Received Feb 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 2 | UK224AC | OT / RL |
The DTaP-IPV component of the PENTACEL was not administered with no reported adverse event; Initial information received on 26-Feb-2026 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 7 months old male patient to whom the DTaP-IPV component of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was not administered 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); Rotavirus vaccine and RSV vaccine (RSV vaccine) for Immunisation. On 12-Nov-2025, the nurse reported that patient was received only administered the Hib component of the (dose 2) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (lot UK224AC; Expiration Date :31-Jul-2026) at dose 0.5 ml via intramuscular route in the right thigh for Immunisation and it was reconstituted using sterile water, the DTaP-IPV component of the Pentacel was not administered with no reported adverse event (single component of a two-component product administered) (latency: same day). It was reported that "Nurse said that it was supposed to be the second dose in the series" 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.
Prevnar 20; Rotavirus vaccine; RSV vaccine