Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | — | OT |
expired dose of QUADRACEL was inadvertently administered to a patient with no reported adverse event; Initial information received on 07-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient of unknown demographics who was inadvertently administered expired dose of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was inadvertently administered suspect unknown dose of expired Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine Suspension for injection (strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation) with no reported adverse event (expired product administered) (latency: on same day). Reportedly, Caller stated the expiration date for vaccine was 10/3, however did not provide date of administration. No additional information was provided. No additional Adverse event reported. Information regarding batch number corresponding to the one at time of event occurrence is 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.