Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
expired adacel vaccine was given with no reported adverse event; Initial information received on 24-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves patient of unknown demographics whom expired diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was given 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 expired suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (expired product administered) (latency: on same day). Action taken was not applicable. Information regarding batch number and expiry date corresponding to the one at time of event occurrence is requested. 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.