Received Aug 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | — | — |
Possible administration in unapproved schedule; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 17-year-old patient who received Men B NVS (Bexsero) for prophylaxis. Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero). On 09-OCT-2024, the patient received the 2nd dose of Bexsero. On 09-OCT-2024, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Possible administration in unapproved schedule). The outcome of the drug dose administration interval too short 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-JUL-2025 The medical assistant reported the GSK to request information about the validity of two doses of Bexsero that were given on 15th May 2024 and 09th October 2024 two a 17-year-old patient. The reporter wanted to know if the series was valid. As data was being collected for a possible adverse event, the health care professional started to act in a rude manner and refused to answer questions. after the information was relayed and they were told that the physician had to decide on the clinical scenario, they rudely ended the call and did not provide any more information. The patient received 2nd dose of Bexsero earlier than recommended interval, which led to shortening of vaccination schedule.
BEXSERO