Received Feb 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | X5T42 | IM / LA |
irritation; redness in her left arm; vaccine was given in a site close to the elbow instead of the left deltoid; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of skin irritation in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number X5T42) for prophylaxis. On 31-JAN-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 31-JAN-2025, less than a day after receiving Shingrix, the patient experienced skin irritation (Verbatim: irritation), erythema of extremities (Verbatim: redness in her left arm) and vaccine administered at inappropriate site (Verbatim: vaccine was given in a site close to the elbow instead of the left deltoid). The outcome of the skin irritation and erythema of extremities were not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the skin irritation and erythema of extremities to be related to Shingrix. It was unknown if the company considered the skin irritation and erythema of extremities to be related to Shingrix. Additional Information: GSK Receipt Date: 15-JAN-2025 The pharmacist is the reporter who stated a patient received her first Shingrix vaccine 31-JAN-2025. Patient called with irritation, redness in her left arm. HCP noticed the vaccine was given in a site close to the elbow instead of the left deltoid, which led to vaccine administered at inappropriate site. This case is linked with case US2020238768 by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020238768:same reporter