Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | OT |
passed out 3 separate times; 3 separate seizure; Initial information received on 02-Mar-2025 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp. This case involves Adolescent male patient who had passed out 3 separate times and 3 separate seizure after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [MenquadfI]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect lot number meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot number, strength, expiry date-unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date the patient developed a serious passed out 3 separate times (loss of consciousness), 3 separate seizure (seizure) (unknown latency). Reportedly- lingering neurological problems, passed out on the pediatricians floor. Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for both the events. Seriousness criteria: These events are medically significant.; Sender's Comments: Sanofi company comment dated 03-Feb-2025: This case involves Adolescent male patient who had passed out 3 separate times and 3 separate seizure after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [MenquadfI]. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.