Received Sep 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | UT8792LA | OT |
administration of fluzone during pregnancy with no reported adverse event; Initial information received on 04-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 26-year-old female patient who was exposed to influenza USP trival A-B subvirion no preservative vaccine [Fluzone] during pregnancy with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported administration of fluzone during pregnancy with no reported adverse event occurred at 27 weeks of pregnancy during third pregnancy trimester. The date of last menstrual period was reported as 28-Feb-2025. The estimated due date is 07-Dec-2025. 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 04-Sep-2025, the patient received an unknown (Dose 1) of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection of lot UT8792LA via intramuscular route (strength, expiry date: not reported) in unknown administration site for prophylactic vaccination (immunization) during pregnancy with no reported adverse event (exposure during pregnancy) (latency: on same day). Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing.