Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | 3CA30C1 | OT |
temperature excursion: estimated less than 24 hours/temperature reached: 82 °F/unsuitable product administered with no reported adverse event; Initial information received on 25-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who had temperature excursion: estimated less than 24 hours/temperature reached: 82 °f/unsuitable product administered with no reported adverse event after receiving diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel]. 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 with unknown strength (lot 3CA30C1 with expiry date 30-APR-2026) via unknown route in unknown administration site for Immunization; temperature excursion: estimated less than 24 hours/temperature reached: 82 °f/unsuitable product administered with no reported adverse event (poor quality product administered). 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.