Received Jul 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
unsuitable product administered with no reported adverse event; Initial information received on 26-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] which was exposed to temperature excursion for 48 hours with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication: No other vaccines On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site which was exposed to temperature excursion for 48 hours with no reported adverse event (poor quality product administered). Information regarding batch number corresponding to the one at time of event occurrence was requested. Reportedly, Nurse stated that she was not sure for the temperature during excursion. There was no human error in this excursion and extended stability data covers this excursion. Action taken was not applicable. 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.