Symptomtext
patients were given expired PENTACEL with no reported adverse event; Initial information was received on 13-Aug-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (Reference number- 00723367). This case involves a 6 months old female patient who administered expired (expired product administered) DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]. The patient's medical history, past medical treatment, vaccination and family history were not provided. Concomitant medications included HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (lot number and expiration not reported) via unknown route in an unknown administration site for prophylactic vaccination. On 03-Aug-2021, the patient received a third dose 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (frequency: Once, Strength: standard, lot number: UJ343ABA and expiry date: 22-Jun-2021) via an intramuscular route in the right thigh for prophylactic vaccination. It was of actual medication error due to expired vaccine used (latency: same day). It was reported as "Caller reported that 2 patients were given expired PENTACEL. Caller requesting a copy of AE (adverse event) report be forwarded to her email". At the time of reporting, no adverse event reported. 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.