Symptomtext
temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes, with no reported adverse event; patient received Pentacel after a temperature excursion occurred, with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves an unknown age and unknown gender patient who had received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (VERO)] after a temperature excursion occurred and temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes, with no reported adverse event . The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Sep-2022, the patient received 0.5ml total dose (0.5 ml 4X) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation, route: unknown) (lot number: UJ666AAA and expiry date: 04-May-2023) in unknown administration site for Immunization. On 23-Sep-2022, non-serious events reported, temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes, with no reported adverse event (product storage error) and patient received pentacel after a temperature excursion occurred, with no reported adverse event (poor quality product administered) (latency: same day). It was reported, a temperature excursion that occurred on 23SEP2022 and was reported on 26SEP2022. The cause of the temperature excursion is unknown and doctor states that the alarm usually sounds but did not in this case. Doctor states that she was told that the vaccines are no longer viable and has discarded all of them. Doctor asked for specific guidance on whether these patients needed to be re-vaccinated before they contacted the patients? Individual patient information was not available at this time. This situation is reported as a medication error due to vaccines being administered post-excursion. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. At time of reporting, the outcome was Unknown for both 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.
