Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | U7908AB | OT / RA |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
inadvertent administration of QUADRACEL to a patient that was intended to receive ADACEL with no reported adverse event; inadvertent administration of QUADRACEL to a patient that was intended to receive ADACEL with no reported adverse event; Initial information received on 14-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 40 years old female patient who was inadvertently administered with diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel (VERO)] that and was intended to receive 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. On 14-Jul-2025, the patient received 0.5 ml of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine Suspension for injection with standard strength (expiry date- 03-OCT-2025 and lot U7908AB) once via intramuscular route in the right deltoid for Immunization instead of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength, expiry date and lot not reported) for prophylactic vaccination (Immunization) with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency- same day). Reportedly, the caller was not aware of any treatment post administration. List concomitant: no other immunizations. 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.