Received Feb 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
patient received Adacel which was exposed temperature excursion during transport of the vaccines from one facility to another, there was no data logger to record the temperature, with no reported adverse event; Initial information received on 03-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] which was exposed temperature excursion during transportation from one facility to another, there was no data logger to record the temperature, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. 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 for immunisation, which was exposed temperature excursion during transport of the vaccines from one facility to another, there was no data logger to record the temperature, with no reported adverse event (product storage error) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. It was reported, " this excursion occurred due to a human error, it was unknown if extended stability data cover the excursion, the product was administered post-excursion. Vaccine did not had any previous excursion. Before they left: 44.6 degree Fahrenheit Hospital refrigerator (destination): 42.9 degree Fahrenheit. When they arrived: 41.9 degree Fahrenheit Duration: Initial transport: 1 hour and 10 minutes, Transporting the vaccines at the facility: 55 minutes - Cumulatively: 2 hours and 5 minutes" 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.