Symptomtext
a patient received a dose from a FLUZONE QUADRIVALENT multidose vial (MDV) that was opened and exposed to 22 Fahrenheit for 23 hours due to a refrigerator malfunction with no A/E; Initial information was received on 15-Dec-2021 regarding an unsolicited valid non-serious case from a pharmacist via a physician Inquiry Number: 00899139). This case involves a 54 years old male patient who received a dose from a INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] multidose vial (mdv) that was opened and exposed to 22 Fahrenheit for 23 hours due to a refrigerator malfunction with no adverse event (product storage error). The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided. On 13-Dec-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number: UJ713AA and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was reported "The caller reported a temperature excursion on FLUZONE (MULTI-DOSE VIAL, UNPUNCTURED) and wanted to know if the products are still suitable for use. Caller reported she needed to confirm, but a patient may have had received this vaccine and wanted to know if they would need to re-administer. She asks if the dose was valid or needs to be repeated." It was case of an actual medication error due to product storage error temperature too low (latency was on same day). At the time of report, no adverse event was reported. 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.