Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8503AA | OT |
patient declined to take the vaccine, so the medical assistant returned it to the refrigerator; Initial information received on 28-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient of unknown demographics and is reported patient declined to take the diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], so the medical assistant returned it to the refrigerator. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-JUL-2025, patient declined to take the vaccine, so the medical assistant returned it to the refrigerator (product storage error) and The vaccine was then used by someone on 22-Jul-2025 at 04:34 pm, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection of lot U8503AA and expiry date: 30-Apr-2027 via unknown route in unknown administration site for immunization 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.