Received Aug 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 3 | — | OT |
patient only had 3 Daptacel when they were months- old to 6 years old with no reported adverse event; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Child and unknown gender patient who only had 3 diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] when they were months- old to 6 years old 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 only 3 dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (unknown strength, lot and expiry date) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) when they were months- old to 6 years old with no reported adverse event (routine immunisation schedule incomplete) Information on the batch number was requested corresponding to the one at time of event occurrence Reportedly, reporter had questioned about the DTAP and TDAP vaccines. They want to know what to give for a 7 year-old to 10 year-old patient when they are not up do date with vaccine. The patient only had 3 Daptacel when they were months- old to 6 years old. She inquired whether they should give Adacel. 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.