Reporte zur Charge U6841AA

Symptomtext

expired PENTACEL was accidentally given to a 10 month old male patient/ No adverse reactions have been reported; Initial information regarding an unsolicited valid non-serious case received from a Nurse via Agency (Reference number- 00661536) and transmitted to Sanofi on 29-Jun-2021. This case involves a 10-month-old male patient who was accidentally vaccinated with expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and HEPATITIS B VACCINE for prophylactic vaccination. On 28-Jun-2021, the patient received third dose in series of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (0.5ml standard, lot U6841AA and expiry date: 22-Jun-2021) once via intramuscular route in the left thigh for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency was on same day) (expired product administered). At the time of reporting, no adverse reactions had been reported. The nurse stated that vaccine was later noted to have expired and asked if it is a valid dose. Treatment reported as dose will be repeated. 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 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. Follow up information regarding an unsolicited valid non-serious case received from a Nurse via Agency (Reference number- 00661594) and transmitted to Sanofi on 29-Jun-2021. Suspect vaccine coding, vaccination details including batch number and expiry date and concomitant medication was added and accordingly narrative was updated.