Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | 3 | U8669AA | OT / LL |
administering adacel instead of dtap, with no reported adverse event; Initial information received on 02-Dec-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11-month-old male patient who was administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] instead of DTAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid), 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 HEPATITIS B VACCINE (HEP B VAX) for Immunisation. On 23-Oct-2025, the patient received a 0.5 ml dose (Dose 3) of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection in pre filled syringe frequency: once, strength: standard of lot U8669AA and expiry date: 30-Sep-2027 via intramuscular route in the left thigh instead of suspect DTAP not produced by Sanofi Pasteur for immunization with no reported adverse event (wrong product administered) (latency: on 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.
HEP B VAX