Symptomtext
seizure like activity; Initial information received on 10-Oct-2022 regarding an unsolicited valid serious case received from a healthcare professional. This case involves a 16-year-old patient (unknown gender), who experienced seizure like activity after receiving vaccine 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 07-Oct-2022, the patient received 0.5ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (strength, formulation, route: unknown) (lot number: U7249AA and expiry date: 11-Mar-2024) in unknown administration site for Immunization. On 07-Oct-2022, on the same day, the patient developed a serious event of seizure like activity (Seizure like phenomena) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. It was reported, Office has since removed all MENQUADFI with that particular LOT# from refrigerator and has ordered more. No additional patient information at the time of call. Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable. It was not reported if the patient received a corrective treatment for the event (seizure like activity). At time of reporting, the outcome was Unknown for the event seizure like activity. Seriousness Criteria: Medically significant for seizure like activity.; Sender's Comments: Sanofi company comment dated on 14-Oct-2022: This case involves a 16 years old and unknown gender patient who experienced seizure like activity while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. The time to onset is compatible with the role of the product. However, information regarding medical history, past medical treatment, vaccinations, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine will be assessed completely after receiving follow up information.