Reporte zur Charge UT8306MA

Symptomtext

temperature excursion for Fluzone QIV NP that was left on the cooler after shipment for 3 days with no reported adverse event; Patient was vaccinated with Fluzone QIV NP that was left on the cooler after shipment for 3 days (with no reported adverse event); Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and unknown gender patient and reporter reported temperature excursion for influenza quadrival A-B vaccine [Fluzone QIV] that was left on the cooler after shipment for 3 days with no reported adverse event and patient was vaccinated with fluzone QIV NP that was left on the cooler after shipment for 3 days (with no reported adverse event). 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 Suspension for injection (lot UT8306MA, expiry date- 30-JUN-2024) via unknown route in unknown administration site for Immunization. Caller reported temperature excursion for influenza quadrival A-B vaccine that was left on the cooler after shipment for 3 days with no reported adverse event (product storage error) (unknown latency) and patient was vaccinated with fluzone QIV NP that was left on the cooler after shipment for 3 days (with no reported adverse event) (poor quality product administered) (latency- same day). Reportedly, Doctor calling from doctor's office wanted to know if the patient who was vaccinated FLUZONE QIV NP that were left on the cooler after shipment for 3 days should be revaccinated if the vaccines used were left inside the cooler with melted icepacks after shipment. Action taken was not applicable. At time of reporting, the outcome was 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 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.