Symptomtext
patient was given the liquid portion only of Pentacel in the left thigh the powder portion was not given with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and consumer/non-health care professional via the Regulatory Authority (Reference number- 00754655) and transmitted to Sanofi on 03-Sep-2021. This case involves 18-month-old male patient who was given the liquid portion only of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] in the left thigh the powder portion was not given (product preparation issue). Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination. On 03-Sep-2021, the patient received the liquid portion only of a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ413AA and expiry date: 09-Oct-2021) via unknown route in the left thigh for prophylactic vaccination the powder portion was not given (product preparation issue). It was reported,"MA (Marketing authorization) states that only the liquid from the PENTACEL was given, MA did not know of the powder. Physician requests on behalf of the MA, to know if there are any AE's (adverse event) that they should be aware about. Does the DTaP and IPV count? What should we do about getting the Hib dose? The caller was referred to the reconstitution guide." This case was an actual medication error 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.