Received Jan 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 4CA34C1 | — |
infant experienced a brief unexplained event (BRUE); Initial information received on 22-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who experienced a brief unexplained event (brue) after receiving DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, suspension for injection (lot 4CA34C1 and expiry 31-May-2027) (dose, strength, route and administration site: unknown) for Prophylactic vaccination (immunization). On an unknown date the patient developed infant experienced a brief unexplained event (brue) (brief resolved unexplained event) (latency 4 days). It was reported that an infant experienced a brief unexplained event (BRUE). The infant was diagnosed with it in the hospital. It was an unresponsive event. The event occurred 4 days after administration of DAPTACEL. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (infant experienced a brief unexplained event (BRUE)). At time of reporting, the outcome was Unknown for the event infant experienced a brief unexplained event (brue).