Received Jan 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
Temperature excursion: negative disposition and product used with no reported adverse event; Initial information received on 08-Jan-2026 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] that had temperature excursion: negative disposition with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Jan-2026, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site that had temperature excursion: negative disposition with no reported adverse event (poor quality product administered) (latency-same day). Reportedly-extended stability does not cover the data of excursion; human error was not involved. 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.