Received Jul 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
5-year-old twins who received ADACEL instead of DTaP, with no reported adverse event; Initial information received on 02-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves 5 years old and unknown gender patient who received 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. On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for immunization instead of diphtheria, tetanus and acellular pertussis vaccine with no reported adverse event (wrong product administered) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. No follow-up is possible as Reporter cannot be contacted by Sanofi. Reportedly, Immunization medical director states that he was made aware of a situation where there were 5-year old twins who received ADACEL instead of DTaP. 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.; Sender's Comments: US-SA-2025SA184064: