Received Jun 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 3CA25C1 | OT |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
35-year-old patient was supposed to receive ADACEL but instead was administered DAPTACEL in error with no reported adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 35 years old female patient who was supposed to receive diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] but instead was administered diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] in error 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 04-Jun-2025, 35 years old patient received a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection (lot 3CA25C1, expiry date Apr-2026, frequency: once and strength: standard) via intramuscular route in unknown administration site in error and was supposed to receive diphtheria-15/tetanus/5 AC pertussis vaccine (formulation Suspension for injection) 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.
HEP B VAX