Reporte zur Charge UJ230AAA

Symptomtext

15 month old female patient was administered expired dose of PENTACEL, no AE; Initial information received on 30-Apr-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 month old female patient who was administered expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 15-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 UJ230AAA and expiry date: 04-Apr-2021) (Frequency: Once) via an unknown route at an unknown administration site 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 nurse asking if there is a time frame that they should wait before repeating the PENTACEL dose. Additional Description of event adverse events: Caller a nurse, stated she has questions regarding expired PENTACEL that was administered to a patient. No additional information was provided. Caller requested a call back to her mobile number today. The lot number and expiration date that they previously provided was from the box (PENTACEL). They do not have the patient date of birth with me. They do not have the route and site, concomitant vaccinations. No further information was provided. Note: The expiration date was previously documented in the Expiration Date field as 01Apr2021, but the nurse stated during call that the PENTACEL expired on 04Apr2021. Reporter relationship: health care professional (HCP) Product used: used 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.