Received Apr 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM |
redness on the vaccinated arm; Injection site pain; Injection site redness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 10-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On 10-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain) and injection site erythema (Verbatim: Injection site redness). On 13-APR-2025, the patient experienced erythema of extremities (Verbatim: redness on the vaccinated arm). In APR-2025, the outcome of the injection site pain and injection site erythema were resolved. The outcome of the erythema of extremities was not resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and erythema of extremities to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site erythema and erythema of extremities to be related to Shingrix. Additional Information: GSK Receipt Date: 16-APR-2025 The reporter was the patient. The reporter reported that a patient received Shingrix vaccine and experienced redness which was worsened. The patient also experienced injection site pain, injection site redness. Three days after injection, she developed redness on the vaccinated arm. This red area is about three or four inches from the injection site, on the inner arm, below the elbow. Nothing else was reported.