Received Jun 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK167AA | OT / RL |
pentacel liquid component was administered, however, not with the ActHIB lyophilized powder with no reported adverse event; first dose of PENTACEL was administered at 3 months instead of 2 months with no reported AE; Initial information received on 03-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional with a live follow-up together (CSD: 03-Jun-2025). This case involves a 3 months old male patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] liquid component was administered, however, not with the ACT-HIB lyophilized powder instead at the age of 2 months 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 for Immunization. On 12-May-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 with strength- standard (expiry date- 31-Oct-2025 and lot UK167AA) once via intramuscular route in the right thigh for Immunization and liquid component was administered, however, not with the ACTHIB lyophilized powder (single component of a two-component product administered) at the age of 3 months instead of 2 months with no reported adverse event (product administered to patient of inappropriate age) (latency- same day). Reportedly, reporter asked if the liquid was a valid dose and what diluent could be used. 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.
PNEUMOCOCCAL VACCINE CONJ 20V (CRM197)