Symptomtext
one dose of ADACEL was given post excursion with no reported adverse event; excursion lasted for 15 minutes and the maximum temperature of the refrigerator reached 8.8 degrees Celsius; Initial information received on 12-Apr-2022 regarding an unsolicited valid non-serious case received from healthcare professional. This case involves an unknown demographic patient to whom one dose of adacel was given post excursion with no reported adverse event and excursion lasted for 15 minutes and the maximum temperature of the refrigerator reached 8.8 degrees celsius while receiving vaccine Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]. 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-2/Tetanus/5 Ac Pertussis Vaccine (lot U6807BA and expiry 21-Sep-2022) (strength, dosage, formulation, route, administration site: unknown) for immunization. On an unknown date the patient reported with one dose of adacel was given post excursion with no reported adverse event (product use issue) and excursion lasted for 15 minutes and the maximum temperature of the refrigerator reached 8.8 degrees celsius (product temperature excursion issue) (unknown latency) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine. It was reported that caller does not have any patient information available at this time. Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine was discontinued on an unknown date. It was not reported if the patient received a corrective measurement for both the events. At time of reporting, the outcome was Unknown for both 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.