Symptomtext
product was exposed to a temperature of 72.0 degrees Fahrenheit and were out of range for a total of 6 days (144 hours), due to it being left out of refrigeration with no reported adverse event; Initial information received on 04-Jan-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who experienced product was exposed to a temperature of 72.0 degrees fahrenheit and were out of range for a total of 6 days (144 hours), due to it being left out of refrigeration with no reported adverse event, while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ773AA, expiry date: 30-JUN-2022, via unknown route in unknown administration site (dose, formulation, strength not reported) as prophylactic vaccination. On an unknown date the patient developed a non-serious event "product was exposed to a temperature of 72.0 degrees fahrenheit and were out of range for a total of 6 days (144 hours), due to it being left out of refrigeration with no reported adverse event " (product storage error) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable. It was not reported if the patient received a corrective treatment for the event (product was exposed to a temperature of 72.0 degrees Fahrenheit and were out of range for a total of 6 days (144 hours), due to it being left out of refrigeration with no reported adverse event). At time of reporting, the outcome was Unknown for the event product was exposed to a temperature of 72.0 degrees fahrenheit and were out of range for a total of 6 days (144 hours), due to it being left out of refrigeration with no reported adverse 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.