Symptomtext
temperature excursion to be 0.0 degrees Celsius human error and occurred for 7 hours with no adverse event; poor quality product administered; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and gender patient who reported temperature excursion to be 0.0 degrees celsius human error and occurred for 7 hours with no adverse event and poor quality product administered while receiving vaccines IPV (VERO) [IPOL], HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. 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 DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number: UJ673AAA EXP: 27-04-2023) via unknown route in unknown administration site, HIB (PRP/T) VACCINE (lot number: UJ665AAA ; expiry date: 11-Mar-2023) and IPV (VERO) (lot number: C1AO21M; EXP: 17-02-2024) (strength, dose, formulation, route,lot number not reported) in unknown administration site all for prophylactic vaccination. On an unknown date the patient reported a non-serious temperature excursion to be 0.0 degrees celsius human error and occurred for 7 hours with no adverse event (product storage error)and poor quality product administered (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, HIB (PRP/T) VACCINE and IPV (VERO). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event product storage error and poor quality product administered. 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.