Symptomtext
Product spent too long in transit and product was no longer suitable for use with no adverse event; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from a other health care profession and non-healthcare professional via [Medical Information under reference - 00778575]. This case involves a 100 patient's of (unknown demographics) were vaccinated INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] which went spent too long in transit and product was no longer suitable for use (product temperature excursion issue). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given. On an unknown date, the patient's received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot - UT7317KA and expiry date 30-06-2022) via an unknown route at an unknown administration site for prophylactic vaccination. It was reported "she had a shipment of FLUZONE QUADRIVALENT which was shipped on Friday and delivered on Monday; caller states she was told that it spent too long in transit and product was no longer suitable for use. Caller states she has already administered this FLUZONE QUADRIVALENT to 100 patients post-excursion." It was a case of actual medication error due to product temperature excursion issue. At the time of reporting, no adverse event reported. Outcome of event was unknown. 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.