Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | 4T8792LA | OT |
Pregnant women given flu zone tiv with no reported ae; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 28 years old female patient who was exposed to vaccine influenza USP trival A-B SUBVIRION NO preservative vaccine [Fluzone] in context of pregnant women given flu zone tiv with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Pregnant women given flu zone tiv with no reported ae occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date is 20-Jan-2026. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Hypoglycaemia. The patient had unknown previous pregnancy/ies. On 19-Sep-2025, the patient received dose 1 of suspect influenza USP trival A-B SUBVIRION NO preservative vaccine Suspension for injection (unknown strength and expiry date) with lot 4T8792LA via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) with no reported adverse event (exposure during pregnancy) (Latency same day) There were no information related to relevant prenatal testing after exposure. Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing.
Hypoglycemia