Reporte zur Charge UT80404A

Symptomtext

maternal vaccine exposure with no reported adverse event; Initial information received on 21-Sep-2023 (with live follow up CSD:22-SEP-2023 processed together) regarding an unsolicited valid non-serious case received from a other health professional. This case involves 30 years old female patient who was pregnant and exposed to influenza quadrival A-B vaccine [Fluzone Quadrivalent] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported maternal vaccine exposure with no reported adverse event occurred at 19 weeks of pregnancy and the patient was exposed to influenza quadrival A-B vaccine at 19 weeks of pregnancy, during second pregnancy trimester for influenza quadrival A-B vaccine. The date of last menstrual period was reported as 09-May-2023. The estimated due date is 13-Feb-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 14-Sep-2023, the patient received a dose 1 of suspect influenza quadrival A-B vaccine Suspension for injection (lot UT80404A) (with an unknown strength, expiry date, dosage) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation). On 14-SEP-2023 the patient had maternal vaccine exposure with no reported adverse event (exposure during pregnancy) (latency-same day) following the administration of influenza quadrival A-B vaccine. Relevant prenatal testing was not reported. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event Additionally, at time of reporting, the pregnancy is still ongoing.