Received Oct 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Reconstitution of Shingrix with an Unapproved Diluent; Reconstitution of Shingrix with an Unapproved Diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 24-SEP-2025, the patient received the 1st dose of Shingrix. On 24-SEP-2025, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstitution of Shingrix with an Unapproved Diluent) and inappropriate dose of vaccine administered (Verbatim: Reconstitution of Shingrix with an Unapproved Diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt date: 01-OCT-2025 A nurse called to report that a Shingrix vaccine had been reconstituted using an unapproved diluent, rather than the adjuvant provided with the vaccine. The reconstituted vaccine was administered to a female patient on 24th September 2025. The nurse contacted the appropriate authority to confirm whether revaccination was required and, if so, when it should be administered. The batch number was not provided upon follow- up with the reporter.