Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK026AA | OT / LL |
only the Dtap-IPV component was administered to a patient, with no reported adverse event; Initial information received on 07-May-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 19 months old and unknown gender patient where only the dtap-ipv component of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was administered to a 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 Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 29-Apr-2025, the patient received a dose 1 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (Strength- standard) Suspension for injection (lot- UK026AA and expiration date- 30-JUN-2025) via intramuscular route in the left thigh for Immunisation where only the dtap-ipv component was administered to a patient, with no reported adverse event (single component of a two-component product administered) (latency- same day). 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.
PREVNAR 20