Received Feb 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | FH9A7 | — |
2nd dose was given 7 months later, 1 month more than recommended; reconstituted with two vials of the diluent; reconstituted with two vials of the diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) (batch number FH9A7, expiry date 16-JUL-2026) for prophylaxis. Previously administered products included Shingrix (First dose received on 07-June-2024). On 17-JAN-2025, the patient received the 2nd dose of Shingrix. On 17-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose was given 7 months later, 1 month more than recommended), inappropriate preparation of medication (Verbatim: reconstituted with two vials of the diluent) and inappropriate dose of vaccine administered (Verbatim: reconstituted with two vials of the diluent). The outcome of the drug dose administration interval too long, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 17-JAN-2025 The patient was older than 50 years old. The pharmacist had a patient who was getting a shingles vaccine, it was his second dose and had a vial of the powder that was reconstituted with two vials of the diluent and then administered, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was reported if dose been a little more diluted so, reporter asked if that would be sufficient or there was just kind of manufacturer's guidance or if needed to, recommended him to come back and to get like a third dose to make sure a third dose, a standardized dose. The patient received 2nd dose was given 7 months later, 1 month 10 days more than recommended which led to lengthening of vaccination schedule. Pharmacist was transferred to second line specialist, after which he stated he/she knew during Covid there were patients that missed the interval for Shingrix and had late second doses. No further context or details provided, The reporter did not consent to follow-up. This case was linked with case US2019236811 reported by the same reporter, for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2019236811:same reporter