Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | e754f | IM / RA |
Inadvertent exposure to vaccine; residual amount of vaccine leaked on the patients arm after injection; The consumer is concerned he did not receive the full dose of vaccine (potential underdose.); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inadvertent exposure to vaccine in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number e754f, expiry date 27-MAR-2027) for prophylaxis. On 09-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid) .5 ml. On 09-MAY-2025, an unknown time after receiving Shingrix, the patient experienced inadvertent exposure to vaccine (Verbatim: Inadvertent exposure to vaccine), exposure via skin contact (Verbatim: residual amount of vaccine leaked on the patients arm after injection) and underdose (Verbatim: The consumer is concerned he did not receive the full dose of vaccine (potential underdose.)). On 09-MAY-2025, the outcome of the exposure via skin contact and underdose were not applicable. The outcome of the inadvertent exposure to vaccine was not applicable. Additional Information: GSK Receipt Date: 12-MAY-2025 The patient was vaccinated with first dose of Shingrix. The health care professional states she was using a retractable needle and the upon removing the needle from the deltoid the needle automatically retracted and some vaccine leaked on the patient's arm, which led inadvertent exposure to vaccine and exposure via skin contact. The patient was concerned he did not receive the full dose of vaccine (potential underdose/potential administration error.)