Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | RA |
Blisters; Itch; bulls eye rash around the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 16-JUL-2025, the patient received Shingrix (right deltoid). In JUL-2025, less than a week after receiving Shingrix, the patient experienced injection site rash (Verbatim: bulls eye rash around the injection site) and pruritus (Verbatim: Itch). On 18-JUL-2025, the patient experienced blister (Verbatim: Blisters). The patient was treated with hydrocortisone. The outcome of the injection site rash, blister and pruritus were not resolved. It was unknown if the reporter considered the injection site rash, blister and pruritus to be related to Shingrix. It was unknown if the company considered the injection site rash, blister and pruritus to be related to Shingrix. Additional Information: GSK receipt date: 21-JUL-2025 The reporter was the patient. The patient received the first dose of Shingrix on Wednesday, 16 July 2025. The patient experienced a bulls eye rash around the injection site. This was a flat rash which has almost fully resolved. The patient treated this rash with Hydrocortisone cream. On Friday, 18 July 2025, the patient noticed a couple of blisters, which she thought was an insect bite, but it continued to worsen over the weekend. The blistering rash contains tiny blisters and they itch. Her arm, neck and upper chest are affected.