Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | U8863BA | OT / LA |
patient was given two doses of FLUZONE NP in the same season with no reported adverse event; Initial information received on 15-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 years old female patient who received two doses of influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] in the same season with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant: No other immunization On 06-Sep-2025, the patient received an unknown dose 1 of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- standard, expiry date- 30-JUN-2026 and lot U8863BA) via intramuscular route in the left deltoid for influenza (Influenza immunization). On 15-Oct-2025 she also received an unknown dose 2 of same vaccine (strength- standard, expiry date- 30-JUN-2026 and U8863BA) via intramuscular route in the left deltoid for influenza (Influenza immunization) in the same season with no reported adverse event (extra dose administered) (latency- same day). 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.