Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
Temperature excursion due to human error, Max/low temperature reached 56°F for 4 hours, 32.2°F for 2.25 hours, 48.8°F for 0.75 hours with no reported adverse event; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received Diphtheria, Tetanus And Acellular Pertussis Vaccine that was exposed to max/low temperature reached 56°f for 4 hours, 32.2°f for 2.25 hours, 48.8°f for 0.75 hours and is recommended to get revaccinated with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria, Tetanus And Acellular Pertussis Vaccine produced by unknown manufacturer (lot number, formulation, strength and expiry date-unknown) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) that was exposed to max/low temperature reached 56°f for 4 hours, 32.2°f for 2.25 hours, 48.8°f for 0.75 hours and is recommended to get revaccinated with no reported adverse event (poor quality product administered) (latency-same day). 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.