Received May 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | — | — |
immunocompromised; This serious case was reported by a pharmacist via call center representative and described the occurrence of immunocompromised in a female patient who received Men B NVS (Bexsero) for prophylaxis. Concomitant products included ravulizumab (Ultomiris). On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced immunocompromised (Verbatim: immunocompromised) (serious criteria GSK medically significant). The outcome of the immunocompromised was not reported. 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: 22-MAY-2025 The pharmacist called to ask if a patient who was currently taking Ultomiris could receive a booster dose of Bexsero or what was the dosing schedule for boosters. Patient was fully vaccinated for Meningococcal B about 4 years ago. The reporter described that after the 2 doses of Bexsero the patient was taking Ultomiris and was immunocompromised. Health care professional was aware about centers for disease control guidance on this topic.; Sender's Comments: Immunodeficiency is an unlisted event which is considered unrelated to GSK vaccine Bexsero and Bexsero Pre-Filled Syringe Device.
Ultomiris