Reporte zur Charge UJ543AAA

Symptomtext

She states that she does not know for sure if a Pentacel was reconstituted with a Merck sterile water and then given to a patient with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00723451) and transmitted to Sanofi on 13-Aug-2021. This case involved (unknown age and gender) patient it was reported that she does not know for sure if a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was reconstituted with a merck sterile water and then given to a patient (product preparation issue) Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On an unknown date, it was reported that she does not know for sure if a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: lot UJ543AAA and expiry date: 10-Jul-2022) (dosing details unknown) via unknown route in unknown administration site for prophylactic vaccination was reconstituted with a merck sterile water and then given to a patient (product preparation issue) It was reported that,"Caller stated that it comes with the 2 vials, (Powder, Diluent). Stated that in the box was an extra diluent in the box, and she thinks it was mixed likely with sterile water. What are the recommendations. She would also like to know what the safety concerns are of a patient getting a second Pentacel vaccine. She states that they will try and figure out which of the four kids this happen to and maybe they can narrow it down to two patients. She was asked for the initials and dates of birth of the potential patient, but she states that she does not have that available at this time". This was an actual medication error case due to inappropriate reconstitution technique (latency same day) At the 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.