Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: FLUZONE QUADRIVALENT MDVS at a high of 52F for an unknown length of time and a low of 31F for an unknown time with no reported adverse event; the patient was vaccinated with the FLUZONE QUADRIVALENT with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics who was vaccinated with the fluzone quadrivalent with no reported adverse event and fluzone quadrivalent mdvs (INFLUENZA QUADRIVAL A-B VACCINE) at a high of 52f for an unknown length of time and a low of 31f for an unknown time 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 fluzone quadrivalent mdvs at a high of 52f for an unknown length of time and a low of 31f for an unknown time with no reported adverse event (product storage error)   On 22-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot UJ899AA, expiration DATE: 30-Jun-2023, in unknown administration site as Immunization.  On 22-SEP-2022 the patient was vaccinated with the fluzone quadrivalent with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was unknown whether products had experienced an excursion at the time of administration. This situation was reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.This case is for 1 patient, 30 patients were vaccinated.  The vaccine had an excursion last weekend due to a power outage, caller also reporting for the past 8 months their products have not been stored properly. Caller reporting using an improper thermometer and the temperatures were either not recorded or not recorded accurately. Caller reporting they have periods of unknown temperatures and periods of recording temperatures too high or too low.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (the patient was vaccinated with the FLUZONE QUADRIVALENT with no reported adverse event, FLUZONE QUADRIVALENT MDVS at a high of 52F for an unknown length of time and a low of 31F for an unknown time 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.