Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 2 | UK356AA | OT / LL |
pentacel powder component was diluted with sterile diluent and given to a patient/the liquid part was not given to the patient with no reported adverse event; Initial information received on 13-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who was given Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] powder component which was diluted with sterile diluent and the liquid part was not given, 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 12-Nov-2025, the patient received 0.5mL (dose 2) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection (lot UK356AA, expiry date Feb-2027, strength standard and frequency once) via intramuscular route in the left thigh for Immunisation and powder component was diluted with sterile diluent and the liquid part was not given, with no reported adverse event (single component of a two-component product administered) (latency same day). Reportedly, they wanted to know if they could revaccinate.They verify that the liquid part was not given to the patient 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 20; Rotateq