Received Apr 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | — | — |
inappropriate use due to administering vaccines that were unsuitable for use with no AE; Initial information received on 07-Apr-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves an unknown age patient of unknown gender who received Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine (Vquadracel) that was unsuitable for use with no adverse event The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On an unknown date, the patient received an unknown dose of Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine [Quadracel] Suspension for injection of unknown strength(batch/lot number and expiry date unknown) via unknown route in an unknown administration site for immunization [Immunisation] that was unsuitable for use with no adverse event. [(Poor quality product administered) (latency: Same day)]. Information regarding batch number corresponding to the one at time of event occurrence is requested. It was reported that, "A pharmacy technician called to ask recommendations regarding administering vaccines that were out of range. The pharmacy technician explained that QUADRACEL and DAPTACEL were administered. The pharmacy technician confirmed one patient for each vaccine. The pharmacy technician advised that they confirmed the viability through the stability calculator" Action taken: Unknown. 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.
Comments: NONE