Received Aug 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | — | — |
Immunocompromised status after Bexsero 2 doses; This serious case was reported by a physician via call center representative and described the occurrence of immunocompromised in a patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced immunocompromised (Verbatim: Immunocompromised status after Bexsero 2 doses) (serious criteria GSK medically significant). The outcome of the immunocompromised was unknown. It was unknown if the reporter considered the immunocompromised to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the immunocompromised to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. 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 :07-AUG-2025 and 08-AUG-2025 Physician reported that a patient had received 2 doses of Bexsero and later became immunocompromised. The reporter wanted to ask should they receive additional dose(s) of Bexsero or not. The reporter consented to follow up.; Sender's Comments: A case of Immunodeficiency, unknown date after Bexsero and Bexsero Pre-Filled Syringe Device, in a patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.