Received Jun 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8252AA | IM / RA |
inappropriate use due to administration of expired ADACEL with no AE; Initial information received on 17-Jun-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP) other. This case involves an 11-year-old female patient who was inappropriately administered to expired Diphtheria/Tetanus/5 Ac Pertussis Vaccine [Adacel] with no adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. Concomitant medication(s) included [meningococcal vaccine (Meningococcal) and human papillomavirus (HPV) vaccine (HPV)]. On 17-Jun-2026, the patient received a 0.5 mL once (1X) dose 1 of Diphtheria/Tetanus/5 Ac Pertussis Vaccine [Adacel] suspension for injection (batch number: U8252AA, expiry date: 31-May-2026) (strength: standard) via intramuscular route in right deltoid for immunization [Immunisation]. This situation was pre-assessed as a medication error (unintentional)/an inappropriate use (unknown intention) due to administration of expired Adacel. A nurse reported administering expired Adacel vaccine to three patients. The nurse inquired about the appropriate next steps and additionally inquired about potential adverse reactions to monitor for. The nurse declined to provide an email address. The patient experienced inappropriate use due to administration of expired Adacel with no AE (Expired product administered, onset date: 17-Jun-2026 and latency: same day). No adverse events were reported. No further details were collected. Action taken was not applicable. Disclaimer: 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
Meningococcal vaccine; HPV vaccine