Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | UA252AA | OT / RA |
administering ADACEL to a 4-year old patient with no reported adverse event; Initial information received on 01-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old male patient who received 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 Influenza Vaccine; Polio Vaccine ; and Varicella Zoster Vaccine all for Immunisation. On 30-Sep-2025, a 4 years old patient received 0.5 ml of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength- standard, expiry date- 30-JUN-2026 and lot UA252AA) once via intramuscular route in the right deltoid for Immunization 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.
INFLUENZA VACCINE; POLIO VACCINE; VARICELLA VACCINE