Symptomtext
temperature excursion "over the weekend" with no adverse event; 1 dose of FLUZONE QUAD was administered with no adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2022SA374787, 2022SA375305, 2022SA377972, 2022SA377654, 2022SA378232, 2022SA377654, 2022SA376599 and 2022SA378232. This case involves an unknown age and unknown gender patient where temperature excursion "over the weekend" with no adverse event and 1 dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was administered with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 07-Sep-2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at an unknown dose (lot UJ882AE, expiry date: 30-Jun-2023) via unknown route in unknown administration site for immunisation. On an unknown date there was temperature excursion "over the weekend" with no adverse event (product storage error) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. On 07-Sep-2022, 1 dose of fluzone quad was administered with no adverse event (poor quality product administered) same day latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported that the refrigerator reached the lowest temperature of 31.3 degrees F for 1 and a half hours before returning to recommended storage conditions. The pharmacist reported that he had called yesterday to obtain stability information and was calling back to gather additional stability information. Alternate temperatures were initially reported therefore the pharmacist confirmed the following temperature readings with the system for verification: MAXIMUM TEMP REACHED: 46.4 degrees F/ 8 degrees C MINIMUM TEMP REACHED: 31.3 degrees F / Below 0 degrees C MAXIMUM TIME PERIOD EXPOSED: 1 hour and 30. Action taken: Not applicable. Outcome: Unknown for both the events. 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 guidelines. 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.