Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | UNK | — |
My son had a febrile seizure; Rash; This serious case was reported by a consumer via interactive digital media and described the occurrence of febrile seizure in a 1-year-old 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 febrile seizure (Verbatim: My son had a febrile seizure) (serious criteria GSK medically significant and other: Serious as per reporter) and rash (Verbatim: Rash) (serious criteria other: Serious as per reporter). The patient was treated with paracetamol (Tylenol) and ibuprofen (Motrin). The outcome of the febrile seizure was resolved and the outcome of the rash was not reported. The reporter considered the febrile seizure and rash to be related to Bexsero. It was unknown if the reporter considered the febrile seizure and rash to be related to Bexsero Pre-Filled Syringe Device. The company considered the febrile seizure and rash 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: US2025AMR129552 Additional Information: GSK Receipt Date: 27-SEP-2025 This case was reported by a patient via interactive digital media. The reporter's son had a febrile seizure after his 1-year-old shots. He had developed a fever and rash and they said it was normal. His fever went higher so they gave baby Tylenol and alternated with baby Motrin as instructed by doctor. Fever didn't go down, he had a seizure, and they rushed to emergency room (ER). He had no more seizures until after they forced him to take the Meningococcal B shot for school when he was 19 years old. The batch number was not provided, and we are unable to contact the reporter. The case had been linked to US2025AMR129552 and US2025AMR129737, reported by the same reporter, for a different patient.; Sender's Comments: A case of Febrile convulsion and Rash, an unknown time after receiving Bexsero and Bexsero PRE-FILLED SYRINGE DEVICE, in 1-year-old male 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-US2025AMR129552:Same patient another dose US-GSK-US2025AMR129737:Original Case Number : US2025AMR124514