Reporte zur Charge UT6656

Symptomtext

temperature excursion/ The excursion lasted for 80 hours instead of the 15 hours previously reported/ The maximum temperature of the refrigerator reached 59.1 degrees Fahrenheit not 52.2 degrees Fahrenheit with no reported adverse event; Initial information received on 26-Jan-2022 regarding an unsolicited processed from non case to valid non-serious case received from a other health professional. This case involves a patient with unknown demographics who had temperature excursion/ the excursion lasted for 80 hours instead of the 15 hours previously reported/ the maximum temperature of the refrigerator reached 59.1 degrees fahrenheit not 52.2 degrees fahrenheit with no reported adverse event while receiving vaccines [DAPTACEL],[ADACEL], [FLUZONE QUADRIVALENT], [IPOL] and [TENIVAC]. 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 VACCINE lot UT6656 via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U7055AA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot 5RM39 via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6669AA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect IPV (VERO) lot T1E872M via unknown route in unknown administration site. On an unknown date the patient had temperature excursion/ the excursion lasted for 80 hours instead of the 15 hours previously reported/ the maximum temperature of the refrigerator reached 59.1 degrees fahrenheit not 52.2 degrees fahrenheit with no reported adverse event (product storage error) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (temperature excursion/ The excursion lasted for 80 hours instead of the 15 hours previously reported/ The maximum temperature of the refrigerator reached 59.1 degrees Fahrenheit not 52.2 degrees Fahrenheit with no reported adverse event). At time of reporting, the outcome was Unknown for the event temperature excursion/ the excursion lasted for 80 hours instead of the 15 hours previously reported/ the maximum temperature of the refrigerator reached 59.1 degrees fahrenheit not 52.2 degrees fahrenheit 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. Additional information was received on 31-Jan-2022 from other health care professional:Case updated from non case to valid case.