Reporte zur Charge UT7701AA

Symptomtext

patient was administered FLUZONE QIV NP post excursion with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via health professional on 17-Oct-2022. RA number: 01324986. This case involves a 62-year-old male patient who experienced patient was administered Influenza Quadrival A-B Vaccine [Fluzone QIV] np post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2022, the patient received suspect Fluzone QIV np vaccine at dose 0.5 ml once via intramuscular route in the left deltoid (lot: UT7701AA, expiry date: 30-Jun-2023) for Immunization post excursion with no reported adverse event (poor quality product administered) at same day latency. It was reported that "Caller previously reported a temperature excursion See cases: 01324650 and 01324926 for details. Caller stated that she needs to report that 1 patient was administered FLUZONE QIV NP post excursion. This situation is reported as a medication error due to temperature excursion that exceeded the stability data and FLUZONE QIV NP was administered to 1 patient post excursion." Action taken: Not applicable. No corrective treatment was received for the event. 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.