Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8823AA | OT |
pregnant patient who was given 2 shots of flu vaccines with no reported adverse event; pregnant patient who was given 2 shots of flu vaccines with no reported adverse event; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 22-year-old female pregnant patient who was given 2 shots of influenza trivalent recombinant vaccine [Flublok TIV] with no reported adverse event. Data regarding this pregnancy was received prospectively, i.e. before pregnancy outcome was known. The reported pregnant patient who was given 2 shots of flu vaccines with no reported adverse event occurred at 31 weeks of pregnancy, during third pregnancy trimester for Influenza Trivalent Recombinant Vaccine. The date of last menstrual period was reported as 21-Feb-2025. The estimated due date is 28-Nov-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 30-Sep-2025, the pregnant patient received a 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection of lot U8823AA and expiry date: 31-May-2026 strength: standard via unknown route in unknown administration site for influenza (influenza immunization) and immunization 2 shots of flu vaccines with no reported adverse event (extra dose administered) (exposure during pregnancy) (latency: on same day). Reportedly, AE (adverse event) symptoms: None and Flu PF on 23-SEP-2025 and Caller also mentioned that the patient would get an RSV (respiratory syncytial virus) vaccine, Abrysvo, a week later and asked if it was okay. No adverse reaction was reported Action taken was not applicable. 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.