Received Jun 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U7999AA | — |
inappropriate use due to administering an expired product with no AE; Initial information received on 22-Jun-2026 regarding an unsolicited valid non-serious case received from an other or unknown healthcare professional (HCP). This case involves a patient of unknown age and unknown gender who had inappropriate use due to administering an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no adverse event (AE). The patient's past medical history, past drug history, vaccination(s), family history, and concomitant medications were not provided. On an unknown date, the patient received a expired dose of unknown amount at an unknown frequency of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] suspension for injection (batch number: U7999AA, expiration date: 08-Feb-2026) (strength: unknown) via unknown route in an unknown administration site for immunization [Immunisation] with no adverse event (Expired product administered, onset date: unknown, latency: same day). 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.
Comments: NONE