Received Feb 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK022AA | OT / LL |
administration of PENTACEL to a 15-month-old, leading to the administration of an extra IPV dose with no reported AE; Initial information received on 07-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves administration of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] to a 15-month-old, leading to the administration of an extra ipv dose with no reported ae (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); and Hepatitis b vaccine (Hepatitis b) for Immunisation. On 30-Jan-2025, the patient received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (strength standard) Suspension for injection dose 0.5 ml 1x(once) lot UK022AA expiry-30-Apr-2025 via intramuscular route in the left thigh for Immunization, leading to the administration of an extra ipv dose with no reported ae (extra dose 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; Hepatitis b