Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK224AC | OT / LL |
powdered component (Hib) was given with a saline solution, instead of the liquid component (DTaP-IPV) that came with it with no reported Adverse event; Initial information received on 11-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2-month-old female patient and is reported powdered component (hib) was given with a saline solution, instead of the liquid component (dtap-ipv) that came with diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 7v (CRM197) (Prevnar); Hepatitis b vaccine (Hepatitis b); and Rotavirus vaccine live oral 1v (Rotarix) all for Immunisation. On 19-Aug-2025, the patient received a 0.5 ml dose (dose 1) of suspect Diphtheria/Tetanus/5 HYBRID AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection of lot UK224AC and expiry date: 31-Jul-2026 frequency: once, strength; standard via intramuscular route in the left thigh for immunization and powdered component (hib) was given with a saline solution, instead of the liquid component (dtap-ipv) that came with it with no reported adverse event (product preparation error) (latency: on same day) Reportedly, She said that PENTACEL comes in 2 vials. She said that they receive pre-filled saline diluent to reconstitute a Varicella vaccine and that was used to reconstitute the Hib component in this situation. She said that she talked to the immunization program in their state and she was told that the vaccine is not counted because it was not reconstituted with the liquid component that came with it. Thus, they're planning to revaccinate the child. She asked if they need to be concerned for the patient. She is wondering if they need to contact the parent of the patient and educate them if there's an increased risk for the child since the vaccine is invalid. Action taken was 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.
Prevnar; Hepatitis b; Rotarix