Received Jul 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | — | OT |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | UA8274AA | OT / LA |
inadvertently administered ADACEL to a pediatric patient instead of the scheduled DAPTACEL with no reported adverse event; administering adacel to a 6-year-old patient with no reported adverse event; Initial information received on 23-Jul-2025 (live follow up processed together) regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 years old pediatric female patient who was inadvertently administered diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] instead of the scheduled diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] with no reported adverse event and administering adacel to a 6-year-old patient 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 Polio vaccine (Polio vaccine) and Hepatitis a vaccine (Hepatitis a vaccine) for prophylactic vaccination (Immunisation). On 23-Jul-2025, the 6-year-old pediatric patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, suspension for injection (lot UA8274AA and expiry date: 30-Aug-2026) (strength not reported) via intramuscular route in the left deltoid for prophylactic vaccination (Immunisation) instead of the scheduled diphtheria-15/tetanus/5 ac pertussis vaccine with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (Latency: same day). Reportedly, The patient's supposed to receive her 5th dose of DTaP, but was given with ADACEL instead. 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.
Polio vaccine; Hepatitis a vaccine