Received May 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included blood pressure high and blood cholesterol increased. Concomitant products included atenolol, losartan, simvastatin and acetylsalicylic acid (Aspirin). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The patient was treated with aciclovir sodium (Acyclovir) and bentonite, calamine, phenol, zinc oxide (Calamine). The outcome of the shingles was 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. 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. For tolerance of 2nd dose of Shingrix, refer case US2025AMR060778.; Sender's Comments: US-GSK-US2025AMR060778:same patient/Dose 2
Blood cholesterol increased; Blood pressure high
ATENOLOL; LOSARTAN; SIMVASTATIN; ASPIRIN