Sex: U
Vaccine: HIBV, TD, UNK
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: The excursion lasted for 1 hour and 5 minutes. The minimum temperature of the refrigerator reached 27.5 degrees Fahrenheit with no adverse event; vaccines were given post excursion with no reported adverse event; Initial information received on 07-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult and unknown gender patient and had excursion lasted for 1 hour and 5 minutes. The minimum temperature of the refrigerator reached 27.5 degrees fahrenheit with no adverse event and vaccines were given post excursion with no reported adverse event while receiving vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC], HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (formulation, strength, route: unknown) lot UJ589AAA in unknown administration site as Immunization.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength, route: unknown) lot U7189AA in unknown administration site a s Immunization.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE(formulation, strength, route: unknown)  lot UJ612ABA in unknown administration site as Immunization. The patient used the products for the first time.  On 24-Jun-2022, the excursion lasted for 1 hour and 5 minutes. The minimum temperature of the refrigerator reached 27.5 degrees fahrenheit with no adverse event (product storage error) (latency: same day).  On an unknown date in 2022 the vaccines were given post excursion with no reported adverse event (poor quality product administered)   Caller does not have the patient information available at this time. None of the other vaccines were accessed. No further information provided by reporter. This situation was reported as a medication error due to temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data and was due to human error.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (The excursion lasted for 1 hour and 5 minutes. The minimum temperature of the refrigerator reached 27.5 degrees Fahrenheit with no adverse event, vaccines were given post excursion 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.