Reporte zur Charge UJ918AAE

Symptomtext

mistakenly giving a patient the FLUZONE HD QUADRIVALENT vaccine who was not supposed to get it due to patient being under the age of 65 with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 44 years old female patient who had been mistakenly given the influenza quadrival A-B high dose HD vaccine [fluzone high-dose quadrivalent] which was not supposed to get it due to patient being under the age of 65 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Sep-2022, the patient received a 0.75 ml dose of suspect (once) influenza quadrival A-B high dose HD vaccine (lot number: UJ918AAE) (Strength: high-dose) (form was unknown) (expiry date: 30-Jun-2023) via intramuscular route in the left arm for Immunization. On 26-SEP-2022 the patient had been mistakenly given the influenza quadrival A-B high dose HD vaccine [fluzone high-dose quadrivalent] which was not supposed to get it due to patient being under the age of 65 with no reported adverse event (product use issue) (latency: same day). Action taken: not applicable. It was not reported if the patient received a corrective treatment. 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.