Received Jun 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | — |
an expired ADACEL was given at one of their clinics with no AE; Initial information received on 30-Apr-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 33 years old female patient who was administered an expired diphtheria-2/tetanus/5 acellular pertussis vaccine (ADACEL) at one of their clinics with no adverse event (AE). The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. On 04-Feb-2026, the patient received an expired 0.5 ml dose diphtheria-2/tetanus/5 acellular pertussis vaccine, suspension for injection (batch/lot number: unknown; expiry date: Sep-2025) (strength: unknown) via unknown route in deltoid for immunization at one of their clinics with no adverse event reported (expired product administered, latency: same day). The patient was re-dosed, no adverse event experienced. 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. Additional information received on 05-Jun-2026. case was updated to valid and dosing details added. Text amended accordingly.
Comments: NONE