Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | U8523CA | SC / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8523CA | OT / LA |
Pregnant patient received an expired dose of fluzone np with no adverse event; Pregnant patient received an expired dose of fluzone np with no adverse event; Initial information received on 23-Sep-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 an expired dose of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] with no adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The event occurred at 36 weeks of pregnancy. The date of last menstrual period was reported as 13-Jan-2025. The estimated due date is 20-Oct-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. List of concomitant: no other immunizations On 23-Sep-2025, the pregnant patient received expired dose of Influenza Usp Trival A-B Subvirion No Preservative Vaccine dose 0.5 ml (frequency once) Suspension for injection (strength standard) lot U8523CA expiry date-30-Jun-2025 via intramuscular route in the left deltoid for Influenza (Influenza immunisation) with no adverse event (expired product administered) (Exposure during pregnancy) (latency same day). Relevant prenatal testing after exposure was not reported Action taken- not applicable. Additionally, at time of reporting, the pregnancy is 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.