Received Jul 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / RA |
Hot at injection site; Injection site redness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 08-JUL-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm). In JUL-2025, less than a week after receiving Shingrix, the patient experienced injection site warmth (Verbatim: Hot at injection site) and injection site erythema (Verbatim: Injection site redness). The outcome of the injection site warmth and injection site erythema were not resolved. It was unknown if the reporter considered the injection site warmth and injection site erythema to be related to Shingrix. It was unknown if the company considered the injection site warmth and injection site erythema to be related to Shingrix. Additional Information: GSK Receipt Date: 10-JUL-2025 The patient received her first dose of Shingrix in her right arm on 08 JUL 2025. Consumer reports the injection site was hot and red. No further information was provided/obtained.