Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK109AA | OT |
partial administration of PENTACEL component, didn't get the Hib portion of the vaccine, they only got the liquid portion with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves 18 months old male patient who had partial administered pentacel component, didn't get the hib portion of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)], they only got the liquid portion 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 Hepatitis B vaccine and pneumococcal vaccine conj 15V (CRM197) for Prophylactic vaccination (Immunisation). On 13-Mar-2025, the patient had partial administered pentacel component, didn't get the hib portion of unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine , powder and suspension for suspension for injection (lot UK109AA) (Expiry date: 30-Sep-2025, Frequency: once, strength: standard) via unknown route in unknown administration site for immunization, they only got the liquid portion with no reported adverse event (single component of a two-component product administered) (Latency: same day). Reportedly, Caller would like to know does this count as the child being vaccinated or does the child need to be re-vaccinated. Call recording disclosed. Nurse stated that the situation did not happen in the office but in a daycare. They found out about the partial administration of PENTACEL when the parent gave a sheet that says patient received the product, but the Hib (Haemophilus influenzae type B) part was crossed out. For DTap:3rd and for IPV: 3rd dose 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.
HEPATITIS B VACCINE; PNEUMOCOCCAL VACCINE CONJ 15V (CRM197)