Symptomtext
administration of an expired vaccine to a patient with no reported adverse event; Initial information received on 21-Dec-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 2-month-old female patient who had administration of an expired 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 Hepatitis B Vaccine (HEPATITIS B [HEPATITIS B VACCINE]), rotavirus vaccine and pneumococcal vaccine CONJ (Pneumococcal Conjugate Vaccine) all for prophylactic vaccination (Immunisation). On 21-Dec-2022, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine at a dose of 0.5 ml once (lot U7054AA, UJ590AA, expiry date: 18-Dec-2022 for both) via intramuscular route in the left upper thigh for Immunization. On 21-Dec-2022 the patient had administration of an expired vaccine with no reported adverse event (expired product administered, latency: same day). 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 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.