Received Sep 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | — | OT |
taking fluzone during pregnancy 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 34 years old female patient who was exposed to influenza quadrival a-b multidose vaccine preserved [Fluzone] in context of taking fluzone during pregnancy with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported vaccine fluzone during pregnancy with no reported adverse event occurred at 8 weeks of pregnancy and the patient was exposed to influenza quadrival a-b multidose vaccine preserved at 8 weeks of pregnancy, during first pregnancy trimester for influenza quadrival a-b multidose vaccine preserved. The date of last menstrual period was reported as 30-Jun-2025. The estimated due date is 06-Apr-2026. 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 patient received a dose 1 of suspect influenza quadrival a-b multidose vaccine preserved, suspension for injection (lot number, strength and expiry date not reported) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) during pregnancy with no reported adverse event (exposure during pregnancy) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. There was no information related to relevant prenatal testing after exposure. Reportedly, Patient was no AE after administration. Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing.