Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion and products were determined to be not suitable to use with no reported adverse event; This situation is reported as a medication error due to FLUZONE QIV NP being administered to patients after it was not suitable to use post temperature excursion with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to cases 2022SA390611(CLUSTER), 2022SA391393(CLUSTER), 2022SA392303(CLUSTER), 2022SA392303(CLUSTER) and 2022SA392531(CLUSTER).  This case involves a 4 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] and had temperature excursion and products were determined to be not suitable to use with no reported adverse event and this situation is reported as a medication error due to fluzone qiv np being administered to patients after it was not suitable to use post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Sep-2022, the patient received dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7695JA, expiration date: 30-Jun-2023 via intramuscular route in the left thigh as prophylactic vaccination.  On an unknown date the vaccine had temperature excursion and products were determined to be not suitable to use with no reported adverse event (product storage error) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 19-SEP-2022 this situation is reported as a medication error due to fluzone qiv np being administered to patients after it was not suitable to use post temperature excursion with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Caller stated she previously reported a temperature excursion and products were determined to be not suitable to use and the product was still placed back in the refrigerator. Caller stated that another physician used the products and administered them to patients post excursion.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (This situation is reported as a medication error due to FLUZONE QIV NP being administered to patients after it was not suitable to use post temperature excursion with no reported adverse event, temperature excursion and products were determined to be not suitable to use with no reported adverse event).  At time of reporting, the outcome was Unknown for all.  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.