Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | UNK | — |
Transient ischemic attack; Tingling lips; This serious case was reported by a other health professional via other manufacturer and described the occurrence of transient ischemic attack in a 76-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero with an associated reaction of allergy to vaccine (For first dose refer US2025AMR115173). On 08-FEB-2024, the patient received Bexsero. On 08-FEB-2024, less than a day after receiving Bexsero, the patient experienced tingling lips (Verbatim: Tingling lips) (serious criteria other: Serious as per reporter). On 03-MAR-2024, the patient experienced transient ischemic attack (Verbatim: Transient ischemic attack) (serious criteria hospitalization and GSK medically significant). On 08-FEB-2024, the outcome of the tingling lips was resolved (duration 1 day). On 05-MAR-2024, the outcome of the transient ischemic attack was resolved (duration 2 days). It was unknown if the reporter considered the transient ischemic attack and tingling lips to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the transient ischemic attack and tingling lips 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. Linked case(s) involving the same patient: US2025AMR115173 Additional Information: GSK Receipt Date: 05-SEP-2025 On 08 Feb 2024, the subject again received co-suspect Bexsero for the treatment of prophylaxis at an unknown dose. On 08 Feb 2024, 1 month and 20 days after the first dose of the study medication, the subject developed after the vaccine was administered subject reports tingling lips (paraesthesia oral). On the same day (in 1 day), the subject completely recovered from paraesthesia oral. On 03 Mar 2024, 2 months and 13 days after the first dose of the suspect vaccines, the subject developed transient ischaemic attack.; Sender's Comments: A case of Transient ischaemic attack and Paraesthesia oral, 24 days and less than a day respectively after receiving Bexsero and Bexsero Pre-Filled Syringe Device, in a 76-year-old female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GSK-US2025AMR115173:1st dose