Received Apr 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | — |
inappropriate use (unknown intention) due to PENTACEL was reconstituted with the incorrect diluent/only received half the vaccine components with no AE; Initial information received on 18-Mar-2026 regarding an unsolicited valid non-serious case received from a pharmacist. This case involved an unknown age patient of unknown gender who experienced inappropriate use (unknown intention) due to Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] was reconstituted with the incorrect diluent and received half the vaccine components with no 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 received an unknown dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine, powder and suspension for suspension for injection (batch number and expiry date: unknown) via unknown route in an unknown administration site for immunization (Immunisation), which was reconstituted with the incorrect diluent and received half the vaccine components with no adverse event (Single component of a two-component product administered) (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.