Received Apr 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
developed redness at the injection site; developed rash at the injection site; developed itchy at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 11-FEB-2025, the patient received the 1st dose of Shingrix (left deltoid). On 11-FEB-2025, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: developed redness at the injection site). On an unknown date, the patient experienced injection site rash (Verbatim: developed rash at the injection site) and injection site itching (Verbatim: developed itchy at the injection site). The outcome of the injection site erythema, injection site rash and injection site itching were resolved (duration 4 weeks). It was unknown if the reporter considered the injection site erythema, injection site rash and injection site itching to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site rash and injection site itching to be related to Shingrix. Additional Information: GSK receipt date: 18-APR-2025 The patient reported that she experienced redness at the injection site the day she received her 1st dose of Shingrix, on 11th February 2025. The patient reported that this red area started getting bigger and bigger, and stayed itchy and red off and on for about a month (no specific date provided). The patient mentioned that she received the first dose of the Shingrix vaccine and developed a very large red, itchy rash at the injection site which lasted about 4 weeks. The patient had a doubt was it safe for her to receive the second dose. The patient received her vaccine at her local pharmacy from the pharmacist. The patient did not have the lot number and expiry information or route of administration.