Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 3CA03C3 | OT / LA |
stated that an 11 year-old patient was given daptacel instead of adacel with no reported adverse event; Initial information received on 15-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 11 years old male patient who received Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] Instead of 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. Concomitant medications included Meningococcal Vaccine A/C/Y/W Conj (Tet Tox) (Menquadfi) for Immunisation. On 09-May-2025, the 11 year-old patient received 0.5ml dose (once) of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, strength standard, Expiry date: 30-Sep-2025 and lot 3CA03C3 via intramuscular route in the left arm instead of suspect, Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination [immunisation] 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.
MENQUADFI