Received Apr 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | 3L339 | — |
wrong vaccine schedule/ approximately 20 patients, about 50/50 male and female, were affected by this; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in an unspecified number of patients who received Men B NVS (Bexsero) (batch number 3L339) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate schedule of vaccine administered (Verbatim: wrong vaccine schedule/ approximately 20 patients, about 50/50 male and female, were affected by this). The outcome of the inappropriate schedule of vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 31-MAR-2025 A registered nurse contacted GlaxoSmithKline to report that they were having issues interpreting the information that was presented in the prescribing information for Bexsero, as it stated that two doses of Bexsero could be given at least one month apart but in the (CDC) Centers for Disease Control and Prevention it stated that the interval had to be a zero- and six-month schedule. The prescribing information was revised, using the most up-to-date version which included the zero- and six-month vaccination schedule or the 0, 1 to 2 and six-month vaccination schedule. The health care professional stated that the reason for which they used the incorrect vaccination schedule was due to the fact that the package insert that had been included in their vaccine container was the prescribing information before the 2024 revision, which led to an inappropriate schedule of vaccine administered They mentioned that approximately 20 patients, about 50 by 50 male and female, were affected by this. The vaccine administration facility was the same as primary reporter. This case was linked with US2025AMR044125, reported by same reporter for a different female patients.; Sender's Comments: US-GSK-US2025AMR044125:same reporter different patient