Received Apr 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | IM |
accidentally mixed the Pentacel liquid DTaP-IPV component with a separate, standalone ActHib lyophilized vial with no reported advesre event; Initial information received on 12-Mar-2026 regarding an unsolicited valid non-serious case received from other or unknown healthcare professional (HCP). This case involves a 4-month-old patient of unknown gender who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO)/HIB(PRP/T) VACCINE (PENTACEL VERO) in which the liquid DTaP-IPV component was accidentally mixed with a separate, standalone ActHib lyophilized vial with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. On an unknown date, the patient received a 0.5 mL once dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO)/HIB(PRP/T) VACCINE powder and suspension for suspension for injection (batch: unknown, expiry: unknown) (strength: unknown) via intramuscular route in an unknown administration site for immunization in which the liquid DTaP-IPV component was accidentally mixed with a separate, standalone ActHib lyophilized vial with no reported adverse event (Product preparation error) (Latency: same day). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported, "The pediatric clinic accidentally mixed the Pentacel liquid DTaP-IPV component with a separate, standalone ActHib lyophilized vial (i. e. not the ActHib vial included in the Pentacel carton). HCP asked if all 5 vaccine components can be counted as valid, or do they need to be repeated." 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.