Received May 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
shingles/ a rashon her right buttock; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of herpes zoster (received 1st dose on an unknown date and 2 days after dose, she experienced a rash on her right buttock that was diagnosed as shingles, refer case US2025060452). Concurrent medical conditions included blood cholesterol increased and blood pressure high. Concomitant products included atenolol, losartan, simvastatin and acetylsalicylic acid (Aspirin). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles/ a rashon her right buttock). The patient was treated with calamine and aciclovir sodium (Acyclovir). Rechallenge with Shingrix was positive. The outcome of the shingles was not resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Linked case(s) involving the same patient: US2025060452 Additional Information: GSK receipt date: 15-MAY-2025 The reporter was the patient who received 2 doses of Shingrix last year. 2 days after each dose, she experienced a rash on her right buttock that was diagnosed as shingles. It was the size of a silver dollar and in both instances, the rash was in the same spot. It did not get bigger or spread. Her doctor prescribed acyclovir 400 mg and the rash went away after 1 or 2 weeks. She also applied calamine lotion to the rash in addition to taking acyclovir. One day prior to the reporting date, she saw redness in the same spot and on the day of reporting, the rash reappeared on her right buttock.; Sender's Comments: US-GSK-US2025060452:same patient/Dose 1
Blood cholesterol increased; Blood pressure high
ATENOLOL; LOSARTAN; SIMVASTATIN; ASPIRIN