Symptomtext
pentacel was given to a consumer 4 days after the expiration date with no reported adverse event; Initial information was received on 27-Oct-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves 15 months old female patient received diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] was given to a consumer 4 days after the expiration date with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Oct-2023, the patient received a dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (Suspension for injection) (lot UJ808AB, Expiry date : 23-Oct-2023, strength was unknown) via intramuscular route in the thigh not otherwise specified and pentacel was given to a consumer 4 days after the expiration date with no reported adverse event (expired product administered) (latency : same day) . Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, ipv and HIB VACCINE (Pentacel (VERO)) was not applicable. At time of reporting, the outcome was Unknown for the event pentacel was given to a consumer 4 days after the expiration date 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.