Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | — | — |
patient fainted; chipped his tooth; This serious case was reported by a other health professional via sales rep and described the occurrence of faint in a male patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced faint (Verbatim: patient fainted) (serious criteria GSK medically significant) and chipped tooth (Verbatim: chipped his tooth). The outcome of the faint and chipped tooth were not reported. It was unknown if the reporter considered the faint and chipped tooth to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the faint to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the chipped tooth to be related 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: 18-SEP-2025 Healthcare professional said that patient fainted and chipped his tooth, had to go to hospital.; Sender's Comments: A case of Syncope, an unknown time after receiving Bexsero and Bexsero Pre-Filled Syringe Device, in a male 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.