Reporte zur Charge U7924AAC

Symptomtext

seizure; fainted (syncope); This case was reported by a other health professional via other manufacturer and described the occurrence of seizure in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENQUADFI (batch number U7924AAC, expiry date unknown) for prophylaxis. On 15th August 2022, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and MENQUADFI (intramuscular). On 15th August 2022, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced seizure (serious criteria GSK medically significant and other: serious as per reporter) and syncope (serious criteria GSK medically significant and other: serious as per reporter). On 15th August 2022, the outcome of the seizure and syncope were recovered/resolved. It was unknown if the reporter considered the seizure and syncope 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: 27-OCT-2022 Reporter's comment: Less than a day after receiving Bexsero and Menquadfi vaccine, the patient had developed a serious event of seizure and fainted (syncope). It was not reported if the patient received a corrective treatment for the events. The reporter considered the seriousness criteria as medically significant for both events. The case listedness was reported as unlisted. The reporter had consented to follow up. It was unknown if the reporter considered the seizure and syncope to be related to Menquadfi.