Received Aug 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | PJ353 | LA |
Inappropriate reconstitution technique; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number PJ353) for prophylaxis. On 13-AUG-2025, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. On 13-AUG-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate reconstitution technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 19-AUG-2025 The reporter stated that the antigen was mixed with sterile water and not with the adjuvant component of the vaccine Shingrix which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. This was the first dose of Shingrix.