Received Jul 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Maladministration of AS01B Adjuvant of Shingrix alone (without the Lyophilized Antigen Component); Maladministration of AS01B Adjuvant of Shingrix alone (without the Lyophilized Antigen Component); This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 01-JUL-2025, the patient received Shingrix. On 01-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of AS01B Adjuvant of Shingrix alone (without the Lyophilized Antigen Component)) and inappropriate dose of vaccine administered (Verbatim: Maladministration of AS01B Adjuvant of Shingrix alone (without the Lyophilized Antigen Component)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 02-JUL-2025 The reporter called to ask about the specific timeframe for a valid dose of Shingrix, since a patient was administered with the adjuvant alone, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Vaccination date and patient demographics were obtained in this call. No vaccine detail was obtained from the Registered Nurse. No further information was obtained in this call. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.