Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 354M3 | — |
Antigen powder prepared with unknown 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 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 354M3, expiry date 13-NOV-2026) for prophylaxis. On 15-SEP-2025, the patient received the 1st dose of Shingrix. On 15-SEP-2025, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Antigen powder prepared with unknown diluent). The outcome of the wrong solution used in drug reconstitution was not applicable. Additional Information: GSK Receipt Date: 24-SEP-2025 Registered Nurse reported that they were not 100 percent sure what happened, but they had a patient come in for Shingrix on September 15th 2025. After the patient left and they were doing inventory, they realized that they had an extra dose of adjuvant and not a dose of antigen. Somehow the patient only received the antigen vial, but do not know the Nurse who administered the vaccine cannot remember if she reconstituted with a different diluent or what happened, maybe diluent of Measles Mumps and Rubella vaccine they have in the counter, but that is just a thought, they have no idea.