Received Dec 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | UA670BA | OT |
ADACEL was inadvertently given to a 19-month-old patient instead of their fourth dose of DTaP with no reported adverse event; Initial information received on 16-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 months old male patient who was inadvertently given Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead of their fourth dose of dtap 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 in Dec-2025, the patient received 0.5mL of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot UA670BA, expiry date 31-aug-2027, frequency once and strength not reported) via intramuscular route in the left leg for Immunisation and was inadvertently given to a 19-month-old patient instead of their fourth dose of dtap with no reported adverse event (product administered to patient of inappropriate age) (latency same day). It was reported "Incident happened yesterday and it was supposed to be the patient's 4th dose of DTaP and she said that the patient did not require any medication or an ER visit after the administration of Adacel, the patient was okay". 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.