Received Mar 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK107AA | OT |
PENTACEL was administered but only the liquid portion containing the DTap-IPV with no reported AE; Initial information received on 12-Mar-2025 (with live follow up process together with CSD: 12-Mar-2025) regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 1 years 2 month old female patient whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] pentacel was administered but only the liquid portion containing the dtap-ipv with no reported AE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine conj 15V (CRM197) (Vaxneuvance) for Prophylactic vaccination (Immunisation). On 05-Mar-2025, the patient received an unknown dose (0.5ml) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine; Suspension for injection with unknown strength (lot UK107AA with expiry date 30-Sep-2025) via intramuscular route in unknown administration site for Immunization. On 05-Mar-2025 the patient developed pentacel was administered but only the liquid portion containing the dtap-ipv with no reported ae (single component of a two-component product administered) (latency: same day). 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. Additional information was received on 12-Mar-2025
VAXNEUVANCE