Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK233AC | OT / RL |
Medical Assistants reconstituted PENTACEL with a sterile diluent (water) with no adverse event; Initial information received on 15-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old male patient for whom medical assistants reconstituted Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with a sterile diluent (water) with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus vaccine and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 10-Jul-2025, the patient received Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine dose 0.5 ml 1x(once) Powder and suspension for suspension for injection (strength standard) lot UK233AC expiry date-31-Aug-2026 via intramuscular route in the right thigh for Immunization and medical assistants reconstituted pentacel with a sterile diluent (water) with no adverse event (product preparation error) (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.
Rotavirus vaccine; Prevnar 20