Received Jun 17, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8927AA | — |
patient received Adacel post temperature excursion; Max/low temperature reached: Unknown to reporter, Duration: 7 hours with no reported adverse event; Initial information received on 12-Jun-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 experienced received diphtheria, tetanus and acellular pertussis vaccine [Adacel] post temperature excursion where Max/low temperature reached: Unknown to reporter for the Duration: 7 hours with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On an unknown date, the patient received an unknown dose diphtheria, tetanus and acellular pertussis vaccine Suspension for injection (batch number: U8927AA, expiration date: 30-Jun-2028) (strength: unknown) via unknown route in an unknown administration site for immunization post temperature excursion where Max/low temperature reached: Unknown to reporter for the Duration: 7 hours with no reported adverse event (Poor quality product administered) (latency- same day). It was reported that, Reason: Power outage. Previous excursion: None. Human error: No. If negative advice, have products been administered post excursion: 1 dose have been administered since the excursion. Does extended stability data cover the excursion: Unknown due to unknown temperature data. 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 medication 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.