Received Dec 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
nurse administered adacel that expired 3 days ago with no reported adverse event; Initial information received on 09-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age/gender patient to whom nurse administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] that expired 3 days ago with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLU [INFLUENZA VACCINE] for Immunisation. On 09-Dec-2025, the patient received 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE,Suspension for injection (strength and lot: unknown) (expiry 06-Dec-2022) that expired 3 days ago with no adverse event (expired product administered) (Latency same day) via intramuscular route in unknown administration site for immunization. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. Action taken was 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.
FLU [INFLUENZA VACCINE]