Symptomtext
administration of FLUZONE QIV NP to a 5-month-old patient with no reported adverse event; Initial information received on 30-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 months old male patient who was administered Influenza Quadrival A-B Vaccine [Fluzone Qiv] 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 vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (vaxelis) for prophylactic vaccination; pneumococcal vaccine conj 7v (crm197) (prevnar) for prophylactic vaccination; and rotavirus vaccine (rotavirus vaccine) for prophylactic vaccination. On 29-Nov-2023, the patient received an unknown dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number: U8200BA) (Expiry date: 30-Jun-2024) (Frequency: Once) (Strength: Standard) via intramuscular route in the right thigh for immunization. On 29-Nov-2023, the patient was administered of was administered Influenza Quadrival A-B Vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). It was reported, Practice manager asks for recommendations following the administration of FLUZONE QIV NP to a 5-month-old patient. This situation is pre-assessed as a medication error/an inappropriate use due to administration of FLUZONE QIV NP to a 5-month-old patient. 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.