Received Feb 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 4CA34C1 | OT / RL |
product administered post excursion with no AE; 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 was administered with the suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] post excursion with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Jan-2026, the patient received 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, lot 4CA34C1, expiry date:31-May-2027 via intramuscular route in the right thigh for Immunization post excursion with no adverse event (poor quality product administered) (latency; same day). It was reported "Cause: Refrigerator malfunction Maximum/Lowest Temperature reached: negative 1.6?Duration out of labelled range: 56 minutes Previous excursion: None Product was Administered post-excursion and no human error was involved". 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; Sender's Comments: US-SA-2026SA054417: US-SA-2026SA054550: