Received Oct 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 3273H | — |
administration of Shingrix reconstituted with an unapproved diluent; administration of Shingrix reconstituted with an unapproved diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 3273H, expiry date 31-MAR-2027) for prophylaxis. On 03-OCT-2025, the patient received Shingrix. On 03-OCT-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: administration of Shingrix reconstituted with an unapproved diluent) and wrong solution used in drug reconstitution (Verbatim: administration of Shingrix reconstituted with an unapproved diluent). The outcome of the inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were not applicable. Additional Information: GSK Receipt Date: 08-OCT-2025 A medical assistant wanted to get recommendations on the administration of Shingrix vaccine reconstituted with an unapproved diluent but she was not sure which of two patients received it. Thus the details of each patient were taken to file the adverse event report and the advice to communicate again, if she had a confirmation of which of the two got it was given. The vaccine administration facility was the same as primary reporter.