Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | LA |
she had a red injection site that was hot; she had a red injection site that was hot; Hot dry skin; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site erythema (For tolerance to first dose refer case US2025AMR115960). On an unknown date, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: she had a red injection site that was hot), injection site warmth (Verbatim: she had a red injection site that was hot) and hot dry skin (Verbatim: Hot dry skin). Rechallenge with Shingrix was positive. The outcome of the injection site erythema, injection site warmth and hot dry skin were resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth and hot dry skin to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site warmth and hot dry skin to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR115960 Additional Information: GSK Receipt Date: 05-Sep-2025 The patient reported that six or seven years ago she received the Shingrix series. In 2018, the patient had all the reported events.; Sender's Comments: US-GSK-US2025AMR115960:same reporter