Sex: U
Vaccine: FLU4
Symptoms: Immunisation reaction, Product storage error
Clinical narrative: exposed to temperatures as low as 31.94 degrees F for an unknown period of time; adverse event; Initial information received on 10-Feb-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient who was exposed to temperatures as low as 31.94 degrees F for an unknown period of time issue with the product going in and out of recommended temperature range for at least 156 hours and experienced adverse event while receiving vaccine influenza quadrival A-B vaccine [Fluzone 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 quadrival A-B vaccine Suspension for injection (formulation, lot number; expiry date: not reported) at an unknown dose via unknown route in unknown administration site as prophylactic vaccination.  It was reported that "HCP called to report for temperature excursion data for unopened Fluzone Quadrivalent single-dose vials, which were exposed to temperatures as low as 31.94 degrees F for an unknown period of time and product out of recommended temperature range for at least 156 hours with no reported adverse event (product storage error, onset and latency: unknown). HCP was still compiling all the data, so she did not know the cumulative duration of exposure or if there might be more that one occasion of going down to 32 degrees F or below. Reporter stated that the highest temperature of which they were aware at this time was 46 degrees F. Data has still compiled, but it was looks like there was an issue with the product going in and out of recommended temperature range for at least 156 hours. The reason for the temperature excursion was unknown. At this time, the HCP did not have the number of Fluzone Quadrivalent single-dose vials that were affected. Additional Description of event Adverse events: Possible human error temperature excursion (reason for the temperature excursion was unknown to the reporter)".   It was reported that, on an unknown date, caller stated that she received a letter stating that a patient experienced an adverse event following the administration of influenza quadrival A-B vaccine (latency: unknown) (caller unsure of presentation).   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (adverse event).  At time of reporting, the outcome was Unknown for the 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 received on 25-Mar-2022 regarding an unsolicited valid non-serious case received from other health professional: case updated from  non-valid case to valid case; event of adverse event added and narrative amended accordingly.