Received Mar 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK110AA | OT / LL |
hib component was not reconstituted with the Dtap-IPV component of PENTACEL, with no reported adverse event; Initial information received on 10-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old male patient and reporter reported that the HIB component was not reconstituted with the DTAP-IVP component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel] 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 Rotavirus Vaccine; Pneumococcal Vaccine Conj 15v (Crm197) And Hepatitis B vaccine for Immunisation. On 07-Mar-2025, the patient received a HIB component was not reconstituted with the DTAP-IVP component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection (lot UK110AA) (expiry date-31-Aug-2025) via intramuscular route in the left thigh as prophylactic vaccination (immunization) (latency-same day) and the HIB component was not reconstituted with the DTAP-IVP component with no reported adverse event (single component of a two-component product administered) 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.
ROTAVIRUS VACCINE; PNEUMOCOCCAL VACCINE CONJ 15V (CRM197); HEPATITIS B VACCINE