Received May 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 3G5T3 | — |
hot area on the arm below the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 3G5T3, expiry date 20-JUL-2026) for prophylaxis. On 12-MAY-2025, the patient received Shingrix. On 15-MAY-2025, 3 days after receiving Shingrix, the patient experienced injection site warmth (Verbatim: hot area on the arm below the injection site). The outcome of the injection site warmth was unknown. The reporter considered the injection site warmth to be related to Shingrix. The company considered the injection site warmth to be related to Shingrix. Additional Information: GSK receipt date: 16-MAY-2025 The pharmacist reported they had a patient who received her Shingrix shot on Monday (12th MAY 2025). The patient had a raised, hot area about 4 inches below the injection site. The reporter assumed that the adverse event was related to the Shingrix vaccine.