Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 3ss4m | — |
Injecting air during withdrawal; leaked from around the metallic skirt during withdrawal of the medication; Pharmaceutical product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in drug usage process in a patient who received Herpes zoster (Shingrix) (batch number 3ss4m, expiry date 16-JUN-2027) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong technique in drug usage process (Verbatim: Injecting air during withdrawal), product leakage (Verbatim: leaked from around the metallic skirt during withdrawal of the medication) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the wrong technique in drug usage process, product leakage and pharmaceutical product complaint were not applicable. Additional Information: GSK Receipt Date: 01-DEC-2025 An experienced user of Shingrix stated the final reconstituted vial of Shingrix leaked from around the metallic skirt during withdrawal of the medication. The Health Care Professional stated the consumer was not able to receive a dose of Shingrix The HCP states she was only able to withdraw 0.38ml due to the leakage. The customer injected air from the syringe into the vial during preparation. The air was injected during the withdrawal step, and the amount of air injected was 0.5 ml. The leak was coming from the outside of the top of the green skirt around the neck, not from a needle puncture in the stopper. The vial rubber stopper or metallic skirt did not detach or become loose during handling or without any manipulation. The customer removed only the plastic flip-off and did not remove the metallic skirt or ring of the vial before handling. There was no evidence of leakage in the package or box/carton, such as a wet PIL or faded label. The HCP states she was only able to withdraw 0.38ml due to the leakage. No further information was provided.