Received Jun 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | P5F7T | — |
Product complaint; 0.8cm laceration to the pad of his left index finger; glass vial, it shattered in the patient's hand suddenly; Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional and described the occurrence of skin laceration in a 38-year-old male patient who received Herpes zoster (Shingrix) (batch number P5F7T, expiry date 27-APR-2027) for prophylaxis. This case was associated with a product complaint. On 28-MAY-2025, the patient received Shingrix. On 28-MAY-2025, less than a day after receiving Shingrix, the patient experienced skin laceration (Verbatim: 0.8cm laceration to the pad of his left index finger), glass ampoule associated injury (Verbatim: glass vial, it shattered in the patient's hand suddenly) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product complaint). On 28-MAY-2025, the outcome of the glass ampoule associated injury was resolved. The outcome of the skin laceration was not reported and the outcome of the inappropriate age at vaccine administration was not applicable and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the skin laceration and glass ampoule associated injury to be related to Shingrix. It was unknown if the company considered the skin laceration and glass ampoule associated injury to be related to Shingrix. Additional Information: GSK Receipt Date: 29-MAY-2025 This report was submitted via the online direct entry reporting system. While preparing to remove the plastic cap from the glass vial, it shattered in the patient's hand suddenly. Patient sustained a 0.8 cm laceration to the pad of his left index finger. First aid was given. The 38 year old patient received dose of Shingrix, which led to inappropriate age at vaccine administration.