Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine exposed to 5 degree F she set the refrigerator temperature to a lower level and the temperature is going down upto 72 hours so it is likely human error with no reported adverse event; patient was given a dose after temperature excursion with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves patient of unknown demographics who was given a dose of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] after temperature excursion as vaccine exposed to 5 degree f she set the refrigerator temperature to a lower level and the temperature is going down upto 72 hours so it is likely human error 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 a dose of suspect Influenza Quadrival A-B High Dose HV Vaccine formulation, strength, dose, expiry date: not reported lot UT8043AA via unknown route in unknown administration site for Immunization and vaccine exposed to 5 degree f she set the refrigerator temperature to a lower level and the temperature is going down upto 72 hours so it is likely human error with no reported adverse event (product storage error).  On an unknown date the patient was given a dose after temperature excursion with no reported adverse event (poor quality product administered) on the same day.  Reportedly, Pharmacist stated she did not know the reason, but she stated that she set the refrigerator temperature to a lower level and the temperature is going down, so it is likely human error in not setting the refrigerator temperature to the appropriate range. Max/low temperature reached: 5 degrees F Duration out of labelled range: over 72 hours Human error? Yes, most likely Does extended stability data cover the excursion? No If negative advice, was the product administered to a patient? No; one patient was given a dose, but at 9:30 am this morning, when the product was still within the 72-hour window and therefore still suitable for use. Pharmacist reported that they have 15 boxes of Fluzone High-Dose Quadrivalent prefilled syringes that was exposed to temperatures higher than recommended in the PI (above 8 degrees Celsius) beginning at 12:23 pm on Friday, 08 Sep 2023, when the product reached 47 degrees F. As far as the pharmacist is currently aware, the product has been out of range for more than 72 hours since that time, because the product was still out of range as of 12:38 pm today (11 Sep 2023). The maximum temperature reached during this period was 51 degrees F. Pharmacist stated that there was one patient who received a dose of one of these Fluzone High-Dose Quadrivalent syringes, but it was at 9:30 am this morning (11 Sep 2023), so the product was still within the 72-hour window and was still suitable for use at that time, although since that time, the product has gone over the 72-hour time limit. Pharmacist was told that the product as of now is not suitable for use. The pharmacist stated that she will be reviewing the temperature data more closely, so see if there were any significant periods of time between Friday, 08 Sep 2023, and Monday, 11 Sep 2023, when the product went back within the recommended storage temperature, so that the cumulative duration of exposure would then possibly be less than 72 hours.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event vaccine exposed to 5 degree f she set the refrigerator temperature to a lower level and the temperature is going down upto 72 hours so it is likely human error with no reported adverse event and was Unknown for the event patient was given a dose after temperature excursion 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.