Received Jun 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTP | DTP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
5-year old twins received ADACEL instead of DTaP with no reported AE; Initial information received on 26-Jun-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 5 years old and unknown gender patient who experienced 5-year old twins received adacel instead of dtap with no reported ae (adverse event) while receiving vaccines diphtheria, tetanus and nos pertussis vaccine and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the 5-year old twins received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine; Suspension for injection for Immunization and received an unknown dose of suspect diphtheria, tetanus and nos pertussis vaccine produced by unknown manufacturer with unknown formulation for Prophylactic vaccination (Immunisation) and both (lot number, strength and expiry date not reported) via unknown route in unknown administration site with no reported ae (wrong product administered) (unknown latency). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. No follow-up is possible as Reporter cannot be contacted by Sanofi. 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.