Reporte zur Charge UT7695KA, UT768

Symptomtext

patient received doses of fluzone quad and fluzone high dose affiliated with the temperature excursion with no reported adverse event; This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient of unknown demographics and where this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and patient received doses of fluzone quad and fluzone high dose affiliated with the temperature excursion with no reported adverse event while receiving vaccines INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK], INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength, route: unknown) lot UT7695KA, UT7681KA in unknown administration site as immunisation. On an unknown date, the patient received an unknown dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE(formulation, strength, route: unknown lot UT7718CA ,UJ882AE in unknown administration site as immunisation. On an unknown date, the suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation, strength, route: unknown) lot number not reported in unknown administration site as immunisation. On 07-SEP-2022 situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error) (unknown latency) following the administration of suspect vaccines. maximum temperature reached was 46.4 degrees F/ 8 degrees C and minimum temperature reached was 31.3 degrees F / Below 0 degrees C maximum time period exposed: 1 hour and 30 minutes. The temperature excursion over the weekend resulting from a refrigerator/temperature monitoring system malfunction. The refrigerator reached the lowest temperature of 31.3 degrees F for 1 and a half hours before returning to recommended storage conditions. On an unknown date the patient received doses of fluzone quad and fluzone high dose affiliated with the temperature excursion with no reported adverse event (poor quality product administered) same day following the administration of suspect vaccines. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events (This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event, patient received doses of fluzone quad and fluzone high dose affiliated with the temperature excursion with no reported adverse event). At time of reporting, the outcome was Unknown for all. 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.