Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | AE2J7 | OT |
used outside of indicated administration age with no reported adverse event; Initial information received on 21-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 months old male patient to whom had received Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] and outside of indicated administration age 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 DIPHTHERIA Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Dtap); HIB vaccine conj (tet tox) (Act hib); Pneumococcal vaccine polysacch 23v (Pneumovax) and Iodinated glycerol (Ipol) for Immunisation. On 17-Feb-2025, the 5 months old male patient received a 0.5 ml dose of suspect Influenza Quadrival A-B Multidose Vaccine Preserved Suspension for injection (strength: standard, frequency: once, expiry date: unknown and lot AE2J7) via intramuscular route in unknown administration site as immunization and outside of indicated administration age with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). Action taken: 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.
DTAP; Act hib; Pneumovax; Ipol