Received Feb 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 4CA34C1 | OT / RA |
Daptacel administered after Temperature reached: negative 1.6? Duration out of labelled range: 56 minutes with no AE (adverse event); Initial information received on 19-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 years old male patient who had administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] after temperature reached: negative 1.6? duration out of labelled range: 56 minutes with no ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB vaccine conj (tet tox) (Acthib) for Immunisation. On 30-Jan-2026, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength: unknown, expiry date: 31-May-2027 and lot 4CA34C1) via intramuscular route in the right arm as immunization after temperature reached: negative 1.6? duration out of labelled range: 56 minutes with no ae (adverse event) (poor quality product administered) (latency: same day). Reportedly, Human Error: No, Suitable for use after the excursion: No 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.
Acthib