Reporte zur Charge UJ015AAA

Symptomtext

expired vaccine administered with no reported adverse event; Initial information was received on 28-Jun-2023 regarding an unsolicited valid non-serious case from an other health professional. This case involves 3 years old female patient who received diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/HIB(PRP/T) vaccine [Pentacel (vero)] 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 13V (CRM197) (Prevnar 13) for Prophylactic vaccination; and hepatitis B vaccine for Prophylactic vaccination (immunisation). On 27-Oct-2020, the patient received a dose 3 of expired suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/HIB(PRP/T) vaccine (lot number: UJ015AAA, expiration date: 26-Oct-2023) via intramuscular route in the left lateral thigh for immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day). No lab data reported. Action taken: not applicable. outcome was Unknown for the event expired vaccine administered with no reported adverse event. 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.