Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
PENTACEL that was given to a patient wherein the HIB portion was mixed with a sterile diluent instead of the DTaP-Polio portion with no reported adverse event; PENTACEL that was given to a patient wherein the HIB portion was mixed with a sterile diluent instead of the DTaP-Polio portion with no reported adverse event; Initial information received on 28-Jan-2026 (Live follow-up processed together on 29-Jan-2026) regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old and unknown gender patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], wherein the Hib portion was mixed with a sterile diluent instead of the DTap-polio portion 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 in Jan-2026, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunisation, wherein the Hib portion was mixed with a sterile diluent instead of the DTap-polio portion with no reported adverse event (product preparation error) (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 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.