Reporte zur Charge U694DBA

Symptomtext

administering Pentacel today that was not reconstituted (only liquid was administered, not powder)v 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- 00672844) and transmitted to Sanofi on 07-Jul-2021 in United States. This case involved a 6 month old male patient who administering pentacel today that was not reconstituted (only liquid was administered, not powder) (product preparation issue) while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [PENTACEL]. Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); HEPATITIS B VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination. On 07-Jul-2021, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Frequency: once) (lot U694DBA) via unknown route in the right thigh for prophylactic vaccination. On 07-JUL-2021 the patient developed a non-serious when administering pentacel today that was not reconstituted (only liquid was administered, not powder) (product preparation issue) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. This was an actual medication error case due to inappropriate reconstitution technique (latency was same day). Additionally it was reported that the caller wanted to know how long they need to wait before starting the series over for this patient. The call became disconnected while the caller was holding and an outbound call was made and the MIA (manufacturing / importers authorisation) continued the call. The call was transferred from MIA. PENTACEL was administered incorrectly. At the time of reporting, no adverse event 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.