Received Aug 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | 5XA2U | — |
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | 9X7DC | — |
Patient passed out; This serious case was reported by a nurse via call center representative and described the occurrence of passed out in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 9X7DC, expiry date 31-JAN-2026) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) (batch number 5XA2U, expiry date 31-MAY-2028) for prophylaxis. On 31-JUL-2025, the patient received Menveo and Bexsero. On 31-JUL-2025, less than a day after receiving Menveo and Bexsero, the patient experienced passed out (Verbatim: Patient passed out) (serious criteria GSK medically significant). The outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the passed out to be unrelated to Menveo, 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: 31-JUL-2025 The nurse reported that a patient received Menveo (1-vial) along with Bexsero on the day of reporting and she had a reaction, she passed out.; Sender's Comments: A case of Loss of consciousness, less than a day after receiving Menveo, Bexsero and Bexsero PRE-FILLED SYRINGE DEVICE, in a 17-year-old female patient. Causal relation is indeterminate considering multiple vaccines given concomitantly.