Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | uk224ac | OT |
only the dtap ipv part of pentacel was given with no reported adverse event; Initial information received on 29-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old male patient to whom only the dtap ipv part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was given 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, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Powder and suspension for suspension for injection (lot uk224ac, Expiry: 31-Jul-2026, Strength: Standard) via unknown route in unknown administration site as immunization and only the dtap ipv part of pentacel was given with no reported adverse event (single component of a two-component product administered) (latency: same day). It Was reported, "The caller states that they didn't mix them first which is apparently what they were supposed to do. She states that she reached out to her contact at the health department, and they told her that the dose will still count for the DTaP and IPV vaccines but the patient would need an extra Hib because they haven't had the Hib in this dose. She was told to call to get the diluent (ActHib diluent) to still give that part of the vaccine. She states that it is a VFC (vaccine for children) vaccine. The caller is requesting to a obtain an ActHib diluent as a Goodwill replacement." 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.