Reporte zur Charge UJ216AA

Symptomtext

2 month old male patient inadvertently administered expired dose of Pentacel with no reported adverse event; Initial information received on 20-Apr-2021 regarding an unsolicited valid non-serious case received from a physician via nurse. This case involves a two month old male patient who was inadvertently administered expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. On 07-Apr-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ216AA and expiry date: 06-Apr-2021) (Frequency: once) via an intramuscular route in the right thigh for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency on same day). It was also reported that Caller with question on whether dose need repeating at only one day past expiration. Reporter relationship: (HCP) health care professional Product used: not Applicable At the time of report no adverse event was 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.