Received Apr 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8654AA | — |
Temperature excursion: 66 degrees fahrenheit/duration of excursion: approximately 60 hours, with no reported adverse event; Initial information regarding this unsolicited valid non-serious case downloaded from database without narrative (level 2A), was received on 10-Mar-2026 from Health Authorities via a healthcare professional (HCP). The following narrative is based on the information retrieved from all other accessible data. This case involves a patient of unknown age and unknown gender and temperature excursion: unknown disposition of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (Adacel): 66 degrees fahrenheit/duration of excursion: approximately 60 hours, 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-2/Tetanus/5 Ac Pertussis Vaccine (batch: U8654AA, expiry: 30-Sep-2027) via unknown route in an unknown administration site for immunization (immunisation) and temperature excursion: 66 degrees fahrenheit/duration of excursion: approximately 60 hours, with no reported adverse event (Product storage error, onset: 10-Mar-2026, latency: unknown). The refrigerator was inadvertently unplugged. The temperature reached 66 degrees Fahrenheit with a duration of approximately 60 hours. The doses remaining in the box appeared cloudy and uniform throughout. One dose had been administered prior to the discovery of the temperature excursion. The remaining doses were not used. The healthcare professional (HCP) was advised not to use the remaining doses as per the Adacel Prescribing Information. 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