Reporte zur Charge U890BA

Symptomtext

fluzone qiv t that causes a lot of bubbles when it was inverted to draw out doses, 6 vials have been given to patients with no reported adverse event; Initial information was received on 04-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who reported that influenza quadrival a-b multidose vaccine preserved fluzone qiv t that causes a lot of bubbles when it was inverted to draw out doses, 6 vials have been given to patients with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a unknown dose of suspect influenza quadrival a-b multidose vaccine preserved (lot U890BA, Expiry date : 30-Jun-2024, strength was unknown) via unknown route in unknown administration site for Immunization. On an unknown date the patient developed a non-serious event of fluzone qiv t that causes a lot of bubbles when it was inverted to draw out doses, 6 vials have been given to patients with no reported adverse event (poor quality product administered) (unknown latency) following the administration of influenza quadrival a-b multidose vaccine preserved. Reportedly "HCP called to report 50 vials of FLUZONE QIV T that appeared to be bubbly or soapy when it was inverted to draw a dose. Caller mentioned that the syringe was hard to push and that 6 vials have been used. Patient information was not obtained during the call. Caller wanted to know if it was still good to use. Caller mentioned that 6 vials have been given to patients. Patient information was not obtained during the call. Call got disconnected." Action taken was not applicable. At time of reporting, the outcome was Unknown for the event "poor quality product administered". 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.