Symptomtext
expired dose of pentacel administered to a patient with no reported adverse event; Initial information received on 02-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center. This case involves a 9-month-old male patient who administered expired dose of pentacel with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel]. 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 Immunisation. On 25-May-2022, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine unknown: strength and formulation, lot UJ465AA, expiry date: 21-MAY-2022, frequency: once, via intramuscular route in the left thigh as immunization. On 25-MAY-2022 the patient developed a non-serious event expired dose of pentacel administered to a patient with no reported adverse event (expired product administered) latency: same day following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (expired product administered). At time of reporting, the outcome was Unknown for the event expired product administered. 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 guidelines. 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.