Received Jul 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 2 | UK174AB | OT |
pentacel vaccine was administered to a child using only one vial, without mixing it with the powdered vial with no reported adverse event; Initial information received on 28-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient who had Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] was administered to a child using only one vial, without mixing it with the powdered vial with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Jul-2025, the patient received a 0.5 ml (dose 2) dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (Frequency: once, strength: standard, expiry date: 30-Mar-2026 and lot UK174AB) via intramuscular route in right leg as immunization and administered to a child using only one vial, without mixing it with the powdered vial with no reported adverse event (single component of a two-component product administered) (latency: same day). 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.