Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component); Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component); This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number YY22P, expiry date 20-JUL-2026) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on 1st November 2024). On 28-FEB-2025, the patient received the 2nd dose of Shingrix. On 28-FEB-2025, 119 days after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component)) and inappropriate preparation of medication (Verbatim: Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component)). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK Receipt Date: 22-APR-2025 The registered nurse stated that they were not 100 percent sure if the patient had received the full dose or only the diluent. If the patient had received three doses of Shingrix, what concerns would have needed to be addressed. Patient received maladministration of AS01B Adjuvant of Shingrix, which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication.