Reporte zur Charge UJ262AAA

Symptomtext

7 month old female patient inadvertently administered an expired dose of Pentacel intramuscularly with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer via Agency (Reference number- 00609761) and transmitted to Sanofi on 20-May-2021. This case involves a 7 month old female patient who was inadvertently administered an 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 13V (CRM197) (PREVNAR 13) for Immunisation. On 18-May-2021, the patient received a 0.5 ml third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ262AAA and expiry date: 14-May-2021) (Suspect formulation: single dose vials) via an intramuscular route in the right leg 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 expire Pentacel was given to a baby and the vaccine was 4 days past the expiry date. Caller would like to know if they need to re-vaccinate. Reporter relationship: health care professional (HCP) Product used: used still using product: no 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.