Received Jan 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | UT8861NA | OT |
administering another dose of FLUZONE NP to a pregnant patient, with no reported adverse event; administering another dose of FLUZONE NP to a pregnant patient within the same season, with no reported adverse event; Initial information received on 29-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 25 years old female pregnant patient who received another dose of influenza USP TRIVAL A-B subvirion no preservative vaccine within the same season with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported events occurred at 32 weeks of pregnancy. The date of last menstrual period was reported as 19-May-2025. The estimated due date is 23-Feb-2026. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown number of previous pregnancy/ies. On an unknown date in September 2025, the patient received 0.5 ml of Dose 1 of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- standard, expiry date- 30-JUN-2026 and lot UT8861NA) once via unknown route in unknown administration site for Influenza (Influenza immunisation). On 29-Dec-2025, the pregnant patient received 0.5 ml of dose 2 of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- standard, expiry date- 30-JUN-2026 and lot UT8861NA) once via intramuscular route in the left deltoid for Influenza (Influenza immunisation) within the same season, with no reported adverse event (extra dose administered) (maternal exposure during pregnancy) (latency- same day). Action taken was not applicable. Additionally, at time of reporting, the pregnancy was still ongoing. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.