Symptomtext
expired dose of PENTACEL was administered to a patient, with no reported AE; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 2 years old female patient who was administered expired dose of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Pentacel] with no reported AE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal Vaccine Conj 7V (CRM197) (Prevnar); Hepatitis A Vaccine Inact (HEP A in vac); HIB vaccine Conj (TET TOX) (ACT-HIB); and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Dtap) for Prophylactic Vaccination. On 21-Jul-2022, the patient received a 0.5 ml (once) dose of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine (lot UJ473AA; expiry date; 09-Jul-2022, strength, formulation: unknown) via intramuscular route in the left thigh for immunization. First time product used : Yes The patient had last administration of vaccine on 21-Jul-2022. On 21-Jul-2022 (latency: same day) the patient was administered expired dose of Pentacel with no reported AE (expired product administered). Action taken: Not applicable. Outcome: Unknown. 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.