Received Oct 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | — | OT / RL |
was administered a Daptacel dose after the product had undergone a temperature excursion and was no longer suitable for use with no reported adverse event; temperature excursion with possible human error, but also possible refrigerator malfunction max temperature reached: 11.10 degrees celsius duration: 168 hours, with no reported adverse event; Initial information received on 26-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who experienced temperature excursion with possible human error, but also possible refrigerator malfunction max temperature reached: 11.10 degrees celsius duration: 168 hours and was administered a Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] dose after the product had undergone a temperature excursion and was no longer suitable for use with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-SEP-2025, the patient received a dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine; Suspension for injection with (unknown dose, strength, lot number and expiry date) via intramuscular route in the right anterior thigh for Immunization; temperature excursion with possible human error, but also possible refrigerator malfunction max temperature reached: 11.10 degrees celsius duration: 168 hours and and was no longer suitable for use with no reported adverse event (product storage error) (unknown latency) and (poor quality product administered) (latency: same day). Reportedly:HCP said that the maximum temperature the Daptacel reached was 11.10 degrees Celsius for a total of 168 hours between 19 Sep 2025 and 25 Sep 2025. HCP stated that she suspects what really happened is that the refrigerator temperature was at 11.10 degrees Celsius on 19 Sep 2025, but that the healthcare team did not clear out the reading as they are supposed to do each day, because the maximum temperature reached every single day from 19 Sep 2025 until 25 Sep 2025 (when she cleared out, the reading herself) was exactly 11.10 degrees. It would be unusual for the maximum temperature of a refrigerator to be exactly 11.10 degrees Celsius for 7 days in a row, which is why she suspects that. However, they cannot assume that, they have to go by what the reading says, so according to the reading, the product was out of range for 168 hours. 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.