Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 2 | UK194AA | IM / LL |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 2 | hn5980 | IM / RL |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 32PF3 | PO / MO |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK194AA | OT / LL |
report an incident where she accidentally mixed 1 of 2 component of pentacel with 1 of 2 component of acthib with no reported adverse event; report an incident where she accidentally mixed 1 of 2 component of pentacel with 1 of 2 component of acthib with no reported adverse event; Initial information received on 04-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked with US-SA-2025SA268368 [Act-Hib] This case involves a 6 months old male patient and it was reported that they accidentally mixed 1 of 2 component of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with 1 of 2 component of ACT-HIB and administered it 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 Rotavirus vaccine; Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20); Pneumococcal vaccine; and HIB vaccine conj (tet tox) (Acthib) all for Immunisation. On 04-Sep-2025, medical assistant accidentally mixed 1 of 2 component of 0.5ml of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (once), Powder and suspension for suspension for injection, (strength standard) lot UK194AA and expiry date 31-Mar-2026 with 1 of 2 component ACT-HIB for Immunization with no reported adverse event (product preparation error) (unknown vaccine product administered) (latency- same day). Reportedly, medical assistant confirmed that she mixed 1 liquid component with a powder component but unsure from which vaccines are these components. Treatment: No reaction, No treatment. ACT-HIB: not planned to be injected. 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-2025SA268368:
Rotavirus vaccine; Prevnar 20; Acthib