Received Mar 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
Passed out 3 separate times; 3 separate seizures 2 years ago after receiving meningococcal booster; Initial information received on 09-Mar-2025 regarding an unsolicited valid serious case received from an unknown reporter. This case involves Child male patient who passed out 3 separate times and 3 separate seizures 2 years ago 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 meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). On an unknown date the patient passed out 3 separate times (loss of consciousness) and 3 separate seizures (seizure) (unknown latency) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine. Information on the batch number was requested corresponding to the one at time of event occurrence. 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: Both the events were assessed as medically significant.; Sender's Comments: Sanofi company comment dated 12-mar-2025: This case involves Child male patient who passed out 3 separate times and 3 separate seizures 2 years ago after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Further information regarding concurrent condition during vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed