Reporte zur Charge U1102AA

Symptomtext

brain swelling; patient had localized reaction; Initial information received on 14-Apr-2023 regarding an unsolicited valid serious case received from a other health professional. This case involves a 9 months old female patient who experienced brain swelling and patient had localized reaction after receiving vaccine Influenza USP Trival A-B Subvirion Vaccine [Fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Oct-2003, the patient received an unknown dose (dose 1) (Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test = 0.5 ml) of suspect Influenza USP Trival A-B Subvirion vaccine Suspension for injection (Strength = standard) of lot U1102AA and expiry: Jun-2004 via unknown route in the left thigh for immunization. On an unknown date, the patient developed a serious event brain swelling (brain oedema) (unknown latency) following the administration of Influenza USP Trival A-B Subvirion vaccine. This event was assessed as medically significant. On an unknown date, the patient developed a non-serious event patient had localized reaction (vaccination site reaction) (unknown latency) following the administration of Influenza USP Trival A-B Subvirion vaccine. No lab data was reported. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events (patient had localized reaction, brain swelling). At time of reporting, the outcome was Unknown for the event patient had localized reaction and was Unknown for the event brain swelling.; Sender's Comments: Sanofi company comment dated 19-Apr-2023: This case involves a 9 months old female patient who experienced brain swelling and patient had localized reaction after receiving vaccine Influenza USP Trival A-B Subvirion Vaccine [Fluzone]. 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.