Received Sep 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | UT8792LA | OT |
fluzone administered while mother was pregnant with no reported adverse event; Initial information received on 27-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 30 years old female patient who was exposed to Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The patient was exposed to vaccine at 22 weeks of pregnancy. The date of last menstrual period was reported as 28-Mar-2025. The estimated due date is 28-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 27-Aug-2025, the pregnant patient received dose 1 of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, (unknown strength) and expiry date Jun-2026 lot number UT8792LA not reported via intramuscular route in unknown administration site for immunization with no reported adverse event (exposure during pregnancy) (Latency Same day). Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing.