Received Sep 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
Rash; Itchy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included lyme disease (diagnosed and treated in 1991) and immune disorder (nos) (due to lymes disease). On 28-JUL-2025, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site rash (Verbatim: Rash) and injection site itching (Verbatim: Itchy). The outcome of the injection site rash and injection site itching were not resolved. It was unknown if the reporter considered the injection site rash and injection site itching to be related to Shingrix. It was unknown if the company considered the injection site rash and injection site itching to be related to Shingrix. Additional Information: GSK Receipt Date: 05-AUG-2025 The reporter states at the injection site she had a rash that was itchy and this started calming down about 3 days later. The reporter states that last night (of reporting) the rash and itching started coming back. The reporter states the rash and itch was not spreading.
Medical History/Concurrent Conditions: Immune disorder (NOS) (due to lymes disease); Lyme disease (diagnosed and treated in 1991)