Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK332AA | OT / LL |
DTaP-IPV liquid component was left in the box, so the HIB component was likely administered to a patient with no reported adverse event; Initial information received on 17-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. this case was linked with US-SA-2025SA311843 (master case). This case involves a 2 months old female patient who received diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] where dtap-ipv liquid component was left in the box, so the hib component was likely administered to a patient 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 20v (CRM197) (Prevnar 20) for Immunisation; and Rotavirus vaccine live reassort oral 5v (Rotateq) for Immunisation. On 14-Oct-2025, the patient received 0.5 ml of dose 1 of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection (strength- standard, expiry date- 31-AUG-2026 and lot UK332AA) once via intramuscular route in the left vastus lateralis for Immunization where DTAP-IPV liquid component was left in the box, so the HIB component was likely administered to a patient with no reported adverse event (single component of a two-component product administered) (latency- same day). It was reported that, "Nurse reported that they discovered that they had 1 component of PENTACEL left in the box, so they presume that they have 1 patient who received an incomplete dose of PENTACEL. They've narrowed it down to three patients that it could be based one when inventory was done. The nurse was not certain what diluent was used to reconstitute the HIB, but it was likely sterile water because sterile water is the only diluent that they have supplied in their office". 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.; Sender's Comments: US-SA-2025SA311843:master case
Prevnar 20; Rotateq