Received May 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 9L5P2 | — |
Site of injection sore; Site of injection warm to the touch; Site of injection red; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) (batch number 9L5P2, expiry date 27-OCT-2026) for prophylaxis. On 02-MAY-2025, the patient received the 1st dose of Shingrix. In MAY-2025, less than a week after receiving Shingrix, the patient experienced injection site pain (Verbatim: Site of injection sore), injection site warmth (Verbatim: Site of injection warm to the touch) and injection site erythema (Verbatim: Site of injection red). The outcome of the injection site pain, injection site warmth and injection site erythema were not resolved. It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site warmth and injection site erythema to be related to Shingrix. Additional Information: GSK receipt date: 06-MAY-2025 Other HCP reported that a patient got first dose of Shingrix on May 2nd 2025, but at the time of reporting the area of injection was red and warm to the touch, and when she presses on it was sore, and it had been like that for 4 days already, was still ongoing till the time of reporting. Consented to follow up.