Reporte zur Charge UT8057PA

Symptomtext

fluzone hd that has been administered twice no reported adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received via other health professional. This case involves a 86-year-old male patient and influenza quadrival A-B high dose HV vaccine [Fluzone High-DOSE QUADRIVALENT] that has been administered twice no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. On 19-Sep-2023, the patient received a 0.7 ml (frequency: twice) dose of suspect influenza quadrival A-B high dose HV vaccine (strength, form: unknown) (lot: UT8057PA, expiry date: 30-Apr-2024) via intramuscular route in right side for immunization and fluzone hd that has been administered twice no reported adverse event (extra dose administered) (latency: same day). Reportedly, Patient got the first dose on 12SEP2023 and got another dose today, 19SEP2023. No adverse reaction was reported by the patient. it was unknown if any lab data/test results available. Action taken with quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent) was not applicable. Outcome: unknown 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.