Received Aug 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 332L4 | — |
Maladministration of AS01B adjuvant of Shingrix without the lyophilized antigen component; were potentially administered with the adjuvant alone; 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 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 332L4, expiry date 04-APR-2027) for prophylaxis. On 29-JUL-2025, the patient received Shingrix. On 29-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of AS01B adjuvant of Shingrix without the lyophilized antigen component) and inappropriate dose of vaccine administered (Verbatim: were potentially administered with the adjuvant alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 08-AUG-2025 Clinical supervisor called to ask about the specific timeframe or additional vaccine administration for a valid dose of Shingrix, since five patients were potentially administered (they were not sure) with the adjuvant alone, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. No further information was provided. The vaccine administration facility was the same as primary reporter. This was 1 of 5 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025103644:Same reporter US-GSK-US2025103162:same reporter US-GSK-US2025103164:Same reporter US-GSK-US2025103160:Same reporter