Symptomtext
administered an expired pentacel with no reported ae; Initial information received on 08-Dec-2022 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 4 months old female patient who administered with an expired diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) 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 Rotavirus Vaccine for Prophylactic vaccination (Immunisation); and pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination (Immunisation). On 08-Dec-2022, the patient received a dose 1 at dosage 0.5 ml once of suspect diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, Suspension for injection, (strength: not reported) (lot number: UJ625AA, expiry date: 07-Dec-2022) via intramuscular route in the thigh nos for Immunization with no reported ae (expired product administered) (Latency: same day). It was reported as: Nurse called to report that they have administered an expired PENTACEL to a patient and is requesting some guidance what to look for and what to do moving forward." Action taken was not applicable. The outcome was 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.