Received Feb 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 4 | UK307AA | OT / RL |
patient was administered only the lyophilized Hib component of the PENTACEL vaccine reconstituted with sterile wate, liquid DTaP-IPV component was not administered, with no reported adverse event; Initial information received on 24-Feb-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 20 months old male patient who was administered only the lyophilized HIB component of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] reconstituted with sterile water, liquid Dtap-IPV component was not administered, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient received no concomitant vaccines. On 24-Feb-2026, the patient was administered only the lyophilized hib component Dose 4 of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection at dose of 0.5 ml (lot UK307AA ; Expiration Date :31-Aug-2027) via intramuscular route in the right thigh for Immunization, reconstituted with sterile water, liquid dtap-ipv component was not administered, with no reported adverse event (single component of a two-component product administered) (latency: same day). It was reported "The liquid DTaP-IPV component of the Pentacel vaccine was not administered" . 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.