Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 3 | UK110AA | OT |
administration of pentacel with only the dtap-IPV component with no reported adverse event; Initial information received on 27-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 months old female patient who was administered with diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIBPRP/T) vaccine [Pentacel (Vero)] with only the dtap-ipv component 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 15V (CRM197) [Prevnar 15]; varivax; and measles vaccine, mumps vaccine, rubella vaccine [MMR] all for Immunisation. On 26-Feb-2025, the patient received 0.5 mL (dose 3) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIBPRP/T) vaccine with only the DTaP-IPV component, Suspension for injection, (unknown Strength),expiry date 31-Aug-2025, lot UK110AA via intramuscular route in unknown administration site for immunization (Single component of a two-component product administered) (Latency Same day). Reportedly, She stated that the ACTHIB was left out of the refrigerator overnight, approximately 16 hours and is at room temperature at around 68°F to 77°F. 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 15V (CRM197); MMR