• Vaccine Injury – Vaers ID:2823838 Date:01/31/2025 Age:1.33 Sex:M

    PENTACEL being inadvertently administered to a patient after being exposed to a shipping temperature excursion with no reported adverse event; Initial information received on 27-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who had Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] being inadvertently administered to a patient after being exposed to a shipping temperature excursion 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 27-Jan-2025, the patient received a dose 1 of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) lot UK114AA, Expiry date: 30-Sep-2025, strength was unknown via intramuscular route in the left vastus lateralis for Immunization and pentacel being inadvertently administered to a patient after being exposed to a shipping temperature excursion with no reported adverse event (poor quality product administered) (latency : same day). Reportedly “This situation is pre-assessed as a medication error/an inappropriate use due to administration of PENTACEL after a shipping excursion.” 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.