Symptomtext
female patient age 54 was given FLUZONE HIGH DOSE with no reported adverse event; female patient inadvertently was administered Fluzone High-Dose Quadrivalent vaccine rather than Fluzone Quadrivalent vaccine with no reported adverse event; Initial information received on 13-Oct-2021 regarding an unsolicited valid non-serious case from other health professional and physician via Agency(under reference 00810932). This case involves a 54 years old female patient who inadvertently was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] rather than INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (product administered to patient of inappropriate age and wrong product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient received no concomitant vaccines. On 28-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ690AB and expiration date: 30-Jun-2022) via unknown route in the arm for prophylactic vaccination. It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (same day latency). It was reported "Caller states on 28SEP2021, a female patient age 54 was given FLUZONE HIGH DOSE; caller would like to report the incident and obtain information regarding re-vaccination and adverse effects to look out for; caller asked for any efficacy and safety information on Fluzone High-Dose administered to patients younger than 65 years of age, and any comparison information on the Fluzone High-Dose and Fluzone vaccines. Reporter was unsure whether it was administered in the left arm or right arm." At time of reporting, no adverse event reported. 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.