Received Apr 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 4CA34C1 | — |
inappropriate use due to DAPTACEL due to use in an 11 yr old patient with no AE; Initial information received on 01-Apr-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves an 11 years old male patient who had inappropriate use/DAPTACEL [DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE] that were out of recommended age range with no adverse event (AE). The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. On 17-Mar-2026, the patient received a dose (dose: unknown) (frequency: unknown) of DAPTACEL [DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE] suspension for injection (batch number: 4CA34C1, expiry date: 31-May-2027) (strength: unknown) via unknown route in an unknown administration site for immunization (Immunisation) that were out of recommended age range (11 year old patient) with no AE (Product administered to patient of inappropriate age, latency: same day). No further information provided by the reporter. 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