Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | 4 | 3CA07C1 | OT / RL |
15-month-old patient was administered with ADACEL instead of DTaP with no reported Adverse event; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who was administered with Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead of Diphtheria, Tetanus And Acellular Pertussis Vaccine 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 A Vaccine Inact (Vaqta) for Immunisation. On 17-Sep-2025, the patient received 0.5mL (dose 4) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot 3CA07C1, expiry date 31-Dec-2025, strength standard and frequency once) via intramuscular route in the right thigh for Immunisation and it was administered instead of Diphtheria, Tetanus And Acellular Pertussis Vaccine (lot, expiry date and strength not reported) with no reported adverse event (wrong product administered) (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
VAQTA