Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
temperature excursion due to a new refrigerator as their old one had multiple excursions, however, in the new refrigerator, their Wi- Fi data loggers were not activated, and the USB data loggers were not engaged for 92.25 hours with no ae; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked with US-SA-2025SA202579 (master case). This case involves a 3 years old and unknown gender patient who received diphtheria, tetanus and acellular pertussis vaccine post temperature excursion due to a new refrigerator as their old one had multiple excursions, however, in the new refrigerator, their Wi- Fi data loggers were not activated, and the USB data loggers were not engaged for 92.25 hours with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Jul-2025, the patient received an unknown dose of diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (formulation, strength, expiry date and lot not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization) post temperature excursion due to a new refrigerator as their old one had multiple excursions, however, in the new refrigerator, their Wi- Fi data loggers were not activated, and the USB data loggers were not engaged for 92.25 hours with no adverse event (product storage error). Reportedly, Max/low temperature reached: 21May2025-26Jun2025: 56°F for 4 hours, 25Jun2025: 32.2°F for 2.25 hours, 11Jul2025: 48.8°F for 0.75 hours, 10- 14Jul2025: 87.5 hours: no temperature data - total hours 92.25 hours ? included 87.5 hours if it was a hot excursion. ? excluding the cold excursion on 25Jun2025. ? excluding 87.5 hours it would only be 4.75 hours cumulatively (hot excursion). There was no previous excursion. Human error was involved. The extended stability data did not cover the excursion. Information on the batch number was requested corresponding to the one at time of event occurrence 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-2025SA202579:master case