Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: the temperature reached 55.5 degrees f for 92 hours with no reported adverse event; vaccines were out of range for a cumulative period of 94 hours, this was not realized until yesterday, by which time some of the vaccines had been administered with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to case 2022SA465778 (CLUSTER).  This case involves an unknown age and gender patient, reported temperature reached 55.5 degrees f for 92 hours and vaccines INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] were out of range for a cumulative period of 94 hours, this was not realized until yesterday, by which time some of the vaccines had been administered with no reported adverse event.  Concomitant vaccine: shingles vaccine. The patient's past medical history, medical treatment(s) and family history were not provided.  On 08-Nov-2022, the patients received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at dose of 0.7ml total, Strength: high-dose (formulation: unknown) (lot number: UJ933AC and expiry date: 30-Jun-2023) and 0.5 ml suspension for injection (lot: UT7695KA) (expiry date, strength: unknown)  via intramuscular route in unknown administration site for Immunisation and the temperature reached 55.5 degrees F for 92 hours with no reported adverse event (product storage error) and vaccines were out of range for a cumulative period of 94 hours, this was not realized until yesterday, by which time some of the vaccines had been administered with no reported adverse event (poor quality product administered) (latency: same day).  It was reported, MA is checking stability of vaccines due to a refrigerator malfunction on 04Nov2022.  She states some patients received the vaccine post excursion, what is the protocol for these patients? HCP states that after the power outage, they thought the refrigerator was working properly, but there was an "auto reset" feature that they were unaware of, so products did not return to stability recommendations.  Medical Assistant reports 1 FLUZONE HIGH-DOSE QUADRIVALENT was given.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for both 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.  Additional information was received on 02-Dec-2022 via other healthcare professional: case is upgraded from non valid to valid , number of number and dose of suspect updated. Text amended accordingly.; Sender's Comments:  01359841: