Received Feb 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 4 | UK305AB | OT / LL |
patient only received the ACTHIB portion that was reconstituted with an incorrect diluent with no adverse event; patient only received the ACTHIB portion that was reconstituted with an incorrect diluent with no adverse event; Initial information received on 27-Jan-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 months old female patient who only received the acthib portion that was reconstituted with an incorrect diluent with no adverse event while receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Jan-2026, the patient only received acthib portion that was reconstituted with an incorrect diluent (dose 4) 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 UK305AB; Expiration date: 30-SEP-2026) via intramuscular route in the left thigh for Immunization with no adverse event (single component of a two-component product administered) (product preparation error) (latency: same day). Caller was not sure what the ACTHIB was reconstituted with but assumed it was the MMR B sterile water since that is the only diluent they have in a syringe 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.