Received Mar 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK149AB | OT / RL |
inappropriate use due to the administration of the dtap-ipv liquid portion of pentacel with sterile water. acthib was not administered to the patient with no reported ae; Initial information received on 11-Mar-2025 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 2 months old female patient who had inappropriate use due to the administration of the DTAP-IPV liquid portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] with sterile water and ACTHIB was not administered to the patient 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 20V (CRM197) (PREVNAR 20) and hepatitis B vaccine, all for Immunisation. On 14-Feb-2025 the patient developed a non-serious inappropriate use due to the administration of the DTAP-IPV liquid portion of standard dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection once (Unknown strength) with lot UK149AB and expiry date 31-Aug-205 via intramuscular route in the right thigh for Immunization with sterile water. ACTHIB was not administered to the patient with no reported adverse event (single component of a two-component product administered) (Latency same day). Reportedly, This situation is pre-assessed as a medication error/an inappropriate use due to the administration of the DTAP-IPV liquid portion of pentacel with sterile water. ACTHIB was not administered to the patient. Medical Assistant reported that pentacel was diluted incorrectly and administered to a patient. The liquid portion (DTAP-IPV component) was mixed with another diluent (sterile water) and administered to a patient. The powder (ACTHIB) portion was not administered. 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.
ROTAVIRUS VACCINE; PREVNAR 20; HEPATITIS B VACCINE