Received Feb 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Inappropriate Reconstitution Technique; Inappropriate dose of vaccine administered portion of Hiberix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 5-month-old female patient who received Hib (Hiberix) for prophylaxis. On an unknown date, the patient received the 1st dose of Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered portion of Hiberix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 Pharmacist states she was contacted by a clinic staff member who was concerned that they might have administered the diluent only portion of Hiberix to a patient within the past 1 to 2 months. The staff does not know for sure if this happened and did not know which patient it would have been, but they did have it narrowed down to 5 patients, of which one of them could have received diluent only, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. It was possible that the 5 patients might all be given another dose, but at the time of reporting this decision has not been made. The reporter consented to follow up. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025002641:Same reporter/Different patient US-GSK-US2025002639:Same reporter/Different Patient US-GSK-US2025002649:Same reporter/Different Patient US-GSK-US2025002647:Same reporter/Different Patient