Shingrix. It was unknown if the company considered the tiredness and pain in arm to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR071843, US2025AMR076267 Additional Information: GSK Receipt Date: 09-JUN-2025 The reporter was the patient. The patient also lives part of the year in another country. The patient received the second dose of Shingrix in 2018 The only side effects experienced by the patient from any dose of Shingrix were arm soreness and tiredness. About 20 years ago, the patient contacted genital herpes (Herpes Simplex 2). The patient had taken Valtrex, then went to Acyclovir for suppressive therapy. For tolerance to third dose, refer case US2025AMR071843; Sender's Comments: US-GSK-US2025AMR076267:Same patient, 1st dose US-GSK-US2025AMR071843:Same patient, 3rd dose
Herpes simplex (contacted genital herpes)
ACYCLOVIR; VALTREX