Reporte zur Charge UG809MA

Symptomtext

fluzone quad a patient should receive if the syringe needle was pulled out before the vaccine was all able to be injected and the rest "spritzed out everywhere with no reported adverse event; fluzone quad administered to a 67 years patient with no reported adverse event; Initial information received on 02-Oct-2023 regarding an unsolicited valid non-serious case received from a Physician. This case involves a 67 years old male patient who was administered Influenza quadrival a-b vaccine [Fluzone QIV] with no reported adverse event and patient receive if the syringe needle was pulled out before the vaccine was all able to be injected and the rest "spritzed out everywhere with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Oct-2023, the patient received 0.5 ml dose of suspect influenza quadrival a-b vaccine Suspension for injection (lot UG809MA) via intramuscular route in the right deltoid (strength and expiration date: not provided) for Immunisation (incorrect dose administered) (product administered to patient of inappropriate age) (latency- same day). Action taken- not applicable. At time of reporting, the outcome was Unknown for the event. 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.