Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPVX | HPV (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | UNK | — |
epilepsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of epilepsy in a male patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis. On an unknown date, the patient received Bexsero and HPV vaccine. On an unknown date, an unknown time after receiving Bexsero and HPV vaccine, the patient experienced epilepsy (Verbatim: epilepsy) (serious criteria GSK medically significant and other: Serious as per reporter). The outcome of the epilepsy was not reported. The reporter considered the epilepsy to be related to Bexsero and HPV vaccine. It was unknown if the reporter considered the epilepsy to be related to Bexsero Pre-Filled Syringe Device. The company considered the epilepsy to be unrelated to Bexsero, Bexsero Pre-Filled Syringe Device and HPV vaccine. 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: 27-SEP-2025 This case was reported by a patient via interactive digital media. The reporter's another son who had epilepsy and he was perfectly fine before 14 yrs old then all of a sudden with meningococcal, HPV vaccines. The batch number was not provided, and we are unable to contact the reporter. This case is linked to case US2025AMR129552 and US2025AMR124514, from the same reporter.; Sender's Comments: A case of Epilepsy, unknown time after receiving Bexsero , HPV vaccine and Bexsero Pre-Filled Syringe Device, in a male patient. Report is inconsistent with causal relation to the vaccine product. Causal relation is indeterminate considering multiple vaccines given concomitantly . US-GSK-US2025AMR129552:Other son (dose at 19 year old), same reporter US-GSK-US2025AMR124514:Other son (dose at 1 year old), same reporter