Received Jun 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | 30A3201 | — |
given Adacel on June 3 2026, but the product Expired on 05 /2026 with no AE; Initial information received on 04-Jun-2026 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a 71-year-old female patient who was given diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] on June 3 2026, but the product expired on May-2026 with no adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 03-Jun-2026, the patient received 0.5 mL once of an expired diphtheria-2/tetanus/5 AC pertussis vaccine suspension for injection (batch number: 30A3201, expiry date: 31-May-2026) (strength: standard) via unknown route in an unknown administration site for immunization with no adverse event reported (expired product administered) (latency: same day). List concomitant: no other vaccines 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