Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | — | OT |
patient received second dose of fluzone after 24 days with no reported adverse event; Initial information received on 19-Nov-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old female patient who received second dose of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] after 24 days with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Oct-2025, the patient received an unknown dose (dose 1) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot number, expiry date not reported) via unknown route in unknown site and on 10-Nov-2025, she also received 0.5mL (dose 2) (lot U8919AA, expiry date 30-Jun-2026 and frequency once) (strength not reported) via intramuscular route in the right thigh as second dose of fluzone after 24 days with no reported adverse event (inappropriate schedule of product administration) (latency same day) It was reported 'Nurse reports that they had a12-month old patient who was supposed to receive 2 doses of Fluzone. The patient's first and second doses were given 24 days apart instead of the recommended 28 days (4 weeks). She asked do they need to administer a 3rd dose of Fluzone to the patient since the second dose was given too early.' 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.