Reporte zur Charge U78708A

Symptomtext

adacel that was exposed to a reported temperature excursion was administered to a patient with no reported adverse event; Initial information was received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] that was exposed to a reported temperature excursion was administered to a 25 years old male patient with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 28-Aug-2023, a dose 2 of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (strength: standard) at dose of 0.5 ml (lot number: U78708A, expiration date: 23-Aug-2025) via intramuscular route in Deltoid NOS for Immunization (immunisation) that was exposed to a reported temperature excursion was administered to a patient with no reported adverse event (poor quality product administered) (latency: same day). No lab data reported. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event adacel that was exposed to a reported temperature excursion was administered to a patient 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.