Reporte zur Charge UJ899AD

Symptomtext

opened vial of FLUZONE QIV reached? 57.15 FHow long did the excursion last? 8 hours with no human error involved with no reported AE; opened vial of FLUZONE QIV reached? 57.15 FHow long did the excursion last? 8 hours with no human error involved with no reported AE; Initial information was received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional. This case involves 16 years old male patient who stated opened vial of fluzone qiv reached? 57.15 fhow long did the excursion last? 8 hours with no human error involved with no reported ae after receiving 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 20-Jan-2023, the patient received an unknown dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: UJ899AD) (expiry date, strength, frequency was unknown) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event opened vial of fluzone qiv reached? 57.15 how long did the excursion last? 8 hours with no human error involved with no reported ae (product storage error) and (unknown latency) following the administration of influenza quadrival A-B vaccine. On 20-Jan-2023 the patient developed a non-serious event opened vial of fluzone qiv reached? 57.15 how long did the excursion last? 8 hours with no human error involved with no reported ae (poor quality product administered)(same day latency) following the administration of influenza quadrival A-B vaccine. It was reported" Product activated/prepared? yes, 1 open vial of FLUZONE QIV Ask how the situation occurred? power outage Max/Low Temperature reached? 57.15 F How long did the excursion last? 8 hours Did it occur due to a human error? no Does extended stability data cover the excursion: no And in case of negative advice: Was the product used by/ administered/ dispensed to the patient: yes . 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. MA reports a received a dose of the vaccine on 20Jan2023, more than 1 week after the temperature excursion occurred on 08Jan2023. MA asked about replacement for the opened vial of FLUZONE QIV, which is no longer suitable for use". Action taken: not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown for 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 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.