Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8827AA | OT |
6-week-old patient received the FLUZONE TRI in error with no reported adverse event; Initial information received on 02-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 6 weeks old female patient who received the Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] in error with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis b vaccine (Hepatitis b), Pneumococcal vaccine (Pneumococcal vaccine), Diphtheria vaccine toxoid, HIB vaccine conj (tet tox), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Pentacel) and Rotavirus vaccine (Rotavirus vaccine) for Immunisation. On 29-Sep-2025, the patient received 0.5mL of suspect Influenza Quadrival A-B Multidose Vaccine Preserved, Suspension for injection (lot U8827AA, expiry date 30-Jun-2026, strength standard and frequency once) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) and 6-week-old patient received the fluzone tri in error with no reported adverse event (product administered to patient of inappropriate age) (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.
Hepatitis b; Pneumococcal vaccine; Pentacel; Rotavirus vaccine