Received Aug 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 5 | 3CA55C1 | OT / RL |
9-year old patient was administered Daptacel when she would have been eligible for ADACEL with no reported ae; Initial information received on 11-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 years old female patient who was administered Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] when she would have been eligible for Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Polio Vaccine Inact 3v (Vero) [Ipol Polio Vaccine] for Immunisation. On 29-Jul-2025, the patient received 0.5ml (Dose 5) of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (once), Strength Standard, lot 3CA55C1 and expiry date 31-Aug-2026 via intramuscular route in the right thigh for immunisation, when she would have been eligible for Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (unknown strength and expiry date) with no reported adverse events (product administered to patient of inappropriate age) (Latency Same day). Reportedly, Vaccine coordinator explains that they had a 9-year old patient, they were doing catch-up vaccines for her, and the patient received DAPTACEL when she would have been eligible for ADACEL. 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.
IPOL POLIO VACCINE