Reporte zur Charge UT7325QA

Symptomtext

a pregnant patient was administered Fluzone, with no reported adverse event; Initial information received on 15-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health professional. This case involves a 28 years old female pregnant patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] [exposure during pregnancy]. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at 31 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] at 31 weeks of pregnancy, during third pregnancy trimester for the vaccine. The date of last menstrual period was reported as 14-Feb-2021. The estimated due date was 08-Nov-2021. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 15-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7325QA; expiry date: 30-Jun-2021; Form: suspension for injection) via intramuscular route in unknown administration site for prophylactic vaccination. It was a case of vaccine exposure during pregnancy (same day latency). It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were laboratory data/results available. At time of reporting, the outcome was unknown for the reported event. Additionally, at time of reporting, the outcome of the pregnancy was unknown.