Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 5 | 3CA55C1 | OT / RL |
inappropriate use due to administration to age group outside PI recommendations; Initial information received on 10-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 8 years old male patient who received Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel], which was outside Prescribing Information (PI) recommendations, 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); Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr); and Varicella zoster vaccine live (Varicella zoster vaccine live) all for Immunisation. On 05-Sep-2025, the patient received 0.5ml (dose 5) (once) of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, Strength Standard, lot 3CA55C1 and expiry date 31-Aug-2026 via intramuscular route in the right vastus lateralis for immunisation, which was outside PI recommendations, with no reported adverse event (product administered to patient of inappropriate age) (Latency Same day). 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; Mmr; Varicella zoster vaccine live