Received Apr 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | — | — |
inappropriate use due to administering vaccines that were unsuitable for use with no AE; Initial information received on 07-Apr-2026 regarding an unsolicited valid non-serious case received from a health care professional (HCP). This case involves patient of unknown demographics who had inappropriate use DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (DAPTACEL) due to administering vaccines that were unsuitable for use with no AE (adverse event). The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On an unknown date in Mar-2026, the patient received an unknown dose with 1X frequency of DAPTACEL Suspension for injection (batch/lot number: unknown) (strength: unknown) via unknown route for immunization had inappropriate use due to administering vaccines that were unsuitable for use with no AE (Poor quality product administered, onset date: unknown, latency: same day). Action taken: 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.
Comments: NONE