Received Apr 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | — | — |
accidentally administered a dose of QUADRACEL to a patient whose age is younger than what's indicated in the prescribing information, with no reported adverse event; Initial information received on 19-Mar-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves a 4-month-old patient of unknown gender who had accidentally administered a dose of Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine [Quadracel] whose age is younger than what's indicated in the prescribing information, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. The patient received an unknown dose of Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine [Quadracel] suspension for injection (strength and expiry: unknown) batch number not reported via unknown route in unknown administration site for immunisation, whose age is younger than what's indicated in the prescribing information, with no reported adverse event (Product administered to patient of inappropriate age) (latency: Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. 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.