Symptomtext
Max/Low Temperature reached to 13.1? Farheinheit and excursion last for 4 hours, 4 minutes, with no reported adverse event; administered with fluzone high-dose quadrivalent, which was exposed to a temperature excursion, with no reported adverse event; Initial information received on 19-Oct-2022 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and unknown gender patient to whom administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], which was exposed to a temperature excursion, and max/low temperature reached to 13.1? farheinheit and excursion last for 4 hours, 4 minutes, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Oct-2022, the patient received 0.7ml total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE strength: standard (formulation: unknown) (lot number: UT7733BA and expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for Immunization, on the same day patient was administered with fluzone high-dose quadrivalent, which was exposed to a temperature excursion, with no reported adverse event (poor quality product administered). On an unknown date, a non-serious event of max/low temperature reached to 13.1? farheinheit and excursion last for 4 hours, 4 minutes, with no reported adverse event (product storage error). Reportedly, Nurse inquiring if they need to revaccinate a patient that was administered with FLUZONE HIGH-DOSE QUADRIVALENT. Does extended stability data cover the excursion: YES And in case of negative advice: Was the product used by/ administered to the patient: YES. This situation is reported as a medication error due to the product administered after experiencing a temperature excursion in which the product was no longer viable Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable. At time of reporting, the outcome was Unknown for both 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 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.