Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 1 | 3CA03C3 | OT / LA |
received Daptacel post excursion with no reported adverse event; received 1 ml of Daptacel post excursion with no reported adverse event; Initial information received on 09-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old female patient who received 1 ml of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included polio vaccine INACT 3V (VERO) (Ipol Polio Vaccine) for Immunisation. On 22-Jul-2025, the patient received 1 ml of dose 1 of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] Suspension for injection with standard strength (expiry date- 30-SEP-2025 and lot 3CA03C3) via intramuscular route in the left arm for Immunization post excursion with no reported adverse event (poor quality product administered) (latency- same day). Reportedly, Reason: Fridge malfunction. Max/low temperature reached: negative 2.4 C. Duration: 13 hours and 30 minutes. There was no previous excursion. Human error was not involved. The extended stability data did not cover the excursion. 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 occurrence of this medication error. ; Sender's Comments: US-SA-2025SA270817:cluster case
IPOL POLIO VACCINE