Reporte zur Charge UJ341AAA

Symptomtext

Expired PENTACEL was administered to a patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via Global Medical Information (GMI) (Reference number- 00682124) and transmitted to Sanofi on 14-Jul-2021. This case involved 4 month old female patient who administered expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [PENTACEL] (expired product administered) Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); HEPATITIS B VACCINE and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (reported as ROTOTECK) for prophylactic vaccination. On 14-Jul-2021, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ341AAA and expiry date: 22-jun-2021) (Frequency: one) (strength: standard) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered) It was reported that, "RMA (Registered Medical Assistant) stated that she accidentally gave an expired Pentacel injection to a patient today because she looked at the Pentacel wrong. Caller asked what she should do". It was an actual medication error case (expired vaccine used) (latency same day) At time of reporting, no adverse event 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.