Received Apr 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | — | — |
1 dose of daptacel has been administered post excursion with no reported adverse event; Initial information received on 16-Mar-2026 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a patient of unknown age and unknown gender who received one dose 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), family history were not provided. On an unknown date, the patient received an unknown dose of diphtheria-15/tetanus/5 ac pertussis vaccine suspension for injection (batch: unknown, expiry: unknown) (strength: unknown) via unknown route in an unknown administration site for immunization post excursion 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. It was reported that, "Reason: UNKNOWN- occurred outside of normal business hours; possible data logger/fridge malfunction Max/low temperature reached: 46.41 F (8.056 C) Duration: UNKNOWN; Caller originally reported that worst case scenario would be 13 hours out of range. Previous Excursion: One previous excursion for all products reached 46.2 F and lasted 03 minutes. It occurred when they were in office so they were able to move the products quickly." Action taken: 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.
Comments: NONE